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By Christopher R. Blunck
 
As we noted in our May 15, 2020, blog item “NGOs Ask EPA to Revise Draft Scope Documents to Comply with TSCA and EPA Regulations,” Environmental Defense Fund (EDF), Earthjustice, Natural Resources Defense Council (NRDC), and Safer Chemicals, Healthy Families filed comments on May 13, 2020, stating that the U.S. Environmental Protection Agency’s (EPA) 20 draft scope documents released on April 9 and April 23, 2020, fail to meet Toxic Substances Control Act (TSCA) and EPA regulatory requirements.  In the comments, linked to in EDF’s May 14, 2020, blog item on the subject (the comments are not yet posted to the EPA dockets), the non-governmental organizations (NGO) called on EPA to revise the draft documents to include the information that both TSCA and EPA’s risk evaluation rule require to be included, and then make the revised draft scopes available for public comment.  In their comments, the NGOs note that TSCA Section 6(b)(4)(D) requires that EPA, “not later than 6 months after the initiation of a risk evaluation, publish the scope of the risk evaluation to be conducted, including the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the Administrator expects to consider” (emphasis added) and that under EPA’s risk evaluation rule at 40 C.F.R. Section702.41(c), the scope of a risk evaluation must, among other things, identify:

  • The potentially exposed populations, including any potentially exposed or susceptible subpopulations identified as relevant to the risk evaluation by EPA under the conditions of use, that EPA plans to evaluate;
     
  • The ecological receptors that EPA plans to evaluate;
     
  • The hazards to health and the environment that EPA plans to evaluate; and
     
  • The “reasonably available information” on which EPA relies to identify these required scope elements.
The NGOs state that EPA regulations at 40 C.F.R. Section 702.41(c)(7) make clear that these elements are to be included in the draft scope made available for public comment, not just in the final scope.  According to the NGOs, despite the regulatory requirements, EPA has not addressed the specific obligations and “Instead, EPA has only generally described some broad categories of hazards, exposures, and potentially exposed or susceptible subpopulations, and has suggested it will identify the specific hazards, exposures, and subpopulations -- and the reasonably available information it relies on to identify them -- only later, well after the current comment periods have closed and possibly even after the scopes are finalized.”  This, the NGOs state, is not allowed under TSCA and the TSCA risk evaluation rule.
 
Furthermore, the NGOs state that EPA also refers in each draft scope to “systematic review documentation” that has not yet been made public.  While EPA states it plans to publish this second document prior to issuing the final scope document, and take comment on it, the comments state that “EPA has wholly divorced any public comment opportunity it will provide on that systematic review document from the current public comment opportunity” and “[g]iven that the systematic review document is not yet available, the public is unable to consider its content in preparing comments on the draft scope document.”
 
The NGOs indicate that given these faults, “EPA jeopardizes the integrity and legality of the entire risk evaluation process.”  They request EPA simultaneously to publish and take comment on, for a period of no less than 30 days, revised draft scope documents that reflect the planned systematic review, and the systematic review documentation for each scope.
 
We agree that the faults identified by the NGOs on the draft scope documents and the associated process are significant and that if not remedied, any risk evaluations with scopes founded on the drafts would be legally vulnerable as not comporting with TSCA and EPA’s risk evaluation rule.  EPA may wish to consider taking corrective measures along the lines urged.  This change would include adding into revised draft scopes for comment the reasonably available information EPA has indicated it will identify through the yet-to-be-completed systematic review process, and will identify the specific hazards, exposures, and potentially exposed or susceptible subpopulations that EPA expects to consider in the risk evaluations.
 

 

By Lynn L. Bergeson and Carla N. Hutton
 
Environmental Defense Fund (EDF), Earthjustice, Natural Resources Defense Council (NRDC), and Safer Chemicals, Healthy Families filed comments on May 13, 2020, stating that the U.S. Environmental Protection Agency’s (EPA) 20 draft scope documents released on April 9 and April 23, 2020, fail to meet Toxic Substances Control Act (TSCA) and EPA regulatory requirements.  According to EDF’s May 14, 2020, blog item, the non-governmental organizations (NGO) called on EPA to revise the draft documents to include the information that both TSCA and EPA’s risk evaluation rule require be included, and then make the revised draft scopes available for public comment.  The NGOs maintain that under both TSCA and EPA regulations codifying the risk evaluation rule, the scope of a risk evaluation must identify:

  • The potentially exposed populations, including any potentially exposed or susceptible subpopulations identified as relevant to the risk evaluation by EPA under the conditions of use, that EPA plans to evaluate;
     
  • The ecological receptors that EPA plans to evaluate; and
     
  • The hazards to health and the environment that EPA plans to evaluate.

The scope document must also present the “reasonably available information” on which EPA relies to identify these required scope elements.  The NGOs note that EPA regulations make clear that these elements are to be included in the draft scope made available for public comment, not just in the final scope.  Instead, according to the NGOs, “EPA’s draft scopes repeatedly indicate that these required scope elements will be developed and provided later -- thereby denying the public an opportunity to provide comment on the specific hazards, exposures and potentially exposed or susceptible subpopulations EPA expects to consider, as required at this stage in the process.”
 
The NGOs state that EPA also repeatedly refers in each draft scope to “systematic review documentation” that has not yet been made public.  EPA will use this separate document to identify the required scope elements and the reasonably available information on which it relies.  While EPA plans to publish this second document prior to issuing the final scope document, and take public comment on it, “EPA has wholly divorced that process from the public comment process for the draft scopes.”  By doing so, “EPA jeopardizes the integrity and legality of the entire risk evaluation process.”  The NGOs urge EPA to publish and take comment simultaneously on the systematic review documentation for each scope along with the revised draft scopes themselves.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on April 23, 2020, announcing the availability of the draft scope documents for the risk evaluations to be conducted for the remaining seven of the 20 high-priority substances designated in December 2019.  85 Fed. Reg. 22733.  The draft scope document for each chemical substance includes the conditions of use, hazards, exposures, and the potentially exposed or susceptible subpopulations that EPA plans to consider in conducting the risk evaluation for that chemical substance.  EPA is also opening a 45-day comment period on these draft scope documents to allow for the public to provide additional data or information that could be useful to EPA in preparing the final scope documents.  Comments are due June 8, 2020.  More information on the draft scope documents is available in our April 21, 2020, memorandum, “EPA Releases Second Set of Draft Scope Documents for Remaining High-Priority Substances.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
On April 17, 2020, the U.S. Environmental Protection Agency (EPA) released the second set of draft scope documents for the seven remaining chemicals designated as high-priority substances for risk evaluation under the Toxic Substances Control Act (TSCA).  As reported in our December 20, 2019, memorandum, EPA designated these chemicals as a high priority for risk evaluation in December 2019.  According to EPA, seeking public input on the conditions of use to be included in the risk evaluations for these chemicals is the next step in the process outlined in TSCA.  EPA states that “[‌i]t is important to note that being designated as a high-priority chemical does not mean that a chemical is high risk.”
 
EPA is releasing draft scope documents for the following chemicals:

 
EPA will publish a Federal Register notice announcing the availability of the draft scope documents for public comment.  Publication of the notice will begin a 45-day comment period.  EPA states that it will use feedback received from the public comment process to inform the final scope documents.  More information on the second batch of draft scope documents will be available in a forthcoming memorandum that will be posted on our website.  Our April 7, 2020, memorandum, “EPA Seeks Public Comment on First Batch of Draft Scope Documents,” offers an overview of the draft scope documents on the other 13 of the 20 chemicals undergoing risk evaluation, as well as an insightful commentary.


 

By Lynn L. Bergeson and Carla N. Hutton
 

The U.S. Environmental Protection Agency (EPA) announced on April 6, 2020, that the first set of draft scope documents for the next group of chemicals undergoing risk evaluation under the Toxic Substances Control Act (TSCA) is available for comment.  As reported in our December 20, 2019, memorandum, EPA designated these chemicals as a high priority for risk evaluation in December 2019.  According to EPA, seeking public input on the conditions of use to be included in the risk evaluations for these chemicals is the next step in the process outlined in TSCA.  EPA states that “it is important to note that being designated as a high-priority chemical does not mean that a chemical is high risk.”
 
EPA is releasing draft scope documents for 13 of the next 20 chemicals undergoing risk evaluation:

EPA will publish a Federal Register notice announcing the availability of the draft scope documents for public comment.  Publication of the notice will begin a 45-day comment period.  EPA states that it will use feedback received from the public comment process to inform the final scope documents.  More information on the first batch of draft scope documents will be available in a forthcoming memorandum that will be posted on our website.