Regulatory DevelopmentsSeptember 8, 2011
On September 7, 2011, the U.S. Environmental Protection Agency (EPA) held a webinar regarding its plans to use a two-step process to identify priority chemical substances for review and assessment under the Toxic Substances Control Act (TSCA). EPA states that its goal is "to identify priority chemicals for near-term evaluation, not to screen and prioritize the entire TSCA Inventory of approximately 84,000 chemicals." EPA held the webinar to obtain public input on the prioritization factors and data sources it plans to use. Bergeson & Campbell, P.C.'s memorandum on the proposed EPA prioritization process is available online.
EPA's presentation closely followed the Discussion Guide it posted describing the two-step process. In Step 1, EPA plans to identify an initial group of priority chemicals for review by using a specific set of data sources to identify chemicals that meet one or more of the Action Plan priority factors. EPA is seeking public input on two related aspects of Step 1: (a) prioritization factors; and (b) data sources for prioritization factors. In Step 2, EPA intends to refine that group by using information from additional exposure and hazard data sources to analyze further the chemicals to select for specific chemicals for further assessment, including possible risk assessment and risk management action. EPA is seeking input on the data sources for further analysis to be used in Step 2. The Discussion Guide is available online.
The Discussion Guide lists the following factors for identifying candidate chemicals for review:
Potentially of concern for children's health (e.g., chemicals with reproductive or developmental effects);
Persistent, bioaccumulative, and toxic (PBT);
Probable or known carcinogens;
Used in children's products;
Used in consumer products; and
- Detected in biomonitoring programs.
Comments during the webinar included a suggestion that EPA expand the factors to include chemicals such as neurotoxins and endocrine disruptors. Other participants urged EPA to make optimum use of data and information generated under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. Additional suggested data sources include EPA's Endocrine Disruptor Screening Program (EDSP), the Substitute It Now! (SIN) List developed by the International Chemical Secretariat, a non-governmental organization (NGO), and EPA's ToxCast Database. Other participants recommended against the use of NGO-derived lists.
According to EPA, after it identifies priority chemicals for review (Step 1), it will publicly announce the data and sources of information that it intends to use to inform its review in Step 2. If stakeholders believe there are better and/or more recent data available that EPA should consider, they will have an opportunity to provide information to EPA for review.
Importantly, EPA stated it would post the Power Point presentation, a summary of comments obtained during the webinar and meetings, and comments submitted through the discussion forum within several weeks of the close of the discussion forum. This is important as presumably the comments received orally during the webinar will all be considered part of the administrative record in the development of EPA's priority chemical identification process.
The discussion forum will remain open for input through 5:00 p.m. (EDT) on September 14, 2011, and all information posted to the forum will remain accessible for reading after posts are no longer being accepted. The discussion forum is available online.