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By Pat Rizzuto
Chemical makers convinced their products are safe can now ask the EPA for a risk assessment, which could be used to allay concerns raised by customers, states, or the public.
It’s unclear yet how companies might use that process, but businesses should “be creative and take advantage of what the statute has to offer,” Karyn Schmidt, senior director of chemical regulation, regulatory, and technical affairs at the American Chemistry Council, said at a recent chemical policy meeting. She urged companies to start thinking strategically about what data they have, what information they may want to generate, and when risk evaluations could be useful.
The updated Toxic Substances Control Act added two options for chemical manufacturers seeking the evaluations. First, they can ask the EPA to evaluate a chemical—or certain uses of it—for a fee. Second, they can submit risks evaluations they have performed themselves to the EPA for evaluation, provided they meet the agency’s recently issued guidance. The guidance calls for the peer review of industry-submitted risk assessments and requires EPA to publish its response to the issues raised in the peer review.
Environmental health groups are worried, however, that the chemical industry—rather than public health and environmental priorities—will drive the EPA’s chemical assessment process. And some former agency officials say the EPA needs to make better use of its authority to demand chemical data from manufacturers.
Speaking at a July 12 session of the Toxicology Forum’s summer meeting in Annapolis, Md., Tala Henry, director of the EPA’s risk assessment division for chemicals, described the process manufacturers would use to request agency risk evaluations.
Within 15 days of receiving a request, the EPA will publish and request comment on it, Henry said. If the EPA decides it needs to look at more uses of a chemical than the company asked it to examine, the agency will make that clear and request comment on whether there are additional uses, populations, environmental exposures, or other situations to analyze, she said.
Sixty days after the comment period closes, the EPA will make a decision to grant or deny the request, Henry said. The agency would launch the risk evaluation after it receives payment, she said.
Exactly how much manufacturers would pay for chemical assessments they submit isn’t clear because the EPA has yet to propose a fee rule. Nor is it clear how the EPA would deal with the costs of risk evaluation when it examines chemical uses at the request of a company and additional uses selected by the agency.
Nonetheless, manufacturer-requested chemical assessments are an important tool that can increase the number of chemicals the EPA evaluates, Mike Walls, vice president of regulatory and technical affairs at the American Chemistry Council, told reporters following the Toxicology Forum.
“All risk evaluations—whether EPA-initiated or manufacturer-initiated—will be conducted in the same manner,” Henry said at the Toxicological Forum meeting.
Company and trade association officials urged the EPA to reach out to industries to obtain data to inform the risk evaluations.
“If we’ve paid for the data, we generally want regulators to see the results of those tests,” said Athena Keene, a senior toxicologist at Afton Chemical Corp.
Suzanne Hartigan, director of science policy and regulatory affairs at the International Fragrance Association North America, urged the EPA to use voluntary data call-ins and talk with companies to collect even more information.
Safer Chemicals, Healthy Families—a coalition of environmental and other organizations—is among the environmental health groups voicing concerns about what they say is the EPA’s deferral to industry to get the data it will need.
The final rules the EPA issued to implement amended TSCA signal that it “will require little, if any, testing to fill data gaps” for chemicals it may be, or is, evaluating, Safer Chemicals, Healthy Families said after the rules were issued.
The EPA’s recent rules don’t mention any intention to use the agency’s new authority under the amended chemicals law to order companies to provide toxicity or exposure data, Richard Denison, lead senior scientist for the Environmental Defense Fund, said June 27 at a TSCA forum organized by the Environmental Law Institute.
Yet, the “long term success of the law lies squarely on Section 4,” Denison said, referring to the provision of TSCA that authorizes the EPA to get data using orders, consent agreements, and rules.
As one of many reasons Denison said he’s wary, earlier this year the EPA rejected two petitions that asked it to obtain toxicity and exposure information on chlorinated phosphate esters and tetrabromobisphenol A.
Charles Auer, who used to run the agency’s chemicals office, and Richard Engler, a chemist who worked for the EPA’s new chemicals program, have told Bloomberg BNA they’d like to see the agency make greater use its new data-gathering authority. Both men now work in the Washington, D.C., office of Bergeson & Campbell, P.C.
The central failing of the original law was the hurdle the EPA had to surmount before it could get the information it needed to assess and manage chemical risks, Auer said during the law institute forum.
Schmidt told Bloomberg BNA she understands the concerns various parties are raising about the EPA’s reticence, so far, to discuss data it may want to collect from industry.
But, “it’s extremely early in the process for EPA to be issuing test orders,” she said. “I think we’ll get there.” Also, risk evaluations are ultimately led by the EPA, Schmidt said at the forum.
The EPA will hold public meetings this fall to discuss ways it could collect chemical data down the road for chemicals it may evaluate.
Chemical manufacturers hope the process the agency will eventually adopt will secure information in a systematic, rational and timely way, Schmidt said.
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