The Society of the Plastics Industry, Inc.
Food, Drug, and Cosmetic Packaging Materials Committee

June 1999

(202) 434-4120
simmons@khlaw.com

Dear Ladies and Gentlemen:

The purpose of this letter is to bring you up-to-date on the continuing media coverage regarding the safety of DEHA and bisphenol-A in plastics, and to discuss FDA's commencement of a new risk assessment of DEHP in medical devices. We are also reporting on California's proposed legislation to expand the state's deposit law, a report by the General Accounting Office (GAO) discussing efforts by other countries to consolidate their food safety activities into a single food safety agency, and on a few other matters of interest to the Committee. With regard to the Food Contact Notification program, there have been no major developments since our last letter. Efforts are continuing to obtain the necessary appropriations for the program; however, prospects for passing fee legislation in this Congress are remote.

Table of Contents

1. Claims Continue to Be Aired about Alleged Health Risks from Phthalate Plasticizers and Bisphenol A in Plastic Food-Contact Articles

2. FDA Conducting Risk Assessment of DEHP in Medical Devices after Harsh Criticism by Advocacy Groups

3. California Assembly Considers Expanding Deposit Law

4. GAO Releases Inconclusive Report Regarding Efforts by Other Countries to Consolidate their Food Safety Activities into Single Food Safety Agency

5. Industry Groups Push for Elimination of Separate USDA Review of Meat Additives

6. Petition Opposing Food Irradiation Submitted to Congress and FDA

1. Claims Continue to Be Aired about Alleged Health Risks from Plasticizers and Bisphenol A in Plastic Food-Contact Articles

In our June 3, 1999 letter, we reported on recent media coverage regarding the safety of certain substances used in making plastic articles. You may recall that, in May, 1999, the Consumers Union issued an alert urging parents to dispose of polycarbonate baby bottles due to the threat that bisphenol A, an alleged endocrine disruptor, could migrate into the baby's formula. Coinciding with that report, the ABC News magazine program, 20/20, aired an episode on the safety of plastics in contact with food, focusing on polycarbonate and certain plasticizers. The program discussed the controversial studies performed by Dr. Frederick vom Saal, who claims that very small amounts of bisphenol A act as an endocrine disruptor to produce adverse health effects in humans. As a follow-up to the May report on polycarbonate baby bottles, the Consumers Union posted an article on their website providing a list of acceptable alternatives to polycarbonate bottles containing bisphenol A.

In the wake of this publicity, on May 12, the National Environmental Trust (NET) and other interest groups submitted a petition to FDA requesting their review of children's risk from exposure to components of food packaging. The petition specifically focuses on alleged potential harm from the presence of di-2-ethylhexyl-adipate (DEHA) in plastic food wraps and residual bisphenol-A in polycarbonate baby bottles. The NET filing also asserts that children may be especially at risk from these substances.

We have discussed the NET petition and the general "endocrine disruptor" issue with the officials at the Food and Drug Administration (FDA) who are responsible for this issue. They confirmed that FDA currently does not believe that exposure to bisphenol A or DEHA presents a safety concern for adults or children. They are aware of the vom Saal work and also the study sponsored by SPI that failed to confirm vom Saal's findings. FDA will continue to monitor the situation, including review of the NET petition, to determine whether a re-evaluation of the safety of these substances becomes necessary. In the meantime, we will remain in contact with FDA on this issue and continue to keep you informed of any developments as they come to our attention.

2. FDA Conducting Risk Assessment of DEHP in Medical Devices after Harsh Criticism by Advocacy Groups

After intense lobbying by patient and environmental advocacy groups, FDA has begun a risk assessment to determine whether di-2-ethylhexyl-phthalate (DEHP), which is added to polyvinyl chloride medical devices to make them soft and transparent, is potentially harmful to patients. Numerous medical devices, including blood bags, intravenous tubing, oxygenators, dialysis equipment, gloves and containers, are composed of DEHP-containing PVC. FDA's Office of Science and Technology (OST) is conducting a study to determine the extent to which DEHP leaches from the devices into the body, and whether exposure to the substance may have carcinogenic or reproductive effects. Although there have been previous studies on the safety of DEHP, they focused on oral administration of the substance rather than examining the effects of exposure through the bloodstream. FDA anticipates a final assessment by the end of the summer.

While patient and environmental advocacy groups continue to promote the need to find alternatives to medical devices containing DEHP, industry groups such as the Chemical Manufacturers Association and the Health Industry Manufacturers Association maintain that these devices are completely safe. Both industry groups have been in constant dialogue with FDA regarding the perils of "junk science," and have emphasized the need to weigh the potential risks of DEHP against the benefits of its use in medical devices. Indeed, OST is planning to examine the benefits of DEHP in medical devices, such as the stabilizing effect on red blood cells and its ability to prolong the storage life of whole blood. Both advocacy and industry groups have begun independent studies on the effects of DEHP migration from medical devices.

3. California Assembly Considers Expanding Deposit Law

Our June 3, 1999 letter reported on the legislation now being considered in California that would remove the existing exclusion for food and cosmetic containers from the state's recycling rate requirements, and increase the overall recycling rate and the minimum recycled content alternatives for compliance from 25% to 35%. Keller and Heckman continues to advise the California legislature, through the California Packaging Alliance, on the issues involved in using recycled content in food and cosmetic packaging in support of the Alliance's effort to preserve the exemption. In particular, we have stressed that, while it is true that recycled content has been accepted as safe by FDA in particular cases, these "no objection" letters apply only to specific recycling processes, and often include limitations on feedstock and conditions of use (food type, temperature of contact and structure of the finished articles).

In a related bill this term, the California Assembly is considering expanding the state's deposit law to increase deposit rates and expand the types of containers subject to the Act. The bill (SB 332) would modify the existing California Beverage Container Recycling and Litter Reduction Act by increasing the redemption payment beverage container distributors are required to pay from 2 cents to 2.5 cents for every beverage container sold or offered for sale in the state. Bottle sizes of 20 ounces or greater, rather than the 24 ounce threshold in the existing act, will be considered two bottles for purposes of redemption rates. The bill also would expand the Act's definition of beverage to include carbonated and noncarbonated water, noncarbonated soft drinks and sport drinks, certain noncarbonated fruit drinks, coffee and tea, and carbonated fruit drinks if the products are sold in plastic, glass, bimetal, or aluminum containers in liquid, ready-to-drink form. Wine, milk, medical food, and infant formula are the only types of beverages exempted by the Act.

4. GAO Releases Inconclusive Report Regarding Efforts by Other Countries to Consolidate their Food Safety Activities into Single Food Safety Agency

As you may recall from previous letters, much discussion has occurred over the last year or two regarding the advisability of consolidating the United States' food safety programs, which now number 12, into one unified food safety agency. Our June 3, 1999 letter discussed a report by the President's Food Safety Council, which concurred with a report by the National Academy of Sciences that a single food safety agency may not be needed. Now, the General Accounting Office (GAO), which expressed early support for the consolidation of the United States' food safety agencies, has completed a report discussing the early experiences of unifying food safety activities in Canada, Ireland, Denmark, and Great Britain. While inconclusive regarding the overall success of a single food agency in these nations, the report stated that "[f]ood safety stakeholders in all four of the countries believe the benefits of consolidating food safety activities will outweigh the additional costs."

The report also outlined several "keys to success" in the process of transitioning from multiple food safety organizations to a single food safety agency. Among the lessons cited by foreign food safety officials were garnering strong initial public support, maintaining organizational flexibility, acquiring adequate funding and maintaining openness in decision-making by including all interested parties in the process. Despite the terms of the GAO report, Senator Richard Durbin (D-Ill) plans to reintroduce legislation proposing the consolidation of food safety activities into one food safety agency in the United States.

5. Industry Groups Push for Elimination of Separate USDA Review of Meat Additives