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EPA Determining How to Select Chemicals For Further Review, Possible Regulation

Wednesday, September 7, 2011

The Environmental Protection Agency will discuss Sept. 7 sources of information it could use and a proposed general approach to determine which chemicals need further examination under its current chemicals management program.

Under the chemicals management program, the agency is seeking to identify priority chemicals for review and possible risk management action under the Toxic Substances Control Act.

Depending on the information EPA has or obtains about possible priority chemicals, it could propose rules to ban or restrict a chemical's use, the agency said in an announcement unveiling its effort to develop a process for prioritizing chemical reviews.

The agency announced the initiative Aug. 18 and plans to hold an online discussion through Sept. 14 on ways to identify Priority Chemicals for Review and Assessment. EPA will hold a webinar on that subject from 1:30 p.m. to 4:30 p.m. EDT on Sept. 7.

A discussion guide released Aug. 18 said the agency plans to use a two-step process to identify priority chemicals.

The eight-page guide also listed sources of chemical data that the agency intends to use and factors—such as whether a chemical may harm children—that the agency said would be part of the criteria it uses to determine which chemicals are a priority for further evaluation.

EPA invited comment on the criteria it plans to use, on whether additional prioritization factors should be added, whether some factors are more important than others, and on the sources of chemical information identified in the discussion guide.

In conjunction with the agency's actions, the American Chemistry Council announced Sept. 6 its own proposed approach to determining which chemicals should be priorities for further review.

In a Sept. 6 press briefing, senior trade association officials said the council's approach would provide EPA with a consistent, transparent, science-based method that incorporates some internationally agreed-upon hazard classifications for chemicals to select compounds that warrant more in-depth assessment.

EPA Considers Six Characteristics

Under the first step of EPA's proposal, chemicals that have one or more of six characteristics would become part of an initial group of compounds subject to further evaluation. The chemicals would be:

• of potential concern for children's health;

• persistent and bioaccumulate in the environment and they would be toxic to people or the environment;

• known or probable carcinogens;

• used in products designed for children;

• used in consumer products; and/or

• detected in human hair, blood, urine, or other parts of the body.

Data Sources

Sources of information EPA would use to select an initial group of chemicals for further evaluation include:

• compounds that the International Agency for Research on Cancer (IARC) or National Toxicology Program have classified as known or likely human carcinogens;

• chemicals determined to pose some level of concern for fetuses, infants, or children by NTP's Office of Health Assessment and Translation, formerly called the Center for the Evaluation of Risks to Human Reproduction; and

• chemicals the Washington state Department of Ecology is developing that list chemicals that are toxic and have either been found in children's products or been documented to be present in human tissue (blood, breast milk, etc.).

After it uses such sources to select a group of chemicals for review, EPA would then obtain additional exposure and hazard information on those compounds from sources such as the data manufacturers are required to report to the agency under the Chemical Data Reporting rule.

That rule, formerly called the Inventory Update Reporting or IUR rule, was updated by EPA in a final regulation issued Aug. 2 (149 DEN A-3, 8/3/11).

During the American Chemistry Council's press briefing, Michael Walls, the council's vice president of regulatory and technical affairs, said EPA's discussion guide did not clearly describe what information the agency would seek from the more than a dozen data sources it listed. Nor did EPA say whether it considers all of the data sources to be reliable, Walls said.

Questions Emerging

These are among the questions the chemistry council will seek to clarify during the Sept. 7 webinar, he said.

At least one law firm is raising similar questions.

In an e-mailed commentary, the firm Bergeson & Campbell PC said the list of chemicals that the Washington Department of Ecology is developing pursuant to the Children's Safe Products Act of 2008 is not designed to provide evidence that a chemical has been used in children's products.

Hence, the list's inclusion as a source of such information “would appear inappropriate,” the commentary said.

Similarly EPA's discussion guide did not clarify what sources it would deem reliable for biomonitoring data, Bergeson & Campbell's commentary said. In the United States, the Centers for Disease Control and Prevention conducts biomonitoring, as do some states, companies, and environmental advocacy groups. Other countries also collect such information.

Regarding the characteristics that EPA said it intends to consider in determining whether a chemical is a priority for further scrutiny, the law firm's commentary said: “Industry stakeholders are likely to disagree strongly with the inclusion of ‘detected in biomonitoring' as an initial prioritization factor, whereas other stakeholders can be expected to support such a broad approach.”

In its approach to prioritization, the American Chemistry Council suggested that biomonitoring and environmental monitoring data be incorporated after EPA has used other types of information to select its priorities for further review.

“Almost any industrial or commercial chemical could be detected at trace levels, given increasingly sensitive analytical methods,” the council said in a description of its approach to selecting chemicals for further review.

“Detection alone primarily reflects only the fact that a specific chemical was included in a measurement program. This criterion will also tend to bias the prioritization of chemicals for which well-established analytical methods are available,” the council said.

By Pat Rizzuto 

EPA's announcement and details on its chemical prioritization effort are available at http://www.epa.gov/oppt/existingchemicals/pubs/chemprioritizations.html.