Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on May 28, 2020, extending the comment and reporting period on the preliminary lists of manufacturers (including importers) subject to fees associated with EPA-initiated risk evaluations under the Toxic Substances Control Act (TSCA).  85 Fed. Reg. 32036.  The new due date is June 15, 2020.  EPA states that it is extending the comment period in response to stakeholder feedback and to allow companies additional time to report, or self-identify, as to whether they are a manufacturer subject to fees for the next 20 TSCA risk evaluations.  EPA intends to issue final scope documents for the next 20 risk evaluations in summer 2020 and will publish the final list of fee payers no later than concurrently with the final scope documents.

EPA held a conference call on TSCA fees on April 16, 2020, and posted the slides and transcript for the call.  EPA’s web page on TSCA fees for EPA-initiated risk evaluations includes frequently asked questions.  Our March 2, 2020, memorandum, “The Essential Value of Forming TSCA Consortia,” provides information on forming a consortium.  More information on the 20 substances designated as high-priority substances is available in our December 20, 2019, memorandum, “Final List of High-Priority Chemicals Will Be Next to Undergo Risk Evaluation under TSCA.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) recently published its 2020 Annual Plan for Chemical Risk Evaluations under TSCA (Annual Plan).  Section 26(n) of the Toxic Substances Control Act (TSCA) requires EPA to publish an annual plan at the beginning of each calendar year that identifies the chemical substances for which EPA expects to initiate or complete risk evaluations that year and the resources necessary for their completion, describes the status of each risk evaluation that has been initiated but not yet completed, and includes an updated schedule for completion of risk evaluations, if appropriate.  The Annual Plan states that in fiscal year (FY) 2020, EPA intends to complete final risk evaluations for the first ten chemicals.  As reported in our April 7 and April 20, 2020, blog items, EPA has published the draft scope documents for the risk evaluations to be conducted for the 20 high-priority substances designated in December 2019.  According to the Annual Plan, EPA expects to issue final draft scope documents in June 2020.  In accordance with statutory timelines, EPA states that it will publish final risk evaluations within three years of initiation, with a possible six-month extension.  In May 2019, EPA received manufacturer requests to conduct risk evaluations of diisodecyl phthalate (DIDP) and diisononyl phthalate (DINP).  EPA expects to release draft scope documents in the third quarter of FY 2020, complying with statutory timelines.  In March 2020, EPA received a facially complete manufacturer request to conduct a risk evaluation on octamethylcyclotetrasiloxane (D4).  EPA expects to ask for public comment on this request and make a final determination as to whether to grant this request within FY 2020.  EPA notes that it may receive additional requests in FY 2020 and will conduct the process to review these requests as directed in the Risk Evaluation Process Rule.  TSCA requires EPA to review fees and consider updating the fees rule every three years to ensure fees are adequate to defray 25 percent of the costs for implementing TSCA Sections 4, 5, 6, and 14, and to consult with stakeholders again if fees change.  In 2020, EPA expects to begin this process to review fees and propose certain exemptions to the current rule’s self-identification requirements associated with EPA-initiated risk evaluations for manufacturers that import the chemical substance in an article, produce the chemical substance as a byproduct, and produce or import the chemical substance as an impurity.


 

By Lynn L. Bergeson and Carla N. Hutton

On May 20, 2020, the Senate Environment and Public Works Committee held an oversight hearing on the U.S. Environmental Protection Agency (EPA).  EPA Administrator Andrew Wheeler was the only witness.  During the hearing, Senator Jeff Merkley (D-OR) questioned Wheeler about the risk evaluations being done under the amended Toxic Substances Control Act (TSCA), particularly the risk evaluation of asbestos.  Wheeler acknowledged that EPA probably will not meet the June 22, 2020, deadline for issuing final risk evaluations for the first ten chemicals.  According to Wheeler, EPA is spending more time on these first risk evaluations to make sure they get them right.  Wheeler noted that the peer reviews are taking longer than expected and that the interagency review process has taken longer than anticipated.  Wheeler stated that he thinks EPA is on track to have at least two of the first ten risk evaluations done by June 2020 and the remainder by the end of summer 2020.  Regarding the asbestos risk evaluation, EPA will do a separate supplemental risk evaluation on the legacy uses since EPA can likely complete the final risk evaluation of asbestos this summer.  Merkley asked Wheeler whether he would commit to examining all significant pathways of exposure to asbestos, including air, waste, and drinking water.  Wheeler responded that when a chemical under the TSCA review process is already being regulated under a different program, EPA decided early on that in setting out the parameters for the TSCA risk evaluations, it would not double regulate to focus its time on the areas of the chemicals that are unregulated at this point.  Wheeler states that the way to meet the strict deadlines required by TSCA is to allow the other programs that are already regulating aspects of those chemicals to continue to regulate them, whether it is a hazardous air pollutant under the air program or a regulation under the water program.


 

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) announced on May 11, 2020, that the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) will meet from June 8 to 11, 2020, to peer review the draft risk evaluation for asbestos.  The public meeting will be virtual, with participation by phone and webcast only.  There will be no in-person gathering for this meeting.  EPA postponed the previously announced virtual meeting for SACC to review the draft risk evaluation for asbestos due to changes in the availability of members for the peer review.  Stakeholders must register online to receive the webcast meeting link and audio teleconference information for participation in this meeting.  Stakeholders may register and participate as listen-only attendees at any time up to the end of the meeting.  Requests to make brief oral comments to SACC during the virtual meeting should be submitted when registering online on or before noon (12:00 p.m. EDT) on June 2, 2020.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on May 4, 2020, announcing the availability of and soliciting public comment on the draft Toxic Substances Control Act (TSCA) risk evaluation of perchloroethylene.  85 Fed. Reg. 26464.  EPA states that it is also submitting the same document to the TSCA Science Advisory Committee on Chemicals (SACC) for peer review and is announcing that there will be two virtual public meetings of the TSCA SACC, with participation by phone and webcast only, and no in-person gathering.  The first virtual public meeting, on May 5, 2020, will be a preparatory meeting for SACC to consider the scope and clarity of the draft charge questions for the peer review.  This meeting will be followed by the peer review public virtual meeting on May 26-29, 2020, for SACC to consider and review the draft risk evaluation.  EPA will provide any written comments submitted on the draft risk evaluation on or before May 20, 2020, to SACC for their consideration before the meeting.  Comments received after May 20, 2020, and prior to the oral public comment period during the May 26-29, 2020, meeting will be available to the SACC for their consideration during the meeting.  Comments on the draft risk evaluation are due July 6, 2020.  EPA will consider all comments received by the end of the comment period.  More information on EPA’s draft risk evaluation is available in our April 28, 2020, memorandum, “EPA Publishes Draft Risk Evaluation of Perchloroethylene.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
On April 27, 2020, the U.S. Environmental Protection Agency (EPA) released the draft risk evaluation of perchloroethylene.  Perchloroethylene is the last of the first ten chemicals to undergo risk evaluation under the amended Toxic Substances Control Act (TSCA).  EPA’s draft risk evaluation preliminarily found unreasonable risk to workers, occupational non-users, consumers, bystanders, and the environment from certain uses.  EPA states that the primary health risk identified in the draft risk evaluation is neurological effects from short- and long-term exposure to perchloroethylene.  The risk to consumers from perchloroethylene’s use in dry cleaning is from skin exposure to items cleaned with perchloroethylene.  EPA notes that it also found environmental risks to aquatic organisms.
 
EPA will use feedback received from the peer review and public comment process to inform the final risk evaluation and will provide “frequent updates” on its progress throughout the process.  EPA notes that if its final risk evaluation finds there are unreasonable risks associated with perchloroethylene under the specific conditions of use, EPA will propose actions to address those risks within the time frame required by TSCA.  EPA’s actions could include proposed regulations to prohibit or limit the manufacture, processing, distribution in the marketplace, use, or disposal of perchloroethylene, as applicable.
 
EPA will publish a notice in the Federal Register announcing the availability of the draft risk evaluation, beginning a 60-day comment period.  EPA will also hold a virtual peer review meeting of the Science Advisory Committee on Chemicals (SACC) on the draft risk evaluation May 26-29, 2020.  The virtual peer review meeting is open to the public to attend and provide comments.


 

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
 
The U.S. Environmental Protection Agency (EPA) has postponed the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) peer review virtual meeting scheduled for April 27-30, 2020, due to recent changes in the availability of SACC members for the review.  EPA states that given the importance of the draft risk evaluation for asbestos, it believes that “rescheduling for a time when more members are available is critical and will allow for a more robust review of the evaluation.”  As a result, EPA will reschedule the SACC meeting “as soon as practicable.”  EPA notes that while it does not anticipate extending the written public comment period on the draft risk evaluation past June 2, 2020, “as needs arise EPA will review and respond appropriately.”  EPA will provide all written comments received by June 2, 2020, to SACC for their review prior to the meeting.  Once EPA has selected a new date for the SACC meeting, EPA will provide an update on public commenting, including registering to provide oral public comments during the SACC meeting.  EPA states that it “remains committed to completing this process as expeditiously as possible.”  More information on EPA’s draft risk evaluation is available in our April 1, 2020, memorandum, “EPA Publishes Draft Risk Evaluation of Asbestos, Will Hold Virtual Peer Review Meeting.”


 
 1 2 3 >  Last ›