Senate Moves Forward With Compromise Food Safety Act

U.S. Senate negotiators apparently reached an agreement last week on food safety legislation in order to have it ready for the full Senate to consider when lawmakers return from the summer recess.

The group that negotiated the framework for the new Senate version of the Food Safety Modernization Act included Tom Harkin, D-Iowa; Mike Enzi, R-Wyo.; the bill's authors Dick Durbin, D-Ill., and Judd Gregg, R-N.H.; and lead co-sponsors Christopher Dodd, D-Conn., and Richard Burr, R-N.C.

The bill would require facilities that manufacture, process, pack, or hold food to have in place risk-based preventive control plans to address identified hazards and prevent adulteration.  It requires importers to verify the safety of foreign suppliers and imported food. It would give the FDA additional resources to hire new inspectors and requires FDA to inspect food facilities more frequently. The bill gives the FDA authority to order a mandatory recall of a food product if the food will cause serious adverse health consequences or death and a company has failed to voluntarily recall the product upon FDA’s request. It has provisions to enhance surveillance systems to detect food-borne illnesses.

Significantly, this version does not include language banning BPA, as originally demanded by Sen. Feinstein.  Her prior insistence, despite a lack of scientific evidence supporting such a ban, was one of the major logjams for the bill. She says she still plans to introduce an amendment to ban BPA from children’s products as soon as the bill arrives on the Senate floor.  Clearly, an abrupt and unnecessary ban on packaging containing BPA would affect consumer ability to find nutritious, valuable, and shelf-stable foods and beverages. The proposed ban runs counter to the fact that BPA has been used for over 30 years to improve the safety and quality of food and beverages, including by providing protective coating for cans. The overwhelming scientific evidence points to the conclusion that at current human exposure levels, BPA is not toxic. What is in fact occurring is that anti-chemical activists are simply manipulating consumers’ fears, and opportunistic politicians are jumping in.



 

 

NRDC Sues FDA Over BPA

The Natural Resources Defense Council brought suit last week against the FDA for allegedly failing to take timely action in response to its petition asking the agency to ban the chemical bisphenol A. NRDC v. Sebelius, D.C. Cir., No. 10-1142 (filed 6/29/2010).

NRDC is one of a number of advocacy groups who allege that this important chemical, used to make polycarbonate plastics in water bottles and epoxy resins used to line cans containing food, causes harmful health effects, particularly to infants and children, including early puberty, reproductive abnormalities.

However, both the scientific process and the public interest are better served by allowing the FDA to complete its ongoing review of the science surrounding the safety profile of BPA -- at its own pace.  Just this January, the U.S. Department of Health and Human Services and the FDA made it clear that BPA has not been proven to harm children or adults.  EPA released its bisphenol A Action Plan in March 2010. Importantly, the agency clearly indicated that it does not intend to initiate regulatory action under TSCA at this time on the basis of human health concerns.

This observation is consistent with a draft assessment issued by FDA in 2008, and the scientific conclusions of many other government regulatory agencies around the world. In January 2010, the German Federal Institute for Risk Assessment (BfR, Bundesinstitut für Risikobewertung) wrote, “Following careful examination of all studies, in particular the studies in the low dose range of bisphenol A, BfR comes to the conclusion in its scientific assessment that the normal use of polycarbonate bottles does not lead to a health risk from bisphenol A for infants and small children. BfR is not alone in this assessment. The European Food Safety Authority (EFSA) and the U.S. Food and Drugs Administration (FDA) share this opinion. Japan, which has conducted its own studies on bisphenol A, does not see any need for a ban either.”
 

In January 2010, FDA Deputy Josh Sharfstein was quoted as noting the FDA does support the use of baby bottles with BPA because the benefits of sound infant nutrition currently outweigh the known risks from BPA. Nevertheless, and perhaps not surprisingly, the California Assembly passed legislation last week to ban the use of bisphenol A in children's food and drink containers beginning in 2012.  The bill passed by a vote of 43-31 vote. The Toxics-Free Babies and Toddlers Act (S.B. 797) moves to the state Senate for approval, since the Senate initially passed a different version early last month.

The bill provides that if the state Department of Toxic Substances Control begins to regulate the chemical through its “green chemistry’’ initiative, S.B. 797 would be repealed.  In the meantime, the law would would limit the level of BPA in baby bottles, toddlers' cups, and food and drinking containers.  Infant formula manufacturers would have until July, 2012, to stop using BPA in the coatings used to line their metal containers.

 

Proposed BPA Ban Undermines Food Safety Bill

Sen. Dianne Feinstein (D-Calif.) announced last week that she would seek to ban the chemical bisphenol-A in food and drink containers as part of an amendment to the proposed Food Safety Modernization Act (S.510). That move has the double distinction of lacking in scientific merit and threatening to undermine the bipartisan support for the good parts of the pending bill.  The Grocery Manufacturers of America and the Chamber of Commerce had expressed support for the food safety bill, but may oppose it if the bill contains language banning the chemical. The food safety bill is expected to come up after Congress returns from its Memorial Day break.

The Senator's ill-supported approach by-passes the safety review that belongs with the FDA, and is ongoing, with a re-review assessment due in 2011. NIH has also launched a study on the safety of low level exposure to BPA.  World-wide regulatory agencies who have reviewed BPA have thus far concluded that BPA is safe for use in canned products.  The European Food Safety Authority has announced a delay in delivering its own latest BPA report, needing more time to review the body of research on the chemical.

Clearly, an abrupt and unnecessary ban on packaging containing BPA would affect consumer ability to find nutritious, valuable, and shelf stable foods and beverages.  The proposed ban runs counter to the fact that BPA has been used for over 30 years to improve the safety and quality of food and beverages, including by providing protective coating for cans. The overwhelming scientific evidence points to the conclusion that at current human exposure levels, BPA is not toxic.  What is in fact occurring is that anti-chemical activists are simply manipulating consumers’ fears, and opportunistic politicians are jumping in.

Even though there is no persuasive scientific evidence that BPA causes the type of harm the politicians speculate about, litigation is well underway in both the Western District of Missouri (MDL 1967) and the Western District of Kentucky (MDL 2137). The former involves class action suits against manufacturers of baby bottles and sippy cups. The claims include alleged violation of state consumer protection acts, fraud, breach of warranty, unjust enrichment, strict product liability, and negligence. MDL 2137, on the other hand, involves suits against an aluminum bottle manufacturer claiming that the manufacturer marketed its product as an alternative to BPA-containing plastic even though its metal bottles were allegedly lined with an epoxy resin containing BPA.  

 

BPA Update- Part II

Yesterday, we posted about events in the MDL.  Today, the science, and it probably shouldn’t surprise readers of MassTortDefense that studies suggesting a product bears some risk get far more media attention than studies showing a product is safe, even when the latter are more rigorous. Similarly, studies funded by industry are dismissed by the media as hopelessly biased, as if product sellers have no interest in exploring their products, but studies from a pro-plaintiff, pro-litigation, anti-business, pro-regulation, big government biased interest group are deemed “neutral.”

Such continues to be the case with BPA. Consumer Union came out with a report of BPA levels detectable in 19 canned foods. They admitted that the study was limited and that the tests only “convey a snapshot of the marketplace and do not provide a general conclusion about the levels of BPA in any particular brand or type of product tested.”  Levels in the same product purchased at different types or places or in other brands of similar foods might differ from CU test results, they acknowledged. Published reports have noted that the group refuses to release the names of the external laboratories they used for testing; and the "study" would not have been published in a peer-reviewed scientific journal without a detailed description of the analytical methods used. The CU also apparently relies on animal studies in which the animals were injected with BPA, instead of ingesting it. Basic toxicology would indicate that the route of administration is important.

However, BPA has been confirmed as safe for use in food contact materials by the world’s major regulatory agencies. The food contact materials in your supermarket, including epoxy can linings, meet current regulatory standards, and as importantly, actually enhance food safety and extend product shelf life. Thus, BPA-based epoxy coatings in metal packaging provide important and measurable health benefits by reducing the potential for the serious and often deadly effects from food-borne illnesses. This packaging enables the high-temperature sterilization of food products when initially packaged and continuously protects against microbial contaminants. The head-long rush by a few zealots to ban BPA overlooks the need to balance this factor.

The levels CU says it detected are substantially below the advisory level of 600 parts per billion established by the European Union as a level of safe consumption for all ages, and below current U.S. guidelines that establish the daily upper limit of safe exposure as 50 micrograms per kilogram of body weight. They thus do not pose a health risk to consumers, of all ages.

The media gave far less attention to a study released that is a significant development in better understanding the safety of BPA. See Ryan, et al., In Utero and Lactational Exposure to Bisphenol A, in contrast to Ethinyl Estradiol, Does not Alter Sexually Dimorphic Behavior, Puberty, Fertility and Anatomy of Female LE Rats (Toxicological Sciences 2009). The study was sponsored by the Environmental Protection Agency. The study conclusion states: “The lack of effect of BPA on female and male rat offspring after oral exposure to low doses in our studies is consistent with the lack of adverse effects on growth, vaginal opening, fertility and fecundity of low doses of BPA in several other robust, well designed, properly analyzed multigenerational studies (Cagen, et al.,1999; Ema, et al., 2001; Tinwell, et al., 2002; Tyl, et al., 2002).”  This new rodent study thus finds that low-dose exposures to BPA showed no effects on the broad range of reproductive functions and behavioral activities measured. Well-conducted, peer-reviewed studies such as this should provide the basis for reasoned government assessments and regulatory decisions -- not the murky at best, results driven CU report.


 

BPA Litigation Update- Part I

In the BPA MDL, Judge Ortrie D. Smith granted in part and denied in part defendants’ motions to dismiss various claims. In re: Bispehnol-A Polycarbonate Plastic Products Liability Litigation, MDL No. 1967 (W.D. Mo.).

Readers of MassTortDefense will recall that last year the Judicial Panel on Multidistrict Litigation centralized fourteen cases; since then, the Panel has continued to transfer cases from around the country, so now about thirty-eight cases have been transferred. In addition, approximately ten cases have been filed in the MDL District and have become part of the consolidation. Defendants roughly fall into two categories: the Bottle Defendants and the Formula Defendants. Generally, the Bottle Defendants make baby bottles, sippy cups and similar products for infants and toddlers, and/or sport bottles. The Formula Defendants sell infant formula packaged in metal cans.

Most of the complaints assert, on behalf of consumers, various causes of action including: (1) violation of state consumer protection laws, (2) breach of express warranty, (3) breach of the implied warranties of merchantability and fitness for a particular purpose, (4) intentional misrepresentation, (5) negligent misrepresentation, and (6) unjust enrichment.

In one Order the court began by addressing the motions to dismiss claims for fraud, misrepresentation and breach of express warranties. The MDL court had previously, mindful of Rule 9, required plaintiffs to identify defendants’ alleged statements that form the basis for their claims of fraud, misrepresentation, and breach of express warranties. Plaintiffs’ continued failure to do so was, said the court, now fatal to these claims. Likely because they were unable to comply, and perhaps because they recognized what compliance would do to their already slim chances for class certification (because of the individual issues that a response would highlight), plaintiffs responded to the aforementioned requirement by saying that they had not identified any advertisements or other media because the allegations are not based on any particular representations. A misrepresentation claim not based on any misrepresentation. Rather, plaintiffs’ allegations are based on defendants’ supposed “overall course of conduct” in marketing and selling the products at issue. Taken as a whole, defendants’ alleged “overall course of conduct” somehow deceptively conveyed the impression or message that the products at issue are safe and healthy for use by infants and children.

By disclaiming reference to any particular fraudulent act, plaintiffs had disclaimed one of the essential elements of a fraud or misrepresentation claim. All states require proof of reliance and causation. For a statement to be relied upon and thus cause a purchaser’s injury, the statement must have been heard by the purchaser. Plaintiffs’ theory – that the placement of a product in a stream of commerce alone somehow conveys a sufficient representation about the product’s safety that can serve as grounds for fraud liability – is a rule that has not been demonstrated to exist in any of the fifty states.

Allowing the mere sale of products to convey an affirmative representation regarding safety would eviscerate the law of warranty and be contrary to the rationale supporting the limited circumstances in which actions constitute representations, noted the court.  Plaintiffs’ failure to identify any expressions made by defendants to them about their products precludes any claim that an express warranty was made, let alone violated. Given the absence of any “affirmation of fact or promise,” (see UCC Article 2-313), plaintiffs cannot allege an express warranty was made. The Supreme Court’s decision in Iqbal requires a plaintiff to identify the basis for, if not the content of, the alleged warranty. And, in a related issue, plaintiffs’ were thus unable to allege how the supposed, non-existent, warranties became “part of the basis of the bargain.”  A representation cannot be part of the “bargain” if the other party to the bargain did not know the representation was made! Merely alleging a representation became part of the bargain does not satisfy Iqbal. If one party (here, the buyer) is not aware of the statement, that party cannot claim the statement became a part of the parties’ bargain.

The court declined to dismiss the claims for fraudulent omissions, based on what it called a “common-sense” view of Rule 9 under which it was unnecessary to require plaintiffs to specifically identify who failed to disclose information and each occasion upon which they failed to disclose it. Rule 9 is satisfied, said the court, with respect to a claim of fraudulent omissions if the omitted information is identified and “how or when” the concealment occurred.

The claim for breach of implied warranty of fitness for a particular purpose was dismissed because while the ordinary purpose for baby bottles can be described as to allow babies and toddlers to drink liquids, a plaintiff cannot rely on this ordinary purpose to support a claim that there was a warranty of fitness for a particular purpose; they must point to some other purpose that is not “ordinary” in order to support their claim.

The court put off ruling on the claims for breach of the implied warranty of merchantability because defendants’ arguments (including lack of privity, untimeliness, and failure to provide notice), seemed premised on the unique characteristics of various states’ laws. Thus, they seemed more amenable to analysis at the time of any class certification decision, which will inevitably raise choice of law issues. A similar deferral was applied to dismissal of all unjust enrichment claims. Many of defendants’ arguments seemed to depend on unique aspects of various states’ laws, found the court.

Defendants also made a strong argument that the claims, at bottom, were improper “no injury” claims. The court agreed as to the category of plaintiffs who disposed of or used up the products before learning about BPA. They received all the benefits they desired and were unaffected by defendants’ alleged concealment. Importantly, the court recognized that while they may contend they would not have purchased the goods had they known more about BPA, these plaintiffs received 100% use (and benefit) from the products and have no quantifiable damages. In this instance, plaintiffs’ position “leads to absurd results.”  These buyers obtained the full anticipated benefit of the bargain. While they may not have paid the asking price, had they allegedly known, offset against this is the fact that they received the full benefits paid for – leaving them with no damages. Plaintiffs here may allege they would not have purchased those products had they supposedly known the true facts, but, again, they obtained full use of those products before learning the truth: the formula was consumed or the children grew to an age where they did not use bottles and sippy cups, so they were discarded. These consumers thus obtained full value from their purchase and have not suffered any damage. These plaintiffs are relegated to the unjust enrichment claim.

The court distinguished, however, those plaintiffs who learned about BPA’s presence and potential effects and either still have the goods or subsequently replaced or disposed of them. Defendants’ argument does not apply to this category, found the court.

That left before the court only plaintiffs’ claims that defendants made fraudulent omissions, violated various state consumer protection statutes, breached the implied warranty of merchantability, and that defendants were unjustly enriched. With these remaining claims pending, the court, in a second order, granted in part defendants’ motion to dismiss on the basis of preemption and denied their motion to dismiss on the ground of primary jurisdiction.

Defendants’ preemption and primary jurisdiction arguments were generally alike in that they both contend their use of BPA should only be subject to regulation by the FDA. Indeed, FDA has issued regulations prescribing the conditions for “safe” use of resinous and polymeric coatings, allowing the coatings to be formulated from “optional substances” that may include “[e]poxy resins” containing BPA. Thus, BPA’s presence in some resinous and polymeric coatings and in polycarbonate resins is subject to regulation by the FDA. It is also a fair reading of FDA’s regulations authorizing BPA’s use that the FDA thinks that food additives containing BPA could be used safely without labeling requirements.

The doctrine of primary jurisdiction applies when enforcement of a claim that is originally cognizable in the courts requires the resolution of issues which, under a regulatory scheme, have been placed within the special competence of an administrative body. The FDA clearly has specialized expertise and experience to determine whether BPA is “safe.” However, said the court, the ultimate issues in these cases, as alleged by plaintiffs, are whether defendants failed to disclose material facts to plaintiffs and thus, for example, whether defendants breached the implied warranty of merchantability through the sale of products containing BPA. FDA’s decision that BPA is “safe” is not determinative of any of those issues, said the court. This conclusion seemed to give insufficient attention, in our view, to the argument that plaintiffs have predicated their claims on proof that BPA is allegedly unsafe: the undisclosed facts are not material unless BPA is not safe. The products are not unmerchantable unless BPA is unsafe, Since plaintiffs base their claims on such evidence, the claims seemed to fall within the primary jurisdiction of the FDA.  The MDL court did not agree.

Turning to the preemption issue, the court first rejected the claim of implied preemption. While noting that FDA has approved BPA use in food additives and noting the agency’s decision not to require labeling, the court concluded that the FDA’s approval of BPA as safe without labeling requirements establishes only a regulatory minimum; nothing in these regulations either required or prohibited defendants from providing the disclosures sought. The court cited Wyeth v. Levine for the proposition that that there is no preemption when federal law did not prevent the drug manufacturer from strengthening its drug label as necessary to comply with the standard to be imposed by state law.

However, the Formula Defendants also raised express preemption; they asserted that the FDA regulations exempt Formula Defendants from having to disclose the presence of BPA in their products. Express preemption exists when a federal law explicitly prohibits state regulation in a particular field. With respect to food labeling, federal law generally prohibits states from establishing any differing requirements for the labeling of food. Thus, plaintiffs’ claims are expressly preempted because they would impose disclosure requirements concerning BPA, the exact opposite of the exemption. Now, here is the interesting twist: plaintiffs asserted that Congress also provided an exception to express preemption under the law for “any requirement respecting a statement in the labeling of food that provides for a warning concerning the safety of the food or component of the food.”  But, the court noted, plaintiffs cannot have it both ways.  If their claims are based on warnings about the safety of food, then their claims would have been subject to dismissal under the primary jurisdiction doctrine because the determination whether BPA is “safe” is solely the province of the FDA, and the FDA has concluded that the use of BPA in epoxy liners is “safe” so long as the manufacturer abides by the FDA’s prescribed conditions. See 21 C.F.R. § 175.300 (2009).  If the claims against the Formula Defendants are not subject to primary jurisdiction, as plaintiffs argued, then they are subject to express preemption analysis.

It may seem clear to readers of MassTortDefense that even with respect to those claims the court concluded should not be dismissed on the pleadings, the court's analysis highlights several issues that may make it difficult for the plaintiffs to proceed as a viable class action. 

 

BPA Update

The FDA's Science Board earlier this week heard  an update from the agency regarding the continued assessment of Bisphenol-A (BPA) in FDA-regulated products. (The Science Board to the Food and Drug Administration provides advice primarily to the Commissioner and other government officials on complex and technical issues as well as emerging issues within the scientific community.  The Board consists of a core of 21 members who are supposed to be authorities knowledgeable in the fields of food safety, nutrition, chemistry, pharmacology, toxicology, clinical research, and other scientific disciplines. Members represent academia and industry.)

At the meeting's update from the agency regarding the continued assessment of BPA,  the FDA Acting Deputy Commissioner briefed the agency's Science Board about agency plans to complete its evaluation of bisphenol A;  Dr. Goodman, who is also FDA's acting chief scientist, reportedly stated that the FDA will decide by Nov. 30 whether it will regulate bisphenol A in food packaging. FDA's National Center for Toxicological Research also described a variety of rodent and monkey studies that FDA is undertaking to further assess bisphenol A and potential health effects.

A representative of the Natural Resources Defense Council was among the public speakers who urged FDA to ban bisphenol A, despite the fact that the few studies of laboratory animals that have suggested an association with reproductive or developmental issues have used nonstandard test methods. Studies using standard protocols have not found any significant problems. The American Chemistry Council, BPA Joint Trade Association, and other industry groups argue that food and beverage containers made with BPA pose no undue risk of harm.  BPA is used in the lining of some food and beverage cans to prevent spoilage and is also used in a variety of other consumer products to enhance the structural integrity of plastic containers. Assessments conducted by Health Canada and California's Environmental Protection Agency suggest that dietary exposure would not pose risk to infants. Infant formula may be the most highly regulated food in the world.

Earlier this month, the Massachusetts Department of Public Health issued a health advisory   to parents and caretakers of children up to the age of two years suggesting they avoid the use of products that contain BPA for making or storing infant formula and breast milk. The state health agency further advised pregnant and breastfeeding women to avoid products that may contain BPA. The agency also noted that researchers caution that more research needs to be conducted.

Readers of MassTortDefense interested in BPA issue may want to look at "Science Suppressed: How America became obsessed with BPA,"  an in-depth examination by the STATS program at George Mason University of the science, risk assessment, and media coverage of the chemical, based on interviews with the lead authors of two major risk assessments, and focusing on the accuracy of the media's campaign to have the chemical banned. Some newspapers' coverage has had a knack, says the study, for avoiding research that showed BPA was safe, including risk assessments by the European Union, NSF International, Japan, and a lot more. Some of the media coverage has relied on a small circle of researchers whose work on BPA has been rejected by risk assessments across the world.


After the National Toxicology Program draft report was issued in early 2008, plaintiffs' attorneys nationwide began filing consumer class action complaints claiming violations of state consumer protection laws, fraud, breach of warranty, unjust enrichment, strict product liability, breach of contract and negligence. The lawsuits were consolidated as an MDL in the Western District of Missouri, last year (MDL-1967).  This multidistrict litigation consists of more than 25 cases that involve allegations concerning in baby bottles.

FDA To Revisit BPA Assessment

The U.S. Food and Drug Administration has reportedly agreed to take a further look at its 2008 decision that bisphenol A in certain food and drink containers doesn't pose a significant safety threat. Newly appointed FDA Commissioner Margaret Hamburg is reported to have put the agency's acting chief scientist in charge of the review, which could take 3-6 months. In her first appearance before Congress as commissioner, Hamburg told the House Energy and Commerce Subcommittee on Health that the FDA is re-examining its position on BPA.

Reps. Henry Waxman, D-Calif., and Bart Stupak, D-Mich., sent a letter to the FDA earlier this month asking the agency to revisit its earlier conclusion. The Committee on Energy and Commerce and its Subcommittee on Oversight and Investigations have been investigating the possible risks of the chemical BPA in consumer products and food product containers, particularly in infant formula containers and other items used by infants and children. The Congressmen pointed to the October, 2008, report of FDA's advisory Science Board Subcommittee, which raised questions about some data aspects of the agency's conclusion. "Based on this information, we request that FDA reconsider the Bush Administration's position that BPA is safe at current estimated exposure levels," said the letter.

In addition to their letter to the FDA, the legislators sent a request to the North American Metal Packaging Alliance, an industry group, creating a straw man about alleged tactics the industry might contemplate using in a future hypothetical public relations strategy to counter efforts to ban BPA. The duo requested a list of all attendees at group meetings, including their affiliations and contact information, certainly a chilling attack on the trade group member's right to free speech and freedom of association.

As reported here at MassTortDefense, FDA had already decided to support additional research with regard to its analysis of BPA safety in plastic baby bottles and food and drink containers. The FDA’s basic position remains that current human exposure to BPA in food-packaging materials provides an adequate margin of safety. FDA has been re-evaluating available data and planning for the acquisition of additional data that will strengthen the exposure estimates from all dietary sources of BPA, with particular attention to dietary sources relevant to infants and children.


Makers of BPA say that the chemical poses no known risk to human health at current exposure levels. In response to public demand, some manufacturers have begun introducing products for infants and children that are BPA-free. The Environmental Protection Agency has calculated that adults and infants can consume 50 micrograms of BPA per kilogram of body weight every day over a lifetime with little appreciable risk of harm.  But Democrats have introduced bills in Congress to ban the chemical.

 

Bills to Ban BPA Introduced in Congress

In the past few days, bills were introduced in both houses of Congress to ban bisphenol A in all food and beverage containers in the U.S.

The so-called Ban Poisonous Additives Act of 2009 is sponsored Rep. Edward Market, D-Mass. in the House, and by Sen. Dianne Feinstein, D-Calif. and Sen. Charles Schumer, D-N.Y. in the Senate. In the House it is H.R. 1523. In the Senate it is S.593

The proposed legislation would ban the sale of reusable beverage containers like baby bottles and thermoses that contain BPA and prohibit other food and beverage containers, including canned food and formula, containing the chemical from entering the market.

The bill, which would take effect 180 days after it is enacted, allows manufacturers who can show that a particular container cannot be made without BPA to obtain a renewable one year waiver to the ban. During that time, the company must label the product as containing BPA and submit a plan for removing the chemical in the future.

The bill also requires the secretary of HHS to conduct a periodic review of the list of substances that have been deemed safe for food and beverage containers, to determine whether new scientific research shows that the substances pose health risks. This review must take place “not less than once every 5 years,” under the bill.

MassTortDefense has posted about BPA issues before. With regard to BPA generally, based on all available evidence, the consensus of regulatory agencies in the United States, Canada, Europe, and Japan is that the current levels of exposure to BPA through food packaging do not pose an immediate health risk to the general population, including infants and young children.

Also in the press, six manufacturers — Avent, Disney First Years, Gerber, Dr. Brown, Playtex and Evenflo — announced that they would ban BPA in baby bottles they sell in the U.S. And Sunoco indicated that it had stopped selling BPA to anyone who would not promise to prohibit its use in products intended for children ages three and under.

Many of these companies are defendants in the ongoing BPA litigation, and their voluntary actions reflect the legal risks far more than the science. The companies noted this decision may address growing public concern and confusion regarding products made with polycarbonate plastic, but was not because these FDA-regulated products are not safe.

Any wide-spread ban of this product – or litigation accomplishing the same result -- may risk the public safety more than enhance it. Epoxy resins derived from bisphenol A are used to manufacture protective polymer coatings for the inner surface of metal food and beverage containers. This critical technology protects the contents of these containers from aggressive food products, thereby assuring a safe, wholesome, and nutritious food supply. Compared to other coating technologies, coatings derived from epoxy resins provide superior adhesion to the metal surface, greater durability, and higher resistance to the wide range of chemistry found in foods and beverages. These attributes are essential to protect the packed food from microbiological contamination, which is a significant food safety issue.

Canning might be the single most important innovation in the preservation of food in history. More than 1500 food items are regularly packed in cans, making out of season foods globally accessible year-round. More than 90% of food and beverage cans use epoxy-based coatings because of their strength, adhesion, formability and resistance to chemical reactions in the food and drinks -- without affecting the taste or smell of the product. They protect the food from the container and from bacterial contamination. They give canned foods their long shelf-life.

 

 

 

Update on BPA From FDA

The Food and Drug Administration has announced a public meeting on BPA to be held on February 24, 2009, by the Science Board to the FDA. This public advisory committee, whose function it is to provide advice and recommendations to the agency on FDA’s various regulatory issues, will discuss updates from the agency on the continued assessment of Bisphenol A in FDA-regulated products. The Science Board will also hear about the plans for (1) The review of FDA Center’s science programs, (2) the review of each Center’s projects within scientific priority areas.

The meeting will be held at the Hilton Washington DC, North/Gaithersburg, 620 Perry Pkwy., Gaithersburg, MD 20877. FDA intends to make background material available to the public no later than 2 business days before the meeting.

Late last month, the FDA and Health Canada’s Health Products and Food Branch hosted a meeting of representatives of U.S. and Canadian manufacturers and users of food packaging materials containing BPA to discuss what is being done to concerning the potential levels of the chemical in food. The meeting was also part of FDA’s efforts to assist industry in its voluntary BPA related efforts.


The meeting was designed to provide a forum for:
• Updating the industry on the FDA’s and Health Canada’s current activities and planned research to further assess the exposure to BPA and manage any potential risks from the chemical.
• Describing manufacturers’ research activities, their work to refine packaging manufacturing practices to minimize migration of BPA into food, and recent marketplace developments.
• Dialogue by the participants about further information from regulated industry stakeholders that would be helpful to the FDA and Health Canada in updating and refining their BPA risk assessments.
• Dialogue about the different uses of BPA in food contact applications and the variation in possible availability of fully functional and evaluated alternative substances.
• Discussion of the possibility whether, because of availability of alternative products, polycarbonate baby bottles could cease to be a substantial component of the North American market in the future.


With regard to BPA generally, based on all available evidence, the consensus of regulatory agencies in the United States, Canada, Europe, and Japan is that the current levels of exposure to BPA through food packaging do not pose an immediate health risk to the general population, including infants and young children.


Health Canada’s Health Products and Food Branch has concluded that current dietary exposure to BPA through food packaging uses is not expected to pose a health risk to the general population, including newborns and infants. However, using an extremely precautionary approach, the Government of Canada has taken steps to reduce exposure to BPA for infants and young children.
The FDA is currently preparing a detailed response to the October, 2008 review by the FDA Science Board of the agency's draft assessment of the safety of BPA for use in food contact applications. The draft assessment focused on the concerns for developmental toxicity identified in recent assessments of BPA, including those of the National Toxicology Program and their expert panel. For example, the FDA is reviewing research about the potential low-dose effects of BPA. 

Update on BPA

Several recent developments concerning BPA.


The Canadian government announced earlier this month that it intends to draft new regulations to prohibit the importation, sale, and advertising of baby bottles containing bisphenol A; the proposed bans are to take effect in 2009.


Environment Canada and Health Canada have released a scientific assessment, concluding that bisphenol A poses no danger to the general public, but expressing some uncertainty about its potential impact on infants up to 18 months of age. The scientific evidence of the neuro-developmental and behavioral impact of bisphenol A on rodent test subjects, although highly uncertain and not capable of easy extrapolation to humans, is apparently providing the basis for taking action to limit exposure to the substance for newborns and infants. The government plans also to allocate almost $2 million to support additional research on bisphenol A.


The first regulatory step comes as Environment Canada and Health Canada published a notice of their intention to designate bisphenol A as toxic under the Canadian Environmental Protection Act, a first step that allows the government to take regulatory action on the chemical. The agencies also issued a draft risk management approach for the chemical that aims to reduce releases of the substance into the environment. The proposed risk management plan, which is open to a 60-day public comment period that started on Oct. 18, said that BPA should be managed using a life cycle approach that prevents or minimizes its release into the environment.


The Canadian draft plan incorporates a regulatory ban on the import, sale, and advertising of polycarbonate baby bottles made with bisphenol A. It calls for the adoption of an “as low as reasonably achievable” principle in the packaging of canned infant formula, and indicates that the government will develop migration target levels for bisphenol A from infant formula cans to the formula they contain. The government proposes exploration of imposing migration targets for bisphenol A in canned foods in general.  The regulations will establish maximum bisphenol A concentrations in industrial effluents and will require the implementation of management systems for facilities where the substance is used, the draft plan said.


In addition, the plan calls for a survey on the content of bisphenol A in medical devices, further research on exposure of pregnant women to the substance, monitoring through the Canadian Total Diet Study, and additional environmental monitoring in waste water effluents and waters downstream from waste water treatment plants.


Meanwhile, back in the States…
State attorneys general from Connecticut, Delaware, and New Jersey called on manufacturers of baby bottles and baby formula to stop using BPA in their products. The AGs cite the recent studies in letters to the companies urging them to stop putting BPA into infant formula containers. “Mounting evidence suggests that BPA from the lining of these cans leaches directly into the infant formula,” claimed the AGs.


The AGs cited a February 2008 publication of the Work Group for Safe Markets, a coalition of liberal public health and environmental advocacy organizations, advocating without much support  that low levels of exposure to BPA may cause damage to reproductive, neurological, and immune systems during stages of fetal and infant development. They also cite the study released by Yale School of Medicine on BPA exposure and effects on brain function and mood disorders in monkeys.


The letters were reportedly sent to: Avent, Disney First Years, Gerber, Dr. Brown, Playtex, Evenflo, Abbott, Mead Johnson, PBM Products, Nature's One, and Wyeth.


Finally, the FDA Science Board Subcommittee on Bisphenol A has just released comments on the FDA’s draft exposure assessment of BPA. The Science Board provides advice primarily to the Commissioner of the FDA and other appropriate officials on specific complex and technical issues as well as emerging issues within the scientific community. This 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 this Subcommittee is the scientific peer-review of the draft assessment prepared by the FDA of bisphenol A for use in food contact applications.

While the Subcommittee agrees with the focus of the draft assessment on dietary exposures to children, they believe that the FDA assessment would be strengthened by considering cumulative exposures and differential risk in neonates. They also recommend that the FDA exposure assessment be expanded to include a larger number of infant formula samples and that it rely on mean values rather than accounting for the variability in samples. Until the qualitative and quantitative information (including application of uncertainty factors) is revised, the Subcommittee cannot yet agree that the Margins of Safety defined by FDA are adequate.
 

FDA Announces Meeting On BPA

The FDA has announced a forthcoming meeting of the Science Board to the Food and Drug Administration, on the topic of BPA. The Science Board provides advice primarily to the Commissioner of Food and Drugs and other appropriate officials on specific complex and
technical issues as well as emerging issues within the scientific community in industry and academia.  At the meeting, on October 31, 2008, the Science Board will hear about and discuss a review of the draft assessment of Bisphenol A for use in food contact applications by the Science Board BPA Subcommittee. The Board will also hear an overview of current methods for detection of contaminants in FDA-regulated products.

In early 2008, FDA formed an agency-wide BPA task force to facilitate cross-agency review of current research and new information on BPA for all FDA regulated products. Medical devices containing the chemical are now also on the FDA’s radar screen. See the note in FDA News.  BPA is used in dialysis tubing, blood oxygenators, and dental sealants. And now that an evaluation examining migration of BPA from food contact materials has been drafted, the agency is apparently planning to publish a document assessing the safety of BPA exposure from regulated devices, biologics and pharmaceuticals.

The FDA's recent assessment was particularly focused on the concerns for developmental toxicity identified in recent assessments of BPA, including those of the National Toxicology Program and their expert panel, based on animal data. FDA concluded that this data was insufficient to merit a change in the exposure levels the agency currently allows for BPA. FDA concluded that an adequate margin of safety exists for BPA at current levels of exposure from food contact uses, for infants and adults. This assessment represents a full examination of data considered pivotal to the relevant exposure levels associated with food contact substances, the FDA said.


 

Latest BPA Update

Here is the latest on BPA:

1. NTP Issues Final Report

The National Toxicology Program issued its final report on bisphenol A (BPA) earlier this month. NTP continued its position from a much publicized draft report (see the post here) that it has some concern that the chemical – used in plastic bottles and other packaging -- could affect the development of the prostate gland and brain and potentially affect the behavior of fetuses, infants, and children. See The Monograph on the Potential Human Reproductive and Developmental Effects of Bisphenol A.

The report provides the NTP’s current opinion on BPA’s potential to cause harm to human reproduction or development. The report is part of a review of the scientific literature on BPA and takes into consideration public and peer review comments received on the earlier draft report. According to NTP, about 2.3 billion pounds were produced in the United States in 2004, with more than 90 percent of the population being exposed to the substance.

The conclusions are based primarily on animal studies. The literature on experimental animal studies is filled with many conflicting findings, NTP says. And NTP admits that there remains considerable uncertainty whether the changes seen in the animal studies are directly applicable to humans, and whether they would result in clear adverse health effects. NTP also states that more research is clearly needed to understand exactly how these findings relate to human health and development. There are a number of remaining uncertainties in the scientific information on BPA, according to the report.

The NTP is an interagency federal research program at the National Institute of Environmental Health Sciences, part of the National Institutes of Health. The report uses a five-level scale ranging from negligible risk to serious concern.

The report expresses “minimal concern” that BPA exposure will affect development of the mammary gland or accelerate puberty in females. (Previously, NTP said it had some concerns about those effects, but a panel of experts concluded that the program overstated its concerns about mammary gland effects and early puberty.) The NTP expressed “negligible concern” that exposure of pregnant woman to BPA will result in fetal or neonatal mortality, birth defects or reduced birth weight and growth in their offspring. And the report also expressed “negligible concern” that exposure to BPA causes reproductive effects in non-occupationally exposed adults and “minimal concern” for workers exposed to higher levels in occupational settings.


The FDA responded to the final report, noting that it would consider this final report at FDA's Science Board meeting concerning the FDA’s draft assessment of bisphenol A.  Which brings us to development No.2.

2. FDA Meeting
FDA held a public meeting last week, with a range of scientists, industry representatives, and consumer advocates debating aspect of bisphenol A usage.

The focus of the meeting was the FDA’s draft risk assessment that found continued use of bisphenol A in food-contact materials would be safe. Among the highlights:

An EPA toxicologist who served on NTP's expert panel said the NTP's statements that it has "some concern" meant more research was needed. It did not imply that the NTP expert panel had concluded that harm was being caused by the chemical.

A toxicologist working at the National Institute of Environmental Health Sciences said that NTP reported it had "some concern" about neurological, behavioral, and prostate effects because the animal studies that found those effects involved exposures at levels similar to those expected for infants.

The head of the pediatrics department of the Medical College of Wisconsin suggested that FDA conduct or fund more exposure research to get a better understanding of infants' exposure. FDA’s estimates and NTP’s estimates of typical exposure were slightly different.

A representative of the polycarbonate business unit of the American Plastics Council noted that there have been at least two studies of bisphenol A levels in infant formula since FDA completed its study, including one by the Environmental Working Group. All have found levels comparable to what FDA used.

Other speakers noted that BPA is a relatively well studied chemical, and compounds that could be used as substitutes are unlikely to have as much information available about their safety. Clearly, some uses of bisphenol A, such as in children's bicycle helmets, provide many safety benefits. BPA has also been found to be safe with an unmatched performance in lining cans. The Environmental Working Group, said there are substitutes, in their view, already on the market for uses such as in baby bottles.

A toxicologist from the University of Missouri-Columbia worried that FDA's recommended tests might mean it would take many more years before the agency might take any necessary regulatory action to reduce exposure.

John van Miller of the American Chemistry Council, cited the multi-dose, multigenerational, significant studies conducted in accordance with internationally agreed-upon protocols that have found bisphenol A to be safe. The "Reproductive Health Technologies Project" disagreed and underscored the need for studies in their view.

The Bisphenol A Subcommittee is to brief FDA's Science Board later this Fall on the subcommittee's recommendations. The Science Board will then develop its own recommendations for BPA.


3. JAMA Study
The Journal of the American Medical Association published a study last week which has been reported in the popular press as showing that subjects with higher levels of bisphenol A in their urine were more likely to report that they had heart disease or diabetes. See Association of Urinary Bisphenol A Concentration with Medical Disorders and Laboratory Abnormalities in Adults.

Higher levels of human urinary BPA were reportedly associated with cardiovascular disease, type 2 diabetes, and liver-enzyme abnormalities, according to the study, which was discussed at the FDA public meeting. The study used data from the National Health and Nutrition Examination Survey (NHANES) 2003-2004. The survey involved the measured urinary bisphenol A concentrations of 1,455 adults, ages 18 through 74 years. 
 

The investigators noted that orally administered BPA is rapidly and completely excreted by humans.  On of the limitations of the analysis is its cross-sectional nature: it does not offer longitudinal data demonstrating that BPA concentrations predict later onsets of biochemical change or disease. The authors cautioned that their method may have resulted in false-positive associations. The authors have recommended an independent replication of the study, and follow-up studies to explore their findings and to provide evidence on whether the associations are causal. Not well reported in the media is the fact that the research team used four methods to measure whether bisphenol A was associated with diabetes, but found that association in only one of the four methods. The study thus is primarily useful for generating hypotheses that can be tested, not for drawing any conclusions on human health effects.

 

FDA To Hold Meeting On BPA Issues

For those readers of MassTortDefense interested in the issues surrounding BPA, the FDA has announced a meeting of its Bisphenol A (BPA) Subcommittee of the Science Board.

The topic to be discussed is the draft assessment of BPA for use in food contact applications. The Subcommittee will hear and discuss the draft assessment of BPA for use in food contact applications, including oral presentations from the public. The meeting will be held on September 16, 2008.

The FDA draft assessment report finds that the chemical does not pose a serious health risk under current uses. The new assessment was particularly focused on the concerns for developmental toxicity identified in recent assessments of BPA, including those of the National Toxicology Program and their expert panel, based on animal data. FDA concluded that this data was insufficient to merit a change in the exposure levels the agency currently allows for BPA. FDA concluded that an adequate margin of safety exists for BPA at current levels of exposure from food contact uses, for infants and adults. This assessment represents a full examination of data considered pivotal to the relevant exposure levels associated with food contact substances, the FDA said.
 

BPA Update

The U.S. Food and Drug Administration has released a draft report finding that the chemical bisphenol A does not pose a serious health risk. BPA is used in several products, including some plastic baby bottles, food containers, and water bottles. The chemical is added to make polycarbonate plastic bottles clear and shatterproof.

As MassTortDefense has noted before, and here, BPA has been much in the news. In May, 2008, FDA officials told a congressional panel that the agency had no reason to recommend that consumers stop using products containing BPA.  FDA has been examining the data on BPA in anticipation of a September meeting on the issues surrounding the potential toxicity of the chemical. The new draft document will be reviewed by the Bisphenol A Subcommittee of the FDA Science Board on Sept. 16th. Details on the science panel's meeting can be found here.

The new assessment was particularly focused on the concerns for developmental toxicity identified in recent assessments of BPA, including those of the National Toxicology Program and their expert panel, based on animal data. FDA concluded that this data was insufficient to merit a change in the exposure levels the agency currently allows for BPA. FDA concluded that an adequate margin of safety exists for BPA at current levels of exposure from food contact uses, for infants and adults. This assessment represents a full examination of data considered pivotal to the relevant exposure levels associated with food contact substances, the FDA said.


To avoid underestimating risk, FDA said it made the conservative assumption that an infant drank only formula from cans lined with a bisphenol A-based enamel coating and that the parents heated that formula in polycarbonate baby bottles. Based on such assumptions, FDA estimated that an infant might consume up to 2.42 micrograms bisphenol A per kilogram body weight. Based on animal studies, FDA estimated that the no observed adverse effect level (NOAEL) for bisphenol A would be 5 milligrams per kilogram body weight. That means the margin of exposure, or the difference between infants' exposure and the NOAEL, is about 2,000x. That is, FDA said, "an adequate margin of safety...."

FDA's draft conclusion is consistent with the European Food Safety Authority's July 23 statement that it considers current uses of bisphenol A to be safe. FDA's draft assessment called for more research, and said data from nonhuman primates would be helpful, along with measurements of bisphenol A in the U.S. population. 
 

In other BPA news, the California Assembly rejected a bill (S.B. 1713) that would have banned bisphenol A in children's products, specifically BPA at levels above 0.1 part per billion in baby bottles, cups, food containers, or any other container designed for children under the age of 3 years. By Jan. 1, 2012, S.B. 1713 would have barred the sale of any liquid, food, or beverage in any can or jar containing 0.5 ppb or more of bisphenol A. The American Chemistry Council and numerous experts have contended the products the bill would ban are safe.
 

MDL Created For BPA Litigation

On August 13th, the JPML created MDL 1967, IN RE: BISPHENOL-A (BPA) POLYCARBONATE
PLASTIC PRODUCTS LIABILITY LITIGATION.

The panel's order found that these actions share factual questions arising out of allegations that various defendants manufactured, sold or distributed polycarbonate plastic bottle products containing Bisphenol-A without disclosing its possible harmful effects. The cases were assigned to Judge Ortrie Smith of the Western District of Missouri.

At the time of the motion to create the MDL, this litigation consisted of fourteen actions pending in eight districts as follows: four actions in the Central District of California; two actions each in the Eastern District of California, the Western District of Missouri, and the Western District of
Washington; and one action each in the Eastern District of Arkansas, the District of Connecticut, the Northern District of Illinois, and the District of Kansas.

While the motion was pending, the Panel was notified that nine additional related actions have been filed: three actions in the Central District of California, and one action each in the Eastern District of Arkansas, the Northern District of Illinois, the District of Kansas, the Western District of Missouri, the Southern District of Ohio, and the Western District of Washington. These actions will be treated as potential tag-along actions.
 

MassTortDefense has posted on BPA and here.  BPA received considerable recent attention due to widespread human exposures and concern for possible reproductive and developmental effects reported in laboratory animal studies. A recent draft report by the Center for the Evaluation of Risks to Human Reproduction (CERHR) of the National Toxicology Program (NTP) examined the Food and Drug Administration finding that bisphenol-A is safe when used to line infant formula cans. The CERHR/NTP draft report expressed "some concern" based on animal studies that the chemical might affect the neurological systems and behavior of fetuses, infants, and children.

The NTP Brief on Bisphenol A is not a quantitative risk assessment, nor is it intended to supersede risk assessments conducted by regulatory agencies. The NTP Brief on Bisphenol A does not present a comprehensive review of the health-related literature; it does not include a comprehensive analysis of the issues related to this chemical. The NTP report relies heavily on animal testing, rather than human epidemiology. Regarding the neural and behavioral effects reported in some studies of rats and mice at relatively low BPA doses, the Panel authoring the report also acknowledges that it is not even clear whether these effects should be construed as an adverse toxicological response. The draft report does not conclude that BPA is dangerous. It notes that further research is needed – that’s the right approach to new data or concerns about a product that has been in use for decades. And the key reported low-dose effects are not replicated or corroborated.

The European Food Safety Authority recently concluded a report with a key conclusion that after exposure, the human body rapidly metabolizes and eliminates BPA. This represents an important metabolic difference compared with rats, and suggests certain animal models are not all that useful. That is, people metabolize and excrete BPA far more quickly than rodents. This evidence further limits the relevance of low-dose effects of BPA reported in some rodent studies used for human risk assessment.

 

 

European Food Safety Authority Weighs In On BPA

The European Food Safety Authority’s AFC Panel has issued a further scientific opinion report on the chemical bisphenol-A (BPA). MassTortDefense has posted on BPA here and here. The goal of the assessment was to focus on the chemicals’ elimination from the body and how that might relate to the risk assessment of BPA in humans. The work took into account the most recent data since the EFSA’s 2006 opinion report, which concluded that exposure to BPA is well below the Tolerable Daily Intake (TDI).  A TDI is a regulatory standard for dietary exposure calculated to ensure that no adverse effects occur.


About EFSA
The European Food Safety Authority is an independent European agency funded by the EU. The EFSA is governed by an independent Management Board whose members are appointed to act in the public interest and do not represent any government, industry, or private sector. EFSA’s role is to assess and communicate on all risks associated with the food chain. Since EFSA’s advice serves to inform the policies and decisions of risk managers, a large part of EFSA’s work is undertaken in response to specific requests for scientific advice from the European Commission, the European Parliament, and EU Member States. The AFC Panel focus is on food additives, flavorings, processing aids and materials in contact with food.

Conclusions

The key conclusion of the Panel on BPA is that after exposure, the human body rapidly metabolizes and eliminates the substance. This represents an important metabolic difference compared with rats, and suggests certain animal models are not all that useful. That is, people metabolize and excrete BPA far more quickly than rodents. This evidence further limits the relevance of low-dose effects of BPA reported in some rodent studies used for human risk assessment.

The Panel further concluded that the exposure of a human in utero to BPA would be negligible because the mother rapidly metabolizes and eliminates BPA from her body. The scientists also concluded that newborns are similarly able to metabolize and eliminate BPA at doses below 1 milligram per kilogram of body weight per day. This implies that newborns could effectively clear BPA at levels far in excess of the TDI of 0.05 mg/kg bw set by the Panel, and therefore its 2006 risk assessment remains valid. The TDI provides a sufficient margin of safety for the protection of the consumer, including fetuses and newborns, EFSA said.

EFSA took note of the U.S. National Toxicology Program’s draft brief on BPA, and of the Canadian government’s recent Draft Screening Assessment on BPA, which took into account findings from low-dose animal studies, notably with respect to neuro-developmental toxicity. It pointed out that these studies were limited in rigor, consistency and biological plausibility.

The new European report is consistent with the statements of the FDA that a large body of evidence indicates that currently marketed products containing BPA, such as baby bottles and food containers, are safe and that exposure levels to BPA from these products are well below those that may cause health effects.

House Committee Holds Hearing On Phthalates And BPA In Consumer Products

The House Energy and Commerce Committee’s subcommittee on Commerce, Trade, and Consumer Protection held a hearing last week on “Phthalates and Bisphenol-A in Everyday Consumer Products.” See webcast here.  (MassTortDefense has posted on BPA before, here and here and here.  Phthalates are chemicals used to soften polyvinyl chloride (PVC) and make it flexible.)


This testimony before Congress pointed out one of the major problems with the knee-jerk reaction of sensationalist media, liberal lobbyists, and uninformed legislators who quickly call for the banning of useful products as soon as any scientific reports even hint of a risk. A chemist from the Consumer Product Safety Commission noted that the banning of di-isononyl phthalate (DINP) from all children's products, could lead to substitute plasticizers that are not as fully studied, not as well known, or not as well characterized toxicologically. And banning BPA could lead to more children injuries.


In addition to the CPSC, officials of the FDA, NTP, and EPA testified as well before the House subcommittee on June 10th. Also, the Science and Environmental Health Network testified in favor of a ban, while the American Chemistry Council opposed it. The hearing came as House and Senate conferees are working out differences in their respective legislation to reform the CPSC. See the MassTortDefense post here on that. The industry voluntarily removed DINP from teethers, rattles, and pacifiers in the late 1990’s. The Senate version of the CPSC bill would essentially prohibit these phthalates from children's toys or child care articles: DINP, di-isodecyl phthalate (DIDP), di-n-octyl phthalate (DnOP), di-(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), and benzyl butyl phthalate (BBP).

Bisphenol-A (BPA) was the other chemical at issue in the hearing. The CPSC official testified that its beneficial uses in items such as helmets and other protective gear to prevent injuries in children needs to be considered. A ban could result in less effective protection of children from head, eye, or bodily injury. Rep. Edward J. Markey (D-Mass.), a member of the House Energy and Commerce Committee, has introduced legislation that would prohibit the use of bisphenol-A in all food and beverage containers. (The “Ban Poisonous Additives (BPA)” Act, text here.)  But the Food and Drug Administration associate commissioner for science testified that available evidence indicates that food contact materials containing BPA currently are safe as exposures from food contact materials are well below the levels that may cause health effects.

The FDA formed a BPA task force in April that is reviewing current research on BPA, and looking at all products regulated by the FDA to better understand potential routes of exposure. The FDA also is looking at concerns raised by the draft report by the National Toxicology Program. See our post here.

Latest BPA Update: Peer Review Panel Weighs In On NTP Draft Report

Latest BPA update. Readers of MassTortDefense know that a recent draft report by the Center for the Evaluation of Risks to Human Reproduction (CERHR) of the National Toxicology Program (NTP) examined bisphenol-A (BPA). The CERHR/NTP draft report, issued April 15th for public comment, expressed "some concern" based on animal studies that the chemical might affect the neurological systems and behavior of fetuses, infants, and children. See our post here.


Officials from the U.S. Food and Drug Administration and the U.S. Consumer Product Safety Commission both told the U.S. Senate Committee on Commerce, Science and Transportation subcommittee on consumer affairs recently that bisphenol-A did not appear to pose sufficient risks that the product should be banned. Although review is ongoing, at this time those agencies have no reason to recommend that consumers stop using products containing BPA. The FDA's associate commissioner for science said that a large body of evidence indicates that currently marketed products containing BPA, such as baby bottles and food containers, are safe and that exposure levels to BPA from these products are well below those that may cause health effects. See our post here on this.


The NTP collected public comments on the draft and scheduled a June 11 peer review meeting for the draft. In comments on the NTP draft report, the American Chemistry Council asserted that the program relied on numerous studies of dubious and limited quality. Certain environmental groups sought stronger statements of concern.

The expert review panel has now concluded that the National Toxicology Program overstated some of the concerns about bisphenol A's potential developmental effects. At a meeting in Research Triangle Park, the panel, called the Board of Scientific Counselors, voted to revise the levels of concern stated in the NTP draft report on bisphenol A. In particular the “some concern" is to change to "minimal concern" regarding the neurological system and behavior of fetuses, infants, and children as might be affected by exposure to low levels of bisphenol A. (The toxicology program regularly uses "statements of concern" about different types of exposures and different groups that may be exposed to a chemical. The five levels of concern used by NTP are from highest to lowest: serious concern, concern, some concern, minimal concern, and negligible concern. )

Following its review of the draft report, the BSC panel decided that NTP had overstated bisphenol A's potential effects on mammary glands and the onset of puberty in young females. The panelists generally felt that there were insufficient scientific data to support any stronger level of concern than minimal.

The review panel said there was sufficient evidence in the studies considered by NTP to support its other statements of concern –minimal and negligible.

• The BSC accepted (7 yes, 4 no, 1 abstention) that the scientific evidence cited in the draft NTP Brief on Bisphenol A supports the conclusion of minimal concern for bisphenol A exposure in fetuses, infants, and children at current human exposures based on effects in the mammary gland. • The BSC accepted (7 yes, 4 no, 1 abstention) that the scientific evidence cited in the draft NTP Brief on Bisphenol A supports the conclusion of minimal concern for bisphenol A exposure in fetuses, infants, and children at current human exposures based on an earlier age for puberty in females.
• The BSC accepted (11 yes, 1 no) that the scientific evidence cited in the draft NTP Brief on Bisphenol A supports the NTP conclusion of negligible concern that exposure of pregnant women to bisphenol A will result in fetal or neonatal mortality, birth defects or reduced birth weight and growth in their offspring.
• The BSC accepted unanimously (12 yes, 0 no) that the scientific evidence cited in the draft NTP Brief on Bisphenol A supports the NTP conclusion of negligible concern that exposure to bisphenol A causes reproductive effects in non-occupationally exposed adults.
• The BSC accepted (11 yes, 0 no, 1 abstention) that the scientific evidence cited in the draft NTP Brief on Bisphenol A supports the NTP conclusion of minimal concern for workers exposed to higher levels of bisphenol A in occupational settings.

The panel also accepted the mid-level “some” concern expressed in two areas.

• The BSC accepted unanimously (12 yes, 0 no) that the scientific evidence cited in the draft NTP Brief on Bisphenol A supports the NTP conclusion of some concern for neural and behavioral effects of bisphenol A in fetuses, infants, and children at current human exposures.
• The BSC accepted (10 yes, 2 no) that the scientific evidence cited in the draft NTP Brief on Bisphenol A supports the NTP conclusion of some concern for bisphenol A exposure in fetuses, infants, and children at current human exposures based on effects in the prostate gland.


The panel called for additional research to better understand bisphenol A's potential effects.

Public comments on the draft , transcripts, list of attendees, etc. found here.

FDA To Form Committee To Analyze BPA Issues

In the latest development on the issues surrounding Bisphenol-A in consumer products, the FDA announced that a subcommittee of the FDA's Science Board will hold a public meeting on the topic of BPA in plastics, review an Agency Task Force report on the topic, and deliver its findings to the Board's annual meeting this fall. Dr. Frank Torti, the FDA's principal deputy commissioner and chief scientist, has asked Science Board Chairwoman Barbara McNeil, head of Health Care Policy at Harvard Medical School, to establish a subcommittee to further assess BPA. (MassTortDefense has posted about BPA here and here.)

BPA is a chemical produced in large quantities for use primarily in the production of polycarbonate plastics and epoxy resins. Polycarbonate plastics in turn have many important applications, including use in certain food and drink packaging, e.g., water and infant bottles, compact discs, impact-resistant safety equipment, and medical devices. Polycarbonate plastic can also be blended with other materials to create molded parts for use in mobile phone housings, household items, and automobiles. Epoxy resins are used as lacquers to coat metal products such as food cans, bottle tops, and water supply pipes. Some polymers used in dental sealants or composites contain bisphenol A-derived materials.

This development comes on the heels of the FDA forming an agency-wide BPA Task Force to facilitate review of current research and new information on BPA. That Task Force is reportedly assembling an inventory of FDA-regulated products that contain BPA. Eventually, the Task Force may make recommendations to the Commissioner of Food and Drugs.

In April 2008, the National Toxicology Program (NTP) of the National Institutes of Health published a draft report indicating that some studies in animals suggest that BPA may raise “some concern” about potential developmental effects in humans. The NTP is still collecting public comments on the draft and has scheduled a June 11 peer review meeting for the draft.

In mid-May, FDA officials assured a congressional panel that the agency had no reason to recommend that consumers stop using products containing BPA, noting that a large body of evidence indicates that currently marketed products containing BPA, such as baby bottles and food containers, are safe and that exposure levels to BPA from these products are well below those that may cause health effects. See our post on the hearing.

Of course, the litigation has already begun, notwithstanding the science, with a proposed class action filed over the use of BPA in baby bottles in the U.S. District Court for the Western District of Missouri.

New BPA Study Released

At MassTortDefense we know the importance of well done scientific studies on causation, whether they be epidemiological studies of relevant populations, in vitro studies, or animal toxicology. While we don’t make a habit of posting about individual studies, BPA has been so much in the news, we thought it worth a mention of a recent animal study just published in the journal Toxicological Sciences. Tyl, et al., Two-Generation Reproductive Toxicity Study of Dietary Bisphenol A (BPA) in CD-1 (Swiss) Mice, with an abstract that can be found hereToxicological Sciences is the official journal of the Society of Toxicology and publishes peer-reviewed, hypothesis-driven, original research articles in all areas of toxicology.


The two-generation study exposed mice to a wide range of doses of bisphenol A, and found the chemical did not cause reproductive or developmental harm. The study was funded by the American Chemistry Council, and conducted under the oversight of the EU Bisphenol A Steering Group. That group, which included reproductive and developmental toxicologists from several countries, also had representatives of the World Wildlife Fund on behalf of nongovernmental organizations. The group impacted the study's design and the specific protocols used, and commented on the draft report analyzing the results.

The study was designed to fill in some of the blanks some felt existed in previous animal studies, by utilizing a species of mice particularly sensitive to hormone disruption; exposing the mice to the low doses where some say reproductive and developmental harm would occur; exposing the mice to the chemical in their feed, to mimic route of exposure; and keeping more of the mice alive longer than is typically done.

Clearly the debate over BPA will continue.

Congressional Developments: Hearings and Research Service Weighs in on BPA Issues

The Congressional Research Service has released a report on Bisphenol A (BPA) in Plastics and Possible Human Health Effects. MassTortDefense previously posted on the BPA issues and the National Toxicology Program (NTP) draft report for public comment on BPA.

 The Congressional Research Service (CRS) serves as a sort of shared staff to congressional committees and Members of Congress. CRS staffers assist at the various stages of the legislative process — from bill drafting, through committee hearings and floor debate, to the oversight of enacted laws and various agency activities.

The BPA report is authored by Linda-Jo Schierow, Resources, Science, and Industry Division; and Sara A. Lister, Domestic Social Policy Division, and comes in the immediate wake of legislation proposed in April of 2008, S. 2928, which would prohibit use of BPA in some products intended for use by children. The report notes that the levels of potential exposure to the chemical from plastics is low, although the potential health effects from such exposures is deemed controversial.

In another BPA development, officials from the U.S. Food and Drug Administration and the U.S. Consumer Product Safety Commission both told the U.S. Senate Committee on Commerce, Science and Transportation subcommittee on consumer affairs last week that bisphenol-A did not appear to pose sufficient risks that the product should be banned. Although review is ongoing, at this time those agencies have no reason to recommend that consumers stop using products containing BPA. The FDA's associate commissioner for science said that a large body of evidence indicates that currently marketed products containing BPA, such as baby bottles and food containers, are safe and that exposure levels to BPA from these products are well below those that may cause health effects.

Sen. Chuck Schumer (D-N.Y.) told the subcommittee about the bill he introduced last month to ban BPA from all products for children up to seven years old. But the CPSC official said Congress should be careful not to ban the use of polycarbonate plastic for protective items such as pacifier shields, helmets, goggles and shin guards prematurely. Such products prevent children from receiving serious injuries, and this beneficial use of polycarbonate should be balanced before acting to ban bisphenol-A from children's products. Such a ban could result in less effective protection to children from head, eye or bodily injury, and less net safety.



 

BPA Litigation Begins- But Why?

Bisphenol A (BPA) is in the news. This is a chemical produced in large quantities for use primarily in the production of polycarbonate plastics and epoxy resins. Polycarbonate plastics in turn have many important applications, including use in certain food and drink packaging, e.g., water and infant bottles, compact discs, impact-resistant safety equipment, and medical devices. Polycarbonate plastic can also be blended with other materials to create molded parts for use in mobile phone housings, household items, and automobiles. Epoxy resins are used as lacquers to coat metal products such as food cans, bottle tops, and water supply pipes. Some polymers used in dental sealants or composites contain bisphenol A-derived materials. U.S. manufacturers produce some 7 billion pounds of BPA annually, and business worldwide has been growing about 4 percent a year, driven by rising demand in Asia.


Recently, BPA has been in the news, with regulatory and legislative attention being applied, scientific data being generated, and litigation being brought. MassTortDefense questions those in the media suggesting this should be the “next mass tort.”

FDA Role

BPA has been in use for decades, and has been long regarded as safe by FDA. (Aside: Attacks on the FDA, and the alleged politicization of science is a favorite line of plaintiffs, and we will see it here. But, the agency relied in part on research backed by the American Plastics Council only because FDA had input on its design, monitored its progress, and reviewed the raw data. The fact is, it is industry's responsibility to demonstrate the safety of the products they sell; that industry generated data is used in looking at product safety is neither unusual or inappropriate. )

NTP Report
BPA received considerable recent attention due to widespread human exposures and concern for possible reproductive and developmental effects reported in laboratory animal studies. A recent draft report by the Center for the Evaluation of Risks to Human Reproduction (CERHR) of the National Toxicology Program (NTP) examined the Food and Drug Administration finding that bisphenol-A is safe when used to line infant formula cans.

The CECHR was established by the National Institute of Environmental Health Sciences (NIEHS) as part of the National Toxicology Program in 1998. CERHR convenes a scientific expert panel that meets in a public forum to review, discuss, and evaluate the scientific literature on a selected chemical. CERHR selects chemicals for evaluation based upon several factors including production volume, extent of human exposure, public concern, and the extent of published information from reproductive and developmental toxicity studies.

The CERHR/NTP draft report, issued April 15 for public comment, expressed "some concern" based on animal studies that the chemical might affect the neurological systems and behavior of fetuses, infants, and children.


Legislative Reaction

The legislative [knee jerk] reaction? Sen. Charles Schumer (D-N.Y.) and Sen. Dianne Feinstein (D-Calif.) announced recently that they have introduced legislation that would prohibit the use of bisphenol-A in all children's products. Canada recently proposed to ban bisphenol-A from polycarbonate baby bottles. Several states also are considering legislative bans or restrictions on the chemical. California legislators, for example, are considering a bill that would ban BPA in children's products.

Litigation?

And the litigation wasn’t far behind. A California woman has initiated a class action accusing Nalge Nunc International Corp. of suppressing key information about the potential health risks of its hard-plastic sports bottles containing bisphenol A. See Felix-Lozano v. Nalge Nunc International Corp., E.D. Cal., No. 08-cv-854, filed 4/22/08). Of course, the suit comes despite the fact the manufacturer already announced it was phasing out the production of bottles using the chemical within a few months. Plaintiff does not claim use of the bottles has harmed her or her children's health. As is typical with product claims in which the plaintiff was not injured by the product, the suit alleges fraud, and violations of consumer fraud laws, specifically the Unfair Competition Law, False Advertising Law, etc. Based on all available scientific evidence, the defendant in this case continues to believe that products containing BPA (bisphenol-A) are safe for their intended use.

However, plaintiffs will try to treat the product-line change/subsequent remedial measure as an admission of liability rather than a simple reflection of the fact that customers indicated they preferred BPA-free alternatives and the company acted in response to those concerns. U.S. retailers Wal-Mart and Toys 'R Us have already removed baby bottles containing BPA from store shelves. Playtex said it would offer free non-BPA bottles to parents and will stop using BPA in all products by the end of the year.

And a purported class action has been filed over the use of bisphenol A in plastic baby bottles and toddler training cups. The suit, Maria Sullivan et al. v. Avent America Inc. et al., 4:08-cv-00309 (W.D.  April 30, 2008), alleges that five baby bottle makers failed to disclose that BPA poses risks to an infant’s brain and sexual development. Plaintiffs allege that defendants continue to represent that their BPA-laced products are safe despite mounting evidence to the contrary. The suit is seeking to recover the amount plaintiffs spent to purchase the defendants’ products and the amount plaintiffs spent and will spend to replace the products.

Does the NTP draft report warrant all this?

The NTP Brief on Bisphenol A is not a quantitative risk assessment, nor is it intended to supersede risk assessments conducted by regulatory agencies. The NTP Brief on Bisphenol A does not present a comprehensive review of the health-related literature; it does not include a comprehensive analysis of the issues related to this chemical. The NTP report relies heavily on animal testing, rather than human epidemiology. Regarding the neural and behavioral effects reported in some studies of rats and mice at relatively low BPA doses, the Panel authoring the report also acknowledges that it is not even clear whether these effects should be construed as an adverse toxicological response. The draft report does not conclude that BPA is dangerous. It notes that further research is needed – that’s the right approach to new data or concerns about a product that has been in use for decades. And the key reported low-dose effects are not replicated or corroborated.

The report found that there was negligible danger in exposure to BPA for adults and pregnant women, and only minimal concern for adults exposed even to high levels of the chemical in an occupational setting. The CERHR Panel also noted the apparent scientific implausibility of any mechanism that would produce endocrine effects at low doses that are not also observed in well conducted studies at higher doses. Again, the need for more research. And the panel report documents that much of the sampling to date on possible migration of BPA into food has been done utilizing an approach subject to interference from substances naturally present in food products.

The American Chemistry Council has noted that the weight of scientific evidence, as assessed by Health Canada and other agencies around the world, provides reassurance that consumers can continue to safely use products made from bisphenol A. Consumer products made from polycarbonate plastic and epoxy resins, including products for infants and children, are accepted as safe for use, and used, around the world. But an FDA re-review of the safety of the chemical for additional reassurance to the public on the safety of consumer products makes perfect sense to industry.

Cure Worse Than Problem

Any wide-spread ban of the product – or litigation accomplishing the same result -- may risk the public safety more than enhance it. Epoxy resins derived from bisphenol A are used to manufacture protective polymer coatings for the inner surface of metal food and beverage containers. This critical technology protects the contents of these containers from aggressive food products, thereby assuring a safe, wholesome, and nutritious food supply. Compared to other coating technologies, coatings derived from epoxy resins provide superior adhesion to the metal surface, greater durability, and higher resistance to the wide range of chemistries found in foods and beverages. These attributes are essential to protect the packed food from microbiological contamination, which is a significant food safety issue.

Canning might be the single most important innovation in the preservation of food in history. More than 1500 food items are regularly packed in cans, making out of season foods globally accessible year-round. More than 90% of food and beverage cans use epoxy-based coatings because of their strength, adhesion, formability and resistance to chemical reactions in the food and drinks -- without affecting the taste or smell of the product. They protect the food from the container and from bacterial contamination. They give canned foods their long shelf-life.

State court jury rooms are a bad place to make policy decisions that can have far-reaching impact on public health.