U.S.-based companies that manufacture (including import), incorporate into products, or use chemical substances of any type should be paying attention to a new initiative underway at the Environmental Protection Agency (EPA) to jump-start and focus the Agency's chemical evaluation program.
In August, EPA requested public comment on plans to establish a program for prioritizing chemicals on the Toxic Substances Control Act (TSCA) Inventory. (The Inventory is an extensive list of all chemicals in U.S. commerce, excluding pesticides, cosmetics and FDA-regulated substances.) EPA's goal is to focus Agency resources on identifying chemicals of the greatest concern for screening and possible regulation. The program plans, first issued in the form of a discussion paper, were also the subject of a webinar hosted by EPA on September 7. During this webinar, EPA projected that the list would likely include 100 or more high-priority chemicals.
EPA is proposing to use a two-step process to identify priority chemicals for review and assessment. In Step 1, EPA would identify an initial group of priority chemicals that are identified by specified data sources (e.g., the National Toxicology Program) as meeting one or more risk-based "priority factors":
- Chemicals identified as potentially of concern for children's health (e.g., chemicals with reproductive or developmental effects);
- Chemicals identified as persistent, bioaccumulative, and toxic (PBT);
- Chemicals identified as probable or known carcinogens;
- Chemicals used in children's products;
- Chemicals used in consumer products; and
- Chemicals detected in biomonitoring programs.
EPA is seeking public input on the appropriateness of these prioritization factors and EPA's list of proposed data sources. In Step 2, also subject to comment, EPA intends to refine the group of chemicals identified in Step 1 by using a broader range of data sources (e.g., to evaluate actual exposure) to analyze and select specific chemicals for further assessment. As EPA works through the initial set of priority chemicals, the Agency may repeat this two-step process to select subsequent chemicals for review and assessment.
There is precedent for this proposal. EPA used these same prioritization factors between December 2009 and April 2011 to select chemicals for the Agency's "Action Plans" program. These plans identified a range of actions that the Agency has since begun to implement, from voluntary phaseouts and alternatives assessments in cooperation with industry and other stakeholders, to the development of test rules to require additional data under Section 4 of TSCA, to controls or use restrictions under Sections 5 or 6 of TSCA. These same control strategies are expected to be applied to highly ranked priority program chemicals.