[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\
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    \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\
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    \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.
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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 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. In my written testimony submitted to the Subcommittee I 
provided a chart showing formaldehyde regulations and standards for 
various other countries. In that chart I showed that both Germany and 
The Netherlands require warning labels for consumers that suggest 
washing of garments before first use if they contain formaldehyde.
    It is my understanding that the forthcoming GAO study will not 
consider this as a policy response.

    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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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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