- FORMALDEHYDE IN TEXTILES AND CONSUMER PRODUCTS

[Senate Hearing 111-56]
[From the U.S. Government Publishing Office]

S. Hrg. 111-56

FORMALDEHYDE IN TEXTILES
AND CONSUMER PRODUCTS

=======================================================================

HEARING

before the

SUBCOMMITTEE ON CONSUMER PROTECTION, PRODUCT SAFETY, AND INSURANCE

of the

COMMITTEE ON COMMERCE,
SCIENCE, AND TRANSPORTATION
UNITED STATES SENATE

ONE HUNDRED ELEVENTH CONGRESS

FIRST SESSION

__________

APRIL 28, 2009

__________

Printed for the use of the Committee on Commerce, Science, and
Transportation

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SENATE COMMITTEE ON COMMERCE, SCIENCE, AND TRANSPORTATION

ONE HUNDRED ELEVENTH CONGRESS

FIRST SESSION

JOHN D. ROCKEFELLER IV, West Virginia, Chairman
DANIEL K. INOUYE, Hawaii KAY BAILEY HUTCHISON, Texas,
JOHN F. KERRY, Massachusetts Ranking
BYRON L. DORGAN, North Dakota OLYMPIA J. SNOWE, Maine
BARBARA BOXER, California JOHN ENSIGN, Nevada
BILL NELSON, Florida JIM DeMINT, South Carolina
MARIA CANTWELL, Washington JOHN THUNE, South Dakota
FRANK R. LAUTENBERG, New Jersey ROGER F. WICKER, Mississippi
MARK PRYOR, Arkansas JOHNNY ISAKSON, Georgia
CLAIRE McCASKILL, Missouri DAVID VITTER, Louisiana
AMY KLOBUCHAR, Minnesota SAM BROWNBACK, Kansas
TOM UDALL, New Mexico MEL MARTINEZ, Florida
MARK WARNER, Virginia MIKE JOHANNS, Nebraska
MARK BEGICH, Alaska
Ellen L. Doneski, Chief of Staff
James Reid, Deputy Chief of Staff
Bruce H. Andrews, General Counsel
Christine D. Kurth, Republican Staff Director and General Counsel
Paul Nagle, Republican Chief Counsel
------

SUBCOMMITTEE ON CONSUMER PROTECTION, PRODUCT SAFETY, AND INSURANCE

MARK PRYOR, Arkansas, Chairman ROGER F. WICKER, Mississippi,
BYRON L. DORGAN, North Dakota Ranking
BARBARA BOXER, California OLYMPIA J. SNOWE, Maine
BILL NELSON, Florida JIM DeMINT, South Carolina
CLAIRE McCASKILL, Missouri JOHN THUNE, South Dakota
AMY KLOBUCHAR, Minnesota JOHNNY ISAKSON, Georgia
TOM UDALL, New Mexico DAVID VITTER, Louisiana

C O N T E N T S

----------
Page
Hearing held on April 28, 2009................................... 1
Statement of Senator Pryor....................................... 1
Statement of Senator Wicker...................................... 2
Letter, dated April 27, 2009, from the American Apparel and
Footwear Association; American Manufacturing Trade Action
Coalition; National Council of Textile Organizations;
National Cotton Council; and Northern Textile Association
to Hon. Mark L. Pryor and Hon. Roger F. Wicker............. 4
Letter, dated May 19, 2009, from David Brookstein, Sc.D.,
Dean and Professor, School of Engineering and Textiles,
Philadelphia University to Hon. Roger F. Wicker............ 42
Statement of Senator Klobuchar................................... 38

Witnesses

Hon. Robert P. Casey Jr., U.S. Senator from Pennsylvania......... 4
Prepared statement........................................... 6
Ruth A. Etzel, M.D., Ph.D., FAAP On Behalf of the American
Academy of Pediatrics.......................................... 7
Prepared statement........................................... 9
David Brookstein, Sc.D., Dean and Professor, School of
Engineering and Textiles, Philadelphia University.............. 12
Prepared statement........................................... 14
Dr. Phillip J. Wakelyn, Consultant, Wakelyn Associates, LLC...... 21
Prepared statement........................................... 23

Appendix

Response to written questions submitted to Hon. Tom Udall by:
Dr. Ruth A. Etzel............................................ 49
Dr. David Brookstein......................................... 49
Dr. Phillip Wakelyn.......................................... 49
Letter, dated May 12, 2009, from Betsy Natz, Executive Director,
Formaldehyde Council to Hon. Mark L. Pryor and Hon. Roger F.
Wicker......................................................... 52

FORMALDEHYDE IN TEXTILES
AND CONSUMER PRODUCTS

TUESDAY, APRIL 28, 2009

U.S. Senate,
Subcommittee on Consumer Protection, Product
Safety, and Insurance,
Committee on Commerce, Science, and Transportation,
Washington, DC.
The Subcommittee met, pursuant to notice, at 10:33 a.m. in
room SR-253, Russell Senate Office Building, Hon. Mark L.
Pryor, Chairman of the Subcommittee, presiding.

OPENING STATEMENT OF HON. MARK L. PRYOR,
U.S. SENATOR FROM ARKANSAS

Senator Pryor. I'll call the meeting to order. Thank you
for coming to the Consumer Protection, Product Safety, and
Insurance Subcommittee hearing on formaldehyde in textiles and
consumer products.
I want to thank everyone who's attending. I want to thank
the panelists. And I certainly want to thank Senator Casey for
his leadership.
We're here to discuss the health effects associated with
formaldehyde exposure and the potential safety standards
necessary to protect the public's health. I'd like to begin by
thanking Senator Casey for his leadership on this issue and for
attending today's hearing. We're also going to allow him to
participate and ask questions as if he's on the Subcommittee
today. The reason we're doing that is because he has been
instrumental in pushing the Consumer Product Safety Commission
to conduct a study on the uses and risks of formaldehyde.
Because of his efforts, the Commission is now required to focus
on public risks that had not received adequate government
attention before.
Before we hear from Senator Casey, we will hear from Dr.
Ruth Etzel. Dr. Etzel is an adjunct professor at George
Washington University School of Public Health and Health
Services. She's an epidemiologist, a doctor, a founding editor
of the American Academy of Pediatrics book on Pediatric
Environmental Health and is here today representing the
American Academy of Pediatrics.
After Dr. Etzel, we'll hear from Dr. David Brookstein, who
is dean at Philadelphia University's School of Engineering and
Textiles. Dr. Brookstein's specialty is the dermatological
effects of formaldehyde in textiles and apparel.
And finally, we'll hear from Dr. Phillip Wakelyn, a
consultant at Wakelyn Associates, also speaking on behalf of
the National Cotton Council. Dr. Wakelyn has over 30 years of
experience in this area.
I'd like to thank all the witnesses for appearing before
the Subcommittee today. Your insight will be extremely helpful
to all of us as we consider our next step.
The Subcommittee has been at the forefront of exposing and
regulating consumer product risks for years. In this Congress,
we will redouble our efforts to improve product safety. The
Consumer Product Safety Commission is implementing the biggest
overhaul to its statutory mandates in a generation. This will
require ongoing, careful Congressional oversight as the new
requirements affect every child's product in the stream of
commerce.
As we continue to strengthen consumer rights in this area
and in others, we'll strengthen the safety net to provide
strong protections for every American. In the end, we certainly
hope that citizens will know that the products they buy and use
each and every day will perform to the highest standards. That
is one of the main purposes of the Subcommittee, and it's a
responsibility that we take seriously and that we'll discuss
today during our subcommittee hearing.
I'd like to now turn it over to my Ranking Member, Senator
Wicker, and congratulate you on being the Ranking Member. I
look forward to working with you this Congress.

STATEMENT OF HON. ROGER F. WICKER,
U.S. SENATOR FROM MISSISSIPPI

Senator Wicker. Well, thank you, Chairman Pryor. And,
indeed, this is the first hearing of our subcommittee, and I
appreciate your chairmanship and your leadership in this
subcommittee, and I appreciate your words of welcome.
Thank you for holding this hearing today. This hearing is a
part of the necessary debate on the issue of formaldehyde in
textiles.
The people in my home State of Mississippi know a thing or
two about textiles. Mississippi is the home to numerous
furniture manufacturers, and northeast Mississippi is
considered the upholstered furniture capital of the world, and
we're proud of that.
Formaldehyde is a substance with a variety of uses. Our
bodies naturally produce formaldehyde in small amounts. It is
also present in our indoor and outdoor environments through
natural and manmade means. Industry produces it for use in many
beneficial products we use every day. It can be found in
antiseptics, medicines, cosmetics, dishwashing liquids, fabric
softeners, shoe-care agents, carpet cleaners, glues, adhesives,
paper, plastic, and other products. And, as I read that list,
Mr. Chairman, I think I see about ten items that I probably
used yesterday and last night, because last night was laundry
night at the Wicker condo.
Now, the textile industry uses formaldehyde mainly in the
finishing process, to give natural textiles the quality and
aesthetics that consumers want, including stain and wrinkle
resistance.
The Federal Government has studied formaldehyde exposure
for decades and has already regulated its use and presence in a
number of different ways. Regulations limit the airborne
concentration of formaldehyde in certain environments, emission
rates from certain products, and concentration rates of
consumer products. OSHA regulates formaldehyde exposure in the
workplace. The Department of Housing and Urban Development
regulates the presence of formaldehyde in manufactured wood
products. CPSC considers formaldehyde a ``strong sensitizer''
when found at levels above 1 percent in consumer products.
Because of health concerns raised over contaminated FEMA
disaster housing used to house Hurricane Katrina victims,
Mississippians and people across the Gulf Coast now have a
better understanding of the use of formaldehyde in consumer
products. FEMA now applies the HUD formaldehyde standards for
manufactured wood products to the Agency's procurement
requirements for travel trailers.
Industries such as the textile industry are looking for
ways of reducing the use of formaldehyde in the finishing
process. While formaldehyde-free options already exist,
research is ongoing to find ways to produce cost-effective
alternatives. For example, the University of Southern
Mississippi has created technology to use soy protein-based
adhesives in place of formaldehyde-based adhesives in the
manufactured wood process. Advances like these will help
further limit excessive formaldehyde exposure in the home,
workplace, and environment.
Senator Casey joins us this morning. He's to be
congratulated for fighting to include a study on formaldehyde
in textiles during last year's consumer product safety debate.
As a result, the Consumer Product Safety Improvement Act of
2008 included language requiring the GAO to work with the CPSC
to conduct a study on the use of formaldehyde in textiles and
any associated risks to consumers.
It is my understanding that the study has not commenced,
but that it will be completed by the statutory date of August
2010. I look forward to seeing that study. It should provide
Congress, the CPSC, and consumers with information necessary
and to evaluate steps forward on formaldehyde use in textiles.
Any further restrictions on use or limits on the inclusion of
formaldehyde in consumer products need to be based on sound
science.
I look forward to working with you, Mr. Chairman, and with
Senator Casey, on not only providing the best consumer
protection that we can possibly have, but also the best
protection for the consumer dollar that we can have at the same
time.
Now, I would like to ask, as I conclude my opening remarks,
for a unanimous-consent request. I received a letter yesterday,
cosigned by the American Apparel and Footwear Association, the
American Manufacturing Trade Action Coalition, the National
Council of Textile Organizations, the National Cotton Council,
and the Northern Textile Association. These organizations wrote
on behalf of Dr. Wakelyn's participation in today's hearing and
stated that his testimony reflects the views and concerns of
these apparel and textile groups. So, at this point, Mr.
Chairman, I ask unanimous consent that this letter be inserted
into the record.
Senator Pryor. Without objection.
Senator Wicker. Thank you very much.
Senator Pryor. Thank you.
[The information referred to follows:]

April 27, 2009
Hon. Mark Pryor,
Chairman,

Hon. Roger Wicker,
Ranking Member,

Senate Subcommittee on Consumer Protection, Product Safety, and
Insurance,
Committee on Commerce, Science, and Transportation,
Washington, DC.

Dear Senators Pryor and Wicker:

This is to advise that the testimony presented by Dr. Phil Wakelyn
during the hearing scheduled for April 28 titled ``Formaldehyde in
textiles and Consumer Products'' reflects the views and concerns of a
broad coalition of textile and apparel interests, including the
National Cotton Council, the National Council of Textile Organizations,
the National Textile Association, the American Manufacturing Trade
Action Coalition, and the American Apparel and Footwear Association. As
you may know, these organizations joined together last year to express
support for a review and update of previous studies on formaldehyde in
textiles and apparel.
The following is an excerpt from that letter. ``There have not been
safety related problems raised in the U.S. concerning formaldehyde in
textile and apparel. CPSC extensively studied formaldehyde and textiles
in the 1980s . . . The listed Associations strongly recommend that in
view of all the studies over the last 30 years and regulations already
in place concerning formaldehyde and textiles, CPSC should only be
required to do an updated review of the situation to determine if there
are unreasonable risks to consumers caused by textiles and apparel due
to the use of formaldehyde containing substances in their
manufacturing. This study should be completed to determine if further
action is necessary before requiring further actions by CPSC or other
regulatory agencies.''
We appreciate the opportunity for Dr. Wakelyn to participate in the
hearing and to respond to questions.

Sincerely,
American Apparel and Footwear
Association
American Manufacturing Trade Action
Coalition
National Council of Textile
Organizations
National Cotton Council
Northern Textile Association

Senator Pryor. Senator Casey has earned a reputation of
being a very reasonable and very hardworking Senator since he
has been here representing Pennsylvania.
Senator Casey, it is an honor to have you with the
Subcommittee today. Please open.

STATEMENT OF HON. ROBERT P. CASEY, JR.,
U.S. SENATOR FROM PENNSYLVANIA

Senator Casey. Mr. Chairman, thank you very much. I hope
this is on. We don't get a chance to be at the witness table
very often, so I'm honored that you would allow me this
privilege and also that you would convene this hearing. I'm
grateful for that. And the same goes for Senator Wicker. Thank
you very much. Thank both of you for your thoughtful statements
on this issue.
I do want to thank you for conveying--or, convening, I
should say, today's hearing, and for this opportunity to
testify, about the dangers to consumers from formaldehyde use
in textiles and other consumer goods. This important safety
issue was first brought to my attention by Dr. David Brookstein
of Philadelphia University. He will be testifying here today,
and I want to thank him for his efforts to bring attention to
this issue. I look forward to hearing his testimony.
Formaldehyde has a number of commercial uses, including as
an adhesive, a resin applied to paper goods, and as insulation.
Formaldehyde has long been used in the textile industry to make
clothing crease-resistant or wrinkle-free.
The Consumer Product Safety Commission has identified
formaldehyde as a potential hazard. In 1997, the CPSC issued a
report on the dangers of formaldehyde. The report, among other
things, stated that, ``Formaldehyde is a colorless, strong-
smelling gas. When present in the air at levels above .1 ppm,
or parts per million of air, it can cause watery eyes, burning
sensations in the eyes, nose, and throat, nausea, coughing,
chest tightness, wheezing, skin rashes, and allergic reactions.
It has also been observed to cause cancer, in scientific
studies using laboratory animals, and may cause cancer in
humans.'' A long quotation from a 1997 Consumer Product Safety
Commission report. Yet, despite these findings, the Commission
has yet to take any action on testing textiles for dangerous
levels of formaldehyde.
The United States currently trails other nations in
responding to threats of formaldehyde. Australia, Germany,
France, the Netherlands, Austria, Finland, Norway, China,
Japan, Poland, Russia, Lithuania, and South Korea have all
adopted standards for formaldehyde use, particularly in
textiles in clothing. We need similar protections in the United
States of America. The risk of not setting standards and
waiting until after major problems surface are too great.
American consumers deserve protection from dangerous goods, and
they necessarily rely upon the government for this protection.
It's a simple fact that consumers can't test products on
their own. We need to make sure that the products we bring to
market are safe, particularly those used by children.
Some may argue that many domestic and international
manufacturers already adhere to self-imposed standards on
formaldehyde use in goods, ranging from apparel to
particleboard. However, these voluntary standards do not carry
the penalties for violators, and there is evidence that foreign
manufacturers in China have ignored the standards. According to
the Associated Press, the New Zealand government launched an
investigation into Chinese garments imported to New Zealand
after children's clothes from China were found to contain
dangerous levels of formaldehyde. In 2007, according to the
American Apparel and Footwear Association, more than 25 percent
of clothes sold in the United States were imported from China.
As a first step to developing regulations, we need to
better understand the dimensions of the problem. Currently, we
do not even have a basic understanding of the scope of
formaldehyde use in products. We need additional information
about the prevalence of formaldehyde in goods, and, most
importantly, the impact it is having on American consumers.
To assist in reaching that goal, I successfully sponsored
an amendment to the Consumer Product Safety Improvement Act
which calls for a study by the U.S. Government Accountability
Office, what we know as GAO, on the use of formaldehyde in the
manufacture of textiles and apparel articles. The law gave the
GAO, as Senator Wicker mentioned, until August 2010 to complete
the study. Of course, they can move that date up if they want.
[Laughter.]
Senator Casey. That's the deadline. And we hope they would.
I understand, from the GAO, that they have not yet begun
work on the report, but we'd all like to take the opportunity
today to encourage GAO to commence work on this important
study.
I look forward to reviewing their findings once the study
is completed, and it's my hope that today's hearing will
provide an opportunity to learn more about the dangers of
formaldehyde use in consumer products. And Congress's oversight
responsibilities with respect to executive agencies, I believe,
and I know my colleagues believe, are among its most important
functions. As such, I'd like to commend Senator Pryor and
Senator Wicker for your efforts at oversight and for bringing
this issue to our attention at this time.
I want to thank both of you for the opportunity to share
these comments. I look forward to joining the members of the
Committee to listen to the expert testimony and ask questions
of the witnesses; I would add, parenthetically, this is a rare
privilege when you're not a member of the Committee, and I'm
grateful for that opportunity. I'm serious about that. It's
rare that we have the chance to do this.
The information added today to the public record, in
addition to the report by the GAO, will lay the groundwork for
necessary regulation of this harmful chemical. I will reiterate
my assertion that we trail other countries in setting a safety
standard on this issue, and I hope that our efforts today will
change this fact and that, in the end, this hearing will result
in stronger protections for children and families.
Mr. Chairman, thank you for this opportunity.
[The prepared statement of Senator Casey follows:]

Prepared Statement of Hon. Robert P. Casey Jr.,
U.S. Senator from Pennsylvania

Thank you, Mr. Chairman, for convening today's hearing and for the
opportunity to testify about the dangers to consumers from formaldehyde
use in textiles and other consumer goods. This important safety issue
was first brought to my attention by Dr. David Brookstein of
Philadelphia University. I understand that that Dr. Brookstein is here
to testify. I thank him for his efforts to bring attention to this
issue and I look forward to hearing his testimony.
Formaldehyde has a number of commercial uses including as an
adhesive, a resin applied to paper goods and as insulation.
Formaldehyde has long been used in the textile industry to make
clothing crease-resistant, or wrinkle-free.
The Consumer Product Safety Commission (CPSC) has identified
formaldehyde as a potential hazard. In 1997, the CPSC issued a report
on the dangers of formaldehyde. The report among other things stated
that, ``formaldehyde is a colorless, strong-smelling gas. When present
in the air at levels above 0.1 ppm (parts in a million parts of air),
it can cause watery eyes, burning sensations in the eyes, nose and
throat, nausea, coughing, chest tightness, wheezing, skin rashes, and
allergic reactions. It also has been observed to cause cancer in
scientific studies using laboratory animals and may cause cancer in
humans.'' Yet, despite these findings, the CPSC has yet to take any
action on testing textiles for dangerous levels of formaldehyde.
The United States trails other nations in responding to the threats
of formaldehyde. Australia, Germany, France, the Netherlands, Austria,
Finland, Norway, China, Japan, Poland, Russia, Lithuania and South
Korea have all adopted standards for formaldehyde use, particularly in
textiles and clothing.
We need similar protections in the United States. The risks of not
setting standards, and waiting until after major problems surface, are
too great. American consumers deserve protection from dangerous goods
and they necessarily rely on the government for this protection. It is
a simple fact that consumers can't test products on their own. We need
to make sure that the products we bring to market are safe,
particularly those used by children.
Some may argue that many domestic and international manufacturers
already adhere to self imposed standards on formaldehyde use in goods
ranging from apparel to particle board. However, these voluntary
standards do not carry penalties for violators and there is evidence
that foreign manufacturers in China have ignored the standards.
According to the Associated Press, the New Zealand government launched
an investigation into Chinese garments imported to New Zealand after
children's clothes from China were found to contain dangerous levels of
formaldehyde. In 2007, according to the American Apparel and Footwear
Association, more than 25 percent of clothes sold in the United States
were imported from China.
As a first step to developing regulations, we need to better
understand the dimension of the problem. Currently, we do not even have
a basic understanding of the scope of formaldehyde use in products. We
need additional information about the prevalence of formaldehyde in
goods and, most importantly, the impact it is having on American
consumers.
To assist in reaching that goal, I successfully sponsored an
amendment to the Consumer Product Safety Improvement Act which calls
for a study by the U.S. Government Accountability Office (GAO) on the
use of formaldehyde in the manufacture of textile and apparel articles.
The law gave the GAO until August 2010 to complete its study. I
understand from the GAO that they have not yet begun work on the
report. I would like to take the opportunity today to encourage GAO to
commence work on this important study. I look forward to reviewing
their findings once completed.
It is my hope that today's hearing will provide an opportunity to
learn more about the dangers of formaldehyde use in consumer products.
Congress' oversight responsibilities with respect to executive agencies
are among its most important functions. As such, I would like to
commend Senator Pryor for his efforts at oversight and for bringing
attention to this issue.
Thank you for the opportunity to share these comments. I look
forward to joining the members of the Committee to listen to the expert
testimony and ask questions of the witnesses. The information added
today to the public record, in addition to the report by GAO, will lay
the groundwork for necessary regulation of this harmful chemical. I
will reiterate my assertion that we trail other countries in setting a
safety standard on this issue. I hope that our efforts today will
change this fact and that in the end this hearing will result in
stronger protections for children and families.

Senator Pryor. Thank you, Senator Casey, and we look
forward to your questions and participation in this hearing.
If I may, now, ask the panel to come up. I'd like you to go
ahead and take your seats. I'd like to hear witnesses on the
panel in this order: Dr. Ruth Etzel first, Dr. David Brookstein
second, and Dr. Phillip Wakelyn third. I've already done a very
brief introduction; I hope that'll suffice. So, I think what
we're doing is 5 minutes for your statement. If you can keep it
to 5 minutes, that would be great, it would help the Committee
flow better and allow us to get to our questions.
Dr. Etzel, why don't you lead off, please. Thank you.

STATEMENT OF RUTH A. ETZEL, M.D., Ph.D., FAAP ON BEHALF OF THE
AMERICAN ACADEMY OF PEDIATRICS

Dr. Etzel. Good morning. Can you hear me?
Senator Pryor. He's adjusting the volume there. Go ahead.
Dr. Etzel. My name is Ruth Etzel, and I'm proud today to
represent the American Academy of Pediatrics at this hearing.
Formaldehyde is a toxic, pungent, water-soluble gas used in
the aqueous form as a disinfectant, fixative, tissue
preservative, and it's a very versatile product for a wide
range of uses. Formaldehyde resins are used in wood products,
such as particleboard, paper towels, plastics, paints, manmade
fibers such as carpets and polyester, cosmetics, and other
consumer products, including many with which children have
regular contact. According to recent research and media
reports, formaldehyde may be found in fabrics and children's
clothing, children's furniture, baby bath products, and other
products.
Formaldehyde gas is known to cause a wide range of health
effects. A common air pollutant in the home, formaldehyde is an
eye, skin, and respiratory tract irritant. In other words, it
can cause burning or tingling sensations in the eyes, nose, and
throat.
Children may be more susceptible than adults to the
respiratory effects of formaldehyde. Even at fairly low
concentrations, formaldehyde can produce rapid-onset nose and
throat irritation, causing cough, chest pain, shortness of
breath, and wheezing. At higher levels of exposure, it can
cause significant inflammation of the lower respiratory tract.
Children may be more vulnerable than adults to the effect of
chemicals like formaldehyde because of the relatively smaller
diameter of their airways. Children may also be more vulnerable
because they breathe more rapidly than adults and they may be
developmentally incapable of getting out of an area quickly
when exposed.
Studies since 1990 have found higher rates of asthma,
chronic bronchitis, and allergies in children exposed to
elevated levels of formaldehyde. In 2004, the International
Agency for Research on Cancer reclassified formaldehyde as a
known human carcinogen.
Formaldehyde can cause contact dermatitis in susceptible
people. Dr. Brookstein will discuss this matter in more detail,
so I will only note that children are just as susceptible as
adults to the effects of formaldehyde exposure on the skin.
Due to its toxicity, various nations have taken steps to
limit the use of formaldehyde in some applications. Several
nations, including Finland, Norway, the Netherlands, and
Germany, have set standards for the presence of formaldehyde
residues in fabrics. Other nations, including Japan, China,
Russia, Lithuania, New Zealand, and South Korea, have set
limits on formaldehyde in textiles and/or other wood products.
The American Academy of Pediatrics has made formaldehyde
recommendations to Congress and the Administration in the past,
and we would like to reiterate those and submit others for your
consideration.
First, the Consumer Product Safety Commission should limit
formaldehyde residues in children's clothing and other
products. Given that at least a dozen other nations already
restrict formaldehyde residues in children's clothing, the CPSC
should collaborate with the EPA and other agencies with
scientific and medical expertise to determine similar limits to
be imposed in the United States. There is already a
considerable body of evidence that is sufficient to allow CPSC
to make a reasonable judgment in this area. The agencies should
also require labels on children's clothing and other products
used for babies and children that indicate the presence of
formaldehyde residues.
Second, more research should be done on formaldehyde and
children's health. In July 2007, the Academy suggested to the
House of Representatives Committee on Energy and Commerce that
FEMA and Federal health agencies undertake a rigorous study to
determine children's exposure to formaldehyde in FEMA trailers
and its correlation with reported symptoms, and determine steps
that should be taken to safeguard their health. To my
knowledge, no such study has been planned or implemented.
Children may be exposed from multiple sources, and it
remains unclear what effect the multiple sources may have on
their developing bodies. The Consumer Product Safety
Improvement Act of 2008 requires the Comptroller General to
conduct a study, within 2 years, of the ``use of formaldehyde
in the manufacture of textile and apparel articles to identify
any risks to consumers caused by the use of formaldehyde in the
manufacturing of such articles.''
Third, EPA should adopt California's proposed restrictions
on formaldehyde emissions from wood products. In January 2009,
the American Academy of Pediatrics joined numerous other
organizations in urging EPA Administrator Lisa Jackson to
adopt, nationwide, the restrictions on formaldehyde emissions
from hardwood plywood, particleboard, and medium-density
fiberboard set under the California Air Resource Board Airborne
Toxics Control Measure.
Finally, fourth, the CPSC should develop educational
materials for consumers about formaldehyde and its presence and
role in various products and its health risks. The CPSC could
provide an important service by providing up-to-date
educational materials about formaldehyde. A search of the
agency's website reveals a number of documents about
formaldehyde, but most of them are from the 1970s and 1980s.
The last version of the comprehensive document, ``Update on
Formaldehyde,'' appears to be the 1997 version.
The American Academy of Pediatrics commends you, Mr.
Chairman, for holding this hearing today to call attention to
the hazards of formaldehyde exposure among children. We look
forward to working with Congress to minimize the exposure of
children and all Americans to all potentially toxic chemicals.
I appreciate this opportunity to testify, and I will be
happy to answer any questions.
Thank you.
[The prepared statement of Dr. Etzel follows:]

Prepared Statement of Ruth A. Etzel, M.D., Ph.D., FAAP On Behalf of the
American Academy of Pediatrics

Good morning. I appreciate this opportunity to testify today before
the Commerce, Science and Transportation Subcommittee on Consumer
Protection, Product Safety and Insurance regarding formaldehyde in
textiles and consumer products. My name is Ruth Etzel, MD, PhD, FAAP,
and I am proud to represent the American Academy of Pediatrics (AAP), a
non-profit professional organization of more than 60,000 primary care
pediatricians, pediatric medical sub-specialists, and pediatric
surgical specialists dedicated to the health, safety, and well-being of
infants, children, adolescents, and young adults. I am the Founding
Editor of the AAP's book on Pediatric Environmental Health, and I am
currently editing a 3rd edition. I am also a former Chair of the AAP
Committee on Environmental Health and the founding chair of the AAP
Section on Epidemiology.
Formaldehyde is a toxic, pungent, water-soluble gas used in the
aqueous form as a disinfectant, fixative, or tissue preservative,
making it versatile for a wide range of uses. Formaldehyde resins are
used in wood products (e.g., particleboard, paper towels), plastics,
paints, manmade fibers (e.g., carpets, polyester), cosmetics, and other
consumer products,\1\ including many with which children have regular
contact.\2\ According to recent research and media reports,
formaldehyde may be found in fabrics and children's clothing,\3\
children's furniture,\4\ baby bath products,\5\ and other products.
Formaldehyde is also used in the resins used to bond laminated wood
products and to bind wood chips in particleboard. Particleboard may be
used in various types of furniture, including cribs and other items
meant for use by or with children. The experience of Gulf Coast
families living in mobile homes and travel trailers after Hurricane
Katrina brought these hazards to the nation's attention; trailers,
which have small, enclosed spaces, low air exchange rates, and many
particleboard furnishings, may have much higher concentrations of
formaldehyde than other types of homes.\6\^,\7\
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\1\ International Agency for Research on Cancer. IARC Monographs on
the Evaluation of Carcinogenic Risks to Humans. Volume 88.
Formaldehyde. Available online at http://monographs.iarc.fr/ENG/
Monographs/vol88/volume88.pdf.
\2\ Kelly T. J., Smith DL, Satola J. Emission Rates of Formaldehyde
from Materials and Consumer Products Found in California Homes. Environ
Sci Technol, 1999;33(1): 81-88.
\3\ ``Poison found in kids' clothes from China.'' New Zealand
Sunday Star-Times, August 19, 2007. Available online at http://
www.stuff.co.nz/sunday-star-times/497.
\4\ Environment California Research & Policy Center. Toxic Baby
Furniture: The Latest Case for Making Products Safe from the Start. May
2008. Available online http://www.environmentamerica.org/reports/toxic-
free-communities/stop-toxic-pollution/toxic-baby-furniture-the-latest-
case-for-making-products-safe-from-the-start.
\5\ Environmental Working Group. No More Toxic Tub: Getting
Contaminants Out of Children's Bath and Personal Care Products. March
2009. Available online at http://www.ewg.org/node/27698.
\6\ American Academy of Pediatrics Committee on Environmental
Health. Air Pollutants, Indoor. In: Etzel, RA, ed. Pediatric
Environmental Health, 2d Edition. Elk Grove Village: American Academy
of Pediatrics, 2003.
\7\ Spengler JD. Sources and concentrations of indoor air
pollution. In: Samet JM, Spengler JD, eds. Indoor Air Pollution: A
Health Perspective. Baltimore, MD: Johns Hopkins University Press;
1991.
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Formaldehyde gas is known to cause a wide range of health effects.
A common air pollutant in the home,\8\ formaldehyde is an eye, skin,
and respiratory tract irritant. In other words, it can cause burning or
tingling sensations in the eyes, nose and throat. Children may be more
susceptible than adults to the respiratory effects of formaldehyde.
Even at fairly low concentrations, formaldehyde can produce rapid onset
of nose and throat irritation, causing cough, chest pain, shortness of
breath, and wheezing. At higher levels of exposure, it can cause
significant inflammation of the lower respiratory tract, which may
result in swelling of the throat, inflammation of the windpipe and
bronchi, narrowing of the bronchi, inflammation of the lungs, and
accumulation of fluid in the lungs. Pulmonary injury may continue to
worsen for 12 hours or more after exposure. Children may be more
vulnerable than adults to the effects of chemicals like formaldehyde
because of the relatively smaller diameter of their airways. Children
may be more vulnerable because they breathe more rapidly than adults
for their size, and they may be developmentally incapable of evacuating
an area promptly when exposed.\9\
---------------------------------------------------------------------------
\8\ American Academy of Pediatrics Committee on Environmental
Health. Air Pollutants, Indoor. In: Etzel, R. A., ed. Pediatric
Environmental Health, 2d Edition. Elk Grove Village: American Academy
of Pediatrics, 2003.
\9\ Agency for Toxic Substances & Disease Registry. Medical
Management Guidelines for Formaldehyde. http://www.atsdr.cdc.gov/MHMI/
mmg111.html#bookmark02
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Formaldehyde may exacerbate asthma in some infants and children.
Studies since 1990 have found higher rates of asthma, chronic
bronchitis, and allergies in children exposed to elevated levels of
formaldehyde.\10\^,\11\^,\12\^,\13\
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\10\ American Academy of Pediatrics Committee on Environmental
Health. Air Pollutants, Indoor. In: Etzel, R. A., ed. Pediatric
Environmental Health, 2d Edition. Elk Grove Village: American Academy
of Pediatrics, 2003.
\11\ Wantke F., Demmer C. M., Tappler P., Gotz M., Jarisch R.
Exposure to gaseous formaldehyde induces IgE-mediated sensitization to
formaldehyde in school-children. Clin Exp Allergy. 1996 Mar; 26(3):276-
80.
\12\ Garrett M. H., Hooper M. A., Hooper B. M., Rayment P. R.,
Abramson M. J. Increased risk of allergy in children due to
formaldehyde exposure in homes. Allergy. 1999 Apr; 54(4):330-7.
\13\ Rumchev, K. B.; Spickett, J. T.; Bulsara, M. K.; Phillips, M.
R.; Stick, S. M. Domestic exposure to formaldehyde significantly
increases the risk of asthma in young children. Eur Respir, J. 2002
Aug; 20(2):403-8.
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In 2004, the International Agency for Research on Cancer (IARC)
announced there was sufficient evidence that formaldehyde causes
nasopharyngeal cancer in humans and reclassified it as a Group 1, known
human carcinogen (previous classification: Group 2A). IARC also
reported there was limited evidence that formaldehyde exposure causes
nasal cavity and paranasal cavity cancer and ``strong but not
sufficient'' evidence linking formaldehyde exposure to leukemia.\14\
The U.S. National Toxicology Program classifies it as ``reasonably
anticipated to be a human carcinogen.'' \15\
---------------------------------------------------------------------------
\14\ International Agency for Research on Cancer, ``IARC Classifies
Formaldehyde As Carcinogenic to Humans,'' Press Release No. 153, June
15, 2004, http://www.iarc.fr/ENG/Press
_Releases/archives/pr153a.html.
\15\ Krzyzanowski M., Quackenboss J. J., Lebowitz M. D. Chronic
respiratory effects of indoor formaldehyde exposure. Environ Res. 1990
Aug;52(2):117-25.
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Formaldehyde can cause contact dermatitis in susceptible people.
Dr. Brookstein will discuss this matter in more detail, so I will only
note that children are as susceptible as adults to the dermal effects
of formaldehyde exposure.
Due to its toxicity, various nations have taken steps to limit the
use of formaldehyde in some applications. Several nations have set
standards for the presence of formaldehyde residues in fabric,
including Finland, Norway, the Netherlands, and Germany. The European
Union limits formaldehyde in children's clothing to 30 parts per
million.\16\ Other nations, such as Japan, China, Russia, Lithuania,
New Zealand, and South Korea have set limits on formaldehyde in
textiles and/or wood products. Among these nations, the strongest
restrictions are in place in Japan, which requires no detectable
residue of formaldehyde in clothing for children birth to 3 years of
age.\17\
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\16\ Information on European Union laws regarding limits on
formaldehyde in textiles available online from the Centre for the
Promotion of Imports from developing countries, http://www.cbi.eu/.
\17\ American Apparel and Footwear Association. Restricted
Substances List. February 2009. Available online at http://
www.apparelandfootwear.org/UserFiles/File/Restricted%20substance
%20List/AAFARSL_Release4Feb09.pdf.
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Recommendations
The American Academy of Pediatrics has made formaldehyde
recommendations to Congress and the Administration in the past, and
would like to reiterate those and submit others for Congress's
consideration.
CPSC should limit formaldehyde residues in children's clothing and
other products. Given that at least a dozen other nations already
restrict formaldehyde residues in children's clothing, CPSC should
collaborate with EPA and other agencies with scientific and medical
expertise to determine similar limits to be imposed in the U.S. While
more research is needed to refine our understanding of formaldehyde's
impact on child health, there is already a considerable body of
evidence that may be sufficient to allow CPSC to make a reasonable
judgment in this area. The agency should also require labels on
children's clothing and products that indicate the presence of
formaldehyde residues.
More research is needed on formaldehyde and children's health. In
July 2007, the Academy suggested to the House of Representatives
Committee on Energy and Commerce that the Federal Emergency Management
Agency and Federal health agencies undertake a systematic,
scientifically rigorous study of this issue to determine children's
exposure levels and correlation with reported symptoms, and steps that
should be taken to safeguard their health. To our knowledge, no such
study has been conceived or implemented. It also remains unclear to
what extent children may be exposed to formaldehyde from multiple
sources, and what effect this may have on their developing bodies. The
Consumer Product Safety Improvement Act of 2008 requires the Consumer
Product Safety Commission (CPSC) Comptroller General to conduct a study
within 2 years of ``the use of formaldehyde in the manufacture of
textile and apparel articles . . . to identify any risks to consumers
caused by the use of formaldehyde in the manufacturing of such articles
. . .'' This report is due in January 2011.
EPA should adopt nationwide California's proposed restrictions on
formaldehyde emissions from wood products. In January 2009, the AAP
joined numerous other organizations in urging Environmental Protection
Agency Administrator Lisa Jackson to adopt nationwide the restrictions
on formaldehyde emissions from hardwood plywood, particleboard, and
medium density fiberboard set under the California Air Resource Board
Airborne Toxics Control Measure.
CPSC should develop educational materials for consumers about
formaldehyde and its presence and role in various products, as well as
potential health risks. The CPSC could provide an important service by
providing up-to-date educational materials about formaldehyde. A search
of the agency's website reveals a number of documents about
formaldehyde, but many of them are from the 1970s and 1980s. The last
version of the most comprehensive document, ``An Update on
Formaldehyde,'' appears to be the 1997 revision.\18\
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\18\ U.S. Consumer Product Safety Commission. An Update on
Formaldehyde, 1997 Revision. Available online at http://www.cpsc.gov/
CPSCPUB/PUBS/725.pdf.
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The American Academy of Pediatrics commends you, Mr. Chairman, for
holding this hearing today to call attention to the potential hazards
of formaldehyde exposure among children. We look forward to working
with Congress to minimize the exposure of children and all Americans to
all potentially toxic chemicals. I appreciate this opportunity to
testify, and I will be pleased to answer any questions you may have.

Senator Pryor. Thank you, Dr. Etzel.
Now Dr.--is it ``Brookstine'' or ``Brooksteen''?
Dr. Brookstein. ``Brookstine.''
Senator Pryor. ``Stine,'' OK. I'm sorry----
Dr. Brookstein. Thank you.
Senator Pryor.--I fouled that up in your----
Dr. Brookstein. It's all right.
Senator Pryor.--in the earlier introduction.
Go ahead, Dr. Brookstein.

STATEMENT OF DAVID BROOKSTEIN, Sc.D., DEAN AND
PROFESSOR, SCHOOL OF ENGINEERING AND TEXTILES,
PHILADELPHIA UNIVERSITY

Dr. Brookstein. Thank you. Thank you, Chairman Pryor and
members of the Committee, for this opportunity to testify on a
matter of great concern to the American public.
I am Dr. David Brookstein, Dean and Professor of
Engineering at Philadelphia University's School of Engineering
and Textiles. My testimony is based on over 35 years of
experience as a textile engineering professor and research,
including co-founding the Institute for Textile and Apparel
Product Safety at Philadelphia University.
I applaud the Committee today for holding this hearing, as
the possible health effects of formaldehyde in textiles have
not been fully examined, nor are the long- term health effects
fully understood.
I'd also like to express my appreciation to Senator Casey
for his interest and leadership on protecting our Nation's
citizens from potentially toxic materials in consumer products.
I am here to discuss the toxicity of chemicals, such as
formaldehyde, used to treat textile-based products. I will also
speak to how other industrialized nations regulate this
chemical, thus ensuring the health and welfare of their
citizens. Finally, I will describe how at least one industry
trade group has dealt with this issue.
Now, in the summer of 2007, reports began to surface about
high levels of lead in children's toys. These reports, and
subsequent inquiries into other product categories, led to
hundreds of thousands of products being recalled. However, the
potential harmful effects to consumers from textile-based
products was one area that escaped the initial scrutiny.
Recalling that many years ago the Federal Government recognized
the lethal toxicity of asbestos fibers and TRIS flame-retardant
children's sleepwear led me to question whether it was cause
for concern with textile-based products currently available to
consumers. So, I began looking to research on potentially toxic
chemicals, like formaldehyde, that are used to treat textiles
and apparel. What I discovered is that, as with toys and other
consumer products, most apparel items are no longer
manufactured in the U.S. and, therefore, are not subject to our
manufacture and environmental standards.
Now, why are formaldehyde-treated textiles a problem?
Formaldehyde is a commonly used chemical in the treatment of
apparel items for permanent press and has long been recognized
as toxic. As early as the 1950s, physicians noted that patients
were presenting with serious cases of contact dermatitis
brought on by skin contact with textile items. The medical
literature is replete with many studies showing the adverse
dermatological effects of formaldehyde. At a recent workshop
held at Philadelphia University and facilitated by Senator
Casey and attended by personnel from the CPSC, Dr. Susan
Nederost, a dermatologist, reported seeing numerous patients
with contact dermatitis caused by allergic response to
formaldehyde exposure from coming in direct contact with
chemicals and apparel. There's particular danger to infants and
small children from being dressed in articles of clothing that
have been treated with toxic chemicals.
People are also exposed, and experience health problems, as
a result of release of formaldehyde vapors from home
furnishings, such as draperies. In recent testimony to the U.S.
House of Representatives, relatively high levels of
formaldehyde in home and office blackout shades and other
drapery items was reported. However, as of yet, there are no
formaldehyde restrictions or standards for clothing and other
textile items that are distributed and sold in the U.S. This is
largely because there's not been enough focus or research to
truly understand and appreciate the seriousness of the problem.
Senators Casey, Brown, Clinton, and Landrieu offered an
amendment in the recent CPSC Improvement Act to study the use
of formaldehyde in textile and apparel articles. The amendment,
agreed to unanimously, calls for a study by the GAO, in
consultation with the Commission, on the use of formaldehyde in
textile and apparel articles, and seeks to identify any risks
to consumers caused by the use of formaldehyde. The law calls
for the study to be completed and reported to the Congress by
August 2010.
Industrialized countries deal with formaldehyde in clothing
and textiles. And I have an exhibit over here, which is also in
my written testimony, that I prepared that shows you the
standards of many of these countries. While currently there are
no U.S. standards or regulations associated with formaldehyde
in clothing and textiles, the American Apparel and Footwear
Association, has issued a restricted substance list and has
requested that its members abide, voluntarily, to the standards
listed, an obvious recognition of a potential problem. While
this hearing is specifically focused on formaldehyde, my
written testimony discusses other toxic chemicals that are
sometimes used, but not regulated, in the U.S.
Now, in view of my testimony and the wide body of knowledge
associated with the use of toxic chemicals in textiles and
apparel, I believe that now is the time to look again at the
issue of apparel--issue of formaldehyde and other potential
toxic dyes and finishes in textile and apparel. I respectfully
recommend the following:
One, that Congress make sure that its recent legislation
calling for a formaldehyde study in textiles and apparel be
conducted in a timely fashion.
Two, that consumer product safety standards be implemented
based on the findings of these studies.
Three, that legislation similar to that for formaldehyde be
enacted for other known toxic chemicals used in textiles and
apparel.
And, four, that a reasonable and ongoing testing program be
established at an independent laboratory similar to the
Underwriters Lab, for textile and apparel items, including
components of such articles in which formaldehyde and other
known toxic chemicals were used in their manufacture.
The suggested study of the use of toxic chemicals in
textiles and apparel products will provide Congress the needed
information to consider whether new laws and/or regulations are
necessary to protect the health and welfare of the American--of
American citizens.
In conclusion, I would like to again express my
appreciation to the Committee and to Senator Casey for this
opportunity to provide testimony on this important issue that
affects the health of our citizenry. I stand ready to serve the
Committee in any way in the future.
Thank you.
[The prepared statement of Dr. Brookstein follows:]

Prepared Statement of David Brookstein, Sc.D., Dean and Professor,
School of Engineering and Textiles, Philadelphia University

Thank you Chairman Pryor and members of the Committee for this
opportunity to provide testimony to the Senate Subcommittee on Consumer
Protection, Product Safety and Insurance. I would also like to express
my appreciation to Senator Robert P. Casey, Jr. who is at the vanguard
of protecting our Nation's citizens from potentially toxic materials in
consumer products. My testimony is based on over 35 years of experience
as a textile engineering professor and researcher including co-founding
the Institute for Textile and Apparel Product Safety at Philadelphia
University.
In the summer of 2007, reports surfaced about high levels of lead
in toys and other consumer goods and there were hundreds of thousands
of items recalled. One area that initially escaped scrutiny at that
time was textile and apparel product safety. Years before, the Federal
Government recognized the lethal toxicity of asbestos fibers and TRIS
flame retardant in children's sleepwear and acted appropriately to ban
their use in consumer products. Today, once again, the question of
safety is front and center and researchers are looking for answers
regarding the safety of textiles and apparel. By researching the
prevalence of other potentially toxic chemicals, such as formaldehyde,
dyes and finishes, used every day in clothing, we will be able to
determine just what chemicals and at what levels could pose risks to
all of us, especially our children--and possibly lead to medical
conditions ranging from contact dermatitis to neurotoxicity, endocrine
disruption and possibly cancer.
Many clothing items are in direct contact with the skin. During
contact there can be perspiration which involves moisture transport
between the skin and the dyed and chemically treated clothing items.
Dyes are used to enhance the appearance of textiles and chemical
treatments affect the performance of textile products. While modern
dyes and chemical treatments are chemically bound to the fibers in the
clothing, there is the possibility that residual dye (dye bleed) and
finishes (treatment chemicals) are released in direct contact with the
skin. Textile materials are a capillary and porous material with
different pore sizes, and can be saturated with both liquid and gaseous
water during wear. The transportation of perspiration through this
material at different temperatures is a very complex process, which can
involve convection, capillary flow, penetration, molecular diffusion,
evaporation, and solidification.
On August 14, 2008 Public Law 110-314 (Consumer Product Safety
Improvement Act) was enacted. The purpose of the law was to establish
consumer product safety standards and other safety requirements for
children's products and to reauthorize and modernize the Consumer
Product Safety Commission.
Formaldehyde is a commonly used chemical treatment for apparel
items and has long been recognized as toxic. Accordingly, Senators
Casey, Brown, Clinton and Landrieu offered an Amendment to study the
use of formaldehyde in manufacturing textile and apparel articles. The
Amendment, agreed to unanimously, calls for a study by the GAO in
consultation with the Commission, on the use of formaldehyde in the
manufacture of textile and apparel articles, or in any component of
such articles, to identify any risks to consumers caused by the use of
formaldehyde in the manufacturing of such articles, or components of
such articles. The law calls for the study to be completed by August
2010 but, to our knowledge, the GAO has not yet begun the study.
Formaldehyde treatment of cellulosic fibers such as cotton was
first taught in an invention by the British inventors Foulds, Marsh and
Wood in U.S. Patent 1,734,516 in 1929. The inventors claimed that ``one
of the greatest defects of a fabric composed entirely of cotton has
been the ease with which such fabric is creased or crumpled when
crushed or folded under pressure in the hand.'' The invention was to
use a mixture of chemicals including formaldehyde to cause a chemical
reaction with the cellulose that would cause cross-linking and thus
render the fabric wrinkle free.
Substantial commercial interest developed as inherently wrinkle-
free synthetic fibers were commercialized and by the 1950s family
fabric caretakers (mostly women) were delighted by the potential of
wrinkle-free fabrics that would add to other labor-saving chores that
were being introduced to the public. As more and more women joined the
workforce the entire family became interested in easy care clothing.
In 1985, The U.S. National Institute for Occupational Safety and
Health (NIOSH) completed its first research study of formaldehyde. The
study examined death certificates among 256 deceased workers from three
plants which made shirts from formaldehyde treated cloth. Formaldehyde
was used at these plants to help make shirts more crease resistant. The
1985 study found a significantly increased risk of cancer of the buccal
cavity (cancer of the inside of the mouth) and for multiple myeloma
(cancer of the bone marrow). In 1988, NIOSH completed its second study
of formaldehyde exposure. This study looked at employment records from
11,030 workers who had been employed at any one of three plants. Two of
the three plants were the same as in the previous study. As in the 1985
study, the 1988 study found a significantly increased risk for cancer
of the buccal cavity. Excess risks were also seen for multiple myeloma
and leukemia.
In 2004, NIOSH conducted a substantially large study of cause of
death among clothing workers exposed to formaldehyde and found that:

1. The death rates from all causes combined and for all cancers
combined among the 11,039 workers in the updated study were
lower than expected, based on the U.S. population rates.

2. There were no deaths from cancers of the nasopharynx (nose).
The death rate for cancer of the buccal cavity (inside of the
mouth) was only slightly elevated.

3. The overall risk for myeloid leukemia was almost 1\1/2\
times what was expected.

4. For workers who were employed at the plants for 10 or more
years and were first exposed 20 years earlier, the risk for
myeloid leukemia was increased over 2 times what was expected.

5. The increase in myeloid leukemia was also seen among those
workers who were first exposed prior to 1963, when formaldehyde
exposures were likely higher.

NIOSH reported that the overall average concentration of
formaldehyde measured by NIOSH at the three plants during the early
1980s was 0.15 parts per million (ppm). This was below the permissible
level at that time, which was 3.0 ppm over an 8-hour work day.
Exposures were similar across departments and plants. In 1987 the
permissible level of formaldehyde exposure was reduced to 1.0 ppm and
in 1992 was further reduced to 0.75 ppm. OSHA regulation 29 CFR 1910-
1048 regulates the exposure limit for workers in the U.S. textile and
apparel industry to 1 part formaldehyde per million parts of air as an
8-h time-weighted average. The NIOSH study was based on a group of
scientific research papers published from 1985-
2004.\1\^,\2\^,\3\
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\1\ Stayner, L.; Smith, A. B.; Reeve, G.; et al., Proportionate
mortality study of workers in the garment industry exposed to
formaldehyde. Am J Ind Med 1985;7:229-240.
\2\ Stayner, L. T.; Elliott L.; Blade L.; et al. A retrospective
cohort mortality study of workers exposed to formaldehyde in the
garment industry. Am J Ind Med 1988;13:667-681.
\3\ Pinkerton, L. E.; Hein, M. J.; Stayner, L. T. Mortality among a
cohort of garment workers exposed to formaldehyde: an update. Occup
Environ Med 2004;61(3):193-200.
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While the NIOSH studies and subsequent regulations were directed at
American workers, the same concerns obtain for American consumers.
In 2004, the World Health Organization International Agency for
Research on Cancer (IARC) categorized formaldehyde as a known cancer-
causing agent in humans.
The United States apparel manufacturing industry has declined
precipitously and today it has been estimated that approximately 90
percent of consumer apparel sold in the United States is not
manufactured in the United States. Accordingly, today the safety
hazards associated with formaldehyde to U.S. apparel workers is
negligible, if any. Yet while there are essentially no occupational
hazards associated with formaldehyde processing of apparel to U.S.
workers there could be hazards to those overseas workers who produce
clothing and textiles for the U.S. marketplace. Additionally, American
workers can be exposed to potential toxic off-gassing from textile
products when imported items are received in U.S. distribution centers.
However, humans can be exposed to formaldehyde associated with
textiles and clothing in an additional manner than that from
manufacturing. For instance, in the clothes treated with formaldehyde
can come into direct contact with the skin. In 1959, Marcussen
(Denmark) reported that during a period between 1934-1958 there were 26
cases (11 percent of studied cases) of garment formaldehyde
dermatitis.\4\ Marcussen also reported results of a study conducted
from1934-1955 a study in which 1-3 percent of 36,000 eczematous
patients showed formaldehyde sensitivity.\5\ In 1965, U.S. dermatology
researchers O'Quinn and Kennedy reported contact dermatitis caused by
formaldehyde in clothing.\6\ Hatch published a complete review of
references to clothing based formaldehyde sensitivity in 1984.\7\ The
medical literature is replete with many studies showing the adverse
dermatological effects of formaldehyde. An excellent current review of
this subject has been written by Fowler ``Formaldehyde as a Textile
Allergen'' in 2003.\8\
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\4\ Marcussen, P. V., Contact Dermatitis Due to Formaldehyde in
Textiles, 1934-1958, Preliminary Report, Acta Derm. Venereol. 39,348-
356 (1959).
\5\ Marcussen, P. V., Dermatitis Caused by Formaldehyde Resins in
Textile, Dermatologica, 125, 101-111 (1962)
\6\ O'Quinn, S. E., and Kennedy, C. B., Contact Dermatitis Due to
Formaldehyde in Clothing Textiles, J. Am. Med/ Soc. 194, 593-596
(1965).
\7\ Hatch, K. L., Chemicals and Textiles, Part II: Dermatological
Problems Related to Finishes, Textile Research Journal, Vol. 54, No.
11, 721-732 (1984).
\8\ Fowler, J. F., Formaldehyde as a Textile Allergen, Elsner, P.;
Hatch, K.; Wigger-Alberti W. (eds): Textiles and the Skin. Curr Probl
Dermatol. Basel, Karger, 2003, vol 31, pp 156-165.
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Below is a table which shows common formaldehyde resins used in
textiles and apparel.

------------------------------------------------------------------------
Relative Formaldehyde
Resin Type Release*
------------------------------------------------------------------------
Urea formaldehyde/DMU High
Melamine formaldehyde High
DMDHEU (Fixapret CPN) Low
DMDHEU blended or reacted with glycols Very low
(modified) (Fixapret ECO)
Dimethoxymethyl dihydroxyethylene urea Very low
(methylated DMDHEU)
Dimethyl dihydroxyethylene urea (Fixapret NF) None
------------------------------------------------------------------------

* High signifies a formaldehyde release of > 1,000 ppm; low, a
release of < 100 ppm; and very low, a release of < 30 ppm.\9\
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\9\ Hatch, K. L, Maibach HI. Textile dermatitis: an update. (I).
Resins, additives and fibers. Contact Dermatitis 1995;32:319-26.

At a recent workshop held at Philadelphia University attended by
personnel from the Consumer Product Safety Commission, Dr. Susan
Nederost of University Hospitals of Cleveland/Case Western Reserve
University reported that patients with allergic contact dermatitis,
such as that caused by allergic response to formaldehyde exposure,
results in substantial amount of days missed from employment.
Another exposure route is from off-gassing of stored or closeted
clothing with relatively high levels of formaldehyde. As early as 1960
researchers reported on release of formaldehyde vapors on storage of
wrinkle-resistant cotton fabrics.\10\ The exposure route from off-
gassing of formaldehyde could soon be recognized as a significant
health risk to United States consumers as a result of recent testimony
to the U.S. House of Representatives which reports the relatively high
levels of formaldehyde in house and office blackout shades and other
drapery items.\11\ Using the AATCC Test Method #112 free formaldehyde
values of between 1000 ppm and 3000 ppm were found in a relatively
large group of imported items available in the United States
marketplace.
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\10\ Reid, J. D.; Arceneaux, R. L., et al., Studies of wrinkle
resistant finishes for cotton textiles (I): Release of formaldehyde
vapors on storage of wrinkle resistant cotton fabrics. Am Dyest Rep
1960: 49, 490-531.
\11\ Berman, M., Testimony to the Ways and Means Trade Subcommittee
U.S. House of Representatives, 2007.
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As of yet, there are no formaldehyde restrictions or standards for
clothing and other textile items that are distributed and sold in the
United States. However more and more nations are adopting standards for
formaldehyde in clothing and textiles. In Japan, textile fabrics are
required by law to contain less than 75 ppm free formaldehyde, as
measured by the method described in Japan Law 112. And no formaldehyde
is tolerated for infant clothing. The Hong Kong Standards and Testing
Center produced the table below which shows the status of formaldehyde
regulations in countries that are currently addressing this
situation.\12\ From the table, the Committee can easily see how other
industrialized countries are dealing with this important issue that
affects the health of their citizenry.
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\12\ http://www.stc-group.org/UserFiles/File/Newsletter/TMD/
Flormaldehyde 2004.pdf

In addition Poland, Russia, Lithuania and South Korea now regulate
formaldehyde in textiles and apparel.
Formaldehyde is also found in glues and adhesive used to bond
materials to each other such as in layers of shoes and fabrics to each
other. In particular, para-tertiary butylphenol (PTBP) formaldehyde
resin is sometimes used. This type of formaldehyde resin can also cause
allergic reactions.\13\
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\13\ Geldof, B.; Am Roesyanto, I. D.; Van Joost, T. H., Clinical
aspects of para-tertiary-butlyphenol formaldehyde resin (PTFR) allergy,
Contact Dermatitis, 1989, 21, 312-315.
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Some have suggested that one way for the consumer to deal with
residual formaldehyde on newly purchased clothing is to just wash it
prior to wearing it. This is fundamentally problematic since many
consumers will not heed this labeling ``suggestion'' and will just wear
newly purchased clothing without taking the time to wash it.
Additionally, further scientific evidence needs to be obtained that
shows there is no residual formaldehyde on clothing even after its been
washed. And finally, there are many items where formaldehyde is used
and there is no opportunity for pre-washing. These items include
baseball caps and footwear.
While currently there are no U.S. standards or regulations
associated with formaldehyde in clothing and textiles the American
Apparel and Footwear Association (AAFA) published a 2008 Restricted
Substance List (RSL) which was refined in 2009. AAFA requested that its
members abide voluntarily to the standards listed. For formaldehyde the
RSL suggests no detectable formaldehyde for infant clothing (0-36
months), 75 ppm for clothing in direct contact with skin (>36 months)
and 300 ppm for textiles with no direct skin contact (>36 months).
In addition to formaldehyde in textiles and apparel, there are
other well documented toxic chemicals that are used in clothing,
furniture and other textile-based consumer items. In particular, there
are two classes of dyes that are commonly used in consumer textile-
based products that are widely recognized as having the potential to
cause allergic contact dermatitis and possibly to cause cancer. These
two dye classes are azoic (azo) and disperse dyes. There is such a
widespread concern associated with the use of azo dyes in textile-based
products that many countries have enacted restrictive standards and
stringent regulations that limit their use. In 2002 the European Union
published a Directive (2002/61/EC) to restrict the marketing and use of
certain dangerous substances and preparations (azo colorants) in
textile and leather products Thus, in the European Union their use is
regulated by law; in the United States, at this time, there exist only
voluntary standards by those companies that agree to regulate their
use.
In 2006 a series of previously unreported cases of dermatitis
appeared in Finland. Rantanen, a Finnish physician, reported that by
2007 ``many cases from all over the country'' were reported in the
Internet discussion forum of the Finnish Dermatological Society. After
an extensive investigation it was found that the cases were due to
exposure to dimethylfumarate (DMF).\14\ It was reported by British
newspaper accounts that sachets of DMF were put in thousands of Chinese
manufactured furniture items to prevent mold while in storage or while
being transported.\15\ Rantenen reported that the patients showed
strong positive patch test reactions to upholstery fabric samples and
to dimethylfumarate, down to a level of 1 ppm in the most severe case.
It was concluded that the cause of the Chinese sofa/chair dermatitis
epidemic was likely to be allergy to dimethylfumarate, a novel potent
contact sensitizer. Thus, a serious health issue can occur, not from
the furniture fabric but from the release of allergenic agents
contained in the foam cushioning. As can be seen from the picture of a
patient exposed to DMF the condition presents itself in a most
devastating manner.
---------------------------------------------------------------------------
\14\ The cause of the Chinese sofa/chair dermatitis epidemic is
likely to be contact allergy to dimethylfumarate, a novel potent
contact sensitizer T. Rantanen British Journal of Dermatology 2008 159,
pp218-221.
\15\ Brown, D.; Thousands injured by `toxic gas from Chinese sofas,
The Times, July 21, 2008 UK.

The European Union acknowledged the dangers of using
dimethylfumurate in consumer products and issued European Directive
(2009/251/EC) on March 17, 2009. The directive requires that products
containing DMF are not to be placed on the market. The Directive also
requires any product containing DMF that has already been placed on the
market be withdrawn by May 1, 2009 and that consumers be made aware of
the potential risks.
Brominated chemicals, used to make fabrics flame retardant, are
another class of toxic substances that is of great concern to
researchers. Of particular concern to child safety advocates are flame
retardant fabrics used in children's car seats. While flame retardant
fabrics play a beneficial role in preventing or minimizing serious
injury, the long-term harmful effects to children exposed to this class
of toxic chemicals is unknown and should be a matter for further
research.
Unfortunately, a recent study conducted at Philadelphia University
using an X-Ray Fluorescence analyzer showed a range of bromine readings
from about 0.43 percent to 0.86 percent. It is widely recognized by the
research community that levels in excess of 0.1 percent are considered
toxic. Consequently, this standard has been adopted by the European
Union in the Restriction of Hazardous Substances (RoHS) standards. The
RoHS Directive is an EU Legal Directive for environmental regulations
concerning the Restriction of Use of Hazardous Substances. The
Directive requires the removal of five hazardous substances from
electric and electronic equipment (Pb, Cd, Cr, Hg, Br compounds). While
these toxic compounds are restricted in electric and electronic
equipment, we were concerned that the same chemical compounds might be
used in children's car seats. Accordingly, an extensive chemical
analysis of the fabric was conducted to determine the bromine compounds
that were present in car seat fabric with relatively high levels of
bromine. Two specific brominated compounds were found:
Hexabromocyclododecane (HBCD)--0.425 percent and Tetrabromobisphenol A
(TBBPA)--1.185 percent.
HBCDs are included on the OSPAR \16\ list of chemicals for priority
action. HBCDs have been identified by the U.K. Chemical Stakeholders
Forum as persistent, bioaccumulative and toxic.\17\ While currently no
specific regulatory actions are being taken in the United States, HBCDs
have been identified for risk assessment in Canada Australia and Japan.
Further regulatory/assessment activities in these countries will take
place over the next few years.\18\
---------------------------------------------------------------------------
\16\ The 1992 OSPAR Convention is the current instrument guiding
international cooperation on the protection of the marine environment
of the North-East Atlantic. It combined and up-dated the 1972 Oslo
Convention on dumping waste at sea and the 1974 Paris Convention on
land-based sources of marine pollution.
\17\ Covaci, A.; Gereke, A.; Law, R.; Voorspoels, S.; Kohler, M.;
Heeb, N.; Leslie, H.; Allchin, C.; Boer, J.; Hexabromocyclododecanes
(HBCDs) in the Environment and Humans: A Review. Environmental Science
& Technology, 2007, vol. 40, No. 12.
\18\ National Chemicals Inspectorate (KEMI) Draft of the EU Risk
Assessment Report on Hexabromocyclododecane, Sundyberg, Sweden, 2005.
---------------------------------------------------------------------------
Studies suggest that HBCD affects thyroid hormone levels, causes
learning and memory defects in neonatal laboratory animals, and has
been detected in breast milk.\19\ There are indications that oral
exposure to HBCDs induces drug-metabolizing enzymes in rats, such as
hepatic cytochrome P450 (CYP),\20\ and that HBCDs may induce cancer by
a nonmutagenic mechanism.\21\^,\22\ There are reports that
HBCDs can disrupt the thyroid hormone system \23\ and affect the
thyroid hormone receptor-mediated gene expression.\24\ Following
neonatal exposure experiments in rats, developmental neurotoxic effects
can be induced, such as aberrations in spontaneous behavior, learning,
and memory function.\25\ HBCDs can also alter the normal uptake of
neurotransmitters in rat brains.\26\
---------------------------------------------------------------------------
\19\ Birnbaum, L.; Staskal, D., 2004. ``Brominated flame
retardants: cause for concern?'' Environmental Health Perspectives Vol.
112:1.
\20\ Germer, S.; Piersma, A. H.; van der Ven, L.; Kamyschnikow, A.;
Fery, Y.; Schmitz, H. J.; Schrenk, D. Subacute effects of the
brominated flame retardants hexabromocyclododecane and
tetrabromobisphenol-A on hepatic cytochrome P450 levels in rats.
Toxicology 2006, 218, 229-236.
\21\ Helleday, T.; Tuominen, K. L.; Bergman, A.; Jenssen, D.
Brominated flame retardants induce intragenic recombination in
mammalian cells. Mutat. Res. 1999, 439, 137-147.
\22\ Ronisz, D.; Finne, E. F.; Karlsson, H.; Forlin, L. Effects of
the brominated flame retardants hexabromocyclododecane (HBCDD) and
tetrabromobisphenol-A (TBBP-A)on hepatic enzymes and other biomarkers
in juvenile rainbow trout and feral eelpout. Aquat. Toxicol. 2004, 69,
229-245.
\23\ Eriksson, P.; Viberg, H.; Fischer, C.; Wallin, M.;
Fredriksson, A. A comparison on developmental neurotoxic effects of
hexabromocyclododecane, 2,2,,4,4,,5,5,-hexabromodiphenylether (PBDE
153) and 2,2,,4,4,,5,5,-hexachlorobiphenyl (PCB 153). Organohalogen
Compd. 2002, 57, 389-392.
\24\ Yamada-Okabe, T.; Sakai, H.; Kashima, Y.; Yamada-Okabe, H.
Modulation at a cellular level of the thyroid hormone receptormediated
gene expression by 1,2,5,6,9,10-hexabromocyclododecane (HBCD), 4,4-
diiodobiphenyl (DIB), and nitrofen (NIF). Toxicol. Lett. 2005, 155,
127-133.
\25\ Eriksson, P.; Viberg, H.; Fischer, C.; Wallin, M.;
Fredriksson, A. A comparison on developmental neurotoxic effects of
hexabromocyclododecane, 2,2,,4,4,,5,5,-hexabromodiphenylether (PBDE
153) and 2,2,,4,4,,5,5,-hexachlorobiphenyl (PCB 153) Organohalogen
Compd. 2002, 57, 389-392.
\26\ Mariussen, E.; Fonnum, F. The effect of brominated flame
retardants on neurotransmitter uptake into rat brain synaptosomes and
vesicles. Neurochem. Int. 2003, 43, 533-542.
---------------------------------------------------------------------------
TBBPAs are included on the OSPAR list of chemicals for priority
action. TBBPA is known to off-gas to the environment, though the amount
of off gassing varies depending how the TBBPA was combined with other
materials.\27\ Lab tests have suggested that it may disrupt thyroid
function.\28\ Studies also suggest that it may adversely affect hormone
levels and the immune system.\29\ Histological findings showed that the
slight enlargement of the hepatocytes, inflammatory cell infiltrations
and focal necrosis of hepatocytes were more marked in liver of treated
groups (from 350 mg/kg Body Weight) than in control group. The present
data suggest the possibility of inducing hepatic lesions by TBBPA.\30\
---------------------------------------------------------------------------
\27\ Birnbaum, L.; Staskal, D., 2004. ``Brominated flame
retardants: cause for concern'' Environmental Health Perspectives Vol.
112:1.
\28\ Kitamura, S.; Kato, T.; Iida, M.; Jinno, N.; Suzuki, T.; Ohta,
S.; Fujimoto, N.; Hanada, H.; Kashiwagi, K.; Kashiwagi, A. 2005.
``Anti-thyroid hormonal activity of tetrabromobisphenol A, a flame
retardant, and related compounds: Affinity to the mammalian thyroid
hormone receptor, and effect on tadpole metamorphosis.'' Life Sciences.
2005 Feb 18; 76(14); 1589-601.
\29\ Birnbaum, L.; Staskal, D. 2004. ``Brominated flame retardants:
cause for concern?'' Environmental Health Perspectives. Vol. 112:1.
\30\ Tada, Y.; Fujitani, T.; Ogata, A.; Kamimura, H. Flame
retardant tetrabomobisphenol A induced hepatic changes in ICR male
mice, Environmental Toxicology and Pharmacology. August 2007.
---------------------------------------------------------------------------
In view of my testimony and the wide body of knowledge associated
with the use of toxic chemicals in textiles and apparel I believe that
now is the time to look again at the issue of formaldehyde and other
potential toxic dyes and finishes in textiles and apparel. It is
recommended that future legislation dealing with consumer product
safety should include a study on the use of formaldehyde and other
known toxic dyes, finishes, and preservatives in the manufacture of
textile and apparel articles, that consumer product safety standards be
implemented based on the findings of these studies, and a reasonable
testing program be established for textile and apparel items including
components of such articles in which formaldehyde and other known toxic
chemicals were used in their manufacture.
The suggested study of the use of toxic chemicals in textiles and
apparel products will provide Congress the needed information to
consider whether new laws and/or regulations are necessary to protect
the health and welfare of American citizens.
In conclusion, I would like to again express my appreciation to the
Committee and to Senator Casey for this opportunity to provide
testimony on this important issue that affects the health of our
citizenry. I stand ready to serve the Committee in any way in the
future.

Senator Pryor. Thank you.
Dr. Wakelyn?

STATEMENT OF DR. PHILLIP J. WAKELYN, CONSULTANT, WAKELYN
ASSOCIATES, LLC

Dr. Wakelyn. Yes, thank you--can you hear me? Thank you for
inviting me to this hearing. I'm Dr. Phillip Wakelyn. I'm here
to try and provide some technical information on formaldehyde
in textiles.
I, too, have been involved in this for a short period of
time, probably for the last 35, 40 years. I have a Ph.D. in
textile chemistry. I was involved as a consultant and advisor
to USDA since the early 1970s on all the fantastic research
they've done on low-emitting resin technology, all the awards
they have won for the outstanding work. So, when people stand
up here and say that, ``Oh, nothing's been done. We don't have
any information,'' I think they've forgotten what has happened.
This issue was extensively studied and looked at in the 1980s
and early 1990s, and CPSC did conduct extensive research, look
at extensive research, and do many things.
But, let me start by saying this, that my testimony this
morning does reflect the views of a broad coalition of textile
and apparel interests, which was mentioned earlier, and these
same interests supported the GAO study in formaldehyde.
I also would like to say, today with me is--sitting behind
me is Hardy Poole, formerly with ATMI. And he and I were party
to all of these studies, extensive studies, that are referenced
in my testimony, by the textile industry, by CPSC, at various
places, like Research Triangle Institute, the Oak Ridge
National Laboratories. And so, if there are additional
questions that he might answer, he can assist in that.
Now, my understanding was that this hearing was to be, and
is supposed to be, about formaldehyde in textiles, and I'll
limit mine to that, even though much of the testimony and much
of the things said so far would go beyond that.
I also would like to say--and you have my full testimony
for the record, so these are a few things that I'd like to
address that have been addressed by others, but, I think,
incorrectly.
There are no valid safety-related problems raised in the
U.S. concerning low levels of formaldehyde in clothing. The
evidence is strong that formaldehyde in textiles does not pose
an unreasonable risk to injury of consumers. This is a finding
that the Consumer Product Safety has already made, and I would
be very sure that, when they review the data from the GAO study
they will come to the same conclusion. There is no need for
legislation or regulatory action, and we'll await the GAO
study.
Now, allergic contact dermatitis in textiles is very rare.
There are many causes for it other than chemical additives. And
there are many claims, nonspecific claims of irritation and
reaction, that are incorrectly blamed on formaldehyde and that
are not part of formaldehyde, including several major cases
that have been recently--where the garment was not treated with
formaldehyde, the garment did not contain formaldehyde, and the
person wasn't allergic to formaldehyde. But yet, that doesn't
stop the press from implicating it.
The--there is a difference between airborne levels and
fabric levels, and I've explained that in my testimony, and in
cross-examination I would be happy to talk about that.
We talk about where formaldehyde is used in textiles. It's
mainly used for easy-care, wrinkle-resistant for sheeting,
shirting, dress goods. There's a tiny bit that's used for
pigment dyeing and pigment printing. And there's a very little
bit that can be used in fire retardants, but are not presently
being used on children's sleepwear.
Formaldehyde-containing chemicals, by the way, are--
formaldehyde per se itself is not used; it's chemicals that
contain formaldehyde that, under certain conditions, can
release trace amounts. As I say, it's mainly used on cotton and
cotton blends.
Of all of the apparel offered for retail in the United
States last year, 2 percent contained any wrinkle-resist, 13
percent of all the cotton sold last year contained some
wrinkle-resist. There is no easy-care in children's products,
and formaldehyde is essentially not used in children's
products. Formaldehyde also is not used on synthetic textiles,
such as fabric and apparel made from nylon and polyester.
Now, one thing that was mentioned earlier was the New
Zealand situation. It would be--the correct story of the New
Zealand situation is that the country of New Zealand tested--
after that news program, tested 99 items, 84 of which were
Chinese. They showed that 97 of those contained very low
levels, if any, formaldehyde, or nondetect; 2 had slightly
above their proposed standard of 100--that is by the
international Japanese standard. And it's very important how
you make this measurement. Those two, by simple washing, were
acceptable levels. So, it's been known for a long time that
Clorox 2 and simple laundering removes--lowers the level--
either totally removes or lowers it to a nondetect or nonlevel
of concern.
In the 1980s, as I mentioned, CPSC looked at the data, they
banned or significantly reduced the urea-formaldehyde
insulation under the Federal Hazardous Substances Act. They
also looked at detailed studies--as I say, did all of these
studies that are listed in my testimony--at Oak Ridge National
Laboratories, Research Triangle Institute--they made a decision
at that time that formaldehyde from textiles did not present an
unreasonable risk of injury. They found that urea-formaldehyde
insulation needed to be regulated, not textiles.
Also, under Proposition 65, you can walk into a hotel, you
can buy a new house, you can go into a restaurant, you see
Proposition 65 signs. For textiles, we presented chamber data,
they studied this, they looked at it. Textiles are below the
40-microgram-per-day safe-harbor level. And when people say we
don't know what's coming off of fabrics--from these chamber
studies, even if it's 500 micrograms per gram or parts per
million on the fabric, they were below the safe-harbor limit in
California.
So, there is a tremendous amount of information. And it was
mentioned that California recently, in 2007, has regulated
pressed-wood products--by the way, EPA had a Advance Notice of
Proposed Rulemaking in the Federal Register in December to
address formaldehyde from pressed-wood products. They have
looked at textiles; they are not concerned with textiles in
California, either, as litigious as they are.
So, there is not a problem. It's not in children's clothing
at all in the United States. No new regulations or legislation
are necessary concerning formaldehyde in textiles unless the
required GAO study--clearly shows that there are areas of
concern, and any of this should be based on sound science and
not people's perception. Many times, formaldehyde is blamed for
any product or any rash or anything that people get from
textiles, and it ? many--most of the time, it's shown that
these people aren't even allergic to formaldehyde.
So, I will try to answer any questions, but my answers, I
hope, will be based on published research and on science.
[The prepared statement of Dr. Wakelyn follows:]

Prepared Statement of Dr. Phillip J. Wakelyn, Consultant,
Wakelyn Associates, LLC

Summary
There have been no valid safety related problems raised in the U.S.
concerning the low levels of formaldehyde on clothing and textiles. In
view of all the studies over the last 30 years indicting that there is
not a formaldehyde problem with U.S. textiles products and regulations
already in place concerning formaldehyde and textiles, no new
regulations are necessary. Because the evidence is so strong that
formaldehyde in textiles does not pose a problem to consumers, there is
no need for legislative or regulatory action concerning formaldehyde
and textiles unless the results of the GAO study, required by Section
234 of the CPSIA which became law August 14, 2008, indicate that action
is necessary.

1. Introduction
Allergic contact dermatitis caused by textiles is rare. There are
many reasons other than chemical additives used in processing of
textiles that can cause irritation/allergic contact dermatitis--the
fabric itself, physical effects of the clothing rubbing the skin, heat
retention from perspiration soaked clothes, poor hygiene, fasteners,
and other devices attached to clothing, etc. For example, some people
may find that fabrics such as wool irritate their skin but it is not an
allergy and not chemically related. It is important to note that
formaldehyde is ubiquitous and is a natural product present in the air
from many sources--natural processes, in fruits, vegetables and blood,
by combustion processes, including motor vehicles, cooking, household
heating and brush fires and produced by cigarette smoking.

2. Fabric levels of formaldehyde should not be confused with airborne
levels of formaldehyde gas
Fabric levels of formaldehyde are determined by two generally
accepted methods (see Appendix 3). Typically, fabric levels are
expressed as micrograms of formaldehyde per gram of fabric (mg/g or
ppm). Airborne levels are expressed as micrograms or milligram of
formaldehyde gas per cubic meter of air (mg or mg/m\3\; ppb or ppm).
There is not a clear correlation between fabric levels of formaldehyde
and airborne levels of formaldehyde gas because release mechanisms are
numerous and complex. Many factors affect releases and airborne levels,
e.g., material and treatment, temperature, humidity, room size, air
exchanges in the room, etc. Chamber studies of textiles indicate that a
300-500 mg/g fabric level would have air emissions less than the
California Proposition ``safe harbor'' level of 40 mg/day per textile.
The health risk of high fabric levels is dermatitis; high airborne
levels can cause respiratory health problems. The CPSC in the 1980s
considered urea formaldehyde foam insulation (UFFI) to be a hazardous
product and took actions under the FHSA against its use. The CPSC
Report, ``An Update on Formaldehyde, 1997 Revision'' indicates: p.3 ``.
. . Formaldehyde is one of several gases present indoors that may cause
illnesses. Many of these gases, as well as colds and flu, cause similar
symptoms.'' To reduce levels of formaldehyde from pressed wood
products, mandatory formaldehyde standards for emissions from pressed
wood products have been promulgated and proposed [CA Air Resources
Board an airborne toxic control measure (ATCM) to reduce formaldehyde
emissions from composite wood products and from finished goods that
contain composite wood products (17 CA Code of Regulations, sections
93120-93120.12) passed 4/07 effective 1/1/09; U.S. EPA, ANPR,
``Formaldehyde Emissions from Pressed Wood Products'', 73 FR 73620, 12/
3/08].
In the 1980s CPSC determined that no standard was needed for fabric
levels or textile product emissions of formaldehyde for textiles and
apparel. CPSC extensively studied formaldehyde and textiles in the
1980s at the Oak Ridge National Laboratory, Research Triangle
Institute, and elsewhere (see data below). After numerous studies, it
was concluded that formaldehyde levels in textiles and formaldehyde
emissions from textiles were so low that they do not pose an acute or
chronic health hazard for consumers, i.e., that clothing/apparel does
not present an unreasonable risk to consumers from formaldehyde.
According to chamber tests and other studies on a wide range of
textiles/apparel products before and after washing that had been
treated with formaldehyde containing chemicals/adducts, the air
emissions levels of formaldehyde gas from textiles and apparel were
below the level of concern. Further, it was concluded that formaldehyde
emissions from textiles and apparel do not require a warning label
under California Proposition 65 or by EPA, because test data have shown
that their emissions are below the level of concern (<40 mg/day per
textile).

3. Dyeing and Finishing of Textiles--where formaldehyde containing
chemicals/adducts are used
Textile fibers can be natural or manufactured. Natural fibers are
cellulose vegetable fibers (bast, leaf, seed hairs) such as cotton or
linen or protein animal fiber such as wool or silk. Manufactured fiber
such as rayon and acetate are cellulose polymers; synthetic polymer
fibers include nylon, polyester, polypropylene, and spandex.
Textiles go through many processes to produce a dyed and finished
commercial textile. As many as twenty or more finishing treatment can
be used (see WD Schindler and PJ Hauser, 2004. Chemical finishing of
textiles, Woodhead Publishing, Ltd). Some textile finishing processes
use formaldehyde containing chemicals/adducts--for easy-care/durable
press/wrinkle resistance for sheeting, shirting, dress goods, knits,
and slacks; for textile pigment dyeing for a small number of sheets and
for pigment printing; and for flame retardance for very little if any
children's sleepwear and protective work clothing.
Formaldehyde containing chemicals/adducts are used mainly on cotton
and cotton blends and other cellulosic fabrics/textiles (see Appendix
5). Easy care/wrinkle resist cotton apparel accounts for 2 percent of
the total apparel offerings at retail and for 13 percent of total
cotton apparel purchased in 2008. The majority easy care cotton apparel
is men's apparel. There is almost no easy care children's apparel and
almost no children' wear is treated with formaldehyde containing
chemicals/adducts of any kind.
Formaldehyde containing chemicals/adduct finishes are not used on
synthetic textiles such as fabrics/apparel/clothing made from nylon and
polyester.

4. Formaldehyde and Textiles
Formaldehyde-releasing finishes provide crease resistance,
dimensional stability, and flame retardance for textiles and can serve
as binders in textile pigment printing and dyeing (Priha, 1995). Easy-
care/durable press/wrinkle resistance finishing is one of the many
finishing operations used to give finished textiles the quality and
aesthetics that consumers demand. These finishes are generally applied
to cellulose and cellulose blend fabrics--fabrics used for sheeting,
shirting, dress goods, knits, and slacks. The primary effects of these
finishes on cellulosic fibers are reduction in swelling and shrinkage,
improved wet and dry wrinkle recovery, smoothness of appearance after
drying and retention of intentional creases and pleats. Commercially
available apparel is not treated with formaldehyde directly to produce
easy-care/durable press/wrinkle resistant textiles. Formaldehyde has
not been shown to be a useful reagent to produce wrinkle resistant
cotton (Priha, 1995). Methylolamide agents (N-methylol compounds,
formaldehyde adducts of amides or amide-like nitrogenous compounds),
which introduce ether cross-links between cellulose molecules of the
cotton fiber, are the most widely used to produce wrinkle resistant
cotton [see P. J. Wakelyn, N. R. Bertoniere, A. D. French, et al.,
2007. Cotton Fiber Chemistry and Technology. Series: International
Fiber Science and Technology, CRC Press (Taylor and Francis Group), pp.
75-76].
Durable-press/wrinkle resistant resins or permanent-press resins
containing small amounts of formaldehyde have been used on cotton and
cotton/polyester blend fabrics since the mid-1920s to impart wrinkle
resistance during wear and laundering. Priha (1995) indicated that
formaldehyde-based resins, such as urea-formaldehyde (UF) resin, were
once more commonly used for crease resistance treatment. However,
better finishing agents with lower formaldehyde release have been
developed and are what is currently used. Totally formaldehyde-free
crosslinking agents are now available but they are expensive and do not
perform as well (e.g., can affect some dye shades).
There are a small amount of sheets where acrylic and acrylic-based
binders that can contain traces of formaldehyde are used for pigment
printing and dyeing. Very little if any halogen phosphorus flame
retardants that contain formaldehyde are used on children's sleepwear
and protective work clothing.
Some apparel that is treated with formaldehyde containing
chemicals/adducts can potentially release trace amounts of
formaldehyde, even though they are bonded to the fiber. If apparel,
cotton and cotton blends and other cellulosic fabrics/textiles, are
treated with formaldehyde-derived chemicals (i.e., formaldehyde adducts
of amides or amide-like nitrogenous compounds, acrylic binders or
halogen phosphorus flame retardant compounds), the potential trace
amount of formaldehyde that could be released should be far below
levels that would cause irritation or any health effects or affect the
environment.
It has been reported that the average formaldehyde level contained
by textiles made in the USA is approximately 100-200 mg free
formaldehyde/g as measured by the AATCC Method 112 sealed jar test
(results using AATCC Method 112 are about 4 times higher than that
measured using ISO 14184-1/Japanese Law 112 Method) (Scheman et al.,
1998). Modern innovations through the use of derivates and scavengers
and other low-emitting resin technology (Wakelyn, et al. 2007 cited
above) keep the levels below 100-200 ppm (as measured by AATCC 112
Method). The AATCC 112 method has been the most common way for
determining formaldehyde levels in fabrics in the U.S. but since
textiles are international products ISO 14184-1 and the Japanese Law
112 Method are now being used more often.
Tests in New Zealand on Chinese textiles (see Appendix 4), which
were conducted after incorrect stories reported high fabric
formaldehyde levels, showed that ``97 of 99 items had no detectable or
very low levels of formaldehyde.'' ``Two items had above the acceptable
level of 100 parts per million, but simple washing reduced formaldehyde
to well below acceptable levels.''
It is easy to neutralize the formaldehyde with Clorox 2. It has
been known for a long time that simple laundering with normal
commercial detergents greatly reduces any formaldehyde or lowers to
non-detectable levels.
Published scientific studies indicate that it is very rare for even
highly sensitized individuals to have a reaction to formaldehyde fabric
concentrations as low as 300 ppm [by AATCC Method 112] (Hatch and
Maibach, 1995). And patch testing with formaldehyde, textile resins
that can release formaldehyde, and formaldehyde-releasing preservatives
lend support to the idea that the causal agent of allergic contact
dermatitis due to wearing durable press fabrics may be the resin rather
than formaldehyde that may be released.
--Hatch, K. L.; Maibach, H. I. (1995) Textile dermatitis: an update
(I). Resins, additives and fibers. Contact dermatitis, 32:319-326.
--Priha, E. (1995) Are textile formaldehyde regulations reasonable?
Experiences from the Finnish textile and clothing industries.
Regulatory toxicology and pharmacology, 22:243-249.
--Scheman, A. J.; Carrol, P. A., Brown, K. H.; Osburn, A. H. (1998)
Formaldehyde-related textile allergy: an update. Contact dermatitis,
38:332-336.
--Clothing Dermatitis and Clothing-Related Skin Conditions, August
2001, (http://www.lni.wa.gov/Safety/Research/Dermatitis/files/
clothing.pdf ).

5. U.S. Government studies regarding formaldehyde and textiles
Both the U.S. Consumer Product Safety Commission (CPSC) and the
U.S. Environmental Protection Agency (EPA) have determined that no
standard for fabric levels or product emissions is necessary for
textiles and apparel.
CPSC extensively studied formaldehyde and textiles in the 1980s at
the Oak Ridge National Laboratory, Research Triangle Institute, and
elsewhere. After these studies, it was determined that formaldehyde
fabric levels and formaldehyde emissions from textiles do not pose an
acute or chronic health problem to consumers.
--Robins, J. D. and Norred, W. P., Bioavailability in Rabbits of
Formaldehyde from Durable Press Textiles, Final Report on CPSC IAG 80-
1397, USDA Toxicology and Biological Constituents Research Unit,
Athens, GA, 1984.
--ORNL/TM-9790 `Formaldehyde Release from Durable-Press Apparel
Textiles' Final Project Report to CPSC Oct 1985 [TG Mathews, CR
Daffron, ER Merchant] http://www.ornl.gov/info/reports/1985/
3445600564985.pdf
--RTI `Percutaneous Penetration of Formaldehyde' (July 1981-83)
submitted in Jan 1984 to ATMI and FI by A R Jeffcoat, RTI [rhesus
monkey study] [Any formaldehyde that was release did not show up in any
organs of the animal. Dr Peter Pruess previously with CPSC and now with
EPA was involved these studies.]
--CPSC Briefing Package on formaldehyde and textiles ``Status
Report on the Formaldehyde in Textiles Portion of Dyes and Finishes
Project'' [Sandra Eberle (to Peter Pruess and others), 1/3/84] p.4
Conclusions: `current evidence, although not conclusive, does not
indicate that formaldehyde exposure from resin-treated textiles is
likely to present a carcinogenic hazard.'
Formaldehyde emissions from textiles do not require a warning label
under CA Proposition 65.
Much work was done by the textile and cotton industries when Prop
65 was first being implemented in 1986. The textile and cotton
industries resolved this issue with the CA Health and Welfare Agency in
1987 to 1992. Chamber and other studies were done with various textile
products before and after washing. The state of CA indicated in a
letter to the textile industry in 1988 that the state has no
information that suggests that textiles pose a risk (Letter to W. A.
Shaw, Textile Industry Coalition from Dr. S. A. Book, Science Advisor
to the Secretary, California Health and Welfare Agency, Mar 22, 1988).
The regulation of Proposition 65 is now under Office of Environmental
Health Hazard Assessment (OEHHA), CA EPA. The concern in CA lately has
been with emissions from wood products not textiles. As far as I am
aware there has not been a bounty hunter suit in CA against apparel. No
product has a ``general exemption'' but a product is not required to
have warning labels and has no requirements under Prop 65 unless that
product causes potential exposure above the ``safe harbor limit'' to
any substance that is on the Prop 65 list. The key point is that the
trace emissions of formaldehyde from an individual textile does not
exceed the ``safe harbor level'' of 40mg/day for formaldehyde (gas)
[http://oehha.ca.gov/prop65/pdf/2009FebruaryStat.pdf].
6. Conclusion
In view of all the studies over the last 30 years indicting that
there is not a problem with U.S. textiles and regulations already in
place concerning formaldehyde and textiles, no new regulations are
necessary. There should be no action concerning formaldehyde and
textiles unless the results of the GAO study required by the CPSIA
clearly show that areas of concern still exist.
______

Appendix 1

Formaldehyde containing chemicals used in textile and apparel dyeing
and finishing are regulated by U.S. CPSC and other U.S.
regulatory agencies.

CPSC has the authority to regulate formaldehyde under the
Federal Hazardous Substances Act (15 U.S. Code 1261-1278). CPSC
already has authority to regulate substances/chemicals or
mixtures of substances on textiles that may cause substantial
personal injury or illness during any customary or reasonably
foreseeable handling or use and has a regulation [under
``strong sensitzer'' in section 2(k) of the Act, 16 CFR
1500.13(d) (repeated in 1500.3(b)(9))]. CPSC has banned
chemicals in the past under the FHSA and investigated
formaldehyde, flame retardants, dyes, and other chemicals used
in preparation, dyeing, and finishing of textiles.

EPA under the Toxic Substances Control Act (TSCA) has
authority over all chemicals in commerce and can set
restrictions or ban chemicals. They currently have a
significant new use rule that covers any flame retardants as
well as any textile chemicals. EPA also can regulate emission
levels from products but is not concerned with formaldehyde
emissions from textiles and apparel.

OSHA has the authority to regulate exposures of formaldehyde
within a workplace (29 CFR 1910.1048). The OSHA workplace level
is 0.75 ppm (8 hr TWA). Also products containing > 0.1 percent
formaldehyde and ``materials capable of releasing formaldehyde
into the air, under foreseeable conditions of use at
concentrations reaching or exceeding 0.1 ppm are subject to
regulation including labeling, worker training and MSDS's.

California Proposition 65 [the Safe Drinking Water and Toxic
Enforcement Act of 1986] requires labeling for chemicals known
to the state of California to be carcinogens or reproductive
toxins that cause exposures of significant risk. Product
emissions of formaldehyde gas from textiles and apparel do not
require labeling under California Proposition 65, because tests
have shown that their emissions are below the level of concern,
i.e., the ``safe harbor level'' for formaldehyde that does
require labeling is <40 mg/day per textile. 40 mg/day per
textile is negligible compared to natural background levels.

There are also national and international voluntary
standards (e.g., American Association of Textile Chemists and
Colorists [AATCC], the American Society for Testing and
Materials [ASTM], and International Organization Standards
[ISO]) that are used in the textile industry. In addition, the
American Apparel & Footwear Association [AAFA] publishes a
Restricted Substances List (RSL) that many companies are using
in addition to their own RSLs.

There are also eco-labeling standards, e.g., the EU Ecolabel
for Textiles, Oeko-Tex Standard 100 and sustainability
standards (e.g., NSF-336) for textiles are being developed by
the American National Standards Institute (ANSI).
______

Appendix 2

International standards, company requirements, voluntary labels

There are governmental restrictions, company requirements (e.g.,
Levi Strauss, Marks and Spencer) and several labels (e.g., EU Ecolabel,
Oeko-Tex Standard 100) that set limits for free or easily freed
formaldehyde in textiles. The European eco-label for textiles [EU
(2002), Ecolabel for Textiles, http://eur-lex.europa.eu/LexUriServ/
LexUriServ.do?uri=OJ:L:2002:133:0029:0041:EN:PDF] has a limit of 300
ppm formaldehyde (by ISO-14186-1/Japanese Law 112 Method). Finished
fabrics for adult clothing and other skin contact textiles may be
labeled and called low formaldehyde finished according to Oeko-Tex
Stanandard 100 when their free formaldehyde content is lower than 75
ppm (Japan Law 112 Method).
Eight counties in the world have formaldehyde requirements for
textiles ranging from 1500 ppm (in Germany) to 75 ppm (in Japan
measured by the Japanese Law 112 Method) for textiles that contact the
skin. The other countries are 100-120 ppm (measured by the Japanese Law
112 Method/ ISO 14184-1).Discussion in the ``Proposed Government
Product Safety Policy Statement on Acceptable Limits of Formaldehyde in
Clothing and other Textiles'' by the New Zealand government [http://
www.consumeraffairs.govt.nz/policylawresearch/product-safety-law/
proposed-statement/proposed-policy-statement.pdf] gives a summary of
International formaldehyde limits is clothing and other textiles (p.
3). International regulatory limits show a diverse spread. Japan has
the most stringent limits for clothing in direct contact with the skin,
75 ppm. The section on Test Method on p. 5 first paragraph states:
Below 20 ppm the result is reported as ``not detectable''. This is for
the proposed acceptable testing method, ISO 14184-1, which is
essentially the same as Japan Law 112 Method. Oko-Tex 100 defines
measured values <20 ppm on the substrate according to Japan Law 112
Method as non detectable. In the AATCC Method 112 the margin of error
or the ``zero'' level in low-level samples is 75 ppm.
______

Appendix 3

Measuring the amount of formaldehyde in textiles

There are currently two generally accepted methods of measuring
formaldehyde in textiles. The method used needs to be specified. It is
important an acceptable testing method be used. It is the only way that
meaningful data can be obtained.

AATCC Method 112 (``sealed jar test'')--Free and releasable/
hydrolysable formaldehyde may be captured by this procedure.
The test specimen is suspended over an aqueous solution in a
sealed jar at a given temperature for a specific time.
Formaldehyde gas given off is absorbed in to the aqueous
solution; formaldehyde in the solution is derivatized and the
color of the resulting complex is measured with a visible
spectrophotometer. Formaldehyde amount is expressed as
micrograms of formaldehyde per gram of fabric (mg/g or ppm).
The margin for error or the ``zero'' level in low-level samples
is about 75 ppm. This has been the predominant method used by
the U.S. Textile Industry.

--AATCC Technical Manual, Test Method 112

ISO-14184-1 and Japanese Law 112 Method [The ISO and the
Japanese methods are essentially the same and give the same
results]--Free formaldehyde is measured and probably only a
small amount of releasable/hydolizable formaldehyde is
measured. The formaldehyde is extracted from the specimen into
water, the formaldehyde is derivatized and measured with a
visible spectrophotometer as above. The limit of detection for
both methods or ``zero'' level is 20 mg/g or ppm. The ISO
Standards for testing formaldehyde provide internationally
agreed methods of testing.

--ISO 14184-1:1998 Textiles--Determination of formaldehyde--Part 1:
Free and hydrolized formaldehyde (water extraction method)

--ISO 14184-2:1998 Textiles--Determination of formaldehyde--Part 2:
Released formaldehyde (vapour absorption method)

--Law for the Control of Household Products Containing Harmful
Substances (Japanese Law 112) and Japanese Industrial standard (JIS) L
1041

An AATCC Method 112 reading of 300 ppm (meeting most U.S.
retailer requirements) may give a ISO-14184-1/Japanese Method
112 value of 75 ppm--an exact correlation between the two
methods is not possible. Other methods for measuring
formaldehyde on fabrics have described but how they correlate
with the ISO-14184-1/Japanese Law 112 Method or the AATCC 112
Method is not published.
______

Appendix 4

New Zealand testing in 2007 on Chinese clothes

http://times.busytrade.com/489/1/
Chinese_Clothes_Gain_Good_Comment_From_New_Zealand.html

Chinese Clothes Gain Good Comment From New Zealand
From:fiber2fashion--(October 23, 2007)
Chinese clothes gained good comment from New Zealand for its high
safety index, which has much to do with the Chinese government' s
Longtime effort on improving product quality. On October 17, the New
Zealand Ministry of Consumer Affairs posted on its website the result
of the formaldehyde test it conducted on 99 items of Chinese clothes.
According to the Ministry, among the 99 items, 97 did not contain
or contained formaldehyde lower than the country's standard, and the
two items that contained formaldehyde higher than the standard could
lower its formaldehyde content through simple cleaning. The test result
of New Zealand authority showed that Chinese clothes were safe.
We noticed the wide publicity of high formaldehyde content in
Chinese clothes on New Zealand media since August this year. The test
that New Zealand government conducted and the result it released proved
that Chinese products were safe. China appreciated the objective
attitude of New Zealand in handling this issue.
Chinese government attached great importance to product quality and
safety. A series of recent measures to tighten quality control and food
safety control would significantly improve the quality and reputation
of Chinese products.
According to the China Customs, China exported about 290 million
U.S. dollars worth of clothes to New Zealand, accounting for 70.5
percent of its apparel market. In the formaldehyde test that New
Zealand conducted this time, Chinese exports made up 84 percent of the
tested clothes. Ministry of Commerce of the People's Republic of China
(MOFCOM) . . .

http://www.fibre2fashion.com/news/textile-news/
newsdetails.aspx?news_id=42744

New Zealand: Formaldehyde tests show no health issue in clothes
October 18, 2007
Test results released show little cause for concern about levels of
formaldehyde in clothing and textiles on sale in New Zealand.
``In response to concerns raised by television programme Target,
the Ministry of Consumer Affairs tested 99 items of clothing and
manchester,'' says Consumer Affairs Minister Judith Tizard.
``97 of 99 items had no detectable or very low levels of
formaldehyde.'' ``Two items had above the acceptable level of 100 parts
per million, but simple washing reduced formaldehyde to well below
acceptable levels.''
Twenty parts per million is accepted internationally as the zero
mark under which formaldehyde in fabric is not detectable.
Ms Tizard says the Ministry used the correct method of testing and
its results were robust and credible. ``Target used the wrong testing
method, which is why their results were so dramatically different.''
``In line with international best practice for testing clothing,
the Ministry tested for free formaldehyde only. Target tested for
combined free and bound formaldehyde. They then compared this with
international standards for free formaldehyde.''
``It was like testing apples and oranges against a standard for
apples only.''
The government is to issue a product safety policy statement
setting acceptable levels of formaldehyde in clothing, a move that will
provide greater certainty for New Zealand consumers.
``We are consulting on the appropriate levels, but expect they will
be similar to those used as benchmarks in the Ministry's testing, which
were based on levels used by overseas regulators.''
Submissions on the proposed policy statement are due by 26
November.
The Ministry of Consumer Affairs have been working closely with the
Australian Competition and Consumer Commission, who are today also
announcing a consistent approach to acceptable levels of formaldehyde
in clothing.
New Zealand Ministry of Consumer Affairs
______

Appendix 5

Easy care market information 1) what is offered at retail, 2) what the
consumer is buying.

1. Retail Offerings
Apparel

Easy care cotton apparel accounts for 2 percent of the total
apparel offerings at retail.

The majority (97 percent) of easy care cotton apparel is
men's apparel.
Easy Care Apparel Categories

------------------------------------------------------------------------
Share of Products with
Category Easy Care
------------------------------------------------------------------------
Total Men's Apparel 4%
Men's Dress Shirts 9%
Men's Casual Pants 14%
Men's Other Pants 15%
------------------------------------------------------------------------

Home Textiles
Easy care cotton apparel accounts for 1 percent of the total
home textile offerings at retail.

------------------------------------------------------------------------
Share of Products with
Category Easy Care
------------------------------------------------------------------------
Bedding 1%
Sheeting 3%
------------------------------------------------------------------------
Source: Cotton Incorporated's Retail Monitor TM is a quarterly survey of
apparel products at 26 major U.S. retailers. Information is collected
in the store and online. In first quarter 2009, data were collected
from 42,564 apparel products. The home textiles data is from the 2009
Home Textiles Audit. Data were collected from over 25,000 products
from nine retailers from four different retail channels--mass, chain,
specialty and department.

2. Consumer Purchases

Easy care cotton apparel accounted for 13 percent of total
cotton apparel purchased in 2008.

The majority (66 percent) of easy care cotton apparel
purchased was men's apparel.
Easy Care Apparel Categories

------------------------------------------------------------------------
Share of Purchases with
Category Easy Care
------------------------------------------------------------------------
Total Men's Apparel 20%
Men's Dress Shirts 39%
Men's Casual Pants 25%
Men's Other Pants 45%
------------------------------------------------------------------------
Source: The consumer purchase data is from NPD Fashionworld's AccuPanel,
a panel of 12,000 consumers who report their apparel purchases on a
monthly basis; therefore, the data are based on purchases from all
retail channels including mass merchants, national chains, department
stores, specialty stores, off-price, factory outlets, warehouse,
Internet, etc. . . . The figures are projected to be representative of
the U.S. population for consumers ages 13 and older--so this does not
include children's apparel.

Senator Pryor. Thank you. Let me go ahead and jump in with
a few questions. Dr. Wakelyn, and you gave us some percentages
and what I would like to know is about what percentage of the
textiles in apparel currently sold in the United States contain
formaldehyde? About what percentage?
Dr. Wakelyn. Offered at retail--this is the latest data
from Cotton Incorporated's lifestyle monitoring and studies,
and they--because their major business is cotton, they do
detailed studies every year on availability. What's offered at
retail, only 2 percent of the products contain any wrinkle-
resist finishes. Everything else is just trace amounts that are
used.
Senator Pryor. All right, let----
Dr. Wakelyn. Then it--then, also what was sold at the
marketplace, the cotton that was sold, 13 percent of that
contained wrinkle--but, most all of this is adult menswear.
That is the major market. They've tried to get into womenswear
to a larger extent, and haven't been as successful. It's really
not used in children's products to speak of.
Senator Pryor. OK. Well, let me ask this. You mentioned
it's used for wrinkle resistance. Are there other chemicals
available to do wrinkle-resistance fabrics?
Dr. Wakelyn. The science behind this--and this is something
that I might mention, that I participated with, and was
involved in, consulting and on task force at the U.S.
Department of Agriculture and also with Cotton Incorporated, on
all the work that they did in the 1970s, early 1980s, with
formaldehyde in textiles that led to the low-emitting resin
technology, and that's what is used. Dr. Brookstein mentioned
several of these in his testimony--the low and very low that he
mentioned are the only things that are used in the United
States. As a result, I also wanted to mention that, in 2007, I
was the lead author of a book, with researchers at U.S.
Department of Agriculture, on cotton fiber chemistry and
technology, and it contains a lot of the chemistry involved
with this low-emitting resin technology----
Senator Pryor. But----
Dr. Wakelyn.--the scavengers and the systems, to keep these
very low levels.
Senator Pryor. But, are there other chemicals available to
do wrinkle-resistant----
Dr. Wakelyn. There are----
Senator Pryor.--fabrics?
Dr. Wakelyn. They have done a good bit of research at USDA
on formaldehyde-free finishes, and some of these are very good,
but they are expensive, for one thing, and they can affect the
dyeing. So, there are some limits in how you can use these
particular products or textiles.
Senator Pryor. OK.
Dr. Wakelyn. Again, remember, the textile situation, where
you're talking about the amount of--small amount of
formaldehyde that can be measured on the surface is different
from formaldehyde gas in the environment.
Senator Pryor. OK.
Dr. Wakelyn, let me ask this--you mentioned formaldehyde is
not used in children's clothes. Is that----
Dr. Wakelyn. Formaldehyde-containing resins are essentially
not used. The children's market in wrinkle-resist is almost
zero. The children's market with regard to children's
sleepwear, those types of products are not used. And the way
it's used--only in a small amount of sheeting for dye printing
and pigment dyeing, they use these materials.
Senator Pryor. And----
Dr. Wakelyn. Those are the overwhelmingly vast majority--
all--almost all the uses of formaldehyde in textiles in the
United States currently.
Senator Pryor. Now, when you say that, are you referring to
just U.S. manufacturers or are you referring to everything in
the U.S. marketplace?
Dr. Wakelyn. Things in the U.S. marketplace.
Senator Pryor. OK. And have the domestically based textile
companies--you know, the folks that actually make the
domestically-produced textiles here--are they self-regulating
in any way?
Dr. Wakelyn. Since the middle of 1980s, when Levi Strauss
set levels for their customers, between the customer and the
textile mill, all of the--several times in the 1980s and 1990s,
a lot of work was done. There was a publication that I
referenced from 1998 saying that the level in the United States
is somewhere between 100 and 200 micrograms per gram. And that
is on the AATCC test. That's the American Association of
Textile Chemists and Colorists. That number is actually four
times higher than the international standard of the ISO or the
Japanese that all of these are based on. So, the real level in
U.S. textiles as of 1998, which was the same as it was in the
late 1980s, and with the modern technology they're using, is
probably somewhere no more than about 50 to 75 micrograms per
gram on the fabric.
Senator Pryor. Dr. Etzel and Dr. Brookstein, let me ask,
based on your experience and scientific research--give us a
sense of about how many formaldehyde-related complaints there
are per year? How many people come in and report symptoms, et
cetera? Could you give us a sense of that?
Dr. Brookstein. The medical, you do it.
Dr. Etzel. That's a very difficult question, Mr. Chairman,
because the kinds of symptoms that we've described that occur
from formaldehyde can also occur from many other chemical
residues. And so, it's almost impossible for an individual
pediatrician or adult physician to identify the specific cause,
unless someone comes in with a product that they think has
injured them. And so, it's very difficult to actually get the
kinds of numbers you're asking about.
Senator Wicker. Well, thank you very much. Well, Dr.
Wakelyn----
Dr. Brookstein. Can I----
Senator Wicker. Oh, I'm sorry.
Dr. Brookstein. There was this question that--while I'm not
talking about the medical, I will tell you this. We did some
preliminary work at the University, where we looked at
children's wear, we looked at children's khaki pants and we
looked at children's dress shirts. These are not infants, but
they were certainly children. And we found 3 out of 11 pairs--
we found, in almost all of the clothing, there was
formaldehyde, but there was only perceptible formaldehyde in 3
out of 11. And, to me, that's significant. In the shirts, it
was 1 out of 10, we found. Now, this was a small random test.
And one of the things that we propose that the GAO does is do a
much more extensive test so we can actually have a body of
knowledge that we can make determination on. But, we did find
formaldehyde in children's clothing in our testing.
Dr. Wakelyn. I would like to respond to that question,
also, and particularly respond to what Dr. Brookstein said. To
be able to say that you detected--formaldehyde is a--in the
atmosphere all the time. Textiles act as a sink. You mentioned
that carpets contain it. No, they don't. They are not treated
with it, but they can pick up as a sink.
OK. He said 3 out of 11, 1 out of 10. What he's--has he
measured that using the standard methods? There are two
standard methods that are recognized in the world on how you
measure this. And if you don't use those particular
measurements, the--your data has, really, no meaning, because
the handheld instrument, some of these other things, have not
been correlated with that.
And, oh, by the way, the zero level or nondetect level in
the Japanese or the ISO's test is under 20 parts per million,
micrograms per gram. That is because of the uncertainties in
the test. In the U.S., it's 75 or 80 in the AATCC test. So,
just because somebody says they detect it, that doesn't mean to
say that it's there in any quantity or that it's not considered
a zero level or that it's at a level that's going to cause any
concern. It creates an improper perception if you say, ``Oh,
well, I've detected it there, so therefore it has to be a
problem.'' Most of the time, when people are exposed to and get
some type of textile irritation, a lot of times, the
dermatologist will say, ``Oh, it has to be formaldehyde.'' Many
of these products don't even contain formaldehyde, were not
treated with formaldehyde, and the person isn't even allergic
to formaldehyde.
Senator Wicker. Thank you.
Dr. Wakelyn, is it likely that you or the other two
panelists brought any formaldehyde into the room today? Are you
wearing any formaldehyde?
Dr. Wakelyn. I would think most of the men in this room
have easy-care, wrinkle-resist shirts on and have been wearing
them for years. These have been in the marketplace, certainly
the more modern ones, for the last 25 years. Ask them if any of
the people in the room have had any problems wearing those
shirts.
Senator Wicker. Dr. Brookstein has raised his hand.
Dr. Brookstein. Yes. Mr. Wicker, I bought this new shirt
yesterday for this hearing. It is permanent press, and I plan
on testing it tomorrow in our laboratory. Unfortunately, I
couldn't test it prior to today, but I will be testing it
tomorrow.
Senator Wicker. OK.
Dr. Brookstein. Using Japanese 112, a standardly--a
standard approved testing method, which we did all our testing
with.
Senator Wicker. Dr. Wakelyn, is that a test----
Dr. Wakelyn. Yes, that----
Senator Wicker.--that you have confidence in?
Dr. Wakelyn. The Japanese test and the ISO 14184-1, are the
standard testing that are used, and that's what these are based
on.
Senator Wicker. OK. Well, Dr. Wakelyn, you mentioned the
test in the 1980s at Oak Ridge, extensive studies of
formaldehyde and textiles. Do you know if the tests brought us
a unanimous result from those scientists? Was there a minority
view offered? And what are the chances that under 2009 and 2010
standards or at the current level of knowledge, there might be
a different result?
Dr. Wakelyn. Well, those----
Senator Wicker. There are two questions there.
Dr. Wakelyn. Those tests, both for primate tests--and with
rabbits, were done on the skin. I doubt that there would be any
difference in the results of those today. They were extremely
extensive studies.
The Consumer Product Safety Commission has been a bit
maligned by some of the testimony here today, too, as though
they don't do anything and haven't done anything. They have
been extremely well respected. Their health sciences department
has done tremendous work in this area, and contributed in that
area, and they continually look at some of these things, when
things are raised. They were involved in these studies. And, in
fact, the person that was at CPSC at that time that was done
was in charge of many of these studies, or was certainly
involved in them, is Peter Pruess, who's head of the
formaldehyde work at EPA presently.
So, no, I think that they were--they used the technology
that was available at that time, but I think that the results
would be the same.
Senator Wicker. Well, do you know if there was a minority
review----
Dr. Wakelyn. There wouldn't be.
Senator Wicker.--minority----
Dr. Wakelyn. I don't think there would be, no. These are
published reports, and they're published in the refereed
journal publications. I've listed four of them in here, and
I'll be happy to provide them to the Committee----
Senator Wicker. Please----
Dr. Wakelyn.--if they so desire.
Senator Wicker. Please do that.
[The information referred to follows:]

1. Robins, J. D. And Norred, W. P., Bioavailability in Rabbits of
Formaldehyde from Durable Press Textiles, Final Report on CPSC IAG 80-
1397, USDA Toxicology and Biological Constituents Research Unit,
Athens, GA, 1984.
2. ORNL/TM-9790 ``Formaldehyde Release from Durable-Press Apparel
Textiles'' Final Project Report to CPSC Oct 1985.
[TG Mathews, CR Daffron, ER Merchant] http://www.ornl.gov/info/
reports/1985/3445600564985.pdf.
3. RTI ``Percutaneous Penetration of Formaldehyde'' (July 1981-83)
submitted in Jan 1984 to ATMI and FI by A. R. Jeffcoat, RTI [rhesus
monkey study] [Any formaldehyde that was released did not show up in
any organs of the animal. Dr. Peter Pruess previously with CPSC and now
with EPA was involved these studies.)
4. CPSC Briefing Package on formaldehyde and textiles ``Status
Report on the Formaldehyde in Textiles Portion of Dyes and Finishes
Project'' [Sandra Eberle (to Peter Pruess and others), 1/3/84].
Studies 1, 3, and 4 are retained in Committee files. Study 2 can be
found at the link mentioned above.

Senator Wicker. Now, I believe the chart belongs to Dr.
Brookstein, is that correct?
Dr. Brookstein. Yes, sir.
Senator Wicker. Well, Dr. Wakelyn, let me ask you, then,
about these other countries. Finland, Norway, the Netherlands,
Germany, have set standards for fabric, beyond what we set in
the United States. And then, with regard to wood and textiles,
we can add Japan, China, Russia, Lithuania, New Zealand, and
South Korea. Why do you think they did that? Do you think that
was based on scientific overkill? Or you--have you looked at
scientific results----
Dr. Wakelyn. Well----
Senator Wicker.--from any of those countries?
Dr. Wakelyn. Let me say this, to begin with. If you'll look
at the numbers there, they range from 1,500 parts per million,
which would be the--Austria and Germany, which are very severe
litigious countries, down to much, much lower levels. One
reason why the Japanese levels have been very low, and have
been very low for years, is, people have looked at that as a
nontariff trade barrier. They require people bringing things
into Japan to have higher levels--I mean, to have lower levels
than what they produce in their own country. They don't really
test their own products. So, you see a great variation of what
is in here; and particularly with regard to infants, they want
a nondetectable level, and most, as I say, infant clothes in
the United States are not treated with formaldehyde of any
kind. And if you make a measurement, it does not exceed what's
considered a zero or nondetect level.
No, these countries have decided that they need some kind
of standard in place. We do have--under CPSC sensitization, we
do have, under various agencies, wood products--pressed-wood
products, that is--although there's very good technology out
now to produce wood products that don't exceed the HUD level or
the California level. There are all kinds of other products,
besides textiles, but textiles have been thoroughly looked at,
at CPSC in the late 1980s. Now, they can take a relook at all
of that information and relook at what's in the published
literature, but there has not been--there has not been a valid
complaint against formaldehyde in textiles in the United
States.
Senator Wicker. OK. Well, thank you very much. And one
final question, the Chair has agreed to indulge me.
Dr. Brookstein, on page 8 of your testimony, there's a very
troubling picture of a patient exposed by dimethylfumarate----
Dr. Brookstein. Fumarate.
Senator Wicker.--fumarate. I thought I did pretty well on
that.
[Laughter.]
Senator Wicker. Dimethylfumarate.
Dr. Brookstein. Got it close.
Senator Wicker. That's not formaldehyde, is it?
Dr. Brookstein. No. It's not formaldehyde. But, I took the
privilege of putting this in there. This is a serious problem
that's occurring in Europe right now. It's starting to break--
it had broken out a little bit in--no pun intended----
Senator Wicker. Yes, right.
[Laughter.]
Dr. Brookstein.--in Canada. These were--this is an example
of a patient that was exposed to something that was inserted--a
preservative in foam for sofas, and it took a while for the
dermatologists in Scandinavian countries to realize what was
going on. And I've been working with a--the physician over
there in Finland, and I wanted the Committee to see this,
because this is an example of what happens when you don't do
the science and don't check things out. Now, this is not
formaldehyde. I make it very clear. But--in my written
testimony--I wanted this picture for you all to see.
Senator Wicker. Right. And when--and I appreciate you doing
that. It--you mentioned in the--on the first page of your
testimony, TRIS----
Dr. Brookstein. Yes.
Senator Wicker.--which was an attempt by consumer advocates
to help the situation by preventing fire-related deaths and
fire-related injuries among infants. It turns out that, in
fact, we were doing harm--we were doing more harm than good,
and TRIS was summarily removed from the market.
I assume that dimethylfumarate was considered to be a
beneficial product and make sofas better and perhaps----
Dr. Brookstein. To my----
Senator Wicker.--cut down on----
Dr. Brookstein.--to my understanding, it was to protect
against mold. You mentioned, though----
Senator Wicker.--cut down on something you don't want.
Mold. It turns out----
Dr. Brookstein. Well, in shipping, yes. In shipping.
Senator Wicker. Right.
Dr. Brookstein. You mentioned the TRIS. There's another
concern I have about children's car seats, that they're putting
brominated flame retardants on them that are clearly
neurotoxins, things like that. There are no regulations
associated with that. We--I've done some testing on this. We've
done--we've put a lot of this material on children's car seats
to make them flame retardant, and I don't see where that's
necessary, and you're exposing children to really dangerous
items.
Senator Wicker. Thank you. Well, let me just say that I
share your concern, and I have a long history of trying to work
with the CPSC on this issue. Let's protect consumers from a
variety of hazards, including toxins, including fire injuries
and fire death, but let's don't, in the name of protecting
against fire, cause another hazard that we have to deal with.
So, thank you very much for your testimony.
Dr. Wakelyn. I'd like to----
Senator Wicker. Thank you, Mr. Chairman, for your
indulgence.
Dr. Wakelyn.--respond. Can I respond to that, please?
The TRIS situation was something that was only used on
synthetic fibers to prevent melt drip, and it was removed from
the test, so it's--it was banned and no longer used, but it was
never used on cotton and cellulosic materials.
The fire retardants that he says there are no regulations,
there are actually several States in the United States and also
the penta and octa version of those are not manufactured
anymore, and EPA has reviewed them. The deca version is not
really used in the United States in these products, and some of
these other brominated fire-retardants that are used in
backcoatings probably will not be used in the United States.
There are various States that have already banned them, and
because they're banned in certain States, the manufacturers, at
least in the United States, are not going to sell them here,
and in Europe they're still under review, whether they really
cause problems or not, and whether they break down. But, some
of these things are not being used anywhere. So, to suggest
that they're being used, and he finds bromine on a particular
compound, doesn't mean anything.
Now, this hearing doesn't deal with flame retardants and
flammability, but--and that should be part of another hearing--
but, we need to have accurate information presented if we're
going to talk about some of these issues.
Senator Pryor. Senator Casey?
Senator Casey. Mr. Chairman, thank you again for calling
this hearing. And I want to thank each of the witnesses before
us today.
I wanted to start with Dr. Etzel and to establish, for the
record, just a little bit about your background. You're a
board-certified pediatrician, is that correct?
Dr. Etzel. I am board certified in two specialties,
pediatrics as well as preventive medicine.
Senator Casey. Both. And also, you have a Ph.D. in
epidemiology, is that correct?
Dr. Etzel. That's correct.
Senator Casey. And I was struck by the beginning of your
testimony in the middle of page 3, where you say, in part--and
this is in the first full paragraph, and I'm quoting your
testimony--``Children may be more susceptible than adults to
the respiratory effects of formaldehyde. Even at fairly low
concentrations, formaldehyde can produce a rapid onset of nose
and throat irritation, causing cough, chest pain, shortness of
breath, and wheezing.'' And then you say, in the next sentence,
``At higher levels of exposure, can cause significant
inflammation of the lower respiratory tract, and--which may
result in swelling of the throat, inflammation of the windpipe,
and bronchial'' and it goes on from there.
I wanted to have you talk about that for a moment, because
there's some conflict here in our testimony. We've heard Dr.
Wakelyn. And I think we'd all agree on one thing, that we can
set aside discussion about the effects on adults, for purposes
of this point I'm making, but I think we're most concerned
about the impact this can have on children. And I'd ask you to
talk about that.
Dr. Etzel. Yes, thank you for that question. A lot of
people, in the past, used to consider children as just
miniature adults, but we pediatricians have tried to educate
the public that, in fact, children are not miniature adults and
that they breathe more, pound per pound, than an adult would.
And their risks are higher, because of their developmental
stage. We know that, at very low levels of exposure to
formaldehyde in the air, levels of .016 parts per million, they
can cough and have respiratory irritation, and as low as .05
parts per million they can develop asthma. And these are rates
that actually are quite low, and rates that children could
routinely be experiencing in the indoor environment.
Senator Casey. And I know that also in your testimony,
starting on page 5, you set forth a series of recommendations.
The first recommendation is that the Consumer Product Safety
Commission should limit formaldehyde residues in children's
clothing and other products, which I think is important to
repeat for the record, and that more research is needed on
formaldehyde and children's health. And then you go on to set
forth two other recommendations: that EPA should adopt
California's proposed restrictions on formaldehyde emissions
from wood products, and then, finally, the Consumer Product
Safety Commission should develop educational materials for
consumers about formaldehyde.
I wanted to ask you about some of the references in the
Committee materials, where there are a series of references to
both--let me just get this; I have it here. Oh, here it is. If
you can speak to the National Cancer Institute reporting that
several studies indicate that embalmers and anatomist
professionals who are potentially exposed to formaldehyde have
increased risk of developing leukemia and brain cancer,
juxtaposed to the general public. And also, the reference in
several studies to the fact that this is a known carcinogen, if
you can speak to either of those.
Dr. Etzel. The levels of exposure for embalmers, for
example, are extremely high, and it's well known that this is
an occupational risk of being employed in the embalming
industry. Based on data from occupational cohorts like this, in
many other occupations, as well, the International Agency for
Research on Cancer looked at updated data, prior to the data
that Dr. Wakelyn talked about, and found that there was lots of
evidence that humans exposed to these occupational levels of
formaldehyde were at risk of developing cancer.
And based on this, we also know that there's probably no
safe level of exposure to this occupational carcinogen. And
because of that, we set more restrictions now, since the IARC
came out with that, than we did prior.
Senator Casey. I know--I'll get to your colleagues, maybe
in a second round, but I know Senator Klobuchar is----
Dr. Wakelyn. Can I respond to some of that? Basically----
Senator Casey. Why don't we do this--why don't we do it in
the next round so we don't----
Dr. Wakelyn. Well, no, but I wanted to put on the record--
--
Senator Casey.--interfere on----
Dr. Wakelyn.--what you were asking her about, respiratory
diseases. That's an airborne exposure, that's not a surface
treatment----
Senator Casey. Right.
Dr. Wakelyn.--from a textile. It's an entirely different
situation. I mean, you were suggesting that I had testified to
certain things that you possibly didn't agree with, and that--
--
Senator Casey. I wasn't suggesting anything about what you
testified to, I was making reference to the testimony.
Dr. Wakelyn. But, if we're going to talk about the
toxicology, IARC report is out, they have done this. National
Cancer is doing a report now. So, if you want to get into
toxicology, you need to get toxicologists here, and we
certainly can give you further details on the toxicology if you
would like answers to those questions.
Senator Casey. Well, we'll go back to that when our time
is----
Senator Pryor. Senator Klobuchar?

STATEMENT OF HON. AMY KLOBUCHAR,
U.S. SENATOR FROM MINNESOTA

Senator Klobuchar. Thank you so much, Mr. Chairman. Thank
you for holding this hearing.
Thank you, Senator Casey, for appearing before our
committee and helping to raise awareness of this issue.
I was very involved in the Consumer Product Safety Act, as
was Senator Pryor, and I know that an amendment to that Act was
championed by Senator Casey and Senator Clinton--to make sure
that more research needs to be done on the long-term effects of
formaldehyde exposure. I also know that the GAO should release
a study next year on this.
Could all three of you say what the status of the studies
here is? It seems that there's some major disagreement. I would
think it would be helpful to get this study, as the CPSC really
hasn't looked at this, from what I understand, for many years.
Dr. Brookstein?
Dr. Brookstein. Senator Klobuchar, I'm under the
understanding, too, the study hasn't been started at all yet.
And, you know, my whole thesis is, every country's looking at
this, we're not. A study has been legislated, and it's not
being done. And that's the bottom line. Let's not be afraid of
what the information's going to be; let's get information and
then we can make decisions based on good, firm, up-to-date
science.
Senator Klobuchar. Dr. Wakelyn?
Dr. Wakelyn. I agree with that, that the GAO study has not
started, and I've checked on it very recently, but it will be
starting soon. And CPSC will be working with the Government
Accountability Office in doing this particular study.
And yes, I agree with Dr. Brookstein, that, rather than
already assuming that there is a major problem that needs a
regulation, as some people have testified to here, we should
wait--we should await this particular study with regard to
formaldehyde in textiles, which is what the study is--it's not
about airborne levels and other effects--it's about
formaldehyde in textiles, and whether there is a problem that
is an unreasonable risk that requires either a fabric-level or
an airborne-level standard from this. And I think that both the
Consumer Product Safety Commission, with their excellent
staff--people may not like some of their commissioners, but
they have never been critical of the technical staff that they
have there, both in health sciences, which are very good, and
they have done outstanding work over the years.
Senator Klobuchar. Thank you. And I think one of the issues
is, they need more commissioners. So.
Dr. Etzel?
Dr. Wakelyn. Oh, I'll agree with you, they need a----
Senator Klobuchar. I'm glad. We're in so much----
Dr. Wakelyn.--third commissioner----
Senator Klobuchar.--agreement, here. This is great.
[Laughter.]
Senator Klobuchar. Dr. Etzel?
Dr. Etzel. The American Academy of Pediatrics touched base
yesterday with the individual at GAO who will be responsible
for conducting the study. He's well aware that he needs to
begin it, and plans to begin it soon. And we look forward to
the results.
Senator Klobuchar. And do you think, Dr. Etzel, just your
perspective on this, that most pediatricians are aware of what
you see as a risk from formaldehyde?
Dr. Etzel. Most pediatricians are well aware of the risks
of formaldehyde. What they aren't aware of is the fact that
formaldehyde is in far more products than most people realize.
And if pediatricians were aware of all these products, they
would probably begin to tell their patients about it. But, the
fact is that that is not common knowledge.
Senator Klobuchar. Dr. Wakelyn, I was just listening----
Dr. Wakelyn. Yes.
Senator Klobuchar.--to your testimony, and, as we've
discussed here, Japan, Germany, France, and a number of other
countries have adopted some different standards for clothing
and textiles. What has been the impact of those standards on
the industry as a whole?
Dr. Wakelyn. Well, some of these, you see, are extremely
high, and just about every standard that's there, U.S. textiles
currently meet. So, what it is, is they're--because various
retailers, various companies, have been requiring these things
for years, they're essentially meeting these standards if
they're importing into those countries, and they have been for
years. And what's coming into the United States, my
understanding is, from the testing I've seen now, they're--
you're correct, I haven't seen any detailed testing, maybe for
10 years in this area, but, if anything, the technology is
better now than it was 10 years ago, and, at that time, they
were very, very low levels.
Senator Klobuchar. OK. And do you agree that the products
coming in would meet--or, the products that we produce in our
country would meet some of these standards? Do you have any----
Dr. Brookstein. I would like to say----
Senator Klobuchar.--information that they wouldn't?
Dr. Brookstein. I would like to answer that, and it's also
related to this question about airborne. We have someone in the
room here today--Mr. Mark Burman--who testified at the U.S.
House of Representatives about very high levels of formaldehyde
that he found in imported draperies. Now, I don't know if that
vaporizes or not, but----
Senator Klobuchar. No, I--and I was just trying to get at
this one point, and I----
Dr. Brookstein. Well----
Senator Klobuchar.--would love, if I had more time----
Dr. Brookstein. OK, all right.
Senator Klobuchar.--to get into it, but I--just this point
that we're producing textiles--and Dr. Wakelyn was saying that
these standards in other countries, which was my question----
Dr. Brookstein. Well----
Senator Klobuchar. Do our textiles meet those standards?
Dr. Brookstein. Most of the textiles that we wear and use
in the United States they are not produced in the United
States--overwhelmingly, over 90 percent are imported.
Senator Klobuchar. OK.
Dr. Brookstein. OK?
Senator Klobuchar. But, the ones that we do produce, do
they meet those standards?
Dr. Brookstein. I don't know. That's part of----
Senator Klobuchar.--know? Maybe we don't----
Dr. Brookstein. That's part of what we would like to study
as part of the----
Senator Klobuchar. And so, then your other concern is the
ones coming in from foreign countries, and that we would have a
standard. Is that----
Dr. Brookstein. That is my concern.
Senator Klobuchar. OK.
Dr. Wakelyn. Let me----
Senator Klobuchar. Dr. Wakelyn?
Dr. Wakelyn.--respond further. One of the things that was
raised earlier is products from China, and that's why the toys
and food and various things were raised issues and, ``Oh, why
didn't we raise this with regard to Chinese textiles?'' And
then, it was mentioned about the New Zealand television
program. And, by the way, after the New--the country of New
Zealand did their tests on 99 fabrics, the television station
had to pay a $4,000 fine, and the Government of New Zealand
apologized to China. But, 84 percent of those fabrics were
Chinese, and they found no problems with the Chinese fabrics.
So--and China has one of the lowest levels, as you can see,
on this. So, you may have problems with other things from
China; I'm not going to discuss that now. But, with regard to
the testing that was done in 2007 and 2008 on almost 100
Chinese fabrics, there was not a problem.
Senator Klobuchar. Well, we're looking forward to the GAO
study and trying to get to the bottom of this so we do
everything we can to protect kids. And I thank you all for your
testimony.
Senator Pryor. Thank you, Senator Klobuchar.
We're going to have a second round, here. For everybody's
notice, the Senate is scheduled to have a vote, about noon,
which is 16 or 17 minutes from now, so I'll ask a few questions
and then I'll turn it over to Senator Wicker.
Let me ask this, if I may, of you, Dr. Wakelyn. Did the
majority of companies that manufacture textiles, apparel, baby
furniture, et cetera acknowledge that formaldehyde is a health
risk?
Dr. Wakelyn. Oh, certainly. That's one reason why the
levels are so low, and the levels are below level--that are
known to cause any skin irritation. In fact, they're
published--Maibach & Hatch, since the early/middle 1980s, have
done tremendous amount of research, they've written I don't
know how many review articles. They've written a book in the--
around 2005 on--talking about allergic contact dermatitis with
regard to textiles and all of this. And they point out--they
point out several things, that the level is where, even a
sensitized person or a sensitive person, an allergic person,
does not have a problem at 300 micrograms per gram of fabric
level. And that's on the AATCC test, so that would be about 75
ppm on this particular test here. OK?
Senator Pryor. Let me interrupt there, because our time is
short. You've said, a few times in the hearing, that this
hearing is limited. This hearing is really not limited. The
Consumer Product Safety Commission has a broad range of product
types that they oversee, about 15,000 total, and we're not
trying to limit this hearing to one category.
Earlier today, I asked you about whether there are other
things that can be added to cotton fabrics that will make them
wrinkle-free, and you said that there are some, they're more
expensive, they have an issue with color, the dyes in the
fabric. But, what about for the other uses of formaldehyde or--
in products like furniture and other textiles, generally--are
there replacement chemicals that we know are safe in other
areas besides just clothing?
Dr. Wakelyn. Well, in furniture, it's not the textiles that
are of any concern, it's the pressed-wood products. And the--I
can't speak for the wood products industry, but I have been
involved with some of them over the years, and the formaldehyde
issue, and they have done a tremendous amount of work. There
are resins that they can use. Senator Wicker mentioned some of
the work that they were doing with soy proteins and other
adhesives. And some of these show great promise.
You have to remember that the reason why the formaldehyde-
containing resins are used in wood products, and that is that
they serve a function that is difficult to replace. But--so, I
can't really talk for the wood products, other than that I know
there's a lot of research and a lot of good products.
With regard to textiles, this research continues, but the
biggest research that was done, along with looking at
nonformaldehyde-containing finishes, which were certain types
of acids that are used--I don't want to get arcane on getting
into the chemistry--but, a lot of things dealing with
scavengers and after-treatments that keep the level very, very
low, either well below--either nondetectable or at very low
levels. And then, after a garment is--if you use Clorox 2, it's
known to neutralize it. If, after a simple commercial wash, as
the New Zealanders found, you've lowered it to almost a
nondetect or a very low level that's below the level that is
published that these things would cause a problem.
I also might say that it's not even sure that, in
formaldehyde-containing resin treatments of textiles, that it's
even the formaldehyde that's causing the problem, with various
studies. And I have a paper in my--referenced in my testimony
that discusses that.
Senator Pryor. Right.
Senator Wicker?
Senator Wicker. Two quick things, I hope. Mr. Chairman, I
ask unanimous consent that Dr. Brookstein be allowed to enter
into the record the result of the test that he's going to
conduct on his shirt.
[Laughter.]
Senator Pryor. Without objection.
Dr. Brookstein. OK, that means I have to do it now.
[Laughter.]
Dr. Brookstein. I will get that to you.
[The information referred to follows:]

School of Engineering & Textiles--Philadelphia University
Philadelphia, PA, May 19, 2009
Hon. Roger Wicker,
U.S. Senate,
Washington, DC.

Re: Request to Test Formaldehyde Level in Shirt I wore at U.S. Senate
Subcommittee hearing on Consumer Protection, Product Safety and
Insurance hearing on April 28, 2009

Dear Senator Wicker;

During the hearing of the U.S. Senate Subcommittee on Consumer
Protection, Product Safety and Insurance, on April 28, 2009, you asked
me if I had tested the newly purchased, unwashed shirt that I was
wearing that day. I responded in the negative and you then asked me to
test it for formaldehyde content.
Responsive to the subject request I tested an exemplar shirt
identical to the one I wore at the Senate Subcommittee hearing. Using
our standard and internationally recognized laboratory procedure (EN
ISO 14184-1) I found a level of 32 ppm of free formaldehyde in the
shirt. The shirt was made from 100 percent cotton and was produced in
China.
While I testified that the U.S. does not currently have allowable
formaldehyde level for clothing and textiles, this value of 32 ppm is
above what is considered the ``detectable levels'' in other countries.
Please feel free to contract me if you require additional
information.
Sincerely,
David Brookstein, Sc.D.,
Dean and Professor.

Senator Wicker. Great, thank you.
And it seems that the essence of the disagreement among
these three witnesses is that Dr. Brookstein and Dr. Etzel
believe more research is necessary, and Dr. Wakelyn's view is
that valid, conclusive tests have already been done that have
provided us with the information we need. So, let me just--this
is my one question, to Dr. Etzel and Dr. Brookstein. Are you
familiar with the CPSC and EPA tests at Oak Ridge in the 1980s?
And why do you feel they're not conclusive or adequate?
Dr. Etzel. I would say one of the issues is that many of
the products that infants and children are exposed to today
didn't even exist in the 1980s, and therefore couldn't be
tested. We're talking about an array of different things, from
baby shampoos to things that get applied to babies' skin to the
kinds of apparel that their parents might wear that the baby
would be exposed to by being on the dad's lap or on the dad's
shoulder. So, circumstances have changed considerably since the
1980s, and to use data that's so outdated to make a decision
about products today seems ill-advised.
Senator Wicker. Is that your view, Dr. Brookstein?
Dr. Brookstein. Yes. And there's a major difference in the
market. In the 1980s, the vast majority of the clothing and the
textile products that we used as consumers were made in the
United States, and there were very strict environmental rules
that prohibited the use of these materials. Today, the vast
majority of what we wear and use as draperies and furniture is
imported, so it's a totally different situation now.
We don't--we can't be sure what's coming in meets any kind
of considered standards such as that, so it's a--it's a totally
different marketplace.
I'm not questioning if the scientific evidence in the 1980s
was good or bad. I'm sure it was very good. The question is--
it's a different marketplace today. We distribute differently
today. We get materials differently today. We have to look at
these. And then, of course, there are different items, as Dr.
Etzel has talked about.
Senator Wicker. And, Dr. Wakelyn, would----
Dr. Wakelyn. Yes, I would like to clarify what you said in
my remarks. My remarks are dealing with formaldehyde in
textiles. I do not think formaldehyde in the textiles that are
sold in the United States present any sort of problem and are
below levels of any kind of concern. But, I did--am not
testifying on, because I have not looked at every consumer
product out there, that a child can be exposed to. But, with
regard to textiles and the textiles that children wear, I think
that there's adequate--more than adequate data to--and I'm sure
GAO will find that in their particular study--to say that there
is not a problem that needs a standard with formaldehyde in
textiles in the United States. But, any other consumer
products, that I can't testify to.
Senator Wicker. Thank you very much.
Senator Pryor. Senator Casey?
Senator Casey. Thank you very much.
Dr. Brookstein, I wanted to go back to your
recommendations, which are set forth on page 4 of your written
statement. One that we haven't talked about, and I think it
bears some attention, is number 4, your recommendation that a
testing program be set up by an independent lab. Can you talk
about that for a moment?
Dr. Brookstein. Yes, I can. In any issue, there are going
to be many different stakeholders that are going to want to
advance their particular thinking. And that's understandable. I
think it's important that we have an organization that can look
at this from an unbiased academic viewpoint and do what we
call, in academics, good science, where there's no one looking
over us with any kind of vested interest. We're there as
scientists, just trying to get the facts and know what the data
is--are.
Senator Casey. In terms of the GAO study, obviously we want
to have that done as soon as possible, and--I don't know if
you're about to say something----
Dr. Brookstein. You know, when I go to the Port of Newark
and I see those containers of materials coming in, and I go to
the Port of Los Angeles and I see those containers coming in, I
would like to know what's in those containers with regard to
textiles, as soon as possible.
Senator Casey. And Dr. Wakelyn, I know that, in your
testimony, in the first paragraph, you say, in part, ``There's
no need''--I'm quoting here--``There's no need for legislative
or regulatory action concerning formaldehyde in textiles,
unless the results of the GAO study indicate such action is
necessary.'' Now, a moment ago, you said--I want to make sure I
understand what you said--that you're limiting what I'll call a
``no action'' recommendation or point of view to formaldehyde,
textiles, and children, or is it more expansive than that?
Dr. Wakelyn. It's formaldehyde in textiles. I do not
think--and I agree with you that we need the GAO study, and we
need it done right away, because there seems to be, I think,
misunderstanding and confusion about nothing being done or the
Consumer Product Safety Commission hasn't done its due
diligence. They have many things on their plate, they have done
much work in this area, they--you would be very impressed with
their health scientists that they have there and the things
they've turned out. So, yes, I think the GAO study absolutely
needs to be done, and needs to be done quickly. But, my
statements deal with just formaldehyde in textiles.
Senator Casey. OK. Well, I think we can all agree on the
need for the GAO study. We may not agree on the following. I
don't understand why it's apparently such a big problem to have
the GAO--or, to have the Consumer Product Safety Commission do
at least one or more of the following:
Number one, update any research they've done in this area
from the 1980s. We're talking more than 20 years ago, now, or
right around 20 years ago.
Number two, it wouldn't have to be the Consumer Product
Safety Commission--there are others, as well but issue some
kind of guidance standards, even something that falls short of
regulations. Why, as important as the GAO study is--and I've
fought hard for this, and I believe it's important--but, why
should we say that all those other studies since the 1980s
which might conflict with or might raise questions about the
GAO--or, the CPSC findings in the 1980s--why should all those
other studies and press reports be completely dismissed and
say, ``We don't need to update from the 1980s, and we're just
going to wait for a GAO study''? I don't understand why they
can't do more. We're not asking them to do something which is
unreasonable, we're just saying to the Consumer Product Safety
Commission, ``Don't wait for GAO; update your research, give
some guidance, set forth some basic standards that might even
not rise to the level of regulation.'' What do you say to that?
Dr. Wakelyn. Oh, no, I--they have a--for strong
sensitizers, they have a standard under Federal Hazardous
Substances Act. But, no, they----
Senator Casey. Say that again. I didn't understand----
Dr. Wakelyn.--update--under the Federal Hazardous
Substances----
Senator Casey. Right.
Dr. Wakelyn.--Act, they have, for strong sensitizers, and
they--under the Federal Hazardous Substances Act, they did ban
urea-formaldehyde insulation, because they thought that was a
problem back in the 1980s.
Now, they could update these studies. These studies are
rather expensive, and if the Senate or Congress, in their
infinite wisdom, will provide the appropriate funds for CPSC to
do this, I'm sure they would be very pleased to do these
particular studies. At the same time, they sort of have their
hands filled with meeting the requirements of the Consumer
Product Safety Improvements Act, with the staff that they have
presently. So, if you can increase their staff, increase their
funds, and get them another commissioner, I think the Consumer
Product Safety Commission would be happy to undertake some of
these studies that you're talking about.
As far as issuing a guidance, sure, they could update that.
The document you referred to from 1997 actually was referring
to airborne levels and referring to an update of the urea-
formaldehyde insulation standard, and was not referring to
levels in textiles.
Senator Casey. I'm glad to hear that, but I----
Dr. Wakelyn. And you also mentioned one other thing about
the New Zealand study. You seemed to not have seen--I have two
news articles attached to my statement that--where the New
Zealand Government did testing after that, made the television
station pay a fine and apologize to the public and apologize to
the country of China, because the--what the television station
had done is not used the proper testing methods, and put out
scare tactics that were not accurate. And when they actually
tested products, they didn't find it.
So, no, I'm not saying that testing isn't out there and it
shouldn't be done; it should be done correctly if it's done----
Senator Casey. We're not hanging our hat on one New Zealand
study. OK? There are a lot of other studies and reports that
we're pointing to here.
Let me say, in conclusion, two things--one is, this
committee--I'm not a member, but I know something about what
this committee's been doing--has been trying to give the
Commission a lot more resources, a lot more help. I hope that
argument for more resources or more staff is bipartisan because
there has not been a lot of support in the last 8 years. OK,
that's number one.
Number two is, I really believe that any Federal Government
agency, like the Consumer Product Safety Commission, for
example, should err on the side of caution when it comes to
something which poses a danger, and, in particular, which poses
a danger to children. There may not be a consensus, conclusive
study, but when you have reports and when you have
epidemiologists and others raising questions about this, I
think they should err on the side of safety and issue some kind
of guidance or standards, which may not rise to the level of
new regulations, in addition to waiting for what the GAO
concludes.
Dr. Wakelyn. I agree with that, but I would also mention--
sure, they should put out guidance; they put out guidance on
all sorts of things, and I would imagine they will be doing
that, just like they're putting out one on lead in textiles and
lead in consumer products. They're putting together these types
of documents, and they are doing that.
Senator Casey. Well, in my judgment, they're not doing
enough. So, we'll keep after them.
Thanks very much.
Senator Pryor. Thank you. We have only another minute or
two before the vote starts, so, if I may, Dr. Etzel, let me ask
you a couple of very brief questions.
One is about Japan. Are you familiar with what they're
doing in Japan?
Dr. Etzel. I have some very basic familiarity.
Senator Pryor. OK. So, they have a national standard in
Japan, and what I was going to ask you is, Do you know whether
there is a study out there that would tell us whether the
incidence of exposure and the health issues related to
formaldehyde have gone down since Japan has done this? Do you
have any idea?
Dr. Etzel. It would be almost impossible to do such a
study, and the reason is that no country has surveillance for
the kinds of health effects that we would see. It isn't done in
the U.S., it isn't done in Japan or even in any European
country, and that's because these are nonspecific health
effects that cannot be attributed by any clinician directly to
a substance unless they do skin testing. Now, you could
probably find a dermatologist in Japan who could systematically
do skin testing and see if the skin tests are less likely to be
positive now, but that would be about the only thing. I don't
think you could get any evidence about the other respiratory
effects.
Senator Pryor. OK. And you are familiar with the California
law?
Dr. Etzel. Yes, sir.
Senator Pryor. And is it your opinion that we should apply
that California law as a national standard?
Dr. Etzel. Yes. We suggest that the EPA Administrator
consider applying it nationwide.
Dr. Wakelyn. Can I respond to that?
Senator Pryor. No.
Dr. Wakelyn. EPA has----
Senator Pryor. No. No.
Dr. Wakelyn. No, EPA has----
Senator Pryor. No, no, no.
Dr. Wakelyn.--proposed some----
Senator Pryor. No. You cannot respond to that, because
you've had twice the air time these two guys put together have
had. And I've tried to move you along, but--no, I'm talking to
Dr. Etzel.
Dr. Wakelyn. Well, I was just wanting to tell you that EPA
has already proposed something.
Senator Pryor. Dr. Etzel, let me ask you. Your view is, and
your association's view is, that we should apply the California
standard nationally. And is that because your primary concern
is exposure to children or to the general population?
Dr. Etzel. The concern of the American Academy of
Pediatrics is primarily for children, because of the reasons I
mentioned earlier, that their exposure to these things because
of their developmental stage is likely to be higher than that
of adults.
Senator Pryor. And is it across the board or is it just in
the fabrics? In other words, is it in the baby cribs, whatever
it may be, or is it just in the fabrics?
Dr. Etzel. The concern of the Academy is that children have
a cumulative exposure to many, many different products that
they encounter on perhaps a daily basis. It could be that they
are encountering a small amount in their crib sheet, and a
small amount in their shampoo, and a small amount from dad's
permanent-press shirt, and another small amount from dad's
permanent-press pants. And the cumulative effect of these and
other exposures can put them at risk for health effects.
Senator Pryor. OK. Do you have a concern that if, Japan
already has a standard, and if Europe may be going down the
track to having a standard, we don't know that for sure yet,
but assuming they are--do you have a concern that those
products that can't be sold in Japan, can't be sold in places
where there are bans, may be, in effect, dumped into the U.S.
market because we don't have a standard?
Dr. Etzel. To be honest, sir, I hadn't thought about that.
I suppose it's a possibility.
Senator Pryor. Dr. Brookstein, do you have anything on
that?
Dr. Brookstein. I can't opine on that.
Senator Pryor. Well, I think that, at this point, we have a
vote going on, on the floor, so what I will do here is, I will
keep the record open for 2 weeks, for 14 days, and we would
encourage our colleagues, including Senator Casey, who's not on
the Subcommittee, but who has been a very important part of
this--we would encourage them to get their questions in to us
as quickly as possible so we can get them to our panel and let
you answer those questions as quickly as you can.
This has been very helpful to us. We know that formaldehyde
is a substance that exists in nature, and we also know that
formaldehyde is a chemical that's added to many, many products,
and I think it's important for the United States to have a good
handle on what the exposure of formaldehyde does and what the
levels would be under the proper circumstances. So, thank you
all, all three of the panelists, for helping us today to take
one step in this process, and we appreciate your testimony very
much.
Thank you.
[Whereupon, at 12:04 p.m., the hearing was adjourned.]

A P P E N D I X

Response to Written Questions Submitted by Hon. Tom Udall to
Dr. Ruth A. Etzel

Question. I would appreciate hearing the panelists' views on
warning labels.
The Australian Competition and Consumer Commission, which is
similar to the U.S. CPSC, encourages textile and apparel makers to
label articles of clothing with a ``wash before first use''
recommendation--since washing should significantly reduce the level of
any residual formaldehyde. Is this a policy response that the
forthcoming GAO study will consider? Based on what is already known
today, do you recommend that textiles and apparel sold in the U.S. have
a ``wash before wearing'' label?
Answer. At this time, the AAP has no knowledge of whether the
Government Accountability Office will examine this issue as part of its
forthcoming study on formaldehyde. We hope to be consulted during the
development of the report and look forward to reviewing the final
product.
The U.S. Federal Trade Commission (FTC) sets Federal guidelines
about how and when clothing must be labeled with regard to fiber
content, washing instructions, and the like. There are currently no
specific guidelines about when or whether clothing should or must be
labeled "wash before wearing." In my personal experience, however, many
parents disregard the "wash before wearing" labels because they do not
understand why they should do so. It would be useful for the FTC or
CPSC to study whether such a label is warranted, and how it could be
improved to ensure that parents follow its recommendation.
______

Response to Written Questions Submitted by Hon. Tom Udall to
Dr. David Brookstein

Question 1a. Based on what is already known today, do you recommend
that textiles and apparel sold in the U.S. have a ``wash before
wearing'' label?
Answer. Based on the practices of other countries and the potential
health and safety risks associated with the use of formaldehyde in
textiles and apparel that the U.S. should have ``wash before wearing''
or the like on apparel sold in the US. Unfortunately though, there are
apparel and other consumer textile items that cannot be washed prior to
first use.
______

Response to Written Questions Submitted by Hon. Tom Udall to
Dr. Phillip Wakelyn

Question 1. I would appreciate hearing the panelists' views on
warning labels.
The Australian Competition and Consumer Commission, which is
similar to the U.S. CPSC, encourages textile and apparel makers to
label articles of clothing with a ``wash before first use''
recommendation--since washing should significantly reduce the level of
any residual formaldehyde. Is this a policy response that the
forthcoming GAO study will consider?
Answer. No, I do not view this as necessary. The incidence of the
use of formaldehyde-containing resins in textiles is very low. The CPSC
has not received valid complaints concerning formaldehyde in textiles
in the U.S. Skin irritation reactions due to chemicals on or in
commercial apparel are extremely rare and there have been no valid
safety problems raised in the U.S. concerning the low levels of
formaldehyde on clothing and textiles that have been treated with
formaldehyde containing resins. And CPSC has already done extensive
testing concerning formaldehyde and textiles.
The purpose of the GAO study mandated in the CPSIA is for GAO to do
an independent, scientific review of the available data concerning the
risk to the public of formaldehyde and textiles. The results of the GAO
risk determination should dictate whether GAO needs to consider `policy
response' options. The inclusion of a ``wash before first use''
recommendation as an option for consideration before the GAO has
evaluated risk to the public from formaldehyde and textiles would
suggest a congressionally expected outcome to the GAO study.

Question 1a. Based on what is already known today, do you recommend
that textiles and apparel sold in the U.S. have a ``wash before
wearing'' label?
Answer. No, a ``wash before wearing'' label is not necessary for
the following reasons:

1. Skin irritation reactions /contact dermatitis due to
chemicals on or in commercial apparel are extremely rare.

2. There have been no valid safety problems raised in the U.S.
concerning the low levels of formaldehyde on clothing and
textiles that have been treated with formaldehyde containing
resins.

3. There are many causes for skin irritation other than
chemical additives to textiles.

4. There are claims of skin irritation that are incorrectly
blamed on formaldehyde--where the textile was not treated with
formaldehyde-containing chemicals, does not contain
formaldehyde by valid testing, and the person alleging that
formaldehyde caused their skin irritation problem is not
allergic to formaldehyde.

5. Easy care/wrinkle resist cotton apparel accounts for only 2
percent of the total apparel offerings at retail and for only
13 percent of total cotton apparel purchased in 2008. And there
is almost no easy care children's apparel and almost no
children's wear is treated with formaldehyde containing
chemicals of any kind.

The CPSC, which is data driven, has not received valid complaints
concerning formaldehyde in textiles. There are no data that indicate
that formaldehyde in textiles in the U.S. presents an ``unreasonable
risk of injury to the public''. Labels already contain too much
information and can be confusing to consumers. Many people routinely
cut labels out of apparel.
The only two countries in the world that I am aware of that suggest
``wash before wearing'' labels for clothing are Germany and the
Netherlands.

Question 2. Dr. Wakelyn, you argue that industry studies and
voluntary standards ensure the consumer safety of clothing potentially
containing formaldehyde.
Yet the specific Japanese and ISO standards mentioned in your
remarks are test methods, not product specification standards which
limit formaldehyde content levels.
Answer. My testimony, oral statement, and responses to questions
did not say that these test methods (i.e., ISO 14184-1 and the Japanese
Law 112 Method) were `product' standards. I clearly indicated that they
were valid, acceptable test methods to determine formaldehyde levels in
textiles. Fabric levels are not the same as airborne levels and should
not be confused with airborne levels.
[Please see my written testimony.]

Question 2a. What is the current voluntary industry standard, if
any, for formaldehyde content in textiles and apparel?
Answer. For years the voluntary level has been 300 mg formaldehyde/
gram of fabric as measured by the AATCC Method 112 sealed jar test.
Although correlation between the AATCC 112 test and the two
international methods (i.e., ISO 14184-1/Japanese Law 112 Method are
essentially the same) is not perfect, results using AATCC Method 112
are about 4 times higher than that measured using ISO 14184-1/Japanese
Law 112 Method, i.e., the level would be about 75 mg formaldehyde/grams
of fabric using those international test methods and the same as the
international voluntary standard Oeko-Tex 100. Testing has shown that
the actual levels are less than half of that level. It was reported in
the published, peered reviewed literature in 1998 that the average
formaldehyde level contained by textiles made in the U.S. is
approximately 100-200 mg free formaldehyde/gram of fabric as measured
by the AATCC Method 112 sealed jar test (25-50 mg formaldehyde/g of
fabric or ppm measured by the Japanese Law 112 Method/ ISO 14184-1)
(Scheman et al., 1998). Below the standards for the few countries that
have standards are discussed (see below).

Question 2b. Is this standard developed and maintained by an ANSI-
accredited organization?
No, there is not an ANSI-accredited or ISO-accredited standard for
formaldehyde levels in textiles. However, there are valid, acceptable
test methods to determine formaldehyde levels in textiles that should
be used to determine fabric levels.

Question 2c. If compliance with this voluntary standard--or other
individual company requirement--ensures consumer safety, why should
such standards not be incorporated into a mandatory consumer rule for
textiles and apparel?
Answer. It is not necessary to have a mandatory standard for
formaldehyde in textiles in the U.S. Apparel products in the U.S.
marketplace today are safe. It is extremely rare to hear of an
irritation problem associated with fabric or clothing and the first
time the item is washed, by normal, simple washing procedures used in
the home, surface chemicals are eliminated, including formaldehyde-
containing resin surface residues. There have been no valid safety
related problems raised in the U.S. concerning the low levels of
formaldehyde on clothing and textiles that have been treated with
formaldehyde-containing resins. In addition, easy care/wrinkle resist
cotton apparel accounts for only 2 percent of the total apparel
offerings at retail. In addition, there is almost no easy care
children's apparel and almost no children's wear is treated with
formaldehyde containing chemicals of any kind.
To promulgate a mandatory standard, the Consumer Product Safety
Commission, which is data driven, has to be able to show that
formaldehyde in textiles in the U.S. presents an unreasonable risks of
injury to the public [CPSA, Sec. 2 (15 U.S.C. 5051) (b)]. The CPSC has
not received valid complaints concerning formaldehyde in textiles in
the U.S. and the evidence is strong that formaldehyde in textiles does
not pose an ``unreasonable risk of injury to consumers.'' CPSC
thoroughly studied this issue when there was concern about formaldehyde
on or released from consumer products in the 1980s. In 1982, after
thorough review, CPSC banned the sale of urea formaldehyde foam
insulation (UFFI) for use in residences and schools based on
unreasonable risk to consumers from the irritation and sensitized
effects of formaldehyde emitted by UFFI. During this same period, CPSC
studies the risk from formaldehyde and textiles. But after extensive
research (see CPSC Briefing Package on formaldehyde and textiles,
``Status Report on the Formaldehyde in Textiles Portion of Dyes and
Finishes Project'' [Sandra Eberle (to Peter Pruess and others), 1/3/84]
p.4) determined that the evidence does not indicate that formaldehyde
exposure from resin-treated textiles is likely to present an
unreasonable risk to the public that requires any action.
A mandatory standard would require all textiles to be tested
unnecessarily. A mandatory standard would clearly pose a costly,
unnecessary burden on the textile and apparel industries through
testing and record keeping plus all the requirements that would come in
under the CPSIA (e.g., certificate of conformity and tracking label
requirements) as well as increasing the cost to the consumer.
Modern innovations through the use of derivates and scavengers and
other low-emitting resin technology (Wakelyn, et al. 2007) keep the
levels below 100-200 mg/g or ppm (as measured by AATCC 112 Method used
in the U.S.; 25-50 ppm measured by the Japanese Law 112 Method/ ISO
14184-1). This technology includes proper choice of agent and using
optimum preparation and curing conditions. Industry buys chemical
formulations marketed as ultra-low formaldehyde resins (N-methylol
agents plus alkyl compounds).
Only eight counties in the world have formaldehyde requirements for
textiles ranging from 1500 ppm (in Germany, measured by the Japanese
Law 112 Method/ISO 14184-1; 6000 ppm by the AATCC 112 test used in the
U.S.) to 75 ppm (in Japan measured by the Japanese Law 112 Method; 300
ppm by the AATCC 112 test used in the U.S.) for textiles that contact
the skin. The other countries are 100-120 mg/g or ppm (measured by the
Japanese Law 112 Method/ISO 14184-1; 400-480 ppm by the AATCC 112 test
used in the U.S.). Discussion in the ``Proposed Government Product
Safety Policy Statement on Acceptable Limits of Formaldehyde in
Clothing and other Textiles'' (p. 3) by the New Zealand government
[http://www.consumeraffairs.govt.nz/policylawresearch/product-safety-
law/proposed-statement/proposed-policy-statement.pdf ] gives a summary
of International formaldehyde limits for clothing and other textiles.
Requirements in some countries are essentially `non-tariff trade
barriers' since they are only enforced on imported textiles.
______

May 12, 2009
Hon. Mark L. Pryor,
Chairman,
Senate Subcommittee on Consumer Protection, Product Safety, and
Insurance,
Committee on Commerce, Science, and Transportation,
Washington, DC.

Hon. Roger F. Wicker,
Ranking Member,
Senate Subcommittee on Consumer Protection, Product Safety, and
Insurance,
Committee on Commerce, Science, and Transportation,
Washington, DC.

Dear Chairman Pryor and Ranking Member Wicker:

The Formaldehyde Council, Inc. (FCI) submits these comments in
response to the April 28, 2009, ``Formaldehyde in Textiles and Consumer
Products'' hearing before the Subcommittee on Consumer Protection,
Product Safety, and Insurance of the Senate Commerce, Science, and
Transportation Committee. FCI is a trade association of the leading
producers and users of formaldehyde that is dedicated to promoting the
responsible use and benefits of formaldehyde and ensuring its accurate
scientific evaluation. We are writing to provide additional information
not reflected in the Senate hearing testimony.

FCI fully supports the testimony of Dr. Phillip J. Wakelyn
of Wakelyn Associates, and we do not repeat his observations
and conclusions here. Our comments therefore primarily address
respiratory health factors associated with exposure to
formaldehyde.

The testimony presented to the Subcommittee regarding the
effects of formaldehyde as a cause of asthma or an agent that
exacerbates asthma was misleading. Frankly, the scientific
literature on the issue provides answers contrary to those
presented at the hearing.

Dr. Ruth A. Etzel's testimony regarding the potential
respiratory effects of formaldehyde on children was not based
on a thorough review of the literature on formaldehyde. While
her general observations on childhood exposure scenarios and
physiology may be sound, these general observations were
misapplied or misleading with regard to formaldehyde. Dr Etzel
incorrectly summarized the scientific literature, as they did
not find ``higher rates of asthma, chronic bronchitis, and
allergies in children exposed to elevated levels of
formaldehyde'' as Dr. Etzel proclaimed.\1\
---------------------------------------------------------------------------
\1\ Dr. Etzel cited to Wantke, F. et al 1996; Garrett, M. H. et al
1999; and Rumchev, K. B., et al 2002.

Formaldehyde is a normal intermediary metabolite and a
---------------------------------------------------------------------------
natural component of exhaled human breath.

Formaldehyde is a well-researched chemical, with a rich literature
of human, animal and other studies. Some of these studies involved the
intentional exposure of human volunteers in exposure chambers for
relatively short periods of time to precisely measured amounts of
formaldehyde in the air. This enabled researchers to assess the levels
at which symptoms are produced or not produced. When discussing the
potential irritant effects of formaldehyde, it is critical to remember
that formaldehyde is naturally produced by all living organisms,
including humans, with measurable levels always present in the blood.
Because of its presence in the blood, known amounts of formaldehyde are
also emitted in the breath quite independently of what might be in the
external environment. Formaldehyde does not accumulate either in the
environment or the human body since the body's ability to metabolize
(i.e., breakdown) formaldehyde is so efficient that when humans (or
monkeys or rats) are exposed to formaldehyde no increase in normal
blood levels of formaldehyde can be detected.

Formaldehyde and Asthma
Asthma, particularly in children, is often mentioned as an endpoint
of concern with respect to either being caused by or exacerbated by the
irritant properties of formaldehyde. With all due respect, however, the
scientific literature and a number of expert reviews demonstrate that
people with asthma are no more sensitive to formaldehyde than non-
asthmatics. The weight of the scientific evidence supports a lack of
association between formaldehyde exposure and asthma induction or
exacerbation.\2\
---------------------------------------------------------------------------
\2\ See, e.g., IOM (2000); Franklin, et al. (2000); and Garrett, et
al. (1999).
---------------------------------------------------------------------------
Discussion of Specific Studies
The following studies were cited to the Subcommittee, and the FCI
feels that the context of the studies and the findings need to be
better described.
1. Wantke et al. (1996)
Wantke et al. (1996) studied 62 students in Austria and reported
finding IgE specific to formaldehyde.\3\ However, among the 24 of the
62 children who had elevated IgE specific to formaldehyde, only 3 had
RAST scores over 2.0.\4\ There was no dose-response relationship
between formaldehyde levels and RAST scores. The three classrooms
studied had 43, 69 and 75 ppb of formaldehyde measured, respectively.
RAST scores were not elevated at 69 ppb compared to the 43 ppb
classroom, as shown below.
---------------------------------------------------------------------------
\3\ IgE refers to Immunoglobulin E, a class of immunoglobulins that
includes the antibodies elicited by an allergic substance (allergen). A
person who has an allergy usually has elevated blood levels of IgE. The
E in IgE stands for erythema (redness).
\4\ RAST stands for RadioAllergoSorbent Test. A sample of blood is
mixed with substances known to trigger allergies. The test measures the
level of allergy antibodies (specific IgE antibodies) in the blood
which are present if there is a allergic reaction.

----------------------------------------------------------------------------------------------------------------
75 ppb (n=22) 69 ppb (n=22) 43 ppb (n=18)
----------------------------------------------------------------------------------------------------------------
RAST over 2.0 2 0 1
RAST 1.3-1.9 10 6 5
RAST 1.0-1.2 10 16 12
----------------------------------------------------------------------------------------------------------------

Thus, there does not appear to be dose-response relationship
between formaldehyde and IgE. Moreover, the IgE levels in the study did
not correlate with either number or severity of reported symptoms. The
authors acknowledge that ``IgE-mediated sensitization to formaldehyde
is rare and a matter of controversy.'' They further state: ``Our data
as well as the literature [ref. omitted] do not conclusively explain
the clinical relevance of specific IgE against formaldehyde.'' The
Wantke et al. Study did not compare children and adults, and thus also
does not speak to any differential sensitivity.
2. Garrett et al. (1999)
Contrary to what was presented to the Subcommittee, Garrett et al.
(1999), found ``no evidence of an association between asthma in the
children and formaldehyde levels.'' This conclusion was founded on a
study of asthmatic and non-asthmatic children in two small towns in
Victoria, Australia. The paper does not address differences in adult
and children's responses because relevant data for adults were not
collected. It does characterize the Wantke et al. (1996) study
relevance as ``unclear'' because the sensitization was not associated
with symptoms.
In full candor, several factors compel caution in relying on this
study:

The paper likely was based on a graduate student thesis (the
acknowledgements note a postgraduate publication award), and
the paper presents extensive multi-variate analysis. Of all the
analyses performed, the study notes:

a crude odds ratio for atopy of about 1.4 with an increase in
bedroom levels of formaldehyde of 10 mg/m\3\ (adjusted for
parental asthma and sex); however, the confidence interval for
this finding is 0.99--2.00; and an adjusted odds ratio of 1.42
for atopy with an increase in the highest recorded formaldehyde
level by 20 mg/m\3\ (confidence interval 0.99-2.04). (As the
majority of scientists and researchers recognize, odds ratios
of 1.4 are generally not considered to be strong evidence of a
causal connection.)

The study took place in two small towns ``surrounded by
open-cut brown coal mines and power stations, which provide
considerable employment.'' The authors had difficulty locating
nonasthmatic children to participate in the study. Outdoor
measurements were taken but not reported.

The authors note there was no significant association
between formaldehyde levels and house age. This is surprising,
since any off gassing of formaldehyde from wood products or
other formaldehyde-containing materials would be expected to
decline over time. Thus, the accuracy of formaldehyde
measurements could be open to question.

In discussing the implications of their findings, Garrett et
al. Note the increased prevalence of allergic diseases in many
Western countries, and suggest that materials emitting
formaldehyde have become increasingly popular at the same time.
The authors apparently do not appreciate that formaldehyde
resin technologies have been improved substantially over the
last two decades, and that releases of formaldehyde have been
greatly reduced.

It is difficult to rule out systematic recall or selection
bias in this case-control study. With respect to exposure
issues, no personal monitors were used, and there were no
associations or trends for levels reported for the bedrooms,
which are the one place in the house where some form of
continuous exposure is likely to occur.

The distribution of results claimed by the investigators
hardly seems to be persuasive evidence of a systematic health
risk. There was no significant increase in the adjusted risk
for either asthma or respiratory symptoms with increasing
formaldehyde exposure.

3. Rumchev et al. (2002) and (2004)
In Rumchev, et al. (2002), household formaldehyde levels were
determined by passive sampling in the homes of 88 children aged 6
months to 3 years who were diagnosed at a hospital with asthma, and
compared with 104 community controls. Cases had a statistically
significant higher mean formaldehyde exposure compared to controls, 32
ppb (38 mg/m\3\) and 20 ppb (24 mpg/m\3\), respectively. After
adjustment for confounding factors, such as indoor air pollutants,
relative humidity, indoor temperature, atopy, family history of asthma,
age, sex socioeconomic status, pets and environmental tobacco smoke,
Rumchev et al. (2002) reported that children exposed to formaldehyde
levels of 60 mpg/m\3\ had a 39 percent increase in odds of having
asthma compared to children exposed to less than 10 mpg/m\3\ (or
estimated to be approximately 1.4 95 percent CI 1.1-1.7 from data
presented in a graph). However, considering the marginally increased
risk observed, together with the number of potential sources of bias,
such as selection bias and validity of diagnosis in the young, this
study should not be considered sufficiently robust evidence of an
association between formaldehyde exposure and increased risk of asthma
in children or an appropriate basis for regulation or governmental
guidance.
In addition, as noted previously, formaldehyde is exhaled in the
breath, with studies suggesting that breath levels may range from 1.2-
72.7 ppb to 300-1,200 ppb (Moser et al. 2005; Ebeler et al. 1997).
Based on the existing literature, the exposure levels reported in
Rumchev et al. (2002) are in the range of formaldehyde expected to be
found in exhaled breath. This raises the questions of causation,
association, and how one might reasonably differentiate self-exposure
from an exogenous source of exposure at approximately the same
concentration.
Those limitations and weaknesses are validated by a second report
by Rumchev, et al. (2004), which raises questions regarding whether
Rumchev (2002) is an adequate basis for the derivation of a reference
concentration specifically for formaldehyde. Rumchev, et al. (2004)
used the same cohort of children and evaluated the same asthma endpoint
as Rumchev, et al. (2002), but focused on the association with the
other chemicals and particulates rather than formaldehyde. As for
formaldehyde, Rumchev, et al. (2004), found that asthmatic cases were
exposed to higher levels of volatile organic compounds (VOCs).
An editorial was published concurrently (Brunekreef, B. 2004) with
Rumchev et al. (2004), which focused on nitrogen dioxide
(NO2), VOCs, and particulates. The editorial indicates that
(1) diagnosis of asthma in children is ``notoriously difficult,'' and
(2) case-control studies, as used by Rumchev, inherently are rife with
potential and actual sources of confounding and bias. An example given
is that Rumchev et al. (2004) did not attempt to evaluate the impact of
recent indoor painting. These issues raise serious questions regarding
the adequacy of the study as a sole source for deriving a reference
exposure.
As Brunekreef (2004) noted in his comments on Rumchev et al. (2004)
and other studies:

The issue of whether indoor VOCs are a risk factor for asthma
in children therefore seems still to be largely undecided. In
view of the methodological difficulties outlined above,
prospective studies are more likely to produce progress in
deciding whether we need to worry about indoor VOCs as
determinants of asthma at the relatively low concentrations
typically encountered in the home environment.

In view of the issues raised by Rumchev (2004) showing that a
number of VOCs were associated with asthma as well as the inherent and
broader limitations associated with Rumchev, et al. (2002), Rumchev, et
al. (2002) does not provide a reasonable basis for adopting a new
level. A careful reading of the studies cited as the basis for
concluding that children are differentially sensitive to formaldehyde
shows essentially no support for that proposition.\5\
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\5\ Sufficient evidence of a causal relationship or an association
with asthma only exists for cats, cockroaches, house dust mites, ETS
(preschoolers), dogs, fungi or molds (Rhinovirus) and high-level
exposures to nitrogen oxides, not formaldehyde or other VOCs. For an
elaboration, see the National Research Council (2004) Emergency and
Continuous Exposure Guidance Levels for Selected Submarine
Contaminants, p. 87.
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While there are isolated reports of an association between
formaldehyde and asthma-like symptoms, these are generally small,
poorly controlled studies that do not show dose-response relationships
between formaldehyde and asthma [or surrogate measures such as atopy
(i.e., a personal or familial tendency to produce antibodies in
response to low doses of allergens, and, as a consequence, to develop
typical symptoms such as asthma or conjunctivitis) or report results at
formaldehyde levels (e.g., low ppb) that are implausible (e.g., at
levels now known to be normally emitted in the breath)]. Poorly
conducted studies that do not control exposure to cold air, nuisance
dust, molds, etc, all of which can contribute to asthma-like symptoms,
should not be relied upon when there is ready data from controlled
chamber studies. Controlled chamber studies surpass other types of
studies because they eliminate uncontrolled variables. And, under these
conditions, asthmatics exhibit no more sensitivity to formaldehyde than
nonasthmatics.\6\
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\6\ There also are studies indicating that asthmatic individuals
are not more sensitive to the irritant effects of formaldehyde than
healthy people (Sheppard et al. 1986, Sauder et al. 1987, Kulle et al.
1993, Green et al. 1987, Witek et al. 1987). In a recent study by
Ezratty et al. (2007), 12 subjects with intermittent asthma and allergy
to pollen were exposed, at rest, in a double-blind crossover study to
either formaldehyde (0.4 ppm) or purified air for 60 minutes. The order
of exposure to formaldehyde and air-only was randomized, and exposures
were separated by 2 weeks. There was also an allergen inhalation
challenge after each exposure. Airway responsiveness to methacholine (a
test that involves the inhalation of increasing concentrations of
methacholine, a potent bronchoconstrictor) and lower airway
inflammation (i.e., as measured by inflammatory cells in sputum) were
also assessed 8 hr after allergen challenge. Formaldehyde exposure did
not affect allergen-induced increase in responsiveness to methacholine,
and there was no formaldehyde-associated effect on the airway
inflammatory response. In this study, exposure to 400 ppb (0.4 ppm)
formaldehyde had no significant deleterious effect on airway allergen
responsiveness of patients with intermittent asthma; in fact the
authors reported a trend toward a protective effect. Overall, the
weight of evidence suggests that asthma is not caused by or exacerbated
by low-level exposure to formaldehyde.
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Based on the preceding discussion, it should be evident that there
is no compelling or reliable evidence that children are more or less
susceptible to the irritant effects of formaldehyde than adults. As
ATSDR concluded, there is no appreciable difference between children
and adults in the targets for irritation, i.e., eyes, nose and throat,
at formaldehyde exposure levels that have been reliably determined to
affect adults. ``Whereas there are numerous studies of adults
occupationally exposed to formaldehyde and exposed under acute
controlled conditions, data regarding the toxicological properties of
formaldehyde in children are limited. Nevertheless, the same type of
effects that occur in adults are expected to occur in children. . . .
Symptoms expected to occur in children include eye, nose, and throat
irritation from exposure to airborne concentrations between 0.4 and 3
ppm. . . .'' ATSDR (1999).
Additionally, in an extensive review on upper respiratory tract and
eye irritation effects of volatile chemicals by a group of experts, a
higher susceptibility of children was not mentioned. (Doty et al.
2004). In a recent study by Meininghaus et al. (2003), the air levels
of several respiratory irritants were measured (e.g., SO2,
ammonia, acetic acid, formic acid, hexanal, butanal, acetaldehyde and
formaldehyde) in school settings. For formaldehyde, the air
concentrations were between 20-25 mg/m\3\ (17-21 ppb). Of interest was
that reported symptoms (i.e., dry sensation of the eyes, irritation of
the upper respiratory tract, headache and a rough tongue) were
initially reported by the adults (i.e., some of the teachers), and it
was only after this that several children complained about similar
symptoms suggesting a higher sensitivity in adults than in children.
The authors concluded that psychological factors (e.g., increased
attention from authorities, the presence of `experts' and sampling
equipment, and a strong group behavior) may have resulted in
individuals paying more attention to health effects related to sensory
irritation.
FCI trusts that you will find this information compelling and the
Subcommittee on Consumer Protection, Product Safety, and Insurance will
give it due consideration. Should you require any additional
information, please do not hesitate to contact me.
Sincerely,
Betsy Natz,
Executive Director
Formaldehyde Council
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