[House Report 110-239]
[From the U.S. Government Publishing Office]
110th Congress Report
HOUSE OF REPRESENTATIVES
1st Session 110-239
======================================================================
POPCORN WORKERS LUNG DISEASE PREVENTION ACT
_______
July 18, 2007.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
_______
Mr. George Miller of California, from the Committee on Education and
Labor, submitted the following
R E P O R T
together with
MINORITY VIEWS
[To accompany H.R. 2693]
[Including cost estimate of the Congressional Budget Office]
The Committee on Education and Labor, to whom was referred
the bill (H.R. 2693) to direct the Occupational Safety and
Health Administration to issue a standard regulating worker
exposure to diacetyl, having considered the same, report
favorably thereon with an amendment and recommend that the bill
as amended do pass.
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Popcorn Workers Lung Disease
Prevention Act''.
SEC. 2. FINDINGS.
Congress finds the following:
(1) An emergency exists concerning worker exposure to
diacetyl, a substance used in many flavorings, including
artificial butter flavorings.
(2) There is compelling evidence that diacetyl presents a
grave danger and significant risk of life-threatening illness
to exposed employees. Workers exposed to diacetyl have
developed, among other conditions, a debilitating lung disease
known as bronchiolitis obliterans.
(3) From 2000-2002 NIOSH identified cases of bronchiolitis
obliterans in workers employed in microwave popcorn plants, and
linked these illnesses to exposure to diacetyl used in butter
flavoring. In December 2003, NIOSH issued an alert ``Preventing
Lung Disease in Workers Who Use or Make Flavorings,''
recommending that employers implement measures to minimize
worker exposure to diacetyl.
(4) In August 2004 the Flavor and Extract Manufacturers
Association of the United States issued a report, ``Respiratory
Health and Safety in the Flavor Manufacturing Workplace,''
warning about potential serious respiratory illness in workers
exposed to flavorings and recommending comprehensive control
measures for diacetyl and other ``high priority'' substances
used in flavoring manufacturing.
(5) From 2004-2007 additional cases of bronchiolitis
obliterans were identified among workers in the flavoring
manufacturing industry by the California Department of Health
Services and Division of Occupational Safety and Health (Cal/
OSHA), which through enforcement actions and an intervention
program called for the flavoring manufacturing industry in
California to reduce exposure to diacetyl.
(6) In a report issued in April 2007, NIOSH reported that
flavor manufacturers and flavored-food producers are widely
distributed in the United States and that bronchiolitis
obliterans had been identified among microwave popcorn and
flavoring-manufacturing workers in a number of States.
(7) Despite NIOSH's findings of the hazards of diacetyl and
recommendations that exposures be controlled, and a formal
petition by labor organizations and leading scientists for
issuance of an emergency temporary standard, the Occupational
Safety and Health Administration (OSHA) has not acted to
promulgate an occupational safety and health standard to
protect workers from harmful exposure to diacetyl.
(8) An OSHA standard is urgently needed to protect workers
exposed to diacetyl from bronchiolitis obliterans and other
debilitating conditions.
SEC. 3. ISSUANCE OF STANDARD ON DIACETYL.
(a) Interim Standard.--
(1) Rulemaking.--Notwithstanding any other provision of law,
not later than 90 days after the date of enactment of this Act,
the Secretary of Labor shall promulgate an interim final
standard regulating worker exposure to diacetyl. The interim
final standard shall apply--
(A) to all locations in the flavoring manufacturing
industry that manufacture, use, handle, or process
diacetyl; and
(B) to all microwave popcorn production and packaging
establishments that use diacetyl-containing flavors in
the manufacture of microwave popcorn.
(2) Requirements.--The interim final standard required under
subsection (a) shall provide no less protection than the
recommendations contained in the NIOSH Alert ``Preventing Lung
Disease in Workers Who Use or Make Flavorings'' (NIOSH
Publication 2004-110) and include the following:
(A) Requirements for engineering, work practice
controls, and respiratory protection to minimize
exposure to diacetyl. Such engineering and work
practice controls include closed processes, isolation,
local exhaust ventilation, proper pouring techniques,
and safe cleaning procedures.
(B) Requirements for a written exposure control plan
that will indicate specific measures the employer will
take to minimize employee exposure; and requirements
for evaluation of the exposure control plan to
determine the effectiveness of control measures at
least on a biannual basis and whenever medical
surveillance indicates abnormal pulmonary function in
employees exposed to diacetyl, or whenever necessary to
reflect new or modified processes.
(C) Requirements for airborne exposure assessments to
determine levels of exposure and ensure adequacy of
controls.
(D) Requirements for medical surveillance for workers
and referral for prompt medical evaluation.
(E) Requirements for protective equipment and
clothing for workers exposed to diacetyl.
(F) Requirements to provide written safety and health
information and training to employees, including hazard
communication information, labeling, and training.
(3) Effective date of interim standard.--The interim final
standard shall take effect upon issuance. The interim final
standard shall have the legal effect of an occupational safety
and health standard, and shall apply until a final standard
becomes effective under section 6 of the Occupational Safety
and Health Act (29 U.S.C. 655).
(b) Final Standard.--Not later than 2 years after the date of
enactment of this Act, the Secretary of Labor shall, pursuant to
section 6 of the Occupational Safety and Health Act (29 U.S.C. 655),
promulgate a final standard regulating worker exposure to diacetyl. The
final standard shall contain, at a minimum, the worker protection
provisions in the interim final standard, a short term exposure limit,
and a permissible exposure limit that does not exceed the lowest
feasible level, and shall apply at a minimum to all facilities where
diacetyl is processed or used.
SEC. 4. STUDY AND RECOMMENDED EXPOSURE LIMITS ON OTHER FLAVORINGS.
(a) Study.--The National Institute of Occupational Safety and Health
shall conduct a study on food flavorings used in the production of
microwave popcorn. The study shall prioritize the chemicals that are
most closely chemically associated with diacetyl to determine possible
exposure hazards. NIOSH shall transmit a report of the findings of the
study to the Occupational Safety and Health Administration.
(b) Recommended Exposure Limits.--Upon completion of the study
conducted pursuant to subsection (a), NIOSH shall establish recommended
exposure limits for flavorings determined by such study to pose
exposure hazards to workers involved in the production of microwave
popcorn.
I. PURPOSE
The purpose of this legislation is to direct the
Occupational Safety and Health Administration to issue a
standard regulating worker exposure to diacetyl, an artificial
chemical butter flavoring product that has been shown to cause
serious lung disease called bronchiolitis obliterans, also
known as ``popcorn lung.'' While the first cases of popcorn
lung were identified in a Missouri microwave popcorn plant in
2000 and the disease was linked to diacetyl shortly thereafter,
the Occupational Safety and Health Administration has not taken
any significant action to prevent worker exposure to diacetyl.
II. COMMITTEE ACTION INCLUDING LEGISLATIVE HISTORY AND VOTES IN
COMMITTEE
Action in previous Congresses
There was no action on diacetyl in previous Congresses.
110th Congress
Hearing on ``Have OSHA standards kept up with workplace hazards?''
On April 24, 2007, the Workforce Protections Subcommittee,
led by chairwoman Lynn Woolsey (D-CA), conducted an oversight
hearing titled ``Have OSHA Standards Kept up With Workplace
Hazards?'' in order to address the lack of OSHA standards
issued over the past six years. The witnesses discussed the
obstacles to issuing OSHA standards, opportunities to speed up
the process and the human cost of failing to issue needed
protective standards. Witnesses included Assistant Secretary of
Labor Edwin Foulke, Scott Schneider Director of Occupational
Safety and Health for the Laborers' Health and Safety Fund of
North America, Frank Mirer, PhD, Professor of Environmental and
Occupational Health Sciences, Hunter School of Urban Public
Health, New York, Baruch Fellner an attorney at Gibson, Dunn
and Crutcher, and Eric Peoples, a former employee of Glister-
Mary Lee popcorn factory, victim of bronchiolitis obliterans
(popcorn lung).
Introduction of H.R. 2693, the ``Popcorn Workers Lung Disease
Prevention Act''
On June 13, 2007, the Popcorn Workers Lung Disease
Prevention Act, as H.R. 2693, was introduced in the 110th
Congress by Representative Lynn Woolsey, joined by 13 original
co-sponsors, including Chairman George Miller (D-CA) as a lead
co-sponsor.
Full Committee markup of H.R. 2963
On June 20, 2007 the Committee on Education and Labor met
to markup H.R. 2693, Popcorn Workers Lung Disease Prevention
Act. The Committee adopted by voice vote an amendment in the
nature of a substitute offered by Mrs. Woolsey which added a
short title.
Mr. Wilson offered an amendment in the nature of a
substitute that would have delayed promulgation of a final
standard until ``the National Institute of (sic) Occupational
Safety and Health concludes there is sufficient data to support
a recommended exposure limit.'' Mr. Wilson withdrew the
amendment pending further discussion.
A second amendment offered by Mr. Wilson was adopted by
voice vote. The adopted amendment requires the National
Institute for Occupational Safety and Health to conduct a study
of possible substitutes for diacetyl in popcorn manufacturing,
and to develop Recommended Exposure Limits for those found to
be hazardous. The Committee voted to favorably report H.R. 2693
by a voice vote.
III. SUMMARY OF THE BILL
A number of individuals employed in microwave popcorn
production and packaging and food flavoring manufacturers have
contracted an irreversible and life threatening respiratory
disease called bronchiolitis obliterans. There is compelling
scientific evidence that a chemical used in artificial butter
flavoring called diacetyl presents a grave danger and
significant risk of bronchiolitis obliterans and other
respiratory disease to exposed employees.
H.R. 2693 would require OSHA to issue an interim final
standard minimizing worker exposure to diacetyl. The standard
must contain provisions for engineering controls, respiratory
protection, exposure monitoring, medical surveillance and
worker training. It must not be less protective than guidelines
issued by the National Institute for Occupational Safety and
Health in 2003.
OSHA would then be required to issue a final standard
within two years. This final standard would apply to all
locations where there is worker exposure to diacetyl and would
include a permissible exposure limit.
IV. STATEMENT AND COMMITTEE VIEWS
The Committee on Education and Labor of the 110th Congress
is committed to ensuring that the federal government does
everything within its power to ensure that workplaces are safe
and that the health and safety of American workers is
protected, consistent with the goals of the Occupational Safety
and Health Act of 1970.
H.R. 2693 addresses the protection of workers from
diacetyl, and food-flavoring chemical that has been shown to
cause serious, irreversible obstructive lung disease, called
bronchiolitis obliterans (or popcorn lung), in exposed
employees working in popcorn production and packaging
facilities, as well as food flavoring production facilities
throughout the country.
The Committee considers this matter an emergency. Urgent
action is needed by OSHA to protect exposed workers. NIOSH has
reported the onset of respiratory symptoms as only months after
exposure to diacetyl. Government officials have been aware of
the disease since 2000 and have linked the disease to food
flavoring chemicals since 2002. Mere guidelines for limiting
diacetyl exposure are not sufficient. California researchers,
for example, have found that despite the fact that government
and industry guidance materials were issued in 2003 and 2004,
many of their recommendations had not been implemented in
flavor manufacturing facilities in California, according to a
compliance survey conducted in 2006.\1\
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\1\Materna B, et. al. ``Fixed Obstructive Lung Disease Among
Workers in the Flavor-Manufacturing Industry--California, 2004-2007,''
Morbidity and Mortality Weekly Report, 56(16) (Apr. 27, 2007) at 389-
393.
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In the absence of government protections, hundreds of
former popcorn plant workers have sued companies supplying or
making diacetyl and more than $100 million has been awarded by
juries or paid in settlements.
The Food and Flavoring Manufacturing Association reported
that at least 3,000 workers are employed in producing
flavorings throughout the country. Thousands of others working
in the microwave popcorn and other food industries are exposed
in the ``downstream'' use of flavorings.
OSHA has failed to act to protect workers even though
effective measures to protect workers from the effect of
exposure to diacetyl are well recognized. For example, the
National Institute for Occupational Safety and Health issued
guidelines to be used by employers to protect workers in 2003,
and the Flavor and Extract Manufacturers Association (FEMA)
issued similar detailed guidelines in 2004.
OSHA has not proceeded aggressively to prevent worker
exposure to diacetyl
The first suspicions that bronchiolitis obliterans among a
group of workers was linked to their work surfaced in 2000.
NIOSH first linked bronchiolitis obliterans to food flavorings
in 2002 and evidence quickly accumulated pointing to an
artificial butter flavoring chemical called diacetyl.
Despite evidence of substantial work-related hazards, OSHA
has not taken action to minimize exposure to diacetyl. In 2002,
it notified its Regional Administrators about the problem and
formed a short term alliance with the Popcorn Board.\2\ Since
then, OSHA has announced its intention to issue a Safety and
Health Information Bulletin, but nothing has been issued as of
this time. Hours before the Subcommittee's April 24 hearing,
OSHA announced a National Emphasis Program (NEP) for the
popcorn industry, where all microwave popcorn facilities that
use diacetyl would be inspected before the end of 2007. Despite
the announcement, the NEP has not yet been implemented, nor has
any significant OSHA action been taken in addressing the
problem in flavoring manufacturing.
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\2\Have OSHA Standards Kept up With Workplace Hazards? Hearing
before the Subcommittee on Workforce Protections, 110th Congress, 1st
Session (2007) (written testimony of Edwin Foulke, at 3).
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In July 2006, two labor unions, the United Food and
Commercial Workers and the International Brotherhood of
Teamsters, petitioned OSHA to immediately issue an Emergency
Temporary Standard for diacetyl. The petition was accompanied
by a supportive letter from 42 of the nation's leading
occupational safety and health scientists and experts (see
Appendix). In August of 2007, U.S. Representatives George
Miller (D-CA), Major Owens (D-NY), and Hilda Solis (D-CA) sent
a letter to OSHA supporting the union petition. OSHA has not
responded to the petition.\3\
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\3\Letter to the Department of Labor Secretary Elaine Chao (Aug. 2,
2006).
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Workers are paying the price for OSHA inaction
Bronchiolitis obliterans is a severe, irreversible and
often fatal lung disease that has been found to be caused by
exposure to diacetyl. Dozens of workers at microwave popcorn
plants and flavor manufacturing facilities have suffered severe
occupational lung disease and several have died.
Eric Peoples, a former microwave popcorn plant worker in
Jasper, Missouri, contracted bronchiolitis obliterans from
exposure to diacetyl. In his testimony before the committee,
Peoples revealed that the company that supplied the butter
flavor, Bush Boake Allen, a subsidiary of International Flavors
& Fragrances (IFF) had extensive notice about the hazards of
butter flavor and took measures to protect its own workers
including respiratory protection and enclosure of the
process.\4\
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\4\Have OSHA Standards Kept up With Workplace Hazards? Hearing
before the Subcommittee on Workforce Protections, 110th Congress, 1st
Session (2007) (written testimony of Eric Peoples, at 2) [Hereinafter
Peoples Testimony].
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He went on to describe how BASF Chemical Company, a
supplier of diacetyl, sent IFF a Material Safety Data Sheet
(MSDS) in 1994 which disclosed rats that had inhaled the
chemical diacetyl developed severe respiratory problems
including emphysema. IFF was also aware of two employees at a
baking company who had been diagnosed with bronchiolitis
obliterans in 1986 while mixing a butter flavoring for use on
cinnamon rolls.
Peoples described how he worked with the hazardous chemical
without information that could have protected him.
Despite all this information the buckets containing
this product said the product was safe. The Material
Safety Data Sheets said the product had ``no known
health hazards'' and that's what I believed.\5\
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\5\Peoples Testimony at 3.
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Peoples paid the price for this negligence:
Let me bring it home to you if I can. I have a 24%
lung capacity. I am currently on the inactive Lung
Transplant registry. One case of pneumonia could cause
me to need the transplant now. The average rate of
survival for someone with a lung transplant is about
five years. Seventy-five percent of lung transplant
patients are dead after 10 years.\6\
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\6\Id.
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Linda Redman worked with Eric Peoples. Her experience was
described in a story in the St. Louis Post Dispatch:
Linda Redman started working as a packer at the
Jasper popcorn plant in 1995, two years after the
original study. Within two years, her breathing was so
bad that she had to quit.
Redman used to work 12 hours a day and then come home
to garden, cook dinner, and do her family's laundry.
Now, she lives alone in Joplin, relying on home health
nurses four days a week to help with basic chores
around the house.
Redman, 55, doesn't have the stamina to change her
bedsheets or cook herself dinner, unless it's something
out of a can.
Only 15 percent of her lung capacity remains. Redman
bides her time while waiting for a lung transplant by
taking breathing treatments every four hours. She is
constantly tethered to an oxygen tank, but she still
gets exhausted walking from the bedroom to the couch.
``There's no amount of money that can ever buy back
what we've lost--our health,'' Redman said of herself
and the other sick workers. ``There's a couple of us I
don't think can make it much longer.''\7\
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\7\Sarah Shipley, ``Study Showed Chemical was Toxic,'' St. Louis
Post Dispatch (Feb. 28, 2004).
Linda Redman died April 30, 2006.\8\
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\8\``Popcorn Lung Victim Linda Redman Dies,'' Associated Press (May
2, 2006).
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The Sacramento Bee reported on Irma Ortiz and Frank Herrara
who also suffered irreversible lung damage due to exposure to
diacetyl.
Hacking and gasping, Irma Ortiz could cart her
groceries only so far before she'd catch other shoppers
glaring at her.
Mortified, she'd abandon her cart on the spot and
bolt for the door.
Frank Herrera could gun his dirt bike only so far
before choking on the rush of air. Go. Stop. Go. Stop.
Exasperated, he gave up riding.
Ortiz, 44, and Herrera, 34, are odd candidates for
lung transplants, being nonsmokers and having
considerable youth on their side.
How they lost 70 to 80 percent of their breathing
capacity is no less astonishing. They acquired the same
rare, lung-ravaging disease from breathing the same
chemicals on the same type of job.
The two weren't working in a chemical or pesticide
plant. Nor in a weapons plant. They didn't metal-plate,
fumigate, degrease, demolish, smelt or weld.
They made, of all things, artificial food flavorings.
* * *
``They never said nothing to us about the chemicals
there, the kinds of dangers or give us a warning like,
you know, `This is bad for you guys, protect yourselves
better,''' Ortiz said of her former employer. ``They
never say nothing to us like that.''\9\
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\9\Chris Bowman, ``Two Workers Need Transplants; Threat Could Be
Widespread,'' Sacramento Bee (July 30, 2006).
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Compelling scientific evidence that diacetyl is hazardous
There is compelling human and animal-based evidence that
diacetyl is hazardous, presents a grave risk to exposed
workers, and must be controlled.
There is evidence as far back as 1985 that flavoring
chemicals, including diacetyl, were hazardous when
bronchiolitis obliterans was identified in flavoring
manufacturing workers, although the cause was not identified at
that time.\10\ In 1993, BASF, a manufacturer and supplier of
diacetyl, conducted an inhalation study of diacetyl using rats.
The study found that that ``mid and high concentrations
resulted in an abundance of symptoms indicative for respiratory
tract injury. In the mid concentration group, these symptoms
developed mainly from day one onward * * *'' The study was
never reported to the government or published in scientific
literature.\11\
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\10\Materna B, et. al. ``Fixed Obstructive Lung Disease Among
Workers in the Flavor-Manufacturing Industry--California, 2004-2007,''
Morbidity and Mortality Weekly Report, 56(16) (April 27, 2007) at 389-
393.
\11\BASF. Report: Study on the Acute Inhalation Toxicity LC50 of
Diacetyl FCC as a Vapor in Rats 4-hour Exposure. Project No. 1310247/
927010 (June 8, 1993).
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In 2002, a NIOSH investigation found ``that workers exposed
to flavorings at microwave popcorn factories are at risk for
developing fixed obstructive lung disease.'' Workers at one
plant had chronic cough and shortness of breath at a rate 2.6
times higher than what would be expected in the U.S.
population. Twice as many workers as expected reported being
told by their physicians that they had asthma or chronic
bronchitis. Lung function testing revealed that three times as
many workers as expected had obstruction to airflow.\12\
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\12\Kreiss K, et al. ``Clinical Bronchiolitis Obliterans in Workers
at a Microwave-Popcorn Plant. N Engl J.Med. 347(5) (2002) at 330-338.
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NIOSH has conducted eight investigations at microwave
popcorn facilities at facilities in a number of locations
throughout the United States, finding respiratory impairment
among workers at a majority of the plants and recommending
actions similar to those recommended in H.R. 2693 to reduce
exposure.\13\
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\13\Centers for Disease Control and Prevention. Morbidity and
Mortality Weekly Report. Fixed Obstructive Lung Disease in a Microwave
Popcorn Factory-Missouri, 2000-2002. 51 (Apr. 26, 2002) at 345-347. See
also: HETA 2006-0303-3043, Carmi Flavor and Fragrance Company, Inc.,
Commerce, California (April 2007); HETA 2006-00195-3044, Yatsko's
Popcorn, Sand Coulee, Montana (April 2007); HETA 2000-0401-2991,
Gilster-Mary Lee Corporation, Jasper, Missouri (Jan. 2006); HETA 2001-
0474-2943, American Pop Corn Company, Sioux City, Iowa, July 2004, HETA
2003-0112-2949, ConAgra Snack Foods, Marion, Ohio (Dec. 2004); HETA
2002-0089, Nebraska Popcorn, Clearwater, Nebraska (July 2003); HETA-
2002-0408-2915, Agrilink Foods Popcorn Plant, Ridgeway, Illinois (Oct.
2003); HETA 2001-0517, B.K. Heuermann Popcorn Inc., Phillips, Nebraska
(final and interim letters) (May 2003); HETA 1985-171-1710,
International Bakers Services, Inc., South Bend, Indiana (July 1986).
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In its most recent report at Carmi Flavor and Fragrance
Company, where workers worked mostly with powdered flavorings,
NIOSH found that ``it is highly likely that exposures to
diacetyl contributed to the occurrence of severe fixed
obstructive lung disease in production workers'' and
recommended engineering controls, respiratory protection,
improved work practices and medical monitoring.\14\
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\14\HETA 2006-0303-3043, Carmi Flavor and Fragrance Company, Inc.,
Commerce, California (April 2007).
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A NIOSH investigation of Gilster MaryLee popcorn plant
found that workers ``had 3.3 times the rate of obstruction on
NIOSH spirometry tests compared to national rates; the
prevalence of obstruction in never-smokers was 10.8 times the
national rate'' and that 19 of 21 affected workers had symptoms
consistent with bronchiolitis obliterans.
Furthermore, ``a strong exposure-response relationship was
demonstrated between quartiles of estimated cumulative exposure
to diacetyl (a volatile butter flavoring chemical contaminating
the air in the plant) and the frequency of airways obstruction
on spirometry tests.'' NIOSH recommended engineering controls
(such as closed systems), air sampling, respiratory protection
and medical monitoring.\15\
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\15\HETA 2000-0401-2991, Gilster-Mary Lee Corporation, Jasper,
Missouri (Jan. 2006).
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Cases of bronchiolitis obliterans have also been found
among diacetyl-exposed workers in flavorings plants. The
California Department of Health Services has recently reported
eight cases among diacetyl-exposed workers employed at
factories at which the flavorings are produced.\16\
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\16\Harrison R, Gelb A, Harber P. Department of Health Services,
State of California. State of California Study: ``Food Flavoring
Workers with Bronchiolitis Obliterans Following Exposure to Diacetyl''
(May 15, 2006).
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There is compelling scientific evidence supporting a
permissible exposure limit at the lowest feasible level, since
there is currently no evidence of a safe level of exposure to
diacetyl. In their evaluation of six microwave popcorn plants
(five of which had workers with flavoring-associated lung
disease), NIOSH scientists reported sick workers were found
even in areas with the lowest exposure levels measurable. On
the basis of this finding, the NIOSH scientists concluded ``it
would seem prudent to maintain worker exposures to diacetyl
below these levels.'' The study also concluded that very high
(peak) exposures needed to be controlled even if average levels
were low.\17\
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\17\Kanwal R, et al. ``Evaluation of Flavorings-Related Lung
Disease Risk at Six Microwave Popcorn Plants,'' J. Occup. Enviro. Med.,
48(2) (2006) at 149-157.
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Some have objected to the requirements of H.R. 2693 because
employers may substitute other chemicals that may be as
dangerous as diacetyl. Substitution of one chemical for an
equally or more dangerous chemical is always a risk. That
possibility, however, could be used as a reason never to
regulate any chemical. Federal law requires manufacturers and
employers to evaluate the safety of chemicals to which workers
are exposed. Due diligence and compliance with the law should
minimize this risk with diacetyl or any other hazardous
chemical.
While many of the studies of food flavoring and popcorn
production workers describe exposure to a variety of food
flavoring chemicals, there is compelling scientific evidence
from animal and human studies showing that diacetyl is the main
chemical causing respiratory symptoms and bronchiolitis
obliterans.
The role of diacetyl in the development of bronchiolitis
obliterans has been confirmed in studies of laboratory animals.
In addition to the BASF study mentioned above, NIOSH scientists
conducted a study in which rats were exposed to airborne
concentrations of heated butter flavoring whose primary
constituent was diacetyl. The rats were exposed for a single,
six-hour period. The scientists reported significant lung
damage among rats whose exposure was as low as 203 ppm, which
according to the authors was ``not extraordinary when compared
with levels measured in the workplace.''\18\
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\18\Hubbs AF, et al. ``Necrosis Of Nasal And Airway Epithelium In
Rats Inhaling Vapors Of Artificial Butter,'' Toxicology and Applied
Pharmacology (2002) at 185, 128-135.
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NIOSH scientists then conducted a study in which rats were
exposed to pure diacetyl and found similar results.\19\
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\19\Hubbs AF, et al. ``Inhalation Toxicity Of The Flavoring Agent,
Diacetyl (2,3-Butanedione), In The Upper Respiratory Tract Of Rats,''
Toxicologist, 78 (S-1) (2004) at 438-439.
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A toxicological study of guinea pigs exposed to diacetyl
found exposure to the chemical caused adverse effects to
respiratory tissue and structure.\20\ And a study of the
effects of diacetyl on the respiratory tracts of mice also
showed respiratory damage.\21\
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\20\Fedan JS, Dowdy JA, Fedan KB, Hubbs AF. ``Popcorn Worker's
Lung: In Vitro Exposure To Diacetyl, An Ingredient In Microwave Popcorn
Butter Flavoring, Increases Reactivity To Methacholine.'' Toxicol Appl
Pharmaco, 215 (2006) at 17-22.
\21\Morgan DL, Flake G, Kirby PJ, et. al. ``Respiratory Tract
Toxicity Of Diacetyl In C57BL/6 Mice,'' Toxicol Sci, 90 (Suppl 1)
(2006) at 210.
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A recent Dutch study of the effects of diacetyl on workers
employed in the manufacture of diacetyl found that the exposed
workers had a considerably higher number of cases of
bronchiolitis obliterans than the unexposed population, as well
as significantly more symptoms of continuous trouble with
breathing, daily cough and asthma. The authors concluded that,
while they could not definitively identify diacetyl as the
cause of the disease cases, the findings were ``consistent with
findings in the literature of bronchiolitis obliterans (BO)
cases associated with butter flavoring exposure and in
particular diacetyl in popcorn workers.''\22\
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\22\Van Rooy, G.B.G.J., et. al. ``Respiratory Effects In Workers Of
A Diacetyl Production Plant With A Special Focus On Bronchiolitis
Obliterans,'' Nederlands Kenniscentrum Arbeid en Longaandoeningen,
University of Utrecht, Institute for Risk Assessment Sciences (2005).
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The California Department of Health Services (DHS), which
is taking an active role in addressing workplace diacetyl
hazards, has strong evidence concerning the threat of diacetyl.
DHS sent a letter to employers last year warning about two
cases of bronchiolitis obliterans among workers at food
flavoring companies in California. ``This disease has been
linked to exposure to diacetyl, a butter flavoring
ingredient.\23\
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\23\``To Cases of Bronchiolitis Obliterans (Life-Threatening Lung
Disease) Among California Flavoring Manufacturing Workers,''
Occupational Health Branch, CA Dep't of Health Services (May 15, 2006).
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California DHS has also issued an Alert specifically
targeting diacetyl use. The Alert states that ``Exposure to
diacetyl used in flavoring manufacturing companies may cause a
serious lung disease called bronchiolitis obliterans.* * * If
you work at a flavoring company that uses diacetyl, see a
doctor immediately to make sure that your health is not being
affected.'' The Alert recommends substitution for less
hazardous flavoring ingredients, closed production processes,
ventilation and respiratory protection.\24\
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\24\``Diacetyl (Butter Flavor Chemical) Use in Flavoring
Manufacturing Companies,'' Hazard Evaluation System & Information
Service, Occupational Health Branch, CA Dep't of Health Services (Aug.
2006).
---------------------------------------------------------------------------
While more study of diacetyl and other food flavoring
chemicals can and should be done, the overwhelming weight of
current evidence points to diacetyl as the culprit chemical
causing respiratory disease. Evidence available today
necessitates action and the passage of this bill. We know how
to prevent workers from getting sick and dying. Inaction is
unacceptable.
Workers can be protected against diacetyl
While more studies are needed to identify the precise
mechanisms by which diacetyl causes lung disease, there are
proven measures that can be implemented immediately by
employers to effectively protect workers from dangerous
exposure. Based on these proven measures, H.R. 2693 directs
OSHA to mandate that these measures be taken--within three
months in microwave popcorn and food flavoring manufacturers,
and within two years for other locations where workers are
exposed to diacetyl.
The National Institute for Occupational Safety and Health
issued guidelines in 2003 after documenting bronchiolitis
obliterans in several different plants where flavorings were
used or where chemicals were handled in the production of
flavorings. NIOSH recommended that companies limit hazardous
exposures by substituting safer chemicals, enclosing operations
that use flavoring chemicals, use local exhaust ventilation,
employ work practices that reduce the likelihood of inhaling
harmful vapors, and use appropriate respiratory protection.
NIOSH also recommended air monitoring, medical surveillance,
worker training and labeling of containers.\25\
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\25\``Preventing Lung Disease in Those Who Use or Make
Flavorings,'' National Institute for Occupational Safety and Health
(NIOSH) Alert (2004).
---------------------------------------------------------------------------
The industry association that represents food flavoring
manufacturers has recognized the hazard and is recommending
measures that employers should take to protect workers. In
August 2004 the Flavor and Extract Manufacturers Association
(FEMA) issued a report, ``Respiratory Health and Safety in the
Flavor Manufacturing Workplace,'' warning about potential
serious respiratory illness in workers exposed to flavorings
and recommending comprehensive control measures for diacetyl
and other ``high priority'' substances used in flavoring
manufacturing.\26\
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\26\``Respiratory Health and Safety in the Flavor Manufacturing
Workplace,'' Flavor and Extract Manufacturers Association of the United
States (2004).
Despite the need for more investigation, FEMA recognizes
that sound respiratory health and safety programs can be
implemented without absolute certainty about the contribution
of other food flavors to the observed effects. It is clear that
flavors can be handled in such a manner that present a minimal
health risk. The Association recommends that employers take the
same measures recommended by NIOSH and includes detailed
information that employers can use to prevent worker exposure.
A 2007 CDC publication recommends basic industrial hygiene
precautions:
Safe occupational exposure levels for diacetyl and
many other flavoring chemicals have not been
established. Employers should implement measures to
minimize exposure. Engineering controls, including
local exhaust ventilation and closed transfer of
chemicals, should be the primary control measures. Work
practices such as covering containers and minimizing
spills also will reduce exposures. Employers should
establish a comprehensive respiratory protection
program for organic vapors and particulates that
adheres to the OSHA Respiratory Protection Standard.
Consultation with an industrial hygienist or
occupational safety and health professional might be
necessary to implement appropriate engineering
controls, work practices, and an appropriate
respiratory protection program.\27\
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\27\Materna, Barbara, Dep't of Health Services, State of
California, Summary of Eight Known Cases of Confirmed or Suspected
Fixed Obstructive Lung Disease in California Food Flavor Manufacturing
Workers (Jan. 11, 2007).
Because we know how to protect workers against diacetyl
exposure, particularly in the production of microwave popcorn
and food flavorings, it would be unacceptable from a public or
occupational health perspective to delay these protections in
microwave popcorn or food flavorings facilities while OSHA
receives comments on the Interim Final Standard by
stakeholders, or reviews the standard under the Small Business
Regulatory Enforcement Fairness Act, the Administrative
Procedures Act or other requirements of OSHA rulemaking. Such
procedures would still be available prior to issuance of the
final OSHA standard.
Workers still are not being protected from diacetyl
exposure
The urgent need for protections, as mandated under H.R.
2693, was emphasized in a CDC Morbidity and Mortality Weekly
Report published in April 2007 that reported that California
food flavoring workers exposed to diacetyl and butter
flavorings still are not being adequately protected despite
government and industry warnings and guidelines issued in 2003
and 2004.
The hazards of diacetyl and butter flavoring were
documented in published literature in 2002. However, by
2006, many flavoring suppliers still had not addressed
the risk for bronchiolitis obliterans in their material
safety data sheets. During 2004, NIOSH and the Flavor
and Extract Manufacturers Association disseminated
information encouraging flavor manufacturers to
implement exposure controls and medical surveillance.
These measures were virtually nonexistent in California
during 2006, when industry wide government intervention
measures began. Before June 2006, only eight California
flavor-manufacturing companies had begun medical
screening.\28\
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\28\Materna B, et al. ``Fixed Obstructive Lung Disease Among
Workers in the Flavor-Manufacturing Industry--California, 2004-2007,''
Morbidity and Mortality Weekly Report, 56(16) (Apr. 27, 2007) at 389-
393.
The report also revealed that a review of material safety
data sheets collected by the California Department of Health
Services from 11 diacetyl manufacturers or distributors
revealed that only ``five mention bronchiolitis obliterans and
none listed potential symptoms or recommended medical
surveillance for the disease.''
California is moving ahead to regulate diacetyl
The California Division of Occupational Safety and Health
is moving ahead to regulate the chemical. CalOSHA established
an advisory committee in 2007 to work on developing a diacetyl
standard. Cal/OSHA expects to send a proposed standard to
protect flavoring industry workers from diacetyl to the
Standards Board in the summer of 2007. (Unlike the federal OSHA
process, the seven-member CalOSHA Standards Board is authorized
to issue OSHA standards.)
Like the interim final standard mandated by H.R. 2693, the
California standard will not address ``downstream'' use of
diacetyl, in the food manufacturing industry. The current
advisory committee will continue to study the issue of how to
address issues in these workplaces.
The draft California standard would apply to:
Places of employment where one or more flavorings
are manufactured, packaged or blended with other flavorings.
Any flavoring containing diacetyl at a specified
concentration and weight, or sprayed or added to powdered food
product or ingredients. Workplaces with enclosed processes that
discharge emissions outside the facility would be exempted from
this provision.
Facilities where an employee has been diagnosed
with fixed obstructive lung disease and no other cause than
occupational exposure to one of more flavorings is readily
apparent.
The California proposal would also require employers to
measure employee exposure in order to determine the
effectiveness of exposure control measures. Employers also
would be required to implement engineering and work practice
controls, and provide respiratory protection, medical
surveillance and training.
The OSHA standard-making process is not protecting workers
The Bureau of Labor Statistics reported that in the year
2005 there were over 5,700 workers, or 16 workers a day, killed
in the workplace. NIOSH estimates that almost 60,000 workers
die each year of occupational disease, many of which are caused
by exposure to toxic chemicals.\29\
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\29\``Workers' Memorial Day--April 28, 2007,'' Morbidity and
Mortality Weekly Report, 56(16) (Apr. 27, 2007) at 389-393.
---------------------------------------------------------------------------
OSHA's standard-making process is broken, particularly
standard-making related to hazardous chemicals. Workers exposed
to diacetyl have fallen victim to this breakdown in the system.
Out of the almost 3,000 chemicals produced in large quantities
(more than one million pounds annually), OSHA enforces exposure
limits for fewer than 500 chemicals, standards that were
adopted when OSHA was created in 1971. Most of those are based
on science from the 1940's and 1950's. Since the OSHAct passed
in 1970, OSHA has issued comprehensive standards for only 27
substances, most issued in the first two decades of OSHA
existence.
In recent years, it appears that the standard-making
process had ground to a halt. Dr. Frank Mirer, a professor of
environmental and occupational health sciences, testifying at
the Workforce Protections subcommittee hearing on April 24,
2007, discussed the breakdown of OSHA's standard making
process:
OSHA, since 2001, has checked out of the standards
business. Slow progress in earlier years has ground to
a halt and may even be moving stealthily backward. OSHA
has staff and other resources to set standards, but
that staff has not been permitted to operate. Since
2001, this Administration set one new chemical
standard, for carcinogenic chromium, under court order.
That standard actually permits employers to increase
exposure levels under some circumstances. Unions were
forced to sue to get improvements, and that litigation
still pends. Regarding employers' responsibility to pay
for required protective equipment like respirators and
wire mesh gloves, Labor Secretary Elaine Chao finally
committed to issuing a final rule in response to a
union lawsuit and a court ordered deadline. That rule
was promised by November 2007. The rulemaking record
was completed in 1999.\30\
\30\Have OSHA Standards Kept up With Workplace Hazards? Hearing
before the Subcommittee on Workforce Protections, 110th Congress, 1st
Session (2007) (written testimony of Frank Mirer, at 3) [Hereinafter
Mirer testimony].
---------------------------------------------------------------------------
At a 2006 hearing on using non-consensus health and safety
standards, Dr. David Michaels, Director of the Project on
Scientific Knowledge and Public Policy and Research Professor
and Associate Chairman Department of Environmental and
Occupational Health at the George Washington University School
of Public Health and Health Services, pointed out that American
workers are left to rely on chemical standards issued by such
organizations like the American Conference of Governmental
Industrial Hygienists because OSHA no longer issues chemical
standards:
The regulatory agencies are simply unable to keep up.
In 1971, OSHA adopted en masse, about 400 ACGIH TLVs,
reached using the science of the 1950's and 1960's,
before we knew as nearly as much as we know today about
the long-term effects of many hazardous chemicals.
Since then, OSHA has updated only a handful of them.
The rest have been unchanged in more than 35 years. The
OSHA standard setting process is cumbersome and easily
delayed by those intent on slowing action. The
political appointees who run the agency at the present
time have no desire to strengthen weak standards;
except when under a court order. Workers cannot rely on
OSHA to issue new regulations on chemical hazards. OSHA
is paralyzed and has abdicated its responsibility to
issue health standards that protect workers.\31\
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\31\Addressing Concerns about the U.S. Department of Labor's Use of
Non-Consensus Standards in Workplace Health and Safety. Hearing before
the Subcommittee on Workforce Protections, 109th Congress, 2nd Session
(2006) (written testimony of David Michaels at 3) [hereinafter Michaels
Testimony].
Scott Schneider, Director of Occupational Safety and Health
for the Laborers' Health and Safety Fund of North America,
testifying at the Workforce Protections subcommittee hearing on
April 24, 2007, pointed out three major problems with OSHA
rulemaking: lack of budget, the burden of regulatory review,
and lack of political will.\32\
---------------------------------------------------------------------------
\32\Have OSHA Standards Kept up With Workplace Hazards? Hearing
before the Subcommittee on Workforce Protections, 110th Congress, 1st
Session (2007) (written testimony of Scott Schneider, at 2)
[hereinafter Schneider Testimony].
---------------------------------------------------------------------------
Dr. Frank Mirer expanded on the political obstacles:
The first barrier to setting a new standard is
getting the Labor Department to recognize that
something needs to be done about a hazard. That's a
political leadership decision. Once there's a decision
to move forward, the task that causes the most delay is
gathering business data to estimate costs. But, OSHA
staff have figured out how to get that cost
information. After that, the barriers, and sources of
delay, are getting approval from the Office of
Management and Budget to put a standard on the agenda,
complete the small business (SBREFA) review, to release
a proposed standard, and to finally promulgate the
final standard. But, OMB is not a free agent. The same
President who appointed the Secretary of Labor and
Assistant Secretary of Labor for OSHA also appointed
the heads of OMB and the Small Business
Administration.\33\
---------------------------------------------------------------------------
\33\Mirer Testimony at 4.
---------------------------------------------------------------------------
OSHA standards protect workers from occupational disease
and injury
One of the most important responsibilities that Congress
gave OSHA under the Occupational Safety and Health Act is the
issuance of safety and health standards. Congress declared in
passage of the Act that its ``purpose and policy'' was ``to
assure so far as possible every working man and woman in the
Nation safe and healthful working conditions. . . by providing
for the development and promulgation of occupational safety and
health standards.''
Mirer illustrated the importance of OSHA chemical
standards:
Chronic illness arising from long term chemical
exposures at work accounts for the large majority of
known work-related mortality. Few of these victims are
named on Workers Memorial Day, and many are not aware
of the chemical cause of their illness. Reducing those
known dangerous exposures is therefore the best
opportunity to protect the lives and health of American
workers. Recognizing the dangers of chemicals at work
also would facilitate controlling those chemicals at
home and in the community environment.\34\
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\34\Mirer Testimony at 5.
OSHA standards have proven to be effective in reducing
exposures and protecting workers' health. According to Mirer:
The standards process, when allowed to proceed
according to law, drastically reduces permissible and
actual exposures. The OSHA asbestos permissible
exposure limit, revised several times, was cut to 1% of
what it was in 1970, and even this limit leaves behind
a substantial cancer risk. We still pay for the legacy
of those old, high exposures. In the accompanying
table, we see that OSHA's new rules have reduced
allowable exposure by up to 1000-fold.\35\
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\35\Mirer Testimony at 6
ANNOTATED CHRONOLOGY OF OSHA PEL'S SHOWING EXTENT OF EXPOSURE LIMITATION
----------------------------------------------------------------------------------------------------------------
Substance 1910 Date Previous Final Reduction
----------------------------------------------------------------------------------------------------------------
Asbestos......................... 1001 1971 12 f/cc 5 f/cc 2.4
13 Carcinogens................... 1003 1974 NA NA
Vinyl Chloride................... 1017 1975 500 ppm 1 ppm 500
Asbestos......................... 1001 1976 5 f/cc 2 f/cc 2.5
Coke Oven Emissions.............. 1029 1977 0.2 mg/M\3\ 0. 15 mg/M\3\ 1.3
Inorganic Arsenic................ 1018 1978 0.5 mg/M\3\ 0.01 mg/M\3\ 50
Lead............................. 1025 1978 200 ug/M\3\ 50 ug/M\3\ 4
DBCP............................. 1044 1978 .................... 0.001 mg/M\3\ na
Acrylonitrile.................... 1045 1978 20 ppm 2 ppm 10
Cotton Dust...................... 1043 1978 1 mg/M\3\ 0.2 mg/M\3\ 5
Asbestos......................... 1984 2 f/cc 0.2 f/cc 10
Ethylene Oxide................... 1047 1986 50 ppm 1 ppm 50
Benzene.......................... 1028 1987 10 ppm 1 ppm 10
Formaldehyde..................... 1048 1988 3 ppm 0.75 ppm 4
Cadmium.......................... 1027 1992 0.2 mg/M\3\ 0.005 mg/M\3\ 40
Methylenedianiline............... 1050 1992 .................... 0.01 ppm na
Lead In Construction............. 1926.62 1993 200 ug/M\3\ 50 ug/ M\3\ 4
Asbestos......................... 1001 1994 0.2 f/cc 0.1 f/cc \*\2
Asbestos in Construction......... 1926.1101 1994 .................... 0.1 f/cc na
Butadiene........................ 1051 1996 1000 ppm 1 ppm 1000
Methylene Chloride............... 1052 1998 500 ppm 25 ppm 20
Chromium (VI).................... 1026 2006 52 g/M\3\ c 5 g/M\3\ **10.4
----------------------------------------------------------------------------------------------------------------
*The four PEL's set for asbestos eventually mandated a 120-fold reduction from pre-OSHA PEL.
**Pre-existing PEL was a ceiling limit in units of a different chemical form; actual permitted exposure under
the new PEL could be higher than previous.
The need for an interim standard
The Committee has determined that exposure to diacetyl
presents the sort of grave danger to workers that warrants
immediate action. A large number of studies and investigations
show that bronchiolitis obliterans and other respiratory
disease have been identified among a significant number of
microwave popcorn and flavoring-manufacturing workers in a
number of states. Extensive evidence exists that exposure to
diacetyl presents a grave danger and significant risk of life-
threatening illness to exposed employees, and that flavoring
and food producers are widely distributed in the United States.
Furthermore, there are effective and feasible means to minimize
exposure to diacetyl.
Despite this grave danger, OSHA has failed to develop a
comprehensive standard that would protect workers. The
Committee also believes that guidance being developed by OSHA
is not adequate to protect workers from the health threat posed
by diacetyl. H.R. 2693 therefore requires OSHA to issue an
Interim Final Standard within 90 days of enactment to be
followed by a final standard that would be promulgated within
two years.
The interim standard must contain provisions for
engineering controls, respiratory protection, exposure
monitoring, medical surveillance and worker training. It must
not be less protective than guidelines issued by the National
Institute for Occupational Safety and Health in 2003.
The interim standard requires employers to simply implement
measures that were recommended several years ago as effective
and feasible by NIOSH as well as the Flavor and Extract
Manufacturers Association, the association representing
flavoring manufacturers. In fact, FEMA supports the bill and
the OSHA regulation. According to a statement issued by FEMA:
``FEMA supports legislation that could lead to
appropriate, science-based regulation to enhance the
safety of workers in the flavor industry'' said John
Hallagan, FEMA General Counsel. ``This legislation
calls for regulation by OSHA that is very similar to
the recommendations to protect workers that FEMA made
three years ago in its report Respiratory Health and
Safety in the Flavor Manufacturing Workplace.\36\
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\36\Statement by the Flavor and Extract Manufacturers Association
(June 13, 2007).
The interim regulation is not an occupational safety and
health standard as that term is defined in section 3(8) of the
Occupational Safety and Health Act of 1970 and must be adopted
notwithstanding any other provision of law. The Secretary of
Labor has previously recognized in promulgating a standard
regulating hazardous waste operations the distinction between
an interim regulation and an occupational safety and health
standard is legally significant because it means that the
procedural requirements of section 6 of the OSH Act do not
apply to the promulgation of the interim final regulation. Nor,
as the Secretary has previously recognized in publishing an
interim final regulation governing hazardous waste operations,
do the notice and comment provisions of the Administrative
Procedures Act apply.
The Committee relied upon these precedents when it directed
the Secretary of Labor to publish an interim final regulation
governing lead exposure in the construction industry. The
Committee intends that the Secretary rely on similar procedures
to publish an interim final regulation governing diacetyl
within three months. These procedures have recently been upheld
by OSHRC the Occupational Safety and Health Review Commission
(OSHRC) in the Manganas Painting Co, Inc decision. OSHRC agreed
with the Secretary of Labor's assessment of Congressional
intent which cited
The preamble to the lead in construction standard
that ``Congress . . . did not impose any procedural
requirements that must be followed'' and that Congress
intended that ``the Secretary need not follow the
procedural requirements of the OSH Act or the APA
[Administrative Procedure Act, 5 U.S.C. 553].'' 58 Fed.
Reg. at 26,591.\37\
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\37\Secretary of Labor v. Manganas Painting Company Inc, OSHRC
Docket No. 94-0588 (March 23, 2007).
While the Secretary is authorized to publish the interim
regulation without the notice and comment procedures required
by section 6 of the OSH Act, it is the Committee's expectation
that OSHA will work closely with the National Institute for
Occupational Safety and Health, as well as the affected
industry, labor representatives and industrial hygiene experts
in developing the interim final diacetyl regulation.
The final standard
H.R. 2693 requires OSHA, within two years of enactment, to
issue a permanent standard regulating worker exposure to
diacetyl in compliance with section 6(b) of the Occupational
Safety and Health Act (OSHAct). The final standard would expand
the scope of the regulation to all locations where workers are
exposed to diacetyl and require OSHA to include a permissible
exposure limit.
While there is compelling evidence, as indicated above, on
which to base an interim standard covering the food flavoring
and popcorn manufacturing industries, additional data must be
collected and analyzed before extending the standard to all
locations where workers are exposed to diacetyl. Workers are
also exposed to diacetyl in downstream food manufacturing
facilities other than microwave popcorn production, although
the level of exposure and health effects suffered by workers in
these establishments have not been characterized to the same
extent as in microwave popcorn production, nor have feasible
means of abatement been fully identified by OSHA or NIOSH.
In addition, scientists at OSHA and NIOSH have not yet
determined an appropriate exposure limit for diacetyl that
would prevent serious health effects.
H.R. 2693 requires OSHA to issue a final standard covering
all workplaces where diacetyl is used within two years of
enactment. The Committee is confident that this standard can be
issued within the timeframe allotted.
It is the Committee's hope and expectation that, in
addition to public and scientific input, OSHA will work closely
with NIOSH to develop the information base and analysis
necessary to develop exposure, feasibility and other
information needed to issue a fully protective diacetyl
standard in a timely manner.
H.R. 2693 does not exempt OSHA from the requirements of
section 6 of the OSHAct that Congress and the courts have
established to ensure that OSHA standards reflect the best
science available, or that the standards are technologically
and economically feasible. In addition, regulatory oversight
laws, including the Administrative Procedures Act, the Small
Business Regulatory Enforcement Fairness Act (SBREFA), the
Regulatory Flexibility Act, the Paperwork Reduction Act, or
Executive Order 12866 are flexible enough to provide for
expedited action in emergency situations like these.
Congress has afforded OSHA a great deal of leeway in
identifying hazards and setting protective exposure limits to
enable the agency to act before large numbers of individuals
were injured as a result. Section 6(b)(5) of the law lays out
the criteria for issuance of standards concerning toxic
materials. Section 6(b)(7) requires standards to include
requirements for labeling, protective equipment, exposure
monitoring and medical monitoring as appropriate.
OSHA is mandated to attain the ``highest degree of health
and safety protection for the employee'' and to base standards
on the ``best available evidence.''\38\ The courts have
recognized, however, that such data is often imperfect and that
``OSHA cannot let workers suffer while it awaits the Godot of
scientific certainty.''\39\ Subsequent court decisions have
also required OSHA to show that substance presents a
``significant risk'' and that the new standard will reduce that
risk. OSHA must also show that the new standard is
technologically and economically feasible.
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\38\29 U.S.C. 655(b)(5).
\39\United Steelworkers of America, etc. v. Marshall, 647 F.2d
1189, 1266 (U.S. App. D.C.); 8 OSH Cases 1810.
Two years provides adequate time for OSHA to develop the
evidence and findings necessary to issue a final standard.
Extensive studies and investigations have been conducted of
workers exposed to diacetyl and serious, readily observable
health effects have been linked to these exposures. The courts
have held that in cases where the risk of exposure ``can be
readily observed,'' OSHA would be able to establish significant
risk without the theoretical modeling involved, for example, in
determining exposure limits for carcinogens at very low
levels.\40\
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\40\Rabinowitz, Ed. Occupational Safety & Health Law 2d Ed. (BNA
2000) at 453-454.
OSHA can establish significant risk without the
theoretical modeling required to construct a dose-
response curve when risk can be directly observed or
the hazard is obvious. For example, in upholding the
Agency's electric power generation standard, the
Eleventh Circuit approved OSHA's reliance on a
videotape showing that certain work clothes were
flammable, finding it ``powerful'' evidence of
harm.\41\ The court did not require OSHA to quantify
the magnitude of the fire hazard. Similarly, in
upholding the standard on logging operations, the
Fourth Circuit observed that common sense and the
opinion of experts were enough to establish significant
risk.\42\
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\41\Alabama Power Co. v. OSHA, 89 F.3d 740, 745 (11th Cir. 1996);
17 OSH Cases 1675.
\42\Homelite v. OSHA, 74 F.3d 1232 (4th Cir. 1996); 17 OSH Cases
1489.
In order to issue a standard under Section 6(b) of the Act,
OSHA also has a number of procedural requirements that must be
satisfied. Again, because of the emergency nature of this
problem, OSHA will be able to meet those requirements within
the two year timeframe. SBREFA\43\, the Regulatory Flexibility
Act,\44\ Executive Order 12866 and the Paperwork Reduction Act
contain flexible provisions for waivers, delay or acceleration
of their requirements under emergency conditions or other
special circumstances. The Committee expects OSHA, the Small
Business Administration, the Office of Management and Budget,
and other agencies involved in the regulatory process to fully
utilize whatever actions are necessary and permitted within
relevant laws and executive orders affecting the regulatory
process to ensure that this mandated Congressional deadline is
met.
---------------------------------------------------------------------------
\43\P.L. 104-121. Small Business Regulatory Enforcement Fairness
Act of 1996.
\44\P.L. 96-354. Regulatory Flexibility Act of 1980, as amended.
---------------------------------------------------------------------------
Experts confirm that OSHA can issue standards much faster
than the agency has acted over the past several years. Frank
Mirer expresses confidence that OSHA should be capable of
issuing standards much faster than it currently does, even
starting from scratch.\45\
---------------------------------------------------------------------------
\45\Mirer Testimony at 5.
---------------------------------------------------------------------------
Adam Finkel, Sc.D., CIH, Professor of Environmental and
Occupational Health at the UMDNJ School of Public Health, and a
visiting professor of public affairs at the Woodrow Wilson
School at Princeton University, submitted testimony for the
record following the April 24 hearing on OSHA standards,
stating that despite the many requirements for OSHA to invite
participation by stakeholders and respond substantively to
their comments, standards can be completed ``cleanly and rather
quickly.'' Finkel is the former Director of Health Standards
for OSHA.
In one 18-month period of activity (late 1996 to
early 1998)--OSHA promulgated three major final health
standards--those for 1,3-butadiene, methylene chloride,
and generic respiratory protection--and defended them
in Congressional oversight hearings and court
challenges, without a single provision being
substantively weakened following any of this
scrutiny.\46\
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\46\Have OSHA Standards Kept up With Workplace Hazards? Hearing
before the Subcommittee on Workforce Protections, 110th Congress, 1st
Session (2007), Letter from Dr. Adam Finkel to Rep. Lynn Woolsey (May
8, 2007).
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History of Congressional intervention in OSHA rulemaking
Congress has a long history of mandating OSHA regulation to
protect workers when the Agency fails to act on its own. H.R.
2693 continues the Congress's tradition of ensuring that OSHA
acts promptly when faced with evidence that American workers
face grave dangers and delay will result in needless illness
and death. In 1986, as part of the Superfund Amendments and
Reauthorization Act (SARA), Congress mandated the issuance an
``interim'' standard for Hazardous Waste Operations and
Emergency Response within 60 days and a final standard within
one year of SARA's enactment.\47\ In 1990, as part of the Clean
Air Act Amendments, Congress required OSHA to issue the Process
Safety Management standard within one year. Congress also
included directions on the content of the standard.\48\ In
1991, Congress ordered OSHA to issue the final Bloodborne
Pathogens Standard by a certain date, and stated that if that
deadline was not met, the previously published proposed
standard would take effect.\49\ In 1992, Congress mandated OSHA
to issue the Lead in Construction standard and required the new
standard to be ``as protective'' as the U.S. Department of
Housing and Urban Development's worker protection guidelines
for identification and abatement of lead based paint in certain
housing. The standard was issued in 1993.\50\ Finally, in 2000,
Congress required OSHA issue an update to the Bloodborne
Pathogens standard, requiring safer syringes and sharps.\51\
That standard was issued in 2001.
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\47\P.L. 99-499. Superfund Amendments and Reauthorization Act of
1986, Title I Sec. 126 a-f (Oct. 26, 1986).
\48\P.L 101-549. Title III, Sec. 304 (Nov. 15, 1990).
\49\P.L. 102-170. Departments of Labor, Health and Human Services,
and Education, and Related Agencies Appropriations Act, Sec. 100
(1992).
\50\P.L. 102-550. This interim final rule was mandated by, and
issued under the exclusive authority of, title X, subtitle C, sections
1031 and 1032, Worker Protection, of the Housing and Community
Development Act of 1992.
\51\P.L. 106-430. Needlestick Safety and Prevention Act.
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Some OSHA experts feel that Congress must take a much more
active role in encouraging OSHA to issue standards that protect
workers' health and safety; Scott Schneider, who testified at
the April 2007 standards hearing argued in favor of Congress
setting strict time limits for OSHA to issue standards:
Congress can set time limits for OSHA to consider and
then issue proposals and final rules. In the past
Congress has mandated that OSHA issue rules within a
six-month period and the agency has done so (e.g. lead,
hazardous waste). Congress should give OSHA a limited
time, say four months, to consider any petition for new
standards and require the agency to publish a response
in the Federal Register as to its reasons for accepting
or denying the petition. The burden should be on the
agency to show why a standard should not be issued.
Once committed to a rule making, the agency would be
given additional deadlines to meet to ensure that rules
are issued in a timely manner, say no more than three
years. Congress would have to provide additional
funding for OSHA dedicated to standard setting in order
for it to meet these deadlines.\52\
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\52\Schneider Testimony at 5.
Due to the serious health effects caused by exposure to
diacetyl and the ready availability of means to prevent worker
exposure, H.R. 2693 requires OSHA to take swift action to
protect workers.
V. SECTION-BY-SECTION ANALYSIS
Section 1. Short Title
Provides that the Short Title of H.R. 2693 is the ``Popcorn
Workers Lung Disease Prevention Act.''
Section 2. Findings
This section declares that an emergency exists concerning
worker exposure to diacetyl and that a standard is urgently
needed to protect workers. This section establishes that there
is strong evidence documenting the link between diacetyl and
serious lung disease. The findings also establish that
government and industry health guidelines have existed since
2003 and 2004. Additionally, OSHA has taken no significant
action to begin the development of a standard and has taken not
other significant action to protect workers.
Section 3. Issuance of Standard on Diacetyl
Section 3 (a)(1). Requires the Secretary of labor to issue
an interim final standard regulating worker exposure to
diacetyl within not later than 90 days after enactment.
Section 3(a)(1)(A). Applies the interim standard to the
flavoring manufacturers that use diacetyl.
Section 3(a)(1)(B). Applies the interim standard to all
microwave popcorn production and packaging establishments that
use diacetyl.
Section 3(a)(2). Requires that the interim standard provide
no less protection than NIOSH guidelines issued in 2003.
Section 3(a)(2)(A). States that the interim final standard
must require engineering, work practice controls, and
respiratory protection
Section 3(a)(2)(B). States that the interim final standard
must require employers to develop a written exposure control
plan that will indicate specific measures the employer will
take to minimize employee exposure. The plan must be re-
evaluated at least biannually or whenever medical surveillance
indicates abnormal pulmonary function in employees exposed to
diacetyl,
Section 3(a)(2)(C). States that the interim final standard
must require airborne exposure assessments
Section 3(a)(2)(D). States that the interim final standard
must require medical surveillance for workers and referral for
prompt medical evaluation
Section 3(a)(2)(E). States that the interim final standard
must require protective equipment and clothing
Section 3(a)(2)(F). States that the interim final standard
must require employers to provide written safety and health
information and training to employees.
Section 3(a)(3). Requires interim final standard to take
effect upon issuance, have the legal effect of an OSHA
standard, and remain in effect until a final standard becomes
effective.
Section 3(b). Mandates OSHA to issue a final standard
regulating worker exposure to diacetyl not later than two years
from the date of enactment. The final standard must contain the
worker protection provisions of the interim final standard as
well as a permissible exposure limit that does not exceed the
lowest feasible level.
Section 4. Study and Recommended Exposure Limits on Other Flavorings
This section requires the National Institute for
Occupational Safety and Health to conduct a study on the
exposure hazards of possible substitutes that are closely
related to diacetyl in microwave popcorn production and
transmit the report to OSHA. NIOSH is then required to
establish recommended exposure limits for those flavoring
chemicals found to be hazardous.
VI. EXPLANATION OF AMENDMENTS
Because regulation of any chemical often encourages users
to substitute for other chemicals, the amendment offered by Mr.
Wilson and adopted by the Committee requires the National
Institute for Occupational Safety and Health (NIOSH) to conduct
a study on the exposure hazards of food flavoring chemicals
closely related to diacetyl that could be used as substitutes
for diacetyl in microwave popcorn production and transmit the
report to OSHA. NIOSH is then required to establish recommended
exposure limits (RELs) for those flavoring chemicals found to
be hazardous. The RELs developed by NIOSH are to be forwarded
to OSHA.
NIOSH was established under the Occupational Safety and
Health Act of 1970 to, among other things, develop and
establish recommended occupational safety and health standards
and to conduct research necessary for the development of
criteria for new and improved occupational safety and health
standards.
VII. APPLICATION OF LAW TO THE LEGISLATIVE BRANCH
Section 102(b)(3) of Public Law 104-1, the Congressional
Accountability Act, requires a description of the application
of this bill to the legislative branch. H.R. 2693 has no direct
application to the legislation branch.
VIII. REGULATORY IMPACT STATEMENT
The Committee has determined that H.R. 2693 will have only
a minor impact on the regulatory burden.
IX. UNFUNDED MANDATE STATEMENT
Section 423 of the Congressional Budget and Impoundment
Control Act (as amended by Section 101(a)(2) of the Unfunded
Mandates Reform Act, P.L. 104-4) requires a statement of
whether the provisions of the reported bill include unfunded
mandates.
(The attached CBO letter addresses this issue)
X. EARMARK STATEMENT
H.R. 2693 does not contain any congressional earmarks,
limited tax benefits, or limited tariff benefits as defined in
clause 9(d), 9(e) or 9(f) of rule XXI.
XI. STATEMENT OF OVERSIGHT FINDINGS AND RECOMMENDATIONS OF THE
COMMITTEE
In compliance with clause 3(c)(1) of rule XIII and clause
2(b)(1) of rule X of the rules of the House of Representatives,
the Committee's oversight findings and recommendations are
reflected in the body of this report.
XII. NEW BUDGET AUTHORITY AND CBO COST ESTIMATE
With respect to the requirements of clause 3(c)(2) of rule
XIII of the House of Representatives and section 308(a) of the
Congressional Budget Act of 1974 and with respect to
requirements of 3(c)(3) of rule XIII of the House of
Representatives and section 402 of the Congressional Budget Act
of 1974, the Committee has received the following estimate for
H.R. 2693 from the Director of the Congressional Budget Office:
H.R. 2693--A bill to direct the Occupational Safety and Health
Administration to issue a standard regulating worker exposure
to diacetyl
H.R. 2693 would require the Department of Labor to issue
regulations intended to protect workers from harmful exposure
to the chemical diacetyl. Interim standards would be issued no
later than 90 days after this bill is enacted, and a final
standard no later than two years after enactment. Diacetyl is a
substance used in many food flavorings, such as artificial
butter flavorings for microwave popcorn. Since 2000, several
organizations, including the National Institute of Occupational
Safety and Health (NIOSH), have raised concerns regarding the
health affects of diacetyl on workers in manufacturing plants
that use the chemical. The Occupational Safety and Health
Administration (OSHA) is developing an inspection program but
no regulations have been issued to date.
In addition, the bill would require NIOSH to conduct a
study of food flavorings used in the production of microwave
popcorn. The study would prioritize which chemicals are most
closely associated with diacetyl in order to determine possible
exposure hazards. Furthermore, NIOSH would establish
recommended exposure limits based on the study's findings and
transmit those findings to OSHA.
Estimated cost to the federal government: CBO estimates
that implementing H.R. 2693 would cost approximately $1 million
in 2008, assuming appropriation of the necessary amounts. CBO
assumes these funds would be used primarily to fund the NIOSH
study required by the bill. Costs in 2009 would not be
significant. Enacting the bill would not affect revenues or
direct spending.
Impact on state, local, and tribal governments: H.R. 2693
contains no intergovernmental mandates as defined in the
Unfunded Mandates Reform Act (UMRA). States may develop and
operate their own job safety and health programs if those
programs are approved by OSHA; currently, 26 states operate
such programs. Those states might incur costs to administer and
enforce the new standards that OSHA would be required to
promulgate under the bill. However, those costs would be
incurred voluntarily, and half of those costs could be
reimbursed through matching grants from the federal government
under an existing program.
The state of California is in the process of developing
standards regulating workers' exposure to diacetyl. Under H.R.
2693, California would be required to demonstrate to OSHA that
the state's standards will be at least as effective as the
standards promulgated by OSHA. If its standards were determined
to be less effective, the federal standards would apply. Any
costs incurred by California to demonstrate the effectiveness
of the state standards would be incurred as a result of its
voluntary participation in the federal program.
Impact on the private sector: H.R. 2693 would impose
private-sector mandates as defined in UMRA on facilities that
use, handle, or produce diacetyl--primarily involving food
flavorings and microwave popcorn. The interim standards
promulgated by OSHA would have to be consistent with the
recommendations in the NIOSH Alert, ``Preventing Lung Disease
in Workers Who Use or Make Flavorings.'' Because a large
segment ofthose two industries has implemented many of NIOSH's
recommended protections for diacetyl exposure, CBO estimates
that the costs associated with compliance with the interim
standard would fall below the annual threshold for private-
sector mandates established by UMRA ($131 million in 2007,
adjusted annually for inflation). The interim standard would
remain in effect until the final standard is issued.
The final standard would contain, at a minimum, the
provisions in the interim standards, as well as limits on
short-term exposure and permissible exposure. The final
standard would apply to all facilities where diacetyl is
produced or used. The cost to the private sector of complying
with mandates in the final standard is uncertain because it
would depend on regulations that have not yet been established.
Because there is no basis for predicting the specific equipment
and procedures the final standard would require and the
industries that would be affected, CBO cannot estimate the
incremental costs that could result from that standard.
Therefore, CBO cannot determine whether the aggregate cost of
the mandates would exceed the UMRA's annual threshold for
private-sector mandates.
Previous CBO estimate: This estimate supersedes the
previous cost estimate for H.R. 2693, which CBO transmitted on
July 13, 2007. Our July 13 estimate erroneously indicated that
the bill would require the NIOSH study to be completed prior to
issuance of final standards from OSHA and that OSHA had already
implemented a diacetyl inspection program. This revised
estimate corrects the description of those provisions but does
not change the estimated cost of the bill.
The CBO staff contacts for this estimate are Sean Dunbar or
Geoffrey Gerhardt (for federal costs), Lisa Ramirez-Branum (for
the impact on state and local governments), and Justin Hall
(for the impact on the private sector). This estimate was
approved by Robert A. Sunshine, Assistant Director for Budget
Analysis.
XIII. STATEMENT OF GENERAL PERFORMANCE GOALS AND OBJECTIVES
In accordance with Clause 3(c) of House rule XIII, the goal
of H.R. 2693 is to provide basic health and safety protections
for workers exposed to diacetyl.
XV. CONSTITUTIONAL AUTHORITY STATEMENT
Under clause 3(d)(1) of rule XIII of the Rules of the House
of Representatives, the Committee must include a statement
citing the specific powers granted to Congress in the
Constitution to enact the law proposed by H.R. 2693. The
Committee believes that the amendments made by this bill, which
direct OSHA to issue an OSHA standard regulating worker
exposure to diacetyl are within Congress' authority under
Article I, Section 8, Clause 3 of the Constitution of the
United States.
XV. COMMITTEE ESTIMATE
Clause 3(d)(2) of rule XIII of the Rules of the House of
Representatives requires an estimate and a comparison of the
costs that would be incurred in carrying out H.R. 2693.
However, clause 3(d)(3)(B) of that rule provides that this
requirement does not apply when the Committee has included in
its report a timely submitted cost estimate of the bill
prepared by the Director of the Congressional Budget Office
under section 402 of the Congressional Budget Act.
XVI. COMMITTEE CORRESPONDENCE
None.
July 26, 2006.
The Hon. Elaine L. Chao,
Secretary of Labor, U.S. Department of Labor,
Washington, DC.
Dear Secretary Chao: We are writing to express our strong
support for the petition submitted by the United Food and
Commercial Workers International Union and the International
Brotherhood of Teamsters calling upon the Occupational Safety
and Health Administration to issue an Emergency Temporary
Standard (ETS) to protect workers exposed to the chemical
diacetyl (2,3-butanedione, CAS # 431-03-8), and to initiate
formal rulemaking for permanent regulations to protect workers
exposed to diacetyl and other harmful flavoring-related
chemicals.
Diacetyl is a commonly used food flavoring and is the
primary constituent of artificial butter flavoring. There is
compelling scientific evidence linking occupational exposure to
diacetyl to bronchiolitis obliterans, a debilitating and
sometimes fatal lung disease.
In the general population, bronchiolitis obliterans is
rare. In the last few years, however, numerous cases have been
reported to or identified by the National Institute for
Occupational Safety and Health (NIOSH) among workers employed
in factories where flavorings containing diacetyl are produced
or used.\1\ Dozens of workers employed at popcorn plants have
developed occupational lung disease, and at least one has died.
Several of these workers are on lung transplant
lists.2 3 4
The sentinel case of the recent outbreak of bronchiolitis
obliterans was a Missouri microwave popcorn plant worker
diagnosed with the condition in 1999. The physician who
diagnosed the case notified Missouri's health department, which
in turn notified the Centers for Disease Control and Prevention
(CDC), NIOSH's parent agency. In August 2000, NIOSH began an
investigation at the Jasper, Missouri microwave popcorn plant
where eight current or former workers had developed the
disease.\5\ In this investigation, NIOSH scientists found that
respiratory symptoms were linked with exposure to diacetyl and
butter flavor. Workers at this plant had chronic cough and
shortness of breath at a rate 2.6 times higher than what would
be expected in the U.S. population. Twice as many workers than
expected reported being told by their physicians that they had
asthma or chronic bronchitis. Lung function testing revealed
that three times as many workers as expected had obstruction to
airflow. These results were reported first in the CDC's
Morbidity and Mortality Weekly Report and then in the
NewEngland Journal of Medicine.\6\\7\ In all, NIOSH has
conducted six investigations at 102 microwave popcorn
facilities, finding respiratory impairment among workers at a
majority of the plants.\3\\8\\9\\10\\11\\12\
Since the initial reports focused on individuals employed
in microwave popcorn factories, the disease is often called
``popcorn workers lung.''\13\\14\ It has become clear, however,
that the disease has struck workers in other segments of the
food and flavoring industry, and is not limited to microwave
popcorn facilities.\15\ The California Department of Health
Services has recently reported two cases among diacetyl-exposed
workers employed at factories at which the flavorings are
produced.\16\
To pursue their investigations, NIOSH has developed
sampling and analytical methods for measuring exposure to
flavoring-related chemicals.\17\ At the Jasper, Missouri plant,
diacetyl was measured in concentrations ranging as high as 98
parts per million parts air by volume (ppm), with a mean of 8.1
ppm.\18\ In their evaluation of six microwave popcorn plants
(five of which had workers with flavoring-associated lung
disease), NIOSH scientists reported that the ``lowest mean TWA
[time weighted average] diacetyl air concentrations that we
measured in mixing areas (0.02 ppm personal exposure and 0.2
ppm area air concentration) were at a plant with an affected
mixer.'' On the basis of this finding, the NIOSH scientists
concluded ``it would seem prudent to maintain worker exposures
to diacetyl below these levels.''\19\
The role of diacetyl in the development of bronchiolitis
obliterans has been confirmed in studies of laboratory animals.
In 1993, a manufacturer of diacetyl conducted a study, which
was never reported to the government or published in scientific
literature, in which rats were exposed to pure diacetyl. The
study found that one four-hour period of exposure to diacetyl
resulted in an ``abundance of symptoms indicative for
respiratory tract injury.''\20\ Following the recent outbreak
of cases among humans, NIOSH scientists conducted a study in
which rats were exposed to airborne concentrations of heated
butter flavoring, of which diacetyl was the primary
constituent. The rats were exposed for a single, six-hour
period. The scientists reported significant lung damage among
rats whose exposure was as low as 203 ppm, which according to
the authors was ``not extraordinary when compared with levels
measured in the workplace.''\21\ NIOSH scientists then
conducted a study in which rats were exposed to pure diacetyl
and found similar results.\22\ A toxicological study of guinea
pigs exposed to diacetyl found exposure to the chemical caused
adverse effects to respiratory tissue and structure.\23\
Although the precise number of workers already suffering
respiratory effects from exposure to diacetyl is unknown, the
potential magnitude of the problem is sizeable. NIOSH is
currently investigating 15 cases of respiratory disease,
including some workers with bronchiolitis obliterans, among the
employees at a single Cincinnati, Ohio flavor manufacturing
plant.\3\
Additional research will provide useful data on the
mechanism through which flavoring related chemicals cause
obstructive lung disease. However, NIOSH has already generated
sufficient information for OSHA to issue rules to reduce
exposure to these toxic chemicals. In their recent report,
NIOSH scientists wrote that ``(b)ecause entirely safe levels of
occupational exposure to butter-flavoring chemicals are not
known, it is important to limit 3 worker exposures as much as
possible.''\19\ It is the regulatory responsibility of OSHA to
protect workers from exposure to workplace hazards. OSHA has
issued permissible exposure limits (PELs) and/or NIOSH has
recommended exposure limits (RELs) for only 46 of the 1,037
flavoring ingredients considered by the flavorings industry to
represent potential respiratory hazards.\1\ This regulatory
gap\2\ needs to be addressed; for this reason, we support the
United Food and Commercial Workers (UFCW) and the International
Brotherhood of Teamsters (IBT) petition to OSHA to initiate
formal rulemaking to establish a permanent standard to protect
workers from lung disease caused by flavoring-related
chemicals.
Until OSHA completes permanent rulemaking on flavoring-
related chemicals, an ETS for diacetyl is essential. The data
gathered by NIOSH indicate an appropriate emergency PEL would
be below 0.2 ppm.\19\ In order to provide a sufficient margin
of safety, the petition calls for an emergency temporary PEL of
0.05 ppm, averaged over an eight-hour day. Although other
flavoring-related chemicals are likely to contribute to the
adverse lung effects as well, controlling exposure to diacetyl,
a known cause of bronchiolitis obliterans and a primary
component of butter flavor, will also result in the reduction
of exposure to other airborne contaminants in the workplace.
In summary, there is compelling epidemiologic and
toxicological evidence linking exposure to diacety to severe
respiratory impairment and disease. It is more than thirty
months since NIOSH issued an alert calling upon employers to
``minimize occupational exposures to flavorings or flavoring
ingredients.''\1\ It is now time for OSHA to use the scientific
evidence to protect American workers from debilitating lung
disease.
If you have any questions regarding this matter, please
contact: David Michaels, PhD, Professor and Associate Chairman,
Department of Environmental and Occupational Health, George
Washington University School of Public Health, 2100 M Street
NW, Suite 203, Washington, DC 20037, Phone: 202-994-2461.
Respectfully submitted,
(Affiliations listed for identification purpose only)
Nicholas A. Ashford, PhD, JD, Professor of Technology and
Policy, and Director, MIT Technology and Law Program,
Massachusetts Institute of Technology.
Dean Baker, MD, MPH, Professor and Chief, Occupational and
Environmental Medicine and Director, Center for Occupational
and Environmental Health, University of California, Irvine.
John M. Balbus, MD, MPH, Director, Health Program,
Environmental Defense.
John R. Balmes, MD, Professor of Medicine, University of
California San Francisco, and Professor of Environmental Health
Sciences, University of California Berkeley School of Public
Health.
Eula Bingham, PhD, Professor, Department of Environmental
Health, University of Cincinnati College of Medicine, and
Assistant Secretary of Labor for Occupational Safety and
Health, 1977-1981.
David C. Christiani, MD, MPH, MS, Professor of Occupational
Medicine and Epidemiology, Harvard School of Public Health, and
Professor of Medicine, Harvard Medical School.
Richard Clapp, DSc, MPH, Professor, Department of
Environmental Health, Boston University School of Public
Health.
Mark R. Cullen, MD, Professor of Medicine and Public
Health, Yale University School of Medicine.
Ellen A. Eisen, ScD, Adjunct Professor of Environmental
Health, Harvard School of Public Health.
Adam M. Finkel, ScD, CIH, Professor of Environmental and
Occupational Health, UMDNJ School of Public Health, and
Director, Directorate of Health Standards Programs, OSHA, 1995-
99, and Regional Administrator, Region VIII, OSHA, 2000-2003.
Arthur L. Frank MD, PhD, Professor of Public Health and
Chair, Department of Environmental and Occupational Medicine,
Drexel University School of Public Health.
Laurence Fuortes, MD, Professor of Occupational and
Environmental Health, College of Public Health, University of
Iowa.
Michael Gochfeld, MD, PhD, Professor and Director,
Occupational & Environmental Residency Program, Environmental
and Occupational Health Sciences Institute, UMDNJ-Robert Wood
Johnson Medical School.
Lynn R. Goldman, MD, MPH, Professor, Bloomberg School of
Public Health, Johns Hopkins University, and Assistant
Administrator for Toxic Substances, Environmental Protection
Agency, 1993-1998.
Philip Harber, MD MPH, Professor and Chief, Division of
Occupational and Environmental Medicine, David Geffen School of
Medicine at UCLA.
Peter F. Infante, DDS, DrPH, Professorial Lecturer,
Department of Environmental and Occupational Health, George
Washington University School of Public Health, and Director,
Office of Standards Review, OSHA, 1982-2002.
Leslie M. Israel, DO, MPH, Associate Clinical Professor,
Center for Occupational and Environmental Health, University of
California Irvine.
Joel Kaufman, MD, MPH, Professor, Departments of
Environmental & Occupational Health Sciences and Medicine, and
Director of the Occupational and Environmental Medicine
Program, University of Washington.
Matthew Keifer, MD, MPH, Associate Professor of Medicine
and Environmental and Occupational Health, University of
Washington.
Joel N. Kline, MD, Professor and Director University of
Iowa Asthma Center, Division of Pulmonary, Critical Care, and
Occupational Medicine.
Roy J. and Lucille A. Carver College of Medicine,
University of Iowa.
David Kriebel, ScD, Professor, Department of Work
Environment, University of Massachusetts Lowell.
Sheldon Krimsky, PhD, Professor of Urban & Environmental
Policy & Planning, School of Arts and Sciences, Tufts
University, and Adjunct Professor, Department of Public Health
and Family Medicine, Tufts School of Medicine.
Stephen M. Levin, MD, Medical Director, IJ Selikoff Center
for Occupational and Environmental Medicine, Mount Sinai School
of Medicine.
Steven Markowitz, MD, Professor and Director, Center for
the Biology of Natural Systems, Queens College, The City
University of New York.
Robert McConnell, MD, Professor of Preventive Medicine,
Keck School of Medicine, University of Southern California.
David Michaels, PhD, MPH, Professor and Associate Chairman,
Department of Environmental and Occupational Health, George
Washington University School of Public Health, and Director,
Project on Scientific Knowledge and Public Policy (SKAPP),
Assistant Secretary of Energy for Environment, Safety and
Health, 1998-2001.
Rafael Moure-Eraso, PhD, CIH, Professor and Chair,
Department of Work Environment, University of Massachusetts
Lowell.
Karen B. Mulloy, DO, MSCH, Co-Director Program in
Occupational & Environmental Health, University of New Mexico
Health Sciences Center.
L. Christine Oliver, MD, MPH, MS, Assistant Clinical
Professor of Medicine, Harvard Medical School, and Associate
Physician, Massachusetts General Hospital.
David Ozonoff, MD, MPH, Professor and Chair Emeritus,
Department of Environmental Health, Boston University School of
Public Health.
Allen J. Parmet, MD, MPH, FACPM, Colonel, United States Air
Force (Retired).
Anthony Robbins, MD, MPA, Professor, Tufts University
School of Medicine, and Assistant Surgeon General and Director,
National Institute for Occupational Safety and Health, 1971-
1981.
Kenneth Rosenman, MD, Professor of Medicine and Chief,
Division of Occupational and Environmental Medicine, Department
of Medicine, College of Human Medicine, Michigan State
University.
Marc Schenker, MD, MPH, Professor and Chair, Department of
Public Health Sciences, University of California at Davis
School of Medicine.
Brian S. Schwartz, MD, MS, Professor of Environmental
Health Sciences, Epidemiology, and Medicine, Bloomberg School
of Public Health, Johns Hopkins University.
Joel Schwartz, PhD, Professor, Environmental Epidemiology,
Exposure, Epidemiology, and Risk Program, Harvard School of
Public Health.
Michael A. Silverstein, MD, MPH, Clinical Professor,
University of Washington School of Public Health and Community
Medicine, and Director of Policy, OSHA, 1993-1995.
Rosemary K. Sokas, MD, MOH, Director and Professor,
Environmental & Occupational Health Sciences, University of
Illinois at Chicago.
Leslie Stayner, PhD, Professor and Director, Division of
Epidemiology and Biostatistics, University of Illinois at
Chicago School of Public Health.
Laura S. Welch, MD, Center to Protect Workers' Rights, and
Professorial Lecturer, Department of Environmental and
Occupational Health, George Washington University School of
Public Health.
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ingredient in microwave popcorn butter flavoring, increases
reactivity to methacholine. Toxicol, Appl Pharmacol (in press).
Abstract: Proc Am Thorac Soc 2005 May; 2(Abstracts):A814.
MINORITY VIEWS
INTRODUCTION
Committee Republicans are united in their support for a
safe and healthy workplace for every American worker. In 2005,
the most recent year for which data is available, the American
workforce saw all-time lows in occupational injury, illness,
and fatality rates. The overall workplace injury/illness rate,
4.6 per 100 employees in 2005, was the lowest since the Bureau
of Labor Statistics began publishing data in 1973.\1\ In the
last five years alone, the nationwide injury/illness rate has
fallen by more than 13 percent, while the overall fatality rate
has fallen by 7 percent since 2001.\2\ These numbers underscore
and highlight Committee Republicans' commitment to and success
in protecting the safety and health of the nation's workforce.
---------------------------------------------------------------------------
\1\See Testimony of the Honorable Edwin G. Foulke, Jr., Committee
on Education and Labor Subcommittee on Workforce Protections Hearing,
``Have OSHA Standards Kept up with Workplace Hazards?'' (April 24,
2007) (hereinafter ``Foulke Testimony''), at 2.
\2\See id.
---------------------------------------------------------------------------
Committee Republicans are equally committed to ensuring
that the regulation of health and safety in the workplace is
always based on science, hard data, and the best available
evidence, and not on political expediency or the agenda of any
single interest, party, or stakeholder, however well-
intentioned. As detailed herein, it is our view that H.R. 2693,
which would mandate the Secretary of Labor to establish
significant new workplace health and safety standards in the
absence of sufficient scientific evidence and reliable data,
wholly fails to meet that standard. For this reason, we oppose
enactment of the bill.
BACKGROUND: THE OSH ACT AND WORKPLACE SAFETY REGULATION
Since its enactment in 1970, the Occupational Safety and
Health Act (``OSH Act'' or the ``Act'')\3\ has fostered safe
and healthy working environments through standards-setting,
employer and worker education and training, and hazard
elimination.
---------------------------------------------------------------------------
\3\29 U.S.C. Sec. 651 et seq.
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Section 5 of the OSH Act requires that a covered employer
must provide its employees with a workplace ``free from
recognized hazards that are causing or are likely to cause
death or serious physical harm.''\4\ In furtherance of that
goal, section 6 of the Act sets forth the procedures which the
Secretary of Labor is required to follow when promulgating
workplace health and safety standards and provides for judicial
review of these standards to any person adversely affected by
them.\5\ These requirements guarantee that in promulgating
regulations, the Occupational Safety and Health Administration
(OSHA) must determine whether there is a significant risk and,
if so, fashion a feasible compliance scheme that provides both
for technical feasibility and economic feasibility from the
standpoint of the regulated community.
---------------------------------------------------------------------------
\4\29 U.S.C. Sec. 654(a).
\5\See generally id. Sec. 655.
---------------------------------------------------------------------------
Throughout its history, the Act's standard-setting
processes have been governed foremost by the Administrative
Procedures Act (APA), which generally requires a federal agency
to develop and draft proposed regulations; issue proposed rules
and regulations via a transparent process which allows for
comment and input from affected stakeholders; and review and
incorporate as appropriate that input in the publication of its
final rule.\6\ In addition to the requirements of the APA, OSHA
must ensure that its proposed regulations adhere to, inter
alia, guidelines specified in Executive Orders, the Paperwork
Reduction Act,\7\ Regulatory Flexibility Act.\8\ the Small
Business Regulatory Enforcement Fairness Act, ultimately, with
the Congressional intent of the law of its underlying\9\
authorizing statute.\10\
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\6\5 U.S.C. Sec. 5 et seq.
\7\See 44 U.S.C. Sec. 3501 et seq.
\8\See 5 U.S.C. Sec. 601 et seq.
\9\See 5 U.S.C. Sec. 801 et seq.
\10\Moreover, as a matter of practice, in recent years it has
become a near-certainty that one or more stakeholders affected by a
rule will pursue a legal challenge to OSHA's final regulation. These
challenges may result in a rule being upheld in its entirety; modified
in some form or fashion by the courts; or struck down in its entirety.
Once the final disposition of any legal challenges have been reached, a
final rule is either implemented or revised according to court
direction and subsequently administered by the Secretary of Labor
through OSHA.
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While the standard-setting process and the legal framework
in which it operates have been criticized by some for its
deliberate pace, it has nonetheless served to ensure that any
agency sets standards based on hard evidence, sound science,
and robust stakeholder input. It is within this framework that
the Committee addresses the question of whether and how OSHA
should regulate exposure to the chemical diacetyl in the
workplace.
RESEARCH AND REGULATORY ACTIVITY RELATING TO DIACETYL
Diacetyl is a chemical compound commonly used in the
production of butter-flavored popcorn, but also used in a wide
range of other products, such as baked goods and snacks.
In 2000, the National Institute for Occupational Safety and
Health (NIOSH) was asked by the State of Missouri's Department
of Health and Senior Services to provide technical assistance
in conjunction with its investigation of workers at a Jasper,
Missouri microwave popcorn plant who were suffering from
obstructed lung function, specifically the condition
bronchiolitis obliterans, potentially relating to exposure to
diacetyl. Following up on its interim 2001 report, in December
2003, NIOSH published an alert entitled ``Preventing Lung
Disease in Workers Who Use or Make Flavorings,'' which
recommended that employers control worker exposure to diacetyl.
In 2004, the Flavor and Extract Manufacturers Association
(FEMA) similarly published recommendations to control workers'
exposure to diacetyl in the workplace.
In January, 2006, NIOSH released its final investigative
report on the Jasper facility, in which it determined that
inhalation exposure to butter flavoring chemicals presents a
risk for occupational lung disease. To date, however,
scientists who have been examining the occurrence of
bronchiolitis obliterans and the issues surrounding diacetyl
exposure have not recommended an exposure standard. In
February, 2006, NIOSH experts published this conclusion in the
Journal of Occupational and Environmental Medicine:
At this time, insufficient data exist on which to
base workplace exposure standards or recommended
exposure limits for butter flavoring. Because the risk
of occupational lung disease may be partly due to
short-term peak exposures, an exposure limit based on
an 8-hour TWA [Time-Weighted Average] may not be
sufficient to protect workers. Moreover, because
flavorings are complex mixtures of many chemicals, most
of which have not been evaluated with respect to
inhalation toxicology, focusing solely on diacetyl air
concentrations may not be adequate to assess risk in
different plants using a variety of different
flavorings.\11\
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\11\See ``Evaluation of Flavorings-Related Lung Disease Risk at Six
Microwave Popcorn Plants,'' Journal of Occupational and Environmental
Medicine, Volume 48, Number 2, February 2006 (emphasis added).
This lack of data notwithstanding, on July 26, 2006, the
International Brotherhood of Teamsters (IBT) and the United
Food and Commercial Workers (UFCW) petitioned OSHA to
promulgate an emergency temporary standard (ETS) regulating
diacetyl in the workplace. This petition is currently under
consideration by OSHA.\12\
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\12\WUFCW has also petitioned California's state occupational
safety and health administration (``Cal-OSHA'') to set a state
Permissible Exposure Limit (PEL) for diacetyl. Rather than implementing
an emergency temporary standard, Cal-OSHA has referred the matter for
further study. NIOSH has been working in a consulting mode with Cal-
OSHA on this matter.
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OSHA ACTIVITY RELATING TO DIACETYL
On April 24, 2007, the Committee on Education and Labor
Subcommittee on Workforce Protections held a hearing entitled
``Have OSHA Standards Kept up with Workplace Hazards?'' While
not devoted exclusively to the question of diacetyl regulation,
the issue was discussed in detail by witnesses. At that
hearing, Department of Labor Assistant Secretary for
Occupational Safety and Health Edwin G. Foulke, Jr. testified
at length as to the actions that his agency had taken with
respect to diacetyl regulation. As Secretary Foulke recounted:
In 2001, OSHA took immediate action when the hazard
of butter flavorings containing diacetyl was brought to
the Agency's attention by NIOSH's interim report on
microwave popcorn manufacturing plants. The report's
findings indicated that uncontrolled exposure to butter
flavorings containing diacetyl was associated with the
development of a severe obstructive lung disease called
bronchiolitis obliterans.
OSHA promptly alerted its Regional Administrators and
Area Directors to NIOSH's findings and instructed its
field personnel to look into the issue when
encountering individuals working around butter
flavoring in popcorn manufacturing. OSHA's Region VII
published a brochure on this topic and arranged for its
distribution in the region. In 2004, OSHA issued a
memorandum to senior field managers and encouraged them
to contact employers in their regions who may have
workers exposed to this potential hazard.
To further protect workers who may be exposed to this
hazard, OSHA is finalizing a National Emphasis Program
(NEP) for butter flavorings containing diacetyl in the
manufacturing of microwave popcorn. The goal is to
direct inspections to the facilities where workers may
be at the greatest risk of exposure to this hazard. In
addition, the NEP contains elements aimed at educating
stakeholders about the hazard posed by butter
flavorings containing diacetyl. Implementation of this
NEP would allow OSHA to begin inspecting microwave
popcorn manufacturing facilities by the end of May, and
to inspect every such facility under Federal
jurisdiction by the end of this year. This will be
followed by a second NEP that focuses on establishments
manufacturing food flavorings containing diacetyl.
OSHA is also developing guidance to alert employers
and workers to the potential hazards associated with
food flavorings containing diacetyl. The guidance will
provide recommendations on how to control these hazards
and to ensure that information about those hazards is
effectively communicated to workers.
The Agency is currently reviewing the petition for an
Emergency Temporary Standard and is engaged in site
visits to microwave popcorn and flavor manufacturing
facilities in order to fairly evaluate the merits of
the petitioner's request.\13\
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\13\Foulke Testimony at 5.
On April 24, 2007, OSHA announced its establishment of a
National Emphasis Program (NEP) to address the hazards and
control measures associated with working in the microwave
popcorn industry where butter flavorings containing diacetyl
are used. Under the NEP, OSHA will target inspection resources
to workplaces where potential exposure to diacetyl is greatest.
Research by NIOSH and other occupational safety and health
experts as to the effects of diacetyl, its relationship (if
any) to bronchiolitis obliterans, and recommended exposure
tolerances continues today.
H.R. 2693, THE POPCORN WORKERS LUNG DISEASE PREVENTION ACT
On June 13, 2007, Workforce Protections Subcommittee Chair
Woolsey introduced H.R. 2693, which would direct OSHA to issue
standards regulating worker exposure to diacetyl. Specifically,
H.R. 2693 would require OSHA to set an interim final standard
relating to diacetyl exposure within 90 days of passage, and
promulgate a final rule (including a Permissible Exposure Limit
or ``PEL'') for diacetyl within two years of the date of
enactment. The interim final rule would apply to flavor
manufacturers who manufacture, use, handle, or process diacetyl
and all microwave popcorn production and packaging
establishments that use diacetyl, and would be based on NIOSH's
2003 alert.
Under the bill, OSHA's interim final rule must include
requirements for:
Engineering, work practice controls, and
respiratory protection to minimize worker exposure to diacetyl;
Written exposure control plans outlining specific
measures to minimize exposure;
Biannual medical surveillance when abnormal
pulmonary functions indicate employees have been exposed to
diacetyl, with appropriate medical evaluation;
Airborne exposure assessments;
Personal protective equipment for workers exposed
to diacetyl; and
Written safety and health plan for training employees and
hazard communication.
Within two years of enactment, the bill requires OSHA to
set a final standard which incorporates the elements of the
interim standard set forth above and establishes a PEL for
diacetyl. This exposure limit will apply to all facilities
where diacetyl is processed or used, expanding application of
the standard from diacetyl manufacturers and microwave popcorn
facilities to all food production facilities.
COMMITTEE CONSIDERATION OF H.R. 2693
No legislative hearing on H.R. 2693 was held in the
Committee on Education and Labor subcommittee of jurisdiction,
the Subcommittee on Workforce Protections.
No legislative hearing on H.R. 2693 was held in the
Committee on Education and Labor.
The Subcommittee on Workforce Protections did not meet to
consider H.R. 2693.
On Wednesday, June 20, 2007, the Committee on Education and
Labor met to consider and mark up H.R. 2693. An Amendment in
the Nature of a Substitute offered by Representative Woolsey
was adopted without objection. Two additional amendments were
offered by Representative Joe Wilson of South Carolina. The
first Wilson Amendment was withdrawn by unanimous consent. The
second Wilson Amendment was adopted by the Committee. The
Committee favorably reported H.R. 2693, as amended, by voice
vote.
REPUBLICAN VIEWS
Over the course of its thirty-five year history, a robust
body of law governing the regulatory standard-setting process
utilized by OSHA has been developed under the OSH Act.
Congress, courts, and the agency's own directives have created
a system to which its regulatory activities must conform, and
which guarantee that any regulation is measured against a
standard of technical feasibility, economic feasibility, and
the agency's overarching mission to protect workers from
recognized hazards, while providing for the input of all
stakeholders and affected parties. As one of the nation's most
experienced OSHA practitioners explained at the Committee's
April 24 hearing:
[T]he OSHA statute, as interpreted by decades of case
law, requires the agency to make detailed findings of
significant risk of material impairment of employee
health before it can pursue regulation of a workplace
hazard. In addition, OSHA must gather credible evidence
with respect to the technological and economic
feasibility of its regulations, and it must do so
industry by industry. Finally, it must perform what
amounts to a cost benefit analysis. These are not
simple tasks and to do them in a cursory fashion is to
invite court rejection of OSHA standards.\14\
---------------------------------------------------------------------------
\14\Testimony of Baruch A. Fellner, Committee on Education and
Labor Subcommittee on Workforce Protections Hearing, ``Have OSHA
Standards Kept up with Workplace Hazards?'' (April 24, 2007), at 1
(citations omitted).
This well-developed system of checks, balances, and
transparency counsels an abundance of caution before Congress
places itself in the role of regulatory standard writer
mandates a standard or outcome which fundamentally lacks an
adequate scientific basis.\15\ Sadly, this is exactly what H.R.
2693 does.
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\15\The Majority may be critical of the pace of standard setting by
OSHA, and plainly objects to the fact that OSHA has not set an
emergency temporary standard (ETS) for diacetyl, as petitioned for by
representatives of organized labor. That objection notwithstanding, it
is worth noting that the ETS process itself has a mixed history of
success. Of the nine emergency temporary standards issues by OSHA in
its history, five of these were challenged in court. OSHA lost four of
those five challenges.
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Most telling and troubling is the principle at the core of
the legislation. Scientists who have been examining the
occurrence of bronchiolitis obliterans and the issues
surrounding exposure have not recommended an exposure standard
for diacetyl, nor, as noted above by NIOSH, does there yet
exist scientific data sufficient to do so. Despite this fact,
H.R. 2693 directs OSHA to set a permissible exposure limit for
diacetyl when there is no clear and convincing science to
indicate what a PEL should be.
To date, there is no standard by a public or private
standard-setting organization for diacetyl. Further, within the
scientific community, many have expressed concern that while
diacetyl is a ``marker'' for bronchiolitis obliterans, it may
not be the true or sole cause of lung obstruction. As detailed
more fully under the discussion of the second Wilson Amendment
below, it may well be that exposure to diacetyl, in concert
with other chemical flavorings, that is harming workers.
These concerns have been repeatedly underscored. The
American Society of Safety Engineers (ASSE), while supportive
of the legislation, has highlighted the lack of science
problem: ``ASSE does recognize, however, that there are wide
gaps in industry's knowledge on this issue, as the NIOSH alert
itself indicates.'' Similarly, the Institute for Risk
Assessment Sciences has found that ``A relation between lung
function abnormalities and exposure to diacetyl could not be
established.''\16\ Without conclusive evidence, H.R. 2693
forces OSHA to undertake a regulatory action for which it has
no justification.
---------------------------------------------------------------------------
\16\Institute for Risk Assessment Sciences, ``Respiratory effects
in workers of a diacetyl production plant with a special focus on
bronchiolitis obliterans: An evaluation among currently working and
retired workers,'' Final Report (December 30, 2005).
---------------------------------------------------------------------------
By circumventing the regulatory process,\17\ it is unclear
if the legislation's intent will be achieved. Put more simply,
the mandate of a regulation by Congressional fiat does nothing
to ensure that workers are ultimately protected in the most
effective way. Indeed, H.R. 2693 in many instances sets before
OSHA tasks that simply cannot be accomplished in the time
provided for under the bill. As stated to the Committee by
Assistant Secretary Foulke:
---------------------------------------------------------------------------
\17\H.R. 2693's circumvention of regular order and legislative
process also deserves mention here. Had the bill proceeded by way of a
legislative hearing, concerns expressed by the Minority in these
views--and equally important, concerns raised by OSHA itself--perhaps
could have been aired and addressed.
The expanded scope of the final rule and the lack of
knowledge about the industries that use diacetyl will
lead to superficial analysis that may fail to provide
needed worker protection. H.R. 2693 would require OSHA
to expand the scope of the final rule to include all
establishments where there is potential for exposure to
diacetyl. Unfortunately, little is known about
industries--other than the microwave popcorn
manufacturing and food flavoring manufacturing
industries--that use diacetyl and diacetyl-containing
flavorings. OSHA would need to identify those companies
that use diacetyl, then conduct site visits to gather
needed data to (1) identify processes where exposures
occur, (2) develop control strategies for each process,
and (3) identify employers who have implemented control
strategies to determine if those control strategies are
effective.. . . OSHA believes that two years is too
short a period of time to develop the information base
and analysis necessary to adequately support the
proposed and final rule, and to afford the public
adequate time to comment on OSHA's proposal.\18\
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\18\Letter to Chairman George Miller from Edwin G. Foulke, Jr.,
Department of Labor Assistant Secretary for Occupational Health and
Safety (June 19, 2007) (emphasis added). A full copy of this letter is
attached to these Views as Appendix A.
In addition, H.R. 2693 requires OSHA to rely on non-
scientific documents as the underpinnings of an interim final
standard which, while helpful, simply do not live up to that
---------------------------------------------------------------------------
task. Again, as noted by OSHA:
As drafted, the bill would require the interim final
rule to impose engineering requirements based on NIOSH
recommendations that lack the clarity and specificity
necessary to form the basis of a new health standard.
H.R. 2693 would direct OSHA to issue an interim rule at
least as stringent as the 2004 NIOSH Hazard Alert. The
NIOSH recommendations serve as good general
recommendations, but do not provide specific
performance criteria that would be necessary to develop
an unambiguous and enforceable interim rule.\19\
---------------------------------------------------------------------------
\19\Id. (emphasis added).
Others have similarly expressed strong concern about the
lack of data upon which to set a standard as well as the
circumvention of the regulatory process embodied in H.R. 2693.
The OSHA Fairness Coalition, an association of employers and
trade groups which seeks to ensure fairness and balance in
---------------------------------------------------------------------------
OSHA's rulemaking, put it most clearly:
This bill would establish a regulation even though
the science and data available are insufficient to
support a regulation. Such a mandate would be
completely at odds with all other laws, judicial
decisions, executive orders and sound policy
considerations under which OSHA currently operates.
This bill mandates that OSHA issue an interim final
regulation within 90 days of enactment, and a final
regulation which would include a Permissible Exposure
Limit (PEL), within two years of enactment.
Unfortunately, no data currently exist as to where such
a line could be drawn. The very NIOSH document cited in
the bill for the recommendations that are to be
enshrined in the OSHA regulation also states with
respect to diacetyl and other flavorings: ``Little is
currently known about which chemicals used flavorings
have the potential to cause lung disease and other
health effects, and what workplace exposure
concentrations are safe. . . . Most chemicals used in
flavorings have not been tested for respiratory
toxicity via the inhalation route, and occupational
exposure limits have been established for only a
relatively small number of these chemicals.''
Most importantly, this bill would completely ignore
the carefully developed, balanced, and necessary
requirements for rulemaking that Congress and the
courts have put in place to make sure OSHA standards
reflect the best science available, are responsive to a
specific hazard, and are both technologically and
economically feasible for the affected employers. Both
Congress and the Supreme Court have made clear that
OSHA can regulate only after it has satisfied specific
requirements for data and analysis.\20\
---------------------------------------------------------------------------
\20\Letter to Members of Committee on Education and Labor from OSHA
Fairness Coalition (June 19, 2007) (citation omitted; emphases added).
Similarly, the American Bakers Association has expressed
---------------------------------------------------------------------------
its strong concern with this legislation to the Committee:
Mandating specific requirements that OSHA must
include in a diacetyl standard sets a precedent that
should be avoided. Congress's role as set forth in the
OSH Act of 1970 is to ``assure so far as possible every
working man and woman in the Nation safe and healthful
working conditions and to preserve our human
resources.'' However, it is the role of the Department
of Labor to use its expertise for implementing
regulations).\21\
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\21\Letter to Chairman Miller from American Bakers Association
(June 19, 2007) (emphasis added).
Committee Republicans, regulators, and the regulated
community are unanimous in their view that regulation of
diacetyl may be warranted--but equally clear that the
scientific evidence that answers that question, or counsels how
best to regulate, is simply not available at this time.
Particularly where, as here, science does not yet suggest, let
alone dictate, the best outcome, Congress should not interject
itself in the process of micromanaging regulatory agencies, or
substituting its view for reliable and objective analysis.
CALIFORNIA IS NOT MOVING AHEAD TO REGULATE DIACETYL IN THE ABSENCE OF
APPROPRIATE SCIENCE
One final argument bears particular note. The Majority
attempts to justify the intervention of federal OSHA in the
absence of appropriate science by suggesting that the State of
California is moving more quickly, and that the federal
government should follow suit. This argument misses the mark.
Foremost, California is not moving with any more or less
urgency on the regulation of diacetyl than federal OSHA. The
California Assembly passed legislation to urge Cal-OSHA to make
the regulation of diacetyl a high priority, but affirmatively
opted not to impose a date certain for the completion of a
regulation. California's regulatory body also did not set an
exposure standard, and is instead working toward setting a
standard that largely relies on engineering controls to control
exposure--far less than that contemplated by H.R. 2693.
Finally--and as noted at hearing--the simple fact is that OSHA
and California's state regulatory agencies do not have the same
regulatory processes and are not subject to the same
constraints. In response to questioning by Chairwoman Woolsey,
Assistant Secretary Foulke elucidated these differences:
Well, you know, with respect to California, I would
just have to say that we have different statutory and
legal burdens to support our rulemaking effort that
California does not have. . . . I would submit to you
that if you look at the regulatory process that we have
in place under the federal system, as opposed to
California, we have things that the Congress has put
in--Administrative Procedures Act. We have things in
the OSH Act that we have to follow, so those are just
three of the things that the Congress has intended.
And all those things were put on for specific
reasons, that the Congress, in its wisdom said, ``You
know, we have got to look at these things, because we
can't rush into a standard, unless we have sound
science.'' And I know that is what you want to have.
Plus, on top of that, the court systems, as part of
their review process on these things, have indicated
that we have to do certain other things on feasibility
and risk assessment.\22\
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\22\Foulke Testimony, at__(not yet printed).
As a general matter, and specifically in this instance, to
assert that there should be a race to promulgate a regulation,
for which the science is simply science, is bad public policy.
AMENDMENTS OFFERED IN COMMITTEE
Woolsey Amendment in the nature of a substitute
An Amendment in the Nature of a Substitute offered by
Workforce Protections Subcommittee Chair Woolsey was adopted
without objection. The Woolsey Amendment simply provided a
short title for H.R. 2693, the ``Popcorn Workers Lung Disease
Prevention Act.''
Wilson Amendment to require scientific data supporting a rulemaking
As noted above, NIOSH has stated--and no party has
seriously disputed--that the current state of scientific data
concerning diacetyl offers an insufficient basis on which to
set a workplace exposure standard. For this reason, and to
ensure that any workplace standard set by OSHA was based on
scientific evidence, during Committee consideration of the bill
Representative Joe Wilson of South Carolina offered an
amendment which would have: (a) required NIOSH to set a
recommended exposure limit (REL) for diacetyl when the
scientific evidence so warranted; and (b) provided that OSHA
would have two years from that time to set a permissible
exposure limit based on NIOSH's findings.
The Wilson Amendment would have allowed the interim final
rule contained in H.R. 2693 to become effective as scheduled
under the bill, while ensuring that any standard set by OSHA
would have been based on the best available science and still
allowing for robust stakeholder input. At markup, the Majority
expressed a willingness to work with Committee Republicans in
fashioning a compromise that might serve these goals. Based on
this representation, the Wilson Amendment was withdrawn without
objection.\23\
---------------------------------------------------------------------------
\23\At the time of the filing of these Minority Views, discussions
as to a possible compromise continue on a staff level. To date,
however, they have not produced a consensus position.
---------------------------------------------------------------------------
Wilson Amendment to require NIOSH to gather data as to other flavorings
As discussed above, scientific evidence is inconclusive as
to diacetyl's causal link to bronchiolitis obliterans, and in
particular, whether a risk of lung damage is presented by
diacetyl, any related compounds, or some combination of both.
Given this lack of information, during Committee
consideration, Representative Wilson offered an amendment which
directs NIOSH to study flavorings that have a chemical make up
similar to diacetyl, so as to determine exposure hazards (if
any) and, where appropriate, set recommended exposure limits.
The amendment further directs NIOSH to inform OSHA of its
findings, so that all parties have this evidence for use in
future regulation. The Wilson Amendment was accepted without
objection.
CONCLUSION
Committee Republicans recognize that the question of
whether and how OSHA should regulate worker exposure to
diacetyl in the workplace is one on which Members on both sides
of the aisle can in good conscience disagree. Committee
Republicans are united, however, in their view that any
workplace regulation, however well intended, must be supported
by objective evidence, sound science, and reliable data. To do
less threatens the thirty-five years of accomplishment achieved
under the OSH Act, and, far worse, does nothing to protect the
health and safety of American workers.
Measured against those standards, H.R. 2693 is, foremost,
fundamentally flawed policy with respect to the discrete issue
of whether and how to federally regulate exposure to diacetyl.
Equally important, in the larger context, it sets an
unfortunate precedent for the consideration of future workplace
safety standards. H.R. 2693 short-circuits the rulemaking
process and thereby eliminates many of the critical features of
rulemaking under the OSH Act which serve to guarantee that
regulation is based on sound science, stakeholder input, and
the best evidence available. At bottom, the bill is based on
incomplete evidence as to appropriate workplace exposure
controls and standards, and, perhaps most disappointing,
provides no guarantee that workers will enjoy greater
protection from the risk of bronchiolitis obliterans.
For all of these reasons, we respectfully oppose this
legislation.
Howard P. McKeon.
Peter Hoekstra.
Mark Souder.
Judy Biggert.
Joe Wilson.
John Kline.
K. Marchant.
Thomas Price.
Luis Fortuno.
C. W. Boustany, Jr.
Rob Bishop.
David Davis.
Tim Walberg.
Ric Keller.
APPENDIX A
----------
U.S. Department of Labor, Assistant Secretary for
Occupational Safety and Health,
Washington, DC., June 19, 2007.
Hon. George Miller,
Chairman, Committee on Education and Labor,
House of Representatives, Washington, DC.
Dear Chairman Miller: I am writing to express my strong
concerns with legislation (H.R. 2693) that would require the
promulgation of an interim final standard (IFR) regulating
employee exposure to diacetyl in the popcorn and flavor
manufacturing industries and mandate that the Occupational
Safety and Health Administration (OSHA) issue a final rule
covering all workplaces that use diacetyl.
I share your goal of protecting workers from the risk of
obstructive lung disease. As outlined below, OSHA is in the
process of taking important steps to strengthen worker
protections in this area. However, after careful review of this
legislation, we have concluded that the regulatory approach
mandated by H.R. 2693 will not afford the best level of
protection for workers. Equally important, the process the bill
would require may result in missed opportunities to provide
needed worker safety. Instead, I urge you to allow OSHA to
thoroughly evaluate all available science concerning the
effects of exposures to food flavorings, feasible abatements,
and related issues.
Several considerations lead us to the conclusion that the
approach mandated by H.R. 2693 would not best protect workers:
1. The expanded scope of the final rule and the lack of
knowledge about the industries that use diacetyl will lead to
superficial analysis that may fail to provide needed worker
protection.
H.R. 2693 would require OSHA to expand the scope of the
final rule to include all establishments where there is
potential for exposure to diacetyl. Unfortunately, little is
known about industries--other than the microwave popcorn
manufacturing and food flavoring manufacturing industries--that
use diacetyl and diacetyl-containing flavorings. OSHA would
need to identify those companies that use diacetyl, then
conduct site visits to gather needed data to (1) identify
processes where exposures occur, (2) develop control strategies
for each process, and (3) identify employers who have
implemented control strategies to determine if those control
strategies are effective, Although OSHA has been obtaining this
information for microwave popcorn and food flavoring
manufacturing establishments, to date little information is
available on the many other industry sectors that would
potentially be covered by the final rule required by the bill.
OSHA believes that two years is too short a period of time to
develop the information base and analysis necessary to
adequately support the proposed and final rule, and to afford
the public adequate time to comment on OSHA's proposaL The
Agency believes that robust public input is essential to
achieving a final rule that provides protection for employees
while addressing potential impacts on all affected industries.
2. Focusing solely on a Permissible Exposure Limit (PEL)
for diacetyl may ignore other components that are playing an
important role in the development of disease.
H.R. 2693 requires OSHA to develop a PEL for diacetyl that
would apply to all facilities where diacetyl is processed or
used. Research is ongoing by groups such as the National
Institute for Occupational Safety and Health (NIOSH), the
National Jewish Medical Center, the National Institute for
Environmental Health Studies and California Department of
Industrial Relations; Division of Occupational Safety and
Health (Cal OSHA) to better determine the role that exposures
to diacetyl and other chemicals may play in the development of
bronchiolitis obliterans.
By focusing solely on diacetyl, H.R. 2693 raises two major
concerns:
a. Focusing on diacetyl ignores the possibility that other
flavoring components--many of which are irritants and airway-
reactive substances--are playing a role in the development of
disease. Given the wide variety of ways and forms (e.g.,
liquids or powders) in which diacetyl and other flavoring
components are used in the food manufacturing industry, a
narrow focus on diacetyl would likely result in the selection
of risk management strategies that may not adequately protect
employees. These might include substitution of diacetyl with
other chemicals that may be as dangerous under similar
circumstances as diacetyl.
b. NIOSH has stated that ``at this time, insufficient data
exist on which to base workplace exposure standards or
recommended exposure limits for butter flavorings.'' Given the
state of the data currently available, OSHA would only be able
to develop an imprecise PEL for diacetyl which would have a
considerable amount of uncertainty associated with respect to
the degree of protection afforded.
3. As drafted, the bill would require the interim final
rule to impose engineering requirements based on NIOSH
recommendations that lack the clarity and specificity necessary
to form the basis of a new health standard.
H.R. 2693 would direct OSHA to issue an interim rule at
least as stringent as the 2004 NIOSH Hazard Alert. The NIOSH
recommendations serve as good general recommendations, but do
not provide specific performance criteria that would be
necessary to develop an unambiguous and enforceable interim
rule. The NIOSH Alert refers to the 2001 ACGIH Ventilation
Manual, which provides some general objective design criteria,
but mixing and blending processes in flavoring establishments
vary greatly. For example, they can range from a zero-gallon
batch operation up to several hundred pounds of batch mixing.
Each of these operations may use similar control strategies but
would require different engineering design parameters to
achieve the same level of effectiveness. Therefore, the NIOSH
Hazard Alert is not helpful to specify required minimum
operating parameters for engineering controls because these
minimum parameters will not provide equal protection to all
employees in affected establishments. Furthermore, there is
simply not enough information available at this point on
flavoring processes and current exposure control practices to
develop a specification-oriented standard.
OSHA traditionally has used PELs instead of specification-
oriented standards to protect workers in this type of
situation, because a PEL will set a precise, measurable
standard to protect workers. However, as previously mentioned,
currently available data do not support setting a PEL for
diacetyl. Thus, OSHA would be forced by H.R. 2693 to issue a
PEL based on imprecise information and an IFR based on a MOSH
Hazard Alert that does not provide specific performance
criteria.
Additionally, the Department of Labor is very concerned
that the IFR that is mandated by this legislation will not be
open for comment by stakeholders, or reviewed in accordance
with the requirements of the Small Business Regulatory
Enforcement Fairness Act (SBREFA), the Administrative
Procedures Act, and the rulemaking requirements of the
Occupational Safety and Health Act These statutes ensure
thorough consideration and transparency in rulemaking. We do
not believe these regulatory requirements should be waived
except in the most exceptional situations. Thorough vetting is
particularly critical when the medical and scientific studies
do not provide unequivocal conclusions.
The Department of Labor is committed to protecting
employees from obstructive lung diseases. The Department
recently announced that OSHA will focus on health hazards of
microwave popcorn butter flavorings containing diacetyl through
a new National Emphasis Program (NEP). The NEP will direct
inspections to the facilities where workers may be at the
greatest risk of exposure to this hazard. Implementation of
this NEP would allow OSHA to inspect every such facility under
Federal jurisdiction by the end of this year. This will be
followed by a second NEP that focuses on establishments
manufacturing food flavorings containing diacetyl.
In addition to the NEP1 OSHA is also preparing a Safety and
Health Information Bulletin (SHIB) to better inform and
instruct employers on how to protect employees from obstructive
lung disease caused or exacerbated by food flavorings used in
the microwave popcorn manufacturing industry. The SHIB will
provide guidance to alert employers and workers to the
potential hazards associated with butter flavorings containing
diacetyl and will provide recommendations on how to control
these hazards. OSHA is also developing a hazard communication
guidance document to ensure that material safety data sheets
and labels properly convey hazard information on diacetyl and
diacetyl-containing food flavorings. Given that NIOSH has
stated that insufficient data exist on which to base workplace
exposure standards or recommended exposure limits for butter
flavorings, the approach we are taking is the quickest and most
effective means of providing protection to workers in the
popcorn and flavor manufacturing industries.
Because of the concerns I have outlined, the Department of
Labor is opposed to H.R. 2693. We have concluded that the
approach proposed by H.R. 2693 will not afford the best level
of protection for workers. By not providing sufficient time to
do a proper rulemaking, OSHA may unintentionally overlook
opportunities to provide needed worker safety and, at the same
time, require expensive process isolation, and ventilation and
other control strategies that may be ineffective. Instead, I
urge you to allow OSHA to thoroughly evaluate all available
science concerning the effects of exposures to food flavorings,
feasible abatements, and related issues.
Sincerely,
Edwin G. Foulke, Jr.