EPA Risk Rules Give Parties More Time to Submit Chemical Data

By Pat Rizzuto

Two final chemical rules the EPA issued June 22 gave manufacturers and other parties more time to submit information to influence whether the agency reviews a chemical’s risks and the conclusions it reaches.

Sun Chemical Corp. already is working with the Color Pigments Manufacturers Association and other groups to prepare information for the Environmental Protection Agency to consider in at least one its 10 chemical risk evaluations.

“We believe CI Pigment Violet 29 has very low aquatic solubility and, therefore, is not toxic to aquatic life,” Robert Mott, global regulatory manager for the corporation, told Bloomberg BNA.

The information pigment manufacturers will provide should allow the agency to determine the chemical is “not likely to present an unreasonable risk,” the corporation said in a statement. The phrase “not likely to present an unreasonable risk” is the safest description of a chemical the agency can make under the Toxic Substances Control Act.

The final rules the EPA issued and the risk evaluations the agency already launched for CI Pigment Violet 29 and nine other chemicals are crucial initial steps the agency has taken to implement the Lautenberg Chemical Safety Act, which overhauled TSCA in 2016.

Revised Definition Adds Time

The EPA’s final “prioritization rule,” (RIN:2070-AK23) which describes the procedures the agency will use to decide whether a chemical is a high or low priority for risk assessment, and its final risk evaluation rule (RIN:2070-AK20), which describes the criteria and process it will use to examine risks, changed the proposed rules’ definition of “reasonably available information.”

Both final rules deleted the proposed requirement that reasonably available information be “existing.”

“We changed that to information that exists or can be obtained in a timely manner considering our deadline,” Nancy Beck, a former American Chemistry Council policy analyst who now serves as EPA’s deputy assistant administrator in the Office of Chemical Safety and Pollution Prevention, told Bloomberg BNA. The change allows the EPA to gather quickly obtainable information yet meet the statutory deadlines the amended law set, she said.

The revised definition allows the EPA to gather information throughout the nine- to 12-month period amended TSCA provides for it to decide whether a chemical is a high or low priority for risk evaluation, Beck said. The change also may allow the agency to gather information throughout the risk evaluation, she said.

The EPA’s final rules said: “It makes sense to view information that can be obtained through testing as “reasonably available” in some instances—especially information that can be obtained through short-term testing, where it can be obtained within the relevant statutory deadlines and the information would be of sufficient value to merit the testing.”

The agency will use the law’s data gathering authority when needed and require companies to conduct longer-term toxicity or other tests to better understand the health or ecological hazards a chemical has, the rules said. Longer tests also may generate information about ways people or different parts of the environment are exposed to a chemical, the rules said. “However, EPA does not think information that could be generated through such testing should be viewed as ‘reasonably available.’”

Potential Abuse

Melanie Benesh, legislative attorney for the Environmental Working Group, and Liz Hitchcock, legislative director for the Safer Chemicals, Healthy Families coalition of public interest groups, said their organizations would like the EPA to have information and, if needed, use its data-gathering authority to obtain more before it begins to decide whether a chemical is a priority or what its risks are.

The agency had suggested doing that during a “pre-prioritization,” data-gathering phase it proposed and that Safer Chemicals, Healthy Families supported, Hitchcock said.

The final rule delayed a decision on that proposed phase, saying the idea needed to be fleshed out by diverse parties.

Ideally, Benesh said, “EPA would order most new testing before prioritization or risk evaluation, but there may be scenarios where EPA would need to order testing during those periods. EPA should be able to do that so long as it is able to meet its statutory deadlines.”

The new definition retains EPA’s obligation to meet the statutory deadlines, she said.

“However, the definition seems to only require the information to be ‘obtained’ before a statutory deadline. It’s unclear if that means industry could submit a new study just before the deadline, which would not give EPA sufficient time to analyze and incorporate the new information. Thus there may be some potential for abuse and last-minute studies that could open the door to legal challenges,” Benesh said.

Ignored Uses or Pragmatic Approach?

Scott Faber, vice president at Environmental Working Group, said other aspects of the three final rules and the 10 risk evaluation strategies the EPA released June 22 favor the chemical industry.

Based on a preliminary review of the EPA’s risk evaluation strategies, Faber said the agency has decided it won’t look at crucial uses of several chemicals.

“To understand whether a chemical is safe, you have to understand all the ways people may be exposed to it,” Faber told Bloomberg BNA.

Faber pointed, as an example, to the the risk evaluation strategy or “scoping document,” the EPA released for 1,4-dioxane, which can be found in tiny concentrations in many consumer products, because it’s an unintentional byproduct generated during certain chemical reactions.

The EPA “made this ridiculous and unscientific determination to include drinking water exposures, but to exclude personal product exposures,” Faber said.

He referred to the scoping document’s “initial analysis plan” in which the agency says it “does not expect to consider and analyze consumer exposures in the risk evaluation.”

Essentially, Faber said, the EPA would examine the 1,4-dioxane “in the water you use to wash your hands, but not the soap you use to wash your hands.”

EPA’s plan, however, said it may examine byproduct concerns related to 1,4-dioxane down the road when it looks at the chemical reaction processes that create the impurity.

Paul DeLeo, an associate vice president for the American Cleaning Institute, described the EPA’s approach to 1,4-dioxane as pragmatic.

The EPA’s regulatory attention should focus on intended uses of chemicals, rather than trace amounts of materials not intentionally added to products, ACI spokesman Brian Sansoni told Bloomberg BNA.

—With assistance from Jennifer A. Dlouhy (Bloomberg News) and Catherine Douglas Moran (Bloomberg BNA).

To contact the reporter on this story: Pat Rizzuto in Washington at prizzuto@bna.com

To contact the editor responsible for this story: Rachael Daigle at rdaigle@bna.com

For More Information

The EPA's prioritization rule is available at http://src.bna.com/qaO, Its risk evaluation rule is available at http://src.bna.com/qaP.

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