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By Pat Rizzuto
Environmental health advocates strongly support the Environmental Protection Agency's October proposal to couple two regulatory approaches to secure information about 45 high-production-volume chemicals.
Chemical manufacturers, however, object to the agency's proposed approach. It could lead to duplicative reporting requirements and require some manufacturers to pay for tests of their chemicals while others making the same compound would not have to, they said in comments submitted to EPA.
Both groups were commenting on a rule EPA proposed Oct. 21, 2011, that would regulate 45 high-production-volume (HPV) chemicals either through a rule requiring toxicity and other test data or through a significant new use rule (SNUR) (204 DEN A-13, 10/21/11).
The proposed rule was the fourth and final in a series EPA has been issuing since 2006 to obtain information on “orphan” chemicals for which manufacturers have not provided data through a voluntary initiative launched in 1998.
EPA's proposal would require chemical manufacturers to generate toxicity data and other information on 23 of the 45 substances, because the agency said it had sufficient information to conclude there was substantial human exposure to them.
That finding gave the agency the authority to propose a rule mandating the generation of data as authorized by Section 4 of the Toxic Substances Control Act.
EPA proposed to regulate the remaining 22 chemicals, for which it could not make the substantial exposure finding, through a SNUR.
Under the SNUR, manufacturers and processors of any of these chemicals would be required to notify EPA if exposure to any of the substances were expected to increase significantly.
That increase would be indicated, the proposal said, by the chemical being used in a consumer product or by uses of the chemical by a single corporate entity that would be reasonably likely to expose 1,000 or more workers to the compound.
Notifying EPA of the expected increase or “new use” would allow the agency to determine whether restrictions or other risk management strategies would be necessary.
The rulemaking marked the first time EPA had proposed to couple two regulatory strategies to get data on the orphan HPV chemicals. Comments on the proposal were due Jan. 19.
A coalition of 15 health and environmental justice groups spearheaded by the Environmental Defense Fund said they “strongly support the current proposed rules.”
“We believe this same approach needs to be expanded to other groups of chemicals,” the coalition wrote.
By using this strategy, rather than approaches it has previously tried, EPA is more likely to be able to require submission of data on the HPV chemicals for which it cannot make the “substantial exposure” finding, Richard Denison, a senior scientist at the Environmental Defense Fund, told Bloomberg BNA Jan. 23.
The coalition made suggestions it said would enhance the proposed rules. These included urging EPA to make the “new use” threshold an exposure of 200 or more workers rather than 1,000.
The American Chemistry Council, American Petroleum Institute, Society of Chemical Manufacturers and Affiliates, and Ecological and Toxicological Association of Dyes and Organic Pigments Manufacturers of North America all voiced concerns about or outright objected to EPA's proposal to couple the test rule with a SNUR.
The petroleum institute said it “does not support the use of SNURs in this rulemaking and definitely not for future rulemakings.”
A SNUR would subject the affected chemicals to EPA's potential oversight and to recordkeeping requirements triggered by SNURs “in perpetuity,” the institute added.
EPA should use its traditional data-collection authority provided by Section 8 of TSCA, the petroleum institute and American Chemistry Council said.
Section 8 data-collection rules are one-time collection efforts. By contrast, SNURs allow the possibility that EPA could require additional data or restrict a chemical's uses at any time after a new use has been triggered.
Further, because similar exposure information is required through the Chemical Data Reporting rule, EPA's proposal could lead to duplicative reporting, the petroleum institute and American Chemistry Council said.
By using the SNUR, EPA could require one company to provide the agency additional data to prove a new use of its chemical would be safe, while other manufacturers of the same chemical would not have to contribute to the costs of that data generation, ACC said.
“The effect would be to impose testing requirements on a single manufacturer or processor, rather than on all manufacturers (and potentially, processors). This raises significant policy and fairness issues,” ACC said.
The trade associations and individual companies commenting on the rule raised other concerns as well.
Nearly all urged EPA, where possible, to obtain desired data from the European Chemicals Agency.
“Registration dossiers on many of the studies identified in the proposal may already have been submitted to the European Chemicals Agency (ECHA) under REACH,” ACC wrote, referring to the European Union's registration, evaluation, and authorization of chemicals regulation.
“EPA should work for an agreement that would allow ECHA to share those studies and others to be submitted under REACH with EPA in confidence. Data and information available under other national or regional regulatory programs have the potential to significantly reduce the likelihood of duplication of cost and effort,” ACC wrote.
People for the Ethical Treatment of Animals voiced a variety of concerns about the regulatory approach EPA proposed and the scope of data the agency said it needs.
Instead of requiring the submission of toxicity data and other information that would satisfy a minimum data set, PETA said EPA should “implement an integrated testing strategy by which the initial data set required for each chemical substance is selected based on all relevant existing information.”
Comments and other documents related to EPA's regulation are available at http://www.regulations.gov by searching for docket number EPA-HQ-OPPT-2010-0520.
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