[Congressional Record Volume 155, Number 44 (Thursday, March 12, 2009)]
[Senate]
[Pages S3086-S3088]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mrs. FEINSTEIN (for herself and Mr. Schumer):
  S. 593. A bill to ban the use of bisphenol A in food containers, and 
for other purposes; to the Committee on Health, Education, Labor and 
Pensions.
  Mrs. FEINSTEIN. Mr. President, I rise to introduce legislation to ban 
Bisphenol A, BPA, from food and drink containers. I am pleased to be 
working with Congressman Markey on this issue, and he will be 
introducing identical legislation in the House. I would also like to 
thank my colleague Senator Schumer, who has agreed to cosponsor this 
legislation.
  I believe this is a good and necessary bill. The science shows that 
BPA is added to food and drink containers, and leaches into these foods 
and beverages, especially when heated in a plastic container.
  Make no mistake, chemicals are everywhere, even in our food. In many 
cases, we know very little about their safety. I strongly believe that 
the time has come to utilize a precautionary standard in all food and 
beverages with respect to chemical additives. If you do not know for 
certain the chemical is benign, it should not be used.
  Bisphenol A, known commonly as BPA, is one such example. It is used 
in consumer products all around us: plastic containers that store food, 
compact discs, water bottles, canned soups and other canned foods, even 
baby bottles.
  More than 100 studies suggest that BPA exposure at very low doses is 
linked to a variety of health problems, including prostate and breast 
cancer, obesity, attention deficit and hyperactivity disorder, brain 
damage, altered immune system, lowered sperm counts, and early puberty.
  The National Toxicology Program in the Department of Health and Human 
Services has cited ``some concern'' that Bisphenol A may affect neural 
development in fetuses, infants, and children at current human 
exposures.
  The solution is simple. My legislation will ban the use of Bisphenol 
A from food and drink containers. This ban will be effective 180 days 
following enactment of the legislation.
  The bill will create a waiver process, in case a company demonstrates 
that it is technologically impossible to replace BPA in that time 
frame. A manufacturer can receive a one year waiver, which is 
renewable, while they work to remove BPA from their product. They must 
submit a plan to remove BPA, and their product must be labeled as 
containing BPA.
  The legislation also directs the Food and Drug Administration to 
routinely review the ``List of Substances Generally Regarded as Safe.'' 
If new evidence emerges that suggests a chemical is not safe for use in 
a particular manner, it will be removed from the product.
  Scientists have raised alarms regarding BPA for some time. It is an 
endocrine disruptor, mimicking estrogen when it is exposed to a cell.
  Scientists at Stanford University accidentally discovered BPA's 
estrogen-mimicking effects in 1993. A mysterious estrogen-like chemical 
skewed results of their lab work, and they finally realized that BPA 
was leaching from laboratory flasks.
  We know that BPA is found in almost everyone. Data from the National 
Health and Nutrition Survey, NHANES, conducted by the Centers for 
Disease Control found BPA in the bodies of 92.6 percent of the people 
surveyed. The study did not examine the exposure of children under 6. 
But it did find that levels were highest in young children, a troubling 
finding given that exposure to BPA is potentially most dangerous during 
these critical early years of development.
  We know a major source of this exposure: the cans that contain our 
food,

[[Page S3087]]

the containers we eat from, even the baby bottles used to serve 
formula.
  The Environmental Working Group commissioned an independent lab to 
study BPA in cans in 2007. They tested 97 cans of some of the most 
popular consumer products. Their findings will alarm any consumer: 53 
of the 97 cans tested had detectable levels of BPA; 20 of the 53 cans 
with BPA have high enough levels that consuming that canned product 
would expose a person to levels near those that have been found to 
impact laboratory rats; 1 in 10 cans contained enough BPA to expose a 
pregnant woman or child to more than 200 times the Government's safe 
level. The same is true for 1 out of every 3 cans of infant formula.
  For women who regularly eat canned food, their exposure level 
throughout a pregnancy may exceed safe doses.
  These are not exotic products, but the canned goods that are in 
pantries across this county: meal replacement shakes, canned soups, 
vegetables, and canned pastas, like ravioli.
  Baby bottles are also a common exposure source. Multiple studies have 
confirmed that many of the most popular brands of baby bottles leach 
BPA. A coalition of health and environmental groups, in their recent 
report ``Baby's Toxic Bottle'', identified several popular brands of 
baby bottles that leach BPA when heated: Avent; Disney, Dr. Brown's, 
Evenflo; Gerber; Playtex.
  Now every parent knows that milk served to babies is often heated, at 
least to room temperature. And these bottles, when heated, leached 
between 5 and 8 parts per billion of BPA, a level that is within the 
range that has been shown to cause harm in animal studies.
  We know that BPA is a hormone disrupting chemical, and may act like 
estrogen when in the human body. While the science is still emerging, 
research is connecting Bisphenol A with a variety of serious health 
effects. These include: early onset of puberty; hyperactivity; lowered 
sperm count; miscarriage.
  The chemical industry will try to reassure consumers that BPA is 
safe, and that studies have found these health effects only in 
laboratory animals exposed to BPA in high doses.
  But new evidence that goes beyond laboratory rat models is emerging. 
Last year, researchers at the Yale School of Medicine linked BPA to 
problems in brain function and mood disorders in monkeys, for the first 
time connecting the chemical to health problems in primates.
  The Yale scientists exposed monkeys to low levels of BPA, which the 
Environmental Protection Agency, EPA, have deemed safe for humans.
  Researchers found that this chemical exposure interfered with brain 
cell connections vital to memory, learning and mood.
  The researchers stated that the findings suggest that exposure to 
low-dose BPA may cause widespread effects on brain structure and 
function.
  In September of last year, the Journal of the American Medical 
Association, JAMA, published a study that links BPA levels in people to 
several serious health problems.
  The study examined the BPA concentrations found in 1455 adults who 
participated in the 2003-2004 National Health and Nutrition Examination 
Survey, NHANES, a study which detected BPA in more than 90 percent of 
Americans tested. Using this data, researchers linked higher BPA 
concentrations to adverse health affects, including: cardiovascular 
disease; type II diabetes; clinically abnormal concentrations of some 
liver enzymes.
  The Los Angeles Times reported on the study on September 17th, 
stating ``that the quarter of the group with the highest BPA levels--
levels still considered safe by the FDA--were more than twice as likely 
to suffer from diabetes and cardiovascular disease as the quarter with 
the lowest levels.''
  This is the first large scale study to be done examining human 
exposure, and I believe it must be taken very seriously.
  Industry continues to insist that BPA is not harmful. But one study 
shows us why we should be skeptical about research coming from chemical 
companies.
  In 2006, the journal Environmental Research published an article 
comparing the results of government funded studies into low dose 
exposure to BPA with studies funded by the BPA industry.
  The results are astounding; 92 percent of the Government funded 
studies found that exposure to BPA caused health problems in animals.
  However, none of the industry funded research identified any health 
problems in animals exposed to low levels of BPA.
  This raises serious questions about the validity of the chemical 
industry's studies. It also illustrates why our Nation's regulatory 
agencies should not and cannot solely rely on chemical companies to 
conduct research into their products.
  The Food and Drug Administration agrees that the science is 
incomplete. The FDA's Science Board released a report in October 2008 
that raised serious questions about the previous FDA assessments that 
found BPA to be safe.
  In response, the FDA has asked for more studies and more research. 
More research is fine, but I feel strongly that we must not leave a 
dangerous chemical on the market while scientists learn exactly how 
dangerous it is.
  Sufficient evidence exists for us to act now. I believe strongly in 
taking a precautionary approach to our chemical policy; people should 
be protected from chemicals until we know that they are safe for use.
  There is a great deal wrong with the regulatory system in this 
country and the way we address dangerous chemicals. Our system is 
essentially backwards. Chemicals are added to products before we know 
much about them. To be removed from the market, a chemical must be 
proven to be exceedingly dangerous.
  That means that while we wait for evidence of harm to develop, our 
children are using dangerous products, and possibly eating contaminated 
food.
  I believe it should be the reverse. We should follow the lead of the 
European Union, and Canada, and remove chemicals until we know them to 
be safe. We should not be waiting for proof of danger, which too often 
comes in the form of birth defects, cancer, and other irreversible 
health harms.
  While we continue to work to change our regulatory system, the time 
has come to apply this precautionary principle to BPA. Without 
question, there is more scientific work to be done. But we must not 
continue to expose our citizens to these risks while we wait to confirm 
BPA's dangers beyond a reasonable doubt.
  The Canadian government has already taken this approach with BPA, 
moving to eliminate polycarbonate baby bottles that contain Bisphenol A 
last year. Canadian officials stated that because safe alternatives are 
readily available, this ban is a prudent way to reduce risk for 
vulnerable infants.
  Many large retailers and producers, including Toys ``R'' Us, Nalgene, 
and Wal-Mart have agreed to no longer sell or produce baby bottles or 
plastic water bottles containing BPA. And just last week, the leading 
manufacturers of baby bottles announced they would no longer sell baby 
bottles made with BPA.
  This is great news. I commend them, but we should not be forced to 
rely on retailers to product American consumers from health hazards.
  The Congress agreed with this precautionary approach and banned six 
plasticizing chemicals, called phthalates, in legislation last year. 
Like BPA, phthalates have been linked to a variety of health problems 
in young children. Instead of doing nothing with the evidence mounts, 
Congress chose to step in and protect children from this risk.
  The time has come to do the same with Bisphenol A.
  Mr. President, I ask unanimous consent that the text of the bill be 
printed in the Record.
  There being no objection, the text of the bill was ordered to be 
placed in the Record, as follows:

                                 S. 593

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Ban Poisonous Additives Act 
     of 2009''.

     SEC. 2. BAN ON USE OF BISPHENOL A IN FOOD AND BEVERAGE 
                   CONTAINERS.

       (a) Treatment of Bisphenol A as Adulterating the Food or 
     Beverage.--For purposes of applying section 402(a)(6) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(6)), a 
     food container (which for purposes of this Act includes a 
     beverage container) that is composed, in whole or in part,

[[Page S3088]]

     of bisphenol A, or that can release bisphenol A into food (as 
     defined for purposes of the Federal Food, Drug, and Cosmetic 
     Act), shall be treated as a container described in such 
     section (relating to containers composed, in whole or in 
     part, of a poisonous or deleterious substance which may 
     render the contents injurious to health).
       (b) Effective Dates.--
       (1) Reusable food containers.--
       (A) Definition.--In this Act, the term ``reusable food 
     container'' means a reusable food container that does not 
     contain a food item when it is introduced or delivered for 
     introduction into interstate commerce.
       (B) Applicability.--Subsection (a) shall apply to reusable 
     food containers on the date that is 180 days after the date 
     of enactment of this Act.
       (2) Other food containers.--Subsection (a) shall apply to 
     food containers that are packed with a food and introduced or 
     delivered for introduction into interstate commerce on or 
     after the date that is 180 days after the date of enactment 
     of this Act.
       (c) Waiver.--
       (1) In general.--The Secretary of Health and Human Services 
     (referred to in this Act as the ``Secretary''), after public 
     notice and opportunity for comment, may grant to any facility 
     (as that term is defined in section 415 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 350d)) a waiver of the 
     treatment described in subsection (a) for a certain type of 
     food container, as used for a particular food product, if 
     such facility--
       (A) demonstrates that it is not technologically feasible to 
     replace Bisphenol A in such type of container for such 
     particular food product; and
       (B) submits to the Secretary a plan and timeline for 
     removing Bisphenol A from such type of container for that 
     food product.
       (2) Applicability.--A waiver granted under paragraph (1) 
     shall constitute a waiver of the treatment described in 
     subsection (a) for any facility that manufactures, processes, 
     packs, holds, or sells the particular food product for which 
     the waiver was granted.
       (3) Labeling.--Any product for which the Secretary grants 
     such a waiver shall display a prominent warning on the label 
     that the container contains Bisphenol A, in a manner that the 
     Secretary shall require, which manner shall ensure adequate 
     public awareness of potential health effects associated with 
     bisphenol-A.
       (4) Duration.--
       (A) Initial waiver.--Any waiver granted under paragraph (1) 
     shall be valid for not longer than 1 year after the 
     applicable effective date in subsection (b).
       (B) Renewal of waiver.--The Secretary may renew any waiver 
     granted under subparagraph (A) for a period of not more than 
     1 year.
       (d) List of Substances That Are Generally Recognized as 
     Safe.--
       (1) Review.--The Secretary, acting through the Commissioner 
     of Food and Drugs, shall, not later than 1 year after 
     enactment of this Act and not less than once every 5 years 
     thereafter, review--
       (A) the substances that are generally recognized as safe, 
     listed in part 182 of title 21, Code of Federal Regulations 
     (or any successor regulations);
       (B) the direct food substances affirmed as generally 
     recognized as safe, listed in part 184 of title 21, Code of 
     Federal Regulations (or any successor regulations); and
       (C) the indirect food substances affirmed as generally 
     recognized as safe, listed in part 186 of title 21, Code of 
     Federal Regulations (or any successor regulations).
       (2) Public comment.--In conducting the review described in 
     paragraph (1), the Secretary shall provide public notice and 
     opportunity for comment.
       (3) Remedial action.--If, after conducting the review 
     described in paragraph (1), the Secretary determines that, 
     with regard to a substance listed in such part 182, 184, or 
     186, new scientific evidence, including scientific evidence 
     showing that the substance causes reproductive or 
     developmental toxicity in humans or animals, supports--
       (A) banning a substance;
       (B) altering the conditions under which a substance may be 
     introduced into interstate commerce; or
       (C) imposing restrictions on the types of products for 
     which the substance may be used,
     the Secretary shall remove such substance from the list of 
     substances, direct food substances, or indirect food 
     substances generally recognized as safe, as appropriate, and 
     shall take other remedial action, as necessary.
       (4) Definition.--In this Act, the term ``reproductive or 
     developmental toxicity'' has the meaning given such term in 
     section 409(h)(6) of the Federal Food, Drug, and Cosmetic 
     Act, as amended by section 3.
       (e) Savings Provision.--Nothing in this Act shall affect 
     the right of a State, political subdivision of a State, or 
     Indian Tribe to adopt or enforce any regulation, requirement, 
     liability, or standard of performance that is more stringent 
     than a regulation, requirement, liability, or standard of 
     performance under this Act or that--
       (1) applies to a product category not described in this 
     Act; or
       (2) requires the provision of a warning of risk, illness, 
     or injury associated with the use of food containers composed 
     of bisphenol A.

     SEC. 3. AMENDMENTS TO SECTION 409 OF THE FEDERAL FOOD, DRUG, 
                   AND COSMETIC ACT.

       Subsection (h) of section 409 of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 348(h)(1)) is amended--
       (1) in paragraph (1)--
       (A) by striking ``manufacturer or supplier for a food 
     contact substance may'' and inserting ``manufacturer or 
     supplier for a food contact substance shall'';
       (B) by inserting ``(A)'' after ``notify the Secretary of'';
       (C) by striking ``, and of'' and inserting ``; (B)''; and
       (D) by striking the period after ``subsection (c)(3)(A)'' 
     and inserting ``; (C) the determination of the manufacturer 
     or supplier that no adverse health effects result from low 
     dose exposures to the food contact substance; and (D) the 
     determination of the manufacturer or supplier that the 
     substance has not been shown, after tests which are 
     appropriate for the evaluation of the safety of food contact 
     substances, to cause reproductive or developmental toxicity 
     in man or animal.''; and
       (2) by striking paragraph (6) and inserting the following:
       ``(6) In this section--
       ``(A) the term `food contact substance' means any substance 
     intended for use as a component of materials used in 
     manufacturing, packing, packaging, transporting, or holding 
     food if such use is not intended to have any technical effect 
     in such food; and
       ``(B) the term `reproductive or developmental toxicity' 
     means biologically-adverse effects on the reproductive 
     systems of female or male humans or animals, including 
     alterations to the female or male reproductive system 
     development, the related endocrine system, fertility, 
     pregnancy, pregnancy outcomes, or modifications in other 
     functions that are dependent on the integrity of the 
     reproductive system.''.
                                 ______