Tuesday, June 10, 2008

House Hearing On Safety of Phthalates and Bisphenol A

Jun 10: The House Energy & Commerce Committee, Subcommittee on Commerce, Trade, and Consumer Protection, Chaired by Representative Bobby Rush (D-IL) held a hearing entitled, Safety of Phthalates and Bisphenol-A in Everyday Consumer Products. Witnesses testifying at the hearing included representatives of the Consumer Product Safety Commission, Food and Drug Administration, National Toxicology Program, U.S. EPA, American Chemistry Council, Science and Environmental Health Network, California Department of Toxic Substances Control, and the Center for Health, Environment and Justice.

Representative John Dingell (D-MI), Chairman of the Full Committee issued a statement saying, "Phthalates are a family of chemicals with more than a dozen individual formulas that are used to make plastics soft. They are used in everything from bathtub mats to toys. Bisphenol-A, or BPA for short, is a component of polycarbonate plastic used to make it hard and shatter proof. It is used in baby bottles and teething rings but also in bicycle helmets and car safety seats. These components have been around for about 50 years, but recent studies have raised significant concerns about the risks posed by use of these substances in certain consumer products and the impact of these and similar substances on human health, especially where fetuses, infants, and young children are concerned. Consumer groups are asking policymakers to take steps to ban these substances in consumer products. . . It is extremely important that Congress, with the help of Government and other scientists, adequately assess the hazards posed by phthalates and BPA, and also to determine the safety of alternative chemicals for essential consumer products. Today’s hearing is a crucial first step in that process.”

WIMS reported on June 9, that on May 29, Health Canada responded to recent concerns about one of the chemicals, bisphenol A (BPA) in canned food, and said, "Based on the scientific evidence available to date, Health Canada does not recommend that consumers make any changes to their dietary habits as a result of the occurrence of trace levels of BPA in canned foods. Consumers should feel confident that canned foods are safe and can continue to be part of a balanced diet. . ." On June 6, in response to the Health Canada announcement, the American Chemistry Council (ACC) issued a statement applauding the Canadian announcement and said, "BPA is one of the most extensively tested of all substances with a track record of safety that spans more than 50 years [See WIMS 6/9/08].

Dr. L. Earl Gray Jr., senior reproductive biologist and toxicologist in the Reproductive Toxicology Division of EPA’s National Health and Environmental Effects Research Laboratory in the Office of Research and Development testified and said his testimony represent his personal views as a scientist and do not necessarily the position of EPA or the Administration. He said, "I have different levels of concern for these two classes of EDCs, with a higher level of concern for some phthalates than for BPA." Regarding phthalates he said he had "concern" for children and women of child-bearing age and "serious concern for children and pregnant exposed to phthalates by medical interventions." Regarding BPA he said he had "some concern" for neural and behavioral effects, and "minimal to negligible concern for other effects."

FDA testified that, "Although the Agency’s review of the newly available reports is continuing, a large body of available evidence indicates that currently-marketed food contact materials containing BPA are safe, and that exposure to BPA from food contact materials, including exposures for infants and children, are below the levels that may cause health effects. We are actively reviewing the data on BPA and will continue to consider the relevance of new data and studies as they appear."

The National Toxicology Program (NTP) submitted 180 pages of testimony and said in part, "There are a number of uncertainties in the scientific information on BPA. The literature from experimental animal studies is large, but with many conflicting findings. Moreover, there are insufficient data from studies in humans to determine directly whether BPA is affecting human reproductive health." On phthalates, NTP said, "The fact that specific phthalates can adversely affect reproduction has been known for more than 25 years, and it is now known is that fetal animals are more sensitive than newborn animals, which in turn are more sensitive than older animals. Since the late 1990s it has been known that certain phthalates specifically affect development of the male reproductive system. Not all phthalates produce adverse reproductive effects in animal studies. . ."

ACC in 31-pages of testimony said, "These materials have been in use for decades. They have been subjected to extensive study worldwide, including by independent researchers as well as government agencies, and scientific review is ongoing. U.S. regulatory agencies charged with regulating these compounds in various applications, after reviewing the large body of scientific data, have reached conclusions supporting their safe use in important applications. The scientific evidence supports the continued use of these important materials."

The Center for Health, Environment and Justice testified that, "Phthalates have been linked to reproductive problems including shorter pregnancy duration and premature breast development in girls and sperm damage and impaired reproductive development in males. . . Safer cost-effective alternatives exist such as PVC-free toys that are manufactured without phthalates as well as phthalate-free plasticizers. . . the European Union and many countries around the world have restricted the use of phthalates in children’s toys. Yet, these chemicals continue to be used in our children’s toys and baby products here in the United States. . .
In the absence of federal action, an increasing number of U.S. states are introducing legislation to ban phthalates and bisphenol A."

On March 6, 2008, the full U.S. Senate approved an amendment by U.S. Senator Dianne Feinstein (D-CA) that would impose a nationwide ban on phthalates in children’s toys and products. The amendment (SA 4104) was approved by voice vote in the Consumer Product Safety Modernization Act (S. 2663/H.R. 4040) bill that passed the Senate on March 6, by a vote of 79-13 [See WIMS 3/7/08]. At that time, Senator Feinstein said, “This is a big victory for parents of small children. It will implement a nationwide ban on toys and products that contain these dangerous chemicals. Europe and California have already stepped forward and made sure that toys laden with phthalates are kept away from the hands and mouths of young children. America’s parents should be able to have the same peace of mind that the toys they buy for their children are safe.”

Access the hearing website for links to all testimony (
click here). Access the complete statement from Chairman Dingell (click here). Access the Health Canada release and link to additional information (click here). Access the U.S. Senate hearing website for links to all testimony (click here). Access the House Committee's Bisphenol A inquiry website for additional information (click here). Access the FDA BPA information website with links to additional information (click here). Access a release from Senator Feinstein listing supporting organizations and other countries banning phthalates (click here). Access legislative details for S. 2663 (click here). Access several posting on the WIMS eNewsUSA Blog on BPA issues (click here). [*Toxics]

Update: October 29, 2008 - A special Subcommittee of the Food and Drug Administration (FDA) Science Board that provides advice primarily to the Commissioner of the FDA and other appropriate officials on specific complex and technical issues has found considerable fault with the draft assessment prepared by the FDA of bisphenol A (BPA) for use in food contact applications [See WIMS 6/10/08, Update September 3]. The temporary Subcommittee was established by the Science Board and consists of two members of the Science Advisory Board and five scientists drawn from academia and government agencies. The focus of the Subcommittee was to provide scientific peer-review of the FDA draft assessment of BPA.

Update: September 3, 2008 - The National Toxicology Program (NTP) Center for the Evaluation of Risks to Human Reproduction (CERHR) released its final report on the potential human reproductive and developmental effects of BPA which provides the NTP's current opinion on BPA's potential to cause harm to human reproduction or development. The report says that current human exposure to bisphenol A (BPA), is of "some concern" for effects on development of the prostate gland and brain and for behavioral effects in fetuses, infants and children. Other recent research from the University of Cincinnati and Yale University suggest new concerns (see links below).

Access a release from NIEHS (click here). Access the complete BPA final report (click here). Access a summary of the NTP evaluation of BPA (click here). Access the FDA draft BPA assessment (click here). Access a release on the UC research (click here). Access a release on the Yale study (click here). Access the FDA statement on the Subcommittee report (click here). Access the Subcommittee's Report (click here). Access the Subcommittee's Briefing Information website for links to extensive BPA documentation (click here). Access the FDA website on BPA with links to additional information (click here).