[House Hearing, 110 Congress]
[From the U.S. Government Printing Office]
DIMINISHED CAPACITY: CAN THE FDA ASSURE THE SAFETY AND SECURITY OF THE
NATION'S FOOD SUPPLY?
=======================================================================
HEARINGS
BEFORE THE
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED TENTH CONGRESS
FIRST SESSION
----------
OCTOBER 11, NOVEMBER 13, 2007
----------
Serial No. 110-33 Pt. B
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
DIMINISHED CAPACITY: CAN THE FDA ASSURE THE SAFETY AND SECURITY OF THE
NATION'S FOOD SUPPLY?
=======================================================================
HEARINGS
BEFORE THE
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED TENTH CONGRESS
FIRST SESSION
__________
OCTOBER 11, NOVEMBER 13, 2007
__________
Serial No. 110-33 Pt. B
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
-----
U.S. GOVERNMENT PRINTING OFFICE
45-731 PDF WASHINGTON : 2008
----------------------------------------------------------------------
For sale by the Superintendent of Documents, U.S. Government Printing
Office Internet: bookstore.gpo.gov Phone: toll free(866) 512-1800; DC
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Washington, DC 20402-0001
COMMITTEE ON ENERGY AND COMMERCE
JOHN D. DINGELL, Michigan, Chairman
HENRY A. WAXMAN, California JOE BARTON, Texas
EDWARD J. MARKEY, Massachusetts Ranking Member
RICK BOUCHER, Virginia RALPH M. HALL, Texas
EDOLPHUS TOWNS, New York J. DENNIS HASTERT, Illinois
FRANK PALLONE, Jr., New Jersey FRED UPTON, Michigan
BART GORDON, Tennessee CLIFF STEARNS, Florida
BOBBY L. RUSH, Illinois NATHAN DEAL, Georgia
ANNA G. ESHOO, California ED WHITFIELD, Kentucky
BART STUPAK, Michigan BARBARA CUBIN, Wyoming
ELIOT L. ENGEL, New York JOHN SHIMKUS, Illinois
ALBERT R. WYNN, Maryland HEATHER WILSON, New Mexico
GENE GREEN, Texas JOHN B. SHADEGG, Arizona
DIANA DeGETTE, Colorado CHARLES W. ``CHIP'' PICKERING,
Vice Chairman Mississippi
LOIS CAPPS, California VITO FOSSELLA, New York
MICHAEL F. DOYLE, Pennsylvania STEVE BUYER, Indiana
JANE HARMAN, California GEORGE RADANOVICH, California
TOM ALLEN, Maine JOSEPH R. PITTS, Pennsylvania
JAN SCHAKOWSKY, Illinois MARY BONO, California
HILDA L. SOLIS, California GREG WALDEN, Oregon
CHARLES A. GONZALEZ, Texas LEE TERRY, Nebraska
JAY INSLEE, Washington MIKE FERGUSON, New Jersey
TAMMY BALDWIN, Wisconsin MIKE ROGERS, Michigan
MIKE ROSS, Arkansas SUE WILKINS MYRICK, North Carolina
DARLENE HOOLEY, Oregon JOHN SULLIVAN, Oklahoma
ANTHONY D. WEINER, New York TIM MURPHY, Pennsylvania
JIM MATHESON, Utah MICHAEL C. BURGESS, Texas
G.K. BUTTERFIELD, North Carolina MARSHA BLACKBURN, Tennessee
CHARLIE MELANCON, Louisiana
JOHN BARROW, Georgia
BARON P. HILL, Indiana
______
Professional Staff
Dennis B. Fitzgibbons, Chief of Staff
Gregg A. Rothschild, Chief Counsel
Sharon E. Davis, Chief Clerk
Bud Albright, Minority Staff Director
______
Subcommittee on Oversight and Investigations
BART STUPAK, Michigan, Chairman
DIANA DeGETTE, Colorado ED WHITFIELD, Kentucky
CHARLIE MELANCON, Louisiana Ranking Member
HENRY A. WAXMAN, California GREG WALDEN, Oregon
GENE GREEN, Texas MIKE FERGUSON, New Jersey
MIKE DOYLE, Pennsylvania TIM MURPHY, Pennsylvania
JAN SCHAKOWSKY, Illinois MICHAEL C. BURGESS, Texas
JAY INSLEE, Washington MARSHA BLACKBURN, Tennessee
JOHN D. DINGELL, Michigan (ex JOE BARTON, Texas (ex officio)
officio)
(ii)
C O N T E N T S
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OCTOBER 11, 2007
Hon. Bart Stupak, a Representative in Congress from the State of
Michigan, opening statement.................................... 1
Hon. Ed Whitfield, a Representative in Congress from the
Commonwealth of Kentucky, opening statement.................... 3
Hon. Diana DeGette, a Representative in Congress from the State
of Colorado, opening statement................................. 5
Hon. Michael C. Burgess, a Representative in Congress from the
State of Texas, opening statement.............................. 6
Hon. Jay Inslee, a Representative in Congress from the State of
Washington, opening statement.................................. 8
Hon. Henry A. Waxman, a Representative in Congress from the State
of California, opening statement............................... 9
Hon. John D. Dingell, a Representative in Congress from the State
of Michigan, opening statement................................. 10
Hon. Gene Green, a Representative in Congress from the State of
Texas, opening statement....................................... 11
Hon. Charlie Melancon, a Representative in Congress from the
State of Louisiana, prepared statement......................... 12
Witnesses
David Nelson, Senior Investigator, Committee on Energy and
Commerce, U.S. House of Representatives........................ 13
Prepared statement........................................... 16
Michael F. Martin, Analyst, Asian Trade and Finance Foreign
Affairs, Defense, and Trade Division, Congressional Research
Service, Library of Congress................................... 38
Prepared statement........................................... 41
James M. Rice, vice president and country manager, Tyson Foods,
Incorporated................................................... 66
Prepared statement........................................... 67
David W.K. Acheson, M.D., Assistant Commissioner, Food
Protection, Food and Drug Administration, U.S. Department of
Health and Human Services...................................... 81
Prepared statement........................................... 84
Answers to submitted questions............................... 124
Margaret O'K. Glavin, Associate Commissioner, Food and Drug
Administration, U.S. Department of Health and Human Services... 97
Richard Raymond, M.D., Under Secretary, Food Safety, Food Safety
and Inspection Service, U.S. Department of Agriculture......... 100
Prepared statement........................................... 102
Submitted Material
Subcommittee exhibit binder\1\................................... 136
NOVEMBER 13, 2007
Hon. Bart Stupak, a Representative in Congress from the State of
Michigan, opening statement.................................... 295
Hon. Ed Whitfield, a Representative in Congress from the
Commonwealth of Kentucky, opening statement.................... 297
Hon. John D. Dingell, a Representative in Congress from the State
of Michigan, opening statement................................. 298
Hon. Marsha Blackburn, a Representative in Congress from the
State of Tennessee, opening statement.......................... 300
Hon. Jan Schakowsky, a Representative in Congress from the State
of Illinois, opening statement................................. 301
Hon. Michael C. Burgess, a Representative in Congress from the
State of Texas, opening statement.............................. 302
Witnesses
Daniel Engeljohn, Deputy Assistant Administrator, Office of
Policy, Program and Employee Development, Food Safety and
Inspection Service, U.S. Department of Agriculture............. 305
Prepared statement........................................... 307
Answers to submitted questions............................... 440
David W.K. Acheson, M.D., Assistant Commissioner for Food
Protection, Food and Drug Administration, U.S. Department of
Health and Human Services...................................... 308
Prepared statement........................................... 311
Mike Picchietti, president, Regal Springs Trading Company;
member, American Coalition for Tilapia, Bradenton, FL.......... 361
Prepared statement........................................... 364
Nancy Donley, president, S.T.O.P. (Safe Tables Our Priority),
Northbrook, IL................................................. 378
Prepared statement........................................... 380
Wenonah Hauter, executive director, Food & Water Watch,
Washington, DC................................................. 387
Prepared statement........................................... 389
Gregory Page, chief executive officer, Cargill, Incorporated..... 403
Prepared statement........................................... 405
Jeffrey M. Ettinger, chairman, president, and chief executive
officer, Hormel Foods Corporation.............................. 408
Prepared statement........................................... 410
Doug Brinsmade, president and chief executive officer Anova Food,
Incorporated................................................... 416
Prepared statement........................................... 417
Submitted Material
Robert Post, Deputy Director, Center for Nutrition Policy and
Promotion, U.S. Department of Agriculture, answers to submitted
questions...................................................... 443
Laura Tarantino, Director, Office of Food Safety Additive, Center
for Food Safety and Applied Nutrition, Food and Drug
Administration, U.S. Department of Health and Human Services,
answers to submitted questions................................. 450
Submitted Material
Subcommittee exhibit binder\2\................................... 452
----------
\1\ Exhibits that have been omitted are on file in the committee
offices.
\2\ Ibid.
DIMINISHED CAPACITY: CAN THE FDA ASSURE THE SAFETY AND SECURITY OF THE
NATION'S FOOD SUPPLY? PART III
----------
THURSDAY, OCTOBER 11, 2007
House of Representatives,
Subcommittee on Oversight and Investigations,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 9:30 a.m., in
room 2123, Rayburn House Office Building, Hon. Bart Stupak
(chairman) presiding.
Present: Representatives DeGette, Melancon, Waxman, Green,
Dingel, Whitfield and Burgess.
Staff present: John Sopko, Scott Schoyel, David Nelson,
Joanne Royce, Kevin Barstow, Richard Wilfong, Kyle Chapman,
Alan Slobodin, Pete Spencer, Garrett Golding, and John Stone.
OPENING STATEMENT OF HON. BART STUPAK, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF MICHIGAN
Mr. Stupak. This meeting will come to order.
Today we have a hearing on Diminished Capacity: Can the
FDA Assure the Safety and Security of the Nation's Food Supply,
Part III. Each Member will be recognized for a 5-minute opening
statement.
Today we hold the third hearing of the subcommittee dealing
with the safety and security of the Nation's food supply. This
hearing will focus on the safety of food imported into the
United States and the adequacy of the efforts of both the FDA
and the USDA to protect Americans from unsafe imported food. We
will also examine what food safety and quality control systems
other countries use to protect their food imports.
Due to the globalization of the American economy, there has
been a dramatic increase in the amount of imported food in
recent years. In the last decade alone, USDA regulated meat and
poultry imports have increased by 87 percent. In the same time,
overall imports to the United States have tripled to almost 2
trillion per year. At a time when food imports are sharply
increasing, FDA inspectors of imported food have decreased by
90 percent from 50,000 inspections in 1972 to just 5,000 in
2006. The FDA now inspects less than 1 percent of all imports,
and only a fraction of that number are even tested. This is
simply unacceptable.
We need a food safety system capable of combating dangerous
food imports. Unfortunately, the Food and Drug Administration's
current system is woefully inadequate. Approximately 150
countries import food into the United States. Because of recent
high-profile events such as melamine contaminated wheat gluten
and seafood laced with unapproved antibiotics, imports from
China have received most of the attention. As with other
countries, Chinese imports in the United States have steadily
increased. However, Chinese imports have increased more rapidly
than the global average.
Between 1996 and 2006, the last 10 years, the volume of
imports of Chinese agricultural and seafood products have
increased by 346 percent. China is now the third largest
exporter of agricultural and seafood products into the United
States. Because of the concerns regarding the safety of Chinese
food imports, on August 17, Chairman Dingell and I dispatched
committee staff to China to ascertain whether food from that
country could be imported safely into the United States and to
determine whether China has taken or is taking the necessary
steps to assure the safety of its food exports. While in China,
committee staff met with government officials from China, Hong
Kong and the United States. They met with American and other
multinational executives and news reporters that covered food
issues for their media outlets.
In our first panel today, we will hear directly from the
committee staff about their findings.
Testifying on the second panel will be Dr. Michael Martin
of the Congressional Research Service. Dr. Martin is an expert
in Asian trade practices and has familiarity with Japan and
Hong Kong's quality control systems for dealing with imported
foods. He will testify regarding the methods employed by Japan
and Hong Kong to ensure the safety of food imports from China.
The committee would like to extend a special thank you to the
Congressional Research Service for its valuable work in
detailing food import issues. The work of Geoffrey Becker is
especially appreciated.
Also testifying on the second panel will be Mr. James Rice,
vice president and country manager for Tyson Foods in China. He
is an executive with over 20 years of experience in China. He
will testify about quality control issues in China, including
steps that the Japanese take to ensure the safety of imports
coming from China and the quality control measures that Tyson
employs in China to ensure the safety of the food it produces
there.
Finally, the third panel will be comprised of officials
from both the USDA and FDA. Dr. Richard Raymond of the USDA
will testify regarding the policies that his agency pursues to
ensure the safety of beef, pork, poultry and egg imports. Dr.
David Acheson and Ms. Margaret Glavine of the FDA will testify
about the process that the FDA employs to ensure the safety of
FDA-regulated food imports. We also expect them to address
specific issues of imported food safety.
Recently, Chairman Dingell and I introduced a bill that
will address many of the FDA's deficiencies. The bill would
give the FDA a credible start in obtaining the resources it
needs to deal with the flood of imported food. This hearing
will also explore whether the FDA has the system or the will to
use any new resources wisely. This subcommittee has already
uncovered evidence of the FDA's ability to squander resources
through giving excessive bonuses to personnel at headquarters,
attempting to consolidate decision making at headquarters
instead of deploying urgently needed resources in the field and
the fraudulent abuse of religious leave.
Simply put, the FDA must use its resources more wisely to
accomplish its mandate of protecting the Nation's food supply.
American consumption of imported food will continue to rise in
the future. So now more than ever our country's Federal food
safety system needs to be strong enough to protect the public
health, our national security and our economy. Today's hearing
will discuss what must be done to make this a reality.
That's the end of my opening statement. I would now like to
recognize the gentleman from Kentucky, the ranking member, Mr.
Whitfield, for his opening statement
OPENING STATEMENT OF HON. ED WHITFIELD, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF KENTUCKY
Mr. Whitfield. Chairman Stupak, thank you very much. We
look forward to this hearing today as we continue our efforts
to answer the question, can the FDA assure the safety and the
security of the Nation's food supply? That's a question that
most Americans want answered, and they want to feel comfortable
with that answer. Every day we read it seems about additional
problems with imports of our food supply such as tainted pet
food, wheat gluten. Seafood from China, for example, made
national headlines earlier this year.
Our concerns over weaknesses and FDA's food import system
persists. Minority committee staff recently learned that, in
February 2006, FDA received information from its pilot program
called Predict that a cancer-causing disinfectant, malachite
green, was detected in Chinese farm-raised seafood in South
Korea and Canada. Canada announced the detentions of all
Chinese eel products starting January 31, 2006, but it took FDA
over 6 months before it imposed an import alert, and still bad
products were shipped into the country.
This morning we will hear about China's food safety system
as well as neighboring systems in Hong Kong and Japan. And
we're hopeful that that information will shed light on measures
that may increase our confidence in the safety of our food
imports. As we examine these issues today, I think we can agree
that FDA, many of us feel, requires fundamental reform of its
approach to import safety. We know that the FDA employees are
dedicated and committed to accomplishing this task. But all of
us are interested in looking at ways that we can improve their
efforts.
The agency's 100-year-old regulatory approach to food
safety cannot deal with the huge growth in food imports over
the past decade. This import surge is really astounding. In
1980, there were 1 million food lines of entry into America.
And today, there are well over 10 million food lines. Imports
have risen 15 percent annually over the last 10 years, and this
number is expected to rise.
At the same time, while imports represent a larger portion
of our food supply, roughly 15 percent overall, some products
such as imported fresh fruits account for up to 60 percent of
our food supply in that category and even 80 percent for
seafood. The percentage of imports inspected by FDA has
plummeted from roughly 8 percent in 1992 to my understanding
roughly 1 percent today. This is a situation with an agency
that has jurisdiction over the 80 percent of our food supply
but operates with only about 20 percent of the U.S. food safety
budget. And that's because the Department of Agriculture has
the largest percent of that budget.
But numbers don't fully explain the problem. As we've
discussed in past hearings, the FDA's import system is not
really set up to deal with the realities of global commerce. We
can no longer rely upon border operations as the primary line
of defense to ensure imported food safety. Giving more money
alone is not the answer. The FDA must deploy a risk-based
import inspection system where the agency identifies and
prioritizes important risks well before a shipment reaches our
shores. To do this, the agency needs to increase its
information about foreign food manufacturers, their products,
their distribution chains. FDA must profile food control
agencies in foreign countries, understand what they do, and
where they are developing new programs. It needs better
information about particular food facilities and production
practices abroad. This requires modern information systems as
well as an increased overseas presence for inspections and
information-gathering activities. To accomplish this, FDA
should have a separate foreign inspections program with
inspectors assigned full time.
An effective system also requires FDA to implement new
information and risk-modelling systems. We understand some of
this information technology already exists today, but the
agency, for whatever reason, has been slow to deploy it. For
example, Predict, an automated import entry system, supports
risk assessments and has been operating only at one port and
only for seafood for the past 3 years. FDA, we hope, will move
quickly to expand use of this system or one similar to it.
I would also just point out that the minority committee
staff requested recently names and locations of individuals
that work at FDA who work full time on import inspections. And
FDA provided the information, showing that there were only 30
full-time import entry reviewers. There were zero full-time
import inspectors and zero full-time import investigators. Now
FDA did provide the name of 213 employees who spend the
majority of their time working on import activities. But even
using the measuring term that FDA has called full-time
equivalents, they said there are 454 investigational
operational import full-time equivalents today. And back in
1992, there were 631. And yet we see this dramatic increase in
the number of imports. And yet the full-time equivalents
working on this area of food inspection safety seems to be
decreasing. So, hopefully, this hearing will supply some
answers for us.
And, Mr. Chairman, we look forward to working with you as
we move forward on this important issue.
Mr. Stupak. I thank the gentleman for his opening
statement.
Ms. DeGette for an opening, please.
OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF COLORADO
Ms. DeGette. Thank you, Mr. Chairman. The most important
thing that this subcommittee can do is continue to be a
watchdog for public health and safety. And I appreciate you
holding this series of hearings.
Until quite recently, it never occurred to ordinary
Americans that they needed to be concerned about the safety of
the food they purchased from their neighborhood grocery store.
But with products affecting ground beef, peanut butter,
spinach, toothpaste, cough syrup, lettuce and even pet food in
the news almost daily over the last year, people no longer
assume, and rightly so, that what they buy is safe.
A recent survey showed an all-time low in consumer
confidence in their food. And who can blame them? Our food
safety system was simply designed for a different era. In 2007,
we are at the mercy of a food safety system that was designed
for the 1970s. If you look at my chart, today we are importing
a dramatically larger percentage of our food than even a decade
ago. If you look at this chart, imports just from China have
skyrocketed in the past 5 years. In fact, according to the
Congressional Research Service, imports of Chinese agricultural
and seafood products alone have increased almost 350 percent
since 1996 from $880 million to over $4 billion in 2006 alone.
And this is just the imports from China. The red line would be
even more dramatic if we looked at food imports from other
countries as well.
At the same time that these imports have increased though,
the FDA's food budget has stayed nearly constant but with more
demands on that budget. The FDA's food division operated under
a shortfall of nearly $140 million in 2006 due to a combination
of increased personnel costs and new terrorism
responsibilities. So that results in essence in a budget cut of
nearly 25 percent.
And as Mr. Stupak said, this indefensible resource
shortfall has been combined with mismanagement of resources at
the FDA. While increasing numbers of imports have provided
consumers with lower prices and more choices, I'm going to
guarantee you, if you asked my constituents, they never
bargained for a corresponding decline in food safety with those
lower prices. They want the lower prices, yes, but they also
want us to ensure that the food coming into this country is
safe for them to consume.
The rise in imports is not necessarily problematic in and
of itself. But when you couple that with an outdated and
underfunded screening system, we've seen the results. And worse
is to come if we don't fix the problem. Adding more inspectors
and finding a way to pay for them is one step, but there are
other steps that we need to take. And some of the members of
this committee I'm sure will talk about it today.
We need to, first of all, ensure that safety is built into
the system so that we eliminate contamination in the first
place. And second, we need to build the regulatory framework
required to effectively deal with an outbreak should one occur.
We all realize this is not just an issue of imported foods.
The Topps beef contamination and yesterday's Sam Club's recall
are just the most recent examples of problems right here at
home. It seems like every time we have a hearing, there's been
a recall about a day before. And that just shows the extent of
the problem.
There's a lot of legislation. Chairman Dingell has
introduced a bill. I have a bill, H.R. 3484, the Safer Foods
Act, which gives the FDA and USDA mandatory recall authority in
the event of an outbreak. And there are other bills as well.
Another bill I introduced was H.R. 3485, the Trace Act, which
sets up a food product traceability system so that we can trace
where our food is coming from so that we can recall it and make
sure it comes off of the shelves.
In today's digital age, there's no reason we can't track
food products from farm to fork. And the fact that many other
industrialized nations are already doing it proves that point.
And finally, we can't pretend to reform our food safety system
while keeping in tact the complex regulatory structure in which
15 separate agencies share food safety jurisdiction. We must
create a single food safety agency to ensure accountability
once and for all.
I want to thank you, Mr. Chairman, for having this hearing.
I expect to hear the latest on what the FDA's doing to combat
this crisis. I also am continuing to monitor the status, as you
mentioned, of a laboratory closing plan because it makes no
sense to consolidate food safety labs at a time like this. We
need to get a grip on this, both legislatively and in an
oversight way. And I welcome this additional hearing in our
series of hearings.
Thank you, Mr. Chairman.
Mr. Stupak. I thank the gentlewoman.
Mr. Burgess for an opening statement for 5 minutes.
OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF TEXAS
Mr. Burgess. Thank you, Mr. Chairman. And I appreciate you
having the hearing today.
So, Mr. Chairman, we've seen recall upon recall all summer
long, consumer product safety questions, consumer confidence
dives. The number of recalls this summer has been alarming.
This committee must take an active role. We're here to provide
oversight to safeguard America from dangerous food, dangerous
consumer products. The public health and the public confidence
are both at stake in this. You just can't help but notice that
all of the products and all of the foods that turn out to be
problematic, all emanate from a single foreign source.
While I want to thank the leadership of this committee for
holding this hearing, third in the series on the Nation's food
supply, the subcommittee has been appropriately aggressive and
pursued a bipartisan investigation on the matter. Really I want
to urge my colleagues on both sides of the dais that this
committee and the full Energy and Commerce Committee
aggressively pursue legislation to deal with this problem.
Chairman Dingell, of course, has introduced H.R. 3610. I don't
know that that's a perfect piece of legislation, but I hope we
get a chance to visit about that in both the subcommittee and
the full committee. And whether we ultimately agree on all of
the points or not, I thank the chairman for introducing the
legislation on this important matter and certainly hope there
will be an opportunity this time for some bipartisan
interaction on what will be important legislation that will
affect the course of this country for decades to come. Its
intentions are good. It's always details, details, details, and
again look forward to really aggressively working on that
legislation.
I think we need to look at how other Federal agencies have
dealt with problems and what tools they have at their disposal
and whether it would be appropriate for the FDA to have similar
tools, similar authorities. I hope that today's hearing will
help us further the goal of transforming the Food and Drug
Administration because truly this is transformational. We're
beyond the point of reform. Reform is, if you've got a little
problem, you need to manage it around the edges.
This is a big problem, and it is going to require true
transformation of the Food and Drug Administration into an
agency that can fully cope with the importation problems of the
21st century. They are not problems that were created by the
FDA. They are problems that are created by where we are in the
world right now, and the FDA right now needs to be able to
respond to those problems. If the FDA needs additional
authorities, needs additional resources to be able to truly
protect Americans, then we need to have a frank conversation
about this, and I look forward to engaging in a candid
conversation with the witnesses today. I continue to be very
interested. We heard from Dr. Bill Hubbard, former FDA
associate commissioner of this committee on several occasions.
His prior proposal, that has been discussed at length and
mentioned in previous hearings, would grant the FDA the
authority to embargo a specified food from a specified country
much like similar authority to the USDA has in regard to meat
and meat products. If this standard is good enough for meat
products, then it makes sense that it should be good enough for
all food and drink imported into this country. And Mr.
Chairman, we might even argue that it also should apply to
other imported goods, such as toys.
While I had hoped to have legislation addressing Mr.
Hubbard's concerns available to introduce, it has been tough
sledding. There are a lot of things that I hadn't considered
when I originally took that project on and my staff, my
personal staff, took that project on. We've had some difficulty
getting answers. It seems that those difficulties seem to be
evaporating now. But I actually welcome the fact to have both
the USDA and the FDA side by side on the panel today. Perhaps
we can pursue some of those questions that have been
particularly vexing. And certainly I welcome an open discussion
regarding the proposal that I've had and Chairman Dingell's
proposal. Again, Mr. Chairman, thank you for holding this
hearing. And in the interest of time, I'm going to yield back
the balance of my time.
Mr. Stupak. I thank the gentleman.
And Members should realize this is the third of five
hearings we have scheduled. The next one will be November 1.
It's going to be drugs that are imported from overseas. On
November 13--that is a Tuesday--we are going to do it on
domestic foods, going back to domestic food. It will be our
second hearing on domestic foods. That hearing is a Tuesday. It
is at 10:00 a.m. If you need us to adjust the time, such as
Members like Mr. Waxman, Ms. DeGette or Mr. Burgess coming in
from Texas, if you need us to shove that back an hour or so, we
can accommodate Members. Some of us will be in on Monday. So
think about it so we can accommodate everybody.
Mr. Inslee, opening statement, please.
OPENING STATEMENT OF HON. JAY INSLEE, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF WASHINGTON
Mr. Inslee. Thank you. I appreciate the chairman talking
about these other hearings because I think it's important that,
while today we focus on the Chinese problem, that this is just
one hole in a safety net that has many holes. The kids who were
damaged by spinach, it wasn't from China. It was from fields in
California, and I'm told we had more food rejected in our
inspection process from India last year than from China. So I
just don't think we can lose sight of the fact that this entire
scheme needs to be changed, and I appreciate the chair's
leadership on that.
I hope today that we'll hear answers to three questions I'd
like to pose. First, do we need to have at least as aggressive
a food safety program as Hong Kong? We will hear testimony
about the Hong Kong process that requires certificates to allow
entry of at least Chinese imports. And the question arises,
should we at least have as vigorous a program as they do?
Second, I'd like to hear whether it's time to have at least as
rigorous an inspection protocol from the FDA as the USDA. Why
are we not providing the same level of protection for nonmeat
and fish products? And I think we're starting to see hazards
associated with those that would justify that action. And
third, I hope we'll have a discussion of the plans or at least
a discussion of the closure of labs at the very moment we have
this continued increase in threats--and it is a great decrease
in confidence; 70 percent of Americans now do not trust these
overseas products. So I hope we'll have a discussion of that,
what appears to me to be a very short-sighted effort. With
that, I yield back.
Thanks, Mr. Chairman.
Mr. Stupak. I thank the gentleman.
Mr. Waxman, an opening statement, please.
OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Mr. Waxman. Thank you very much, Mr. Chairman, for your
vigorous efforts in oversight in the area of the safety of food
and drugs and other products that are consumed by the American
people.
Over the years, we have had a lot of hearings when there
has been a scare but not a lot of sustained activity after the
hearings to make sure that we do protect the American people
from unsafe products. We are seeing the downside of two
predominant views of our economy. One has been that we should
rely more and more on a globalized economy. Well, the downside
of that is that we don't have control, as we would like, for
the evaluation of the safety problems when we bring in products
from other countries. In many ways, we rely on these other
countries to assure us that we are importing a product that is
maybe not otherwise available here but is going to be safe when
it is consumed here.
The other theory that we are seeing the downside is
deregulation. For years now, we've seen proposals to
deregulate, to get government out of the way, to allow the
private sector to solve problems. And thus, we now have an FDA
with diminished resources to do its job, with inadequate
authority to do its job. So for those who have argued that we
need to deregulate, to starve the regulatory agencies, we are
seeing the results come home.
In the great tradition of oversight, this committee has
sent our investigators to China. And what they've reported back
to us is really pretty startling. They have indicated that what
they have seen is that the Chinese food supply chains do not
meet international standards. The Chinese Government is very
concerned about bad press or bad appearances or embarrassment
in the export market, and the branding of ``Made in China'' in
a negative way around the world. But they have no meaningful
regulatory system to make sure that the farming and food
processing in China will lead to safety even for their own
consumers. There have been many outspreads, wide outspreads of
poisoning of Chinese from unsafe foods. So when they have
problems, they don't do enough to stop the entrepreneurs, so-
called, from smuggling in food supplies into the export market
even if they are unsafe.
Well, what can we do about this? We have had hearings, and
we have certainly come to the conclusion the FDA is not doing
its job. Well, we want to rely on an FDA that can and will do
its job. So we need to give them the resources. We need to give
them the authority. But other proposals have been put forward,
such as the legislation by Chairman Dingell, to say that we
ought to not just rely on inspections here in the United States
but to try to ascertain that a country has a regulatory system
in place to protect the supply that is going to be brought into
the U.S. market.
Well, that sounds like an ideal way to resolve things, but
I don't think in the real world it's going to happen for quite
a while. Then the legislation suggests that we ought to have
the FDA certify individual marketers. Well, if that is what we
are going to rely on, that is going to involve thousands and
thousands of individual places to inspect. We have to deal with
a modernization of a regulatory system, a modernization of an
effort here in the United States to protect the American
consumers.
Our colleague, Ms. DeGette, just talked about how consumers
welcome globalization when it leads to a wider variety of
products that are not available and to lower prices for those
products. But her consumers nor do my consumers want to have a
lower price for a food product that may cause genuine harm. I
am encouraged that we are holding hearings; we are looking at
legislation, not only for imported product safety but for
domestic safety as well.
I commend you, Mr. Chairman, for your efforts. We have got
to make sure that we are not just holding hearings but that we
follow through so that the daily press that we see of food
problems becomes something that is dealt with in a realistic
way. Thank you.
Mr. Stupak. Thank the gentleman.
The chairman of the full committee, Mr. Dingell, for an
opening statement please.
OPENING STATEMENT OF HON. JOHN D. DINGELL, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF MICHIGAN
Mr. Dingell. Mr. Chairman, I thank you. And I commend you
for holding this hearing and for the superb leadership you are
giving in terms of protecting the American consumers. I also
want to commend you for the excellent and far-reaching
investigation into the effectiveness of our laws and the
administration activities in support of those things.
The food safety challenges our country now faces and the
questions that we confront with regard to prescription
pharmaceuticals, plants and devices is a matter of great
concern to this committee. As we have seen in prior hearings,
food safety affects us all. But it is particularly most
dangerous to the most vulnerable, the poor the young the very
old and those with compromised immune systems.
Today we focus on food imports, not only from China but
also from other countries with regulatory systems that are not
the equivalent or even close to ours. Importing food from such
countries is risky to begin with and even more dangerous if the
resources for the regulatory agencies entrusted with ensuring
their safety are bigger and their management is passive or
ineffective.
Mr. Chairman, we sent committee staff, as you know, to
China to help us understand whether importing food from that
country made sense, given the spate of recent incidents
involving tainted food imports. By sending committee staff to
look at these problems firsthand, we have gained insights that
are unique from other congressional committees now looking at
food import safety. I very much look forward to the staff's
testimony today.
I am interested in the analysis of our expert witnesses,
Mr. Rice and Dr. Martin, regarding regulatory efforts of Hong
Kong and Japan, which import a substantial amount of the food
that they use from China. The subcommittee will also hear from
representatives in the Department of Agriculture and the Food
and Drug Administration, the primary regulatory agencies that
ensure the safety of our food imports.
I look forward to comparing and contrasting their budgets
and their efforts. I especially look forward to hearing from
USDA regarding efforts to protect Americans from contaminated
beef, pork, chicken and eggs. I understand their system is far
more selective as to who can import into this country and from
where and that the USDA inspects a larger portion of the
imports that they are responsible for regulating than does FDA.
Most of all, I look forward to the testimony of FDA witnesses
today. Two weeks ago, when the FDA was called in to discuss
food safety in the context of the bill that you and I and other
members of this committee have offered, Mr. Chairman, H.R.
3610, they sent one of the least-prepared witnesses ever to
testify before this committee. That FDA official, Dr. Lutter,
repeatedly told us how ignorant he was of the most basic facts
regarding the food import crisis. I hope that we will have
better performance from the FDA today.
I also trust that FDA witnesses are not going to try to
sell that old often repeated falsehood that we can do more with
less. The only thing FDA has established with regard to this
particular point is that they can do less with less. FDA needs
resources to deal with the cavalcade of imports from China and
other countries that cannot or will not ensure the quality of
their food imports to the United States. I intend to see that
the FDA gets the budget that it so sorely needs.
Finally, Mr. Chairman, I understand that you intend to hold
hearings in November dealing with the safety of drug imports
and the inadequate regulation of our domestic food supply. I
endorse your plans, and I commend you for doing this because it
is an activity by this committee desperately needed. The bill
that you and I and other Members of this committee sponsor
addresses these matters as well as providing the crucial
resources necessary to strengthen the import protections. I
expect that the hearings today and in the future will help us
to refine the legislation. I've always found that legislation
informed by the work of the Subcommittee on Oversight and
Investigations makes for far better law and far better public
policy. I also look forward to contrasting and comparing
budgets and efforts at FDA. I especially look forward to
hearing from USDA regarding its efforts to protect Americans
that we so desperately need.
In any event, Mr. Chairman, if anyone here has been to
China, many of us have, they will know that you have to be darn
careful about what you eat over there. I see nothing which has
changed, the quality of the food that they send us, from the
quality of the food which they send to their own people. And I
intend to see to it that the best food and drug law in the
world, which we have, is properly administered, properly
enforced and properly financed. I commend you for these
hearings. And I thank you, Mr. Chairman.
Mr. Stupak. I thank the gentleman and thank the chairman of
the full committee. And thank you for your continued support of
our efforts as we reach out globally to address this issue of
food imports.
Next I would like to hear the gentleman from Texas, Mr.
Green, for an opening statement, please.
OPENING STATEMENT OF HON. GENE GREEN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TEXAS
Mr. Green. Thank you, Mr. Chairman, for holding this
additional hearing and also the announcement for the hearings
later. I would also like to thank the chairman of our full
committee for authorizing the staff delegation trip to China
over the August recess. I am grateful for the ONI staff for
making the trip so we can learn firsthand about the regulatory
scheme present in that country which is one of the top food
importers to the U.S. We cannot necessarily dictate how food is
regulated in another country. This knowledge of Chinese
regulation will help us identify the safety gaps in China and
implement the necessary safeguards to protect the American
people from dangerous contaminated food products bound for our
country. As we examine the Chinese regulatory scheme for food,
we should keep in mind that China is not our country's top food
importer from the developing world; Mexico is.
The problems also are not coming disproportionately from
China. According to FDA import alerts, there are 20 Mexican
firms on import alerts while there are 16 import alerts facing
Chinese firms. The monthly tally of imports refused at the
border also indicates that Mexico, China and India are at the
top of the list of oasis refusals by country in any given
month.
Whatever policies we implement based on our understanding
of the Chinese system must be applicable to all our trading
partners, including Canada and Mexico, which are the top
exporters of agriculture and seafood products to the U.S. The
staff investigators' trip to China shed light on the fractured
regulatory framework for food in China and the numerous
agencies involved. The lengthy supply chain and food processing
procedures in China give us important insight on how these
problems arise.
In our country, we celebrate the family owned small
business and consider a family's entrepreneurial success a
realization of the American dream. As the investigators pointed
out in their report, however, family farmers in China often
face difficult economic conditions and downward pressure on
prices to make crop survival the highest priority, even at the
expense of safety. With such fragmented regulation, a Chinese
farmer is probably willing to take that gamble.
It appears the Japanese have protected their citizens from
this problem by allowing only Chinese imports from a certain
number of certified producers who have met their quality
standards. Hong Kong has taken a different route by
implementing a robust registration and inspection regulatory
framework.
It is unclear whether any of these systems can be applied
to a country as large as the United States and with such demand
for the products. We can certainly learn from them and
determine what elements can be workable for the U.S. supply
system that is in dire need of improvement. And as my
colleagues have pointed out, it is not just our imports.
Whether it is hamburger meat, whether it is spinach, whether it
is any other issue, we need an active and robust FDA. And I am
glad that the chairman of the full committee is committed to
providing the resources to the FDA so they can do not only what
we expect them to do on the drug side but also on our food
safety.
Thank you, Mr. Chairman. I yield back my time.
Mr. Stupak. I thank the gentleman.
Mr. Melancon for an opening statement.
Mr. Melancon. Thank you, Mr. Chairman. I would just submit
my remarks for an opening and reserve my time for questions if
you would.
[The prepared statement of Mr. Melancon follows:]
Prepared Statement of Hon. Charlie Melancon, a Representative in
Congress from the State of Louisiana
Mr. Chairman, Thank you for holding this hearing today. I
am quite concerned about the lack of screening of 80 percent of
the United States' food supply. My district, which depends
largely on the fishing industry--shrimp, crawfish, fresh caught
fish, is struggling to compete with imports from foreign
countries that do not have the same food safety standards as we
have in the United States. Countries like China, Taiwan, and
Vietnam--just to name a few--import seafood that is produced in
farms, not fresh caught. Catching wild shrimp and fish is much
more labor- and capital-intensive, so fresh caught seafood is
more expensive than farm raised. Farms try to produce as much
product as possible, so they overpopulate ponds. Because the
ponds have no fresh water circulation, they become filled with
bacteria. The farmers then pump antibiotics and other chemicals
into the water to kill the bacteria. These chemicals have been
shown to cause cancer in animals and humans.
Since the Food and Drug Administration only tests 1 percent
of food imports, Louisiana's Department of Agriculture has
taken it upon themselves to test for these dangerous chemicals.
They have repeatedly found concentrations of chloramphenicol
and fluoroquinolones, among other chemicals, in imported
seafood--particularly from producers based in China. Despite
evidence of chemicals and antibiotics in imported seafood, the
FDA still allows tainted food to enter the United States.
I am happy that the FDA finally made an Import Alert for
farm-raised catfish, basa, dace, eel, and shrimp from China in
June, but we've known about tainted and contaminated imports
from China for years. Louisiana's Department of Agriculture has
also found evidence of chemicals and antibiotics in crawfish
tail meat from China, yet the FDA is still allowing this
tainted meat to enter our food supply.
Furthermore, an Import Alert does not necessarily mean that
these tainted products will be prevented from entering the
United States. Rather, an Import Alert means that field agents
detain the product--not destroy it or return it to the
originating country--and wait for the importer to show that the
shipment is not tainted. The FDA requires an independent lab
test for proof, but the FDA doesn't certify labs, so anyone can
open a lab and provide test results.
These are just a few of the problems that we in this
committee have discussed previously and will continue to
examine until the food we import is safe. I am seriously
concerned about the safety of food imported from countries that
lack food safety standards equivalent to those in the United
States and hope that we can soon find a better system for
monitoring food imports.
Thank you, Mr. Chairman.
----------
Mr. Stupak. Very good. That concludes the opening
statements by members of the committee. I will now call our
first panel of witnesses to come forward.
On our first panel, we have Mr. David Nelson, senior
investigator for the Committee on Energy and Commerce; Mr.
Kevin Barstow, investigative counsel for the Energy and
Commerce Committee; Mr. Richard Wilfong, investigator with the
Energy and Commerce Committee.
It is a policy of this subcommittee to take all testimony
under oath. Please be advised that our witnesses have the right
under the Rules of the House to be advised by counsel during
their testimony. Do any of you wish to be represented by
counsel? Indicating no one wishes to be represented by counsel,
please raise your right hand to take the oath.
[Witnesses sworn.]
Mr. Stupak. Let the record reflect the witnesses have
answered in the affirmative. You are now under oath. And Mr.
Nelson, I understand you are going to give the opening
statement, a 5-minute opening statement. You may submit a
longer statement for inclusion in the hearing record.
Mr. Nelson.
STATEMENT OF DAVID NELSON, SENIOR INVESTIGATOR, COMMITTEE ON
ENERGY AND COMMERCE; ACCOMPANIED BY KEVIN S. BARSTOW,
INVESTIGATIVE COUNSEL, AND RICHARD A. WILFONG, INVESTIGATOR
Mr. Nelson. Thank you, Mr. Chairman.
Good morning, I am David Nelson, an investigator with the
Committee on Energy and Commerce. I am accompanied by Kevin
Barstow, counsel, and Richard Wilfong, an investigator with the
committee staff.
Mr. Chairman, you and Chairman Dingell dispatched us to
China on August 17 to ascertain whether food stuffs from that
country could be imported safely into the United States. We met
with Chinese and Hong Kong government officials, U.S.
Government officials, American and other multinational
executives involved in processing and distributing food in
China and Hong Kong and reporters from bureaus in Beijing and
Hong Kong that cover food issues for their media outlets. The
report of that trip is attached to this summary statement.
Based on information gathered before and during the trip,
the staff made the following observations:
First, the Chinese food supply chain does not meet
international safety standards. It is in fact responsible for
very serious domestic Chinese food-poisoning outbreaks.
Second, the Chinese Government appears determined to avoid
embarrassing food safety outbreaks in its export markets due to
the damaging and potentially lasting effect this would have
upon the Made in China branding.
Third, the lack of meaningful internal regulation of
farming and food processing in China, the advanced development
of the document counterfeiting industry and the willingness of
some entrepreneurs in both China and the United States to
smuggle foodstuffs that do not meet quality standards
necessitates a much more vigorous program of inspection and
laboratory testing in China and in U.S. ports of entry than the
Food and Drug Administration has been willing or able to pursue
today.
The responsibility for quality assurance both of imports
and exports rests with the AQSIQ in China, the General
Administration of Quality Supervision, Inspection and
Quarantine of the People's Republic of China. The AQSIQ
officials issued a white paper on August 17, 2007, which is
included in the exhibit book dealing with food safety. This
paper details China's export quality assurance program.
While in China, we had an opportunity to discuss the
components of this program with AQSIQ officials as well as
other Chinese agency officials. We were advised that a sample
from each lot of product for export is pulled by a government
inspector and tested in a government laboratory to ensure it
meets Chinese standards and the standards of the importing
country. Export certificates are then granted by the local
Chinese inspection and quarantine CIQ offices, CIQ or local
municipal equivalents to AQSIQ.
We are shown how importers' paperwork is joined with
laboratory test results before the certificate is issued. When
the certificate is issued, the information is sent to the port
of exit electronically to ensure that the fiscal goods
correspond to the export certificate before loading. The
Chinese position is that theirs is a closed system that ensures
the safety of foods that bear the CIQ certificates and seal.
Today, FDA has refused to acknowledge the Chinese
certificates. If the Chinese system worked as described, it
would be a very safe system. However, we did not find any
American or other multinational executive operating in China
that believed that China has a competent independent inspector
overseeing each of the 12,714 plants that are approved for
export or even of the 3,700 plants that according to Chinese
officials are fully HACCP controlled. Nor did we find anyone
that believed that every single lot was sampled.
Finally, it was widely believed that the export
certificates were subject to counterfeiting. There was
agreement among everyone we talked to about the sincerity and
scope of the AQSIQ's efforts but much less enthusiasm about the
willingness of local CIQs to follow the central government's
dictates. And we were told it's at the local level where the
system succeeds or fails.
We made inquiries about two possible models. One of the
models, the Chinese food exports to Hong Kong, was broached
directly with the Hong Kong Government. The other, the Chinese
food delivered to Japan, was discussed with knowledgeable
sources but not the Japanese Government due to the time
limitations of the trip. An overview of their findings of our
findings regarding these two models is presented in the trip
report.
Can food be imported from China safely? The Japanese and
Hong Kong models are each safer than the FDA's system for
regulating food imports. The Hong Kong system involves massive
sampling and thus may not be practical for an economy of our
size. Last year, the Hong Kong Government tested in their
laboratory 64,000 samples. If we were to test an equivalent
proportion of samples to a country the size of the United
States, it would be over 2 million in FDA labs. That simply is
so far beyond the capacity that it's hard to even imagine if we
could build that much laboratory space very quickly.
The Japanese system of inspecting a very limited number of
facilities that are permitted to supply food to China does
appear to offer a much better control system than currently
employed by the FDA. But the Japanese also inspects and tests
15 percent of their food imports. We inspect 1 percent and test
a fraction of that. However to the extent that the Chinese
products for the Japanese market are insulated from excessive
downward pressure on prices--and that's a real problem, the
incessant pressure on downward prices on people that are
producing at the margin causes a lot of shortcuts to be taken
in a lot of products over there--to the extent they're
insulated from downward pressure on prices, the Japanese
consumers pay for the added safety in the form of somewhat
higher prices. The size of the price effect is not known. At a
minimum, it would appear the U.S. could cut safety risks
significantly were FDA to limit food imports to China to those
firms that have obtained the appropriate certificates from the
Chinese Government.
For all the reasons noted in this report, such certificates
are no guarantee of safe imports, particularly if there's not
an electronic transmittal system in place of the paper
certificates. However, the absence of such certificates most
certainly means the Chinese quality control system has been
evaded by their exporters.
Mr. Chairman, thank you for the opportunity to testify
before this subcommittee. Mr. Barstow, Mr. Wilfong and myself
look forward to answering any questions you or other Members
may have about our testimony or the investigation.
[The prepared statement of Mr. Nelson follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Stupak. Thank you, Mr. Nelson.
We'll begin questioning. We can go 5 minutes, maybe we can
go two rounds. We do not have votes today, so we should not be
interrupted.
Mr. Nelson, in your report, it states that the USDA does
not permit any beef, pork, chicken or eggs into the U.S. from
China. You say that it would be impractical for the FDA to take
the same stance. Would you explain that?
Mr. Nelson. Well, yes, there's a far different matter
excluding four specific products versus all the rest of the
food products. And we say, and truthfully, that USDA has
responsibility for 20 percent of our food supply. But it's 20
percent by value. It's not 20 percent by volume or by number of
products. If we were to exclude all food products from China,
it would have substantial effects on the economy of the United
States. We get a large proportion of fish, of amino acids, of
vitamins, of intermediate products like wheat gluten and a lot
of finished products. I mean, and those exports to us are
growing.
Mr. Stupak. In your opinion, based on the last answer then,
in your opinion, are imports from China more or less dangerous
than food from other parts of the world, such as India, Mexico
or the Dominican Republic, all which are important food
suppliers to the United States?
Mr. Nelson. No, not necessarily. We have a substantial
portion of the rejections of foods for--because they're
unsanitary, contaminated, decomposing, from these other
countries that have less developed economies and less developed
regulatory systems. China is certainly one of the problem
countries. But it is only one of the problem countries.
Mr. Stupak. China indicates they will certify the food.
That is, certified to their standards, not necessarily the
country that they're exporting the food to, in this case the
United States. It's not U.S. standards. When they certify, it
is to the Chinese standards.
Mr. Nelson. They claim it is the U.S., it is the standards
of any country for which they're exporting.
Mr. Stupak. That's what they claim. But what did you find
when you were there?
Mr. Nelson. We found laboratories, at least the one we
looked at in Beijing is comparable to the FDA laboratories we
have here.
Mr. Stupak. How many of those type laboratories did they
have?
Mr. Nelson. They claimed to have 323 laboratories.
Mr. Stupak. Three hundred and twenty-three laboratories?
How many farms supply those laboratory samples from their
farms? How many farms are there that grow food for export?
Mr. Nelson. They claim that they've approved some 360,000
hectares of land, farm land for export.
Mr. Stupak. Three hundred and sixty hectares, but how many
farms?
Mr. Nelson. Three hundred and sixty thousand. I'm not sure
how many farms that translates to.
Mr. Stupak. But a hectare can be as large as a basketball
court, or it could be much larger, can it not?
Mr. Nelson. It could be. But it could be as small as a
basketball court. Much of the Chinese domestic food supply
anyway--we're talking about literally hundreds of millions of
farmers----
Mr. Stupak. Correct.
Mr. Nelson. Are from these very, very small parcels of land
the products of which are then gathered by intermediaries and
consolidated. There's simply no way that the Chinese Government
can have control over the conditions of farming on so many
farms.
Mr. Stupak. Well, I understand the central government in
China does not have complete control of what happens at the
provincial or the local government level. So what does that
mean for food safety if you have tens of millions of farms,
which first contact would be local government, then you have
provincial government; then you have the central government.
You have three layers of government there. How do they work
government to government?
Mr. Nelson. Well, I don't think anybody knowledgeable about
the system can say that the Chinese food supply is safe, even
their export systems.
Mr. Stupak. Who puts forth the regulatory regime on food
safety? Is it the central government, provincial government or
the local government?
Mr. Nelson. The provincial and local governments are where
the rubber meets the road. They're the ones that are issuing
certificates.
Mr. Stupak. So can each local government or each province
have a different regulatory scheme in which chemicals or
pesticides they use?
Mr. Nelson. They are bound by a common national scheme,
which is to meet the Chinese national standards and the
importing country's standards. But whether or not they do,
whether or not those regulations are enforced is very
problematic.
Mr. Stupak. On reading your report, I found a lot of issues
that--not only from government to government but government to
the farmer, there's less regulation. And when we deal with the
certification, China has a rather sophisticated
counterfeiting--is that what you found?
Mr. Nelson. There was unanimity on virtually everybody
outside of the Chinese Government themselves as to the quality
of counterfeiting. And it's not limited to documents. But
modern publishing techniques make counterfeiting very, very
easy anywhere in the world. And the Chinese technology in such
matters is as good as anywhere in the world.
Mr. Stupak. Well, I have many more questions for Mr.
Barstow and Mr. Wilfong. My time's up. Hopefully, we'll get a
second round of questions in.
Mr. Whitfield for questions, please.
Mr. Whitfield. Thank you, Mr. Chairman.
Mr. Nelson, in your testimony, you state emphatically that
the Chinese food supply chain does not meet international
standards. And it is, in fact, responsible for very serious
domestic Chinese food poisoning outbreaks. Now, one of the
areas that I'm a little bit puzzled about relates to this
concept known as equivalence. And that basically means that
although food products imported into the United States must
meet the same safety standards as domestically produced foods,
international trade rules permit a foreign country to apply its
own differing standards, regulatory authorities in
institutional systems in meeting standards under this
internationally recognized concept known as equivalence. And so
my question is, if the Chinese food system does not meet
international standards even though we can apply this
equivalence standard, how is it that we're able to bring their
food into America in a safe way?
Mr. Nelson. Well, U.S. law is bifurcated in that regard.
USDA, for meat and eggs, has an equivalence standard. And as a
consequence, we import no eggs, pork, chicken or beef from
China. And it's unlikely----
Mr. Whitfield. Because they don't meet the safety
standards?
Mr. Nelson. They don't meet the equivalence standard.
Mr. Whitfield. All right. So we don't allow any meat,
poultry products, eggs from China?
Mr. Nelson. Right. That same standard is not in the Food,
Drug and Cosmetic Act.
Mr. Whitfield. The same standard is not in the Food, Drug
and Cosmetic Act?
Mr. Nelson. That's correct.
Mr. Whitfield. So the USDA, their inspection
responsibilities of the meat products, they can prevent these
items from coming in. But you are saying the FDA does not have
the authority to prevent----
Mr. Nelson. The Food, Drug and Cosmetic Act does not have
an equivalence standard. Now, there are very strong authorities
for--and very strong authorities and much discretion for FDA at
the border, much more than there is within the United States.
But there is no equivalency standards. So FDA does not go over
and determine whether or not the spinach or fish or wheat
gluten or toothpaste from China is produced under standards
that are equivalent to the United States.
Mr. Whitfield. Well, your statement, that's a pretty strong
statement. I mean, you all went there, and you met with
officials, and you looked at processing plants and facilities.
And you make the statement, the Chinese food supply does not
meet international safety standards.
Mr. Nelson. That's right.
Mr. Whitfield. That's all food; correct?
Mr. Nelson. That's all food, in terms of the country as a
whole. Now it's really important to understand that the food
for export is handled and treated by the government much
differently than food for domestic consumption. And USDA's
laws, as I understand it, or law, requires an evaluation of the
entire system of growing chickens, for example, plucking
chickens, processing chickens and preparing them for
consumption, whether for export or for import. And under those
standards, it's hard to imagine China reaching an equivalence
level in my lifetime.
Mr. Whitfield. Yes. Mr. Nelson, we're going to have some
other people testifying today from FDA and Tyson's and others
who are experts in this field. But you have a long history and
background in this area also, and certainly one of the experts
on this committee. But if you were speaking to a Rotary Club
say in the State of Kentucky and you were going to just make a
statement to the members of that Rotary Club if they ask you a
question, ``do you think it is safe to eat food from China that
comes into the U.S.,'' what would your answer be?
Mr. Nelson. I would say that you're taking your chances on
any imported food and some processed foods within the United
States. But those chances of any single person being seriously
harmed from food are really small.
Mr. Whitfield. OK.
Mr. Nelson. Food of any kind.
Mr. Whitfield. My time is expired.
Mr. Stupak. My time has expired. Thank you, gentlemen. Mr.
Dingell for questions, please.
Mr. Dingell. Mr. Chairman, I thank you.
Gentlemen, can FDA under current circumstances protect
American food supplies from unsafe imports with the resources
which it has?
Mr. Nelson. That would be an emphatic ``no.''
Mr. Dingell. Gentlemen, should we continue to allow food
imports to enter through 321 ports of entry?
Mr. Nelson. That would not appear to make any common sense
at all. We have 321 ports of entry in the United States and the
Food and Drug Administration doesn't cover but a fraction.
Mr. Dingell. How many of the Nation's ports--air, sea and
land--are staffed by FDA personnel?
Mr. Nelson. They tell us it is 90 ports, but it is highly
doubtful that that is 24/7 coverage of those ports.
Mr. Dingell. What percentage of imports are checked at
these 90-some ports, and what is the success in terms of
protecting consumers.
Mr. Nelson. Well, the agency says they inspect less than 1
percent. They test a fraction of what they inspect. And I think
there is still substantial risk. I mean, they don't make a
serious--they don't test enough to make a statistical statement
about the safety of food. I mean, the Japanese test 15 percent
of a highly regulated import system that goes to the countries
which supply the food. Inspections there. And they still test
15 percent, because that is a large enough sample for them to
have confidence that the food coming in is safe. But our tests
are so meager it is hard for me to imagine anybody having much
confidence in the results of the FDA inspections.
Mr. Dingell. Is the Chinese food production system
comparable to the United States system?
Mr. Nelson. No.
Mr. Dingell. What are you telling us there?
Mr. Nelson. When China ceded to the WTO, and perhaps
before, the collectivized farming systems collapsed. And you
have now literally hundreds of millions of small farm--some, as
the report said, no larger than the size of a basketball court,
producing the food supply. You have a lot of Chinese
bureaucrats, but nowhere near enough to police the number of
farms that they have and the number of small processors, which
is another issue. I mean, most of the food processed in China,
we are told, is by family processors, plants that employ less
than 10 people, that are just as marginal as the farms they get
the produce from.
Mr. Dingell. Is the Chinese regulatory system, in terms of
protecting consumers' health and safety, comparable to that in
this country?
Mr. Nelson. Not at all.
Mr. Dingell. Why do you say that? What percentage of the
foods that the Chinese produce are inspected or undergo some
kind of a safety procedure in China with regard to domestic
consumption or with regard to export?
Mr. Nelson. I would say virtually none with regard to
domestic consumption.
Mr. Dingell. Is it true that we can import food from China
safely under current Chinese practices and under current U.S.
practices?
Mr. Nelson. No.
Mr. Dingell. You have discussed briefly how Hong Kong
protects the food supply. Would you like to amplify on that?
Mr. Nelson. First of all, Hong Kong is a city of 7 million
people. It is about the size of Chicago. It is an
administrative district of China itself now, after the British
left in 1997. It is under special administration. It has got 40
more years to run before it is fully integrated into the
governmental system of China. It keeps its own tariff
territory. Importing in Hong Kong is separate and distinct from
importing into China, and China imports into Hong Kong. They
grossly limit the number of ports of entry for fish, or other
foods being brought in by sea, to perhaps two or three; land,
one or two.
They test intently because the SARS and other outbreaks
threaten not just the health of Hong Kong's citizens, the
physical health, they really have threatened the economic
viability of that entity. So food safety is a huge issue in
Hong Kong. They do a lot of testing, 64,000 samples last year,
of which only 0.3 percent were out of spec. That is partly
because the Chinese themselves are very, very concerned that
food outbreaks not occur in Hong Kong. It reduces the political
stability of the administrative entity, and they are constantly
aware of and concerned about the level of engagement of the
Hong Kong citizenry in policy issues and just as soon things
keep as quiet as possible.
Mr. Dingell. Mr. Chairman, I have used my time. I thank you
for your courtesy.
Mr. Stupak. Thank you. Mr. Burgess for questions, please.
Mr. Burgess. Thank you, Mr. Chairman.
Mr. Nelson, you and members of your staff and minority
staff who were there in China--and you have partly already
answered this question--but China internally has a domestic
problem with their food supply?
Mr. Nelson. A serious problem.
Mr. Burgess. And did you see evidence of that in either
news reports or did people talk about that when you were there?
Mr. Nelson. Yes.
Mr. Burgess. Many years ago, probably 15 years ago, as a
physician I went on a trip to China with some other doctors,
and I remember getting very ill when I was there in China. So I
was wondering, what did you and your staff eat?
Mr. Nelson. We ate what was served to us.
Mr. Burgess. Are you OK?
Mr. Nelson. I was. That is not true of everyone at this
table.
Mr. Burgess. And I note the absence of the minority staff.
Were they your testers?
Mr. Nelson. We have always joked about taking the minority
along to taste the food, yes.
Mr. Burgess. And, of course, we are teasing about it, but I
remember over there seeing some of those small farms that you
talk about, the size of basketball fields. And at the time, the
collective system was still very much up and running, but these
were small individual plots that were allowed, and people were
allowed to develop, as entrepreneurs, small farms.
There wasn't much in the way of automobile or truck traffic
in 1993, but there was a lot of bicycle traffic. So there was,
in my mind at least--and I wasn't a student of the issue by any
means at the time. But you had these small farms that were
irrigated and fertilized essentially by raw sewage. And that
raised a host of questions. And then to get these products to
market, they were put on the backs of these bicycles, in large
baskets or things that would then run along the road, and all
of the water, of course, whipped up by the bicycle wheel
splattered up on the basket. And you couldn't help but wonder
if a bacteria or two would find its way through the basket
weaving. So I did wonder about that at the time.
So that is why I was interested if you found the problem
was still, in fact, still present or maybe worse than what I
saw.
Ranking Member Whitfield asked some questions about
equivalency, which I think are particularly relevant to the
discussions that we are going to have not only today but in the
hearings to come, whatever legislative markups we have in the
future. Why do you think there is no equivalency standard
written into the Food and Drug Act?
Mr. Nelson. I mean, I think it is a matter of the way that
the commodities have been treated historically. I think there
are far more serious outbreaks regarding meat historically in
the United States than there have been for other products.
Mr. Burgess. Well, I have, I guess, a paper from the United
States Department of Agriculture, the Food Safety Inspection
Service Office of Internal Affairs. Under ``definitions,''
equivalence is defined as a state wherein sanitary measures
applied in an exporting country, though different from measures
applied in the importing country achieve, as demonstrated by
the importing country, the importing country's appropriate
level of sanitary protection; hence, the term ``equivalence.''
That seems like a pretty reasonable standard that the USDA
applies. Is there some problem from just a trade perspective
that prevents us from having an equivalency standard in the
Food and Drug Act?
Mr. Nelson. Well, we would cut off a substantial portion of
food imports from the world if we had such a standard. The USDA
is here today and we invited them--Mr. Stupak invited them
specifically so we could get a better understanding of the two
systems.
Mr. Burgess. Correct. And I am anxious to hear that--on
page 14 of this document that has been provided to me.
Paragraph 8, ``equivalence verification,'' they give their
equivalence triad a little description or drawing of how
document analysis is balanced with port-of-entry reinspection,
balanced with on-site audit. And that just seems so reasonable
applied to what we are talking about today that would prevent
problems. Yes, expensive perhaps, but we see the Japanese are
willing to pay that premium.
And I have got to tell you, if I went to Kentucky Fried
Chicken tonight and they said, You can have this bucket of
chicken for eight bucks but you are maybe going to get sick, or
you can buy this one for nine bucks and you will probably stay
well, I'll take the $9 chicken, please.
It doesn't seem that from the consumer side--we sat here
and saw just really moving testimony from the family whose
daughter had the renal damage from eating the spinach, and that
wasn't even an imported product. That, at least we were told,
was grown in the United States. It was not imported. I have got
to believe that consumers would go to the ends of the Earth not
to bring bad products home to feed their family. I mean, it is
not even common sense. I don't even think we would have to
debate it.
Let me just ask you one question before my time expires. I
am interested in the comment you make on the very last page of
your testimony in talking about the Hong Kong--the methods they
use there would not be viable even if the political environment
were not a factor. How is the political environment a factor in
the Hong Kong-type of regulation?
Mr. Nelson. Well, the Chinese Government generally, and the
Guangdong Government specifically--which is a province across
the border from Hong Kong--are very concerned that Hong Kong be
stable. And bad food, particularly poultry coming in from
China, destabilizes the--it is not a colony anymore--
administrative district much more than they would like.
For example, the person with food safety responsibility in
Hong Kong told us that if an import--and again, they test so
much. If that 0.3 percent that is out of spec comes in and is
just marginally out of spec, the central government in Beijing
will shut down the ability of that food processor or that farm
to ship to Hong Kong or anywhere else until the problem is
taken care of.
Mr. Burgess. Mr. Chairman, I know my time is up, but that
is such an important point. They have the ability to hit the
red button on the conveyor belt, stop the process so no one
else gets sick. And really what I'd like to see, whatever we do
legislatively, I want us to have that red button in this
country for our consumers.
And I will yield back the balance of my time.
Mr. Stupak. I thank the gentleman.
And country-of-origin labeling we have been trying to do
since 2002. Hopefully the administration will allow that in, so
we know if it is an $8 bucket of chicken or a $9 bucket of
chicken, so we know.
Second, the poultry issue in Hong Kong and the Guangdong
province is because of the bird flu and SARS and all the other
problems we face. Why is it there, but not in the rest of the
world where it doesn't seem to be concerned about it----
Mr. Burgess. I do need to make a comment about the country-
of-origin labeling, because Dr. Hubbard addressed this. When
you have got Canadian olive oil, unless global warming is a lot
worse than I thought, you can't have Canadian olive oil if you
have got appropriate country-of-origin labeling.
Mr. Stupak. But you certainly wouldn't know where the
poultry, the beast, the eggs and all the way down the line,
where it comes from.
Mr. Burgess. Country-of-origin labeling is meaningless
because the----
Mr. Stupak. Let the consumer decide.
Mr. Burgess. If you have Canadian olive oil--clearly there
are no olives grown in Canada. How can you have Canadian olive
oil, again, unless Al Gore was absolutely right.
I yield back.
Mr. Stupak. Ms. DeGette for questions.
Ms. DeGette. Thank you, Mr. Chairman.
Mr. Nelson, you had told several other members that you
toured a food laboratory in Beijing, part of the China
inspection and quarantine offices, one of those. I take it that
those offices are roughly the equivalent of an FDA district or
regional office with a lab; is that right?
Mr. Nelson. That is correct.
Ms. DeGette. Can you talk about what you saw at that food
laboratory during your visit to that lab?
Mr. Nelson. Well, none of us here is a scientist, much less
a food scientist. But as you are aware, we have been to a
number of FDA labs during the course of this investigation,
particularly those that the FDA has threatened to shut down,
And we have some acquaintanceship with what the various and
sundry machines look like. And the Beijing CIQ lab was
equipped, the visual opinion of a nonscientist here, was
equipped at least as well as any FDA lab we saw in the United
States. And we have no reason to believe that their food
scientists are any less qualified. The question is: Is Beijing
atypical? And the response is ``probably.''
Ms. DeGette. It is atypical?
Mr. Nelson. Yes.
Ms. DeGette. And why do you say it is probably atypical.
Mr. Nelson. Because everyone--not everyone. People we talk
to in the U.S. Government or our multinational corporations
that have businesses throughout China that have knowledge of
the way things operate throughout China believe that the
quality of inspection, the quality of sampling, the quality of
regulation varies widely among the provinces.
Ms. DeGette. How many of these labs are there throughout
China?
Mr. Nelson. The Ministry of Agriculture told us there were
323 labs capable of certifying that food meets international
standards. When we got talking to the AQSIQ, they reduced that
number to 50.
Ms. DeGette. What is the AQSIQ?
Mr. Nelson. That is the agency in China responsible for
food exports.
Ms. DeGette. And what did they say?
Mr. Nelson. They said 50.
Ms. DeGette. Fifty. And you don't have any idea what the
staffing levels or the technological levels of those offices
are?
Mr. Nelson. No.
Ms. DeGette. Now, did you talk to the Chinese about the
problems we have been having here, in particular the melamine
and the wheat gluten? Any of you? Mr. Barstow?
Mr. Barstow. Yes.
Ms. DeGette. How did they explain that? Mr. Wilfong.
Mr. Wilfong. Yes, ma'am. The wheat gluten--we had a long
discussion with AQSIQ, with Vice Minister Wei, and it was
repeatedly brought up that while China is willing to certify--
they are willing to certify their food exports, which they
require all their food exports to be certified, tested and
certified as food, the wheat gluten incident, the melamine and
wheat gluten was a way since the U.S. doesn't recognize the
certification, the FDA doesn't require it for imports from
China, so therefore it is not looked for on the paperwork on
this end. The wheat gluten was actually exported from China as
industrial use.
Ms. DeGette. So they didn't consider that to be food? Is
that what you are saying.
Mr. Wilfong. On their end it was exported as industrial
use, not as food. And then the disconnect between the two
systems on this end--since that certification isn't required
and looked for for a food import on this end, it was actually
imported as a food product;.
Ms. DeGette. So it was a problem in the two countries'
standards in what it was called and what was required to be
reported?
Mr. Wilfong. Yes, ma'am. And that is their main contention,
is that they are willing to certify that there are exports of
food, that they do certify all food they export. Yet our lack
of recognition and requirement for these certifications leaves
a big loophole for valid companies to actually import into the
United States or export to the United States.
Ms. DeGette. They say that is not their problem if there is
a loophole. That is not their problem.
Mr. Wilfong. They recognize the problem. We probably had a
1-hour discussion with the vice minister and they brought it up
three times, that they really wish we would recognize their
certifications. They are doing their work on their end; we are
just not requiring that certification paperwork on our end.
Ms. DeGette. Yes. I mean, what about the processing system?
I mean, that is at the lab. What about coming up to the export
level?
Mr. Nelson. What their system is--and we watched this in
the Beijing CIQ--an export certificate has to come from a farm
or food processor that is approved, registered and approved for
exporting, and that requires some form of local inspection. So
only a certain number of entities can bring a request for an
export certificate to the CIQs. And allegedly, a CIQ inspector
samples the proposed lot from the lot, brings it to the CIQ
laboratory where it is then tested to both Chinese and
international standards. If it meets those standards, it is
granted a certificate and that information is transferred
electronically to the proposed port of exit so that people can
feel assured that what has been tested is what gets loaded.
Now, if the system worked like that, it is a very safe,
closed system. No one that we talked to in the industry really
thinks that it works that well. But it certainly works better
than products that are exported from China without those
certificates.
Ms. DeGette. Thank you. My time has expired.
Mr. Stupak. Thanks, Ms. DeGette. Mr. Inslee for questions,
please.
Mr. Inslee. Thank you. I appreciate Ms. DeGette's questions
about this not accepting or reviewing the Chinese certification
process, which apparently was one reason for the melamine
problem, because there is a disconnect.
What possible reason is there for us not requiring at least
that? Even if the Chinese system internally is ineffective, or
at least not totally proficient, why wouldn't we at least
require their certification process to be complied with before
we accept any product that could end up in our food chain here?
Does that make any sense?
Mr. Nelson. No. We posed that question to some of the
people that are engaged in negotiations, with HHS on FDA's
behalf, with China right now. And the responses we got were,
Well, we might not want to exclude small farms and small
processors from exporting to the United States; that somehow or
another that was ideologically unacceptable; and the Chinese
could use it, possibly to exclude American firms that wanted to
set up operations in China for export to the United States.
These were some of the excuses. But we have FDA witnesses. You
best put those questions to them.
Mr. Inslee. But these are excuses by our side of----
Mr. Nelson. By our side.
Mr. Inslee. Do we do that in any other context for other
countries? To me it is difficult to understand in any country
that has any regulatory system, to not at least allow that
minimal level of inspection to require that. Do we do that in
any other context?
Mr. Nelson. None comes to mind. What's important about the
certification system in China is that it excludes almost all
producers--it is a very small percentage of farms and food
processors that qualify for those export certificates. It
doesn't mean that the food they produce is going to be 100
percent safe or 100 percent inspected, as the Chinese
Government maintains it is. But at least you are not getting it
from the 90, 95 percent of the food industry in China that
doesn't go through the system.
Mr. Inslee. And do you sense one of our failures to require
that is actually some fear that American firms would be
disadvantaged somehow?
Mr. Nelson. That is one of the excuses that we heard. I
don't think that the administration has really thought this
through. At least the people we were talking to didn't seem to
be aware of how the system works, for example.
Mr. Inslee. If you were going to rank the top three
priorities from your experience in China for us to adopt, where
would you put them?
Let me ask it a little easier. The most cost-effective.
Tell us, from your observations, what would be the three most
cost-effective things we could do to tighten this net?
Mr. Nelson. As an economist, I'd tell you, first, you would
have to tell me how you value safety. If you put a high value
on safety, the system that we heard about that the Japanese
employ appears to be a far safer system than we have, because
they actually have government inspectors going to a limited
number of plants who produce food for the Japanese market. So
those plants are not only part of this Chinese certification
system, they are also part of a Japanese inspection system.
And then Japan, on top of that, does 15 percent laboratory
testing of the imports. That is a pretty expensive proposition
both in terms of the government resources involved in Japan and
in terms of the prices of these products in China.
One of the real problems with toys or food or anything else
in China is the incessant downward pressure to get cheaper and
cheaper and cheaper. And we are dealing with entities, people
that are living at the margin. That means that niceties, like
the downside safety effects of what they do, get less and less
important. And what the Japanese system does is--as far as I
can tell--as it has been described to me--is create some pretty
valuable franchises, franchises whose prices can't be
depressed. So there is a price effect to that. There is a price
premium and food is more expensive, I understand, in Japan than
it is here. And they get a lot of it from China.
Mr. Inslee. Thank you.
Mr. Stupak. Thank you, Mr. Inslee. Mr. Waxman for
questions, please.
Mr. Waxman. Thank you, Mr. Chairman.
Mr. Nelson, does China treat the food that is going to be
consumed domestically differently than the food that is going
to be exported?
Mr. Nelson. That is what we are told.
Mr. Waxman. What do they do differently for the exported
food?
Mr. Nelson. For the exported food, they tell us they
inspect every lot, that they largely come from HACCP-controlled
plants, which means there is an ongoing testing program at
various stages of the production process, and that they sample
every lot and test it in a government lab to both Chinese
standards and the standards of the country to which it is to be
sent. And certainly that is not done for the domestic food.
Mr. Waxman. This is what they tell you they are doing for
the exported food. Do you believe it?
Mr. Nelson. We couldn't find anyone that thinks that that
practice is universal throughout China. But I think that the
Chinese Government certainly wants that system. The AQSIQ wants
that system to function well.
Mr. Waxman. They want it to function well. But you cannot
testify to us that it is functioning well?
Mr. Nelson. That is right. All of this is done at the local
level and the quality of the local officialdom, we are told,
varies widely.
Mr. Waxman. I'm really stunned by the amount of imports
that we are taking into the United States. In 2005, 84 percent
of all fish and shellfish consumed in the United States was
imported; 54 percent of all tree nuts, 43 percent of all
noncitrus fresh fruit, 37 percent of all processed fruit in the
U.S. were imported in the same year. That is not just from
China; that is from other countries as well. Is China better or
worse than some of these other countries where we are importing
food?
Mr. Nelson. We haven't been to other countries, but to the
extent that you can rely on FDA's very small sample, China is
in the top three. Virtually all categories for rejected food.
But it is not the top one. We reject more food from India. We
reject more food from Mexico.
Mr. Waxman. We have to rely on our Food and Drug
Administration here in the United States when it comes to these
agricultural products, including fish. One of the proposed
alternatives that we have pending in the Congress is to have
the FDA see whether a country has a certification process that
would indicate that it is checking the safety of the food that
might be imported. And it appears that China claims that they
have such a system, but it doesn't sound like one we can rely
on. Is that where you come down on that issue?
Mr. Nelson. From the evaluation of the investigation we
have done today, yes. But a certification system, an evaluation
of equivalence, anything like that would require far more work
than we have done. The legislation that we are considering in
the committee not only requires a certification for the
country's evaluation of the safety, but if that is not adequate
enough, then the Food and Drug Administration could go to each
individual farm. Is that what it would be? Or a processing
plant? What would we then do if the country didn't meet the
standards?
Mr. Nelson. Without commenting on the legislation per se,
which is not our assignment, we would need a lot more people if
we were going to adopt a Japanese-like system of going over and
inspecting every plant that was going to be shipping food to
the United States from China. And that is just China. I mean,
there is still the Dominican Republic, there is still India,
there is still Mexico.
Mr. Waxman. So, when we hear about 15 percent of all food
consumed in the United States is imported, the American
consumers assume that they are taking on the risk because we
are not confident that the food that is brought into the United
States is safe?
Mr. Nelson. Consumers are taking that risk. They also take
risks with food that is produced here. Almost all of the
really, truly serious outbreaks last year, that you experienced
in 2007, has come from domestically produced food. Now, part of
that is great good fortune, and the good fortune was that wheat
gluten was intended for pet food and not human food. If it had
been put in the human food supply, I don't think the statistics
would be the same.
Mr. Waxman. Thank you, Mr. Chairman.
Mr. Stupak. Mr. Melancon for questions, please. You have
some extra time also.
Mr. Melancon. Thank you, Mr. Chairman. I appreciate the
time. And I come from an agriculture background. And one of the
things I have attested to on all of these free trade agreements
is that we have taken away the authority of the Congress to
govern or oversee the commerce in this country. And now it has
taken us to have hearings about food safety, when we had the
safest food supply in the whole world until the time we started
giving away that entity, I guess, to foreign producers.
I have a lot of seafood in my district, as you are quite
aware. I believe in country of origin labeling. It is as
complicated as putting produced or grown and produced in
whatever country or State it was, and bottled and shipped from
whatever State it is, and those computers do that quite easily
these days. So I don't think it is such a complicated task to
ask for that.
On seafood, does Hong Kong allow seafood from China with
any evidence or traces of antibiotics into their country?
Mr. Nelson. No. And they also very much limit the ports of
entry. And they take one added step. Hong Kong is China. I
mean, the stuff is coming down from the Pearl River. So they
limit the imports to two piers, and they have gone to a system
where not only does the stuff have to be certified at the fish
farm, but they put a net over the hold and physically seal it,
like you would seal a container in order to prevent bad fish
from being substituted for good fish along the way.
The mainland Chinese--the PRC and the Hong Kong Government
are very, very sensitive to the quality of food that is
imported into the administrative district.
Mr. Melancon. It kind of sounds like the piece of drum I
had the other night that was called Chilean sea bass. And there
is a distinct difference between the two. But I guess they
figure that most people wouldn't know. When the farm-raised
fish, the farm-raised shrimp, the produce that comes into the
United States from China--or from any other country for that
matter--we have a limited--well, we have an enormous number of
ports, as I appreciate it, that will accept imports, whether it
is agency-tested, or take samples or not.
How many do we have in this country for food or seafood
imports? Do you know?
Mr. Nelson. Well, there are 321, as we understand it.
Customs mans 321 ports of entry.
Mr. Melancon. And I understand in Europe they will send
back, or not allow into the country, food that doesn't meet
their standards. They have limited, I believe, the number of
ports that foodstuffs can come through in the European Union.
Mr. Nelson. I don't know.
Mr. Melancon. Do you know how many ports they may have for
importation into the European Union.
Mr. Nelson. No.
Mr. Melancon. I'm trying to get an analogy for myself,
because we have in the United States the importers all up in
arms because you want to constrain where you bring your
foodstuff in, which they all want to bring it in wherever they
want to bring it in. Those that don't want to abide by the
rule, obviously because they are not going to get tested, and
they will get it in. I saw a copy of an ad for a firm that was
advertising, ``If you have been rejected by FDA, get in touch
with us; we can help you market your seafood.''
Is that a repackaged resell, or is that they are going to
send it to another country?
Mr. Nelson. Well, it could be they are a laboratory that is
going to assure the importer gets the kind of results that will
get through the FDA system. Back in June, the FDA issued an
import alert. And that import alert covered five varieties of
fish, one of which is shrimp; so four varieties, and shrimp
from China for antibiotic and possible fungicide, malachite
green contamination.
Now, the Chinese, when we were over there, kept telling us
that this was awful, that it was going to cost them $500
million because we were banning the import of fish. And I don't
think they had any appreciation of how lax the regulations
regarding import alerts are, and we had to explain to them that
nothing was being banned. In fact, the fish were going to
exactly the same place, that they would go through without an
import alert. That is to say, they were going to be delivered
to the importer's premises, at which point the importer is
required to have the fish in this case tested to see whether or
not it is contaminated with antibiotics or malachite green.
And any source from China, not the country but the
processing plant, the entity that is exporting, if they pass
muster on these private lab tests five times, then they are off
the import alert and can bypass the requirement of private
laboratory testing.
But we have become very, very skeptical about laboratory
testing for a lot of reasons--private laboratory testing for a
lot of reasons, and our skepticism is growing.
Mr. Melancon. It wouldn't have anything to do with you get
what you request when you pay?
Mr. Nelson. We have heard there are laboratories that don't
find products--fish, produce, whatever they are testing--ever
to be out of compliance. And then we find other laboratories
that do something we would never allowed in the drug area. If a
drug company did was a clinical study, the efficacy didn't show
up, or the safety problems developed and they told the people
doing the study to throw it away, they would be in very serious
trouble, both the clinicians that were doing the study and the
sponsoring company.
But apparently there is no real penalty, and it is in fact,
we are told, a practice within the food system that if a
private laboratory gets a result that the importer doesn't
like, that they work not for the FDA--in fact, they were not
inspected or certified or in any way controlled by the FDA--
they have nothing on the line. The FDA can't even ban them from
being used by these importers. They work for the importer, and
if the importer tells them to put the test results in a dust
bin and just send them a bill, that is very common practice.
Mr. Melancon. Do we in this country have the ability to get
away from the contractors' lists and utilize universities,
would that give us more credibility in the results? If, in
fact, we are not able to stand up enough labs because of the
cost, are there enough universities that could take samples and
do the work for us, and do you think the integrity of the tests
would be pretty upstanding?
Mr. Nelson. We do use universities in what is called the
FERN system, and the FDA does contract with universities to do
some of the testing now. And those universities are qualified,
the ones that are in the system, to do testing of--particularly
involved in----
Mr. Melancon. Is there a standard regimen of tests they are
required to make when they are a contractor?
Mr. Nelson. FDA witnesses are coming up. I'd suggest if you
want the specific details you talk to them about it. We do use
universities, though.
Mr. Melancon. One more question. Does Hong Kong use private
contractors or is that state-run?
Mr. Nelson. No. That is all government labs. They, of
course, don't have to maintain all the other governmental
expenses that we do.
Mr. Melancon. Thank you, sir.
Mr. Stupak. Thank you, Mr. Melancon. Mr. Green for
questions.
Mr. Green. Thank you, Mr. Chairman.
First I'd like to thank our investigators for spending part
of their August in China. Having been there once, but having
both family and friends who have gone there to spend a lot more
time in doing work like what you do, it is probably not as
pleasant as what we did in just meeting with officials.
One of the interests I have is comparing what, for example,
Hong Kong and Japan is doing with--Hong Kong actually has a
vigorous inspection system, whereas Japan actually has the
preferred importers, so to speak, I guess they investigate what
they do in China, for example. Does the Japanese, though, have
a food inspector at every port of entry that brings in food or
is authorized to bring food in?
Mr. Nelson. That is my understanding. We are very
fortunate, in the next panel, of having people with a lot of
expertise on Hong Kong and Japanese and Chinese regulatory
systems.
Mr. Green. One of the interests I have, though, is I note
for example, the testimony we will hear in a few minutes is
that FDA has inspectors at 90 ports now, and USDA has it at 140
ports, both land and ocean, and yet FDA has 80 percent of the
responsibilities as compared to the USDA which has 20 percent.
I would assume that the countries that you looked at would have
that percentage reversed; you would actually have more
inspectors for the food that the FDA would do under ours as
compared to the Department of Agriculture. But anyway, that is
just a question, and I will wait until our next panel.
You mentioned the Chinese efforts to strengthen the safety
of imports through what's called a red list and a black list.
And can you talk about the effectiveness of that red list and
black list in rooting out some of the bad actors? Was that part
of your investigation?
Mr. Nelson. We talked with the AQSIQ about the systems.
They listed it as one of five essential parts of their program
for guaranteeing the safety of the food exports. They told us
that there were 55 firms on the black list, which, given the
press reports of what happens to people when the Government of
China is truly upset with them, is a list I wouldn't want to be
on. It was not clear what the preferential treatment for the
good actors was.
Mr. Green. Another question is the export certificates are
certificates granted at the local level? And the political
situation I know varies from province to province and there has
always been a geopolitical question about how much the central
government controls in some of the provinces as compared to the
local officials.
Can you speak to any of the concerns about corruption? Is
there any particular--that the Federal Government may not
actually have the apparatus to make sure those export
certificates are valid when they are issued by the local
government.
Mr. Nelson. Except for the power to yank a firm's ability
to acquire an export certificate, all of the decisions are made
on a local level. I mean, if a firm gets caught exporting
something out of spec, then the Beijing Government will yank
their authority to export until the problem is solved. But they
don't do any of the inspections, they don't control any of the
budgets.
The rubber meets the road at the local level, and we are
told that that varies widely. Some provinces like Guangdong
have apparently very effective CIQ systems. The province that
is immediately across the sea from Japan that sends a lot of
the produce on a just-in-time basis to Japan apparently has a
fairly good regulatory system, but other provinces may not.
Mr. Green. Mr. Chairman, one last question, I guess, is
that if produce is exported to Hong Kong, it is rigorously
inspected, is there any transshipment of that produce? Could
Hong Kong, because of their rigorous system, be someplace that
would be a preferred export port, for example, because of their
effort as compared to the other ports in China?
Mr. Nelson. I don't think Hong Kong exports food. They
import 95 percent of the food they consume. And almost all of
that is from China. I mean, you can get French wine, you can
get some form of Iowa beefsteaks without the bone. But they are
not a food exporter.
Mr. Green. Thank you, Mr. Chairman.
Mr. Stupak. Thank you, Mr. Green.
If anyone else has questions, we will just do another quick
round here. You mentioned a couple of times the AQSIQ. That
stands for the Administration of Quality, Supervision,
Inspection and Quarantine?
Mr. Nelson. Yes.
Mr. Stupak. Mr. Barstow, when you met with Chinese
officials, what was their opinion about the concerns Americans
have concerning the quality and safety of Chinese food?
Mr. Barstow. The AQSIQ said they had been studying the
concerns that Americans have, and the exported food problems
are perceived to come from China. And they came up with three
conclusions.
The first conclusion was that there are some real safety
and quality problems in China. The example they cited for this
conclusion was the melamine in wheat gluten. They said when
this kind of problem happens, they are dealt with according to
law and regulations. In the melamine case, they said that they
shut down the factories as soon as they learned about it and
that they filed suit against the two companies that were
responsible.
Mr. Stupak. Did you ask why they wouldn't let the FDA
inspectors in to check these melamine plants?
Mr. Barstow. That is another issue.
Second, they said that there are different international
standards that create problems. In this conclusion, they cited
the toothpaste example. Earlier this year, toothpaste from
China was found to contain diethylene glycol, or DEG. In China,
it is permitted to be present in up to 15.6 percent of
toothpaste there, and international standards said that DEG
could not be in any toothpaste. China said that there were no
real safety problems with DEG in toothpaste but they succumbed
to international pressures and now banned its use.
However, that still doesn't explain why the DEG was listed
as glycerin, which is the harmless ingredient that it replaces.
Third, they said that they believed the Western media,
particularly the media in the United States, has blown the
safety and quality problems out of proportion. They believe
press reports have been unfair.
Mr. Stupak. Thank you.
Mr. Nelson, at the last food safety hearing, we spoke about
the FDA food import alerts, specifically import alerts that
contained the instruction, ``detention without physical
examination.''
Remind us again, what does that mean, ``detention without
physical examination''?
Mr. Nelson. I think all import alerts contain that. It
means that the product goes to the importer's premises. And
before it can be released into the commerce of the United
States, the importer has an obligation to prove to the agency
that it is nonviolative. That is done by the importer
contracting with a lab to test it.
Mr. Stupak. So the FDA doesn't take control of it. They
don't send their inspectors in. The processor or the importer
has the food, and then he hires a private lab to test the
product?
Mr. Nelson. That is overwhelmingly the case.
Mr. Stupak. At the last hearing you spoke about port
shopping and how some importers choose to shift their products
to places without FDA inspectors or labs, and how some
importers try to get around the import alerts. Have you learned
of schemes being used?
Mr. Nelson. The one that was most disturbing was in talking
to people about private labs. An issue arose as to whether not
only--foods under import alert, but the surveillance testing
that the FDA does, the more randomized testing of imports
coming into the United States, there was a proposal that that
be contracted out to private labs. So we have been talking to
people in private laboratories. And the most shocking thing
that we have learned is that there is no apparent ethic within
the community nor is there any regulatory concern about taking
negative results, results that would indicate the food is
contaminated or decomposed or otherwise unfit for human
consumption, and just discarding them if the importer gives
them that instruction.
Mr. Stupak. If the Chinese Government says they certify
their labs and they certify these farms and things like this,
does the FDA certify the labs that the importers use to check
the results or for suspicious----
Mr. Nelson. Neither the FDA or any other governmental
agency.
Mr. Stupak. So these labs are unregulated. They work for
the importer and basically they get the results that they pay
for?
Mr. Nelson. Right. The FDA does audit. I doubt whether it
is significant. We have asked them what percentage. I suspect
it is very small. But the audits are largely an audit of the
paper. It is not an audit of the lab or its capacities to
produce the results that they claim to produce.
Mr. Stupak. You mentioned on drugs it does not occur. Are
those labs certified by the FDA for drug imports?
Mr. Nelson. Those labs--well, actually not necessarily.
University labs certainly are well supervised, and some of the
other labs that are used by drug companies for testing are not
anything more than doctors' offices, and some of them are even
done overseas now. But if a drug company gets caught cheating,
the FDA treats it as a criminal offense with serious
consequences for the individuals involved.
Mr. Stupak. What happens if a food importer gets caught
cheating at these labs?
Mr. Nelson. Nobody asks whether the food importer cheats or
not.
Mr. Stupak. So no one inquires?
Mr. Nelson. No.
Mr. Stupak. And, of course, your teams work on food safety
issues. I brought up last time other areas of concern,
particularly when we uncovered evidence of questionable
compensation at the FDA. Have you uncovered other questionable
practices?
Mr. Nelson. One of the practices which is detailed in--
well, the FDA information was received so far from--it has been
placed in the exhibit book and presumably into this record, as
well as into the record of the last hearing.
Mr. Stupak. Tab No. 35.
Mr. Nelson. Yes. It involves the abuse of the concept of
religious compensation, a concept where people are allowed to
work some overtime, so that they can take a religious holiday
every now and then, without taking vacation time. This has been
grossly abused in some cases.
Mr. Stupak. All right. I mentioned that we're going to have
a hearing on November 1 on drug imports, and November 13 on
domestic food again. You and your team will continue to work on
these issues, plus compensation issues at the FDA; is that
correct?
Mr. Nelson. That is our instruction.
Mr. Stupak. Thank you and thank you for your investigation.
Mr. Whitfield, any questions? Mr. Green any questions? Mr.
Melancon.
Mr. Melancon. I am back on seafood. Does China allow a high
concentration of antibiotics in their seafood domestically than
we do in the U.S.?
Mr. Nelson. Certainly more than we do. I don't know whether
it would be considered high. But we don't permit it.
Mr. Melancon. But we don't permit it, but we don't check
it?
Mr. Nelson. We haven't been doing a very good job of it.
The FDA has known about this problem since 2000, 2001. But they
didn't act on a countrywide basis until June 2006, about a
month after the first letter came from the subcommittee
requesting information about their regulation of seafood
imports.
Mr. Melancon. And we talked about shipping products and the
problem of different countries, different regulations and
guidelines and whatever. Don't you think it could be done,
particularly in these trade agreements on a WTO level, if we
are going to do it on a level playing field, that we have a
minimum requirement for all countries, and then each country
has its own specific requirements that these things can be
adjusted or adhered to if these countries want to export their
products to countries that have higher standards?
Mr. Nelson. They're supposed to meet our standards for
entry and they are supposed be denied entry if they don't meet
our standards. That's the law.
Mr. Melancon. But there are no teeth there to get them if
they don't?
Mr. Nelson. We don't have the resources to do the
inspections and the testing that we need to assure that the
problem is under control.
Mr. Melancon. Thank you. Thank you, Mr. Chairman.
Mr. Stupak. Mr. Burgess, we have been going around with
last-minute questions of this panel before we excuse them. Do
you have any further questions of this panel.
Mr. Burgess. Yes, Mr. Chairman. Thank you.
For a point of clarification, Mr. Nelson, when you talked
about the FDA testing only a fraction of what they inspect, you
made the statement they don't test enough and that there was no
confidence in their statistical standards. Did I understand
that correctly?
Mr. Nelson. Yes, sir.
Mr. Burgess. I'm not a statistician and I'm not really a
student of statistics. But from the very brief and unfortunate
association I had with the study of statistics in college and
graduate school, I recall that there were some scientific tests
and some scientific standards by which you could assure
yourself or--you didn't just pick a sample size out of the air.
There were actually formulas that could be followed to arrive
at a statistical number over which you'd have a certain degree
of confidence. So are you telling us that the principles of
statistics are not being applied in the metrics that are used
in our inspection facilities?
Mr. Nelson. Not only are the principles of statistics not
being applied, we have seriously degraded the percentage of
imports that we have tested for the last two decades.
Mr. Burgess. But there should be someone--not up here on
this dais--but someone who knows statistics, who is able to
advise our FDA on what is the sample size you should be testing
and what are the confidence limits that you can then project
from that sample size you've tested. Is that not correct?
Mr. Nelson. Theoretically.
Mr. Burgess. In your observation, were those statistical
methods not applied?
Mr. Nelson. The sample size is so small relative to the
size of the imports that I think probably you can't generalize
across all food imports.
Mr. Burgess. But we shouldn't have to intuit whether a
sample size is too small, just right, or too large. Someone,
presumably, who knows the science of statistics, should be able
to tell us this is the sample size that should be tested if you
want these confidence limits on the results that you are
seeking.
Mr. Nelson. I have seen that for drug safety, actually.
There have been some articles in journals published in the last
year on drug safety as a whole in the United States. I have
never seen it done for food.
Mr. Burgess. But again, presumably, the science of
statistics has developed enough where someone would have this
information and be able to share it with us.
Mr. Nelson. Quantitative risk assessment is possible. The
data isn't there.
Mr. Burgess. Well, whether the data is there or not from
the FDA standpoint, someone should be able to tell us if we are
doing not enough, if we are doing just right, or if we are
doing too much, as you may think in Hong Kong. Someone should
be able to rationally tell us what the sample size is we should
be testing. We shouldn't, again, be making that up as
legislators. We shouldn't be asked to make that up on the basis
of emotion, this looks right, this looks too small. Someone
should be able to tell us scientifically what the number is.
That would be my estimation.
Thank you, Mr. Chairman. I will yield back.
Mr. Stupak. Thank you, Mr. Burgess. With no further
questions, we'll excuse this panel. Thank you, gentlemen, for
your work.
And I will call our second panel of witnesses to come
forward. On our second panel we have Dr. Michael Martin, who is
an analyst in Asian political economy at the Congressional
Research Service. Mr. James Rice is vice president and country
manager for Tyson Foods in China.
It is the policy of this subcommittee to take all testimony
under oath.
Please be advised that witnesses have the right under the
rules of the House to be advised by counsel during their
testimony. Do any of you gentlemen wish to be represented by
counsel at this time?
Let the record reflect that both witnesses indicate that
they do not.
[Witnesses sworn.]
Mr. Melancon [presiding]. Let the record reflect the
witnesses replied in the affirmative. You are now under oath.
Dr. Martin, would you like to start with the opening
statement for 5 minutes?
STATEMENT OF MICHAEL F. MARTIN, ANALYST, ASIAN TRADE AND
FINANCE, FOREIGN AFFAIRS, DEFENSE, AND TRADE DIVISION,
CONGRESSIONAL RESEARCH SERVICE, LIBRARY OF CONGRESS
Mr. Martin. Chairman Stupak, Ranking Member Whitfield,
distinguished members of the subcommittee, thank you for the
opportunity to appear before you today. With your permission I
would like to submit my statement for the record and provide
you with a brief summary of its contents.
You have asked me to testify on how Hong Kong and Japan
ensure the safety of their food imports from mainland China.
While concern about the safety of food imported from China has
arisen in the United States in 2007, this issue has been
important to Hong Kong and Japan for a number of years. In
December 1997, Hong Kong slaughtered over 1.5 million chickens
to combat an outbreak of avian flu that claimed the lives of
six people. Virtually all those chickens had been imported from
China. In July 2002, Japan banned the import of frozen spinach
from China after several shipments were found to contained an
unacceptable level of pesticides. Prior to the ban, China had
supplied Japan with 99 percent of its imported spinach.
As a result, the Hong Kong Government has been aware of the
issue for at least 10 years and the Japanese Government has
been aware of it for at least 5 years. Food imports from China
are of particular concern to the Hong Kong and Japanese
Governments because China's an important source of food. China
supplies Hong Kong with about 80 percent of its food and Japan
with more than 10 percent of its food, second only to the
United States.
Under Hong Kong law, the primary responsibility to ensure
the safety of all food imported or domestically produced is
placed in the Hong Kong Food and Environmental Hygiene
Department in its recently established Centre for Food Safety.
In 2006, the Centre for Food Safety was given specific
responsibility for planning and implementing Hong Kong's food
safety policies, negotiating and managing relations with
overseas food authorities, including China, and consulting with
the businesses and people of Hong Kong about its food safety
system.
Over the last 10 years Hong Kong's Food and Environmental
Hygiene Department and its mainland China counterpart have
agreed to a set of administrative procedures to ensure the
safety of food shipped to Hong Kong. These special procedures
include joint visits to farms and food production facilities in
China, technical exchanges and frequent meetings to discuss
food safety issues.
In order to expedite inspection, Hong Kong limits the
number of points of entry for imported food. Failure to comply
with Hong Kong's laws and regulations governing the imported
food is punishable by up to 6 months in jail and a maximum fine
of about 50,000 Hong Kong dollars, or about 6,400 U.S. dollars.
In 2006, the Centre for Food Safety took over 64,000
samples for microbiological and chemical testing. The overall
failure rate was 0.3 percent. However, in its latest report,
which covers from July until August 2007, the center found a
slightly higher failure rate of 0.6 percent. Neither report
indicated what percentage of the imports were tested.
Turning to Japan, the Food Safety Basic Law disseminates
the enforcement of food safety throughout Japan's federal,
provincial and local governments. In general terms, the federal
agencies handle food safety enforcement for imported goods and
the provincial and local governments focus their efforts on
domestic enforcement issues. The Food Safety Basic Law also
created the Food Safety Commission, a cabinet-level independent
agency that overseas the government's activities on food
safety.
Food imported into Japan is subject to inspection by
roughly 300 inspectors located at 300 quarantine stations.
Inspections cover over 300 food products, nearly 800
agriculture chemicals and include nearly 55,000 inspection
criteria. Between April and September 2006 the ministry
inspected 10.3 percent of the shipments, 0.7 percent were found
to be in violation of Japanese law. The most recent amendment
to Japan's food sanitation law raised the highest penalty for
violation of the law to up to 3 years in jail or a fine of up
to 3 million yen, approximately 26,000 U.S. dollars.
Relations between Japan and China on the issue of food
safety take place in two separate arenas, government-to-
government relations and company-to-company relations. On the
government-to-government side, Japan has negotiated over 30
separate agreements with China, specifying equivalency
standards for the range of food items. Under these agreements,
Chinese health officials certify that specific farms and food
production facilities meet the agreed standards. In Japan, food
shipments from these certified Chinese farms and facilities are
afforded preferential treatment to imports from noncertified
farms and facilities. As a result, on the business-to-business
side, Japanese importers tend to source their food products
from the certified farms and facilities, often offering a
higher price for the goods in order to lower the risk of
shipments being inspected or impounded.
Based on the preceding summary as well as my written
testimony, I would like to offer four somewhat interrelated
observations. First, collaboration generally has been used more
than confrontation. Part of the overall strategy of Hong Kong
and Japanese food safety officials when dealing with their
mainland Chinese counterparts seems to be focusing on the
shared issue of protecting people from unsafe and unsanitary
food.
Second, the carrot has been used more often than the stick.
In their dealings with Japanese officials and businesses, both
Hong Kong and Japan appear to have adopted an approach of
providing incentives for the Chinese Government to cooperate
rather than penalizing failures to comply.
Third, food safety is not simply a matter of laws and
regulations. Another element of the Hong Kong and Japanese
approach to food product safety is the apparent focus on
creating incentives for businesses to comply with the laws and
regulations. Both Hong Kong and Japan seek to create an
environment in which it's in the best interest of the Chinese
food producers and exporters as well as the Hong Kong and
Japanese food importers to make sure that the imported food are
safe and sanitary.
Fourth, no system is perfect. No matter how well designed
the policy or how well the policy is implemented, it is
impossible to guarantee that every morsel of imported food,
whether it's from mainland China or some other location, is 100
percent safe and sanitary. The Hong Kong and Japanese
Governments have food safety policies in place but they both
continue to experience problems with tainted and unsafe
imported food products.
Chairman Stupak, Ranking Member Whitfield, distinguished
members of the subcommittee, this concludes my statement. Thank
you again for the opportunity to testify on these issues. I
will be pleased to respond to any questions you might have.
[The prepared statement of Mr. Martin follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Melancon. Thank you, Dr. Martin. We appreciate your
testimony. And I will wait for questioning.
Mr. Rice, you have a 5-minute opening statement if you
would, and if you have anything longer, if you would like to
submit it.
STATEMENT OF JAMES M. RICE, VICE PRESIDENT AND COUNTRY MANAGER,
TYSON FOODS, INC.
Mr. Rice. Thank you. My name is James Rice, and I am vice
president of Tyson Foods, Inc. I also served on the Board of
Governors of the American Chamber of Commerce in Shanghai. I've
worked with Tyson for the last 3\1/2\ years, but my involvement
in China began 20 years ago when I was an exchange student from
the University of California in 1987. In 1991, I returned to
China and have worked and lived there continuously until now.
Tyson Foods has a significant export business from the
United States to China. Of the U.S. poultry industry's $500
million in exports to China this year, Tyson's share will be
approximately $200 million, and our business is growing at 25
percent a year. China is now the largest destination of U.S.
poultry exports, and the largest U.S. exporter to China by
dollar value is poultry. Tyson also exports cattle hides and
pork from the U.S. to China.
In China, Tyson produces meat and poultry products for both
domestic and export consumption through two joint venture
operations. We maintain relationships with Chinese poultry
companies who produce products on our behalf for global
customers in Japan and in Hong Kong. So I hope to draw from
this experience to share with you some insights on China's
quality management processes.
Despite wide news coverage, China does have modern food
producers who are able to produce quality products for domestic
and for export consumption. China's General Administration of
Quality Supervision, Inspection and Quarantine, commonly known
as the AQSIQ, has processes that ensure quality food products
are exported. The evidence on the ground from what I have seen
indicates that modern manufacturers and the AQSIQ can do their
jobs, and their processes are improving.
China has a vital interest in improving its food safety
programs for many reasons, and the country is learning that
national food safety assurance systems require time, resources
and flexibility to accommodate industrial technological
changes. For example, the AQSIQ is now developing a food recall
system, improving labor requirements and also a traceability
system. Another example is China's Export Food Safety Program,
which requires that all export food must originate from an
AQSIQ-registered plant and be certified by a local China
inspection and quarantine agency, which is the local version of
AQSIQ.
The AQSIQ only authorizes 12,700 of the country's 450,000
food producing companies to export. This list is expanded and
shortened by the AQSIQ based on the performance of companies,
just like the USDA maintains a list of authorized meat and
poultry exporters in the United States. The way it works is
that Chinese food processors are certified to export. They will
notify the AQSIQ when they are going to produce for export, and
the AQSIQ or CIQ inspectors will be present during the process.
These inspectors will evaluate the suppliers, the raw
materials, the production process and the finished products.
Only after this process will they issue a certificate for
export. It is my understanding that for the most part food
safety issues we have heard about in the United States have
come from companies other than those authorized by the AQSIQ.
Chinese poultry exports to Japan have an additional level
of quality assurance. The AQSIQ has selected 35 of the best
poultry producers in China to be eligible to export to Japan.
Then Japanese Ministry of Agriculture, Forestry and Fisheries,
the MAFF, visited and certified these plants. They are
inspected annually by Japan's MAFF, but it's the AQSIQ that has
responsibility to ensure these 35 plants meet compliance with
both the Japanese import regulations and also the Chinese
export regulations. Today these plants operate at a higher
level than do their competitors, not only because the Japanese
customers require it but because the responsibility for food
quality and safety is shared equally and completely between the
manufacturer, the AQSIQ and the Japanese MAFF.
When Tyson manufactures products in China, both for
domestic and for export consumption, we use only these Japanese
certified suppliers, ensuring that we start with the best
suppliers. These suppliers and their suppliers are audited
regularly by our American quality assurance manager and we
practice at our facility 100 percent inspection of all incoming
raw materials. When Tyson products are manufactured by our
partners, our quality assurance manager and our American plant
manager are in those facilities to ensure the same quality
standards are maintained. Our global customers also audit our
plants and our suppliers, and the net result is that
regulators, the manufacturer, and the customers are working
together to ensure the quality of our products.
As a brand owner, our job is to be certain that all levels
of private and public sector quality assurance work together to
identify, manage and mitigate all food safety risks. In this
way, regulators, brand owners share food safety responsibility
with foreign regulators and manufacturers. Not that the
responsibility is divided but that every entity shares 100
percent responsibility to be sure the product is right before
it leaves the Chinese plant.
There's no question that China plays an enormous role in
the global economy as both an importer and an exporter of foods
and many other products, but we need to consider how to work
with China and make sure that relationship is mutually
beneficial. The end result is that both countries can implement
the same quality standards and sell the same high-quality
products to both countries.
Thank you.
[The prepared statement of Mr. Rice follows:]
Testimony of James M. Rice
My name is James Rice and I am vice president of Tyson
Foods, Inc. and Country Manager for Tyson's China Operations. I
also serve on the Board of Governors of the American Chamber of
Commerce in Shanghai. I have worked with Tyson for the last
three and a half years. My involvement with China began 20
years ago when I was an exchange student from the University of
California in 1987. I returned to work in China in 1991 and
have lived and worked continuously in China ever since.
Tyson Foods, Inc. has a significant export business from
the U.S. to China. Of the U.S. poultry industry's $500 million
in exports to China this year, Tyson's share will be
approximately $200 million and our business continues to grow
at a rate of more than 25 percent a year. China is now the
largest destination for U.S. poultry exports. And the largest
U.S. export to China, by dollar value, is poultry. Tyson also
exports cattle hides and pork from the U.S. to China.
Tyson also produces meat and poultry products in China for
both domestic and export consumption through two joint venture
food processing facilities. We maintain relationships with
local Chinese poultry companies who produce products on our
behalf for global customers in Japan and Hong Kong. I hope to
draw from this array of experience to share with you some
insights on China's quality management processes.
Despite wide news coverage of its challenges, China does
have modern food producers who are able to produce quality
products for domestic and export consumers. China's General
Administration of Quality Supervision, Inspection and
Quarantine (AQSIQ) has processes that ensure quality food
products are exported. The evidence on the ground indicates
that the modern manufacturers and the AQSIQ can do their jobs,
and they are rapidly improving their processes.
China has a vital interest in improving its food safety
programs for many reasons, and the country is learning that
national food safety assurance systems require time, resources
and flexibility to accommodate industrial and technological
changes--as well as shifting global demands. For example, the
AQSIQ, from what I understand, is developing a food recall
system, improved labeling requirements and a product
traceability system.
Another example is China's export food safety program,
which requires that all exported food must originate from
AQSIQ-registered plants and be certified by the local China
Inspection and Quarantine agency, or CIQ. From what I
understand, AQSIQ only authorizes 12,700 of the country's
450,000 food companies to produce for export. This list is
expanded and shortened by the AQSIQ based on the performance of
the companies, just like the USDA maintains a list of
authorized meat and poultry exporters in the US.
The way it works is that Chinese food processors certified
to export will notify the AQSIQ when they are producing for
export, and AQSIQ inspectors will be present during the
process. They will evaluate the suppliers, raw materials,
production processes and finished products. Only after this
will a Certificate for Export be issued. It is my understanding
that for the most part, food safety issues we have heard about
have come from companies other than those authorized by the
AQSIQ.
Chinese poultry exports for Japan have an additional level
of quality assurance. The AQSIQ selected the 35 best poultry
producers for eligibility to export to Japan. Then, Japan's
Ministry of Agriculture, Forestry, and Fisheries (MAFF) visited
and certified these plants. They are inspected annually by
Japan's MAFF, but it is China's AQSIQ that is responsible for
ensuring these 35 plants' continuous compliance with both the
Japanese import standards and the Chinese export standards.
Today, these plants operate at a higher quality level than do
their competitors not only because their Japanese customers
demand it, but because the responsibility for food quality and
safety is shared equally and completely by the manufacturer,
the AQSIQ and the Japanese MAFF.
When Tyson manufactures products in China--for both
domestic and export consumption--we use only suppliers that are
already certified for Japanese export, ensuring that we start
with the best suppliers. These suppliers, and their suppliers,
are audited regularly by our American quality assurance
manager, and we practice 100 percent inspection on all raw
materials coming into our facility. When Tyson products are
manufactured by our partners, our quality assurance manager and
our American production manager are in those facilities
ensuring that the same quality standards are maintained. Our
global customers also audit our plants and our suppliers. The
net result is that regulators, the manufacturer, and customers
are working together to ensure the quality of our products.
As the brand owner, our job is to be certain that all
levels of private and public sector quality assurance work
together to identify, manage and mitigate all food safety
risks. In this way, U.S. regulators and brand owners share food
safety responsibilities with foreign regulators and
manufacturers. Not that the responsibility is divided, but that
each entity shares 100 percent responsibility to be sure the
product is right before it leaves the Chinese plant for the
United States.
There is no question: China plays an enormous role in the
global economy as both an importer and exporter of foods and
many other products. We need to consider how we work with China
to be sure our relationship is mutually beneficial. The end
result will be that both countries can implement the same
quality standards, and guarantee that high quality products
could be sold to consumers in both countries.
----------
Mr. Melancon. Thank you, Mr. Rice. Appreciate your
testimony. Mr. Green, would you like to entertain some
questions?
Mr. Green. Thank you, Mr. Chairman. Mr. Rice, in your
testimony, you stated that Tyson manufactures products in China
and uses only suppliers that are already certified for Japanese
export. Do you pay a premium for that?
Mr. Rice. Yes. The purchasing of raw meat from a Japanese
certified supplier will cost us about 20 to 30 percent more
than any other uncertified poultry company.
Mr. Green. I know there are lots of other companies that
import from China. Do you know any of the other companies that
make that determination to only use the Japanese export
certification?
Mr. Rice. No, I don't. It's our policy because we want to
start with the higher quality. I don't know about the other
guys.
Mr. Green. You state that 35 poultry producers are eligible
to export to Japan, these producers selected by China's AQSIQ.
Do you know how many of these 35 plants actually export to
Japan?
Mr. Rice. All 35 of them.
Mr. Green. All 35 are eligible. How many actually do?
Mr. Rice. All 35 plants actually export to Japan.
Mr. Green. I'd like to ask about the quality control in
China. Is it possible to use manufacturing processes with
application of Western standards in Chinese production?
Mr. Rice. Yes. For our plant, and I'm sure for many
American companies, we use the same processes that we use in
the United States.
Mr. Green. And is it possible to use the same quality
internal mechanisms that are here in the United States?
Mr. Rice. Yes.
Mr. Green. Is it possible to use the same HACCP programs in
China?
Mr. Rice. Yes. Our plant uses this.
Mr. Green. Can you explain the importance of producers
using those HACCP programs?
Mr. Rice. Can I explain the what? I didn't understand the
question.
Mr. Green. The importance of the producers using those
programs.
Mr. Rice. Well like I say, it works for us. It's a proven
process. It's one of many quality control tools that you can
use in your plant. And for Tyson, we use it in all of our
facilities. So it's very successful for us.
Mr. Green. Since you're on the Board of Governors, American
Chamber of Commerce in Shanghai and you have contact with other
counterparts, I would assume, and do other firms in China
operate--American firms use that same quality control
practices? Or I know you said earlier your competitors, you
don't know what they do. But you know what you do. Do you know
of any other companies that, for example, just in talking with
your other members of the Chamber?
Mr. Rice. Yes. I believe that most of my counterparts are
using the same quality standards. And I think that is the case
for any consumer products company that's using their brand. And
I think you will want to protect your brand by using your same
quality standards that you have in the United States.
Mr. Green. You told the staff that good manufacturing
processes can be summed up in one phrase, inspect what you
expect.
Mr. Rice. That's right.
Mr. Green. And could you elaborate on that?
Mr. Rice. That, I was speaking in the context of when
you're using third-party plants to manufacture your products.
In some cases where we use a copacker. And in this case if you
want high quality results, you have to put people on the ground
to make sure you do it. When we run products at a facility that
we work with that we don't own, in that case I have five
quality control people from my plant there to be sure that
that's the right product.
Mr. Green. And in China--I know, Mr. Chairman, we're
talking about food today. But it seems like with the other
jurisdiction in our committee, on the toys and with Mattel, it
would seem like that would have been a good example for maybe
some of our product manufacturers other than food to use that
if they inspect what you expect. So it would seem like they
would check the paint that they would use on those toys even
before they bring them over.
Thank you, Mr. Rice.
Mr. Rice. Thank you.
Mr. Green. I yield back my time, Mr. Chairman.
Mr. Melancon. Thank you, Mr. Green. Mr. Burgess, did you
have some questions?
Mr. Burgess. Yes. Thank you. Dr. Martin, on the issue of
the safety record in Hong Kong and Japan, I think you
referenced 0.3 failure rate and 0.6 failure rate for each of
those countries respectively. Or I may have got that backwards.
And I will just preface this by saying any time that you have
me up here talking about statistics, it's a bad day for me and
whoever I'm talking to. But since this is the subject we're on,
and you heard the discussions that I had with the previous
panel, I guess my question to you is, at this point from your
testimony and your observation, your study of the two systems
in Hong Kong and Japan, we can kind of get an idea of how
strict they are, but do we really have an idea of how good they
are? That is, do we know if they in fact are detecting, and you
reference it in your testimony, it's difficult to prove a
negative. Do we know that they were only getting the very best
products coming in to them because after all, they're Japan and
Hong Kong and they're going to look real hard? Or is this the
normal stream of products that would go to any importer and
this is the failure rate that's discovered from just the native
stream of exports?
Mr. Martin. The figure 0.3 percent was from Hong Kong for
2006; 0.6 was in 2007, the most recent 2-month period in Hong
Kong. In Japan 0.7. As far as I could ascertain, USDA and the
FDA do not come out with a comparable figure. And you do have
statistical problems in coming up with comparable figures. But
I think you're putting your finger on a very important issue,
which is when you are looking at a large population, you're
taking out a select sample from it, inspecting those and then
finding out an incident rate in which they failed to meet
whatever your standards are. Are you representative of the
population in general? Can you extrapolate from the smaller
sample to the larger one? And as you were asking earlier, yes,
there are statisticians out there that could give you that
information. But then the question becomes, is that the result
you want? In other words, if you find out that 0.3 percent of
the subpopulation is indeed representative of the overall
population, of all the goods coming in you're effectively
saying that 0.3 percent of the shipments coming into your
country from a location, from an area, from a company, whatever
the case may be, are tainted or unsafe.
So then the other question gets to, if I understood
earlier, what kind of goals do you have for your sampling
technique? Last comment on this then is, my sense from the
Japanese and Hong Kong system is that because they're using a
preferential system of determining which shipments to sample,
that they anticipate that the incident rate in the
subpopulation, sample population is higher than the overall
shipment level. So it sets sort of an upper bound of the
theoretical number of unsafe shipments coming into Japan and
Hong Kong.
Mr. Burgess. So that is a knowable number, or a range of
numbers.
Mr. Martin. It's a knowable number for that population.
Mr. Burgess. For that year?
Mr. Martin. For that year and that time.
Mr. Burgess. That underscores the complexity of all this.
And you heard some of my earlier comments. I guess my
frustration sitting here as a Member of Congress ostensibly
with oversight over the agencies that are responsible for
ensuring the safety of the Nation's food supply is we get
recall, recall, recall, product safety violation, product
safety violation, product safety violation. We don't have the
red button on the conveyor belt that we can hit and stop and
then go back and do these statistical analyses to find out
where the problem is and how to correct the problem. Right now
we're just sort of at the receiving end of all this either
spoiled, tainted, food, junk, toys, whatever it is. And even
from the standpoint of the toys, although that's not the--what
we're dealing with today, you've got to imagine that this
conveyor belt dumping all these lead-based toys in our country,
what are we going to do with them? And Mattel couldn't really
answer the question of what they're going to do with them. With
spoiled fish it's a little bit different. But it is still the
same point, how can we as legislators--and this is what I'm
struggling with and I don't think Chairman Dingell's bill has
gone quite the direction I would like to see it go. How do we
put that stop button on the conveyor belt and say, don't do
this anymore until we figure out what's going on?
Mr. Martin. I can't comment on the particular specific
legislation before you. But what I could say is in the case of
Hong Kong and Japan, what they appear to be using is a tiered
approach. They try to, to a certain extent if I may, export the
issue of monitoring evaluation certification to the exporting
entities, the exporting companies as well, to make sure that
the products that are coming in are to a certain extent safe.
Then they go through a rigorous inspection procedure, again to
make sure at a second step that the products are safe. And then
in the case of both Hong Kong and Japan, internal to the
country you have inspectors that are going around--there's a
recent case in Japan where they pulled some eels off the
shelf--and this in my testimony--found out that there was an
unsafe level of pesticide in it, and pulled all the fish off
the shelf. So the process that seems to be used, the method
that's being used in Hong Kong and Japan is, you don't just
check once, you check twice, you check three times. And I
believe if I may, from the testimony that Mr. Rice is
indicating, and also what I tried to indicate in my written
testimony, you also have this going on in a parallel process in
the private sector. They're checking once, they're checking
twice, they're checking three times.
Mr. Burgess. That brings us to our next point. Mr. Rice,
maybe you can weigh in on this as well. If you find at the
endpoint, oh, my gosh, there has been a problem, what is the
mechanism that you have or that you need, Dr. Martin, to be
able to say stop, let's go back to square one and see where the
problem is because we definitely have a problem. And not just
continually read about it in the Wall Street Journal or the New
York Times over and over and over again.
Mr. Rice. Well, in the case of my plan we have
traceability. So we keep records of all incoming raw materials
and what batches they were made into so we can pull it back.
Mr. Burgess. If I may interrupt for a second. You can trace
it, but can you stop it once that hits the news wires, once
that hits the public consciousness that once again we've got a
tainted product coming in from the People's Republic of China?
Can you stop it?
Mr. Rice. I can't stop the news, but I can stop my product.
Mr. Burgess. You can stop your product and go back and
investigate why the problem occurred?
Mr. Rice. Yes.
Mr. Burgess. Why do you suppose we're not seeing that
process followed? Why are we not seeing the conveyor belt
stopped, the inspections done and the problem solved? Why do we
have to keep having the same news stories over and over and
over again?
Mr. Rice. I don't know. You have to have traceability to
some extent so you can trace where your product goes and where
it came from.
Mr. Stupak. [presiding]. Thank you. Mr. Melancon for
questions, please.
Mr. Melancon. Thank you, Mr. Chairman.
Mr. Rice, does Tyson export from the United States
foodstuff? Pork, chicken?
Mr. Rice. From the U.S., yes.
Mr. Melancon. The standards by which they meet, is it that
the use for export from the United States to other countries,
is it the same that we use for domestic production and sales?
Mr. Rice. Yes. Same plants.
Mr. Melancon. The imports to other countries from your
plants around the world, are they the same standards as you
would do in the United States, say, from China to Hong Kong or
to Japan?
Mr. Rice. No, they can be different.
Mr. Melancon. They can be different. Is there some cost
differences that makes some tremendous amount of difference
that you couldn't have it uniform across your operations around
the world?
Mr. Rice. Well, every country is different. So it is hard.
We have specific plants in the U.S. whose products might go to
China, in other plants it would go to Russia. So we keep them
separate. But you couldn't make one product applicable to the
whole world.
Mr. Melancon. Poultry, are we a net importer or exporter?
Mr. Rice. Exporter.
Mr. Melancon. And for Japan for poultry?
Mr. Rice. Japan is an importer.
Mr. Melancon. China?
Mr. Rice. China imports from the United States poultry and
exports to Japan poultry.
Mr. Melancon.So they buy some of our chicken and send it
over there.
Mr. Rice. From the United States we export mostly chicken
paws and wing tips. And China is exporting leg thighs to Japan.
Mr. Melancon. I have been to Eastern Market and am still
trying to figure out what they do with those chicken paws.
Mr. Rice. I have eaten one and I sell the rest.
Mr. Melancon. I think I'd grind them all and sell them. I
guess what I'm trying to figure out is what complications is
there to try and have one standard for a company such as Tyson
so that when we know we get product from say Japan or from
China coming into this country, poultry product, that it would
be the same or the equivalent of what we would ship out of this
country or consumed in this country? Is it that complex a
problem that it couldn't be standardized to those expectations,
because of the nature and the size of your company for
instance?
Mr. Rice. Well, the best for us would be the USDA
equivalent. That's the product we ship out.
Mr. Melancon. So USDA basically does keep monitoring pretty
well your products?
Mr. Rice. Right.
Mr. Melancon. But does FDA have any authority or
jurisdiction? Or do they monitor or check any of your outgoing
or incoming?
Mr. Rice. Not that I know of. But I don't work in the
United States.
Mr. Melancon. But you are glad to be home?
Mr. Rice. Yes.
Mr. Melancon. Am I'm going looking to see if I have any
other questions, Mr. Chairman.
Mr. Stupak. Thank you, Mr. Melancon. Mr. Rice, besides
poultry, any other products you produce in China?
Mr. Rice. We are minority owner of a pork processing plant,
but we don't export from there.
Mr. Stupak. You indicated you use poultry. You obtain them
from Japanese certified farms, right?
Mr. Rice. Right.
Mr. Stupak. Are there other countries that have certified
plants or farms in China, Korea or----
Mr. Rice. Korea has certified plants. Singapore has
certified plants, so does Malaysia. And I believe the European
Union is working on something.
Mr. Stupak. And the U.S. doesn't have any certified plants?
Mr. Rice. Not that I know of.
Mr. Stupak. Do you use other certified plants then for
poultry or just the Japanese ones?
Mr. Rice. We use just the Japanese ones.
Mr. Stupak. Have you considered using any other country
farms there?
Mr. Rice. Well, I have. But there's less quality control
systems in place in those plants. So I would have a higher risk
if I did so.
Mr. Stupak. Is it fair to call them poultry farms?
Mr. Rice. Yes.
Mr. Stupak. Is the feed used in that poultry farm and all
other things used, is it all generated from China internally or
do you bring it in from Japan or the United States, the feed
and other medicines and things like this you'd use?
Mr. Rice. It's domestically sourced.
Mr. Stupak. In China?
Mr. Rice. Yes.
Mr. Stupak. So those sources would also have to be
certified then for feed and everything else?
Mr. Rice. Yes. And for Japanese plants, for sure, because
they have different requirements on residuals.
Mr. Stupak. You, Tyson, have been there for how long, 20
years?
Mr. Rice. I have been there 20 years. I think Tyson's been
there about 5.
Mr. Stupak. So this agreement they use with the Japanese
for the company of Tyson just came about in the last 5 years?
Mr. Rice. Yes. The Japanese certification process began
about 3 or 4 years ago.
Mr. Stupak. And that's because of an outbreak of illness
they had in Japan, right?
Mr. Rice. That's because of China's outbreak of avian
influenza.
Mr. Stupak. They didn't want to give it to Japan, so that's
why they used the certification?
Mr. Rice. Right.
Mr. Stupak. Any reason why that certification would not
work with the U.S.? Any reason why the U.S. could not go and
certify?
Mr. Rice. I don't believe so. I don't know why it wouldn't
work. It's at least a good starting point to consider how to
manage that process.
Mr. Stupak. Mr. Martin, if I may, and Dr. Martin, thanks
for being here. How do they determine whether specific farms
and production facilities in China meets Japanese safety
standards and thus able to export? How do they do that?
Mr. Martin. Basically through a process whereby Japanese
officials go over to China, meet with Chinese counterparts.
They go out to the facilities and inspect it jointly.
Mr. Stupak. Does Japanese have people permanently stationed
in China?
Mr. Martin. They don't have people permanently stationed
there as far as I understand, but they have people who will go
over there and check out facilities.
Mr. Stupak. When does Japan inspect food shipments from
China?
Mr. Martin. When do they physically inspect the shipments?
Mr. Stupak. Right.
Mr. Martin. Japanese officials will inspect it when it
arrives in Japan at the port. They will make a determination on
whether or not that food shipment will be selected for
inspection.
Mr. Stupak. And you said there's three layers of
inspections, right?
Mr. Martin. Correct.
Mr. Stupak. First comes in----
Mr. Martin. The first is not done by Japanese officials.
They're basically relying on the Chinese system. And part of
which Mr. Rice explained. The second part is when it comes into
port and is clearing customs or is being brought in. If that
particular shipment is selected for inspection, it goes to a
quarantine center. There's 31 of them I understand in Japan
where it will go through a physical inspection. If it passes
the inspection, then it's released. The importers can take the
shipment and then it goes into the market of Japan. But at that
point, municipal authorities are prefectural employees. The
equivalent of some state here will then inspect on the shelves
on a regular basis.
Mr. Stupak. In the testimony from our previous panel of our
investigators here from the committee, we're talking about
China's certification process. Japan doesn't rely on China's
certification. They have their own certification process, is
that correct?
Mr. Rice. Japan,only for the poultry plants.
Mr. Stupak. Right.
Mr. Rice. For the 35 poultry plants that ship to Japan, the
Japanese have certified their process. But when the product is
shipped, AQSIQ is validating that was compliant with the
Japanese law.
Mr. Stupak. The point I was trying to get at, from the
testimony, it looked like the Deputy Minister Wei was telling
our group that if you just rely upon our system, it would all
work. You would not have the problem with the melamine as you
had because it wasn't certified by us. It was certified--but it
sounds like there's--I wouldn't say a lack of trust but maybe a
double checking or a check and balance system. Not only do you
rely upon the Chinese system but you have your own
certification. Japan has its own certification, or I should say
inspection and certification. And even though China may have
other certified farms, poultry farms, you rely upon the ones
the Japanese have inspected and you inspect. Is that correct?
Mr. Rice. That's correct. If you can understand it as, of
all food processors in China, if you rely on that system, your
universe of food companies that could be shipped to you is
450,000. So it's this big. If you rely on the AQSIQ system,
that shrinks to 12,700. And in the case of the Japanese, they
can shrink that to 35.
Mr. Stupak. And then the premium you said was 30 percent
more.
Mr. Rice. It can be 20 to 30 percent more for price.
Mr. Stupak. What would that mean for the average consumer,
do you think? Just use your own product.
Mr. Rice. Because that's not 100 percent of the cost of a
product, it could mean a 10 percent to 15 percent increase in
pricing.
Mr. Stupak. Of the product?
Mr. Rice. Right.
Mr. Stupak. Each country can create its own food safety
standards for Chinese imports. My impression is Japan has one
set of standards, Hong Kong has another, and Russia has another
you mentioned. Everyone has a different standard. You are
shaking your head yes, right?
Mr. Rice. Yes. I'm sorry.
Mr. Stupak. That's all right. I think my time's expired.
Mr. Burgess, Mr. Whitfield, questions?
Mr. Whitfield. Thank you, Mr. Chairman. I'm sorry I missed
you all's testimony a few minutes ago.
But Dr. Martin, let me just ask you, what was your
methodology in gathering information about the food safety
systems in Japan and Hong Kong?
Mr. Martin. Multiple systems. Hong Kong specifically, I
lived there for an extended period of time. I continue to have
contacts there. I worked there for a number of years.
Similarly, I lived in Japan for a period of time and continue
to have contacts back there. I also do have the standard
contact with the Japanese Embassy here and the Hong Kong
Economic and Trade Office here for asking for information,
checked out scholarly materials on the information, looked at
publications coming from U.S. Government agencies as well as
other agencies, the Japanese agencies and the Hong Kong
agencies overseas. I also checked the press and the media for
information that's available. Basically as wide a search of
materials as I could.
Mr. Whitfield. And from your knowledge of the Japanese food
safety system and the Hong Kong food safety system, are there
any lessons that FDA could take from those two systems that
could help improve its food safety system?
Mr. Martin. I wouldn't use the word ``lessons.'' That would
be an issue for them to make the determination of whether they
see value or merit in a particular idea. What I tried to
indicate in the written report, as well as my oral testimony,
is that they seem to have methods that they find--Hong Kong and
Japan that is--that they find to be effective in making or
getting a reasonable level of surety of the safeness of the
food that they're importing from China.
And if you wish, could I specify, basically----
Mr. Whitfield. Yes. Just go over a few.
Mr. Martin. Well, one of them goes back to a point that I
saw or I heard in Mr. Stupak's question, which is when they
find an incident, when there is a particular shipment that
seems to be problematic, the response both in Japan and Hong
Kong is to contact their counterpart in mainland China. And in
both systems they are trying to develop a very rigorous
traceability process.
For example, all pork coming from mainland China into Hong
Kong right now has a radio frequency ID tag on it. So they know
exactly where that came from, which farm in mainland China that
came from. What they do is they go back to the mainland
authority and say, we have a problem here. It's generally
framed in the terms, we have a problem here. How did this
happen? How can we prevent it from happening again? So the
approach is, we have a shared problem. Go back over. Go back
through the system. Find out where it broke down in this three-
tiered process and fix it.
Mr. Whitfield. Right.
Mr. Martin. So that would be one example of an observation
of the approach in common in Hong Kong and Japan.
Mr. Whitfield. Now Mr. Rice, you indicated that Tyson
exports from the U.S. to China poultry product, correct?
Mr. Rice. Yes.
Mr. Whitfield. Now is that the whole chicken or is that
chicken parts?
Mr. Rice. It's chicken paws and wing tips mostly.
Mr. Whitfield. Chicken paws and wing tips. Yet you have
facilities in China where you produce chickens as well, is that
correct?
Mr. Rice. In China we don't grow chickens but we buy raw
chicken meat from other producers and we make further processed
products, like nuggets or patties.
Mr. Whitfield. And you export that from China to----
Mr. Rice. To Japan and mostly to the domestic market in
China.
Mr. Whitfield. All right. And based on your experience do
you feel that food can safely be imported from China to the
U.S.?
Mr. Rice. If the universe of exporters was narrowed down to
AQSIQ-certified plants and they're inspected, I believe the
Chinese can do it.
Mr. Whitfield. And well, Mr. Chairman, I see that my time
is just about expired. I want to thank you all for being with
us today. We appreciate you taking time to give your expert
advice. Thank you.
Mr. Stupak. Further questions? Mr. Melancon.
Mr. Melancon. And I'm not sure. But maybe Dr. Martin or Mr.
Rice had experience.
I'm hearing that China can monitor its exports when the
importing countries require it. But the U.S. obviously doesn't
demand this, which kind of makes me wonder, if Hong Kong, Japan
and even the European Union don't allow tainted food, where
does this tainted food go when they turn it down?
Mr. Martin. In the case of Hong Kong and Japan, Japan will
destroy tainted food that they capture and is quarantined in
the testing process. And Hong Kong, I believe they also destroy
the food.
Mr. Melancon. If it goes to the European Union, do you
know?
Mr. Martin. I don't know about the European Union.
Mr. Melancon. I'm of the understanding, at least on
seafood, that they just ship it to another country, like the
United States, that doesn't have the requirements.
Mr. Martin. I couldn't comment on the European Union
practice.
Mr. Melancon. Maybe somebody could look into that. It goes
back to that ad that I was shown for a company that's online
that says, if you've got FDA-rejected food or if you've got
food that's been rejected for importation, contact us, which
tells me they're sending it someplace. Sort of like Mr.
Burgess. I'm not sure who got those lead-tainted toys, but I'm
sure somebody's going to get them. They're not just going to
disappear.
But thank you. I yield back my time.
Mr. Stupak. Mr. Burgess, anything?
Mr. Burgess. Thank you, Mr. Chairman. If I could, Mr. Rice.
By an accident of marriage, I have family in Arkansas and so
from time to time will travel in Arkansas and will see a lot of
your company's logos. And the chicken-growing facilities that
are licensed by Tyson seem to be pretty secure sites. You can't
just wander into one. You have to be there for a reason. There
seems to be a lot of reproducibility of the types of chicken
houses and how they're constructed. So obviously your company
goes to great pains to make sure that the product that is grown
in our country meets their standards and presumably that is
also product that's available for export now. You mentioned in
response to a question that in China you don't grow your own
chickens, but you do buy some raw material for export. And in
your written testimony you say you practice 100 percent
inspection on all raw materials coming into our facility. Can
you kind of just give us a quick sketch of what that inspection
comprises?
Mr. Rice. Yes. Well, you are talking about our biosecurity,
which is keeping the security clear so you can't contaminate
your chickens with wild birds or other humans. And that exists
in China and in the United States. When I was talking about the
raw materials that we use to manufacture our products inside
China, inside our plants, are raw chicken meat, flour,
breading, oil and these things. And for everything that comes
into our facility, we visually inspect it and we also test for
residuals and chemicals. So I have eight full-time employees in
a plant of 250 that only inspect incoming raw materials. So we
want to be sure that 100 percent of what comes in is right
before we make our product.
Mr. Burgess. Now, do you ever find any problems?
Mr. Rice. Yep, we do. That's why we keep that level of
inspection.
Mr. Burgess. When you find a problem, do you communicate
that to say the U.S. authorities so that they know to be on the
lookout of similar products in other facilities?
Mr. Rice. No, we don't. Because these are local Chinese
suppliers, and we are making product mostly for the Chinese
market. So we would go straight to our supplier with our
quality assurance team and inspect their facility and then look
for why that problem came.
Mr. Burgess. But there would be no dialog with, say,
someone else who may be serviced by that same supplier to look
out for the bad stuff that's in these chicken wing tips or
whatever it is we're selling?
Mr. Rice. No. But Tyson does not source raw materials from
China at this time.
Mr. Burgess. If you see a persistent problem coming from
one supplier, what do you do to identify or do you identify
that supplier to other companies or to U.S. authorities, to
boy, be on the lookout for these guys.
Mr. Rice. No, we would not. But we would stop using that
supplier and switch to a new one.
Mr. Burgess. The only clue that our guys, who are also over
there tasked with making sure that products that come into this
country are safe is that, hey, Tyson's is giving these guys the
cold shoulder. Maybe we ought to look at other stuff coming out
of their facility.
Mr. Rice. There is no formal way to notify.
Mr. Burgess. There is no formal way?
Mr. Rice. No.
Mr. Burgess. Not even as just an internal company policy,
hey, if we find a bad problem, we're going to blow the whistle
here and notify others?
Mr. Rice. No. There's no procedure for that.
Mr. Burgess. Dr. Martin, if I could ask you, I mean, in
response to when you elaborated on the answer to Mr.
Whitfield's question. You talked a little bit about some of the
same issue about Hong Kong and Japan tracking problems if they
identify problems. Is that not correct?
Mr. Martin. Yes. That's common specifically in the case of
the pigs or pork coming in from mainland China, yes.
Mr. Burgess. So they do, they do keep some track of if
there are persistent problems, it heightens their own internal
security. But do they communicate with anyone else?
Mr. Martin. Outside of Hong Kong, the Hong Kong Government
and Japanese Government with mainland counterparts?
Mr. Burgess. Yes.
Mr. Martin. I do not know specific examples where the Hong
Kong-Japan Government have contacted a fourth party, that is to
say somebody other than mainland China, about the problem.
Mr. Burgess. So they would not contact another foreign
government, say, hey, if you're getting pig's feet from
amalgamated pig's feet farm in wherever China, this is a
problem for us and it may be a problem for you?
Mr. Martin. The example you are giving is of a specific
farm and a particular problem. I do not know of any particular
case where they would do that. They do hold international
meetings where they discuss common problems, we are noticing
that a high percentage of this particular food product coming
from mainland China is problematic; where is the source of the
problem coming from?
Mr. Burgess. So in general, there is discussion about where
the hotspots are, where the problems are, is that correct?
Mr. Martin. My sense of it from looking at the proceeds
from those meetings, it tends to be at the technical level and
on the product level. That is to say, we have a problem product
that has this technical problem that comes up time and time
again. I suspect on the next panel with USDA and FDA, they can,
probably specifically talk about events of that sort because I
am sure that they have had some in mainland China and in Hong
Kong.
Mr. Burgess. There would at least be a route for the
authorities in this country to be notified of a problem that
has occurred and is persistent?
Mr. Martin. Yes, there are avenues of communication, sure.
Mr. Burgess. But there is not a specific obligation to say,
hey, this is trouble.
Mr. Martin. There's nothing under current Japanese or Hong
Kong law that requires those agencies to notify the
international community it's a problem.
Mr. Burgess. Thank you, Mr. Chairman.
Mr. Stupak. Thank you, Mr. Burgess. Mr. Rice, does Tyson
notify the Japanese officials if they find a problem with one
of their suppliers, something coming into your plant?
Mr. Rice. No.
Mr. Stupak. But you receive your product from Japanese-
certified suppliers?
Mr. Rice. That's correct.
Mr. Stupak. Why wouldn't you notify them?
Mr. Rice. Because we're talking about isolated shipments
where we might find foreign, foreign objects like hair or a
piece of wood or something like that.
Mr. Stupak. What if it was a chemical that shouldn't be----
Mr. Rice. Then we would notify the AQSIQ. And one process
that might help, such a company would end up on the blacklist
of the AQSIQ, which would be available publicly to all
countries.
Mr. Stupak. Well, yes, would the AQSIQ, whatever it is
there, are they required to pass it down to the Japanese or
just publish it?
Mr. Rice. I don't know what the agreement is between AQSIQ
and MAFF.
Mr. Stupak. The growers or suppliers that you use, do they
supply exclusively to Tyson and to Japan or can they--other
countries or other processors like yourself?
Mr. Rice. They would supply to multiple customers who would
be part of their business. In general it's not more than 10 or
20 percent of their business is Japan and the rest would be a
domestic market. It could be Southeast Asia or Korea as well.
Mr. Stupak. We've indicated throughout this testimony that
in Japan I think they inspect about 15 percent. U.S., it's less
than 1 percent. Is there a number you think would be
appropriate, 5 percent, 15 percent, 25 percent of the food
products coming into this country should be inspected?
Mr. Rice. I would not know that.
Mr. Stupak. Dr. Martin, any guess on that?
Mr. Martin. I couldn't give you a number. But what I would
say is that my anticipation is that a statistician would ask
you what's your goal or objective.
Mr. Stupak. Mr. Rice, you said you have eight lab people or
inspectors out of 250. What percentage of your budget is for
safety, for inspection, for going to that farm to make sure
things are right? Can you give me an estimate?
Mr. Rice. I would guess it's between 3 and 4 percent.
Mr. Stupak. Does Tyson use carbon monoxide when you ship
any of the poultry?
Mr. Rice. No, we do not.
Mr. Stupak. No further questions. Thank you, Dr. Martin.
Thank you, Mr. Rice. Thank you for your testimony. It was very
helpful.
We'll dismiss this panel and call up our third panel of
witnesses. We have Dr. David Acheson, Assistant Commissioner
for Food Protection at the Food and Drug Administration; Ms.
Margaret Glavin, Associate Commissioner for Regulatory Affairs
at the Food and Drug Administration. They're accompanied by Mr.
Michael Rogers, Director of Field Investigations Division at
the FDA; Mr. Domenic Veneziano, Director of Import Operations
and Policy at FDA; and Mr. Donald Kraemer, Deputy Director of
the Office of Food Safety and the Center for Food Safety and
Applied Nutrition at the FDA.
We also have Dr. Richard Raymond, who is the Under
Secretary for Food Safety at the U.S. Department of
Agriculture. Dr. Raymond is accompanied by Dr. Bill James, who
is the Deputy Assistant Administrator for International Affairs
at the USDA Food Safety and Inspection Service.
It's a policy of this subcommittee to take all testimony
under oath. Please be advised that our witnesses have the right
under the rules of the House to be advised by counsel during
their testimony. Do any of you wish to be represented by
counsel? Everybody indicating they do not, so we will move
forward. Please rise and raise your right hand to take the
oath.
[Witnesses sworn.]
Mr. Stupak. Let the record reflect the witnesses have
replied in the affirmative. They are now under oath.
We will now hear a 5-minute opening from the witnesses, and
they may submit a longer statement for inclusion in the hearing
record.
Mr. Stupak. Dr Acheson, would you like to start for an
opening statement?
STATEMENT OF DAVID W.K. ACHESON, M.D., ASSISTANT COMMISSIONER,
FOOD PROTECTION, FOOD AND DRUG ADMINISTRATION, U.S. DEPARTMENT
OF HEALTH AND HUMAN SERVICES
Dr. Acheson. Good morning, Mr. Chairman and members of the
subcommittee. I am Dr. David Acheson, Assistant Commissioner
for Food Protection at the U.S. Food and Drug Administration.
FDA Commissioner Andrew von Eschenbach has appointed me to this
new position to provide leadership on strategic and substantive
food safety and food defense matters.
Thank you for the opportunity to discuss the important
issues relating to the safety of imported food. FDA regulates
everything Americans eat except for meat, poultry and processed
egg products, which are regulated by our partners at the
Department of Agriculture. The agency's committed to ensuring
that the Nation's food supply continues to be as safe as
possible.
In recent years FDA has done a great deal to detect and
prevent both unintentional and deliberate contamination of
imported products. But we continue to face many significant
challenges to food safety, including changes in consumer
expectations, changes in production, manufacturing and
processing techniques, increased globalization and terrorism.
One of the major issues we face is the rapidly increasing
level of food imports. Currently FDA oversees more than 9
million line entries of imported food annually. Shipments of
food represent about 60 percent of FDA regulated imports. We're
looking to enhance product safety by broadening our knowledge
and applying enhanced risk-based criteria to the entire life
cycle of imported products.
The President is engaged directly in the effort to ensure
that FDA and other agencies are doing everything we can to
protect Americans from unsafe imports. On July 18, the
President issued an Executive order creating a Cabinet level
Working Group on Import Safety, which I will discuss in more
detail later.
My priority assignment as Assistant Commissioner is to
coordinate the development of a new Food Protection Strategy.
This will enhance our food safety and food defense systems by
addressing the challenges we face. The Food Protection Strategy
will be comprised of three fundamental elements: First, a
proactive prevention strategy to build safety in from the
start; second, risk-based interventions to ensure preventive
approaches are effective; and, third, rapid responses when
contaminated food is detected or when there's harm to humans or
animals. This integrated approach will build on existing
partnerships with industry, other regulators and consumers and
fully utilizes advances in technology.
FDA's overall goal is to ensure a comprehensive and robust
food safety and food defense program that will provide the
level of food protection American consumers expect. With regard
to imports, we need a fundamental shift from the current model
that relies on snapshots at the border to a cost-effective
prevention focused model that identifies and targets those
steps in the life cycle of imported food where the risks of
unsafe products are greatest.
This model is consistent with the President's Interagency
Working Group on Import Safety. The working group includes
members from 12 Federal departments and agencies, and its
mission is to review the procedures, regulations and practices
under which we manage the safety of all imported consumer
products. The Secretary of Health and Human Services, Michael
Leavitt, chairs the working group and FDA plays a key role.
Secretary Leavitt and Commissioner von Eschenbach have
traveled extensively throughout the United States during the
past few months. The insights that they've gained during their
reviews helped shape the strategic framework that was released
by the working group on September 10. That report outlines an
approach, like FDA's Food Protection Strategy, that's based on
the organizing principles of prevention, intervention and
response.
With respect to the recent well-publicized issues with
regard to the safety of imported products from China, FDA's
conducting a series of meetings with Chinese officials to
negotiate memoranda of agreements aimed at creating a framework
to help assure the safety, quality and effectiveness of
products exported from China to the U.S. The agreements also
aim to increase cooperation and information sharing between the
regulatory bodies of the two nations with a goal of
strengthening China's regulatory process. These negotiations
are ongoing, with a goal of finalizing the agreements by year's
end.
Ensuring the safety of imported foods is a difficult task,
but I want to ensure you that FDA is diligently working to
efficiently and effectively use the resources and authorities
we have been provided by Congress to help protect American
consumers.
Thank you for the opportunity to discuss FDA's activities
to enhance the safety of imported food. I would be happy to
answer any questions you may have.
[The prepared statement of Dr. Acheson follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Stupak. Thank you, Dr Acheson. Ms. Glavin, opening
statement, please.
STATEMENT OF MARGARET O'K. GLAVIN, ASSOCIATE COMMISSIONER,
REGULATORY AFFAIRS, FOOD AND DRUG ADMINISTRATION, U.S.
DEPARTMENT OF HEALTH AND HUMAN SERVICES; ACCOMPANIED BY MICHAEL
C. ROGERS, DIRECTOR, DIVISION OF FIELD INVESTIGATIONS, OFFICE
OF REGULATORY AFFAIRS, FOOD AND DRUG ADMINISTRATION, DOMENIC J.
VENEZIANO, DIRECTOR, DIVISION OF IMPORT OPERATIONS AND POLICY,
OFFICE OF REGULATORY AFFAIRS, FOOD AND DRUG ADMINISTRATION, AND
DONALD W. KRAEMER, DEPUTY DIRECTOR, OFFICE OF FOOD SAFETY,
CENTER FOR FOOD SAFETY AND APPLIED NUTRITION, FOOD AND DRUG
ADMINISTRATION
Ms. Glavin. Good afternoon, Mr. Chairman and members of the
committee. Thank you for inviting me. I'm Margaret Glavin. I'm
the Associate Commissioner for Regulatory Affairs at the Food
and Drug Administration. The Office of Regulatory Affairs is
the lead organization within FDA responsible for enforcing
FDA's public health laws and regulations. We're guided in our
mission, which is to protect consumers and enhance public
health by maximizing compliance of FDA-regulated products and
minimizing risks associated with those products. To meet these
responsibilities, ORA is staffed with a workforce of
approximately 3,200 employees, 2,700 of whom are dispersed
geographically throughout the country.
My testimony today will discuss ORA's import operations and
the tools we have at our disposal to prevent adulterated or
misbranded imported goods from entering domestic commerce. I
will also provide an overview of the challenges that confront
us and measures that are being contemplated to enhance our
coverage of imported goods.
In July, when I testified before this committee, I
discussed ORA's proposed Transformation Initiative, a component
of which involved consolidating FDA's field laboratories. That
effort, including the proposal to close laboratories, is no
longer under consideration. What remains as relevant today as
it was in July are the challenges that confront ORA in our
efforts to fulfill our mission to protect the public health.
These challenges have not gone away and are continuing to grow.
For these reasons ORA has undertaken a planning process
that examines how we can best meet our future needs and public
health mandates. This process, which is drawing on the
experience, expertise and input of all ORA employees, will
allow us to be more strategic in our efforts to ensure that we
invest in the right tools, skill sets and programs to meet the
challenges posed by emerging threats, ongoing public health
emergencies, increasingly complex technological advances in the
industries we regulate and burgeoning imports, one of the
topics this committee is addressing today.
The volume of goods offered for entry into the United
States is growing exponentially, and these imported products
include every type of FDA-regulated product and come from more
than 200 countries and more than 300,000 manufacturers
worldwide.
As has been said many times this morning, we physically
inspect less than 1 percent of the imported food that is
offered for entry into the U.S. To better ascertain which food
we ought to physically inspect, FDA uses a number of approaches
to help us make risk-based decisions. One of these involves
having FDA inspectors conduct inspections of foreign
manufacturing facilities that export FDA-regulated goods to the
U.S. to make certain that they are following good manufacturing
processes and other regulatory requirements, such as HACCP for
seafood and juice products.
In addition, we conduct outreach to food processors and
food producers in foreign countries to enhance their
understanding of food safety and good agricultural practices.
FDA also works with and provides training to our regulatory
counterparts in foreign countries. This training focuses on
U.S. public health requirements and methods to improve food
safety in order to ensure that exporters are able to meet our
requirements, and FDA works with our foreign regulatory
counterparts to share information regarding each country's
laws, requirements and food safety systems and which also allow
for notification to each other when significant violations are
found.
In 2002, Congress provided us with significant new
authorities to enhance the protection of the food supply
through the provisions of the Bioterrorism Act.
FDA utilizes a significant new tool provided under this
act that requires us to receive prior notification before food
is imported or offered for import into the United States.
Advanced notice of imported food shipments allows us, with the
support of Customs and Border Protection to electronically
screen the shipments for potentially serious threats to health
before the food arrives and to target those products flagged by
the system as presenting the most significant risk. This allows
us to conduct more intensive import security reviews on
potentially high-risk entries and to allocate resources for
inspections more effectively.
All prior notice data is validated against FDA's OASIS
system for completeness to ensure that it meets minimal data
submission requirements. Once the data is validated, it is
screened against specific food security criteria established in
the system to identify and flag high-risk shipments. Prior
notice of high-risk screening criteria are based on a number of
factors, including risk assessments conducted in accordance
with operational risk management and CARVER plus Shock
methodologies to identify those food shipments that present the
highest food security risk and are most vulnerable. Additional
screening criteria are established based upon contemporary
intelligence reports.
To conduct intensive, manual high-security reviews, the
prior notice staff utilizes information contained in internal
FDA data systems, as well as those of other agencies such as
CBP and the Treasury Enforcement Communication System to
further assess specific risks associated with subject food
shipments as well as any links that parties associated with the
shipment may have to terrorist organizations or criminal
intelligence records. They also consider anomalies in shipping
patterns and past shipping histories.
Based on these risk factors, the prior notice center staff
makes the determination whether the shipment poses a
significant security risk to the American people. Those
shipments of imported foods that are determined to pose a
significant security risk are held upon arrival in the U.S. for
joint examination by FDA and CBP personnel. Those shipments
that are not deemed to be a security risk are released for an
import admissibility review for food safety concerns.
Another significant provision of the BT Act provided FDA
with the authority to commission CBP employees to conduct
examinations and investigations of imported foods on FDA's
behalf so that they can assist us in the examination and
investigation of imported food at ports of entry or other
facilities and locations in close proximity to such ports. This
provides FDA with operational assistance from our CBP
colleagues when necessary and has proven to be useful,
especially at remote ports of entry.
After prior notice requirements have been met, incoming
shipments are subject to an admissibility decision as to
whether or not a particular shipment of imported food should be
allowed to enter domestic commerce. To make this decision, we
often use targeted examinations called physical examinations or
field examinations. A field examination is a visual examination
of a product to determine whether the product is in compliance
with our requirements, and it involves actual physical
examination of the product for admissibility factors.
In addition, a field exam can be supplemented with other
activities such as sample collections and analyses for
microbiological or chemical contamination. When relevant
product information is gathered from our domestic surveillance
and inspection program, FDA factors this information into its
import decisionmaking process.
Another key tool used to screen imports is the import
alert. Import alerts are used to provide direction to our field
personnel indicating that FDA has sufficient evidence or
information about a particular product to refuse admission of
that article being offered for entry without physically
examining the product. This is a practice that was referred to
as detention without physical exam.
Mr. Stupak. Can you summarize, please.
Ms. Glavin. Absolutely.
As I said, we do those things. We also determine if an
imported product should be denied. And once we determine that
an imported product should be denied entrance into the U.S., a
notice of detention and hearing is issued. We detain the goods,
and we allow the importer to present evidence supporting the
admissibility of the questionable goods. Based upon our review
of the evidence, we may release the goods. But if we maintain
our position that the goods cannot be allowed admission into
the U.S., the goods must either be destroyed or reexported
within 90 days.
As I described in my testimony today, we use our available
tools and authorities to manage the ever-increasing volume of
imported food to achieve the greatest protection possible. And
ensuring the safety of the food supply continues to be a top
priority of the FDA. As Dr. Acheson has indicated, FDA,
including ORA, understands the need to focus our resources to
improve consumer protection in the import arena and is
committed to moving towards a cost-effective prevention focus
model that identifies and targets those steps in the life cycle
of imported products where the risk of unsafe products are the
greatest.
Thank you for the opportunity to testify, and I'll be
pleased to answer any questions.
Mr. Stupak. Dr. Raymond, please. Opening statement.
TESTIMONY OF RICHARD RAYMOND, M.D., UNDER SECRETARY, FOOD
SAFETY U.S. DEPARTMENT OF AGRICULTURE; ACCOMPANIED BY BILL
JAMES, D.V.M., DEPUTY ASSISTANT ADMINISTRATOR FOR INTERNATIONAL
AFFAIRS, FOOD SAFETY AND INSPECTION SERVICE
Dr. Raymond. Yes, sir.
Mr. Chairman and members of the subcommittee, I'm very
pleased to have the opportunity to appear before you here
today. I am Dr. Richard Raymond, Under Secretary for Food
Safety at the USDA, and I'm here to discuss how the USDA
regulates meat, poultry and egg products to protect American
consumers.
As the Under Secretary for Food Safety, I do oversee the
Food Safety and Inspection Service, FSIS. FSIS is the USDA
public health regulatory agency responsible for the
administration of laws and regulations that are designed to
ensure that the Nation's commercial supply of meat, poultry and
egg products is safe, wholesome and properly labeled regardless
of whether those products are sold in the United States or
imported to or exported from the United States.
In contrast to the rise seen in other imported products,
the amount of FSIS-regulated imported meat and poultry products
has remained approximately the same in the last 5 years,
hovering around 4 billion pounds of meat and poultry from the
33 countries that have equivalent food safety systems. In that
time, the amount of imported product that was detained,
destroyed or returned has doubled as we have become more
effective in what we do.
FSIS employs a comprehensive three-part system for imports
that helps to ensure the safety of imported product. This
system consists of, one, establishing the initial equivalence
of the meat, poultry or egg product inspection system of the
country wishing to export to the United States; two, verify and
continue equivalence of foreign systems through annual audits;
and, three, providing 100 percent reinspection with a few
exceptions when products enter the country.
Equivalence is the foundation for our system of imports. It
recognizes that an exporting country can provide an appropriate
level of food safety even if those measures are different from
those applied here in the United States. FSIS begins the
process of determining equivalence by analyzing the country's
meat or poultry regulatory system with a document analysis to
assess whether the country has the laws, the regulations and
the infrastructure to support an equivalent system. This
document review focuses on a country's practices and five risk
areas. They are sanitation, animal diseases, slaughter
processing, residues and enforcement.
If the document review is satisfactory, then the process of
determining equivalence moves to the on-site review. During an
on-site review, an FSIS audit team evaluates all the aspects of
a country's inspection program from the headquarters of the
inspection system to regional offices and local offices, and
ultimately to individual establishments within the country, and
to laboratories that will be testing the product that is
destined for the United States.
The second part of our system is to verify continuing
equivalence through audits. This means that once a country is
determined to have a system equivalent to the United States
system, that country is then responsible for ensuring that the
entire system that is exporting to the United States employs
standards equivalent to those of the United States. To verify
that this is happening, FSIS conducts annual audits of foreign
food safety systems and procedures through on-site visits by
FSIS personnel, including certified establishments,
laboratories and review of the government's controls. If a
country fails an audit, FSIS can, and we have in the past,
suspend imports from that country from individual plants or for
specific products.
Finally, the last part of our system for ensuring the
safety of FSIS-regulated imports is verifying the continuing
equivalence of foreign systems through reinspection of products
at the border at our 140 import houses. It is here that the
initial checks for proper documentation, evidence of tampering,
transportation damage and proper labeling are conducted.
In addition to the initial reinspection of product entering
the United States, FSIS then performs intensive random
reinspection on approximately 10 percent of the shipments of
meat, poultry and egg products. More intensive reinspections
are automatically applied to future shipments of product from a
foreign establishment when that product fails reinspection.
Access to Customs and Border Protection's Automated
Commercial Environment database has provided FSIS with a more
targeted approach to identifying and controlling ineligible
entry of FSIS-regulated products that did not present to an
import house for reinspection as required, and it gets us
closer to the entry point rather than chasing it down after its
release in commerce. Use of the ACE database is one of our many
success stories. While the amounts of imports have been stable,
we've markedly increased the amount of detected ineligible
product using existing personnel through a collaborative effort
with our Federal partners at CBP. In fiscal year 2005, prior to
FSIS's use of the ACE system, the amount of ineligible product
removed from commerce that did not pass the import houses was a
little over 36,000 pounds. In fiscal year 2006, this amount
increased to 1.6 million pounds. In the fiscal year 2007, 2.1
million pounds was identified, destroyed or redirected to FSIS
for reinspection. That is more than three AirBus 3AD jetliners'
worth of product in fiscal year 2007 alone.
Our three-part approach to imports is supplemented by our
critical food defense efforts that protect against accidental
or intentional food contamination. Dr. Acheson has already
mentioned the Interagency Working Group on Import Safety, and I
will not repeat many of his comments except to say that I do
represent the USDA on that panel, so I do have working
knowledge of its products and how it is going about its
business.
I'd now like to take just a moment to clarify the current
status regarding the importation of FSIS-regulated poultry
product from China as they requested in April of 2004. As I
mentioned earlier, any country can apply to be evaluated for
equivalence by submitting a request to FSIS. This is exactly
what happened when China requested the authority to export
poultry to the United States in 2004. After careful study,
China's poultry-processing inspection system was determined to
be equivalent to our own. In addition, the Animal and Plant
Health Inspection Service found no risk to U.S. animal health
from import of this type of product if it meets the cooking
standards as approved by APHIS.
After the formal rulemaking process was concluded, China
was then added to the list of countries eligible to export
processed poultry, But the poultry they could process would
have to come from either the United States or another country
that is approved to export raw poultry products to the United
States. In essence, we're talking about processed poultry
originating from Canada or the United States, not poultry
raised and slaughtered in China. Currently no plants from China
are exporting processed poultry originating from the United
States or any other country to the United States. In addition,
USDA has not published a rule permitting China to export to the
United States poultry that is raised and slaughtered in China.
I want to assure everyone that we do have a strong system
in place for imported products regulated by the USDA. I believe
that our approach to regulating the safety of imported meat,
poultry and egg products is one of the best systems in the
world. This is due to our rigorous three-part approach
determining the initial equivalence, the continuous evaluation
of that equivalence through annual audits, and our vigilant
surveillance of meat, poultry and egg products entering the
country.
Mr. Chairman and all members of this subcommittee, I'd like
to thank you for this opportunity to explain the important
process that FSIS employs in protecting consumers by ensuring
the safety of imported food products. I do look forward to your
questions.
Mr. Stupak. Thank you.
[The prepared statement of Dr. Raymond follows:]
Testimony of Richard Raymond, M.D.
Mr. Chairman and Members of the SubCommittee, I am pleased
to appear before you today. I am Dr. Richard Raymond, Under
Secretary for Food Safety. I am here to discuss how the United
States Department of Agriculture (USDA) regulates the importing
of meat, poultry and egg products to protect American
consumers.
As the Under Secretary for Food Safety, I oversee the Food
Safety and Inspection Service (FSIS). FSIS is the USDA public
health regulatory agency responsible for the administration of
laws and regulations that are designed to ensure that the
nation's commercial supply of meat, poultry, and egg products
is safe, wholesome, and properly labeled, regardless of whether
those products are sold in the United States or imported to, or
exported from, the United States.
The amount of FSIS regulated meat and poultry imported
products has remained approximately the same over the past five
years, hovering around four billion pounds of meat and poultry
from 29 of the 33 eligible countries. However, egg product
imports have increased in this past year.
FSIS employs a comprehensive three-part system for imports
that helps to ensure the safety of imported product. This
system consists of:
Establishing the initial equivalence of the meat,
poultry and egg product inspection system of a country wishing
to export to the United States;
Verifying continuing equivalence of foreign
systems through audits; and
Providing 100 percent re-inspection, with a few
exceptions, when products enter the country.
Establishing Equivalence
Equivalence is the foundation for our system of imports. It
recognizes that an exporting country can provide an appropriate
level of food safety, even if those measures are different from
those applied here at home.
FSIS has always required an assessment of foreign
inspection systems before those nations can export to the
United States. This prior review is mandated by our laws, which
originally required that a foreign system be ``equal to'' our
system before the foreign product could be admitted. That
standard was changed in 1994, to one of equivalency after the
United States signed the Final Act of the Uruguay Round of
Multilateral Trade Negotiations.
Any country can apply for equivalence by submitting a
request to FSIS. An importing country maintains the sovereign
right to maintain any level of protection that it deems
appropriate to address food safety hazards within its borders.
An exporting country has the burden of proving that its system
is equivalent to our own if that country wishes to export to
the United States.
FSIS begins the process of determining equivalence by
analyzing the country's meat or poultry regulatory system with
a document analysis to assess whether the country has the laws,
regulations, and an infrastructure to support an equivalent
system.
This document review focuses on a country's practices in
five risk areas: sanitation, animal disease, slaughter and
processing, residues, and enforcement. FSIS uses the document
review to ensure that the country has in place measures that
encompass the standards, activities, resources, and enforcement
mechanisms inherent in the US regulatory system for these five
areas.
If the document review is satisfactory, the process of
determining equivalence then moves to on-site review. During an
on-site review, an FSIS audit team evaluates all the aspects of
a country's inspection program, from the headquarters of the
inspection system to regional offices and local offices, and
ultimately to individual establishments within the country and
to laboratories that will be testing product destined for the
United States. Through these evaluations we seek assurances
that the country's inspection program is, in fact, what the
documentation claims.
The process for announcing initial equivalence
determinations for foreign countries is open and transparent.
When FSIS makes an initial equivalence determination, a
proposed rule is published in the Federal Register setting
forth the determination and our reasoning for it. After a
comment period, FSIS reviews all comments submitted on the
proposal and, as appropriate, publishes a final rule to add the
country as eligible to export meat, poultry or egg products to
the United States. This ensures an open and transparent
process.
Verifying Continuing Equivalence through Audits
The second part of our system is to verify continuing
equivalence through audits. This means that once a country is
determined to have a system equivalent to the United States,
that country is then responsible for ensuring that the entire
system exporting to the United States employ standards
equivalent to those contained in the Federal Meat Inspection
Act (FMIA), the Poultry Products Inspection Act (PPIA), and the
Egg Products Inspection Act. FSIS conducts annual audits of
foreign food safety systems and procedures to verify that this
is taking place. This process includes on-site visits by FSIS
personnel, including certified establishments, laboratories and
a review of government controls. There is a particular focus on
implementation of any new requirements we have put forth since
the last audit. For fiscal year 2007, FSIS visited 145
establishments, 39 laboratories, and 86 government offices in
the process of auditing all countries actively exporting to the
United States. The final audit reports of these countries are
posted on the FSIS Web site. If a country fails and audit, FSIS
can, and has in the past, suspend imports from that country,
from individual plants, or specific products.
Verifying Continuing Equivalence through Re-inspection at the Border
Finally, the last part of our system for ensuring the
safety of FSIS-regulated imports is verifying the continuing
equivalence of foreign systems through re-inspection of
products at the border. Every shipment of meat, poultry, or egg
products that enters the United States must be presented to an
FSIS inspector at one of the approximately 140 official FSIS
import establishments strategically located at major ocean
ports of entry and land border crossings. It is here that the
initial checks for proper documentation, evidence of tampering,
transportation damage, and proper labeling are conducted. This
process is currently assisted by FSIS' Automated Import
Information System (AIIS). AIIS is a database that schedules
re-inspection tasks and stores the results of the re-inspection
from each point in the process.
In addition to the initial re-inspection of product
entering the United States, FSIS performs intensive random re-
inspection on approximately 10 percent of the shipments of
meat, poultry, and egg products. These re-inspection tasks
include product examinations, microbiological analysis for
pathogens, and/or a test for chemical residues. Acceptable
products are marked as ``Inspected and Passed'' and released
into commerce. Non-compliant products are rejected, marked as
``Refused Entry,'' and either destroyed or returned to the
originating country. More intensive re-inspection is
automatically applied to future shipments of product from the
foreign establishment when product fails re-inspection.
I would like to take a moment to discuss the laboratory
system that FSIS relies on to carry out these more intensive
inspections. Depending on where the samples are taken, they are
shipped to the Eastern, Midwestern, or Western laboratories.
These three laboratories are operated by FSIS and are staffed
with FSIS personnel. We are constantly working to enhance the
capacity of these labs so they are prepared to respond to food
emergencies that can be caused by a vast array of contaminants.
Indeed, in recognition of our interest in keeping these
laboratories up-to-date, we requested $2.5 million in fiscal
year 2008 to enhance these important labs.
The important work carried out by import re-inspection
personnel I described earlier is supplemented by the twenty-
three Import Surveillance Liaison Officers (ISLOs) currently
employed by FSIS. These ISLOs are charged with identifying,
tracking, and detaining ineligible, illegal, or smuggled
product. Like our import re-inspection personnel, they work
regularly with other agencies, including Customs and Border
Protection (CBP), USDA's Animal and Plant Health Inspection
Service (APHIS), the Food and Drug Administration (FDA), and
the U.S. Fish and Wildlife Service, as well as brokers and
importers at U.S. ports of entry. Access to CBP's Automated
Commercial Environment (ACE) database has provided FSIS a more
targeted approach to identifying and controlling ineligible
entries of FSIS-regulated product closer to the entry point,
rather than after its release into commerce. In fiscal year
2005, prior to FSIS' use of the ACE system, the amount of
ineligible product removed from commerce that did not pass
through import houses was a little over 36 thousand pounds. In
fiscal year 2006, this amount increased to 1.6 million pounds,
and in fiscal year 2007, 2.1 million pounds was identified,
destroyed, or redirected to FSIS for re-inspection.
The Agency and other key Federal partners are working to
become fully integrated with CBP's ACE system. This effort will
eventually lead to a linkage of all inspection and border
control data systems, known as International Trade Data System
(ITDS), across all Federal agencies involved in imports.
Food Defense
Our three-part approach to imports is supplemented by our
critical food defense efforts to protect against accidental or
intentional food contamination.
To this end, the Agency performs vulnerability assessments
for imported food and, potentially, for food that has illegally
entered the U.S. market. These vulnerability assessments help
us to strengthen our food import system. Armed with these
vulnerability assessments, the Agency conducts ongoing training
to increase awareness of food defense issues among our
international trading partners.
FSIS inspectors also engage in ongoing and comprehensive
training and education efforts that assist them in preventing
and responding to any potential threat to the food supply.
Coordinated food defense awareness training is conducted in
locations nationwide in conjunction with our food defense
partners throughout government. They include the Department of
Homeland Security (DHS), the Department of Health and Human
Services (HHS), other USDA agencies, as well as State and local
food defense partners.
FSIS is working jointly with FDA on the continued
development of the Food Emergency Response Network (FERN) with
other national, State, and local laboratories to provide
ongoing surveillance and monitoring of food and to prepare for
emergency response stemming from a food illness outbreak,
intentional contamination, or even a hoax.
In addition, FSIS is participating in a consortium of lab
networks developed by DHS. This integrated consortium will
improve coordination among Federal and State partners that are
focused on food and agriculture issues. In the process, it will
ensure consistency of methods development and the reporting and
sharing of lab results between Federal and State partners.
FSIS has also developed and distributed model food security
plans for use in import establishments. These plans help the
importers develop a personalized Food Defense Plan that takes
into account the unique characteristics of the establishment.
Finally, while import inspectors conduct their regular re-
inspection at import facilities, their activities also include
efforts aimed at protecting consumers from intentional attacks
on the food supply. These activities include facility checks to
identify, among other things, suspicious activities in product
re-inspection or port areas, evidence of product tampering, or
signs that a facility's water supply may have been compromised.
The specific procedures performed change according to the
threat level.
Interagency Working Group on Import Safety
Mr. Chairman, I have gone over how imported meat and
poultry products are currently inspected through a systems
approach, reviewed our re-inspection procedures at our border
and detailed how our food defense efforts improve our
effectiveness. USDA is also working closely with the recently
formed Interagency Working Group on Import Safety to look at
what we can do better. As the USDA representative for the
working group, I am speaking from first hand experience.
The President formed this Working Group, which is chaired
by Health and Human Services Secretary Michael Leavitt, to
ensure that we are doing everything we can to promote the
safety of imported products. The mission is critical--and that
is to conduct an across-the-board review of import safety by
U.S. importers, and by Federal, State, and local governments.
It has also been given the task of providing recommendations to
the President that will help to further improve the safety of
imported products.
In September, the Working Group issued a strategic
framework for doing more to ensure the safety of imported
products. This framework outlines a risk-based approach that
includes the principles of prevention, intervention, and
response. The framework supports USDA's long-standing approach
to evaluating and verifying the ability of foreign food safety
systems to meet food safety requirements for meat, poultry, and
egg products exported to the United States.
The next step in advancing the framework will be the
Working Group's mid-November release of an implementation
action plan. The action plan will provide specific short- and
long-term recommendations for import safety improvements and
will reflect stakeholder input received through several
outreach activities conducted over the past two months, as well
as from a public meeting that was held on October 1 at USDA
headquarters here in Washington.
I want to assure everyone that we have a strong system in
place for imported products regulated by USDA. I believe that
our approach to regulating the safety of imported meat,
poultry, and egg products is the best system in the world. This
is due to our rigorous three-part approach: determining initial
equivalence; the continuous evaluation of that equivalence to
ensure that it is maintained; and our vigilant surveillance of
meat, poultry and egg product entering the country. The safety
of our food supply is also due in large part to the work of our
food safety partners.
But the state of public health is constantly evolving, and
we must be sure we're evolving with it. We cannot afford to let
ourselves, our food safety partners, or our nation's food
safety systems grow complacent. That is why the Import Safety
Working Group is so important. It gives us an opportunity to
step back and look at how we can improve our vital import
inspection procedures. We all know that we can protect
consumers with sensible policies, and together we will do just
that.
Mr. Chairman and all Members of the Subcommittee, I would
like to thank you for this opportunity to explain the important
process that FSIS employs in protecting consumers by assuring
the safety of imported food products.
----------
Mr. Stupak. Dr. Acheson, if I may, I will start questions.
We heard Mr. Rice with several countries, in fact even Tyson
Foods, that have their own certification process in China. Why
doesn't the U.S. have a certification process in China?
Dr. Acheson. There is a complex answer to that. A lot of
the ground has been covered on that already earlier on. But let
me try to summarize from the FDA's perspective.
We are able to hold the product, inspect the product at the
port of entry if there is an appearance of adulteration. That
is a fairly low bar. Right now we do not have the authority at
FDA to require certification from a foreign country.
Mr. Stupak. Are you trying to tell me you need specific
requirement from Congress to go certify farms and food
producers in China?
Dr. Acheson. It depends on what you mean by certification.
If you are talking about certification as a requirement for
entry into the United States, then we would need a specific
legal authority to require that as a reason to refuse if it
doesn't have the certification.
Mr. Stupak. So the United States--Russia has one, Japan has
one, Hong Kong has one, all of them. Are you saying they all
have legislative authority to do that before they can have
certification of farms in another country to bring it in?
Dr. Acheson. I'm not familiar with the laws in Russia or
those other countries, but in the United States, my
understanding of U.S. Law is, yes, we would require that legal
authority to put in place a system whereby we require
certification of certain products from particular countries. We
don't have that currently.
Mr. Stupak. You talked about this Import Working Group that
is working, and you indicated the President is directly
involved in it. Is certification of farms or food-processing
plants in other countries part of that discussion you're having
in this working group?
Dr. Acheson. I think certification is part of the general
discussion that is being had around--certainly with regard to
ensuring the safety of imported products. But again, as it has
come out in the earlier panels, one of the things that we need
to be certain of at FDA with regard to food safety and food
defense is what does that certification mean. Simply having a
piece of paper that is a certificate may not be adequate. If we
set that system up, we have to verify that that certification
system is working to a level that meets the standard that we're
comfortable with.
Mr. Stupak. Well, if we're not certifying, we're only
inspecting 1 percent of food coming into this country. We're
not keeping the American people very safe then, are we? If
you're not certifying the farms, you can't certify the food
coming in, you can only certify 1 percent, and 99 percent is
not inspected. So how can you assure the American people that
the food they're consuming is going to be safe?
Dr. Acheson. What we're doing is we're reacting when
problems occur.
Mr. Stupak. How can you react? You don't even have recall
authority.
Dr. Acheson. We can undertake recalls voluntarily with
firms, and we do that on a regular basis.
Mr. Stupak. The firm has to voluntarily do it.
Dr. Acheson. Exactly. But what we recognize is that there
is a need to build prevention up front. That is where we're
headed.
Mr. Stupak. For prevention up front, wouldn't you want to
certify the farm or the processing plants that are processing
the food before it comes here? Isn't that really the first
upfront line of defense you could have.
Dr. Acheson. You certainly need to ensure that the product
is being manufactured safely, whether it be domestically or
from China or India or wherever. Certainly requiring
certification is an option that is under consideration as part
of that process.
Mr. Stupak. Well, let me ask you this. The produce industry
has called on the FDA to enact tough new regulations regarding
the handling of fresh produce; however, the FDA has not done
this. And according to--right there is the exhibit book,
exhibit No. 20, an article from the Wall Street Journal in
February, Health and Human Services officials rejected the
FDA's plan for tough new regulations on the handling of
produce. Is it true that the FDA sought mandatory regulations
but were overruled by HHS.
Dr. Acheson. I wasn't part of that particular meeting, but
my understanding of that was that the FDA did not take requests
for specific mandatory regulations to HHS.
Mr. Stupak. What did they do with them? The produce
industry has been calling for you to do it. According to news
reports, the FDA brought it to HHS. So that is not true, they
never brought it to HHS.
Dr. Acheson. Those earlier meetings with HHS were high-
level discussions around food safety in general. At that time
that was fairly recently after we had had spinach and----
Mr. Stupak. Most produce----
Dr. Acheson. Yes. But it was not a specific request for
authority that was ultimately turned down.
Mr. Stupak. So it was ultimately turned down?
Dr. Acheson. No, I said it was not a specific request for
authority that was----
Mr. Stupak. So you had high-level meetings. What came of
the high-level meetings, anything?
Dr. Acheson. Absolutely. Part of those high-level meetings
was a recognition that we needed to step up and do different
things to face these new challenges. That's one of the reasons
why Commissioner Von Eschenbach created my position and
instructed me to develop a food-protection plan, which we're
working on, which I anticipate will be launched sometime within
the next month or two.
Mr. Stupak. What can you tell us in this committee that is
going to be preventive so we can prevent the action of people
getting sick like on E. coli? And again, I agree it came from
spinach from Salinas Valley, the hearings we have had on it.
But what are you doing to prevent that?
Dr. Acheson. There are a number of things. To put
preventive strategies in place, you have to understand what
caused the problem in the first place. Again, as has been
alluded to earlier, the close proximity of cattle to a spinach
field may be----
Mr. Stupak. That has been going on for 10 years. We've had
20 outbreaks, and the FDA has done nothing to prevent the
cattle from polluting the water so it doesn't go on the spinach
fields. So where is the preventive action here? You haven't
even done an epidemiology study to figure out where it is
coming from.
Dr. Acheson. What you're alluding to there is the need of
the basic sciences to put those preventive strategies in place.
That is not all there.
Mr. Stupak. If we don't have basic science, how are we
going to have advanced science to inspect food?
Dr. Acheson. You need the basic science principles to
understand how E. coli gets on the spinach in the first place.
Yes, we know it is in cattle, but is it coming via the water,
via wild animals.
Mr. Stupak. That's why an epidemiology study would
determine that; would it not? Twenty outbreaks in ten years and
you still haven't determined that. You haven't even requested
an epidemiology study, have you.
Dr. Acheson. We certainly recognize there is the need for
that science, and we have not----
Mr. Stupak. So are you going to recommend an epidemiology
study for Salinas Valley, the Salad Bowl of America.
Dr. Acheson. What we're going to do is to focus more than
on leafy greens in the Salinas Valley. There is a need for more
science.
Mr. Stupak. But are you going to ask for an epidemiology
study to try to get down to the source of the E. coli bacteria
which pollutes the Salinas Valley, which ends up in 20
outbreaks in 10 years?
Dr. Acheson. You're absolutely right. One of the key
questions is to answer that. An epidemiology study is maybe a
mechanism to get to that. How does the E. coli get from the
cattle to the spinach? It is a key question. There is no doubt
about that.
Mr. Stupak. Key question? When are you going to study it or
do an epidemiology study.
Dr. Acheson. The Food and Drug Administration is not a
research agency.
Mr. Stupak. I'm not asking you to do research. Don't you
have to have the study be done?
Dr. Acheson. The FDA doesn't have the resources to require
that study, but we certainly put out to our research
colleagues----
Mr. Stupak. You've been the drug czar for some time now.
Have you asked for money to do an epidemiology study? Have you
asked for more money from the OMB to do inspections?
Dr. Acheson. As part of the budget process of 2009 and the
rolling out of the Food Protection Plan, we've recognized that
in order to get where we need to go, we will be needing new
resources, yes. That is part of the ongoing process.
Mr. Stupak. So you haven't asked for it yet, but you think
you will in 2009?
Dr. Acheson. That budget process has to follow its tracks.
And we recognize that that is just the way the system is set
up.
Mr. Stupak. I'm over my time. I'll turn to Mr. Whitfield
for questions. I'm sure we'll have another round of questions
here.
Mr. Whitfield. Thank you, Mr. Chairman.
Dr. Acheson, you and Ms. Glavin both have a responsibility
for protecting the food supply in the U.S., which is an awesome
responsibility. And with your expertise and with your
experience and with that responsibility, what concerns you most
from your position about guaranteeing the safety of the
American food supply? What are two or three things that concern
you the most?
Dr. Acheson. I think the principal concern is to move away
from a reactive situation in responding to outbreaks when
somebody is sick to building in safety up front, whether that
be domestic, as we've just been discussing with regards to
spinach, or whether it be from an imported product.
I believe the key to success is to build in preventive
strategies at the manufacturing level right up front, wherever
that is happening, domestically or foreign.
Mr. Whitfield. What kind of progress are we making in doing
that?
Dr. Acheson. The progress that we're making is determining
what would be the steps to get there. That is a significant
part of the Food Protection Plan that we're talking about, a
shifting emphasis into prevention, yet maintaining inspections,
focused on risk. Again, the prevention has to be focused on
risk and building a more robust response system. We do respond
well already, but I would be happier if we were even faster
getting a handle on illness quicker, to get it off the shelves
faster and protect consumers.
Mr. Whitfield. So one thing, then, is going from a reactive
to a more preventive method? And we're not there yet. And what
is the second thing?
Dr. Acheson. Well, I've summarized that with the focused,
risk-based inspections. We need to continue to inspect,
obviously, but those inspections need to be focused in the
areas of greatest risk. And as part of that, which is the third
point, is the need to integrate that with modern technology;
not just information technology, which is critical, especially
in the area of imports, of getting better, faster systems to
integrate the mountain and the ever-increasing amount of
information, but also detection technology. We need to be able
to detect problems in foods faster, hopefully in a matter of
hours as opposed to days. So we need to build those in as well.
Mr. Whitfield. Well, I notice that the largest import
refusals come from Mexico, China and India. So how often do we
send inspectors to those countries to look at their facilities,
or do we?
Dr. Acheson. I think in the last year--and my colleagues
can give you the specific numbers there. It is in the order of
100 to 150 foreign inspections we've done. We can certainly
provide you information on which countries that we have----
Mr. Whitfield. Are budgetary concerns an issue there or
not?
Dr. Acheson. Certainly the amount of inspections that we do
both domestically and foreign are limited by resources.
Mr. Whitfield. What is the overall budget for your area of
responsibility?
Dr. Acheson. Within foods, it is about $400 million, I
believe. I certainly can get you the exact number.
Mr. Whitfield. Four hundred million dollars? That doesn't
really seem like very much. And what is the total FDA budget?
Do you all know that?
Dr. Acheson. It is about a billion dollars, the total FDA
budget. Two billion. I'm sorry. I'm not familiar with these
numbers. We can get them to you for the record.
Mr. Whitfield. Let me ask you another question. In February
2006, the FDA had information in hand that other foreign
countries, particularly Canada and South Korea, had banned the
import of Chinese eel because of the presence of malachite
green. Now, that was in February 2006. FDA did not issue an
import alert on Chinese eels until around November 2006, some
6, 7, 8 months later. Why did it take so long for FDA to issue
an import alert in that situation?
Dr. Acheson. Again, I have colleagues who can speak more to
the specifics of an import alert, But let me try to summarize.
In order to issue an import alert, we have to have the data
to show that we can do it, which essentially means
demonstrating through a sampling strategy that there is a level
of contamination in a certain product of concern, in this case
eel, with a certain agent, malachite green, that is of
sufficient degree to pose a problem and of sufficient extent to
issue a countrywide alert.
What we've done when we see problems with individual
companies is we can issue an alert very quickly. We did that
with melamine. Two companies were of concern. The import alert
for melamine, for protein concentrates was issued in a matter
of weeks in that situation. But the malachite green required
more testing to get to the point where we could say this is a
countrywide issue, it is not just one or two firms that are
causing the problem.
Ms. Glavin. We also had people from the Center for Food
Safety in China trying to gather that information and trying to
get information and data on the extent of the problem, which
helped us in putting that import alert out.
Mr. Whitfield. Let me just ask one other question. My time
has expired. But why do you refuse to acknowledge China's
certificate of export?
Dr. Acheson. It is not that we're refusing to acknowledge
it. My point is that we cannot require it as a condition of
entry into the United States.
Mr. Whitfield. So legally you cannot require it?
Dr. Acheson. Legally we cannot say that that is a
requirement and without it we would refuse entry.
Mr. Whitfield. Thank you.
Mr. Stupak. Mr. Melancon with questions.
Mr. Melancon. Thank you, Mr. Chairman.
Ms. Glavin, you talked about high-risk food shipments. I
guess focusing on that, what is a high-risk food shipment? Does
somebody have to be critically ill or die?
Ms. Glavin. There are a large variety of factors. If we're
talking about food safety, the factors would be things such as
what is the food. Certain foods are inherently more risky than
others. Where is it coming from? Is it coming from a country
where we have a history of problems? Is it coming from a
manufacturer where we have a history of problems? Do we have
any data that shows that there are illnesses connected with
that product? So there are a variety of things that--it is not
a single piece of information.
A number of you have mentioned a new system that we're
piloting at one port right now, and that is the PREDICT system,
a system that is designed to take the real-time information we
have and make--help us make decisions in real time about what
we should look at and what we can let go through without a
physical examination.
Mr. Melancon. You talked about the Department had different
authorities, some that may be new, some that you're using. How
many times has the Department implemented any of these
authorities in recent times?
Ms. Glavin. I'm sorry.
Mr. Melancon. When you were doing your testimony, you
talked about these different authorities that the Department
had. And I'd have to go back. Both of them were acronyms.
Ms. Glavin. I'm sorry. I do use acronyms. I apologize.
There are two issues with respect to food. There are two
different kinds of things that we do. The first one is unique
to food, and that is we look for--we have a specific
responsibility to look for evidence of bioterrorism,
intentional adulteration or tampering of food. And that is done
in conjunction with CBP. It is done on all food coming into the
country. All food coming into the country has to note--we have
to be notified before it can enter the country so that we can
do that screen.
The second screen is our food safety screen, and that is
where we look for food safety problems and look--that is the
second set of criteria that are used that are specific to
safety, not to the security side. And that would include things
like the type of food, where it is sourced, what the company
history is, what the history of that importer is, et cetera.
Mr. Melancon. When you get a product that comes in that has
no certificate, shouldn't that be a flag that we ought to be
testing that food immediately?
Ms. Glavin. Not all countries have certificates. But if a
country offers a certificate, we certainly can consider the
lack of the certificate if a certificate is available as one of
the factors. What Dr. Acheson was saying is that we can't use
the lack of a certificate as the sole reason for denying
admission.
Mr. Melancon. Why can't we require a certificate on all
food products?
Ms. Glavin. We don't have that authority.
Mr. Melancon. USDA, you have the authority.
Dr. Raymond. The Federal Meat Inspection Act and the
Poultry Products Inspection Act gives us the authority and
requires us to determine if the country has the equivalent food
safety system.
Mr. Melancon. So I guess the question is, has anybody ever
asked for that authority over at FDA?
Ms. Glavin. I'm not aware that they have.
Mr. Melancon. We know we have got a problem, and nobody
wants to say, maybe you all need to help us give us the tools.
Dr. Acheson. Let me respond to that. We certainly recognize
that we've got challenges. And I have acknowledged in my
testimony that part of the Food Protection Plan that we're
developing is to address those very challenges that we're
discussing today.
Mr. Melancon. The large quantities of commodities that come
in--and, of course, maybe it is easier or harder. I'm not sure.
USDA has the ability--maybe FDA needs to be talking to them
about how to monitor this stuff and get it done. And somebody
needs to say to the Congress, look, we've got a problem, food
safety and other issues that are coming in that are creating
problems. And in this day and time, I find it difficult,
especially after I've been through 2 years of excuses from FEMA
and other agencies about why they haven't done anything. As a
member of the bureaucracy that is supposed to be trying to
protect America, tell us what we need to do. Don't come here
and give me an excuse why we can't do it. I can find excuses
not to do it. FEMA has got a great agency for telling me how to
do that.
So where I am, and I think where we're trying to come from,
is I don't want to continue to see food products coming into
this country--and I've said this on many occasions, we've got
the dumbest system in the world for negotiating trade deals. It
is give them anything they ask for, don't check what comes in,
and just go about your business. And it is not a good system.
One person negotiates the deal, and then nobody is back here to
follow it up.
Shouldn't you be talking with the USTR and saying, we need
food safety, we need country of origin, we need labeling, we
need certification? If we're going to protect Americans,
shouldn't you as the protectorate of the food supply be asking
for that authority or that in those trade deals or that of this
Congress?
Dr. Acheson. Again, I find I'm repeating myself. I agree
with everything you're saying. Our mission is to protect the
public health at FDA. That's what we're about. And part of my
job is regards to food safety and food defense. That is
critical.
The plan that I keep mentioning is through getting into the
throes of clearance, and I would look forward to bringing that
to this committee or to you personally and saying here is where
we think we need to go, and let's have a dialog and establish a
partnership in terms of whether the feeling is that this meets
the needs.
We recognize that we have got challenges. We recognize that
we need to make changes, we need a new approach. And that is
exactly what we're working on. We're just not quite to the
point yet where this is out for public viewing.
Mr. Melancon. My time has run out.
Mr. Stupak. Thank you, Mr. Melancon.
Mr. Burgess for questions, please.
Mr. Burgess. Thank you, Mr. Chairman.
Dr. Acheson, thank you for being with us today. Dr. Raymond
testified earlier--his written testimony has a much more
eloquent definition of equivalence than I used when I spoke a
little earlier. Why doesn't the FDA have a similar program of
that equivalence concept that the USDA uses?
Dr. Acheson. There are two answers to that at least, if not
more.
Mr. Burgess. Give me the short answer. And I'm actually
going to submit this for a written response because I think it
deserves a written response. Let me just ask you to please make
that timely. We've been working with--and make no mistake, I
love the FDA, I love everything you do, but you guys are slow
when it comes to getting responses. So give me the short answer
on equivalence and then I really would appreciate a much longer
written response.
Dr. Acheson. The short answer is authority and complexity.
Mr. Burgess. The authority being you don't have the
authority, and you need us to give you the authority
legislatively.
Dr. Acheson. We don't have the same authority that USDA
has.
Mr. Burgess. You need that from us in legislation; is that
correct? Are you asking us for that authority?
Dr. Acheson. I'm not asking you for that authority. I'm
answering your question as to why do we not have it.
Mr. Burgess. I think it would be a good idea if you had it.
So if I want you to have it, then we need to write you the
legislation that gives you the authority to have it.
Dr. Acheson. I think that leads into my second answer,
which is complexity.
Mr. Burgess. Before we get into complexity, let me just ask
the other question. Would you use it if we gave it to you?
Dr. Acheson. Within the confines of complexity, you have
got to look at whether it is usable.
Mr. Burgess. I was hoping to stay away from complexity for
just a moment.
Dr. Acheson. You can't disassociate the two.
Mr. Burgess. Would you use it? Would it be a useful tool?
Would it be a part of your armamentarium that you could go
forward and provide the protection that Mr. Melancon so
eloquently requested of your agency?
Dr. Acheson. If equivalency was applied uniformly to all
countries, to all products that FDA regulates, it would,
frankly, be crippling.
Mr. Burgess. Crippling in the fact that we would have such
an enormous bureaucratic burden, we could never surmount it?
Dr. Acheson. In many ways. We're talking about 200-plus
countries, hundreds of products.
Mr. Burgess. Is there a way to develop a program of
equivalency that has the proper safeguards and parameters and
boundaries so that it is not crippling, but at the same time
provides a base code of safety that we can once again assure
the American people that we're doing? Because they don't
believe us right now.
Dr. Acheson. I think with adequate resourcing of both
finance and brain power----
Mr. Burgess. Fast forward. Have you reviewed the
legislation that has been put forward by Chairman Dingell? Does
the resourcing present in the legislation put forward by
Chairman Dingell, does that provide an adequacy of resources
for you?
Dr. Acheson. It is more than just money. To sort out all of
these issues of complexity--and I apologize that I keep coming
back to that----
Mr. Burgess. That's where I want your written response
because I know that is important.
Dr. Acheson. That's where it gets complex, because we're
not just talking about meat, poultry and egg products. We're
talking about hundreds of different regulated commodities with
many, many different standards in different countries, and
developing that level of equivalency would be unbelievably
complicated.
Mr. Burgess. Again, I do look forward to a timely written
response. We'll phrase that as a written question.
Mr. Chairman, I really do want to see the response to that
because I think it has to be part of our discussion when we
craft this legislation.
Let me just ask you with the little time I have left, were
you astounded by the response that if someone is up there
checking for their own product in another country, and they
find something really bad, they don't feel obligated to
disclose that to any of the regulatory agencies that are also
charged with protecting food safety?
Dr. Acheson. As a person who spent many years in clinical
practice as a physician, it worries me that there may be
problems out there that we can perhaps do something about and
don't hear about it. That is a business decision. Is not a
requirement.
Mr. Burgess. A business decision to be sure, but do you
have--with your regulatory authority, do you have the ability
to go in and assess the quality-control measures that are being
used by a private company that is then importing to the United
States? Whether it be an American or foreign company, can you
go in and look at their quality assurance methods to make sure
they're up to snuff?
We talked about the statistical tests before. Do you have
the authority to do that? And if so, would you find such a
problem with the analysis of just the quality assurance, or do
you need another method of getting that information?
Ms. Glavin. With respect to food, sir, we do not have the
authority to mandate an inspection of a foreign firm if they
choose not to have us come.
Mr. Burgess. I don't mean to interrupt, But I'm just
astounded by that. So if a private company that is importing
poultry to this country says, whoa, on this shipment we have
got polonium under the chicken wings, we're not going to bring
it in, but we just don't say anything about it?
Ms. Glavin. Well, poultry is under the USDA, but if it was
peaches, yes.
Mr. Burgess. If it was whatever, shellfish or whatever, if
you found a problem to that order or magnitude, which to me
means bioterrorism, would you not have authority under the
Bioterrorism Act to require that information be given to you?
Ms. Glavin. If we had information, absolutely.
Mr. Burgess. But if they have information, and they just
choose not to tell you as a business decision because they
don't want to irritate the People's Republic of China, that is
OK?
Ms. Glavin. I'm not saying it is OK. I'm saying that we
don't have the authority to mandate that they give it to us.
Mr. Burgess. And that would be the situation, that if they
said, well, we just don't want to irritate our host, so we're
not going to give you that information, that is what would
happen?
Ms. Glavin. That's right.
Mr. Burgess. So as we sit up here on this dais attempting
to assure the American people we're providing oversight, we've
really got no mechanism to go back and check that; is that
correct?
This gets back to Mr. Melancon's questions about the trade
agreements. And I realize it is out of the purview of this
committee and this argument, but clearly that seems to me that
is a gaping hole that has got to be closed. Or am I missing
something?
Dr. Acheson. I think in the context of foreign companies,
you're correct. And as Ms. Glavin has pointed out, we don't
have the authority to do that.
Mr. Burgess. Do you agree that that is a potential
liability for us, a potential vulnerability for us?
Dr. Acheson. It is one of the areas that we're considering
in the Food Protection Plan is what do we need to do to address
those kinds of gaps.
Mr. Burgess. I'm not one that normally eats Chinese eels,
and I don't intend to ever begin, but just the whole story with
the malachite green stuff is a little disturbing, that you
found the problem and it took so long to control the problem.
What if it were something much more serious? When I say
serious, i.e., involving a food that I might eat.
Dr. Acheson. If it was food you were eating, we'd be right
on it, I can assure you. No. A serious point. We did react very
quickly when we had issues with melamine. That was in a matter
of days or weeks once we knew there was a problem.
Mr. Burgess. And I'd submit that I don't know that we
really know when that problem began. I have just uncorroborated
testimony from veterinarians back in my district, boy, we were
losing a lot of pets, and we didn't know why. And that worries
me because I don't--again, I don't--and then it comes back to
the point that if someone knew that we're grinding up
countertops and putting them in our dog food, they've got to
tell you that so you know to look for it. Somewhere along the
line there has to be some responsibility of the companies that
are providing imports into this country or they lose their
license, I think. Just my opinion.
Mr. Chairman, I yield back. I know I've gone over.
Mr. Stupak. Thank you. And I'm sure we'll go another round
or two at least with this panel.
You mentioned melamine. That was Customs and Border Patrol
that stopped melamine. It wasn't FDA.
Dr. Acheson. No, it was FDA which issued the----
Mr. Stupak. We had a hearing. It was Customs and Border
Patrol that was stopping melamine before the FDA ever got
around to it. Even after the FDA got around to it, it took your
lab, like, 48 hours to discover the melamine because it didn't
know what it was looking for, right?
Dr. Acheson. I beg to differ. It was FDA labs who
identified that it was indeed melamine. And then it was FDA----
Mr. Stupak. That was the lab----
Dr. Acheson. And then it was FDA that set up the import
alert. We then worked with Customs and Border Protection to put
that into practice.
Mr. Stupak. When is this plan going to be done? You keep
talking about this plan you want. When is it going to be done?
Dr. Acheson. As soon as possible.
Mr. Stupak. That means what?
Dr. Acheson. I would anticipate--and as I've said earlier,
it is within high levels of clearance within our Department
right now, within HHS.
Mr. Stupak. When do you anticipate it is going to be done?
Dr. Acheson. I hope within the next 2 to 3 weeks we'll be
able to get this out.
Mr. Stupak. And are you going to ask for an equivalency
standard like the USDA has in this plan?
Dr. Acheson. The specifics of that plan are still under
discussion with our Department. I can't get into the specifics
of what may be----
Mr. Stupak. Why can't you get into the specifics of it?
Dr. Acheson. Simply because it has not been cleared by my
administration.
Mr. Stupak. Who is the administration, the White House or
HHS?
Dr. Acheson. It is both.
Mr. Stupak. So you're getting pressure from the White House
and HHS to do certain things in this----
Dr. Acheson. I didn't say we were getting pressure.
Mr. Stupak. No, I did.
Dr. Acheson. No, I'm not getting pressure. There is a
required process of clearance, and it is just not completed.
Mr. Stupak. Does the FDA require additional legislative
authority to apply HACCP requirements to all domestic food
producers, processors like we have for juice and seafood.
Dr. Acheson. As you have just acknowledged, we have put out
HACCP requirements for two products, for juice and seafood.
Mr. Stupak. Right. So you require further legislative
authority to do all domestic food producers and processors is
my question. Do you require additional authority, or can you do
it underneath the existing HACCP authority since you've done it
for juice and seafood?
Dr. Acheson. I'd have to seek a legal answer to that. I'm
not an attorney, but my understanding of that is if we've done
it for two, we could potentially do it for more using that same
approach.
Mr. Stupak. Sure. So why wouldn't you do that then, use
those requirements to make American consumers safer? You did it
for juice and seafood. Why not do it for the rest?
Dr. Acheson. As I said, I believe that we do need to be
seriously looking at putting in preventive controls, and using
a HACCP-type approach is potentially a way to do that.
Mr. Stupak. You indicated to Mr. Burgess that you needed
more resources. We indicated that the Dingell-Pallone-Stupak
bill which is currently pending, which would generate $500 or
almost up to $600 million a year for food. Would that be
adequate resources.
Dr. Acheson. It would certainly help.
Mr. Stupak. But would it be adequate?
Dr. Acheson. Adequate to do what?
Mr. Stupak. To provide food safety, to inspect the 99
percent we're not inspecting.
Dr. Acheson. No. If the goal is to inspect 100 percent----
Mr. Stupak. The goal isn't 100 percent. Or is that going to
be the goal of your plan, 100 percent?
Dr. Acheson. No.
Mr. Stupak. Is there a percentage your plan indicates?
Dr. Acheson. No. Simply throwing more money at this to do
more inspections is not a solution.
Mr. Stupak. I agree.
Dr. Acheson. What we've got to do is do smart inspections,
and that means the risk--and it gets back to your earlier
point----
Mr. Stupak. Let's go back to the Dingell legislation. Has
the FDA taken a position on the Dingell legislation?
Dr. Acheson. Not that I'm aware of.
Mr. Stupak. Has the FDA taken any position on any of the
bills that have been introduced for the last 10 years on food
safety? Have you taken any positions on them.
Dr. Acheson. I'd have to get back to you on what the
official positions are on any of those previous bills that
predate my time in this position.
Mr. Stupak. Ms. Glavin, do you know?
Ms. Glavin. I don't know. Sorry.
Mr. Stupak. I can tell you I wrote the first one in 1998.
We're still waiting for an answer. So I hope your plan is not
going to be 10 years.
Let me ask you this: What specific requests have you made
in terms of resources from the Commissioner or Office of
Management and Budget? Have you made requests to them for more
money for resources, for inspections, for overseas work?
Dr. Acheson. We've made requests through the 2008 budget
process for an increase----
Mr. Stupak. And how much was that increase?
Dr. Acheson. I think it was about $10 million or
thereabouts.
Mr. Stupak. What was the $10 million going to be targeted
for? Hopefully not bonuses.
Dr. Acheson. I know a portion of it was for research, some
for foreign inspections. Again, for the record, I could get
back to you the breakdown exactly of what the 2008 budget
request was.
Mr. Stupak. Let me ask you this: Do you support recall
authority to be given to the FDA, Dr. Acheson?
Dr. Acheson. We've managed for years without it, and I
believe we have an effective system. It is certainly one more
tool in the toolbox that could potentially be used in certain
situations.
Mr. Stupak. Do you support recall authority for the FDA?
Dr. Acheson. Are you asking me personally?
Mr. Stupak. I'm asking you, first of all, as a drug czar.
Dr. Acheson. Food czar.
Mr. Stupak. Food czar. We'll get to drugs next week,
November 1.
Dr. Acheson. As I've said, I believe that it could be a
tool in the toolbox that could under certain situations
expedite recalls. Since I've been working at FDA in this role
for----
Mr. Stupak. What do you want? Do you want only recall
authority for certain types of food or what? I mean, why would
you be opposed to a recall authority?
Dr. Acheson. I'm not opposed to it.
Mr. Stupak. You are saying only under certain
circumstances. You've got to have the authority before you can
use it. Just because you have the authority doesn't mean you'll
use it. So you'll use it where you want. You can't use it if
you don't have it.
Dr. Acheson. I'm not opposed to us having that authority at
all.
Mr. Stupak. Good.
Let me ask you this: You said that your group is looking
at--in proactive, risk-based and rapid response, correct?
Dr. Acheson. Right.
Mr. Stupak. Proactive, explain that. In what way are you
going to be proactive?
Dr. Acheson. That is getting back to the prevention issue.
What we've got to do is build safety in right up front with the
manufacturer, at the processor, so that what is being done at
the manufacturing level is building preventative controls up
front as opposed to reacting to them when we get illness.
Mr. Stupak. Sure. I agree with that. So let's go back to
certification, let's say like in China, the farms and plants or
food processing place. If that is going to be proactive--and
even the President is fond of saying we have to fight terrorism
overseas so we don't have to fight them on our own shores. So
why don't we have that same attitude when we have to fight food
safety issues instead of waiting for it to arrive in America?
How come we're not being proactive in taking it overseas;
instead we allow 99 percent of the food to come in without ever
being inspected.
Dr. Acheson. That's exactly what we're proposing to do.
Mr. Stupak. How----
Dr. Acheson. What you're alluding to is pushing the borders
out. What we're trying to get away from is this snapshot of the
port of entry where we make a determination based on the
information that we receive.
Mr. Stupak. How are you going to get it overseas? How are
you going to be proactive overseas? Are you going to assign
inspectors overseas in countries?
Dr. Acheson. There is a number of avenues that we can take.
One is to have a greater foreign presence physically from FDA.
Mr. Stupak. Is that one you recommend?
Dr. Acheson. It is certainly one of the possibilities that
we're looking at.
Second is to develop memorandums of agreement with foreign
governments and to work with foreign governments and, as part
of that, to get a better insight into the processes and
standards that are occurring in foreign countries, particularly
in the foreign countries that we have concern about with
regards to food safety.
And then the second part is working with the industry in
terms of working with them to look at their processes, their
data in terms of what they're doing in foreign countries to
help determine relative risk of a product coming into the
United States.
Mr. Stupak. All right. My time is up.
Mr. Whitfield for questions.
Mr. Whitfield. Just one other question I wanted to ask Dr.
Raymond. Dr. Raymond, the Food and Drug Administration has a
list of--in their regulations--they have a list of drugs. And
they say if one of these drugs is present in an animal that is
to be slaughtered for human consumption, then it is disallowed.
At a time when they were slaughtering horses in the U.S., even
though that meat was being exported to other countries, about
four of the listed drugs were specifically used by--in animals
that were used in horse racing. And it was a common drug, and a
significant number of these horses that were slaughtered were
racehorses. How do you ensure that those drugs are not present
when the animal is slaughtered?
Dr. Raymond. Part of our regular testing is testing for
residues. I don't know that I could answer your question that
we know--we test them----
Mr. Whitfield. I was told that not every animal was tested.
Dr. Raymond. That would be correct.
Mr. Whitfield. That's correct. So there is a likelihood
that--I mean--fortunately, it is not consumed in the U.S., but
it was going to Europe and Japan. And these drugs, many of them
as a matter of course are given to animals that race. So they
are in there. So there is a likelihood that a lot of this meat
going abroad had a prohibited substance in it, I would say.
Dr. Raymond. I would think that a lot of the drugs that
you're referring--I don't know the exact ones, of course, but
they were probably things that were used to treat ailments like
a tender knee or something like that, like an anti-inflammatory
drug that may be in the system for a very short period of time.
And most of the horses that would go to slaughter are horses
that have long since quit racing, and they may not be taking
those drugs, and they are probably not drugs that stay in the
meat.
Mr. Whitfield. But some of them haven't been off the track
long when they're slaughtered. But you've answered the
question. So thank you very much.
Mr. Stupak. Let me just ask a few more questions, if I may.
Ms. Glavin, you made mention of the detain without physical
examination alerts, that our food products are actually
delivered to the importer premises, correct?
Ms. Glavin. That's right.
Mr. Stupak. And isn't it also true that the importer may
obtain a private lab certification that the product is not in
violation.
Ms. Glavin. Well, when something is detained without
physical examination, it is the importer's responsibility to
demonstrate that the product should be admitted and----
Mr. Stupak. The way to do that, they go to a private lab to
show that the food----
Ms. Glavin. That is one way they can do it, yes, sir.
Mr. Stupak. May the FDA audit the private laboratory
results?
Ms. Glavin. We have no regulatory authority over the labs
themselves. We certainly look at the lab worksheets in
determining whether or not we're going to accept those results.
Mr. Stupak. So you can't even audit the lab?
Ms. Glavin. No. We do some audits, but we have no
regulatory authority over those labs.
Mr. Stupak. Do you want regulatory authority over the labs,
certify these labs that are doing the testing.
Ms. Glavin. I think that would be something very
interesting to look into, yes, sir.
Mr. Stupak. Not interesting. Would you like that authority
as part of the Dingell bill? Certification of these labs?
Because there is no certification of these labs, is there?
Ms. Glavin. No.
Mr. Stupak. There is no FDA inspections to make sure they
are doing the testing properly?
Ms. Glavin. That is right.
Mr. Stupak. And you have heard testimony today, and we have
had it this morning, that basically if you don't get the test
result you want, you dump it in the garbage can and get another
test until you get the one you want. Isn't that sort of what is
being said about these private labs?
Ms. Glavin. I have heard that said, yes, sir.
Mr. Stupak. So wouldn't it appear you would want to certify
these labs to make sure that the test results are accurate
before we allow this food out in the mainstream commerce?
Ms. Glavin. I think that would improve the system. It would
also be a resource concern.
Mr. Stupak. A resource concern. You mean inspection of
these labs?
Ms. Glavin. Yes, sir.
Mr. Stupak. And have you ever asked for any money to hire
inspectors to inspect the labs or to certify labs?
Ms. Glavin. I am not aware that we have ever asked for
that.
Mr. Stupak. Dr. Raymond, if I may, recently the USDA
announced recalls of two brands of ground beef. In one of those
cases, it took the USDA 18 days to recall the product after
learning about its potential health hazard. Why did it take so
long?
Dr. Raymond. In that case we had one illness, one person.
Cultures from that person's stool did grow out E. coli 0157:H7.
That person had consumed frozen hamburgers from the freezer. We
went and got the remaining hamburgers that were in a box that
had been opened and tested, 13 tests, and two of them did turn
out positive for E. coli O157:H7.
At the same time we went out and obtained product that were
still in enclosed, sealed boxes, so there would be no risk of
having them tampered with, as is routine and normal for us. And
all of those samples tested negative.
So we had no rock-solid, concrete proof to say that that
contamination of the young lady occurred from a product that
was contaminated in the plant. And at that time, with just one
case, we didn't feel we had the legal standing to go do a
recall.
With the recall, when it did occur 18 days later was
because of other illnesses that had eaten product that had been
produced prior to that product that we are talking about.
So what I'm trying to say, not defensively, but a recall in
7 days after we found out would not have prevented any of the
other illnesses, but it took the other illnesses to line up
everything to say beyond a shadow of a doubt it came from that
plant on this production date. And that is when the recall was
initiated.
Mr. Stupak. Does USDA have recall authority, or do you have
to work with the producer?
Dr. Raymond. We work with the producers.
Mr. Stupak. So you don't have recall authority either?
Dr. Raymond. We can seize and detain, but we cannot recall.
Mr. Stupak. You indicated that on your equivalency
standard, you have 33 countries that are allowed to ship food
into here because they have an equivalent standard to ours?
Dr. Raymond. Yes, sir.
Mr. Stupak. Does the Department of Agriculture limit the
number of ports in which USDA-regulated products can be brought
into the country?
Dr. Raymond. Mr. Chairman, we don't limit the ports, but
all product has to go through one of our import houses. So it
can come through a port where we don't have an import house,
and it will have to be moved by truck or rail to an import
house.
Mr. Stupak. How many import houses do you have then?
Dr. Raymond. There are about 140.
Mr. Stupak. And I take it they are in close proximity to
some of the main shipping ports?
Dr. Raymond. They are all either at water ports or on
cross-border border crossings, yes.
Mr. Stupak. Ms. Glavin, how many ports does the FDA allow
food to come into?
Ms. Glavin. Food can come into any U.S. port. FDA-regulated
food can come into any U.S. port.
Mr. Stupak. Any port?
Ms. Glavin. Yes, sir.
Mr. Stupak. How many ports are there in the United States
then?
Ms. Glavin. I believe there are in excess of 300.
Mr. Stupak. Do you have import houses or anything where you
limit?
Ms. Glavin. No, we have inspectors at approximately 90 of
those ports.
Mr. Stupak. So if there is 300 and some, and there is 90,
so one-third at best have inspectors at?
Ms. Glavin. Yes, sir.
Mr. Stupak. And are they limited in what hours they can
come into a port, 8:00 to 5:00, or they can come in at any
time?
Ms. Glavin. That is right.
Mr. Stupak. Dr. Raymond, how does the USDA decide which
ports of entry to designate as eligible to receive the
shipments? Again, is it just because they are in close
proximity to the----
Dr. Raymond. Mr. Chairman, meat and poultry products can
come into any port. It cannot enter commerce until they have
gone through an import house. So we do not limit the ports. The
import houses are located----
Mr. Stupak. But the import houses, what happens? They come
to a port, but they get to an import house. What happens in
between there? Do they have to maintain them frozen? How do you
maintain the integrity of the product in between the port and
your import house?
Dr. Raymond. Excellent question. Obviously, one of the
things we do look at at the import house is to make certain
that it appears that there has been no change in the integrity
of the product. For instance, if it is a frozen product, and
the box appears to have had moisture on it, we are going to get
concerned that perhaps the integrity was not maintained. But
obviously these products are going to be shipped under certain
conditions, refrigerated trucks, et cetera, depending upon the
product.
Mr. Stupak. How often are the samples of these products
collected for testing by a lab? How are often are the samples
collected? Is that every box?
Dr. Raymond. No, sir. A little over 10 percent of all the
lots that come into this country through an import house are
opened and are more intensively inspected. Probably about 50
percent of those boxes that are opened are then further tested
for pathogens or residues.
Mr. Stupak. So these lots that come in, you inspect 10
percent, correct?
Dr. Raymond. We reinspect all lots, but we open about 10
percent of the boxes.
Mr. Stupak. Who does your inspection or lab test? Do you
have private labs you send this to?
Dr. Raymond. No, sir, we have three laboratories that we
use.
Mr. Stupak. All testing is done in-house?
Dr. Raymond. In USDA labs staffed by USDA personnel.
Mr. Stupak. The system you use at USDA, could that be
duplicated at the FDA for food?
Dr. Raymond. You mean using the import houses, et cetera?
Mr. Stupak. Yes. Testing with your own labs, not private
labs, and----
Ms. Glavin. Are you asking me? I am sorry.
Mr. Stupak. No, I am asking Dr. Raymond. Could your system
be duplicated for the FDA?
Dr. Raymond. I don't know that I can answer for the FDA.
Perhaps portions of our system could be modeled. But I have to
point out that it is our authorities that require what we do,
and it is our authorities that Congress funds us to have those
resources available so we can meet the authorities in the
Federal Meat Inspection Act.
Mr. Stupak. Your resources comes from an inspection fee; do
they not?
Dr. Raymond. No, sir. Congress gives us a great majority of
our resources to do what we do.
Mr. Stupak. Have you had to come back to Congress to ask
for extra resources to do your job, USDA, to do the
inspections?
Dr. Raymond. We have, and we will continue to do so, I am
sure.
Mr. Stupak. Have you received the resources that you
requested from Congress or----
Dr. Raymond. Periodically, sir. Sometimes yes, sometimes
no.
Mr. Stupak. Are you short of resources now?
Dr. Raymond. I think we have what we need right now to do
the job that we are asked to do.
Mr. Stupak. Thank you. I have nothing further.
Mr. Whitfield?
Hearing no other Members seeking to ask questions, we will
dismiss this panel. Thank you all very much for being here.
That concludes our questioning. I want to thank all of our
witnesses for coming today and their testimony.
I ask for unanimous consent that the hearing record will
remain open for 30 days for additional questions for the
record. Without objection, the record will remain open.
I ask unanimous consent that the contents of our document
binder be entered into the record. Without objection, the
documents will be entered into the record.
That concludes our hearing. Without objection, the meeting
of the subcommittee is adjourned.
[Whereupon, at 1:32 p.m., the subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
DIMINISHED CAPACITY: CAN THE FDA ASSURE THE SAFETY AND SECURITY OF THE
NATION'S FOOD SUPPLY?--PART IV
DECEPTION IN LABELING
----------
TUESDAY, NOVEMBER 13, 2007
House of Representatives,
Subcommittee on Oversight and Investigations,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 11:07 a.m., in
room 2123, Rayburn House Office Building, Hon. Bart Stupak
(chairman) presiding.
Present: Representatives Schakowsky, Dingell, Whitfield,
Burgess, and Blackburn.
Staff present: David Nelson, Kevin Barstow, Richard
Wilfong, John Sopko, Scott Schloegel, Kyle Chapman, Alan
Slobodin, Peter Spencer, Krista Carpenter.
OPENING STATEMENT OF HON. BART STUPAK, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF MICHIGAN
Mr. Stupak. This meeting will come to order.
Today we have a hearing on ``Diminished Capacity: Can the
FDA Assure the Safety and Security of our Nation's Food
Supply?--Part IV--Deception in Labeling.'' Each Member will be
recognized for an opening statement. I will begin.
This is the fourth in a series of hearings this
subcommittee has held on FDA's ability to assure the safety of
our Nation's food supply. Future hearings in this series are
expected to include a review of the President's newly announced
plan to stiffen the inspection of food imports. Our hearing
today, however, will focus on the treatment of the packaging of
meat and fish in carbon monoxide.
This recent innovation adopted by some members of the food
processing industry is highly deceptive. Carbon monoxide
artificially preserves the color of meat, making it appear
fresh even after it has spoiled. For that reason, consumers
cannot rely on the age-old method of looking at the appearance
of meat and fish to gauge its freshness when it has been
treated with carbon monoxide. Unfortunately, most consumers are
unaware of this fact.
Frankly, I was astonished to learn that carbon monoxide
treatment provides no consumer benefit at all. Carbon monoxide
does nothing to preserve the freshness of meat and fish; carbon
monoxide does nothing to prolong the food's shelf life; and
carbon monoxide does not make food safer; carbon monoxide does
none of these things.
To put it bluntly, the sole purpose of carbon monoxide
packaging is to fool consumers into believing that the meat and
fish they buy is fresh no matter how old it is and no matter
how decayed it might be. That's because the carbon monoxide
keeps the meat looking bright red. It even makes fish look
better after treatment.
Over the past few years, some of the largest food
processors in the United States have decided to treat their
meat with carbon monoxide, both Cargill and Hormel, which our
tests find today treat large quantities of meat with carbon
monoxide to artificially preserve its color indefinitely. Both
companies will say this is not only a safe product, but a safer
product because no butcher has touched it. That argument might
have some weight if E. coli were not still appearing in carbon
monoxide-packaged meat in Cargill and in other meat processing
plants.
Over the past year, there have been more than 40 meat
recalls. Since October, Cargill has had two major recalls, one
involving approximately 800,000 pounds of frozen ground beef,
and, most recently, more than 1 million pounds of fresh ground
beef. It should be pointed out that approximately 11 percent of
Cargill's fresh ground beef recall comprising 119,000 pounds
had been treated and packaged with carbon monoxide. That
recalled meat still looked fresh, red and wholesome, but it
contained the deadly E. coli bacteria.
Carbon monoxide treatment also disguises rotten fish,
something the FDA has known about since at least the mid-1990s.
Nevertheless, that didn't stop the FDA from allowing fish
importers to treat fish with so-called ``tasteless smoke,''
whose only active ingredient is carbon monoxide. Originally,
the carbon monoxide was derived from smoke, but today most fish
packers are using carbon monoxide from canisters rather than
from the smoking process. This begs the question of whether an
FDA-approved label referring to carbon monoxide as ``tasteless
smoke'' isn't further deceiving consumers. The U.S. market has
been flooded with fish whose color is preserved or even
enhanced by carbon monoxide.
The committee learned from staff visits to several U.S.
ports and FDA labs that a high percentage of this carbon
monoxide fish is refused entry into the United States because
it is decomposing or it contains dangerous levels of histamine.
The rejection rate of carbon monoxide fish at the Port of San
Francisco, for example, is between 20 and 30 percent. Today we
will be hearing from the president of one of the major
importers of carbon monoxide-treated fish.
Despite the deceptive nature of the carbon monoxide
treatment and the potential health threat, the FDA and USDA
have turned a blind eye to this practice. The FDA, for example,
has simply ignored Federal law which requires a formal
rulemaking with public input and comment for the use of food
additives or coloring. Instead, the agency has granted its
permission to use carbon monoxide through an odd process in
which the FDA announces it has no questions about carbon
monoxide's use. I'm looking forward to exploring this matter
further with both the FDA and USDA witnesses today, for I and
the American people have a number of questions that need to be
answered.
Lastly, I would note that soon after we opened this
investigation, there were recent letters to a number of
prominent food processors and retailers requesting information
and records on the blasting of meat and seafood with carbon
monoxide. In response, Tyson's Food, Safeway, Giant Food, and
Stop & Shop all agreed to stop selling carbon monoxide-treated
meat. In addition, Target decided to label all individual meat
packages to inform the consumer the meat they are selling is
treated with carbon monoxide, and to further caution the
consumer that neither the color nor the ``use by'' or ``freeze
by" date can be relied upon as an indicator of freshness.
Perhaps we can make additional progress today. If meat and
seafood companies want to blast their products with carbon
monoxide to artificially enhance the color, the least they
should do is label the products and warn consumers not to rely
on the color, texture and apparent wholesomeness of their
products.
My time is up. I will next turn to the ranking member of
the subcommittee, Mr. Whitfield from Kentucky, for an opening
statement, please.
OPENING STATEMENT OF HON. ED WHITFIELD, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF KENTUCKY
Mr. Whitfield. Chairman Stupak, thank you very much.
We certainly welcome all of the witnesses today for this
important hearing. Today's hearing focuses on using modified
atmospheric packaging, which uses a mixture of gases, including
small amounts of carbon monoxide, nitrogen, oxygen, et cetera,
to maintain fresh color and to enhance the shelf life of meat
products. I might add that this same technology, in addition to
being used in meat, has been used in the packaging of many
other products for some time like potato chips, lunch meats,
bagged salads, and other products.
Now, the FDA has reviewed the use of modified atmospheric
packaging a number of times since the late 1990s, and on every
occasion it has agreed that it can be classified as a safe way
to package food. In addition, the Food Safety and Inspection
Service reviewed scientific data on MAP and decided not to
require labeling for atmospheric gases.
Mike Doyle, who is the director of food safety at the
University of Georgia, in a study said that the benefits of
carbon monoxide, MAP technology, far outweigh arguments against
the technique. Scientists at the University of Georgia, for
example, contaminated meat samples with E. coli and packaged
them using MAP. A controlled sample was also packed in
traditional packaging tainted with E. coli, and when left at an
environment of 50 degrees Fahrenheit, the meat packaged without
MAP technology had 12 times as many E. coli cells. So you can
make the argument that this packaging using carbon monoxide
provides a safer product.
Another study conducted by Texas Tech University found that
the use of carbon monoxide in packaging dramatically decreased
the growth of pathenogenics, bacteria, on meat. Of the
estimated 100 million packages of carbon monoxide meat that has
been sold and consumed in the United States, it's almost
negligible of any problems with it.
I know that Chairman Stupak and Chairman Dingell have been
focused on this issue for some time and have introduced
legislation, and I might say that their legislation, from my
understanding, does not ban the use of this technology, but
requires a more prominent labeling of its use to provide better
notice for consumers.
The use of this technology became an issue in the United
States when a company called Calsak began an effort to ban the
use of this modified technology. Calsak sells a rosemary
extract that meat processors use in traditional packaging that
maintains the red coloring of meat; in other words, they have a
competing technology with the MAP technology. So is this issue
about technology, or is this about safety?
Now, we know that Japan, Singapore and Canada have banned
the use of MAP packaging for tuna, and we know that the
European Union has banned it for the packaging of meat and
tuna. Interestingly enough, in Norway they used it for a period
of 17 years with no ill effects, and I might also point out
that the European Union Scientific Committee that looked at
this technology concluded that there is no health concern
associated with the use of 0.3 to 0.5 percent CO and a gas
mixture with CO\2\ and N2 as a modified atmosphere of packaging
gas for fresh meat provided that the temperature during storage
and transport does not exceed a certain temperature. So even
the EU Scientific Committee has said that this is not a safety
issue.
I look forward to the testimony today because all of us are
committed to the maximum safety for the consumers in America. I
might say, though, that on the second panel of witnesses,
unfortunately, our staff did not have an opportunity to
interview them, and normally we do have that opportunity.
I would also point out that while a certain percent of
seafood coming in through San Francisco--I guess 20 to 30
percent of the imported seafood--treated with carbon monoxide
was decomposed, it would be helpful to know what percent coming
in without carbon monoxide also had the same problem.
I know that Chairman Stupak and Chairman Dingell issued a
letter to all of the health departments in 50 States in the
U.S. about a year ago, and it's my understanding that the
health departments have replied, but we have not been given
access to those studies. So I'm assuming that the replies do
not indicate any safety issue from those 50 States.
As I said, we look forward to this testimony on this
important consumer safety issue, and I see my time has expired.
Mr. Stupak. The Chair recognizes Mr. Dingell, the chairman
of the full Committee on Energy and Commerce, for any opening
statement, please.
OPENING STATEMENT OF HON. JOHN D. DINGELL, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF MICHIGAN
Mr. Dingell. Mr. Chairman, thank you, and thank you for
holding this important hearing and also for the excellent
series of safety investigations that you have conducted this
year. Each of these hearings has not only helped the committee
to develop legislation, but it has also increased Americans'
awareness of the risks they face every day in their kitchens or
neighborhood restaurants.
Today we turn to the approval of carbon monoxide to
disguise the true colors of fish and meat, and to the refusal
to disclose to the American consumer the use of this process.
This is not to say that sometimes meat and fish treated with
carbon monoxide are not perfectly fine when they reach the
grocery stores or even the restaurant kitchens, but it concerns
us greatly that the treatment with this gas enhances colors,
particularly reds, to the point where spoiled meats or fish
look fresh as the day they were packaged.
The regulatory agencies responsible for protecting the
public health, the Food and Drug Administration--the FDA--and
the U.S. Department of Agriculture--have permitted this
potentially deceptive practice in the United States even though
Canada, Europe and Japan all ban it. In doing so, the FDA and
USDA have also refused to require the companies to label their
products as treated with carbon monoxide, something that every
consumer should know before a purchase.
One of the key factors for consumers in selecting meat or
fish is its color, followed by its smell. We have a nice
example of meat down on the hearing table. Some of the meat is
a year old. I suspect that it is spoiled, although you can't
tell so by the color. You probably can't tell by the smell
since the packaging is totally sealed, although I suspect that,
if the packaging were open, we might find that the contents are
not as nice as they look.
Finally, you can't tell by the labeling because the
companies have apparently convinced the regulators that
consumers might be confused or frightened if they knew they
were eating foods which were treated with carbon monoxide. They
also might know that the food is packaged in a way which
conceals the smell while the color looks good.
One of our USDA witnesses says that the packaging, if it is
not bulging, is fine. Committee staff have actually been told
by a Hormel scientist that the worst thing that can happen even
if a food product is spoiled is that the consumer might have a
``unpleasant dining experience.'' They argue that the spoiled
meat won't hurt us. The bacteria that cause the meat to spoil
are not pathogens.
Let's test these arguments. I think they are false.
We all know that Cargill, in particular, should know that
meat packed in CO can also contain pathogens that can kill or
harm us. Last week Cargill recalled more than 1 million pounds
of ground beef suspected of containing the dangerous E. coli
germ. Of that amount, some 119,000 pounds were treated with
carbon monoxide and, therefore, would look as fresh and as
pleasant as the day they were butchered until some unsuspecting
customer purchased it.
Mr. Chairman, I urge you to get to the bottom of how and
why these decisions were made by FDA and USDA. I also urge you
to lead us to find why the companies still refuse to let the
American people know that their meat or fish is being treated
with carbon monoxide.
I commend you for your leadership, Mr. Chairman, in this
matter and that you are helping us to understand that here we
have a problem which may need a legislative fix or which will
require, perhaps, an unpleasant experience by the FDA before
this subcommittee, which is so ably chaired by you.
Mr. Chairman, again, thank you for holding this hearing. It
is important, and it is important to the safety of the Nation's
food supply. I look forward to the testimony of the witnesses
today and particularly the response to our questions from both
the FDA and USDA.
Mr. Chairman, this committee has a proud record of working
to protect the consumers, and I am sure, under your leadership,
we will continue to fight for a strong food safety system in
this country. Today I hope we will move one step closer to
making this necessity a reality.
Thank you, Mr. Chairman. I yield back the balance of my
time.
Mr. Stupak. I thank the gentleman.
Mrs. Blackburn for an opening statement, please.
OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TENNESSEE
Mrs. Blackburn. Thank you, Mr. Chairman.
I thank you for the hearing that today we are going to use
to examine the issue of carbon monoxide technology used in meat
packaging, which provides protection against food-borne
bacteria and the extended shelf life for fresh meat products.
Unfortunately, this technology is being called into question
over supposed safety concerns of the packaging format.
Modified atmospheric packaging has been used for over 75
years, Mr. Chairman, to prolong shelf life and to maintain
color freshness. Despite situational arguments to the contrary,
no conclusive evidence has been presented that links this
packaging and this process to increased food-borne illness and/
or death. The decomposition of meat products, spoilage alone,
does not correlate to food-borne illness such as E. coli, and
if anyone has ever had a food science class, in fact, they will
know that contamination and spoilage are two very distinct
issues. They are different issues. According to the University
of Minnesota's Center for Infectious Disease Research and
Policy, and I'm quoting from them, ``There is a major public
health difference between food contaminated with pathogens not
detectable to human senses and that of spoiled food
characterized by changes in food color, taste and texture in
such ways as to make consumption unacceptable,'' end quote.
No packaging format creates E. coli or other food-borne
bacteria. Instead, packaging is a marketing tool used to manage
consumer expectations. If regulation eliminates the use of
carbon monoxide packaging, the result will be increased meat
handling, leaks and a lack of tamper-resistant packaging, which
means there will be more human interaction with the product
from the time it is packaged until it moves to its final
destination with the consumer. The result would likely lower
the quality of meat provided to consumers and would increase
the potential for bacteria. This is clearly a step in the wrong
direction.
Mr. Chairman, let's give consumers some credit. People eat
with their eyes. If they don't trust their eyes, they surely
know that they can trust their noses when confronted with
rancid meat. In addition to smell, other obvious signs of
spoilage exist. Consumer studies have shown that people rely on
the ``sell by'' date, the smell and the color when determining
if meat is fit for consumption.
Those advancing the argument that this carbon monoxide is
bad science for meat are misleading the public. There is no
need for the Federal Government to implement overzealous
regulation that will likely take a step backward and away from
safe and efficient meat packaging. Such regulation might open
the door for the increased opportunity for further
contamination. How many experts have to say that the use of
carbon monoxide in meat packaging is not a food safety issue
before we believe them? This hearing has nothing to do with
food-borne illness. Not one case of human illness has been
reported due to the consumption of spoiled food, so the case
for public health risk cannot be made.
I hope that we are not participating in a kangaroo court
due to certain economic interests and an intra-industry fight.
I hope that we will continue to put our focus on food safety
issues that have come before us that need our attention, and
that we will not participate in a fight under the guise of food
and consumer safety.
Thank you, Mr. Chairman, for the hearing, and I yield back
my time.
Mr. Stupak. Ms. Schakowsky for an opening statement,
please, for 5 minutes.
OPENING STATEMENT OF HON. JAN SCHAKOWSKY, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF ILLINOIS
Ms. Schakowsky. Thank you, Mr. Chairman. I appreciate your
holding this hearing today on deceptive labeling in meat
packaging.
As someone who began my career in consumer advocacy by
leading a housewives' campaign in 1969 to put freshness dates
on food products sold in the supermarkets, this issue is one I
care deeply about. It was a package labeled as skirt steak, I
think, of a questionable color that led me to ask the butcher
at that time in my local supermarket how old the meat was, and
I was shocked by his response. He said, ``Look, lady, it's
fresh, and if you don't like it, you can shop somewhere else.''
That really launched my campaign with a number of my women
friends to seek dates on food, expiration dates.
Consumers expect and deserve as much information as
possible about the food they consume even when it comes to
questionable packaging practices such as using carbon monoxide
to keep meats looking fresh. Some may argue that because carbon
monoxide is only used in the packaging, it is not a direct
ingredient or a component of the food product, and that,
therefore, it doesn't need to be labeled, but when carbon
monoxide has the same impact on meat products as red dye or
other color additives, this is important information that
consumers want to have.
It's no surprise, then, that, according to a recent
Consumer Federation of America poll, 78 percent of consumers
said that the unlabeled use of carbon monoxide in meat
packaging is deceptive, and 68 percent of consumers said they
would support a law requiring the mandatory labeling of carbon
monoxide.
The city of Chicago, part of which I have the honor of
representing, held hearings on this issue in 2006. At that time
I joined with several of my colleagues in sending a letter to
the Illinois Department of Public Health, asking that the
agency prohibit the sale of meat and fish products treated with
carbon monoxide in Illinois.
Businesses are taking notice. Already several major retail
stores, such as Safeway and Giant, have announced they will
stop selling the product, and Tyson's recently phased out the
system in their packaging.
Make no mistake. The practice of treating meat and fish
with carbon monoxide gives the product virtually an indefinite
red color regardless of the temperature or the storage
conditions. Given the fact that the EU, Canada and Japan have
all banned the practice due to its misleading nature, I look
forward to hearing an explanation from the USDA and from the
FDA as to their rationale for approving this practice without
at least a labeling requirement.
I am also looking forward to hearing from Nancy Donley, a
good friend of mine, who started Safe Tables Our Priority, or
S.T.O.P., a Chicago-based organization with a long track record
of fighting food-borne illness and raising consumer awareness
of important food safety issues that she started after a
tragedy affecting her son.
Finally, I want to make sure we think about how this
packaging process impacts the elderly and the disabled who may
have impaired vision, reduced senses of smell and weakened
immune systems. Freshness dates can be difficult to read, and
changes in odor brought on by spoilage may not be apparent in
the early stages. The bright red color of a meat product may be
a key element in their purchasing decision, and I worry about
their being misled or, even worse, their purchasing a product
that will make them ill.
Mr. Chairman, on the subject of deceptive food labeling, I
also look forward to the committee's looking into deceptive
practices in labeling chicken infused with salt water as all
natural. This practice makes the chicken heavier, and it raises
the sodium content substantially, and it has led to consumers
spending an additional $2 billion annually on chicken infused
with salt water.
I thank you, Mr. Chairman. With that, I yield back.
Mr. Stupak. Thank you.
Mr. Burgess for an opening statement, please.
OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF TEXAS
Mr. Burgess. Thank you, Mr. Chairman. As always, I
appreciate your holding this series of hearings on the Food and
Drug Administration's ability to assure the safety and security
of the Nation's food supply.
Throughout the hearings I feel that we have been able to
shed some light on some real problems affecting our food supply
here in this country. I also think we've been able to identify,
perhaps, some real solutions.
It has become apparent that our Federal agencies that are
tasked with helping keep Americans safe from harmful foods and
harmful products are using 19th or 20th century tools when
dealing with a 21st century problem. However, the Food and Drug
Administration does not shoulder all of the blame in this
situation.
Somehow Congress failed to intuit and to recognize the
rapid change that was going to be incurred by globalization, by
living in a global village. There are multiple points to which
we can affix responsibility, but it would be sheer fantasy to
believe that Congress does not own its own share of the
responsibility. Although the change that we can attribute to
globalization did not happen quickly, it did not happen
overnight. It is now up to Congress to absolve itself for not
maintaining situational awareness. I believe that Congress does
need to step up and give the Food and Drug Administration the
resources and authorities they need to keep Americans safe.
This series of hearings on the Food and Drug Administration's
ability to assure the safety and security of the Nation's food
supply will help us do just that.
For instance, during a hearing this summer, we learned that
the Food and Drug Administration lacks the ability and the
explicit authority to immediately stop dangerous food and
products from coming into this country. For that reason I
introduced H.R. 3967, the Imported Food Safety Improvement Act
of 2007, to stop countries from sending harmful food and
products into the United States. H.R. 3967 will allow us to
finally take control of the food that is being sent to America.
It will also send a strong message to countries that in the
past have allowed harmful products entry into our stream of
commerce.
So, when it comes to food safety, I feel just as strongly
as many of us profess to feel about terrorism on a broader
scale. We need to say to other countries, ``You're either with
us or against us. Solve the problem on your end, or we'll take
measures to solve the problem on ours.''
A review of the hearing timeline clearly shows that this
legislation came about through a series of important hearings.
I continue to believe in the mission we are trying to
accomplish today; however, while I realize that today we are
only focusing on one single form of food technology, that is
the use of low oxygen in meat packing, I do wish we would have
observed adherence to the original plan of holding a hearing
that focused on a variety of technologies aiming at keeping our
food safe. Considering the enormity of the problems we are
facing in food safety, I have found the scope of today's
hearing to be very narrow in its focus. In fact, it's so narrow
that it limits the utility of what we should be about.
Today's hearing involves a controversy about the use of
carbon monoxide in modified atmospheric packaging in meat. Fair
enough. Industry is responding to demands and is moving much
faster than Congress can in this regard, and the controversy is
rapidly being addressed by the efforts in the marketplace and,
to some degree, in response to letters from the majority.
I do appreciate the efforts of the majority's detailing
this to the principal players of the industry. I would be very
interested to know if the changes being contemplated in the
industry are as a result of rigorous scientific investigation.
I hope they are not merely a capitulation to the demands of the
majority and of their staff. The majority can be commended for
making this a disappearing oversight problem if what they did
were to shine a bright light on a real problem; but, again, I
do wonder, Mr. Chairman, if we have this response as a result
of rigorous scientific investigation and sound science.
Mr. Chairman, very briefly, we have heard from the majority
staff about a trip they took to China. I took a trip to China
in 1993 with the Association of Aerospace Physicians. Let me
tell you, I gained a new appreciation for modern American
packaging and cellophane during that trip. One afternoon I took
a side trip and walked through what was the equivalent of the
Beijing Safeway. It was there I learned that modern American
innovation was, indeed, a wonderful thing. In China, they had
meat out in the open. Well, let's be honest. They had live
snakes in bins, and you don't normally see those in a Safeway
even here in DC, but they had meat out in the open with no
covering, rendering it pretty unappetizing because of the
smell, the sight of flies and the overall color. So flies,
discoloration and olfactory assaults were such to make even the
most ravenous of appetites vanish.
Mr. Chairman, if you are correct about the use of low
oxygen being deceptive, then you are to be commended for making
this a disappearing oversight problem; however, I would also
like to commend Hormel for trying to make their product better
by finding a way to address the issue of long-term color change
through new interventions. In Mr. Ettinger's testimony, he
mentions that his company has filed a patent on this new
technology, so I look forward to hearing more about the
technology and how it may remove some of the concerns that the
use of the carbon monoxide may be deceptive.
I also look forward to the discussion with the Food and
Drug Administration regarding the ``generally recognized as
safe'' determination. I recognize that the majority leadership
of this subcommittee is concerned that this process does not
include a review or a comment period. I would just briefly
point out that it was not during this administration, but
during the previous administration that this decision was made.
Apparently the Clinton administration did not have a problem
that there was no review or comment period allowed.
Again, Mr. Chairman, thank you for holding the hearing. I
hope we will be able to hold hearings on a broader array of
topics within the entire context of food safety.
I yield back the balance of my time.
Mr. Stupak. That concludes the opening statements by
members of the subcommittee.
Our first panel is before us. On our first panel, we have
Mr. Daniel Engeljohn. He is the Deputy Assistant Administrator
of the Office of Policy, Program and Employee Development, Food
Safety and Inspection Service, the U.S. Department of
Agriculture. He is accompanied by Dr. Robert Post, the Deputy
Director of the USDA's Center for Nutrition Policy and
Promotion.
We have Dr. David Acheson, the Assistant Commissioner for
Food Protection at the FDA. He is accompanied by Mr. Lane
Highbarger, the Consumer Safety Officer for the FDA's Division
of Biotechnology and GRAS Notice Review in the Center for Food
Additive Safety and Applied Nutrition; Mr. Philip Spiller, the
Senior Advisor for Special Projects in the FDA's Center for
Food Safety and Applied Nutrition; Mr. Donald Kraemer, the
Deputy Director of the Office of Food Safety at the FDA's
Center for Food Safety and Applied Nutrition.
Dr. Tarantino with the Office of Food Additive Safety, the
Center for Food Safety and Applied Nutrition, Food and Drug
Administration. So, Dr. Tarantino, thank you for being here.
It's the policy of this subcommittee to take all testimony
under oath. Please be advised that witnesses have the right
under the rules of the House to be advised by counsel during
their testimony.
Do any of you wish to be advised by counsel?
Everyone is shaking their heads ``no,'' so I'll take that
as a ``no.'' Therefore, I'm going to ask you to rise and to
raise your right hands to take the oath.
[Witnesses sworn.]
Mr. Stupak. Let the record reflect the witnesses replied in
the affirmative.
You are now under oath.
We will now hear a 5-minute opening statement from our
first panel. You may submit a longer statement for its
inclusion in the hearing record.
Dr. Engeljohn, if you'd like to start, please.
TESTIMONY OF DANIEL ENGELJOHN, DEPUTY ASSISTANT ADMINISTRATOR,
OFFICE OF POLICY, PROGRAM AND EMPLOYEE DEVELOPMENT, FOOD SAFETY
AND INSPECTION SERVICE, U.S. DEPARTMENT OF AGRICULTURE,
ACCOMPANIED BY ROBERT POST, DEPUTY DIRECTOR, CENTER FOR
NUTRITION POLICY AND PROMOTION, U.S. DEPARTMENT OF AGRICULTURE;
Mr. Engeljohn. Mr. Chairman and members of the committee,
thank you for inviting me to appear before you today to discuss
carbon monoxide in meat packaging.
I am Dr. Daniel Engeljohn of the USDA's Food Safety and
Inspection Service. I am a senior executive with the
Department, developing food safety policy, where I have been
for the last 29 years. My educational background is in animal
science, food science and allied health science. I hold a Ph.D.
in human nutrition with an emphasis on experimental research
methods, and my work experience at the USDA has centered on
risk management policies associated with the safety of meat,
poultry and processed eggs. I currently serve on the National
Advisory Committee on Microbiological Criteria for Foods,
whereby the committee provides guidance to the USDA and to the
Food and Drug Administration on food safety issues.
The development in new technologies is largely initiated by
industry itself as it responds to consumer demands. In 2000,
FSIS and the FDA entered into a Memorandum of Understanding,
allowing the simultaneous review of new technologies to
increase the speed with which useful new technologies could be
used. The FDA determines the safety of a food ingredient and
its safe levels of use while, simultaneously, FSIS evaluates
whether the ingredient has its intended technical effect.
Allowing these evaluations to occur at the same time
effectively decreases the time any food ingredient spends in
review.
Under the Federal Meat Inspection Act, FSIS is responsible
for determining the efficacy and suitability for food safety
ingredients and additives in meat products as well as for
prescribing safe conditions for use. ``Suitability'' refers to
the effectiveness of the ingredient or additive in performing
the intended purpose of use, and it refers to the assurance
that the conditions of use will not result in an adulterated
product or one that would mislead the consumer.
One form of technology used by the meat industry that has
received a great deal of attention in recent months is carbon
monoxide in packaging. Carbon monoxide is used to stabilize the
color pigment of meat when it is red and, therefore, most
appealing to consumers. The use of carbon monoxide in packaging
does not impart a color to the meat; it simply maintains its
naturally occurring color. Carbon monoxide does not become a
part of the product and dissipates as soon as the package is
opened. This is unlike other ingredients used to stabilize the
red color of meat, such as citric acid, sodium ascorbate and
rosemary extract, all of which actually do become a part of the
product and may have a lasting effect on product color even
after packaging is removed.
In 2002, carbon monoxide, for use as a component of
modified atmospheric packaging, was accepted by the FDA as
being generally recognized as safe, or GRAS. In accordance with
our Memorandum of Understanding with the FDA, the USDA in 2004
reviewed the GRAS notice submitted by Precept Foods and wrote
two letters to the FDA dated April 28 and June 2, 2004, in
response. It is common for FSIS to find data in original GRAS
notices to be insufficient for a suitability determination and
for us to notify the FDA that we consider the petition to be
incomplete. The petitioners then provide additional data, which
may result in our accepting the suitability of an ingredient or
the acceptance with or without specific use conditions.
On April 28, 2004, we sent the FDA a letter that reflected
the preliminary FSIS decision based on the data we were
submitted with the original GRAS notice from Precept Foods, the
petitioner. As a result of the April 28 letter, the petitioner
submitted additional data to address our concerns that the
application of carbon monoxide may be misleading to consumers
if used as described in the initial GRAS notice.
The June 2, 2004, letter describes that our earlier
concerns have been addressed by Precept Foods. Precept provided
data evaluating shelf life, the microbiological outgrowth and
the color of meat products treated and packaged using various
methods, including that proposed in the original GRAS notice.
These data are generally described in the third paragraph of
the June 2 letter.
As stated in the June response, Precept provided additional
information to FSIS, addressing specific suitability concerns
raised in the April 28 letter. Based on the spoilage
information and use conditions provided by Precept, FSIS
reversed its decision and determined that the use of carbon
monoxide is suitable in modified atmospheric packaging, but
only when a ``use by'' or a ``freeze by'' date is applied.
``Use by'' or ``freeze by'' dates are required on all systems
in which carbon monoxide is in direct contact with meat.
FSIS will continue to make its labeling decisions and its
suitability reviews on the basis of the FDA's safety
conclusions. Based on the data presented at the time of the
letters, FSIS stands by its 2004 decision on suitability for
the use of carbon monoxide in meat packaging; however, as
always, FSIS would reassess the situation if new data become
available. FSIS has also asked our sister agency at the USDA,
the Agricultural Research Service, to conduct research related
to packaging systems.
Thank you for the opportunity to testify before you today.
I look forward to addressing questions you might have.
[The prepared statement of Mr. Engeljohn follows:]
Testimony of Daniel Engeljohn
Mr. Chairman and members of the committee, thank you for
inviting me to appear before you today to discuss carbon
monoxide (CO) in meat packaging. I am Dr. Dan Engeljohn of
USDA's Food Safety and Inspection Service (FSIS).
FSIS is the USDA public health regulatory agency
responsible for the administration of laws and regulations that
are designed to ensure that the Nation's commercial supply of
meat, poultry, and egg products is safe, wholesome, and
properly labeled, regardless of whether those products are sold
in the United States or imported to, or exported from, the
United States. FSIS is also responsible for determining that
foreign meat and poultry plants operate under an inspection
system equivalent to the United States before they can export
to the United States.
Reviewing Technology in the Meat Industry
The development of new technologies is largely initiated
by industry itself, as it responds to consumer demands. There
are two different types of technologies that are subject to
review: processing technologies and ingredient technologies.
Processing technologies are those technologies developed to aid
in the production of meat, poultry, and egg products. Examples
of processing technologies include carcass washes, the steam
vacuum, and steam pasteurization.
Ingredient technologies are those technologies that
involve the addition of an ingredient, generally as defined by
FDA, to a product or the use of packaging to ensure safety or
increase shelf life. Examples of this kind of technology
include carbon monoxide packaging and irradiation.
Prior to 2000, the review process for new ingredients was
lengthy and cumbersome. FDA was responsible for the initial
safety review. This was then followed by a review by FSIS to
determine the acceptability or suitability of the technology;
that is, to determine whether the ingredient served the purpose
for which it was intended. In 2000, FSIS and FDA entered into a
Memorandum of Understanding allowing simultaneous review of new
technologies to increase the speed with which useful new food
ingredients could be used.
FDA determines the safety of a food ingredient and its safe
levels of use, while simultaneously FSIS evaluates whether the
ingredient has its intended technical effect. Allowing these
evaluations to occur at the same time effectively decreases the
time any food ingredient spends in review.
Under the Federal Meat Inspection Act (FMIA), FSIS is
responsible for determining the efficacy and suitability of
food ingredients and additives in meat products as well as
prescribing safe conditions of use. Suitability refers to the
effectiveness of the ingredient or additive in performing the
intended purpose of use and the assurance that the conditions
of use will not result in an adulterated product or one that
will mislead consumers.
Carbon Monoxide in Meat Packaging
One form of technology used by the meat industry that has
received a great deal of attention in recent months is carbon
monoxide in packaging. Carbon monoxide is used to stabilize the
color pigment of meat, when it is red and, therefore, most
appealing to consumers. Use of carbon monoxide in packaging
does not impart a color to the meat; it simply maintains its
naturally occurring color.
Carbon monoxide does not become a part of the product and
dissipates as soon as the package is opened. This is unlike
other ingredients used to stabilize the red color of meat, such
as citric acid, sodium ascorbate, and rosemary extract, all of
which actually do become a part of the product and may have a
lasting effect on product color even after packaging is
removed.
In 2002, carbon monoxide, for use as a component of
modified atmosphere packaging, was accepted by FDA as being
``Generally Recognized as Safe,'' or GRAS. GRAS refers to a
chemical or substance that is added to food and is exempt from
regulation because its extensive use has produced no known
harmful effects. GRAS notifications must be accompanied by
scientific data establishing that, under the proposed
conditions of use, the substance is safe, and that it will be
used at the lowest levels necessary to accomplish the intended
functional effects. USDA assesses suitability of use under the
proposed conditions after FDA has assessed the ingredient's
safety.
In accordance with our Memorandum of Understanding with
FDA, USDA in 2004 reviewed the GRAS notice submitted by Precept
Foods, and wrote two letters to FDA, dated April 28 and June 2,
2004 in response.
It is common for FSIS to find data in original GRAS
Notices to be insufficient for a suitability determination and
for us to notify FDA that we consider the petition to be
incomplete. The petitioners then provide additional data which
may result in our accepting the suitability of the ingredient
or substance with or without specific use conditions.
On April 28, 2004, we sent FDA a letter that reflected a
preliminary FSIS decision that was based on the data that were
submitted with the original GRAS Notice from Precept Foods,
LLC, the petitioner. As a result of the April 28 letter, the
petitioner submitted additional data to address our concern
that the application of carbon monoxide may be misleading to
consumers if used as described in the initial GRAS notice.
The June 2, 2004 letter describes that our earlier concerns
had been addressed by Precept Foods, LLC. Precept provided data
evaluating shelf life, microbial outgrowth, and color of meat
products treated and packaged using various methods including
that proposed in the original GRAS notice. These data are
generally described in the third paragraph of the June 2
letter.
As stated in the June response, Precept provided
additional information to FSIS addressing specific suitability
concerns raised in the April 28 letter. Based on the spoilage
information and use conditions provided by Precept, FSIS
reversed its decision and determined that the use of carbon
monoxide is suitable in modified atmosphere packaging, but only
when a use-by or freeze-by date is applied. Use-by or freeze-by
dates are required on all systems in which carbon monoxide is
in direct contact with the meat.
In November 2005, FDA received a petition asking it to
withdraw its decision that carbon monoxide in meat packaging is
Generally Recognized as Safe. FSIS will continue to make its
labeling decisions and its suitability reviews on the basis of
FDA's safety conclusions. Based on the data presented at the
time, FSIS stands by its 2004 decision on the suitability of
the use of carbon monoxide in meat packaging. However, as
always, FSIS would reassess the situation if new data becomes
available. FSIS has also asked USDA's Agricultural Research
Service (ARS) to conduct research related to packaging systems.
Thank you for the opportunity to testify before you today.
I look forward to addressing any questions you might have.
----------
Mr. Stupak. Thank you. Dr. Post, I understand you're not
going to give an opening, or are you?
Mr. Post. No, I am not.
Mr. Stupak. OK.
Dr. Acheson, I think you're the next one to give an opening
statement then.
TESTIMONY OF DAVID W.K. ACHESON, M.D., ASSISTANT COMMISSIONER
FOR FOOD PROTECTION, FOOD AND DRUG ADMINISTRATION, U.S.
DEPARTMENT OF HEALTH AND HUMAN SERVICES, ACCOMPANIED BY LANE
HIGHBARGER, CONSUMER SAFETY OFFICER, DIVISION OF BIOTECHNOLOGY
AND GRAS NOTICE REVIEW, OFFICE OF FOOD ADDITIVE SAFETY, CENTER
FOR FOOD SAFETY AND APPLIED NUTRITION, FOOD AND DRUG
ADMINISTRATION
Dr. Acheson. Good morning, Chairman Stupak and members of
the subcommittee. I am Dr. David Acheson, the Assistant
Commissioner for Food Protection for the Food and Drug
Administration, and I'm joined today by my colleagues at the
FDA and the USDA.
The FDA appreciates the opportunity to testify this
morning. To start, I'll briefly highlight the recently released
Food Protection Plan and the Import Safety Plan. I will then
address your concerns about the use of carbon monoxide in
modified atmospheric packaging for meat and as a preservative
for fish.
In May 2007, the FDA was charged with developing a
comprehensive and integrated food protection plan to keep the
Nation's food supply safe from both unintentional and
deliberate contamination. The underlying principle of the Food
Protection Plan is to build in safety measures across a
product's life cycle from production to consumption.
Mr. Stupak. Doctor, if I may, we will have that hearing in
January. So, if you want to go right to carbon monoxide, we
could probably expedite it because we do have quite a few
people on this panel if we're going to get right to our
testimony. So, if you want to go to carbon monoxide and GRAS,
we'd appreciate it.
Dr. Acheson. It would be my pleasure to do that.
Mr. Stupak. Thank you.
Dr. Acheson. Turning now to carbon monoxide, the Food, Drug
and Cosmetic Act, section 201(s) provides that a substance that
is generally recognized among qualified experts as having been
shown to be safe under the conditions of its intended use is
excluded from the definition of a ``food additive.'' It is
therefore not subject to the food additive petition process.
For these substances that are generally recognized as safe,
or GRAS, an interested party such as a food manufacturer may
notify the FDA of its conclusion that a substance is GRAS under
the intended conditions of use. The FDA reviews the GRAS notice
to determine whether it provides a sufficient basis to support
the party's GRAS self-determination and then responds to the
notifier as to whether the agency has any questions.
To show that a substance is generally recognized as safe,
the proponent must show that there is a consensus of expert
opinion regarding the safety of the specified use of the
substance. Unanimity among experts regarding the safety of a
substance is not required.
During the period 2000 through 2005, the FDA responded to
three GRAS notices for the use of carbon monoxide in modified
atmospheric packaging systems for meat and one for notice of
the use of tasteless smoke in tuna. The FDA responded by
stating that the agency does not question the basis for the
GRAS determinations.
The FDA routinely consults with the USDA's Food Safety and
Inspection Service to address our related but separate roles in
the regulation of ingredients in meat, including the three GRAS
notices for meat. The FDA can and does place additional
limitations on the use of GRAS substances beyond those
specified in the notifications.
We are aware that concerns have been raised about the
possible misuse of CO in seafood and the use of CO-containing
MAP systems for meat. The FDA has received citizen petitions
which challenge the FDA's acceptance of the GRAS status of
these products. We continue to receive information submitted
for consultation under the citizen petition process, and we are
continuing to review and to analyze that information.
In conclusion, ensuring that FDA-regulated products are
safe and secure is a vital part of FDA's mission. The Food
Protection Plan provides an updated approach to assure that the
U.S. food supply remains one of the safest in the world, and I
look forward to presenting that to you later.
We look forward to working with this committee and with the
Congress on implementing the Food Protection Plan and the
Import Safety Plan. Thank you for the opportunity to discuss
the FDA's activities to enhance food safety. I'd be happy to
answer any questions.
[The prepared statement of Dr. Acheson follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Stupak. Thank you, and thank you for your comments on
carbon monoxide.
Do any other panelists wish to give an opening statement?
Hearing none, we will begin questions, and I'll begin.
Dr. Acheson, you indicated that the FDA approved carbon
monoxide on a GRAS, generally accepted as safe, without any
questions, correct?
Dr. Acheson. There was never a petition submitted for
carbon monoxide specifically. It was tasteless smoke for which
the GRAS notice was submitted.
Mr. Stupak. OK. Did the FDA then make any approval of
carbon monoxide for the use in packaging?
Dr. Acheson. The FDA has not been submitted a specific
petition on carbon monoxide per se.
Mr. Stupak. So this is basically a USDA issue?
Dr. Acheson. The FDA has no concerns about the use of
carbon monoxide in modified----
Mr. Stupak. Right, but you just said that no petition was
before you, so you didn't have anything on which to deal with
this on carbon monoxide, correct?
Dr. Acheson. There was no petition submitted. That doesn't
mean that the agency didn't review the situation to determine--
--
Mr. Stupak. Did the agency review a carbon monoxide
petition by Precept Foods?
Dr. Acheson. The agency has reviewed the safety issue
surrounding carbon monoxide.
Mr. Stupak. Let me try it again.
Did you review the Precept application for the use of
carbon monoxide, the matter before us?
Dr. Acheson. I'll ask----
Mr. Stupak. Dr. Tarantino is shaking her head ``yes.''
Ms. Tarantino. Yes, we did.
Mr. Stupak. OK. Were you the person who reviewed it then?
Ms. Tarantino. It was reviewed in my office, in the office
I lead.
Mr. Stupak. OK. Dr. Acheson said the FDA had no questions.
Do you agree there are no questions?
Ms. Tarantino. That was our final determination after the
questions that FSIS raised and the information that we received
in the final----
Mr. Stupak. OK. So that was in 2004 that you had no
questions?
Ms. Tarantino. That's right.
Mr. Stupak. OK. Before you indicated you had no questions,
your office--does the European Union allow carbon monoxide in
your packaging?
Ms. Tarantino. The European Union itself does not.
Mr. Stupak. OK. How about Canada, does it allow?
Ms. Tarantino. In meat packaging, I'm not sure.
Mr. Stupak. OK. It does not.
How about Japan, does it allow?
Ms. Tarantino. I don't know.
Mr. Stupak. With the fact that these major countries and
the European Union do not allow it, did that raise a question
with the FDA?
Ms. Tarantino. We looked at all of the information that was
in front of us, all of the information that we are aware of.
Mr. Stupak. Did you specifically look at the European
Union, Japan and Canada?
Ms. Tarantino. We were aware of the Scientific Committee on
Food, which is the risk assessors, and we were aware of the
studies that had been done in Norway that supported their use
of the technology for about 20 years.
Mr. Stupak. Correct. Norway is part of the European Union;
is it not? Therefore, they no longer use carbon monoxide,
correct?
Ms. Tarantino. Correct.
Mr. Stupak. So they used it at one time, and now they
don't. So, obviously, there were some questions there.
Ms. Tarantino. Not about safety apparently.
Mr. Stupak. OK. For what, consumer deception?
Ms. Tarantino. I don't know.
Mr. Stupak. So did you ever explore why Norway and the
European Union went from using it to not using it?
Ms. Tarantino. The European Union system is quite different
from ours. Our understanding was that another member country
or, in fact, a nonmember country petitioned the EU not to
permit it in the EU, and they decided not to.
Mr. Stupak. OK. Dr. Engeljohn, let me ask you this. You
indicated that this Memorandum of Understanding between the FDA
and the Department of Agriculture was to increase the speed on
issues of food safety and packaging and issues like this,
correct?
Mr. Engeljohn. Yes. The MOU is to make it so that we would
do a simultaneous review.
Mr. Stupak. OK. In your speed to review and to approve
things, where does public input come in? When does the public
have a chance to comment on your review process here?
Mr. Engeljohn. In the review such as the one on carbon
monoxide, there was no public review process in that the issue
becomes one of our providing input to the FDA about the
suitability of the use, and then they make that final
determination, but there is no public process on this
particular issue.
Mr. Stupak. OK. So there was no public input.
So the only way someone could really challenge your issue
is through a citizen's petition, correct?
Mr. Engeljohn. Petitions are one way to do it. The agency
does listen in terms of any input that we hear in terms of
questions or new data becoming available for which we might re-
review the issue.
Mr. Stupak. In your testimony you also said that one of the
purposes when you review it is not to mislead the consumer; is
that correct?
Mr. Engeljohn. Yes.
Mr. Stupak. OK. All of the studies we've seen for the last
50 years indicate that consumers purchase their meat or seafood
based on appearance; is that correct?
Mr. Engeljohn. Appearance is one indicator.
Mr. Stupak. OK. Has appearance been overturned as one of
the indicators that citizens rely upon when they purchase their
meat or seafood?
Mr. Engeljohn. In this particular case, the agency did put
a ``use by'' ``freeze by'' date, knowing that that, in fact,
would be the best indicator as the appropriate and optimal use
of this product for the consumer.
Mr. Stupak. Well, tell me. How many studies show that
people buy meat based on ``use by'' or ``freeze by'' dates?
Mr. Engeljohn. The agency did contract for a study, which
we did receive in 2002, which did identify that an overwhelming
majority of consumers relies heavily upon the ``use by'' or
``sell by'' date.
Mr. Stupak. Do they also rely upon color?
Mr. Engeljohn. They do rely on other indicators, but the
``use by'' date is the primary mode for which they rely.
Mr. Stupak. Will you submit that study to us? We've asked
for those documents. You've never provided those to us.
Mr. Engeljohn. We did supply that study, but we will make
sure that you do have it.
Mr. Stupak. OK. Turn to exhibit No. 28. It's the 33rd
Reciprocal Meat Conference, 1980.
The first page of that study talks about ``studies the
importance of meat color that was demonstrated by Newman, et
al.'' I'm on the right-hand side, at about the third paragraph.
I'm at the last sentence that says, ``Certainly, consumers have
few, if any, means of estimating the flavor, juiciness,
tenderness of a cut of meat while it is in the showcase, so
they must base their selection on visual appearance. Color, of
course, is much of what the consumer bases his choice on.''
You're saying you have a study that contradicts this study?
Mr. Engeljohn. We have a study that does indicate that
``use by'' dates is a predominant means by which a consumer
makes that decision, but color also is one of those indicators.
Mr. Stupak. Let me ask you about the--you talked about the
April 28 letter. I believe Dr. Post was the author of that one.
In that letter three times he mentions consumers and the
deceptive practice that carbon monoxide would add if this
process were approved; is that correct? That's exhibit No. 18
in your book. It's exhibit No. 18. It's an April 28 letter
that, I think, Dr. Post authored in which you say, ``It is our
opinion that the use of Precept Foods' MAP system that is
described in the GRAS notice for use with case-ready, fresh
cuts of meat and ground meat could potentially mislead
consumers into believing they are purchasing a product that is
fresher or of greater value than it actually is and may
increase the potential for masking spoilage''; is that correct?
Mr. Post. That is correct.
Mr. Stupak. OK. Then the next exhibit, No. 19, is on June
2, 2004. You reversed your opinion in a letter to the FDA,
stating that you no longer believe Precept's system could
mislead consumers; is that correct?
Mr. Post. Yes.
Mr. Stupak. OK. Now, Dr. Engeljohn stated, as a result of
the letter of April 28, Precept submitted additional data to
address your concerns that the use of carbon monoxide could be
misleading to consumers; is that correct?
Mr. Post. Yes. Additional data were----
Mr. Stupak. What additional data did Precept submit to you
to get you to reverse your decision?
Mr. Post. Well, the April 28 letter to the FDA indicates
that there was a failure in study design, and that the samples
of steaks actually contained a solution, including potassium
and other ingredients--potassium and sodium diacetate. The
results would not be indicative of a spoilage pattern
associated with whole muscle cuts of meat not containing any
added substances, and those data on whole muscle cuts not
containing added ingredients were needed.
Also, it indicated that no samples were tested to establish
a spoilage pattern for ground meat products stored under
modified atmospheric packaging, and so data were needed there
as well.
Mr. Stupak. So did they ever submit that data to you
without the antimicrobial agents so that it would not show
spoilage?
Mr. Post. Yes. Those data were received in May 2004.
Mr. Stupak. All right. Now, Dr. Post, you are a scientist
evaluating microbial growth in meats. Would you question a
study where the microbial levels started high and ended up low,
and where microbial counts correlated inversely with gas
formation and odor scores? Would you question that as a
scientist?
Mr. Post. Yes, I would.
Mr. Stupak. OK. Well, go to exhibit 71(e).
That is the data you relied upon. If you look at 71(e), you
will see that there is a question where the microbial levels
started high and ended up low, and where microbial counts
correlated inversely with gas formation and odor scores. Do you
see that in exhibit 71(e)? It's on the last three pages. In the
columns marked CT/MG, it shows a decline in all microbial
counts from day 26 to day 30 and day 41. So, if anything,
microbial counts should go up, not down the longer it sits,
correct?
Mr. Post. That is correct. However the information that we
received did not show the growth of microorganisms in the shelf
life of the product.
Mr. Stupak. Well, this is the information right here. This
is the information you received from Precept; is it not? Look
at 71. It's from their attorneys. There's a two-page cover
letter, then there's the whole study. I just directed you to
the last three pages. I'm not a scientist, but even I figured
it out that the microbial level should go up, not down, and the
gas odors and formation were reversed in this study. That's
true, right, in looking at those last three pages?
Mr. Post. Yes. I haven't examined these thoroughly, but I'm
understanding what you're saying.
Mr. Stupak. Well, you would have examined them thoroughly
before you approved this process, wouldn't you?
Mr. Post. Yes, and we did.
Mr. Stupak. Well, then, if that's the case, Dr. Highbarger,
Dr. Engeljohn, any of you there, or even Dr. Acheson, you said
if new evidence presented which would show that this practice
isn't safe, that you would reverse your decision. So, based
upon the questions here, would you not reverse your decision
because the study you relied upon, to your understanding, is
incorrect?
Mr. Post. Well, data that were submitted in May did, in
fact, sample steaks, whole muscle cuts--the kind of product
data that we wanted--as well as ground beef data, and no signs
of spoilage were detected in any of the samples through 41
days.
Mr. Stupak. Well, that's your conclusion, but the charts
show us differently on those last three pages, don't they? We
just went over them. It shows it differently than your
conclusion. That's the data.
Let me go a little farther because Precept Foods--which is
a joint venture between Cargill and Hormel, right? That's what
Precept Foods is, correct?
Mr. Post. I'm not aware.
Mr. Stupak. OK. Go to the last 2 pages of exhibit 71(e).
Because Precept also realized the data they submitted is the
opposite of what you concluded, still they submitted the data.
Look at the last two pages there, at the last three pages,
actually. It's an e-mail, Monday, May 10, 2004. It's to Ann
Waylan from it looks like, D. Rusick at Hormel.com. 71(d). Go
to 71(d). OK. We're talking about this study now.
Do you see this? This is the last 3 pages. It's an e-mail.
Mr. Post. Yes, I found that.
Mr. Stupak. OK. This is on May 10th that they submitted
these documents to you.
It says, ``Ann, obviously, you have had other things on
your mind recently, but when you get a chance to review this
report, please let me know if you see any other funny data in
it. I welcome any insights or questions you may have. Quite
honestly, this test seems to raise more questions than it
answers. Thanks much.''
Now, that was at 3 o'clock in afternoon. If you go there,
Ann Waylan responds 3 hours later: ``I've read the report a
couple of times.'' This is her e-mail response back to Mr.
Rusick. ``These data do bring some interesting thoughts. Why
are the samples with the most off-odor have micro counts that
aren't different than the samples that have acceptable odor?
The sample with the last date have more desirable odor than the
samples without last date. Why are micro counts decreasing as
the number of days increase?'' That's the inverse that I talked
about. ``Also, micro counts are decreasing, but odor is
increasing.'' That's reversed. It should be just the opposite.
``When the environment has bugs, I think there would be an
increase in CO\2\, but on the package tested, the CO\2\ has
decreased. Just a thought. Why put a claims statement in the
summary of these data that don't show results that can be
patentable? Why not let the patent lawyers determine?''
Would you agree with me that that questions the validity of
the study they submitted which you based your approval upon?
Would you agree with me? Is that what that e-mail says?
Mr. Post. Based on this information, I think this leads to
some questions, yes.
Mr. Stupak. Based on this information, don't you think you
should reconsider your approval of the use of carbon monoxide
until we get these questions answered?
Mr. Post. Well, I suppose my best response is that based on
the data that we received in May 2004, no signs of spoilage
were detected in any of the samples. The additional data were
from studies that were conducted in February 2000----
Mr. Stupak. By Precept Foods as the data submitted to you
on which you based your decision upon, correct?
Mr. Post. Exactly.
Mr. Stupak. So the questions I raised and the questions
raised in this e-mail, would you not want to reconsider it, the
use of carbon monoxide in packaging?
Mr. Engeljohn. This is Engeljohn on behalf of the
Department FSI. So I would say as I said in my opening
statement, if in fact we receive new data or information for us
to reassess the information that we were previously provided,
we certainly will do that. And we have in fact----
Mr. Stupak. So you'll now reassess your--based upon this e-
mail, the information that I pointed out?
Mr. Engeljohn. We clearly will look at the data and we have
asked our research arm of the Department to actually work with
us on the design of a study to actually, in fact, look at this
particular issue as well as the broader one.
Mr. Stupak. Can you assure the American people that based
upon this faulty study on which you made your approval, you
will suspend the use of carbon monoxide in modified packaging
until you get the answers resolved here? This raises some
serious issues, does it not?
Mr. Engeljohn. I think we would still go back to the issue
of the data that we were looking at were specific to the issue
of whether or not spoilage would be an indicator here and
whether or not we did not look at this from a safety
perspective.
Mr. Stupak. And you also look at deception, whether or not
this packaging is deceptive to the American people?
Mr. Engeljohn. Again, from our perspective, we did
establish a use-by/freeze-by date as the mode in which a
consumer would in fact be able to tell if this product were
spoiled.
Mr. Stupak. Let me ask Dr. Highbarger. I had asked you
earlier. You've seen these studies. You saw these studies,
right?
Mr. Highbarger. I saw them, I don't recall them at all. I
can't pull the numbers out of my head. That was 3 years ago.
Mr. Stupak. All right. You're looking at the book there. Do
you agree with me that when the microbial counts should have
gone up, they were decreasing? When odor should have gone up,
it decreased? That there are problems here as pointed out in
those e-mails? Do you agree that there are problems in those
studies based upon their own internal e-mails of Cargill and
Hormel under Precept Foods? That we have some serious questions
here now?
I take it that is a ``yes.''
Let me ask Dr. Engeljohn. Dr. Engeljohn, you mentioned
about the GRAS. Was there ever a GRAS study panel for this
carbon monoxide use in the packaging? You usually get a panel
together, don't you, to review it on the GRAS?
Mr. Engeljohn. Not that I'm aware of, sir.
Mr. Stupak. You usually do one, don't you?
Dr. Post, you look like you want to answer. You usually do
a GRAS review panel, you have a panel to review it before you--
--
Mr. Post. I'll answer ``no'' to that, but I'll also defer
to my FDA colleagues to answer.
Mr. Stupak. So there was no outside review, just your
internal review of these studies submitted by Precept Foods,
correct?
Mr. Post. Yes.
Mr. Stupak. My time is gone over. I know we talked about
going 10 minutes. It looks like I went more than 10 minutes.
Let's go for 10 minutes of questioning by Mr. Whitfield.
Mr. Whitfield. Dr. Engeljohn and Dr. Post and Dr.
Highbarger, I might say that our side of the aisle did not
receive any of these documents that you were being questioned
about until last night. And they're very technical documents.
There is one aspect in here where it says that microbial growth
was acceptable throughout the test for all treatments. We
received them last night.
Mr. Stupak. Excuse me. Mr. Whitfield, if I may. These
documents were provided for some time. We found them over the
weekend. Our staff worked yesterday. I worked yesterday, even
though it was a holiday. We did find them last night. We
presented them to your staff last night.
Mr. Whitfield. We got them last night.
Mr. Stupak. Right. They were attached, we believe,
erroneous to a different document. And being good investigators
that our staff is----
Mr. Whitfield. I'm not questioning how it happened. I'm
just expressing the fact that we received it last night and
these gentlemen were not aware of it until they were questioned
about it just a few minutes ago.
Mr. Stupak. Right. The question was not only on e-mail, but
also studies that they've had since 2004.
Mr. Whitfield. These were e-mails that Hormel had. These
were internal documents, and I doubt that these gentlemen had
access to it. But it certainly raises the question that you all
can review this and come up with it.
But to suggest that you would be able to give the explicit
answers to these questions at this time, I think is
unreasonable. Have you seen any of these documents before, any
of the three of you?
Mr. Post. No, we haven't.
Mr. Whitfield. And so that is the point that I wanted to
make on those.
Mr. Stupak. If you may defer for a moment.
Mr. Whitfield. Sure.
Mr. Stupak. You never saw the e-mails until now. I never
saw them until last night. But you've certainly seen the
studies since 2004. You're the guys who reviewed it, right?
Mr. Post. We have seen the studies that supported the
decision in----
Mr. Stupak. So the issues I brought up about the converse
order here where microbials were going up when they should have
been going down, those are things you should have picked up in
2004, correct?
Mr. Post. To my recollection, those were not the kind of
results we saw.
Mr. Whitfield. So those were not the results that you saw.
But from the analysis that you did and from your decision, you
made the decision that this using carbon monoxide and modified
atmospheric packaging was safe from your standpoint; is that
correct?
Mr. Engeljohn. FSI has made the determination that the use
of this technology and carbon monoxide was suitable for the use
of meat and that a use-by/freeze-by date would be appropriate
to identify the product would not be spoiled.
Mr. Whitfield. And all packaging that uses it does have a
date that it must be used by; is that correct?
Mr. Engeljohn. We preapprove labels and all labels in
carbon monoxide packaging on meat or poultry products must have
a use-by or freeze-by date.
Mr. Whitfield. Would it be accurate to say that the
consensus of expert opinion and scientific opinion is that
there is not a safety issue with using this packaging? Would
that be accurate?
Dr. Tarantino, would you agree with that statement?
Ms. Tarantino. It certainly appears to. We haven't seen any
real evidence of a public health issue or safety issue.
Mr. Whitfield. Now, there has been some discussion about
the European Union. Do you recall, Dr. Tarantino, receiving a
letter from a Norwegian scientist at the Norwegian Food
Research Institute?
Ms. Tarantino. I do.
Mr. Whitfield. And explaining that the use of CO in meat
packing was banned by the EU for safety reasons?
Ms. Tarantino. He expressed that and also expressed that it
wasn't actually banned. It just was not approved in the EU, and
it was not for safety reasons.
Mr. Whitfield. So from your knowledge, it had nothing to do
with safety issues?
Ms. Tarantino. Not as far as I know.
Mr. Whitfield. Dr. Acheson, in your testimony you noted
that FDA had received a citizens petition challenging the FDA's
acceptance of the GRAS status for carbon monoxide packaging in
meat and tasteless smoke; is that correct?
Dr. Acheson. That's right, yes.
Mr. Whitfield. And what individuals or entities filed that
petition?
Dr. Acheson. I'd ask Dr. Tarantino specifically to give you
the very specific answer to that, if I may.
Mr. Whitfield. Dr. Tarantino?
Ms. Tarantino. Calsak submitted the citizen petition for
challenging our decision on carbon monoxide in meat and
EnviroWatch, a group in Hawaii, filed a citizen petition about
the decision on tasteless smoke.
Mr. Whitfield. Do any of the followers, specifically Calsak
have an economic interest in the FDA withdrawing GRAS
acceptance for carbon monoxide?
Ms. Tarantino. I'm aware they have a competing product.
Mr. Whitfield. They have a competing product. So they do
have an economic interest.
Now, Dr. Acheson, let me ask you. What do you consider your
responsibilities that you have at the FDA? What do you consider
as the three most important food safety problems or the three
biggest public health threats to the U.S. food supply?
Dr. Acheson. Well, there are two ways that we could answer
that. One is to look at the bigger picture of where do we need
to go with food safety, which is essentially focused on
building strong safety and upfront prevention, appropriate
intervention, and rapid response. If you're going to address
specifically what foods do we have the greatest concern about,
then the way to approach that is what is causing illness, what
is the public health risk? And what we're seeing is a variety
of different types of fresh produce where we've seen repeated
outbreaks. Issues with eggs is another high priority. So there
are a number of them. And this particular issue is not a safety
concern even remotely high on our radar screen.
Mr. Whitfield. OK. So this carbon monoxide in packaging, as
you said, is not remotely an issue?
Dr. Acheson. From a safety perspective with limited
resources, we have to look where the public health risks are.
Mr. Whitfield. Now, Dr. Engeljohn, what about from your
perspective, do you view this issue as one of your priorities
for food safety?
Mr. Engeljohn. This is not a priority for the Agency with
regard to public health. We have other pathogens and other
issues related to that. Labeling is an issue for which we do
have statutory requirements to address, and we'd fit all of our
labeling issues into a matter of prioritization that we have,
with public health being the No. 1 focus.
Mr. Whitfield. Now, I know that there are some consumer
groups here in the second panel. But as a Member of Congress, I
have not received any complaints that I'm aware of from any
citizen about this packaging being a problem for consumers in
my district. And you all, are you being besieged with letters
from consumers expressing concern about packaging using carbon
monoxide? Are you all receiving any information about that?
Dr. Acheson. I'm not aware that we're being bombarded with
those kinds of letters, but we recognize that this is clearly a
concern for consumers and our committee to think further about
it.
Mr. Whitfield. Is the USDA at this time restricting
competitors from advertising or marketing their products as
carbon monoxide-free? Or USDA?
Mr. Engeljohn. At USDA and the Food Safety Inspection
Service, I'm not aware of any labeling. We would not consider
such a label to be appropriate. All of the technologies that we
approve labeling for are, in fact, safe; and the issue being
whether or not it is suitable.
Mr. Whitfield. Would there be any prohibition of a company
putting on its label as carbon monoxide-free?
Mr. Engeljohn. To my knowledge, we would not allow such a
statement.
Mr. Whitfield. You would not allow?
Mr. Engeljohn. Would not.
Mr. Whitfield. Dr. Post?
Mr. Post. We'd allow statements about any technology that
are truthful and not misleading, because we have a pre-approval
requirement. The word ``free'' I think is a little problematic,
I think, in this case.
Mr. Whitfield. OK. All right.
Now, have you all heard of Dr. Michael Osterhome at the
University of Minnesota, or Mike Doyle of the University of
Georgia? Any of you familiar with them?
Dr. Acheson. Yes.
Mr. Whitfield. And I think both of them and their
institutions have conducted some studies on this issue; is that
correct?
Dr. Acheson. I believe so, yes.
Mr. Whitfield. And from their studies, they have concluded
that safety is not an issue with this packaging; is that
correct?
Dr. Acheson. I believe so, yes.
Mr. Whitfield. OK. And both of them are leading experts in
this field, with extensive scientific knowledge; is that
correct?
Dr. Acheson. Correct.
Mr. Whitfield. OK. I have no further questions. Thank you.
Mr. Stupak. I thank the gentleman.
Ms. Schakowsky for questions, please. Ten minutes.
Ms. Schakowsky. First, Mr. Chairman, let me congratulate
you and our staff of researchers and investigators for
providing us with information that makes it possible to really
explore, apparently more fully even than the USDA on some of
the information that we have. I've actually been pretty
surprised that in preparation for this hearing, that the
witnesses have not--for example, Dr. Acheson, you seemed
unaware of the FDA's involvement with the issue of carbon
monoxide. And I'm looking at your written testimony when it
says GRAS, generally recognized as safe, notice for carbon
monoxide right here; the notice to the FDA; the response dated
February 21, 2002.
I would have imagined that you would have been aware of
your own testimony that referred to the involvement of the FDA
in this issue. Let me put on my consumer hat; that is where I
started in the grocery store, dealing with getting freshness
dates on.
Why do you think that this packaging is used? What is the
intention of the packaging, Dr. Engeljohn?
Mr. Engeljohn. The packaging, as with all packaging, would
be in part to ensure that the product doesn't become
recontaminated. That is the first issue. And it is the
importance of packaging throughout the distribution chain. The
use of the gas, in this case carbon monoxide, has a specific
purpose which in this case is to remove oxygen and to----
Ms. Schakowsky. I guess I'm asking, again, from a consumer
point of view. Is it not to make the product more acceptable to
consumers by making it look fresher?
Mr. Engeljohn. I think from the FSI's perspective, is that
the use of the technology retains a color that is there in the
product naturally within the shelf life that it normally would
have for optimal use.
Ms. Schakowsky. So you would not agree that the--that at
least a partial intention of this technique is to make
consumers believe--because we do look at color. Go into any
meat department of any grocery store and watch people choose a
product. And what they're looking for--because you can't put
your face on the product and smell it--is looking for color. Is
that not true?
Mr. Engeljohn. Color is a very important indicator for the
freshness of the product, yes.
Ms. Schakowsky. OK. And so this technology takes away that
signal from consumers. Is that not true?
Mr. Engeljohn. This technology does not take away the
signal entirely. It retains a color that would be there
throughout the normal shelf life and optimal use of this
product. And that's what we established the use-by date time.
Ms. Schakowsky. One of the packages in front of you is 2
years old and it might look OK to consumers. Is that not a
problem?
Mr. Engeljohn. It is a problem from the perspective that it
is critical that the use-by date be adhered to. And that is the
reason why we approved the label with the purposeful intent of
having a use-by date that is in fact based on the shelf life
studies that we were represented.
Ms. Schakowsky. Target has presented a letter--it is
exhibit 76--asking the USDA to approve a label that Target
would like to put on its meat packages that are packaged with
carbon monoxide.
They are seeking approval to affix a label containing the
following information on those meat products. ``Consumer
notice: Carbon monoxide has been used to preserve the color of
this product. Do not rely on the color or the use or freeze-by
date alone to judge the freshness of the product. For best
results, please follow the safe handling instructions'', which
I understand are on the product as well.
Will you approve this label and allow Target to label its
meat in this manner?
Mr. Engeljohn. The Agency did receive that letter late
Friday evening and it is under consideration. And our primary
objective in evaluating that statement as one being submitted
was to ensure it is truthful and not misleading. So we'd look
at all aspects of what the statement would say.
Ms. Schakowsky. And if you approve that language, will you
direct that all meat packaged in an atmosphere containing
carbon monoxide be labeled with the same language?
Mr. Engeljohn. The issue would be making sure that the
label is truthful and not misleading in those aspects, and then
we'd make some consideration as to whether or not we need to
reevaluate our original approval condition, which was solely
the use of a use-by/freeze-by date. So it would be a part of
the consideration that we would have.
Ms. Schakowsky. Let me tell you that I think this
discussion represents a kind of tone-deaf understanding of what
consumers expect and want. Safety is certainly a major
consideration, but we have technologies now that can take junk,
really old food, and do all kinds of things to it so that if
you consumed it, it would not hurt you, it would be OK.
That is not the standard that American consumers want. They
want to know that this product--that's why we look at color, so
that we bring something home to our family that is fresh for
them. Freshness is a concern for families regardless of whether
or not it is going to make someone sick or, horribly, perhaps
kill a child.
So this is--I really would--if you want to be besieged by
letters and phone calls and opposition, I assure you that that
could happen if people feel that they are being deceived by a
product, because it is not simply the notion of making someone
sick. We have enough right now in the way of--I don't even know
what you do when you put lights on things and all kinds--to get
rid of the bacteria. It is not comforting to me to know that
you can take fecal matter and make it not hurt me. I don't want
it in my food.
And the same issue, I want to be able to use my senses to
decide what is for my family, and I feel that it is deceptive
to allow a packaging that would take that away from me,
especially since in the grocery store itself I can't literally
smell the food, so I don't really have a lot of questions about
it.
But I think you ought to question the decision that you're
making. I think that consumers do want, as consumers in Europe
and other places--and you ought to look at the reasons for
their--the decisions that they've made--want not to have
something that discolors or artificially colors in some way
their food products. I assure you that shoppers across the
country will not be simply complacent about this.
Thank you. I yield back.
Mr. Stupak. Thank you. Mr. Burgess for questions, please.
Mr. Burgess. Thank you, Mr. Chairman.
Dr. Acheson, let me just ask you a question about the
imports of fish and imported tuna that some of your testimony
revealed elevated histamine levels, is that correct, in
imported tuna?
Dr. Acheson. [Non-verbal response.]
Mr. Burgess. Is there any difference between carbon
monoxide-treated tuna and noncarbon monoxide-treated tuna as
far as the histamine levels are concerned?
Dr. Acheson. Carbon monoxide really doesn't have anything
to do with the formation of histamine. And this is actually a
fairly complicated process in that there is a formation of
histamine as a process that can occur in fish, and there is
also the formation of odors that can form in fish which we'd
normally call spoiled fish. These things happen generally in
very different tracks. They are not the same thing causing one
from the other.
And so I think the complication here is that it would be
nice if we could use the odor of fish to tell us whether there
was histamine present. As a matter of fact, we can't. It
doesn't work that way. And CO doesn't really have any impact on
that ability.
Mr. Burgess. So what is the purpose in using the carbon
monoxide in the treatment of fish?
Dr. Acheson. Either tasteless smoke or carbon monoxide is
used principally in frozen fish because with the freezing and
thawing, you get a change in color in that fish to something
that is fairly unappetizing, you might say. There is nothing
wrong with the fish. It is not spoiled, it is not decomposed,
it is not dangerous, it is not lower in quality in any way. It
has just changed color because of the freezing and thawing
process. And as a result, there is difficulty in marketing that
kind of product, and the industry has found by treating the
fish with either CO or tasteless smoke, they are able to retain
that color that it had immediately before freezing, which
actually serves some benefit because marketing of frozen fish
that can produce histamine is a safer way to market the fish,
because it very much reduces the ability of the fish to produce
histamine when it is frozen as compared to when it is marketed
as refrigerated. So there is actually some health benefit
there.
Mr. Burgess. So the freezing then, the physical activity of
freezing the fish, delays the production of histamine in the
fish, and the carbon monoxide treatment allows you to market
the fish that has been frozen. So indirectly, then, there may
well be a benefit to the consumer of lower levels of histamine
in fish that still looks palatable when it is thawed.
Dr. Acheson. That is fairly possible, yes.
Mr. Burgess. Have you ever done a study that compares high
histamine levels and decomposition in carbon monoxide-treated
foods versus those present in noncarbon monoxide-treated
seafood and concluded that a higher percentage of decomposition
histamine levels are found in seafood treated with carbon
monoxide?
Dr. Acheson. I'm not aware of any study that has done that.
We're certainly aware that carbon monoxide-treated fish do
sometimes have histamine present. We're also aware that fish
that are not carbon monoxide-treated also have some occasions
where histamine is present. And, of course, this is something
that FDA tries to regulate at the border through testing.
Mr. Burgess. So are there other products besides tuna that
are treated with carbon monoxide, other seafood products?
Dr. Acheson. We are aware that tilapia might also be
treated, and probably is with some regularity.
Mr. Burgess. Is that OK? Is that within the scope of the
regulations? Or is that an adulteration of the product?
Dr. Acheson. There has been no GRAS notification for the
use of CO or tasteless smoke in tilapia. But by the same token,
the statute does not require someone using CO or carbon
monoxide--a GRAS substance, let me put it that way--does not
require someone to notify FDA if they are using a substance
they believe to be GRAS. That is just the way the statute is
written.
Mr. Burgess. And it makes no difference whether that
tilapia--is any tilapia produced domestically, or does it all
come from foreign sources?
Dr. Acheson. I believe there is some produced domestically,
but it is mostly a foreign product.
Mr. Burgess. And there would be equal treatment of that
product with carbon monoxide whether it is produced
domestically or imported?
Dr. Acheson. Yes.
Mr. Burgess. OK. If FDA did make a determination that the
use of carbon monoxide was resulting in an adulterated product,
you would stop that at the border; is that correct?
Dr. Acheson. The difficulty here is that, as you have heard
the discussion before, is that with limited resources we try to
focus our resources on food safety issues.
Mr. Burgess. But if you thought it was dangerous----
Dr. Acheson. If we thought it was dangerous, we'd certainly
stop it at the border. That's absolutely correct.
Mr. Burgess. Is this just enforcement discretion or does
this speak to the benign nature of carbon monoxide treatment of
seafood products?
Dr. Acheson. I think it is enforcement discretion. The
issue of--first of all, tilapia doesn't produce histamines. So
that issue isn't even an issue for tilapia. So that takes out
even the discussion of that issue associated with tilapia. But
the fact that it may in fact constitute an economic
adulteration, arguably that could be the case. But FDA does
need to decide where we need to put our resources. So I think
this is, in fact, enforcement discretion and putting our
recourses on the food safety issues that Dr. Acheson mentioned
a few minutes ago.
Mr. Burgess. Would you restrict competitors who were
selling this competing seafood product that didn't use carbon
monoxide, would you restrict them from mentioning in
advertising or marketing that competing imports are using
carbon monoxide without FDA notification or acceptance?
Dr. Acheson. In their advertising?
Mr. Burgess. Yes.
Dr. Acheson. I'm not aware that that is a prohibition.
Mr. Burgess. Again, does that speak to a problem with the
laws in that arena, or does it speak to the fact that carbon
monoxide treatment is again a real--regarded as a relatively
benign process?
Dr. Acheson. Because if competitors felt it was an
advantage, they'd be--they'd be advertising in that way?
Mr. Burgess. Yes.
Dr. Acheson. I'm assuming that they made the decision that
it is not worth their while to market in that way.
Mr. Burgess. We all recall the tuna advertising plans that
dealt with the--I forget whether it was the capture of tuna or
sea turtles in the nets that captured the tuna. Was it
walruses? It was dolphins.
Obviously there was a competitive advantage to advertising
dolphin-friendly tuna. I know that's what I always look for. I
would never buy dolphin-unfriendly tuna knowingly. What does
the--in your opinion, what does the FDA believe would be the
public health impact from requiring notice and comment for all
of the generally regarded-as-safe petitions? Is there any
concern that this would stifle advances in innovation that
might in fact, if not stifled, improve food safety?
Dr. Acheson. I think Dr. Tarantino is probably better able
to answer that question.
Ms. Tarantino. Sure. First of all, I think as Don mentioned
as well, if something is GRAS, you don't have to notify us or
come to us at all. Notice and comment rulemaking certainly
takes a very long time and there are situations when you have
to do it.
Mr. Burgess. How long a period of time?
Dr. Acheson. It depends on what the issues are. It does
require a publishing proposal, taking comments and then doing
rulemaking.
Mr. Burgess. Days, weeks, months or years?
Ms. Tarantino. Years. And I think what is also true is the
process. The GRAS notification process is about as transparent
as the food additive petition process. In both cases--in one
case we put the notice on the Web, and in the other case we put
a notice in the Federal Register. And in neither case do we go
out and actively solicit comments, but people have an
opportunity to comment and give information as much as
possible. So we try to make the GRAS notice process as
transparent as is possible, while keeping it a fairly efficient
process, because we want to encourage people to come to us,
because we get much more information about what is in the food
supply and can stop it if we know about it.
Mr. Burgess. I see. Let me just ask anyone on the panel who
can answer the question. I've been primarily talking about
seafood products, but this would apply to beef products as well
that are treated with carbon monoxide.
What happens to the carbon monoxide when the food is
cooked? Does the hemoglobin molecule denature and break apart
and the carbon monoxide is then released? And since we're
talking about concentrations of four-tenths of 1 percent, that
obviously would not pose a hazard to someone inhaling carbon
monoxide, would it?
Mr. Highbarger. I can't give you any numbers, but the
majority of the carbon monoxide would be just blown off from
cooking. So you'd be eating almost nothing. I can't give you
numbers.
Mr. Burgess. The exposure to carbon monoxide to
temperatures normally involved in cooking would not create any
new compound or substance which might in turn be harmful to the
consumer?
Mr. Highbarger. There is no chemistry there that could
happen, no.
Mr. Burgess. Thank you, Mr. Chairman. I will yield back.
Mr. Stupak. Thank you. We will go for another round of
questions.
Mr. Kraemer, Mr. Burgess had asked you about the treatment
of fish with either tasteless smoke or carbon monoxide,
correct?
Dr. Acheson. Yes.
Mr. Stupak. And you said they treated it with using either
one, tasteless smoke or carbon monoxide, correct?
Dr. Acheson. Yes. I referred to--I responded to both, yes.
Mr. Stupak. Does the FDA decipher between the two for
labeling purposes?
Dr. Acheson. Yes. The labeling would be different depending
upon what was being used.
Mr. Stupak. What is the label for tasteless smoke?
Dr. Acheson. Tasteless smoke would need to say ``preserved
with tasteless smoke,'' I think is the correct terminology.
Mr. Stupak. Tasteless smoke is really carbon monoxide, is
it not?
Dr. Acheson. One of the components of tasteless smoke is
carbon monoxide.
Mr. Stupak. OK. What is the label for carbon monoxide,
then?
Dr. Acheson. Presumably, it would need to say ``preserved
with carbon monoxide.''
Mr. Stupak. OK. Let me show this picture up there. The
person is wearing a respirator, spraying seafood. Would that be
tasteless smoke or carbon monoxide?
Dr. Acheson. I can't tell from the photograph. I don't
know. I've not seen the operation of either process.
Mr. Stupak. All right. If tasteless smoke is the same as
carbon monoxide, then why not just label truthfully as carbon
monoxide and not tasteless smoke?
Mr. Burgess. Mr. Chairman, I'm going to object. How can he
possibly know what that individual would be spraying? No one
can tell just from a picture like that. We don't see a
canister, we don't see a label, we don't see a skull and
crossbones, a biohazard label. It is illustrative only for the
purposes of inflaming the rhetoric. I see nothing to be gained
by showing us that picture. I yield back.
Mr. Stupak. We'll get to the picture with the second panel.
We'll lay the proper foundation, OK? So if tasteless smoke is
the same as carbon monoxide, then why not just label it
truthfully as carbon monoxide and not tasteless smoke?
Dr. Acheson. They are not the same. One of the components
of tasteless smoke is carbon monoxide, but there are other
components as well.
Mr. Stupak. What else do you get with tasteless smoke other
than carbon monoxide on your seafood?
Dr. Acheson. What else is in tasteless smoke? I believe
nitrogen is one of the components.
Mr. Stupak. Does that adhere to the fish, then, when you're
using tasteless smoke?
Dr. Acheson. No. I don't think it has any effect on the
fish. It is essentially inert.
Mr. Stupak. So the only thing that reapplies into the fish
when using tasteless smoke is carbon monoxide, right?
Dr. Acheson. The component that causes the effect of color-
fixing is carbon monoxide.
Mr. Stupak. So why don't you just call it carbon monoxide
and not tasteless smoke?
Dr. Acheson. I think it is a truthful statement to call it
tasteless smoke, because in fact that is what it is.
Mr. Stupak. But there is no smoke, there is no taste
because it is tasteless. It is carbon monoxide.
Dr. Acheson. It is tasteless.
Mr. Stupak. You take tasteless smoke and put all the
impurities, what do you have left, carbon monoxide, correct?
And a little nitrogen? Same as CO carbon monoxide, right? When
you use carbon monoxide, you have a little nitrogen left over
too?
Mr. Kraemer. The active ingredient, if you will, is carbon
monoxide.
Mr. Stupak. OK.
Let's go back to Dr. Post. Mr. Whitfield sort of indicated
like we sort of sprung a surprise on you, even though you're
the guy that did the study 3 or 4 years ago.
Let's go back to your document binder, 71(d) and 71(e);
71(d), I'll grant you, is the document we found in our files
that we received from Hormel with the e-mail.
And in 71(d), pages 3, 4 and 5, are the data that I
referred to when I said that the microbial levels start out
high and ended low, and where the microbial counts correlated
inversely to gas formation and odor scores. So those are the
three labels.
If you go to 71(e), exhibit 71(e), which is--starts off,
first two pages, from the law firm of Hogan & Hartson. Then
inside, page 3 is Excel, the use of carbon monoxide in lid
stock on ground beef. And that is the study they submitted in
which you based your approval and--am I correct?
Mr. Post. I would need more time to look at this and the
original submission. I can't tell from the complexity of the
data.
Mr. Stupak. That is a copy we got from you, from FDA and
from the Department of Agriculture.
Well, let's go to the last three pages of exhibit E and
exhibit D, they are the same. The data is the same, is it not?
It shouldn't take a lot of time to figure that one out. It is
pretty clear that the last three pages in E, the data submitted
to you, the last three pages in exhibit D, the internal memo
with the e-mail that questions the validity of the study, those
are the same three pages, the data, whether it is the e-mail or
your study was based on those three pages of data--is that
correct--where the microbial levels started off high and ended
up low and where microbial levels correlated inversely to gas
formation in the overall score; is that correct?
Mr. Post. They appear to be the same, yes.
Mr. Stupak. OK. Thank you.
Let me ask this question. Dr. Acheson, you said there has
been no complaints at the FDA about carbon monoxide. Has the
FDA done any studies to determine if consumers are aware, in
fact, that carbon monoxide is being used to treat their meat?
Dr. Acheson. No, the FDA hasn't. But we're considering
undertaking some.
Mr. Stupak. So if no one knows about it, they can't really
complain, can they?
Dr. Acheson. I think people know about it.
Mr. Stupak. No.
Dr. Tarantino, let me ask you this. You mentioned the
Norway study in questions, I believe, with Mr. Whitfield. And
you said Norway--in fact, it is exhibit No--if you want to look
in the exhibit book, I believe it is exhibit No. 30. That is
the Norway study I believe you were referring to, correct?
Ms. Tarantino. My No. 30 is a publication from the
University of----
Mr. Stupak. Go to the next one, 31. Mr. Whitfield asked you
about Minnesota, too. So I'll ask about that later.
Ms. Tarantino. That is one publication from their data.
Mr. Stupak. Right. Is that the Norway study you're talking
about, where you thought they had no concerns about carbon
monoxide?
Ms. Tarantino. It is not the only one, but we have the raw
data from their studies. But this is one publication.
Mr. Stupak. Sure. That starts with page 201. Go to page 218
of that study. Page 18 right in there. Lower right-hand corner,
last sentence says ``and the safety of MAP,'' or modified
packaging, ``products are mostly threatened by temperature
abuse.'' Would you agree with that statement?
Ms. Tarantino. The author of this study I think has written
to say his words have been misinterpreted. What he was saying
was that safety of meat is threatened by temperature abuse of
any kind, including this modified atmosphere packaging and any
other packaging.
Mr. Stupak. Sure. So let's go to exhibit 30, then, the
first one I asked you to refer to. And this is our University
of Minnesota, Department of Food Science and Nutrition, where
both Cargill and Hormel are located in Minnesota. And it starts
off that the abstract basically says that the temperature
abuse's main concern is for chilled and/or MAP meat and poultry
products, since it is not the only cause of economic loss, but
also made to food-borne illness hazardous, correct?
Ms. Tarantino. I don't see the terms, but OK.
Mr. Stupak. OK. Let's go to page 218 of that study. It
starts on page 201 and goes to page 218. And let me just ask
you this based upon your knowledge--or maybe Dr. Post or one of
the others would like to comment on it.
It says in the middle of the page that the microbial
population of fresh meat is affected by many factors such as
the number and distribution of microbial species present at the
start; health and handling of the live animal; slaughtering
practice; chilling of the carcass; sanitation; type of
packaging and handling throughout distribution and storage; is
that correct?
Ms. Tarantino. I see the line, yes.
Mr. Stupak. Would you agree with that, all of those factors
go to microbial?
Ms. Tarantino. It certainly sounds like it, yes. But I
would defer to the USDA, too.
Mr. Stupak. OK, thanks.
Mr. Highbarger, in the letters from Dr. Post or to you to
Dr. Post, back and forth, on approving this process here, did
you look at the data that was submitted by Precept Foods in
response to the April 28 letter? Did you look at that data?
Mr. Highbarger. I don't believe so on that one.
Mr. Stupak. OK.
Mr. Highbarger. That was not submitted to us.
Mr. Stupak. The letters going back and forth were to you,
correct?
Mr. Highbarger. That's correct.
Mr. Stupak. From ``Mr. Post developed this,'' and on the
April 28, 2004 letter he brought up again three times, on top
of page 2, bottom of page 2, about the deception that may cause
or mislead consumers into believing the product they are
purchasing is fresher than it actually is, correct?
Mr. Highbarger. Yes.
Mr. Stupak. It is exhibit No. 18 if you want to look at it.
Then on exhibit 19, when he apparently goes through the
study and comes up with the wrong conclusions of the study
based on the data, he never mentions the deception to the
consumer.
Did you ever ask him why--if that was--you raised it three
times in your initial letter, the deception to the consumer.
How come before you gave final approval you never discussed the
deception to the consumer? What happened in the next 6 weeks or
so? No one cared about the deception to the consumer, or you
didn't have any concerns about it? Because he was addressing
the letter to you. You see, he never mentions deception. The
first letter, he mentioned it three times. The second letter to
get the approval from you, he never mentioned deception. What
happened?
Mr. Highbarger. Well, I would interpret to say--because I
haven't seen this letter for 3 years, obviously. Under the
proposed conditions of use, the scores and subjective
evaluations were shown to be acceptable during a shelf life of
20 save days under the proposed conditions----
Mr. Stupak. Correct. But you never mentioned deception to
the consumer. I guess that is the part that bothered me.
Mr. Highbarger. That is inherent in it.
Mr. Stupak. That is inherent in it. OK. Dr. Post wrote to
you. So you're the person who then finally approved the carbon
monoxide in the packaging to be used?
Mr. Highbarger. I'm a member of the team who evaluates all
the information, yes. I'm the point of contact. All the
communication comes through me.
Mr. Stupak. You said you didn't see the studies then. How
did you evaluate to reach your conclusion it was OK to do this,
to put carbon monoxide in packaging, if you never reviewed the
studies, those three pages I talked about in exhibit 71(d) and
71(e)?
Mr. Highbarger. I obviously deferred to the USDA.
Mr. Stupak. To whom at the USDA would you have deferred to;
to Mr. Engeljohn?
Mr. Highbarger. Through the memos that they sent us saying
that it was acceptable under the proposed conditions of use.
Mr. Stupak. OK. You're a scientist, right?
Mr. Highbarger. Yes, I am.
Mr. Stupak. So if you had seen where the microbial levels
started high and ended low and where microbial counts
correlated inversely with gas formations and odor scores, you
would have caught that and you would have rejected that study?
Mr. Highbarger. I would have to look at it before I could
say anything.
Mr. Stupak. OK. So will you look at it now? Because if my
statement is correct, then in the study you based your decision
upon, the microbial levels started high and ended low and where
microbial levels correlated inversely with gas formation odors.
If that is true, as in exhibit 71(d) and 71(e), you've got to
reverse your decision then, right?
Mr. Highbarger. I'll certainly look at it.
Mr. Stupak. When can you do that? This is a matter of
importance to this committee. That's why we're having this
hearing. When can you convene your GRAS panel and review this
data? Dr. Tarantino?
Ms. Tarantino. We'll talk to FSIS and look at the data and
look at the study. But remember, our decision on whether we do
something on the pending matter of the citizen petition or
overturn the GRAS will depend on everything we see, including
this study and including looking at what these numbers say.
Mr. Stupak. But if your initial decision was wrong based on
this study, shouldn't you suspend the GRAS then until--is there
a procedure to suspend the GRAS while you study this further?
Is there a procedure? Can you do that?
Ms. Tarantino. The procedure would be that we'd have to say
that we no longer agree that it is GRAS, that it is an
unapproved food additive, and build a record and a case that
supports that.
Mr. Stupak. An unapproved food additive. Why wasn't it
considered a food additive when it was first considered?
Ms. Tarantino. Because, as was said earlier in the
testimony, that GRAS substances are exempt from the definition
of a food additive. They do not require premarket approval.
Mr. Stupak. Well, we look forward to you convening your
GRAS review panel and review this study in depth, and I hope
you have all the raw material, not just the flow charts given
to us.
Mr. Whitfield with questions.
Mr. Whitfield. Thank you, Chairman Stupak. We focused a lot
with this panel on safety issues of which the general consensus
seems to be there are no safety issues. And then we also
focused on deception. And there has been a lot of discussion
about deceiving the consumer to believe that meat is more fresh
than it really is because of the use of carbon monoxide.
From a legal standpoint, what legal responsibility does
FSIS at USDA have about food deception, of policing food
deception?
Mr. Engeljohn. Our statutory authority requires us to
ensure that product is not misbranded, mislabeled, and so it is
an issue which we'd take into consideration in our
determination of whether it is----
Mr. Whitfield. Could you give us an example of something
that has been referred to as deception from your jurisdiction
in the last couple of years?
Mr. Engeljohn. Well, one issue that is probably easier to
understand in terms of a deception and why we don't allow it in
meat products to begin with would be paprika. It is a compound
that--or spice--when used has a red color. And although it does
cause the lean tissue to turn red or stay red, it also causes
the fat to turn red and stay red. So the product appears to be
more lean than it is. So that is a determination of perhaps an
economic adulteration situation. So we do not allow it for that
reason.
Mr. Whitfield. But on this particular issue from the
perspective, the official position of USDA, is that you do not
view this as deception by the use of carbon monoxide; you do
not view that as a deception, do you?
Mr. Engeljohn. We do not view the use of carbon monoxide as
a deception when there is a use-by/freeze-by date on the
package which is, in fact, the determinant for whether the
product is optimal.
Mr. Whitfield. And I don't know if you've seen all these
samples that are out there, but I'm assuming that all these
sample packages have use-by dates on them; is that correct?
Mr. Engeljohn. If they are treated with carbon monoxide,
they must have it on there, or they are improperly labeled, and
that would be a violation of our requirements.
Mr. Whitfield. But if they do not use carbon monoxide, they
do not have to have a use-by date on there?
Mr. Engeljohn. That is true. If they do not use carbon
monoxide in the packaging, and use other gases including oxygen
or any series of other combinations of gases, there is no use-
by or freeze-by date, and they do in fact have a tendency to
cause the color to be retained as long as the product is in the
package. So virtually any product in a package is going to have
delayed spoilage in terms of changes with microbiological
content as well as color and other indicators.
Mr. Whitfield. Were you going to say something, Dr. Post?
Mr. Post. I'm just agreeing with him.
Mr. Whitfield. OK. I yield back.
Mr. Stupak. Ms. Schakowsky, questions?
Ms. Schakowsky. I do. Let me see if I understand about the
imported fish that we have. About 80 percent of the fish that
we have is imported; is that correct?
Dr. Acheson. That is correct.
Ms. Schakowsky. Would you say that almost all of it is
packaged with CO?
Dr. Acheson. I'll ask Mr. Kraemer to try to give you an
estimate as to what percentage of that is packaged with CO.
Mr. Kraemer. I would say for all fish, it is a very small
percentage. But for tuna, we don't know what the exact
percentage is. But I would say it is a significant percentage.
Ms. Schakowsky. And what percent of FDA tests show that the
fish is actually decomposed or may have histamines--or do we
know--of the inspected fish?
Dr. Acheson. What I do know is that between 2001 and 2005
we had about 4,800 samples of decomposed fish. But what I don't
know--if we can find for the record--is what the denominator is
for that.
Ms. Schakowsky. Apparently we've been asking this question
on this committee since May, and we really would like to get
that information from you.
Dr. Acheson. OK. Sure.
Ms. Schakowsky. Dr. Tarantino, isn't it true that under
FDA, that any substance that is a component or otherwise
affects the characteristics of any food is considered a food
additive?
Ms. Tarantino. Yes, unless it is subject to one of the
exemptions in that definition.
Ms. Schakowsky. Isn't it also true that as a food additive
the substance is then subject to premarket review and approved
by FDA unless it falls within one of those definitions?
Ms. Tarantino. That's right.
Ms. Schakowsky. One of the major exclusions is GRAS are
generally recognized as safe under the conditions of its
intended use, correct?
Ms. Tarantino. Correct.
Ms. Schakowsky. So today we're discussing meat packaged in
an atmosphere containing carbon monoxide and the exposure of
seafood to carbon monoxide before freezing. And these processes
were determined to be GRAS. That's correct, right?
Ms. Tarantino. Yes.
Ms. Schakowsky. Under 21 CFR, paragraph 170.35, the
affirmation of GRAS status must occur through the notice and
comment rulemaking process in which FDA publishes a notice in
the Federal Register, allows 60 days for comments, evaluates
the comments and then determines whether the substance is
GRAS--Generally Recognized As Safe--is that correct?
Ms. Tarantino. Or FDA to affirm that something is GRAS,
that's correct. We did not do that in this case.
Ms. Schakowsky. Well, that's really where I'm going. It
says, however, GRAS notice 015, which allows tuna to be exposed
to tasteless smoke, and GRAS notice No. 143, which allows meat
to be packaged in an atmosphere containing carbon monoxide were
both determined to be GRAS without following the notice and
comment rulemaking process; isn't that true?
Ms. Tarantino. The GRAS exemption does not require FDA to
participate in the GRAS determination at all. So in those
cases, it was the party, the manufacturer, who made the
determination that it was GRAS, and then voluntarily notified
us of both its determination and all of the information and
studies on which it based that determination, and gave us an
opportunity to react to that and to see whether we had any
questions or not.
Ms. Schakowsky. So in other words, you're saying that it is
on the say-so--I'm trying to understand this process and how it
differs from 21 CFR that the GRAS status must occur through the
notice and comment rulemaking process which FDA publishes in
the Federal Register, comment period, et cetera.
Ms. Tarantino. The regulation that you're referring to is
that if--how we do it if the FDA decides to make a statement
that something is GRAS and to affirm the GRAS status. That is
the current regulation for how to do that. As I say, people can
determine GRAS status without coming to us, without notifying
us, without coming to us at all. The GRAS notification
procedure gives them an opportunity to voluntarily come to us
and gives us an opportunity to know better about what is in the
food supply so that if there are safety issues or are issues
about the GRAS status, we can raise questions about it.
Ms. Schakowsky. OK. Well, forgive me, then. Are you saying
that for something to be determined generally recognized as
safe, who is the arbiter, then, of that?
Ms. Tarantino. Experts, experts. The definition says
generally recognized to be safe by experts who are qualified by
training and experience to judge the safety of food.
Ms. Schakowsky. And who can be those experts? Can these be
experts that work for or are hired by the company seeking this
GRAS----
Ms. Tarantino. They can be. But the information on which a
GRAS determination is based is not just a company doing its own
studies in its own laboratory and then submitting it to the
Agency. That information needs to be generally known. So, often
that is through publications in the peer-reviewed literature.
It can be in many different ways. It can be through principles
in chemistry as part of the reason for carbon monoxide. It can
be a lot of different ways that the information is publicly
known so those experts, wherever they are in the world, can see
whether the information does support the safety or does not.
Ms. Schakowsky. We are hearing today that there is some
difference among experts. And the GRAS notices that we're
talking about today were determined under a proposed rule
dating back to 1997. The proposed rule would replace the GRAS
petition process, create a new GRAS notification procedure
under the proposed rule, no notice, no comment process. And as
you said, the FDA doesn't perform its own research, but instead
only looks at what the notifier has supplied in support of its
GRAS determination. So essentially this is an ex parte process
where FDA only considers the information that the notifier
wants it to.
Ms. Tarantino. We also look at other data that is out in
the public arena. We look at any information available to us in
our files or available to us through the literature and the
scientific basis.
Ms. Schakowsky. It looks to me like this is just another
example where the FDA has filed proposed rules instead of its
own regulations. Under Federal law it is a well-settled rule
that an agency has to file its own regulations. So it looks to
me like the FDA violates the law by not doing this.
Ms. Tarantino. If we were to affirm the GRAS status of a
compound on our own, we would use notice and comment
rulemaking. The regulation you are reading was a regulation we
proposed to give a mechanism for those who wanted to get an
opinion from us as to whether their GRAS determination was
correct. That was one mechanism that we put in the regulations.
The GRAS notification is a mechanism that we have also
proposed and are using, which does the same thing. It allows
people who have made a GRAS determination to come to us, to let
us know what they are doing, what they're selling, what they're
marketing, and gives us the opportunity to object if we see a
problem with it.
In many cases, when the process was very burdensome, people
just didn't come to us at all. So one of the big advantages of
the notification process is it encourages people to come in
with some regularity, we do object to their GRAS determination.
Ms. Schakowsky. When something is determined to be
generally recognized as safe, it is pretty hands-off then.
Ms. Tarantino. No. There are processes by which we can go
back and revisit those decisions and we----
Ms. Schakowsky. Like we think maybe today's hearing might
prompt----
Ms. Tarantino. No. The citizen petitions that have been
filed are processes that have been developed specifically for
that purpose.
Ms. Schakowsky. Did you say some petitions? Oh, yes. The
petition on this, I was just told, is 2 years old. So how
promptly is----
Ms. Tarantino. Well, I think everyone here has said we're
interested in new information, and there has been a lot of
information submitted to that docket on that petition up until
quite recently that we are very interested in looking at.
Ms. Schakowsky. And wouldn't a notification and comment
period make it easier to solicit other expert testimony as well
as consumer input? Whether or not the FDA actually does its own
testing?
Ms. Tarantino. It would be one way, I suppose. But I think
we've tried to accommodate that by making sure the people have
notice that the notification is in and with the agency who
submitted it, what it is for, as promptly as is feasible.
Ms. Schakowsky. Dr. Acheson, I think, said that people know
that meat is treated with CO. Wrong. I think that's absolutely
not true that most people think when they're at the grocery
store that the reason for that bright red color is because it
has been treated. Hopefully, that word will get out more and
will help people in their decision-making, but I don't think at
this point that is true.
Thank you.
Mr. Stupak. Thank you.
Mr. Burgess, questions?
Mr. Burgess. Thank you, Mr. Chairman.
Dr. Tarantino, maybe you could expand or provide a little
context for the answers to the questions you just gave Ms.
Schakowsky. What would be the effect of expanding the comment
process for determining whether a process was generally
regarded as safe?
Ms. Tarantino. I'm not entirely clear how one would do
that, but I suppose you could say that we could, in a final
rule, for the GRAS notice process or in some part of the
process, go out and explicitly seek comments. We do get
comments on GRAS notices pretty regularly.
Mr. Burgess. But expanding the notice and comment process,
would that have the net effect of slowing things down?
Ms. Tarantino. Oh, sure.
Mr. Burgess. Well, we keep talking about 1997. I referenced
it in my opening statement, and we heard it mentioned here
again just a minute ago. What happened in 1997?
Ms. Tarantino. In 1997, I think there was a general
recognition--no pun intended--that the process that we were
using for doing petitions to look at whether something is GRAS
was kind of an unusual situation. We had set up a petition
process for people to ask us whether they need to petition us
as a food additive, and we would say no, but it would take a
long time because it was a very cumbersome rulemaking process.
And the end result of that is that most people made their own
GRAS determinations, went to market, and then depended on us to
make a postmarket finding. If we disagreed with them, we'd have
to take an enforcement action.
Mr. Burgess. We already talked about the timelines to some
degree. Again, are we talking about days, weeks, months, years
or decades?
Ms. Tarantino. Years. It was years. So it was a big
disincentive for people to come to us and tell us about what
they were planning to market.
As to the process we did, one of the main reasons was to
make it a more efficient process while encouraging people to
come to us so we would have a much better view of what was in
the marketplace, what was being developed, what the new
technologies were, and that if we did have an issue, we could
review what was sent. We could review the information that was
out there publicly, and if we had an issue or a concern, we
could express that concern right away.
Mr. Burgess. So, in other words, the agency made the
decision, rather than to be punitive, they'd try to be helpful?
Ms. Tarantino. That certainly was a better way of going
about it to do it ahead of time so that we wouldn't need to use
enforcement resources, but have the review done before it went
to market.
Mr. Burgess. Well, since it seems to be the object of a lot
of discussion--I've got to tell you, I'm kind of mystified as
to why we're having this hearing. There are a lot of other
things we could be talking about--salmonella, E. coli, you name
it--but we're talking about bugs that I can hardly pronounce.
What would be required just to simply close up this
process--close up the rulemaking process and get a
determination on the rulemaking process? From 1997 to 2007,
that's a decade. Even for a slow-moving Federal agency, that
seems like a reasonable amount of time.
Ms. Tarantino. We are all very interested in closing that
out and in writing a final rule to put this process in the
regulations.
Mr. Burgess. So, as a practical matter, what is left to do?
Ms. Tarantino. To make sure that, in the intervening years,
nothing has changed. And we may look for additional comments to
see if anything has changed, but we want to get that final rule
out as much as anyone does.
Mr. Burgess. Well, in the intervening decade a lot has
changed. We're getting much more of our foods from--we've
already heard in other panels before this committee that we're
getting an enormous number of our foodstocks imported from
overseas. It seems to me that the American public would be
better served if we were to allow the agency to be a little bit
more flexible, a little bit more agile about responding to
these new threats that are coming in, and we, yet, seem to be
mired in the 1997s and not able to move forward.
Ms. Tarantino. The process we are operating under now is
operating under that proposal because it was a voluntary
process.
Mr. Burgess. Do you feel like it's working?
Ms. Tarantino. I do very much. I think it works quite well.
Mr. Burgess. Would you be in favor of our turning the clock
back and going back to 1997 or prior to 1997?
Ms. Tarantino. Before? Personally, no.
Mr. Burgess. You don't think that American public safety
would be greatly enhanced by doing that?
Ms. Tarantino. No. I believe the current processes are very
protective of public health.
Mr. Burgess. Would it be detrimental to go back to the type
of processes that we had prior to 1997?
Ms. Tarantino. I think it would be much more resource-
intensive, and it would be hard to know whether you would get
very much benefit from it.
Mr. Burgess. OK. Thank you. You've been very candid with
your answers, and I appreciate that.
We've got a lot of doctors on the panel. Do we have a
lawyer? Someone needs to help me with this term ``ex parte''
because it keeps coming up. Being a simple country doctor, is
that like a unilateral comment that's made? Let me just ask
anyone on the panel, either the FDA or the USDA. Does it
violate some process, or is it in any way illegal to have these
ex parte comments on regulation or guidance?
Dr. Acheson. I personally cannot answer your question. I
don't know. Maybe one of my FDA colleagues can. I would have to
get back to you with an answer for that.
Mr. Burgess. OK. It keeps coming up. We saw it in the
majority's report to the committee.
Mr. Burgess. Kind of going back to carbon monoxide for just
a moment, either Dr. Acheson or Mr. Kraemer, does the FDA have
any concerns about the safety and the use of the 0.4 percent
atmospheric carbon monoxide in packaging?
Dr. Acheson. From a safety perspective, we do not.
Mr. Burgess. Can we regard it as simply a packaging
material? We've already heard in the last round of questioning
I had that it's volatile; it goes away when the food is cooked.
So, from the consumer's perspective, is it any different from
the cellophane that helps to keep the food fresh?
Dr. Acheson. It's considered by us to be a fixative, a
preservative of color. It has got nothing to do with freshness
per se. It's color.
Mr. Burgess. It's coloration. So is it bound by the same
rules that other coloration agents are held to?
Dr. Acheson. Well, my understanding--and I'll ask Dr.
Tarantino to clarify--is that it's bound by preservative
approaches as opposed to that it's not considered to be a color
additive.
Mr. Burgess. Oh, it's not a color additive.
Ms. Tarantino. Right. It is a color fixative, which is
different from a color additive. A color additive imparts new
color.
Mr. Burgess. So, as a scientific matter, there is a
difference between a fixative and an additive?
Dr. Acheson. Yes. A fixative maintains color as is. An
additive is, by definition, an addition.
Mr. Burgess. Is there any difference in the use of carbon
monoxide in seafood products as opposed to meat products?
Dr. Acheson. Well, what do you mean?
Mr. Burgess. Does the FDA have a view as to the carbon
monoxide used in seafood, in fish products? Is it identical in
all respects as a fixative in fish products as it is in meat
products?
Dr. Acheson. Yes.
Mr. Burgess. OK. Thank you, Mr. Chairman. I yield back a
minute and a half.
Mr. Stupak. Thank you, Mr. Burgess.
Mr. Dingell for questions, please.
Mr. Dingell. Mr. Chairman, thank you.
This question is to Dr. Tarantino.
Doctor, what record was completed by the FDA in connection
with the issuance of whatever rule was issued by Food and Drug
with regard to the CO insertion into the packaging? Was there
any record established at all by Food and Drug on this matter?
Ms. Tarantino. There is an administrative file for each of
the GRAS notices.
Mr. Dingell. Was there any action taken by Food and Drug
which would comply with the requirements of the Administrative
Procedures Act? If so, what? Was there a finding made that the
actions of Food and Drug were in compliance with the
Administrative Procedures Act?
Ms. Tarantino. The notification to the agency was made
voluntarily by companies who chose to notify us----
Mr. Dingell. What about consumer groups? Was there ever
notice given to the public?
Ms. Tarantino. The----
Mr. Dingell. Yes or no? Was there notice given to the
public? Was notice filed in the Federal Register?
Ms. Tarantino. The notices were put on the Web.
Mr. Dingell. On the Web. They were not printed in the
Federal Register?
Ms. Tarantino. No. We were using the Web.
Mr. Dingell. What responses were received? How many?
Ms. Tarantino. On the notices for the meat, I do not
believe we got any comments between the time that we put the
notice on the Web and when we made the final decision. On tuna,
we may have. I think we did, but I'd have to check.
Mr. Dingell. So the answer is you don't know?
Ms. Tarantino. As I said, I think we did for tuna.
Mr. Dingell. Does anybody at Food and Drug know?
Ms. Tarantino. We can find out and get back to you.
Mr. Dingell. Don't you think you ought to be able to answer
that question when you're appearing here to discuss these
matters? It would seem so to me.
Dr. Acheson. Sir, we try to be as prepared as we can, but
certainly there are times when we just don't have all the
information. We'd be happy to get back to you for the record on
that.
Mr. Dingell. I find myself surprised.
Now, Dr. Tarantino, why are there no e-mails, drafts or
like documents that would indicate your thinking as the carbon
monoxide questions were under consideration that have been
produced to this committee? Are there such documents? Are there
such e-mails? Are there such drafts in the records of Food and
Drug?
Ms. Tarantino. We have made an attempt to be responsive to
your----
Mr. Dingell. All right. I'm going to ask you to submit them
to the committee, all of them.
I'm going to ask unanimous consent, Mr. Chairman, that the
record remain open so that they may be submitted and may be
included.
Now, why have several documents regarding communications
with the Office of Chief Counsel regarding seafood been
produced from the Office of Seafood files, but there's nothing
regarding the meat decisions? Can you answer that question?
Ms. Tarantino. We have produced everything we have found
thus far, and we are continuing to look.
Mr. Dingell. So you don't have anything with regard to the
meat decisions?
Ms. Tarantino. Only the things that have been produced thus
far are what we've found so far.
Mr. Dingell. Now, were the lawyers consulted on this
matter?
Ms. Tarantino. No, not that I recall.
Mr. Dingell. So they were not consulted.
Mr. Highbarger, why were no e-mails or other documents from
your office produced until last week when the Office of
Legislation was attempting to have you removed from the witness
list?
Mr. Highbarger. I just found those e-mails. I don't have a
better answer.
Mr. Dingell. When were you first asked to search for
documents relative to this committee's request? When did you
deliver the e-mails and to whom? Please answer the question.
Mr. Highbarger. Early August.
Mr. Dingell. Mr. Chairman, we will submit a letter to the
witness requesting more specific answers as to when, what was
submitted and why.
Now, Mr. Highbarger, since you were charged with the
responsibility of analyzing the submissions relative to the
question of carbon monoxide meat, why do none of your e-mails
reflect any analytical work from you or the colleagues that
were asked to also opine on the submissions? Please tell me
why.
Mr. Highbarger. Because there was no analysis to discuss.
It was simply do you have any questions about the validity of
the studies, and does it cover the entire--does it encompass
it.
Mr. Dingell. So you're saying you did no analysis; is that
what you're telling me?
Mr. Highbarger. My scientific reviewers reviewed the data
submitted.
Mr. Dingell. I find myself curious. How do you come to a
decision at Food and Drug if you don't analyze those questions?
Mr. Highbarger. It's not me, personally, who is doing the
analysis. We have a team of scientists who are reviewing the
data. At the end of the period of time, they tell us. We have
no questions about the submission.
Mr. Dingell. All right. Let me ask you this: You have
produced no records whatsoever from that group to this
committee, have you?
Mr. Highbarger. Just e-mails that I sent you.
Mr. Dingell. Are there such records?
Mr. Highbarger. I would have to talk to my reviewers to see
if they have any. I don't know.
Mr. Dingell. You have been requested to deliver those
records; have you not?
Mr. Highbarger. I've delivered everything that I have found
so far.
Mr. Dingell. You have delivered everything that you have
found so far. Is this to have us believe, then, that we have
everything that is in Food and Drug's files, and, if you submit
nothing more, that there is nothing more to support the
decision of Food and Drug? Is that right?
Mr. Highbarger. We are continuing to look for additional
data.
Mr. Dingell. You're continuing to look. OK.
Now, kind of inform me. Has Food and Drug ever come to a
decision on the application with regard to the carbon monoxide
and its use in the packaging of meat and fish products? Is
there a formal ruling or some action that has been taken, Dr.
Tarantino, by Food and Drug?
Ms. Tarantino. There is not a formal ruling or action. What
we did was respond to those who made their own GRAS
determination as to whether we had a concern.
Mr. Dingell. So you essentially took no action; is that
right?
Ms. Tarantino. That's right.
Mr. Dingell. And the folks in the industry are now out busy
using this device without any formal ruling by Food and Drug;
is that right?
Ms. Tarantino. That's correct.
Mr. Dingell. That's rather curious, isn't it? Is that the
regular practice at Food and Drug just to hold a proceeding,
arrive at no decision, and then let everybody do what they want
to do?
Ms. Tarantino. If a substance is GRAS under its conditions
of use, they may use it without a formal ruling from FDA. That
is correct.
Mr. Dingell. Do you have any opinions by the lawyers at the
Food and Drug or at the Department of Health and Human Services
saying that this is the proper procedure for Food and Drug to
take in this matter?
Ms. Tarantino. The GRAS notice procedure has been reviewed
by attorneys, yes.
Mr. Dingell. What rulings do you have from the lawyers
saying that this is a proper procedure for Food and Drug to
take?
Ms. Tarantino. Well, the attorneys reviewed the proposal
that we published in 1997.
Mr. Dingell. The attorneys reviewed the proposal, but the
attorneys, what did they do after they had reviewed the
proposal? Did they say this is proper or not proper?
Ms. Tarantino. We published the proposal, so it was with
their concurrence, yes.
Mr. Dingell. Did they say it was proper?
Ms. Tarantino. Yes.
Mr. Dingell. Do you have a written opinion on that from the
attorneys?
Ms. Tarantino. We have their sign-off on the proposal from
1997.
Mr. Dingell. The sign-off. What does that mean?
Ms. Tarantino. They concurred.
Mr. Dingell. Why did the attorneys not come forward with a
written finding on this? They did not come forward with any
written finding. They just signed off. What does that mean?
Ms. Tarantino. The proposal laid out what we were planning
to do as to how we would run a program for doing GRAS notices,
for reading GRAS determinations.
Mr. Dingell. Has this matter ever been finalized? Has there
ever been a final order by Food and Drug on this matter?
Ms. Tarantino. We're working on that.
Mr. Dingell. Now, how long has it been that you have been
working on it?
Ms. Tarantino. Too long. The proposal was issued in 1997.
Mr. Dingell. How long has it been that this process has
been used?
Ms. Tarantino. Almost 10 years.
Mr. Dingell. Ten years. You're still working on it?
Ms. Tarantino. We're working on finalizing the regulations
that would underpin the proposal.
Mr. Dingell. When do you expect to have the matter
finalized?
Ms. Tarantino. I can't answer that.
Mr. Dingell. What comments have you received from consumer
groups on this matter?
Ms. Tarantino. We certainly received comments. I don't
know. I would have to go back and look at the comments from
consumer groups.
Mr. Dingell. Do you have a formal record to support the
findings?
Ms. Tarantino. We have an open docket with the comments,
and we have a record that supports the proposal.
Mr. Dingell. Do you have an opinion from your attorneys
that this complies with the requirements of the Administrative
Procedures Act?
Ms. Tarantino. The GRAS proposal? Yes.
Mr. Dingell. Do you have an opinion that says that it's
proper for them to proceed, to continue, under the process they
have with regard to the carbon monoxide gas being used in
packaging without formal approval by the Food and Drug?
Ms. Tarantino. Not specifically about the meat packaging,
no.
Mr. Dingell. Well, Mr. Chairman, it looks like Food and
Drug is in need of reform, and I guess we're going to have to
give it. Thank you, Mr. Chairman.
Mr. Stupak. Thank you, Mr. Dingell.
Mr. Whitfield. May I just do a quick follow-up here.
Mr. Stupak. Sure.
Mr. Whitfield. Dr. Tarantino, just to make sure I
understand this, in 1997, the Congress passed the Food and Drug
Administration Modernization Act of 1997, which created a
notification procedure for food contact substances; is that
correct?
Ms. Tarantino. That's correct.
Mr. Whitfield. Under that law, the FDA has three methods to
adopt a substance as GRAS. One, you can list the substance in
your own regulations; is that correct?
Ms. Tarantino. Yes. That has nothing to do with the food
contact substance part, but go ahead.
Mr. Whitfield. OK. All right.
Well, on the approval of the GRAS substances, let me talk
about that. You can adopt that yourself in your own
regulations?
Ms. Tarantino. Right.
Mr. Whitfield. Or you can rely on industry self-
determination of the substance.
Ms. Tarantino. Correct.
Mr. Whitfield. Or you can make this substance the subject
of a GRAS notice.
Ms. Tarantino. Correct.
Mr. Whitfield. Those are the three options available; is
that correct?
Ms. Tarantino. Correct.
Mr. Whitfield. OK. I have no further questions. Thank you.
Mr. Stupak. Hearing nothing further from the Members, this
panel will be dismissed. Thank you.
Mr. Stupak. Our second panel of witnesses will be Mr. Mike
Picchietti, the president of Regal Springs Trading Company and
a member of the American Coalition for Tilapia; Ms. Nancy
Donley, president of the S.T.O.P. Organization, which stands
for Safe Tables Our Priority; and Ms. Wenonah Hauter, executive
director of the organization of Food & Water Watch.
It is the policy of this subcommittee to take all testimony
under oath. Please be advised that witnesses have the right,
under the rules of the House, to be advised by counsel during
your testimony.
Do any of you wish to have counsel?
The witnesses have indicated not. Therefore, I will ask you
to please stand and to raise your right hands to take the oath.
[Witnesses sworn.]
Mr. Stupak. Let the record reflect all witnesses answered
in the affirmative. They are now under oath, including with
their opening statements.
We will go with Mr. Picchietti for your opening statement
for 5 minutes. Your full statement will be part of the record.
STATEMENT OF MIKE PICCHIETTI, PRESIDENT, REGAL SPRINGS TRADING
COMPANY MEMBER, AMERICAN COALITION FOR TILAPIA, BRADENTON, FL
Mr. Picchietti. Thank you, Chairman Stupak, Ranking Member
Whitfield and members of the subcommittee, for the opportunity
to testify regarding the consumer deception with tilapia fish
that have been artificially colored using carbon monoxide.
Throughout the United States, frozen carbon monoxide-gassed
tilapia fillets are routinely being removed from import
packaging and placed into fresh seafood counters to be thawed
out and sold as refreshed or previously frozen or simply,
unethically, as fresh tilapia fillets. The misidentification
and the total lack of identification of carbon monoxide as an
ingredient is now widespread for tilapia, and from what I've
learned today, there is no ``use by'' date in the fresh
counters at all.
The issue that unites this group of competitors, our ad hoc
coalition, that produces approximately 80 percent of fresh
tilapia fillets for the U.S. market is the impact that carbon
monoxide-gassed tilapia is having on our businesses and on the
potential of long-lasting harm on the current positive image
that tilapia has on the market.
We are here today because of our concern in losing the
trust and confidence for tilapia with the American consumer
because of this disguised practice of keeping the knowledge of
carbon monoxide as an ingredient from the consumer. What
concerns us is that the American consumer is not aware of what
they are buying and eating. How could they be if it is not
labeled? Most Americans realize that carbon monoxide is a very
common poison, and therefore, using it as an ingredient is
alarming.
According to the current United States National Marine
Fishery Service import statistics, 125 million pounds of frozen
tilapia fillets have been imported from China into the United
States through August of this year. Members of the American
Coalition for Tilapia estimate that at least 70 percent of this
volume of product is gassed with carbon monoxide. Therefore,
that's about 88 million pounds of frozen carbon monoxide-gassed
fillets that have been consumed by Americans so far. That's
approximately 176 million meals of carbon monoxide-gassed
tilapia that have been consumed in the first 8 months of this
year.
To illustrate industrywide uneasiness surrounding this
trade in carbon monoxide seafood products, buyers and sellers
use a kind of code terminology to identify trade of the
product. Names like ``cold-smoked,'' ``izumidai,'' ``sashimi
grade,'' and ``CO'' are all used to identify carbon monoxide-
treated product rather than using the correct name to identify
carbon monoxide. At the consumer level every attempt is made to
keep the identification disguised at the point of purchase.
Given all the exotic names, the ingredient is nothing more than
the carbon monoxide molecule.
Without using CO, frozen tilapia fillets turn brown when
thawed out just like fresh fillets do in the natural aging
process. From a competitive standpoint, frozen tilapia fillets
produced in China are much cheaper than fresh tilapia fillets
produced in the Americas, frequently by as much as 75 percent
less. Thawing out CO-gassed Chinese frozen tilapia fillets for
sale in the fresh counter has become one of the most profitable
seafood items in the category.
Fresh fillets from our coalition cost more to produce and
to deliver because we deliver by expensive airfreight, rushing
to beat the negative impact of time and temperature on the
shelf life of our product. Our products are untreated and more
perishable because they are never frozen. We have to rush to
maintain the red and natural fresh colors without the aid of
preservatives like carbon monoxide treatments. If a vendor can
simply use carbon monoxide on a cheaper product without the
risk of a consumer's asking questions about the ingredient
because there is no label, why buy true, fresh tilapia?
We understand the right of choice and the effort of the
vendors to provide value to the consumer. The cost advantage of
frozen product will provide ongoing sales for Chinese tilapia.
We feel Chinese frozen tilapia sales will continue to find a
healthy growth without the need for using carbon monoxide. We
have no problem with that. America needs low-cost fish to meet
the demands of a healthy diet and the decreasing wild catch.
What we find objectionable is competing on an uneven
playing field against a product that is chemically enhanced and
then unlabeled so the consumer will misperceive the ingredient-
enhanced bright pink or red color as a sign of freshness, which
is far from the truth.
This deceptive practice has been going on for 10 years. The
American Tilapia Association visited the Food and Drug
Administration in the spring of 1998 to protest this carbon
monoxide fraud. During the meeting with the FDA's Office of
Seafood, arranged by the National Fishery Institute, the FDA
indicated that it did not consider carbon monoxide in seafood a
public health risk, but they understood that economic fraud
could take place. They concluded that they did not have the
manpower to enforce the law, and so the issue was one that
producers would have to deal with. I was personally present at
the meeting and have witnessed the development of this issue
for the last 10 years. It has taken 10 years for someone inside
the Government to finally ask the same questions about carbon
monoxide in seafood.
Following the FDA's recommendation of nearly 10 years ago,
we made repeated attempts to address the issue from within the
industry. In our opinion, it's clear the problem will not be
solved voluntarily from within the industry. The market has
grown so large and so profitable that producers using carbon
monoxide are unwilling to voluntarily forego these easy
profits. There is no risk since there is no enforcement or
clarity on the labeling laws. It has been a domino effect.
Vendors are pressured to sell these CO products to remain
competitive.
We believe the best way to protect the American consumer is
either to legislate effective labeling or to ban this carbon
monoxide use in tilapia, because enforcement has proved
impossible. We fear the worst case, that the American consumer
will place a blanket of distrust over all tilapia products if
this carbon monoxide issue continues its disguised status. The
consumer would be justified in seeking revenge against an
industry that was unable to control such massive fraud.
The bottom line is that this carbon monoxide GRAS approval
is a passport for fraud. The wholesome image we worked so hard
to establish for tilapia could be destroyed by this deceptive
practice. We hope the investigations will shed light on this
practice so we can find a solution before it's too late.
Thank you.
[The prepared statement of Mr. Picchietti follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Stupak. Thank you.
Ms. Donley, your opening statement, please.
STATEMENT OF NANCY DONLEY, PRESIDENT, SAFE TABLES OUR PRIORITY,
NORTHBROOK, IL
Ms. Donley. I would like to thank you, Chairman Stupak and
members of the subcommittee, for giving consumers an
opportunity to weigh in on a subject that is critical to our
very existence, and that is the safety of our food.
My name is Nancy Donley, and I am the president of
S.T.O.P., Safe Tables Our Priority. S.T.O.P. Is a national
grassroots, nonprofit organization whose mission is to prevent
illness and death from pathogens in the food supply. Our work
involves sound policy advocacy, building awareness of food-
borne risk and its management, and providing victim assistance.
I personally became involved in food safety after the death of
my 6-year-old son Alex from E. coli O157:H7 poisoning in 1993.
It is very important to emphasize that modified atmospheric
packaging systems, or MAPs, have been used for years. The
traditional MAP system for meat includes the use of carbon
dioxide and nitrogen, which provides an antimicrobial benefit.
The current debate centers on the addition of small amounts of
carbon monoxide into this mix. Adding carbon monoxide creates a
chemical reaction that changes the color of the meat to a very
bright red. That color change is maintained indefinitely until
the package is opened. This unnatural but appealing color
change is the sole purpose for adding carbon monoxide into the
process. The addition of carbon monoxide does not contribute
any additional antimicrobial properties to its traditional MAP
system using carbon dioxide and nitrogen.
Meat packaged with carbon monoxide might be very unsafe,
but the consumer would never question this because of its
artificial bright red color. Microorganisms, including deadly
pathogens, breed whenever there is a breach in the cold chain.
Meat will turn brown or gray if it has been temperature-abused,
something that consumers know to look for. However, meat
packaged with carbon monoxide will still appear bright red and
safe even after extreme temperature abuse. High pathogen levels
could be present, putting the consumer at risk of serious food-
borne illness.
A change in color also keeps the entire food system honest.
Meat processors, storage facilities, transportation carriers,
and retail establishments have strong incentives to maintain
the cold chain because otherwise the product is easily
identified as compromised, rendering it unsalable. That safety
check disappears with meat that always remains red regardless
of extreme temperature abuse.
Proponents of using carbon monoxide argue that consumers
would be warned via an odor if the product were spoiled. We
have two concerns with this. There are people with compromised
olfactory senses who may not notice an off-order. Seniors often
experience this, and they are one of the populations most at
risk of contracting the most severe forms of food-borne
illness. Odors are only detectable once the package is open,
which doesn't occur until the purchaser has brought it home.
The customer has the choice to return it, which is a hassle, or
to throw it away. In each case the customer has been cheated.
These and other factors all point to the need for labeling
any meat that has been packaged using carbon monoxide.
Consumers have the right to know what processes and additives
have been used in the food they purchase. Full disclosure is
necessary. In this case the label would need to state that
carbon monoxide was used in packaging, which causes meat to
artificially maintain a bright red color. It should also state
that the customer must heed the ``use by'' or ``freeze by''
date listed and not rely on color, and that to do so is unsafe.
Color is a tool heavily used by consumers to judge if their
meat is fresh and safe. We are concerned that people will
choose to eat meat that has been packaged using carbon monoxide
after the ``use by'' date because they don't want to throw out
what appears to be a perfectly fine-looking $10 steak; hence
the need for clearly worded information to minimize this risk
from happening.
Lastly, I want to comment on the process used by the FDA
and the USDA to grant GRAS status to meat packaged with carbon
monoxide. First and foremost, we believe that this is a color
additive issue that should have gone through a general
rulemaking process, but, obviously, this did not happen.
Regardless, the way that our regulatory agencies handle these
GRAS petitions cause us deep concerns. I am neither a scientist
nor a statistician, but even I can tell after looking at this
study submitted to the FDA and to the USDA by the companies in
support of their petitions that sound science was not used.
The number of samples of ground beef used was
extraordinarily small. For instance, they only used six in one
study and 15 in the other. In each study all of the samples
were taken from one plant at a single point in time. The
temperature abuse study was done at 50 degrees Fahrenheit,
which is far colder than even room temperature, and last is
that the sampling was done at the point of production rather
than on retail product that had passed through the cold chain.
The FDA itself has acknowledged that temperature abuse is
common throughout distribution and retail markets. As a
consumer who relies on our Government to evaluate processes
used on the foods I feed my family, I'm appalled. The FDA and
the USDA need to revisit these GRAS approvals and also need to
reevaluate how they accept the science of companies seeking to
use new additive and food technologies.
Thank you for your attention. I'll be happy to answer any
questions.
[The prepared statement of Ms. Donley follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Stupak. Thank you.
Ms. Hauter, your opening statement, please.
STATEMENT OF WENONAH HAUTER, EXECUTIVE DIRECTOR, FOOD & WATER
WATCH, WASHINGTON, DC
Ms. Hauter. Good morning, Chairman Stupak, Ranking Member
Whitfield and members of the subcommittee.
I am Wenonah Hauter, executive director of Food & Water
Watch. We're a consumer advocacy group located here in
Washington, DC. Regrettably, we're spending more and more of
our time watchdogging the Federal agencies that are supposed to
be protecting our food safety.
I appreciate the opportunity to participate in this hearing
because we are outraged that the FDA is putting the economic
interests of the industry before the health and safety of
consumers. We expect industry to maximize profits. We expect
the Federal agencies to protect the citizens of this Nation.
Color is one of the most important factors for a consumer
in determining that meat is fit to eat. In 2003, a study was
prepared by the National Cattlemen's Beef Association showing
that U.S. retailers lose about $1 billion each year in fresh
beef sales because of discoloration, and that's what this is
all about. Let's be honest. This is about making sure that
consumers will buy old meat that may be contaminated. At worst,
it's dangerous; at best, it's a consumer rip-off.
Now, I've brought my own package of meat today, and we sat
here this morning and heard that it's OK that the meat is still
pink even though this meat was purchased on October 27, had a
``sell by'' date of October 31 and has been sitting out for 2
days, but we heard it was OK because there is a ``sell by''
date. This ``sell by'' date is so small that I can hardly see
it with my progressive lenses, and an elderly person would not
be able to see it. This is deceptive packaging.
Meat that's processed within a store butcher shop and that
is wrapped for display in meat cases normally has a shelf life
of 4 to 5 days. Case-ready meat that's packaged with modified
atmospheric packaging that doesn't have carbon monoxide has a
shelf life of 10 to 12 days, but the U.S. Department of
Agriculture has approved a ``use by'' date of 28 days for
ground beef and 35 days for muscle cut beef that's treated with
carbon monoxide. Month-old meat is not fresh, in my opinion.
Now, we've heard extensively about GRAS this morning, and
we agree with the other speakers on this panel. This process
needs to be reviewed and changed.
Second, since carbon monoxide imparts a new color to the
meat that's treated, we believe that the FDA should have
considered this technology to be a color additive under the
Federal Food, Drug and Cosmetic Act.
Third, we believe that the use of carbon monoxide for red
meat products is a violation of the Federal Meat Inspection Act
because the USDA is allowing adulterated products into commerce
since they have not been properly approved and with the use of
a color additive, and it makes the product look better or of a
greater value than untreated products.
Fourth, the FDA did not conduct any consumer research to
determine whether there would be any issue with deception from
this technology.
Fifth, the USDA inexplicably reversed its position on
allowing this process to be used on red meat products, which
we've heard about this morning.
Now, consumer organizations have done research about how
consumers feel about the carbon monoxide treating of meat. The
Consumer Federation of America used a public opinion research
firm, Opinion Research Corporation, and they found three out of
four consumers, or 75 percent, are very concerned or are
somewhat concerned about the practice of adding CO to meat to
make the meat appear bright red. Over three-fourths of
consumers, 78 percent, said that the practice of treating red
meat with CO is deceptive.
In the July 2006 issue of Consumer Reports, the Consumers
Union reported findings on red meat that had been treated with
carbon monoxide. The Consumers Union scientists tested 10
packages of ground beef and steaks that had been treated with
CO, and they found that even though the meat appeared to be
red, some of the meat samples had spoiled or had bacterial
counts that were close to indicating spoilage. By their ``use
by'' or ``freeze by'' dates, seven samples were fresh, but two
packages of ground beef from one company were spoiled.
We have attached this information to our testimony, and we
hope that this committee will continue investigating this. We
believe that this practice should be banned.
Thank you.
[The prepared statement of Ms. Hauter follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Stupak. Thank you.
We will go to questions. Let me start with you, Ms. Hauter.
You indicated you had your study done, but did you ever hear of
a study where they considered consumers and how they purchase
their meat products or seafood by a ``use by'' date? Are you
aware of any study like that?
Ms. Hauter. No, I've never heard of such a study.
Mr. Stupak. Thank you.
In your study, did you have any baseline to see what the
respondent's knowledge was of carbon monoxide used in meat
before your survey?
Ms. Hauter. No. This was a Consumer Federation of America
study, and as far as I know, they didn't look at this issue. In
fact, I think that the reason Members of Congress are not
hearing from their constituents is, I would bet, that almost no
one knows about this.
Mr. Stupak. In your study what was the significance of your
findings? You mentioned your meat there, and on the far left--
my far left, your far right--there is actually hamburger that
was just purchased here on November 10 with an expiration date
of yesterday. So give me the significance of your findings of
your study there.
Ms. Hauter. Well, people don't want this kind of deceptive
packaging, and it's by a very large percentage.
Mr. Stupak. OK. Ms. Donley, you used the words ``cold
chain'' in your testimony. Is that the temperature of meat and
how it's processed? Do you want to explain that a little
further?
Ms. Donley. The cold chain is the various points along the
route from production all the way through to the retailer where
there has to be a cold enough temperature maintained to keep
bacteria from breeding. So the chain would include warehouses
and trucking companies where we're counting on all of those
points to maintain that temperature, that safe temperature.
Mr. Stupak. You also indicated the ``use by'' date. Do you
believe that's a valid notification to consumers?
Ms. Donley. No, I don't, because consumers really use their
eyes to make their decisions, and there is going to be the
person who is going to say, ``Hey, there must be something
wrong with the date. This looks perfectly fine. I'm going to go
ahead and eat it,'' who can put himself or herself at serious
risk of food-borne illness.
Mr. Stupak. OK.
Mr. Picchietti, if I may, you were talking about tasteless
smoke in your testimony, but you gave it other words. What were
the other names you were using?
Mr. Picchietti. Well, I wasn't talking about tasteless
smoke. I was talking about industrial carbon monoxide. The
other names I mentioned are----
Mr. Stupak. So are these names that have to be on packages
of tilapia, these other names?
Mr. Picchietti. Some of them are.
Mr. Stupak. What are they?
Mr. Picchietti. Izumidai, which is a Japanese word used in
Japan, I guess. It signifies CO. Everyone knows.
Mr. Stupak. All right.
Mr. Picchietti. Cold-smoked--of which that's something
else; actually, that's done to salmon, I believe, but the main
thing is that's just not mentioned is ``carbon monoxide.''
Mr. Stupak. Nor would it trigger the thought in a
consumer's mind that this is carbon monoxide.
Mr. Picchietti. Yes. Exactly.
Mr. Stupak. Let me ask them to put those pictures up.
Do you want to explain the pictures that we were talking
about earlier? I actually had one up, and Mr. Burgess sort of
objected to it. It was the guy with the respirator who was
spraying the fish.
Mr. Picchietti. Well, that's just how it's done.
Mr. Stupak. Let's see if we can get one of these pictures
up. If you can get those up for us, because I want to ask you a
couple of questions about it. OK. Here is the picture I had up
before it was objected to.
Could you explain what that is and what's going on there?
Mr. Picchietti. Well, when the fish is filleted, they are
put in like a cookie tray, and then a big plastic bag is put
around it, and it's like filling up a balloon. You put the pure
carbon monoxide gas, industrial gas, into the bag for an hour
or so, and the hemoglobin has an affinity to it. It gets inside
the hemoglobin, and it turns the fish red, actually a different
color than the actual red normally.
Mr. Stupak. I think we have a picture of that. We have a
picture of the fish side by side. One is red and the other is--
--
Mr. Picchietti. Carbon monoxide is poisonous, so it's
dangerous for the workers. In the early days----
Mr. Stupak. That's why the respirator?
Mr. Picchietti. Yes, that's why the respirator.
Mr. Stupak. Right here, is this--no. There's carbon
monoxide, and there's naturally aged.
Mr. Picchietti. Right. That would be both frozen products,
the same age thawed out, and one looks like that, and that's
what normal frozen would look like.
Mr. Stupak. But the redness, that's brought out by the
carbon monoxide?
Mr. Picchietti. Yes. And you can see it's actually not even
natural red; it's very heightened. So, with the discussion
earlier about additive/fixative, it seems like an additive.
Mr. Stupak. Now, you and your companies go with the fresh
tilapia. You say that it is more expensive, of course, because
you get the fish, and you've got to fly it, right, air express?
Mr. Picchietti. Yes.
Mr. Stupak. Where is most of your fish produced, grown?
Mr. Picchietti. The coalition's fish is all from Latin and
Central America.
Mr. Stupak. OK.
Mr. Picchietti. It's fresh because it's closer. Asia, at
least now, can't fly it over.
Mr. Stupak. How long would you consider the product to be
fresh? How long will it last?
Mr. Picchietti. Oh, 10 to 14 days from harvest.
Mr. Stupak. OK. You come in from Latin America or Central
America, you said. What ports do you have to bring your tilapia
into?
Mr. Picchietti. Miami, Boston, Los Angeles. Mostly Miami.
Our farm is only an hour and a half from Miami.
Mr. Stupak. I have no further questions at this time.
Mr. Whitfield for questions.
Mr. Whitfield. Thank you, Mr. Chairman.
I want to thank this panel for your time and for being with
us this afternoon.
Mr. Picchietti, in your testimony, you talked about 125
million pounds of tilapia that's imported into the country; is
that correct?
Mr. Picchietti. Well, as of August.
Mr. Whitfield. Now, is that coming in from China, or does
that include the tilapia that you all bring in from Central
America.
Mr. Picchietti. No, it doesn't include that. I had a graph
up there which showed what we all brought in.
Mr. Whitfield. OK. So the 125 million pounds is coming from
Asia.
Mr. Picchietti. That's just China which is about 85 to 90
percent of----
Mr. Whitfield. Do you have any idea how many millions of
pounds of tilapia is consumed in the United States in a year?
Mr. Picchietti. Yes. One pound per person. We surpassed cod
and catfish in 2006, 350 million pounds.
Mr. Whitfield. Now, to make sure that I understand, are you
claiming that using carbon monoxide is a safety issue, or is it
basically an unfair trading practice and deception.
Mr. Picchietti. Well, I don't have all kinds of scientific
data about the safety issue.
Mr. Whitfield. Yes.
Mr. Picchietti. What I do know is it's not labeled, and the
fellow today said it has to be labeled, and it's not being
labeled in the fresh case.
Mr. Whitfield. When you say ``not labeled,'' do you mean
used by a certain date?
Mr. Picchietti. Well, basically the FDA fellow said you can
use the CO tilapia as long as it has a ``use by'' date on it.
Mr. Whitfield. Right.
Mr. Picchietti. The other thing is at the fresh seafood
counters in grocery stores, there's no ingredient label either.
So those are the two issues we're objecting to, which is that
we feel it should be labeled in the fresh seafood case. We
never thought of the ``use by'' date.
Mr. Whitfield. Yes. So, from your perspective, it's really
an unfair situation because of the issues that you discuss in
your testimony primarily.
Mr. Picchietti. Well, it's illegal, right? That's what this
fellow said today.
Mr. Whitfield. Yes, it is illegal. It's on the books. So,
if that's occurring, then it needs to be enforced in some way.
It's an enforcement issue, right.
Now, Ms. Hauter, you're the executive director of Food &
Water Watch. How old is Food & Water Watch?
Ms. Hauter. We're 2 years old, but we're a spin-off from
Public Citizens where, for 10 years, we ran a food safety
program.
Mr. Whitfield. Do you have dues-paying members?
Ms. Hauter. Yes, we have dues-paying members.
Mr. Whitfield. Would those be companies, or would those be
individuals.
Ms. Hauter. We take no corporate money, just public
support.
Mr. Whitfield. Just donations from individuals.
Ms. Hauter. Donations and foundation money.
Mr. Whitfield. Yes. OK.
Now, back in September 2006, in tab 26 of the booklet
there, which you can look at if you want to--you don't have
to--the Consumer Federation of America did a survey, and they
asked consumers what are some of the issues that they used to
decide which products to purchase, and the No. 1 item that they
looked at in making a decision to purchase was the ``use by''
or the ``sell by'' date; No. 2 was packaging/appearance; No. 3
was smell; No. 4 was color; No. 5 was texture; No. 6 was taste.
I know there has been some testimony today that the one item
that consumers look at most is color, yet according to this
survey conducted in September, the No. 1 issue that they looked
at was the ``sell by'' date.
Would you disagree with that, or are you aware of that?
Ms. Hauter. I think that a ``sell by'' date is different on
different kinds of products. When you, for instance, purchase
milk, the ``sell by'' date is kind of up there at the top. It's
large. Everybody looks at it. I think it--I know that you can't
see this, but if you look at a ``sell by'' date that is so
small that it's under all of the information about safe
handling, people would not notice this when you pick up a----
Mr. Whitfield. So, if the ``sell by'' date would be larger,
that would make it easier for you to accept?
Ms. Hauter. I think it's important to have a ``sell by''
date----
Mr. Whitfield. Oh, I do, too, absolutely.
Ms. Hauter. But I think it's also, for meat, that
traditionally people look at the color, and I think if you were
going to actually do research on this, you would have to look
product by product to see how people purchase items.
Mr. Whitfield. Now, in your ConsumerReports.org that you
submitted earlier in tab 41, I guess, you reported that you all
did limited tests on carbon monoxide-packaged meat, and you
found that three out of 10 samples had gone bad within the
``use by'' date. I'm assuming you've seen this report. I would
ask: Do you know if Consumer Reports tested traditionally
packaged meats as well?
Ms. Hauter. I'm not sure if they did or not. I can't answer
that.
Mr. Whitfield. Now, I understand that the shelf life of
traditionally packaged meat is shorter than the carbon monoxide
MAP-packaged meat. So, if that's true for the MAP carbon
monoxide-packaged meat, I would think it would also, maybe,
even be a worse case for the traditional package. Do you have
any thoughts on that?
Ms. Hauter. Could you restate that? I didn't understand.
Mr. Whitfield. Well, what I said was in your report, you
all point out that three out of the 10 samples of carbon
monoxide-packaged meat had become contaminated prior to the
``use'' date's expiring.
Ms. Hauter. Right.
Mr. Whitfield. They evidently did not do any testing of
traditionally packaged meat, which most studies indicate does
not last as long in the shelf life as the carbon monoxide meat.
So I would say that if they had been fair on this test and had
tested both samples, it's more than likely that the
traditionally packaged may have turned out worse than the
carbon monoxide meat.
Ms. Hauter. But I think, sir, with all due respect, the
point is that with regular packaged meat, there will be
discoloration, but with carbon monoxide-treated meat, there
will not be discoloration, and so consumers won't realize that
there may be contamination. The longer meat sits, and when
there's bacteria on it, which there almost always is, the
bacteria continues to multiply, but a consumer would not be
aware of it or is likely be aware of it when the meat is still
pink and pretty like this.
Mr. Whitfield. Now, let me ask both you and Ms. Donley,
because I know that you both are committed to this issue, and
all of us are very much concerned about food safety, obviously.
Do you have the names of anyone who has been sickened by
spoiled meat that was masked by carbon monoxide?
Ms. Hauter. Well, I think it's very difficult to determine
when or how people get sick from meat, and I think we would
have to go to the CDC and see if they have been able to--in the
information they collect, if that's one of the questions they
ask, because I'm not sure that we would be aware, when people
do get sick, that it was because of carbon monoxide.
Mr. Whitfield. But you're not aware of anything
specifically?
Ms. Hauter. I'm not aware of anything specifically.
Mr. Whitfield. What about you, Ms. Donley?
Ms. Donley. I'm not aware of anything specifically either,
but then again, someone who had become sickened probably would
not be aware either that it was from the packaging, the process
by which it had been packaged, because there is no requirement
even to say how it was processed, so a person wouldn't know.
Mr. Whitfield. Do you all have the names of any companies
or supermarkets that purposely have sold bad or spoiled meat to
consumers?
Ms. Donley. I can't imagine any supermarket's wanting to
intentionally sell spoiled meat. It may have unknowingly sold
spoiled meat, but I can't imagine anyone doing that
intentionally.
Mr. Whitfield. But you do feel like, if they're using
carbon monoxide, that it is a deceptive practice?
Ms. Donley. Definitely.
Mr. Whitfield. OK. Ms. Donley, you testified about breaking
the chain of refrigeration, warning that a consumer will not
know by color or by the ``use by'' date whether meat has been
temperature-abused at the store or elsewhere.
How does a consumer know that opaque packages, such as
sealed hamburger packs or wrapped sausage, have not been
temperature-abused?
Ms. Donley. They don't. You bring up an excellent point,
and I wish that the technology would be used that shows that
the temperature has been compromised. There are--I can't come
up with the term right now--devices that can be used in a
package that would show it. So I think it's an excellent idea
that all meat contain that.
Mr. Whitfield. Now, you all heard testimony earlier today
about scientific studies conducted at the University of
Georgia, the University of Minnesota, and Texas Tech in which
the consensus was, in scientific opinion, that MAP packaging
using carbon monoxide was not a safety hazard.
Do you all have any scientific studies indicating that
those studies are inaccurate?
Ms. Donley. I don't have any studies that my organization
has done of their own.
I would like to say, though, that it's important to take a
look at what is being compared in those studies. For instance,
I know that some of the referrals that have been made to Dr.
Doyle, who is a very good scientist from the University of
Georgia, that what he reported on--and it's not even a
published study, to my knowledge--but what he took a look at in
his research centered on looking at meat that--at samples that
had been wrapped in just the regular overwrap process, and he
compared that to meat that had been in the MAP process using
the CO. So it's really an apples-and-oranges comparison.
Mr. Whitfield. But the consensus of scientific opinion is
that this is not a safety hazard, and you all are not aware of
any additional scientific studies that would refute that is I
think what you testified to.
Ms. Donley. I think we need to define here what I'm talking
about as far as safety. And what I'm referring to that is that
I think it--pretty much it seems to be the general consensus
among the scientists that this is not an issue that is going to
do something to render the meat itself unsafe. But the safety
factor enters into it is how it appears to people when
temperature abuse could have happened, but the act in and of
itself or the process in and of itself is not unsafe.
Mr. Whitfield. Mr. Chairman, I think my time has expired.
Mr. Stupak. Thank you.
There is a company that has labels that will turn colors if
the temperature is abused.
Ms. Schakowsky for questions, please.
Ms. Schakowsky. I just wanted to comment on that. It is not
that the CO necessarily is the defect, but that it masks other
problems that may exist and may present a safety hazard. So I
can't imagine a study that would show in and of itself that the
CO was the problem, and that's the problem.
I wanted also to mention--I wanted to respond to something
Mr. Whitfield said about the ``sell by'' date or a date on a
product. I think that--I'm very proud of those dates. I feel
like in 1969 our little group of housewives helped to get that
on there. But you look at those dates primarily when you don't
have other indicators. If you're going through the meat case,
and you see something that looks fine, you may be prone to buy
it. When you look at the date, it is because it doesn't look
right, or you can't see through it, like milk or something, I
think.
I wanted to--there are a couple of things. One, I wanted to
comment--Mr. Picchietti--sashimi grade was another. I love
sashimi, and if I saw sashimi grade--I think I have seen
sashimi grade on something. I think that is a good thing
because I didn't know that, that it meant that it was treated.
I think those names are really deceptive. And for me,
particularly sashimi grade, I had no idea. I thought it was a
positive because I like sashimi. I just wanted to let you know
that. So I'm agreeing with your testimony.
Mr. Picchietti. I'd just like to clarify that it is a real
term used for real sashimi grade products. But as in the trade
and among buyers and sellers, when you say is your tilapia
sashimi grade, it is usually understood that it has got
industrial carbon monoxide in it.
Ms. Schakowsky. Not being in the industry, in the business,
I certainly wouldn't know that.
I wanted to ask Ms. Donley a question. You were saying that
you thought that the process was faulty, but also that had it--
were it called a color additive, that the process would be
entirely different. Could you explain that?
Ms. Donley. Sure. First of all, it is great to see you
again, Congresswoman.
If this had been determined, which we think it should have
been determined, that this was a color additive, it never would
have been subject to GRAS approval. It would have gone through
a formal rulemaking process, and it would have been open for
public comment, and that a lot--all of this--it would have
fleshed out additional science. It would have fleshed out
consumer concerns and been a much better process than what
actually happened here.
Ms. Schakowsky. In any case, I think that there ought to
have been a regular rulemaking process so that there was a
comment period. And I agree with you, Ms. Hauter, that people
don't know--I don't know. Maybe it is a lot of men who don't
shop, frankly, who are making these comments. Excuse me, guys
who go to the store and actually shop. But, I think most people
actually are unaware that--and I wanted to ask you about
relying on industry data. If you could expand on your comments
on that.
Ms. Hauter. We just generally have a concern when industry
data is used because they have a bias, and the questions that
are asked may be different than the questions that we would
ask. We think that it is generally a problem----
Ms. Schakowsky. Were you satisfied--were you here when the
FDA was testifying?
Ms. Hauter. I was here, and I thought that they were not
able to answer the questions that they should have been able to
answer. And I know from our experience--we just did a very
extensive report on imported fish that we had to wait over a
year to get our Freedom of Information Act request answered,
and when the data came to us, it was in such poor shape that we
couldn't use it and had to have it manipulated to----
Ms. Schakowsky. When it is old, it gets decomposed.
Ms. Hauter. So I was not surprised. And that has been our
experience and our concern about the FDA.
Ms. Schakowsky. Well, this committee has asked for
information. You have asked for information. The FDA has failed
to act for over 10 years. So timeliness in dealing with all of
these is a problem.
And I also recognize the competitive issues as well. I want
fresh fish. I don't want fresh-appearing fish. And you would
know the difference in colors, but I wouldn't know that it is
too red or not too red.
I think we have to resolve this for safety and for
deceptive--consumer deception reasons. Thank you.
Mr. Stupak. Thank you.
Ms. Donley, you were asked--Mr. Whitfield and others asked
about the studies in temperature. In the exhibit book, they are
exhibit 30 and 31. I had asked--and you have it right in front
of you there. I asked the FDA about these studies. One was from
Minnesota, the other one was Norway. The Norwegian study on
page 218 says the safety of the modified atmospheric packaging,
products are mostly threatened by temperature abuse. And if you
go to exhibit No. 30, again that study, which is out of the
University of Minnesota, says temperature abuse is a main
concern for chilled and/or modified atmosphere packaging, meat
and poultry products, since it will not likely cause economic
loss, but may also lead to food-borne illness hazard. A major
question of such products is whether spoilage due to microbial
or chemical action will occur before pathogen numbers or toxic
levels become a risk when a product undergoes abuse
temperatures.
So is that the temperature or the code part that you were
talking about?
Ms. Donley. Right. That is the cold chain process. And
anywhere along those points, if the temperature is raised
higher than what it should be to keep bacterial growth from
occurring, bacteria has a way of multiplying very, very
rapidly.
Mr. Stupak. Let me ask this question. Ms. Hauter, you have
your package there. Right there we have samples E, F and G on
your extreme left and my right. Take a look at those samples.
What do they look--appear to you, E, F and G?
Ms. Donley. These three?
Mr. Stupak. Yes, the three on the end.
Ms. Donley. They look very, very fresh to me. And I think--
if I might, when we talk about these ``use by'' or ``freeze
by'' or ``sell by'' dates, I think consumers look at those
dates when they are making their purchase. When I go to the 7-
Eleven next to my office and I buy my sandwich, I look to see
when it was prepared on so I'll buy the one that was prepared
most recently. The consumer buys this package of meat, sticks
it in the refrigerator. When they go to use it and it looks
that color, they're not even going to--it is not going to occur
to them to even look to see that ``use by'' date because it
looks perfectly fresh.
Mr. Stupak. Ms. Hauter, do you think E, F and G look fairly
fresh?
Ms. Hauter. They look perfectly----
Mr. Stupak. Mr. Picchietti?
Ms. Hauter. They look like they were just cut.
Mr. Stupak. OK. Well, E was purchased on January 12, 2007.
That is, what, 10 months ago. F was purchased 1 year and 8
months ago, and G nearly 2 years ago. Needless to say, they are
temperature-abused, I take it, sitting here, and yet they are
staying fresh-looking.
I have no further questions. Anyone else?
With that I'll thank and dismiss this panel. Thank you.
I call up our third and final panel if we will for today.
The panel consists of Mr. Gregory Page, CEO of Cargill,
Incorporated; Mr. Jeffery Ettinger, chairman, president and CEO
of Hormel Foods Corporation; Mr. Doug Brinsmade of the Anova
Food, Incorporated.
It is a policy of this subcommittee to take all testimony
under oath.
Pleased be advised that witnesses have the right under the
rules of the House to be advised by counsel during your
testimony. Do any of you wish to be represented by counsel?
Everyone indicated no. Therefore, I ask you to stand and
raise your right hand. Please take the oath.
[Witnesses sworn.]
Mr. Stupak. Let the record reflect that all three gentlemen
indicated they are under oath.
We will begin with opening statements. Who would like to
begin?
Mr. Page, you're on my right. If you want to start, please.
STATEMENT OF GREGORY PAGE, CHIEF EXECUTIVE OFFICER, CARGILL,
INCORPORATED
Mr. Page. Thank you, Mr. Chairman and subcommittee members.
You have requested as the chief executive officer of Cargill I
speak to you today about the production of meat products and
Modified Atmosphere Packaging, otherwise and often referred to
as MAP. We in the food science community consider this
packaging to be one of the most important food safety
innovations ever.
Packaging innovations have a long history of improving food
safety. Many advances now seem simple, canned goods,
pasteurization, vacuum packaging and tamper-resistant fresh
food packaging to name just a few. There was a time when the
salt curing of meat was the most advanced technology available,
and it performed fairly well as a critical health protection
for a thousand years or more.
We now know a lot more about food safety and have many,
many more technologies available to help make food as safe and
as accessible to consumers in ways we never imagined. Basic
food science and food safety principles have evolved. And these
principles direct some of the most critical research and
innovation of our product offerings. We know the importance,
for instance, in prohibiting cross-contamination. We know about
the importance of controlling temperature and moisture, of
controlling the oxygen and the interior atmosphere of a
package, and of controlling the pH. We also know that
processing technology, preservatives and additives play a
critical role in consumer protection.
Consumer demands and scientific knowledge also direct
research and innovation. Today's consumers want a wide variety
of perishable items, including produce, fish and meat. They
often want products that can be labeled as natural or organic.
And they want these items to be available at their local stores
year round, 24 hours a day for their convenience. It is this
drive to safely satisfy consumer demand that leads us to the
technologies of today.
Scientists have long known the importance of controlling
the interior atmosphere of food packages, and one of the
earliest applications of modified atmosphere packaging was in
1927 when storing apples in an atmosphere of reduced oxygen and
increased carbon dioxide resulted in increased shelf life.
The early understanding and use of gas mixtures led us to
the case-ready systems available today. Beef is typically
delivered to a grocery store in one of three ways, as a box
product sealed in a vacuum package, or as individual packages
with high oxygen or low oxygen-modified atmosphere packages
ready for display in the meat case for consumer purchase.
Boxed, vacuum-packaged product is opened at the grocery store
and cut into steaks or roasts and then wrapped in the store for
retail display. Case-ready products come completely packaged
and labeled and can be taken from a line box and placed
immediately in the retail display. The case-ready system
eliminates the need to open, handle and repackage the product
in the store and greatly reduces the chance of cross-
contamination.
We want consumers to have all the benefits of these
advanced packaging systems. We believe it unfortunate that
there has been misinformation about low-oxygen MAP. We have
seen some retail customers who have found this technology
serves them and their customers best find the need to back away
from it because of public pressure.
We recently had the opportunity to host investigators from
this committee at one of our case-ready plants. We as a company
learned clearly from our guests the important issue concerning
the committee members was the potential that a consumer may not
fully understand that color is not the only indicator of
freshness. For this reason we will be adding wording to our
labeling, pending, of course, USDA approval, to include the
following statement: ``Color is not an indicator of freshness.
Please refer to `use' or `freeze by' dates.'' We believe this
effectively addresses the concerns expressed by the committee
visitors to our plants regarding the protection of public
health, while not undermining the adoption of the safety and
the convenience afforded through this case-ready packaging
technology.
We stand firmly by our previous statements that color is
not a proper indicator of freshness or safety, and we support
the FDA's and the USDA's decisionmaking. While there are many
foods like eggs, ketchup, salad dressing and carrots that all
maintain their coloration, only observing freshness dates will
tell you when the products are past their peak of flavor or
quality.
My point is this: science should guide our regulatory
decisions. Consumers suffer a great disservice when competitive
pressures drive a debate that leads consumers away from the
superior food safety and freshness performance inherent in the
packing we are discussing today.
I'm sure the individuals in the salted meat industry were
discouraged when new innovations led to canning and ultimately
packaging, and I'd relate a story specific to meat. In 1904, a
guild of more than 600 butchers in San Francisco formed the
Butchers Board of Trade, And the purpose of their organization
was to oppose the adoption of ammonia-based mechanical
refrigeration, which was newly being introduced at that time.
Their self-serving opposition would have prolonged the
continued unsanitary use of block ice to chill meat. In fact,
at that time people resisted this pressure, and the adoption of
mechanical, rapid refrigeration of meat was adopted, to the
great benefit of consumers.
Cargill is deeply committed to serving the needs of our
customers. The low-oxygen technology that we've discussed today
is an important evolution in packaging and is but one example
of our commitment.
I'd like to thank this committee for its commitment and
leadership in the area of food safety. I want to recognize the
work of the committee staff and would be pleased to answer any
of your questions to the best of my ability. Thank you.
[The prepared statement of Mr. Page follows:]
Testimony of Gregory Page
Thank you Chairman Stupak and subcommittee members.
You have requested that as the chief executive officer of
Cargill I speak to you today about the production of meat
products in Modified Atmosphere Packaging--known as MAP. We,
and the food science community consider this packaging to be
one of the most important food safety innovations ever.
My testimony today has been crafted with a great deal of
input from our research and development leaders, and since I am
not a scientist, I will be relying on their expertise for any
questions of a scientific nature.
Food Packaging Innovations
Packaging innovations have a long history of improving food
safety. Many advances now seem simple--canned goods,
pasteurization, vacuum packages, and tamper resistant fresh
food packaging, just to name a few. There was a time when the
salt curing of meat was the most advanced package available,
and it performed fairly well as a critical health protection
for a thousand years or so. We now know a lot more about food
safety and have many, many more technologies available to help
make food as safe and accessible to consumers in ways never
before imagined.
Basic food science and food safety principles have evolved,
and these principles direct some of the most critical research
and innovation of our product offerings. We know the importance
of prohibiting cross contamination. We know about the
importance of controlling temperature and moisture, of
controlling the oxygen and interior atmosphere of a package,
and controlling pH. We also know that processing technology,
preservatives and additives play a critical role in consumer
protection.
Consumer demands and scientific knowledge also direct
research and innovation. Today's consumers want a fresh and
wide variety of perishable items including produce, fish and
meat. They often want products that can be labeled as natural
or organic. And, they want these items to be available at their
local stores, year-round, for their convenience.
It is this drive to safely satisfy consumer demand that
leads us to the technologies of today.
Packaging Gases, Food Products, and Food Safety
Scientists have long known the importance of controlling
the interior atmosphere of food packages. One of the earliest
applications of Modified Atmospheric Packaging (MAP) was in
1927, when storing apples in an atmosphere of reduced oxygen
and increased carbon dioxide resulted in increased shelf life.
In the 1930s a modified atmosphere was used in the storage
and transportation of fruit in the holds of ships, and
increasing the carbon dioxide concentration surrounding beef
carcasses transported long distances was shown to increase
shelf life by up to 100%.
Today, nitrogen is probably the most widely used gas in
food packaging. Nitrogen is often used as the principle gas to
flush oxygen out of packages that will be vacuum packed. The
Food and Drug Administration and the United States Department
of Agriculture have long accepted the safe use of nitrogen as a
packaging gas.
As previously mentioned, carbon dioxide has also been
utilized as a key packaging gas. Fresh fruits and vegetables
are often shipped in a mixture of gases, where the carbon
dioxide level plays a key role in both suppressing microbial
activity as well as helping regulate the ripening process which
in turn greatly extends shelf life, and helps guarantee product
safety.
The careful use and application of this gas has long
benefited consumers by helping the produce industry manage
supplies and meet consumer demands. For perishable items, like
bananas, we in the U.S. do not have the climate to produce
adequate quantities to meet demand. Carbon dioxide and other
packaging gases allow the American consumer to become
accustomed to a perpetual supply of fresh fruits and
vegetables. Without Modified Atmosphere Packaging, we would not
have fresh bananas, berries or apples in winter, and packaged
or organic salad greens.
Much like carbon dioxide, gas mixtures containing ethylene
are critical for a wide number of fresh fruits and vegetables.
Ethylene promotes the ripening of apples, avocados, bananas,
citrus, dates, mangos, melons, papayas, pears, pineapples and
tomatoes.
In the context of historical innovations, the use of carbon
monoxide is relatively new. The Food and Drug Administration
approved the use of this gas in 2002. It is used in combination
with carbon dioxide and nitrogen, all of which have important
food safety and freshness properties. Unique to the FDA
approval is that we asked for, and FDA supported, the mandate
that foods packaged in this format must include tamper-proof
freshness dating.
Modified Atmosphere Packaging and Case Ready MeatsThrough a
MAP system, meat is packaged at a central processing plant and
is then delivered to the retail grocery store in a tray covered
with a protective film. This helps eliminate the potential for
cross contamination that can come from human handling both at
the retail store and in the home. The package is both leak-
proof and tamper proof, adding additional consumer protections.
Mr. Chairman, you have recently raised the question that
MAP packaging containing CO may allow meat to retain its
characteristic red coloration for too long, potentially masking
spoilage. I appreciate the opportunity to help ensure that this
technology is more fully understood and to convey our deep
commitment to consumer protection.
Today beef is typically delivered to a grocery store in one
of three ways--as boxed product sealed in a vacuum packaged
bag, or as individual packages with high oxygen or low oxygen
modified atmosphere packages, ready for display in the meat
case for consumer purchase. Boxed, vacuum-packaged product is
opened at the grocery store and cut into steaks or roasts and
then wrapped for retail display. Case ready products come
completely packaged and labeled, and can be taken from a lined
box and placed in the retail display. The case ready system
eliminates the need to open, handle, and re-package the product
in the store, greatly reducing the chances of cross
contamination.
Meat products in a vacuum bag have a shelf life of about 35
days. The shelf life of case ready products will vary depending
on the packaging technology used.
There are two types of case ready MAP product offerings--
those packaged in a high oxygen (high-ox) format and those in a
low oxygen (low-ox) format. We believe that both are good
formats, but the low-ox format, in many respects, has
significantly better functionality, especially in the area of
ensuring freshness and convenience for the consumer.
Steaks and roasts that are packaged in a low-ox environment
have a shelf life roughly equivalent to the 35 days of the
vacuum bag. Steaks and roasts in high-ox packaging have a
shorter shelf life of only 14 or 15 days. You can observe this
shelf life concern not only in meat packaging but also in
produce. As a point of reference, note that the spoilage of a
head of lettuce accelerates rapidly after the packaging is
removed.
The technology in MAP produces a shelf life similar to
packages using vacuum technology. And, it achieves this
equivalent shelf life in a manner that is much more convenient
and appealing to consumers.
Protecting freshness and shelf life are indeed critical.
Beyond preserving freshness and reducing microbial activity,
low-ox packaging also protects against flavor degradation. High
levels of oxygen in a high-ox packaging such as a traditional
tray wrap will deteriorate the flavor of meat. Many university
studies have shown that meat in a high ox package can look
acceptable, but will have a significantly less acceptable
flavor than low oxygen products. Low oxygen packaging helps to
maintain the natural flavor of meat.
There are additional benefits of low-ox packaging. By
giving retailers the shelf life similar to vacuum packages in a
direct to consumer format, small retail stores in both rural
and very urban areas have the opportunity to offer diverse
product lines. The packaging reduces waste, because retailers
can make more efficient purchasing decisions. The packaging is
also more tamper-proof, through the use of imprinted use-by or
freeze-by instructions that cannot be removed.
Oxygen and Product Color
Let me cover just a little bit about the science of our
packaging technology as outlined by our R&D team.
One of the challenges with low oxygen packaging is that the
removal of oxygen has a visual impact on meat coloration. As
you may recall from high school biology, blood appears bluish
when it has not been exposed to oxygen. Once exposed to oxygen,
blood becomes red. This same principle also applies to meat
coloration and MAP packaging.
While substantial food safety benefits are attained in low
oxygen packaging, a dull red to almost purplish discoloration
of the product would make the product unattractive to the
consumer. In contrast, the traditional grocery tray is more
exposed to oxygen, and therefore it appears red.
To gain the functional and appearance performance for low-
ox packaging, we substitute the oxygen with other acceptable
and safe gasses. One of these gasses we use involves a trace
amount of carbon monoxide (0.4 percent). As previously noted,
this is fully approved by the FDA, based on volumes of
scientific study.
As the committee is no doubt aware, many of the leading
food scientists have submitted papers and testimony that show
the superior freshness and food safety performance of this
packaging. I want to note that with all MAP products, the
packaging gas dissipates immediately once the package is
opened. Once the package is opened, product degradation
continues in a manner similar with other opened packaging
systems.
Continual Innovations in Food Safety and Packaging Technology
We want consumers to have all the benefits of MAP. But to
do so, the package must be as attractive as competing products
in the case. We believe it unfortunate that there has been
misinformation about low oxygen MAP. We have seen some retail
customers who have found this technology serves them and their
customers best, find the need to back away from it because of
public pressure campaigns led by a Michigan-based competitor
offering a different technology. As advertised, this competing
technology uses a different method to inhibit oxidation, and
includes a masking effect for flavor. Our technology has no
such feature. We are hopeful that greater understanding of the
facts will help to abate this pressure.
We recently had the opportunity to host investigators from
the House Committee on Energy and Commerce at one of our case
ready plants. We learned clearly that the most important issue
concerning committee members was the potential that a consumer
may not fully understand that color is not the only indicator
of freshness. For this reason, we will add wording to our
labeling, pending USDA approval, to include the statement,
``Color is not an indicator of freshness. Please refer to use
or freeze by dates.'' We believe this effectively addresses the
concerns of the Committee in protecting public health, while
not undermining the adoption of the safety and convenience
offered through case ready packaging.
We stand firmly by our previous statements that color is
not a proper indicator of freshness or safety, and we support
the FDA's and the USDA's decisionmaking. While there are many
foods like eggs, ketchup, salad dressing, and carrots that all
maintain their coloration, only observing freshness dates will
tell you when the products are past their peak of flavor or
quality.
My point is this--science should guide our food regulatory
decisions. A well orchestrated, but non-science based press
campaign, should not. Consumers suffer a great disservice when
competitive pressures drive a debate that leads consumers away
from the superior food safety and freshness performance
inherent in this particular packaging.
I'm sure the individuals in the salted meat industry were
discouraged when new innovations led to canning and ultimately
vacuum packaging. However, consumers were better off, and most
importantly, more safely served as innovations in food safety
and preservation continued.
The need for continual food safety innovations and product
marketing is recognized by all of us. We want our competitors
to continue to innovate. We are going to continue to innovate.
We encourage our suppliers to innovate. Consumers demand it;
food safety demands it; it raises the bar for everyone; and
it's the right thing to do.
Cargill is deeply committed to serving the needs of our
customers. The low oxygen technology that we have discussed
today is an important evolution in packaging technology and is
but one example of our commitment.
I want to thank this committee for its commitment and
leadership in the area of food safety. I want to recognize the
work of the committee staff. I would be pleased to answer any
questions to the best of my ability, and ask that the committee
allow my colleague Dr. Eilert to answer questions of science
that are beyond my expertise.
----------
Mr. Stupak. Thank you.
Mr. Ettinger, please.
STATEMENT OF JEFFREY M. ETTINGER, CHAIRMAN, PRESIDENT, AND
CHIEF EXECUTIVE OFFICER, HORMEL FOODS CORPORATION
Mr. Ettinger. Thank you, Mr. Chairman, for the opportunity
to testify today.
There appear to be many misconceptions about our modified
atmosphere packaging technology, so we appreciate the chance to
explain why we believe so strongly in this product line.
Our company, Hormel Foods, was founded 116 years ago on the
twin principles of innovation and quality. Indeed, our
reputation for quality and wholesomeness is really our most
important company asset. For the past 20 years, we've dedicated
considerable research to the fresh meat case for both pork and
beef. As a result of this research, we contributed to the
design of a low-oxygen packaging system that provides a
fresher, safer product to consumers.
Oxygen is the enemy of many food products, including meat,
because it accelerates spoilage. Grocery stores are replete
with examples of the use of modified atmosphere packaging to
keep products fresh. These include potato chips, cereals, bag
salads, lunch meats and shredded cheese.
In the case of fresh beef and pork, our process controls
the atmosphere in the package to a ratio of 64.6 percent
nitrogen, 35 percent carbon dioxide and four-tenths of a
percent of carbon monoxide. In our GRAS petition, we provided
clear evidence that meat packed in this matter maintains
freshness for up to 35 days. This technology was found
acceptable by the FDA and approved by the Food Safety and
Inspection Service.
Our low-oxygen packaging system has received overwhelming
support from the scientific community because it is both safe
and beneficial to consumers. Mr. Chairman, I have 10 letters
from leading scientists supporting the safety of the
technology. And with your permission, I'd like to submit them
for the record.
Mr. Stupak. Without objection.
Mr. Ettinger. Thank you, Mr. Chairman.
I would like to speak now to the benefits provided to
consumers by this product line. First off, it puts much more of
the available shelf life in the hands of the consumer,
providing the consumer with a fresher, better eating
experience. Second, it is leak-proof, preventing possible
contamination from raw meat in a grocery basket or the
consumer's refrigerator. Third, it eliminates the potential of
cross-contamination at the store. Fourth, it allows for the
packaging and code dating of meat in a temperature-controlled
environment under USDA inspection. And fifth, the packaging is
tamper-resistant.
The main area of inquiry I've heard today relates to the
question are consumers being deceived by the red color. Let me
first lay to rest the notion that we'd deliberately attempt to
deceive consumers by, in essence, coloring bad meat to look
good. All the products sold in this joint venture is branded
with our Hormel brand. The last thing we would do is enter a
category with new product, put our brand on it, and endanger
our overall company reputation by selling bad product.
We do recognize that the inclusion of carbon monoxide in
the package stabilizes the color of the meat. This is why we
put a ``use by'' date on the front of this product in type
three times larger than normal and put another ``use by''
statement on the back. Given the extensive testing we
performed, we were confident that the packaging system would be
beneficial to consumers, and indeed this has been the case.
This product has been in the market now for 3 years, and we've
sold nearly 23 million packages of it. Every package has our
800 number on it. Every package contains a guarantee of
satisfaction. This product has enjoyed one of the highest
levels of consumer acceptance of any product we have recorded,
and we have no documented cases of food-borne illness
associated with this package. So the concern about potential
color confusion is really unsupported by our real-life
experience.
The U.S. Government labeling authority for these products
has determined that our current labeling with its prominent
``use'' or ``freeze by'' freshness date is truthful and not
misleading. Nonetheless, in an effort to address the concerns
about color expressed by subcommittee staff, we have offered
language to modifying the proposed bill that we'd be willing to
adopt, the same language Mr. Page mentioned, and that is,
``Color is not an accurate indicator of freshness. Refer to the
`use' or `freeze by' date.'' In addition, we have informed the
subcommittee staff about ongoing efforts we are making to
improve this packaging and address long-term color change.
We appreciate what the subcommittee is ultimately trying to
do, protecting consumers from harm, and as a trusted American
brand for 116 years, that has always been and will remain our
goal as well. I would be pleased to answer any questions to the
best of my ability. Thank you.
Mr. Stupak. Thank you.
[The prepared statement of Mr. Ettinger follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Stupak. Mr. Brinsmade.
STATEMENT OF DOUG BRINSMADE, PRESIDENT AND CHIEF EXECUTIVE
OFFICER, ANOVA FOOD, INCORPORATED
Mr. Brinsmade. Good afternoon, Mr. Chairman and members of
the subcommittee. My name is Doug Brinsmade, and I'm the
president and CEO of Anova Food, Incorporated. We are a
division of the Anova Food Group. The Anova Food Group is a
global seafood company specializing in sourcing, processing and
distributing the seafood products from worldwide sources. We
supply frozen seafood products to a majority of retailers, food
service distributors and restaurant chains across America under
our patented process called Clearsmoke, of which Blane Olson,
president of Clearsmoke, and I are the patent holders.
Mr. Chairman, I'm here today as a representative of the
seafood industry with 20 years of involvement in the industry
and over 12 years of experience in the use of filtered wood
smoke technology of which natural-occurring carbon monoxide is
part of the wood-burning process. We have utilized filtered
wood smoke technology under full consumer labeling mandated by
the FDA since 1999. We also utilize the U.S. Department of
Commerce NOAA Seafood Inspection Program. These two combined
items with an outstanding corporate quality assurance program
has allowed Anova to sell over 150 million portions without a
single food safety issue. That is over 1,200 container
shipments.
The goal of filtered wood smoke technology is to produce a
frozen-at-source seafood product which is then delivered safely
through frozen distribution to the food service distributor,
supermarket chain, restaurant chain or consumer with a level of
quality that comes as close as possible to the quality of the
seafood item when it is caught.
Filtered wood smoke technology is considered GRAS by the
U.S. Food and Drug Administration because of the longstanding
food safety record of smoked food products. Our Clearsmoke
branded seafood products, as well as other competitors'
products, have maintained an impeccable safety record for the 9
years since the inception of the technology. Since 1999, under
the FDA Import Bulletin 16B-95, the seafood industry has been
mandated to label all seafood products with filtered wood smoke
as processed with filtered wood smoke as a preservative for
color retention. We put this label on each individual package
of our fish and on our primary box the fillets come out of.
We also explain the Clearsmoke filtered wood smoke process
on our retail bags so that the consumer is fully aware of the
process. I have brought a retail bag that fully explains our
process, and I'd like to submit our retail bag and our label to
this subcommittee.
Industrial carbon monoxide is also used by the frozen
seafood industry. It is not the choice of Anova to utilize CO,
but after my 12 years of industry experience, I am willing to
state that if CO is used properly, in moderation and with
integrity, it can be successful. Some of the largest seafood
companies in the United States successfully use industrial
carbon monoxide in their seafood programs. The use of
industrial carbon monoxide is also considered GRAS by the FDA.
All packed seafood items containing CO must be labeled
``processed with carbon monoxide as a preservative for color
retention.''
Both filtered wood smoke and CO have increased the
consumption of seafood since the processes have opened up new
menu and retail opportunities. This has increased the
consumption of seafood which is healthy and a very important
part of one's diet.
We feel that the labeling that we have used in the last 9
years mandated by the FDA is consistent and in line with our
food safety record. We continue to work with the FDA and the
USDC to guarantee that our seafood is processed under HACCP and
all labeling requirements.
I'd like to clarify to the subcommittee that the term
``tasteless smoke'' is a patented process. Both Clearsmoke and
tasteless smoke are filtered wood smoke processes.
I want to thank the chairman and the committee for allowing
Anova Food to come up and present the history of our filtered
wood smoke process. Please let me know if I can answer any
questions you might have.
[The prepared statement of Mr. Brinsmade follows:]
Testimony of Doug Brinsmade
Good Morning Mr. Chairman and Members of the subcommittee.
My name is Doug Brinsmade and I am the President and CEO of
Anova Food, Inc. The Anova Food Group is a global seafood
company specializing in sourcing, processing, and distributing
seafood products from worldwide sources. Anova maintains buying
offices, plants, and operating partnerships in 15 different
countries within Africa, Asia, and South America. We supply
fresh and frozen seafood products to a majority of retailers,
foodservice distributors, and restaurant chains across Europe
and America. Anova has over 100 employees worldwide and handles
approximately 60 million pounds of fish a year.
Mr. Chairman, I am here today to discuss a food
preservation technology know as Clearsmoke. Clearsmoke is a
patented, filtered wood smoke generation process used for over
8 years to preserve seafood. The goal of Clearsmoke and the
Anova Food Group is to continue to provide safe, healthy
seafood products to our customers. We deliver frozen-at-source
seafood products to the consumer which exhibit ninety percent
of the quality characteristics of a fish that's just been
caught. Because of the many questions and concerns about the
use of carbon monoxide and filtered smoke in seafood, I would
like to start off by making the distinction that Clearsmoke is
not an additive. Clearsmoke is a smoking process that
incorporates only one ingredient to preserve seafood: filtered
wood smoke. Filtered wood smoking is a food preservation
process based on the centuries old process of wood smoking,
created specifically to extend or preserve the shelf life of
fresh and frozen seafood products. A naturally occurring
component of all wood smoke is carbon monoxide, and as with all
smoked foods, it has an effect of preventing the oxidation of
colors in the seafood products we process and freeze.
Filtered wood smoke (as is all wood smoke) is considered
GRAS or ``Generally Recognized As Safe'' by the FDA because of
the long standing food safety record of smoked products. Our
technology does not use industrial carbon monoxide or
commercially mixed carbon monoxide. We only use natural hickory
wood chips to create smoke. Hickory is chosen because of its
ability to produce a very clean smoke with lower tar output
compared to softer woods. The wood chips are burned in a
conventional off-the-shelf smoke generator. The resultant smoke
is scrubbed and cooled to 80--F using existing standard smoke
industry techniques. The smoke that is generated is first
passed through a primary filter which removes all of the
particulate components of the smoke, including tar, ash, and
soot. This process is done by a purely passive filtration means
and does not concentrate or chemically alter the natural
composition of the smoke. The smoke is then passed through the
secondary filter which reduces, but does not eliminate, the
odor and color components of the smoke. The smoke is
accumulated in an accumulation chamber and then either pumped
directly to the ``smoke house'' and applied directly to the
product or compressed into storage containers for later use.
Warm smoke is applied to the product before it is sent into the
chiller for ``sleep over'' at 0--C to 3--C. The smoking step is
followed by an ozone step for bacterial and smoke odor
reduction. Finally, the product is vacuum packed and quick
frozen, preventing spoilage and the potential for forming
histamine.
The action of the smoke in this process is that of smoke
preservation and not of a flavoring or color additive. There
are no added chemicals, additives or preservatives of any kind
used in the Clearsmoke process. What remains are the natural
preservation gasses and standard phenolic compounds that are
present in all natural wood smoke. As the wood smoke is
applied, naturally occurring carbon monoxide (CO) in the
preservation gasses is responsible for the ``locking in'' of
the existing color of the product, which is maintained through
the freezing process.
The Clearsmoke process is similar to grilling a steak at
home. If you barbeque on the grill with wood, the smoke
contains, among many things, carbon monoxide. The Clearsmoke
process does not increase or adulterate the color or quality of
the product in any way; it simply retains the existing quality
and color of the product at the time of processing and
subsequent freezing.
Since the development of the Clearsmoke technology
preservation process, Anova Food Group has provided over 150
million portions using this technique without a single report
of a food safety incident. Our Clearsmoke products are sold in
some of the largest restaurant and supermarket retail accounts
in the USA. One of the most important points of the process is
that it allows us to deliver a frozen seafood item that is very
close in quality to fresh seafood items at a fraction of the
cost and with impeccable food safety. We have avoided the
rigors and high risks associated with global fresh seafood
transportation.
As an example of the success of the utilization of
Clearsmoke products by supermarket accounts, in 2004 a major
supermarket, using Clearsmoke frozen tuna, planned a tuna
advertisement for a summer weekend. The commercial benefits
were as follows:
They were able to plan the ad 3 months in advance
with a guaranteed price since the product was frozen.
The product was stocked in the stores a week prior
to the sales, with backup in the local warehouse.
An advertisement for $5.99 per pound was placed in
the local newspaper. The ad stated ``Clearsmoked Tuna Loins''
and the words ``previously frozen.''
Over 40,000 lbs of tuna was sold in 5 days and a
further order of 8,000 lbs was given for the next week.
There were zero complaints, zero returns, and two
calls from consumers asking what ``Clearsmoke'' was.
This ad was considered extremely successful by the
supermarket and there were over 100,000 happy customers.
In 1999, the FDA issued an ``Import Bulletin'' No. 16B-95
to explain its policy concerning the appropriate legal status
of filtered smoke and carbon monoxide to its inspectors. The
bulletin indicates that when fish are treated with either
compound, the fish can no longer be labeled as ``fresh.'' The
use of carbon monoxide or filtered smoke is allowed to be used
to preserve the color of fresh fish, but not allowed to make
bad fish look good. Therefore, all imported filtered wood smoke
products and carbon monoxide processed products must be labeled
since filtered wood smoke and carbon monoxide are considered by
the FDA to be ingredients. In addition, it states that the
labeling must disclose the presence of tasteless smoke or
carbon monoxide as an ingredient of the fish on the package
label along with a description of its technical function.
Anova Food labels all of our products and we've done so
since the very beginning. We've not missed one label since
1999, when FDA issued the import bulletin. Our label reads,
``Ingredients: Tuna processed with filtered wood smoke as a
preservative for color retention.'' Since our products are
vacuum packaged, the labels must also state ``Remove from
Vacuum Packaging before Defrosting'' and includes other
handling instructions. Our consumers understand our clearly
labeled products, but because FDA is concerned that the use of
filtered smoke or carbon monoxide could mask the visual signs
of decomposition, new laws are being introduced to protect
against this. The law states that ``a food shall be deemed to
be adulterated if damage or inferiority has been concealed in
any manner.'' In addition, it states that ``a food shall be
deemed to be adulterated if any substance has been added
thereto or packed therewith so as to make it appear better or
of greater value than it is.''
We oppose the use of carbon monoxide to mask any
decomposition in fish. The use of carbon monoxide can be an
effective means to provide the consumer with a safe product,
but we agree that it must be labeled properly. We also strongly
oppose any company that uses carbon monoxide to retain color,
freeze the product, unfreeze the product and then claim that
it's fresh. We believe if a product has been frozen, then
thawed, it must be labeled as ``previously frozen.''
Clearsmoke technology is 100% safe and has been fully
tested at the University of Florida. The process is FDA and
USDC approved. Anova Food has embraced the inspection of all of
its processing plants by the United States Department of
Commerce NOAA Fisheries Inspection Program since 1999. The USDC
sends competent inspectors to each of our processing plants
around the world, twice per year, to verify the use of Good
Manufacturing Processes, HACCP and general food safety. Over
the last 5 years the USDC has built an extensive database on
fish 'color' in order to specifically verify that no color
adulteration is taking place under FD&C section 401(b&c). These
inspectors do an excellent job for us as well as protecting the
US consumer.
The Clearsmoke method of preserving seafood continues to be
a safe and innovative way to provide fish to millions of
Americans at a time when the Federal Government is encouraging
us to consume seafood at least twice a week for its many health
benefits. We continue to work towards making heart-healthy
seafood products more readily available. Because of the global
nature of our industry, the seafood community places
exceptional emphasis on the safety of the international seafood
supply. Our seafood products are some of the safest items on
restaurant menus and grocery store shelves today. There have
been no reported illnesses of Clearsmoke imported seafood
because we take pride in what we do to ensure that our products
have been properly handled, stored and prepared.
Thank you Chairman Stupak. I appreciate the opportunity to
testify today. I look forward to answering any questions you
may have.
----------
Mr. Stupak. Thank you all for your testimony.
Mr. Page, Precept Foods that we've been talking about, or
Precept, that is a common partnership between you--by you, I
mean Cargill and Hormel, right?
Mr. Page. That's correct.
Mr. Stupak. And you said that science should be a
controlling factor here. Should science be allowed to deceive
the consumer of the product that they're about to purchase?
Mr. Page. I think it has been said by Mr. Ettinger very
clearly that it is no one's intention to do that. And I think
the purpose of the technology clearly is to enhance food safety
and the consumer's experience, both the quality of the food
they eat and also the safety of it.
Mr. Stupak. But it also deceives the consumer, right?
Mr. Page. I don't believe--I think that is a matter of
intention or motive, and it is clearly not the case.
Mr. Stupak. Then why don't you tell the consumer, then,
that you use carbon monoxide in your packaging; if it is not to
deceive the consumer, why won't you tell them?
Mr. Page. I think it is important--first of all, in the
regulatory environment, that has not been the requirement. The
labels have been approved.
Mr. Stupak. So you're only going to do it if you're
required, not if it is for the best interest of the consumer?
Mr. Page. I was going to finish my answer. I think the risk
in a lot of cases--there are other gases that play an important
part of food safety.
Mr. Stupak. But we're talking about carbon monoxide right
now. My question is about carbon monoxide.
Mr. Page. I understand. But I think the issue is relevant
in the sense that what consumers would like to know and have is
great faith in the regulatory environment that surrounds the
product, not necessarily to become chemists or to be faced with
packages that are cluttered with all of the information
surrounding the product in agonizing detail. The important
issue is around the healthfulness----
Mr. Stupak. Don't you think the consumer would want to know
how the food is treated or prepared, any food? Don't you think
they want to know that?
Mr. Page. I don't.
Mr. Stupak. You don't think they want to know that?
Mr. Page. I don't think that people want to be distracted
by information that is not helpful to their purchasing
decision. I think we could go over a variety of things. I
talked about the fact that chlorine, for instance, forms a very
important part of our food safety environment. If we had
brochures----
Mr. Stupak. How is not knowing----
Mr. Page. If we had a big sign over every product in the
grocery store where chlorine was part of the food safety chain,
it would have a detrimental effect on people----
Mr. Stupak. We're talking about carbon monoxide. How would
the consumer be helped by not knowing? How is that helpful? If
I don't know something, how is that helpful to me?
Mr. Page. OK. If the standard is to be helped----
Mr. Stupak. You said it is helpful to the consumer. How is
it helpful if I don't know what it is?
Mr. Page. Do they have the context for it? It is not to
disparage anybody's judgment.
Mr. Stupak. So you think consumers are not sophisticated
enough to make a decision?
Mr. Page. I said not to disparage that, but I think from a
clarification standpoint, if it does not become part of the
product, I think----
Mr. Stupak. One of your customers is Target; is it not?
Mr. Page. They are.
Mr. Stupak. And they're willing to put on there it is
carbon monoxide-treated, the ``sell'' date. Do you think they
don't understand their consumers, Target consumers, are not
sophisticated? What is it?
Mr. Page. At this moment we're not dealing directly with
Target on this specific issue. And I may want to defer to Jeff
for the specific answer with regard to Target, but we have
other customers where we are having the discussion about what
they'd like included on the packaging that goes into their
stores.
Mr. Stupak. Mr. Ettinger, you wanted to put in those 10
documents there from your experts, and we accepted them. Did
you ask in those experts how people chose their food, what
factors went into consideration under food?
Mr. Ettinger. The testimony within the letters really
focuses on the food safety of the technology.
Mr. Stupak. So you didn't ask them about carbon monoxide
and if consumers should know?
Mr. Ettinger. No, sir. That was not part of those letters.
Mr. Stupak. Mr. Whitfield asked questions here from Hormel,
and consumers used the following to determine wholesomeness:
``sell by'' date, packaging, smell. He went through it. Did you
tell your consumers in the survey that you package your meat in
carbon monoxide?
Mr. Ettinger. I'm not sure that that was our survey that
you're referring to.
Mr. Whitfield. Mr. Chairman, actually that was a Consumer
Federation----
Mr. Stupak. You're Hormel, right?
Mr. Ettinger. Yes, sir. It is in a document we submitted,
but it was not our survey that was conducted.
Mr. Stupak. But this is what you submitted, right, to the--
--
Mr. Ettinger. Yes.
Mr. Stupak. Did you tell the consumers you have carbon
monoxide meat here?
Mr. Ettinger. No, sir.
Mr. Stupak. Do you tell your customers that you have carbon
monoxide in your meat? Do you think your survey would be
different if they people knew there was carbon monoxide in the
meat?
Mr. Ettinger. I don't know that it would. I think that the
survey goes to the priority that consumers place on information
that is useful for them to make decisions.
Mr. Stupak. Were you here when the last panel testified?
Mr. Ettinger. Yes, I was.
Mr. Stupak. And they said that 75 percent of the consumers
stated that they were very concerned about the practice of
adding carbon monoxide to meat. Do you dispute that?
Mr. Ettinger. No. I heard that testimony.
Mr. Stupak. OK. Let me go to exhibit 30, which I think is
right there in front of you. I've referred to it throughout.
Mr. Page. Is it in this book, sir?
Mr. Stupak. Yes. I'm not sure that is the right one. There
are two books there.
In those 10 letters you submitted, did your experts take in
the microbial population of fresh meat as affected by many
factors, such as the number and distribution of microbial
species present at the start of the health and handling of live
animals, slaughtering practices, chilling of the carcasses,
sanitation, type of packaging, handling throughout distribution
and storage; or were they just talking strictly about carbon
monoxide?
Mr. Ettinger. I don't know that they specifically looked at
that, but clearly, as experts within the field of food science,
they would recognize, yes, that there are varying conditions
that need to be monitored.
Mr. Stupak. And every one of those can affect the safety of
the food, correct?
Mr. Ettinger. That's correct.
Mr. Stupak. And you don't feel that if anything is wrong
with the handling of the food, like, say, sample G there that
looks quite fresh, that your carbon monoxide doesn't mask over
any microbial pathogens or agents in that fish--or, excuse me,
that meat that has been sitting there for 2 years?
Mr. Ettinger. You reference that that package was over 2
years old. Yes, we would have a problem with that. We would
hold the companies with whom we do business on this product
line. We have a contract with each one of them that they will
pull products at code date. We recognized that testimony
earlier today from the Government indicated that that was a
critical element of this project--of this packaging being
approved was that the code date had to be prominent.
Mr. Stupak. Do you think that is deceptive to the consumer?
Mr. Ettinger. I think that they shouldn't be consuming a
product that is 2 years old.
Mr. Stupak. Would you consume it?
Mr. Ettinger. Absolutely not.
Mr. Stupak. But yet you think adding carbon monoxide to
keep it fresh-looking is OK?
Mr. Ettinger. We don't add carbon monoxide to make product
look fresh beyond its code date. I can explain more
thoroughly----
Mr. Stupak. So why isn't that turning all brown and nasty
then if it has been 2 years if it is past the code date? It has
got carbon monoxide, E, F, G.
Mr. Ettinger. The carbon monoxide does have a tendency to
stabilize color in the meat.
Mr. Stupak. That may not be the purpose of carbon monoxide,
but as we can see there--it may not be your purpose when you
add it, but it is the end result, is it not, in E, F and G? It
looks fresh well past the code date?
Mr. Ettinger. Those aren't our packages.
Mr. Stupak. I know. So therefore it would appear at least
to be deceptive to the average person.
Mr. Ettinger. We'd be concerned if consumers are eating
that product beyond the code date.
Mr. Stupak. OK. Thanks.
Mr. Brinsmade, you stated that you supply seafood products
to retailers, distributors and restaurants across the United
States and Europe. Do you sell any of your products to Europe
that have been exposed to your Clearsmoke technology?
Mr. Brinsmade. Yes, sir. Up until December of this prior
year, we were selling Clearsmoke products in the EU.
Mr. Stupak. So until December 2006? What happened? You
don't anymore?
Mr. Brinsmade. Yes, sir. So what occurred is that we are
actually a Dutch corporation, and we had won five suits with
the Dutch health authorities and proved through science that
this process was actually a valid process. What then occurred
was that some of the member states, specifically some of the
southern states who rely on specifically tuna for their
economy, felt that this was deceptive. So there was a bit of
economic issues; therefore they changed legislations. We are
now currently still fighting this battle in the EU.
Mr. Stupak. OK. So they thought it was deceptive. So since
December of last year, you can't bring it into the EU. Do you
still sell your products over there without Clearsmoke?
Mr. Brinsmade. Yes, we do sell fish products without
Clearsmoke.
Mr. Stupak. So in order to economically--economic--it is
not an economic thing then. You can still make a profit and all
that by selling to the EU even though you don't have Clearsmoke
on your fish products, right?
Mr. Brinsmade. Yes, sir. We diversified into other species
of fish.
Mr. Stupak. OK. What is in your Clearsmoke besides carbon
monoxide that affects fish?
Mr. Brinsmade. Yes, sir. You asked this question before, so
I'm glad I've had the opportunity to answer this. In smoked
processes, be it tasteless smoke or Clearsmoke, it is a wood-
smoking process, which means we burn hickory wood. The
attributes of the wood, such as phenols, which is the No. 1
ingredient that retards bacteria--you have hydrogen, you have
phenols, you have nitrogen, carbon dioxide--all of those are
used for the preservation of the product. And it is a process
that has been going on, as we all know, for hundreds and
hundreds of years. So we are smoking the product.
Mr. Stupak. OK. So when I asked Mr. Kraemer the same
question, you were right, when he said it was just carbon
monoxide and nitrogen, there is more to it than that?
Mr. Brinsmade. Much more to it, sir.
Mr. Stupak. Is that what helps enhance the color, then, of
the seafood? I think we have had some slides in the last
testimony where the tilapia side by side, one was enhanced and
much brighter. Was it the pathogens that do that, the nitrogen?
What is it that----
Mr. Brinsmade. The actual--what fixes the color is the
carbon monoxide component of the smoke in our smoke process.
But you receive the same amount of carbon monoxide when you
throw a T-bone on the grill through our process. Any time you
burn anything on a grill or when you burn a table, you're
getting the same levels of carbon monoxide.
Mr. Stupak. OK. Mr. Whitfield for questions.
Mr. Whitfield. Thank you, Chairman Stupak.
Thank you all very much for being with us today and
testifying on this important issue.
I would like to ask this question to, I guess, Mr.
Ettinger. In the first panel, Chairman Stupak referred to e-
mails among employees of Hormel, and it related to an April
2004 FDA letter requesting more information. And the documents
indicated that internal Hormel employees had some concerns
about the samples' microbacterial counts, the stats of the
studies conducted by David Rusack. And I was wondering, Mr.
Ettinger, if you can tell me, were those concerns addressed,
and, if so, how?
Mr. Ettinger. Mr. Whitfield, that is the first I had heard
of that. However Dr. Phillip Minerich, who is the head of our
research and development facility, and who Mr. Rusack works
for, is here today. And if the committee would like to take
testimony from Mr. Minerich on that topic, he'd be very welcome
to provide that.
Mr. Whitfield. We appreciate that very much. Thank you.
I've been a little bit perplexed about this hearing,
truthfully, even though I recognize that everyone is certainly
acting with the very best of motives. But we have a situation
here where a process, a packaging process, using carbon
monoxide has been approved by the Department of Agriculture.
They have a Memorandum of Understanding with the FDA. We have a
consensus of expert scientific opinion that this is a safe
process. We have a package that has a date on it that it must
be used by a date certain. You all have contracts with the
people who purchase your meat and sell it in grocery stores
that they must agree to not keep it past the ``best use'' date.
And I know that being a publicly traded company, you're always
obviously concerned about legal liability and everything else.
And you, too, Mr. Ettinger, and Mr. Page, all of you chief
executive officers are responsible for taking care of your
stockholders and the public as well with the very best of
products.
So I would just ask you, do you have any concern whatsoever
about the safety of this product for your consumers? Mr. Page?
Mr. Page. I think, as I've said, the technology enhances
safety. It clearly inhibits the growth of bacteria and of
pathogens if they're present; that it affords the consumer the
opportunity to carry products home in their shopping cart or
their grocery bag into their refrigerator without the risk of
cross-contamination. It enhances food safety not just in the
store by eliminating this by doing it in the back room, but in
the home by avoiding the cross-contamination that can take
place with other packaging technologies.
I think clearly it would be our intention to encourage the
adoption of technologies that allow consumers to buy these
products, to use them safely in their homes.
Mr. Stupak. Mr. Ettinger?
Mr. Ettinger. What I would add to that is we have the added
benefit 3 years later of having had actual experience in the
marketplace, and as I mentioned in my testimony, we've sold
nearly 23 million packages of this case-ready lid-stock
product. We have our 800 number on every package. It is all
branded Hormel. It tends to be a high-ticket item. These are
beef and pork whole muscle items in the case of the joint
venture, and so if consumers have a bad experience with it,
we're going to hear about it.
During that entire timeframe, we've received 48 consumer
calls relating to flavor or off condition of any type. We are
very open to trying to address to knock the No. 48 down, and
that is part of the discussions we've had with subcommittee
staff where we're open to adding language to the package
talking about color to see if we can make that number even
lower. But clearly the experience has been that consumers are
not eating bad product and are not being deceived by this
technology.
Mr. Whitfield. Mr. Brinsmade, did you want to make a
comment?
Mr. Brinsmade. No, sir. Listening to these gentlemen, I
have nothing more to state.
Mr. Whitfield. Now, it has been referred to a sample there
is 2 years old. I'm assuming if we opened that package up,
there would be a little bit of an odor. Would there? Would
there be an odor in this package that is over 2 years old?
Mr. Ettinger. There should be a very significant odor.
Mr. Whitfield. Now, we have heard a lot today about
consumer deception, and certainly there is a distinction
between consumer deception and consumer acceptance. And I think
your goal was to facilitate the consumer, give them an
attractive product. Anybody in the business of selling food
products wants an attractive package. And so your intent here
was not to deceive anyone, but was to help provide consumer
acceptance, I'm assuming. Was that correct?
Mr. Ettinger. I think that is an element of this packaging
system that is really not understood. What we're trying to do
with this packaging is provide the available freshness to the
consumer.
I can give you an illustration of this. Our company is
headquartered in Austin, MN, a small town in rural Minnesota,
south Minneapolis. We basically have two major grocery stores
in the town. I went to both stores on Saturday to look at what
was available in terms of the fresh meat offerings in those
cases. One of the stores uses the traditional overwrap method
done in the store, and the typical product life left that would
be available to the consumer in that store was 2 to 3 days. The
other store in town sells the product line that utilizes our
low-oxygen-modified packaging, and the typical available
freshness to consumers in that store was 10 to 11 days. The
consumer then has the opportunity to bring that product home
and doesn't have to decide the first night, gee, do I grill
this up now, or do I have to put it in the freezer? This
provides them with the available freshness that prior to this
technology was often in the back room of the store and not
available to them.
Mr. Whitfield. Now, one last question. I know that a
petition has been filed at the FDA asking them to review the
GRAS determination relating to this packaging. It was filed by
a Calsak Company. Are you all familiar with Calsak Company?
Mr. Page. Not intimately, but in preparing for today, I was
made aware----
Mr. Whitfield. And you are aware that they use rosemary
extract, and it is competing with your technology; is that
correct?
Mr. Page. That's what I was told, yes.
Mr. Whitfield. I yield back. I have no time left.
Mr. Stupak. Mr. Dingell for questions.
Mr. Dingell. Thank you.
Gentlemen, your testimony today has been very helpful, and
I want to express to you my appreciation for your presence.
First of all, I note here in the comments made by you, Mr.
Ettinger, you said this
Inclusion of carbon monoxide in a package does stabilize
the color of meat. If improperly handled or used well beyond
the ``sell'' or ``use by'' date, it is possible that it could
be spoiled in the package, yet still look red. We put sell by
the dates--''sell by'' dates on the front of this product in
type three times larger than normal to address this. We put
another ``sell by'' date on the back of the product.
Then you said this
Hormel will comply with any labeling of the product that
is determined to be necessary and fair through the legislative
or regulatory process.
Then in your rather helpful comments, Mr. Brinsmade, I note
you said this on behalf of yourself and your company
We oppose the use of carbon monoxide to mask any
decomposition in fish. The use of carbon monoxide can be an
effective means to provide the consumer with a safe product,
but we agree that it must be labeled properly.
Gentlemen, do you all agree with those statements? Is there
any disagreement on the part of anyone with those three
statements? Yes or no?
Mr. Ettinger. Mr. Dingell, there were quite a few
statements, and I think I would be in agreement with all of
them, except if you're incorporating by reference Mr.
Brinsmade's statement that carbon monoxide should be on the
label, I would respectfully disagree with that.
Mr. Dingell. OK. Now, gentlemen, we have a little problem
here. We have a situation where it is possible that if the
labeling doesn't warn the consumer, that consumer is libeled by
a product where decomposition or overage or the safety of the
meat product is masked by the presence of the carbon monoxide
treatment; is that right?
Mr. Ettinger. Well, two things would have to happen for
that to occur.
Mr. Dingell. That is a possibility; is it not?
Mr. Ettinger. Well, the consumer would have to not notice
the code by date, and the store would have to violate our
contract and not pull the product prior to the code by date.
But it is certainly conceivable that both of those things could
happen.
Mr. Dingell. Hormel says this here: The inclusion of carbon
monoxide in the package does not stabilize the color of meat.
If improperly used or used well beyond the ``sell'' or ``use
by'' date, it is possible it could be spoiled in the package
and still look red.
So we have then here a problem, don't we? We can--the
consumer, if this is not properly labeled, can be buying
overaged meat which is unsafe, which looks good, but which,
when he gets it home, he'll find either it smells bad, is
unpleasant to eat, or can, in fact, be unsafe. Isn't that a
true statement?
Mr. Ettinger. We feel that the product line provides----
Mr. Dingell. Just yes or no.
Mr. Ettinger. It is possible that a consumer could bring
the product home, and it would be----
Mr. Dingell. And there is no disagreement there, I think,
at the table there.
Now, tell me, what do we do to see to it that this is
properly labeled so that the consumer gets the warning he
needs, industry gets the ability they need to properly process
the food, and at the same time see to it that the public
interest and the public are safe because the regulation is
adequate to ensure proper protection of the consumer? How do we
do that?
Mr. Ettinger. Due to helpful discussions we've had with
subcommittee staff and a third meeting where they actually flew
out to the facility at Cargill, we've had an opportunity to at
least engage in dialog about some of the possible ways to
address that, and we really have kind of proposed two of them.
One is the additional label language that both Mr. Page and I
referred to, that color and freshness--color is not--excuse
me--an accurate indicator of freshness, that the consumer
should refer to the ``use'' or ``freeze by'' date.
Mr. Dingell. The Food and Drug--Food and Drug does not
require anything be done with regard to a ``sell by'' date, do
they?
Mr. Ettinger. My understanding is it is not required
under----
Mr. Dingell. Under regulation. And yet some of the
companies, I think Hormel, has put a ``sell by'' date on there,
don't you?
Mr. Ettinger. Yes. All the products sold----
Mr. Dingell. And that is done out of concern for the safety
of your consumer?
Mr. Ettinger. That's correct.
Mr. Dingell. Because you believe that that is necessary to
protect them.
Now, there are other companies that do not do that, aren't
there?
Mr. Ettinger. I know on the products that we sell through
Hormel, both the joint venture and on a regular basis----
Mr. Dingell. So if that is not done, the consumer then is
not protected, is he? The consumer doesn't know what the ``sell
by'' date is. He buys himself a nice-looking red meat, and he
finds that that consumer is perhaps put at risk because he
didn't know when that had to be used or sold or frozen; isn't
that right?
Mr. Page. The USDA made it a condition of their approval of
the use of this technology that there be a ``sell by'' date. So
you said the FDA, and I think Mr. Ettinger answered correctly
to that question. With the USDA the Government----
Mr. Dingell. But Food and Drug doesn't require a ``sell
by'' date, nor does the Department of Agriculture, do they?
Mr. Page. No. As a requirement of this technology, we're
obliged to put a ``use by'' date----
Mr. Dingell. Are you required to do that?
Mr. Page. It is a condition----
Mr. Dingell. Where is that in the regulation?
Mr. Page. It is a condition of our approval.
Mr. Dingell. I am of the view, read correctly, that there
is no regulation on this, that the regulation has never been
promulgated. Am I in error on that point?
Mr. Page. I won't speak technically or legally to the issue
of the regulation, but I do know we're not allowed to produce
this product with this technology in our facility without a
USDA-approved label.
Mr. Dingell. This is a very good answer, sir, but it
doesn't answer the question. Food and Drug does not have in
place any regulation with regard to labeling or a ``sell by''
date, do they? They simply permit you to do this. And there is
no published regulation. The regulation, if such has been put
forward, has never had either the comments of consumers or
anybody other than the industry groups; isn't that right?
Mr. Page. Not to restrike a dead horse, but the letter we
received back from the USDA authorizing the implementation of
this packing technology excludes the specific requirement that
the label must show a ``use by'' date.
Mr. Dingell. See, here is my concern. The consumer is not
protected. You folks don't have a clear regulation. Honest
folks like the three of you sitting there at the table, you
don't have a regulation you can point to. And on top of that,
rascals in the industry don't have to pay to heed any
regulation because there is no regulation in place. And I'm not
sure how we prosecute them from misbehavior or how we protect
the consumers or how we protect you from unfair competition by
rascals who aren't troubled about these matters.
I think we have a bad situation on our hands. Are you here
to defend that situation? I find myself hard put to defend it.
I think you're at risk. I think the consumer is at risk. And I
think Food and Drug is not doing its job. Am I in error in my
thesis on these matters?
Mr. Ettinger. I really wouldn't have a comment as to the
entire regulatory ambit, but we know in terms----
Mr. Dingell. Well, we have got rascals out there that are
able to disregard this. They make their meat look red, they
sell rotten meat, and you three, who I think are interested in
doing an honest job, find yourself in a position where you're
competing with folks who don't feel themselves pressured to do
us right. I think that is a bad situation. So we've got you
folks getting badly treated and the consumer shabbily treated.
This is a bad situation. Something has got to be done. How
is it that I can defend it, or, even more importantly, how is
it, gentlemen, that you can defend it?
Mr. Ettinger. I guess we can only rely on the regulatory
experience we have had with this product.
Mr. Dingell. And we have already talked about the
regulatory system. And we are going to have a nice letter off
to Food and Drug asking them to explain how they've complied
with the requirements of the administrative procedure. And I
have to say that if somebody--some reasonably intelligent
lawyer were to sue Food and Drug, Food and Drug would all the
sudden have a very large problem on its hands.
But you, marketing your foods, if somebody gets bad meat,
which is colored to be a nice pink--are going to have a very
fine lawsuit on your hands. And I think this is something that
we've got to address here in this committee, see to it that
Food and Drug does its job, see to it that Food and Drug
protects you, see that you are protected, see that the
consumers are protected and that everybody is treated in a
proper and decent fashion. And I don't see that today. And I
wonder how it is that you're so comfortable appearing here
before the committee when you're confronting a situation of
this kind.
Mr. Page. I want to address the regulatory environment, and
certainly some of the testimony regarding the processes
surrounding GRAS are not clear. But I do believe that both of
our companies or all three of our companies have spent a great
deal of time with our technical staff and are very comfortable
with the science surrounding this packaging.
Mr. Dingell. I'm not attacking your company. I'm just
saying, fellows, I think you have a problem on your hands, and
I think the consumer has got a problem on his hands. And I
think Food and Drug is the architect of this misery, and I
think we've got to see to it that Food and Drug does a better
job. And we're going to dissect Food and Drug in a very nice
communication in which we are going to ask them about how it is
they are doing it and why it is that they are doing this.
So, gentlemen, thank you for your patience with me.
Mr. Chairman, members of the committee, I thank you for
your courtesy to me, and I yield back the balance of my time.
Mr. Stupak. Thank you, Mr. Chairman.
Mr. Burgess for questions, please.
Mr. Burgess. Thank you, Mr. Chairman.
Let's just follow up on that for just a moment because the
chairman of the full committee has said that the FDA was the
architect of this misery. Let me ask you each in turn, how many
cases of illness are we talking about having been caused by
this type of packaging?
Mr. Ettinger. Well, the packaging involved in the Precept
venture all carries the Hormel brand. It carries our Hormel
Foods 800 line, and we've received no documented cases of food-
borne illness out of 22-plus million packages sold.
Mr. Burgess. And either Mr. Page or Mr. Brinsmade, either
one of you recorded any instances of illness?
Mr. Brinsmade. No, sir. Out of the seafood side of the 150
million portions that we have supplied the U.S. market, we have
zero food-borne illnesses.
Mr. Burgess. And I'm going to assume there are no deaths
that are directly attributed to this type of packaging and this
technology. Is that a correct assumption?
Mr. Brinsmade. Yes, sir.
Mr. Burgess. What about the number of complaints? People
didn't die. How many complaints have you had that people have
been misled or deceived by what the focus of this investigation
has been today?
Mr. Brinsmade. As far as our company is concerned, we've
had zero.
Mr. Burgess. Mr. Ettinger?
Mr. Ettinger. As I mentioned earlier to Chairman Stupak, we
do have 800-line consumer information on the package, and we do
get calls from our consumers on this product line and a lot of
our other product lines as well. Out of the entirety of the 3
years we've been selling the product and the over 22 million
packages sold, we tallied up that there had been 48 comments
from consumers relating to flavor or off-condition complaints
for this product line. That is a very low ratio in terms of
what would be typical in the food industry. But we also
recognize that we'd like that number to be zero. We'd be
looking for ways to make that happen.
Mr. Burgess. So 44 out of 22 million?
Mr. Ettinger. That's correct. Forty-eight.
Mr. Burgess. Forty-eight.
And, Mr. Page?
Mr. Page. None that I'm aware of.
Mr. Burgess. So the architect of the misery has really not
got much to show for their architecture.
How do you measure--how do you measure the likelihood of
deception? If deception is the issue here, Mr. Chairman, I have
got to assume that is the issue here because, for the life of
me, we have got no illness, no death, no complaints. We have
got plenty of problems with salmonella in peanut butter and E.
coli in lettuce leafs, things we legitimately should be
focusing on. But how do you measure the likelihood of deception
from this packaging? Has anyone done an audit to see if the
consumer is, in fact, misled by the color of the food that they
purchased or misled by the ``use by'' or ``freeze by'' date?
Mr. Ettinger. We are not aware of any consumers that have
stated specifically that they feel they were misled by it, but
I think it goes beyond that. I think there has just been a
general confusion about the purpose of carbon monoxide in this
packaging system to the notion that the reason we're utilizing
it is we are attempting, in essence, to color bad meat and make
it look good.
That is not the purpose of carbon monoxide in this overall
packaging system. This system was introduced as a food safety
enhancement. It allows us to pack case-ready product in our
plant, and provide maximum available shelf life to consumers,
and provide them with a tamper-proof, leak-proof package that
they then can rely on in their own homes.
Mr. Burgess. I appreciate the leak-proof aspect of it.
Let me just ask, do you audit the store shelves to make
certain that food that is beyond the ``use by'' or ``freeze
by'' date is not appearing or is not maintained on the grocery
shelves?
Mr. Ettinger. The retailer is obviously a different company
than ours. In this case and this particular product line, we do
have very specific contracts in place with each retailer with
whom we partner, and this has really been very significant to
them. They don't typically turn over their entire meat case to
a case-ready program unless we maintain certain obligations in
our facilities as well.
One of the other aspects that was not talked about in terms
of preserving the freshness and protecting the consumer is when
our product goes from our production--the production plant of
the venture to the retailer, it goes in a truck that has
temperature indicators in the truck to make sure that it is
maintained at the proper temperature during that whole time,
and then the cold chain then becomes the responsibility of the
retailer. We train them in that, we audit them in that, and we
make sure that that is being maintained for the consumer's
protection.
Mr. Burgess. So you do provide audits on the maintenance of
temperature. And those trucks that you talked about that have
the temperature-sensing devices, do those go to some type of
recording device so that that information is maintained over
time?
Mr. Ettinger. Yes, we do.
Mr. Burgess. Thank you.
And let me just ask, Mr. Ettinger, and I apologize for not
being here when you gave your oral testimony, but in your
written testimony you elaborate on a new technology that Hormel
is developing to address the issue of long-term color change.
Can you tell us a little bit about what the technology is and
how it would address some of the concerns raised by the
witnesses on the consumer panel?
Mr. Ettinger. One of the things I mentioned in the
testimony and I have spoken to in a couple of times during the
question and answers, we really feel that this product line
provides many benefits to consumers, the product safety, the
additional available shelf life.
We recognize through our discussions with the subcommittee
and the subcommittee staff that the lack of color has been a
potential downside. We felt we were addressing that by putting
code dating on it in three-times-larger type. And I know that
in testimony earlier, they were looking at a package where they
couldn't see it. I think if you look at our package, it is
really very clear on both the front and the back of the
package. But in addition to that, we stand ready to try to
eliminate even the 48 complaints that we have received related
to flavor. We want to make sure that people are not having a
bad experience with this product.
So we have offered to include the language relating to
color, and we are working on a technology that would allow the
meat, when it goes beyond code date, to turn a brown color that
would be more typical of overwrapped meat in the grocery store.
If we can accomplish that without compromising any of these
other advantages on food safety, then we will be happy to roll
that out, and we are working earnestly in that regard.
Mr. Burgess. It almost brings to mind the old Mission
Impossible thing. You could have a product that self-eliminated
after the expiration date, but I guess that would be hard on a
grocer's shelves.
The chairman brought up that there was no actual rule you
were following, Mr. Page. I think you tried to speak to that
when you said that the USDA has made a suitability
determination that is based on the labeling; is that not
correct? So there actually are rules in place that you follow,
rules put forward by the U.S. Department of Agriculture.
Mr. Page. There was a process that was outlined to us,
which we followed, to gain consensus from prominent scientists,
to take that body of evidence and bring it forward. I
understand from this hearing that that evidence passed back and
forth between the FDA and the USDA. The outcome of their effort
following some requests for additional information were a
letter to our company and to our joint venture company,
allowing us to begin to utilize this technology provided that
we had prominent ``use by'' information for the consumer on the
retail-ready package. So we experienced the regulatory
administrative process and the science focusing to be quite
intense.
Mr. Burgess. And I appreciate the large-print edition of
the ``use by'' dates that you have on there so that I don't
inadvertently bring home something that's close to its
expiration, because it does cause domestic problems.
Mr. Ettinger, let me ask you just to finish up here--and I
wasn't here when Mr. Whitfield did his questioning. Apparently,
the issue came up that there was a study that Hormel had
submitted to the U.S. Department of Agriculture where there
were some problems with the study; is that correct?
Mr. Ettinger. That is correct.
Mr. Burgess. And that the U.S. Department of Agriculture
relied upon this study to make their determination?
Mr. Ettinger. Yes. What I testified to Mr. Whitfield was--
he brought up the e-mail exchange that was in the evidence
Chairman Stupak had referred to, and I stated that I really had
not been familiar with that e-mail prior to hearing it in the
testimony today but that along with me today is Dr. Phillip
Minerich, who is the head of our Research and Development
facility and whom Mr. Rusick, who was the author of that one e-
mail, worked for, and that he could explain what's going on in
that e-mail if the committee would like to have that testimony.
Mr. Burgess. I think it would be beneficial to the
committee if we were to hear that explanation, because it was
kind of left as an unresolved question.
Mr. Stupak. OK. You have to stand and be sworn in. If
you're going to testify, you have to be sworn in. Do you not
want to be sworn in? Do you want to testify? You have to do it
for the record.
State your name first, please.
Mr. Minerich. Phillip Minerich.
Mr. Stupak. Spell it, please.
Mr. Minerich. M-I-N-E-R-I-C-H.
[Witness sworn.]
Mr. Stupak. OK. The record should reflect the witness has
been sworn in.
Mr. Burgess. And I appreciate your willingness to provide
us additional information. I just feel like the question was
left out there not fully answered, and if you can provide us
some additional information, I think that would be helpful to
the committee.
Mr. Minerich. Yes. I think there was some discussion about
some data that was submitted to the FDA. I know Dr. Post was
trying to recall a few years back what that data was, and then
there was an e-mail correspondence.
What this, in essence, boils downs to is the suppression of
microbial growth, that this data demonstrates, really supports
the agency's determination that this packaging system is safe
and does not mask spoilage or odor. The data indicate that a
low-oxygen, high-carbon dioxide packaging system actually does
control microbial growth, and this result was later confirmed
and replicated and validated through the work of Dr. Mike Doyle
at the Center of Food Safety at the University of Georgia.
We see this as a good thing, that this high CO\2\
environment, low oxygen environment does suppress microbial
growth, not only from a spoilage perspective but also from the
food safety perspective; and of all of the packaging systems
that we want to deliver our products to the consumers in, we
want to choose the one that delivers the most safety to the
consumer with an adequate product for an enjoyable eating
experience.
Mr. Burgess. So your data----
Mr. Stupak. Your time has expired, Mr. Burgess. We'll go
around for a second round if you want to ask more questions.
Mr. Burgess. Your data would support the fact that a micro
atmosphere high in carbon dioxide would, in fact, suppress that
type of microbial growth?
Mr. Minerich. Yes. This data did a very good job in two
types of bacteria--the total plate count, which is a general
microbial count, and then also in psycrophiles, which are
bacteria that specifically grow under refrigerated conditions--
and our data supported that.
Mr. Burgess. I thank the witness for his testimony.
Mr. Chairman, I yield back. I'll have no further questions.
Mr. Stupak. Mr. Minerich, let me ask you this question
then, and these are questions I put forth.
The microbial levels started high and ended low in your
study, and the microbial counts correlated, virtually, gas
formation and odor scores; is that true? Yes or no?
Mr. Minerich. Looking at the data, the microbial growth
really is almost stabilized.
Mr. Stupak. Well, it started high, and it ended up lower.
It should go up high, should it not, after time?
Mr. Minerich. No, sir. This packaging system, because of
its low oxygen atmosphere and its high CO\2\ atmosphere,
suppresses microbial growth.
Mr. Stupak. Let me ask you this then. Let's go to 71(d) if
you want to go there.
Now, you are actually listed on the copy list, are you not,
in 71(d)? You are the ``Phil Minerich;'' is that correct?
Mr. Minerich. Yes, sir.
Mr. Stupak. You're Research and Development; is that right?
Mr. Minerich. Yes, sir.
Mr. Stupak. Who is Dave Rusick then?
Mr. Minerich. Dave Rusick is a development leader who works
in my department.
Mr. Stupak. OK. So you're his boss.
Mr. Minerich. Yes, sir.
Mr. Stupak. All right. As to this e-mail we've been talking
about, had you seen that e-mail before today?
Mr. Minerich. I don't recall seeing this e-mail before
today.
Mr. Stupak. All right. I'm looking at 71(d). I'm in the e-
mail now.
Mr. Minerich. What page is that?
Mr. Stupak. Well, it's the last two pages of the exhibit.
Mr. Minerich. Yes, sir.
Mr. Stupak. OK. I read earlier about Mr. Rusick's and Ms.
Ann Waylan's going back and forth. Then Mr. Rusick says
Thanks for the response, Ann. Believe me. We are also
puzzled by the data.
So he is puzzled by the data, but you are not.
But this is the second time it has happened regarding micro
counts, gas and color. The first time is when we made samples
for the FSIS.
That would be the Department of Agriculture
there is something going on. I don't have the answers.
It goes on, and he lays out the questions.
There doesn't appear to be a clear correlation between
micro counts, gas and odor. You would think the counts would be
highest in packages with the most gas and odor, but that's not
necessarily the case . . . Basically, however, there is a
difference in the micro counts between the four treatments,
which was a real surprise. I would have thought the lactate
would have further retarded the bacterial growth therein.
Now, ``lactate'' is an antibacterial agent, right, to keep
it down?
Mr. Minerich. Yes.
Mr. Stupak. Then if you go on, you say
It appears to me that the micro counts that you talked
about remain relatively constant, as you said, across the four
treatments during the three sampling periods. I could see the
micro counts eventually dying off after they reached the multi
millions, but data didn't come close to that. Regarding odor,
we may not be checking for the right bug.
Then it goes on to say
I think we have to at least determine what the data tells
us before we send it to lawyers, but it was forwarded on.
So are you disputing Mr. Rusick then?
Mr. Minerich. No. I think this is a really good example of
what happens in a company such as ours where innovation is just
ingrained. Ann Waylan initiated the dialog. Dave Rusick
responded, saying this was very early in this technology. He
has repeated a study that shows some interesting data that this
is really suppressing microbial growth, and the concern with
the attorneys is really--the question was at that time: Is
there potential that between lactate and high CO\2\ and low CO
and low oxygen that there might be some discoverable or
patentable opportunity here? That's what this discussion was
really around.
Mr. Stupak. But it said that he had already discussed it
with the USDA, that Forest Dryden may have used these--Forest
Dryden is one of your workers, one of your employees?
Mr. Minerich. Forest Dryden was the vice president of
Research and Development before he retired.
Mr. Stupak. He used the tables to discuss it with Dr. Post,
who we know is with the USDA.
The part that bothers us is you had questions about the
studies--that's what this e-mail indicates--and this data,
which is in 71(d), is the same evidence or the same data in
71(e), the next exhibit which was submitted to the USDA for
your approval. That's what bothers us.
The other part that bothers me is you extol the virtues of
modified atmospheric packaging. And I'm not here to attack that
type of packaging, and there is no doubt that there may be many
benefits associated with it, but our concern is in using carbon
monoxide in this type of packaging.
Your testimony is that--Mr. Ettinger and Mr. Page both
indicated you stated that the modified atmosphere that you use
in your packaging suppresses microbial activity. However, isn't
it true that the addition of carbon monoxide to this packaging
process does not contribute any additional antimicrobial
properties? Carbon monoxide doesn't give you any antimicrobial
properties.
Mr. Minerich. At the time of this study, it was unknown.
That's why the curiosity.
Mr. Stupak. But we know that today, in sworn testimony by
Mr. Page and Mr. Ettinger, they said that it did suppress
microbial activity.
Mr. Minerich. Correct.
Mr. Stupak. So we didn't know when we did the study, even
though we submitted it to the USDA. Today, we know it doesn't
provide microbial activity. Yet we testified it does produce
antimicrobial activity. So who is telling whom the truth here?
Mr. Ettinger. I don't know, from my testimony at least,
that the carbon monoxide had anything to do with that. Carbon
monoxide is used as part of the total MAP packaging system as a
substitute for oxygen so that the product will turn red, just
as meat products naturally turn red when they're exposed to
oxygen in the back room of a retail establishment.
Mr. Stupak. But carbon dioxide is chiefly responsible for
antimicrobial activity, isn't it, for suppressing it?
Mr. Ettinger. Yes.
Mr. Stupak. Nitrogen is basically a filler to replace the
oxygen, correct?
Mr. Ettinger. That would be my understanding.
Mr. Stupak. So then why, in your testimony, did you mention
that modified atmospheric packaging here that you ought to use
would suppress microbial activity?
Mr. Ettinger. We believe that the complete packaging system
used in a case-ready environment versus a store overwrapped
product have many food safety benefits. It's all of it put
together.
Mr. Stupak. Then why couldn't you have just used carbon
dioxide with the nitrogen and not use carbon monoxide?
Mr. Ettinger. Because the product that we would then put
into the retail case would be purple, and the consumer doesn't
want to buy purple meat.
Mr. Stupak. So what is more deceptive, the purple meat or
bright red meat?
Mr. Ettinger. Meat is purple in its natural state unless
it's exposed to oxygen. In a regular opportunity at a grocery
store, meat is shipped in a vacuum-packed package that is
purple; and when it's held--it's perfectly fresh as long as
it's held in a refrigerated environment, and it isn't until
that product is cut open and then put into cases and exposed to
oxygen that it turns red.
Mr. Stupak. So let's go back to the purpose of the hearing.
As I said in my opening statement, carbon monoxide does nothing
to preserve the freshness of the meat or fish, true? It does
nothing to preserve the freshness?
Mr. Ettinger. Not by itself.
Mr. Stupak. OK. Carbon monoxide does nothing to prolong the
food's shelf life, does it?
Mr. Ettinger. No.
Mr. Stupak. Carbon monoxide doesn't make food safer, does
it?
Mr. Ettinger. No, not by itself.
Mr. Stupak. Then what's the purpose of using carbon
monoxide other than to deceive the consumer?
Mr. Ettinger. Because it allows us, in combination with the
packaging technology itself and the carbon dioxide in nitrogen,
to provide consumers with fresher products and with enhanced
food safety.
Mr. Stupak. What is your 800 number? You mentioned your 800
number that consumers can call. What is it?
Mr. Ettinger. It's a number that's on every package or
product.
Mr. Stupak. Yes. What is it? What is the number?
Mr. Ettinger. Oh. Let me see if it----
Mr. Stupak. I know it's hard to read. It's so small.
Mr. Ettinger. Yes, that would be my difficulty.
Mr. Stupak. It's not deceptive, but----
Mr. Ettinger. I would need to borrow some glasses.
Mr. Stupak. OK. You don't know it off the top of your head.
Mr. Ettinger. No, I don't.
Mr. Stupak. Mr. Page, do you know your 800 number?
Mr. Page. I do not.
Mr. Stupak. How about you, Mr. Brinsmade?
Mr. Brinsmade. Yes, I do.
Mr. Stupak. It's on your package, probably.
Mr. Brinsmade. Could I look at it?
Mr. Stupak. Sure, if it's on your iPod. I carry your 800
number on my BlackBerry.
Mr. Brinsmade. I do have it, sir. I don't know it off the
top of my head.
Mr. Page. I'll give Hormel's, while he's looking, with your
permission.
Mr. Stupak. Hormel's is 1-800.
Mr. Page. 523-4635.
Mr. Stupak. 4635. OK.
Mr. Brinsmade. I will submit my 800 number to you in a
second, sir.
Mr. Stupak. It's probably on your package there. It might
be quicker than modern technology.
Mr. Brinsmade. Actually, our 800 number is not on this
package, sir.
Mr. Stupak. OK. Well, just submit it.
Mr. Ettinger, you indicated you had 48 complaints over
thousands and thousands, but none of those people knew or
complained about carbon monoxide in your meat, did they?
Mr. Ettinger. No.
Mr. Stupak. Because you never told them there was carbon
monoxide there.
Mr. Ettinger. No, but the complaints I was referring to are
related to flavor or an off-condition.
Mr. Stupak. Right, but now, once we know your 800 number,
people can now call, who might be watching this, and voice
their opinions on carbon monoxide. Would that be fair?
Mr. Ettinger. Yes.
Mr. Stupak. OK. Mr. Page, would that be fair if they called
your 1-800-523-4635 to express their concerns?
Mr. Page. Yes.
Mr. Stupak. Because you guys have said you have never done
any kind of studies to determine how consumers feel about it,
right?
Mr. Ettinger. No. That's correct. This would be an
excellent environment for consumers to learn all about the
advantages of the technology.
Mr. Stupak. OK. Let me ask you another question, if I may,
Mr. Ettinger.
Mr. Ettinger. Yes.
Mr. Stupak. Let me ask you this question. In your testimony
and in Precept's letter to the committee, dated August 11, you
stated that using carbon monoxide does not mask spoilage.
``Spoilage is manifested by changes in meat color, flavor or
appearance. We know that packaged meat in atmosphere containing
carbon monoxide will appear red indefinitely even if spoiled.''
In your testimony and in your letter, you stated that other
spoilage indicators like odor will alert consumers that a
product is spoiled even if it does not look like it. Please
explain to me how the consumer can detect off-odors in sealed
packages at the point of purchase.
Mr. Ettinger. They would not be able to. That is one of the
trade-offs of having a tamperproof/leakproof packaging, is it
would diminish the amount of odor. However, it also has the
added effect that, if a consumer were to take it home and open
it, it has trapped in any potential spoilage odors, and so they
would actually experience them much more strongly than
traditional meat items.
Mr. Stupak. But the point of deception is when I purchased
the meat. If it's spoiled because it's hermetically sealed, I
can't smell it if I wanted to in the store.
Mr. Ettinger. Not at the point of purchase, but then our
expectation is we would have heard about it from our consumers.
Mr. Stupak. In fact, when you talked about the samples in
your answers, you said you had one here, and in about 2 years,
that would have a significant odor, but you can't smell it
right there, can you?
Mr. Ettinger. That is correct.
Mr. Stupak. OK.
Mr. Page, Mr. Burgess asked you about the safety and all
that of carbon monoxide, but, just recently, Cargill recalled
over 1 million pounds of ground beef in November, right?
Mr. Page. That is correct.
Mr. Stupak. Isn't it true that the last recall was for E.
coli O157:H7, a particularly dangerous pathogen? Right?
Mr. Page. It was.
Mr. Stupak. Eleven percent of that recall, 119,000 pounds,
was shipped to grocers in packages that contained carbon
monoxide; isn't that correct?
Mr. Page. Yes.
Mr. Stupak. OK. I have no further questions.
Mr. Burgess.
Mr. Burgess. Yes, but just to follow up on that, the
product that was shipped that had the toxigenic E. coli that
also concomitantly had carbon monoxide, those two facts are
true and not related. Like the carbon monoxide did not cause
the E. coli. It didn't cause it to be more toxigenic. It didn't
cause it to be more virulent than it would have been under
normal circumstances. We really should be having this hearing
about toxigenic E. coli and how it finds its way into the
ground beef products that are sold in our stores.
Mr. Stupak. I agree.
Mr. Burgess. Instead, we're talking about a packaging
component where realistically--again, I'll reiterate, there
have been no illnesses, no deaths, no complaints or 48
complaints out of 22 million items sold.
I agree with Mr. Ettinger completely. If you open a package
that has been sealed against leakage and the micro atmosphere
is escaping and you open it up and it's a bad product, you're
going to know about it pretty quickly, and if you're in my
family, you'd probably take it back to the grocery store and
get reimbursed or an additional product dispensed.
Would that not be the case, Mr. Ettinger?
Mr. Ettinger. Yes, sir.
Mr. Burgess. So he's familiar with my family.
Look, as to this line of questioning that we've just heard,
there's a lot of things that I could say.
To any one of you, is it deceptive that you put nitrogen in
the micro atmosphere of those packages before you seal them up
in those leakproof containers? Do you feel it's deceptive to
the consumer that you're not disclosing that there is nitrogen
in those packages?
Mr. Ettinger. No, we don't believe so. We think it has been
fairly common practice to have modified atmosphere for a number
of food products to enhance freshness and safety.
Mr. Burgess. Well, of course, nitrogen occurs--it's
ubiquitous in our atmosphere, and it's generally an inert gas
as far as human and plant life is concerned and as far as the
process of respiration is concerned, but carbon dioxide is not,
so you're putting in 40 percent carbon dioxide. That would
probably be a lethal partial pressure of carbon dioxide for any
one of us if we were to breathe 40 percent carbon dioxide for
any period of time.
Do you disclose that?
Mr. Ettinger. No, sir, because it is just in the package,
and it dissipates upon opening.
Mr. Burgess. Exactly. So the issue of the carbon monoxide,
again, is to extend the shelf life of the product, which is
clearly defined and delineated on the product that you sell on
the shelves.
I would be interested if there has been any type of audit
done to show whether or not the product is in a timely fashion
removed from the grocery shelves if it extends beyond its ``use
by'' or ``freeze by'' date. There is no way that this Congress,
that this committee, can ever, ever prevent a consumer from
mishandling a product. That's going to happen from time to
time, and it's regrettable, but we can't go into every
refrigerator and every home and make certain that all the food
that has a ``use by'' or a ``sell by'' date is disposed of in a
proper manner.
I support and encourage Mr. Ettinger to continue with that
technology that would, perhaps, be an additional visual cue to
the consumer that maybe this stuff has gone beyond its date.
Again, short of self-inhalation or some type of warning buzzer
on the package of bacon, I don't know how you would get that
accomplished.
Again, I'll just tell you, Mr. Chairman, that I'm a little
disappointed with the hearing. There are plenty of things--
we've devoted a whole day to this. There are plenty of other
things we could have done. For heaven sakes, we never had a
hearing in subcommittee on SCHIP, and we've devoted a whole day
to this. I'm, frankly, mystified by the behavior of the
majority.
I yield back the balance of my time.
Mr. Stupak. Obviously, you missed the hearing on SCHIP. It
was on Medicare Advantage, which we did have a very good
hearing on.
So this hearing is necessary for a number of reasons. Last
week, Agriculture had their hearing, and they did not have very
balanced panels, shall we say, when the consumer groups were
not invited. Here, we've had both sides.
Second, legislation pending before our committee does call
for the labeling of carbon monoxide-treated packaging in meat.
That's our food safety bill. We've done most of our work on
inspections, all of our food safety. Seafood especially we did
some hearings on earlier this year. So we've had about three or
four hearings. This is right up the line, and it's an
appropriate hearing.
With that, let me dismiss and thank this panel for coming.
Thank you for adding your testimony today.
Mr. Ettinger, we'll need those 10 letters or letters you
said you had by scientists, because we agreed to put that in
the record. We would like to do that, please.
Mr. Ettinger. Yes, sir.
Mr. Stupak. So I want to thank all of our witnesses for
coming today and for your testimony.
I ask unanimous consent that the hearing record will remain
open for 30 days for additional questions for the record.
Without objection, the record will remain open.
I ask unanimous consent that the contents of our document
binder be entered into the record. Without objection, the
documents will be entered into the record.
That concludes our hearing. Without objection, this
hearing of the subcommittee is adjourned.
[Whereupon, at 3:30 p.m., the subcommittee was adjourned.]
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