In the News

Proposed Bills to Ban BPA Would Fundamentally Alter FCN Program

Mar 17, 2009

Legislation has been introduced in the U.S. Senate that is intended to ban the use of Bisphenol A (BPA) in all food and beverage containers, require FDA review of substances that are listed in the regulations as Generally Recognized as Safe (GRAS), and change the data requirements and standard of review for Food Contact Notifications. The "Ban Poisonous Additives Act of 2009" is sponsored by U.S. Senators Dianne Feinstein (D-Calif.) and Chuck Schumer (D-N.Y.). Representative Edward Markey (D-Mass.) sponsored companion legislation in the House of Representatives. A copy of the Senate Bill (S. 593) introduced Thursday, March 12, 2009 into the Senate Committee on Health, Education, Labor, and Pensions, may be accessed here. A summary of the bill's key initiatives is set out below.

Proposed Ban on BPA in all Food and Beverage Containers

Under the bill, any food or beverage packaged in a container composed in whole or in part of BPA would be considered adulterated under Section 402(a)(6) of the Federal Food, Drug, and Cosmetic Act. Such treatment would apply to single-use and repeated-use containers alike. The effective date of the ban would be 180 days following enactment of the bill.

Facilities that manufacture, process, pack, hold, or sell particular food products may apply for a waiver of the ban, if the facility can demonstrate that there is no technologically feasible alternative for BPA in the type of packaging used to hold their products. As part of their application for a waiver, facilities must submit to the Health and Human Services Secretary a plan and timeline for the removal of BPA from packaging for their products. The Secretary may only grant such requests for a waiver after a public notice and comment period. Any initial waiver granted by the Secretary would be valid for no longer than one year. Companies may seek to renew waivers on an annual basis, but no waiver can last longer than one year in any event. Any food product for which the Secretary grants a waiver must contain a "prominent warning" on its label that the container holding the product is made with BPA.

The bill provides expressly that the Act would not preempt more stringent state laws banning the use of BPA in food and beverage containers.

GRAS Substances

The bill requires FDA within one year of enactment of the Act, and at least once within every five years thereafter, to conduct a review of (1) substances listed as GRAS in Part 182 of the food additive regulations, and (2) substances affirmed as GRAS in Parts 184 and 186 of the food additive regulations. Public notice of the reviews and an opportunity for comment is also required.

The bill states that if, during the course of its review, the Agency becomes aware of new scientific evidence that supports (1) banning the substance, (2) altering the conditions under which the substance may be introduced in commerce, or (3) imposing restrictions on the types of products for which the substance may be used, FDA must remove the substance from Parts 182, 184, or 186 of the regulations, as the case may be, and take other remedial action, as necessary.

Amendments to Section 409(h) of the Act Authorizing the FCN Program

Section 409(h) of the Federal Food, Drug, and Cosmetic Act (FFDCA) authorizes the Food Contact Notification (FCN) Program, which has been the principal vehicle FDA has used since 2000 to clear new food-contact substances. (For a history of the FCN program, please see the PackagingLaw.com article, The Food Contact Notification Story.) The new bill proposes to amend subsection (h) of Section 409 in three key ways. First, paragraph (h)(1) would be modified to state that a manufacturer "shall" rather than "may" notify FDA of the identity and use of a food-contact substance. It appears that the intent of the bill may be to mandate the submission of an FCN for all food-contact substances, eliminating the exemptions in the FFDCA that apply to all food additives.

A large number of food-contact substances are marketed today under a determination that the material would not reasonably be expected to migrate to food or would be considered generally recognized as safe (GRAS) under its intended conditions of use. The existence of these exemptions could be in doubt if the proposed bill were to pass as introduced.

Second, the proposed amendment to Section 409(h) would require a notifier to include with the FCN a determination that no adverse health effects result from low dose exposures to the notified food-contact substance. This provision seeks to legitimize the controversial scientific theory that health effects can flow from low dose exposure to substances, even when no effects are seen at high doses.

Third, Section 409(h) would be amended to require that an FCN include a determination that a substance has not been shown, after tests which are appropriate for the evaluation of the safety of a food-contact substance, to cause reproductive or developmental toxicity in humans or animals. While not clear, this provision could be interpreted as a new type of "Delaney Clause" for developmental and reproductive toxicity studies, which would ban the use of any substance that has been shown to cause reproductive or developmental toxicity, just as the Delaney Clause does now for carcinogens.

In June 2008, Representative Markey introduced H.R. 6228, titled the "Ban Poisonous Additives Act of 2008," which we reported on in a previous PackagingLaw.com article, Markey Proposes Ban of BPA in All Food and Beverage Containers. The 2008 bill also sought to ban the use of BPA in all food and beverage containers, but did not contain the waiver provisions, the preemption language, nor the requirement that facilities label their products prominently if they are packaged in containers made with BPA. The 2008 bill also did not include the additional provisions mandating FDA's review of substances listed as GRAS and proposing modifications to the existing FCN Program. Also in 2008, Senator Schumer, together with other Senators, introduced S. 2928, which was titled the "BPA-Free Kids Act of 2008." This bill sought to ban any detectable amount of BPA in products intended for use by children under the age of seven. Neither H.R. 6228 nor S. 2928 were reported out of their respective Committees last year.