Chemicals Regulation

Neither industry nor environmental and health activists are satisfied with Congress’ new proposals for reforming the Toxic Substances Control Act (TSCA), which governs the manufacture of chemicals. Much of their concern revolves around the main pillar of the legislation, which would require commercial substances to be shown as safe to remain on the market.

The legislation, a Senate measure (S. 3209) and a House of Representatives “discussion draft” of a not-yet-introduced bill, would modernize TSCA. That law has remained virtually unchanged since it was signed by President Gerald Ford in 1976. It requires EPA to prove that a chemical is harmful before the agency can regulate the substance.

In contrast, manufacturers would have to demonstrate—and EPA would have to concur—that a chemical is safe for its uses under S. 3209 and the House draft, both of which were unveiled earlier this month. Sen. Frank R. Lautenberg (D-N.J.) introduced S. 3209, and Rep. Bobby L. Rush (D-Ill.) and House Energy & Commerce Committee Chairman Henry A. Waxman (D-Calif.) are behind the draft bill (C&EN, April 19, page 27).

Part of the chemical industry, led by the trade group American Chemistry Council, has pushed for safety determinations as a part of modernizing TSCA. But ACC is worried about the proposed safety standard in the legislation.

A safe chemical, according to the House draft and the Senate bill, would present “a reasonable certainty of no harm.” EPA has used such a risk-based standard, which encompasses both hazard and exposure, to assess pesticides since the late 1990s.

As part of the proposed safety assessments of commercial chemicals, the legislation would require EPA to consider exposure in two different ways. One, called aggregate, adds together the public’s exposure to a single substance from all sources, such as air, water, and food. The second is cumulative, which sums the public’s aggregate exposures to chemicals that have similar effects, such as mimicking estrogen.

ACC says the proposed chemical safety standard “may be legally and technically impossible to meet” because of these exposure assessment requirements.

The Society of Chemical Manufacturers & Affiliates (SOCMA), another trade group, has trepidation about the creation of any federal safety standard for industrial chemicals. “This would create major challenges for SOCMA members, many of whom manufacture intermediates for which there may be limited exposures and many possible uses that are sometimes unknown,” the industry group says.

Safer Chemicals, Healthy Families, a coalition of more than 200 public health and environmental organizations, is generally backing S. 3209 and the House draft. But it wants lawmakers to close what it sees as a loophole in the proposals: allowing many new chemicals to enter the marketplace before they undergo a safety assessment. After new chemicals are commercialized, they would join a queue of tens of thousands of substances already on the market that would be awaiting safety assessment by EPA, under the proposals.

Another part of the legislation that has created less controversy would require chemical manufacturers to justify in writing any claims that information they submit to EPA about a product is proprietary and needs protection from disclosure. The agency would have to approve all requests for confidential treatment of data and set a deadline of five years or less for these protections to end.

“That represents quite a change from the status quo,” says Richard Denison, senior scientist with the Environmental Defense Fund. Currently, companies merely have to assert confidentiality claims, and it is up to EPA to review or challenge them, and the protections do not expire.

Chemical & Engineering News

ISSN 0009-2347

Copyright © 2011 American Chemical Society