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By Pat Rizzuto
Aug. 9 — The Environmental Protection Agency should help the marketplace by identifying chemical uses that pose little or no risks as well as those that do, industry representatives said Aug. 9.
Tim Brown, with the Consumer Specialty Products Association, was among several industry representatives who told the agency the procedures it establishes to evaluate chemical risks should require it to identify low-risk uses of a chemical even if there are particular uses that would pose health or ecological risks.
That information would provide clear information for the marketplace, Brown said.
Brown was among more than 660 people from trade associations, consulting companies, California's EPA, the AFL-CIO, animal welfare groups, environmental health organizations and academics who registered to attend or listen to a public meeting the EPA organized to discuss a rule it must develop under the Toxic Substances Control Act as amended on June 22 by the Frank R. Lautenberg Chemical Safety for the 21st Century Act.
The rule, which must be issued as final by June 22, 2017, would describe the process the agency will use to evaluate the risks of high priority chemicals. The rule also will describe the process the agency will use to evaluate the risks of chemicals that manufacturers nominate for agency review. Companies are responsible for paying some or all of these manufacturer-initiated risk evaluations.
Neither Morris nor Tala Henry, director of the EPA Office of Pollution Prevention and Toxics' Risk Assessment Division, described the range of information that would or could be in the rule that the EPA plans to propose by the end of December.
That matters a lot, according to comments made during the public comment period and perspectives industry and environmental health organizations shared with Bloomberg BNA on the sidelines of the meeting.
Sarah Brozena, an attorney and a senior director in the American Chemistry Council's Regulatory and Technical Affairs Department, and Kimberly Wise, a risk analyst who helps manage the council's Center for Advancing Risk Assessment Science and Policy (ARASP), told EPA the rule it must issue is much more than a “procedural” regulation.
Congress intended this rule to describe how the EPA will evaluate chemical risks using the law's scientific standards and analytic requirements, Brozena said.
That means the EPA's rule must define some statutory terms in ways that all interested parties understand what the agency means by words and phrases such as “best available science” and “weight of the evidence,” she said.
Wise said the rule should make clear how the EPA will carry out, or how manufacturers that choose to submit risk evaluations should carry out, the problem formulation and scooping stages of a risk evaluation.
Parties reading the rule should understand how the agency will evaluate data quality, Wise said.
The clearer the EPA can be in how it defines these terms, the better the data it will get, the more consistent its risk assessments will be and the easier it will be for the agency to meet the law's chemical risk evaluation deadlines, Brozena said.
Gina Solomon, deputy secretary for science and health at the California EPA, urged the federal EPA to craft a rule that focuses on the process it would use to evaluate chemicals.
“Give yourself maximum latitude and flexibility,” Solomon said. “A lot of the science issues discussed today are best dealt with through science guidelines.”
The rule itself should allow the EPA to complete risk evaluations under deadlines mandated by the TSCA amendments, Solomon said.
By the end of this year, the EPA must be evaluating the risks of at least 10 chemicals. Within 42 months, the agency must be evaluating at least 20 chemicals. Each risk evaluation must be completed within three years, with a possible six month extension. As soon as the agency completes an evaluation, it must begin another one.
“We are hoping you don't get bogged down with too many details in this rule or narrow your own latitude too much,” Solomon said.
Jennifer McPartland, a senior scientist at the Environmental Defense Fund, urged the EPA to focus, in this rulemaking, on procedures it would use to evaluate risks.
“Rulemakings are not the appropriate vehicle to tackle broader scientific issues,” she said.
Guidance and policy statements are more nimble approaches to defining the types of information the agency wants and the standards it sets for acceptable data, McPartland said.
The guidance that would define terms such as best available science will be binding, Richard Denison, lead senior scientist with the Environmental Defense Fund, told Bloomberg BNA. The law mandates the EPA's use of best available science along with scientific models analytic approaches that meet other criteria, he said.
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