In the News

Proposed TSCA Legislation Would Require Exposure Data on New Chemicals From All Sources

May 6, 2010

The "Safe Chemicals Act of 2010," introduced by Senator Frank R. Lautenberg (D-NJ) on April 15, would significantly amend the Toxic Substances Control Act (TSCA). Parallel legislation, "Toxic Chemicals Safety Act of 2010," was released as a "discussion draft" by Representatives Bobby Rush (D-IL) and Henry Waxman (D-CA) on the same day. Originally enacted in 1976, TSCA established a framework to regulate chemicals not regulated under other federal statutes, such as the Federal Food, Drug, and Cosmetic Act (FFDCA). However, manufacturers of food contact substances could be impacted by this proposed legislation.

While the proposed legislation would not impact the FFDCA exemption that exempts food packaging and other substances regulated by the Food and Drug Administration (FDA) from the requirements of TSCA, this exemption applies only as long as end-uses are limited solely to uses regulated by FDA. Consequently, to rely on this exemption, manufacturers would need to monitor the end-uses of their products, and ensure that they are not manufactured for sale into other applications. (For more information on the FFDCA exemption from the requirements of TSCA, see the PackagingLaw.com article, TSCA: Italian Opera or EPA Regulation?)

As an overview, the Senate bill would amend TSCA to:

• Require manufacturers to develop and submit a minimum data set for each chemical they produce, and provide EPA with authority to request additional information.
• Prioritize chemicals based on risk.
• Require that a safety threshold is met for all chemicals on the market and shift the burden of proof to manufacturers to prove the safety of their chemicals.
• Require EPA to take expeditious action to reduce risk from chemicals that have already been "proven" dangerous.
• Establish a public database to catalog information submitted by chemical manufacturers and EPA's safety determinations.
• Promote green chemistry and establish grant programs and research centers to foster the development of "safe" chemical alternatives.
• Impose a five-year limit on claims of Confidential Business Information (CBI).

More specifically, once the legislation was enacted, EPA would have one year to establish the data required for the minimum data set. The legislation specifies that the minimum date set must be sufficient to establish safety for both the general population and vulnerable subpopulations—such as children—and it must include: information on the substance's characteristics, hazard information, exposure data, use data, and other "useful" information as determined by EPA. The exposure data would include aggregate exposure, which the legislation defines to include "a chemical substance or mixture from the manufacture, processing, distribution, use, and disposal of a chemical substance that is not considered to be a chemical substance under this chapter solely because of the use of the substance as or in a food, food additive, cosmetic, or device." In other words, aggregate exposure would take account of exempt uses.

The data would be due when a notice of intent to manufacture a new chemical was filed or 18 months after a chemical was placed on a rolling priority list. After a manufacturer submitted the data, EPA would be required to make a positive safety determination or find that the chemical meets certain criteria—including that it is not found in food—before issuing an approval for a new chemical. In the case of an existing chemical, EPA could ban the chemical or impose restrictions on its manufacture or use, based on the agency's review of the data. The House discussion draft contains a list of substances subject to expedited action, including bisphenol-A, formaldehyde, short-chain chlorinated paraffins, certain phthalates, lead, mercury, and other chemicals.

Relationship to FDA and Other Federal Agencies

Both the Senate bill and the House discussion draft would require EPA to submit a report to other federal agencies when a chemical substance or mixture does not meet the safety standards and when action may be taken to address the use of or exposure to such chemical substance or mixture under laws administered by other federal agencies. The report would be published in the Federal Register. In addition, the report would include requests to the other relevant agencies to determine whether action may be taken under laws they administer and, if so, to initiate such action.