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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) 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.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on March 20, 2020, inviting the public to nominate scientific experts from a diverse range of disciplines to be considered for appointment to the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC).  85 Fed. Reg. 16094.  EPA is seeking nominations of individuals who have demonstrated high levels of expertise in scientific and/or technical fields relevant to chemical safety and risk assessment, including, but not limited to:  human health and ecological risk assessment, biostatistics, epidemiology, pediatrics, physiologically based pharmacokinetics, toxicology and pathology, and the relationship of chemical exposures to women, children, and other potentially exposed or susceptible subpopulations.  In addition, nominees should have backgrounds and experiences that would contribute to the diversity of scientific viewpoints on the committee, including professional experiences in government, labor, public health, public interest, animal protection, industry, and other groups, as the EPA Administrator determines to be advisable (e.g., geographic location, social and cultural backgrounds, and professional affiliations).  Any interested person or organization may nominate qualified persons to be considered for appointment to SACC.  Individuals also may self-nominate.  The preferred method for submitting nominations is via e-mail to Steven Knott, the SACC’s Designated Federal Officer (.(JavaScript must be enabled to view this email address)).  Nominations are due no later than April 20, 2020.

Background
 
SACC serves as a primary scientific peer review mechanism of EPA’s Office of Chemical Safety and Pollution Prevention and is structured to provide independent scientific advice and recommendations to EPA on the scientific basis for risk assessments, methodologies, and pollution prevention measures and approaches for chemicals regulated under TSCA.

 

By Lynn L. Bergeson and Carla N. Hutton
 
In a Federal Register notice published on March 20, 2020, the U.S. Environmental Protection Agency (EPA) announced that the March 24-26, 2020, Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) meeting to review the draft risk evaluation for trichloroethylene (TCE) is being changed to a virtual public meeting.  85 Fed. Reg. 16096.  Participation will be by telephone and webcast only.  EPA states the meeting times and dates have been adjusted, and that the meeting will be held on March 24-27, 2020, from 10:00 a.m. to approximately 5:00 p.m. (EDT).  EPA asks that stakeholders who want to make oral comments register by noon on March 20, 2020.  Stakeholders must register online to receive the webcast meeting link and audio teleconference information for participation.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register on February 26, 2020, announcing the availability of the draft risk evaluation for trichloroethylene (TCE), “a chemical used as a solvent and an intermediate for refrigerant manufacture in industrial and commercial processes, and with limited consumers uses like as a spot cleaner in dry cleaning facilities.”  85 Fed. Reg. 11079.  EPA assessed 54 conditions of use of TCE, and the draft risk evaluation includes the following findings:

  • EPA did not find risk to the environment; and
  • EPA’s draft risk evaluation preliminarily found unreasonable risk associated with dermal and inhalation exposure for workers, occupational non-users, consumers, and bystanders.

EPA notes that the draft risk evaluation and the initial risk determinations are not a final action.  The draft represents EPA’s preliminary conclusions, findings, and determinations on TCE and will be peer reviewed by independent scientific experts.  According to EPA, the draft risk evaluation includes input from other EPA offices, as well as other federal agencies.
 
The TSCA Science Advisory Committee on Chemicals (SACC) will meet March 24-26, 2020, to peer review the draft risk evaluation of TCE’s conditions of use.  EPA asks that comments on the draft risk evaluation be submitted by March 18, 2020, to allow SACC time to review and consider them before the peer review meeting.  EPA states that comments received after March 18, 2020, and prior to the end of the oral public comment period during the meeting will still be provided to SACC for their consideration.  EPA will hold a preparatory virtual meeting on March 3, 2020, for SACC and the public to comment on the clarity and scope of the draft charge questions for the March 24-26, 2020, meeting.
 
Comments on the draft risk evaluation are due April 27, 2020.  More information on the draft risk evaluation is available in our February 26, 2020, memorandum, “EPA Releases Draft Risk Evaluation for TCE, Announces SACC Peer Review Meeting.”

 

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) released on February 21, 2020, the draft risk evaluation for trichloroethylene (TCE), “a chemical used as a solvent and an intermediate for refrigerant manufacture in industrial and commercial processes, and with limited consumers uses like as a spot cleaner in dry cleaning facilities.”  EPA assessed 54 conditions of use of TCE, and the draft risk evaluation includes the following findings:

  • EPA did not find risk to the environment; and
  • EPA’s draft risk evaluation preliminarily found unreasonable risk associated with dermal and inhalation exposure for workers, occupational non-users, consumers, and bystanders.

EPA notes that the draft risk evaluation and the initial risk determinations are not a final action.  The draft represents EPA’s preliminary conclusions, findings, and determinations on TCE and will be peer reviewed by independent scientific experts.  According to EPA, the draft risk evaluation includes input from other EPA offices, as well as other federal agencies.
 
The TSCA Science Advisory Committee on Chemicals (SACC) will meet on March 24-26, 2020, to peer review the draft risk evaluation of TCE’s conditions of use.  EPA asks that comments on the draft risk evaluation be submitted by March 18, 2020, to allow SACC time to review and consider them before the peer review meeting.  EPA states that comments received after March 18, 2020, and prior to the end of the oral public comment period during the meeting will still be provided to SACC for their consideration.  EPA will hold a preparatory virtual meeting on March 3, 2020, for SACC and the public to comment on the clarity and scope of the draft charge questions for the March 24-26, 2020, meeting.
 
EPA will publish a notice in the Federal Register announcing the availability of the draft risk evaluation and beginning a 60-day comment period.  More information on the draft risk evaluation will be available in a forthcoming memorandum that will be posted on our website.

 

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By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency will publish a Federal Register notice on October 29, 2019, announcing the availability of and soliciting public comment on the draft Toxic Substances Control Act (TSCA) risk evaluation of methylene chloride (MC).  EPA states that it is also submitting the same document to the TSCA Science Advisory Committee on Chemicals (SACC) for peer review and that SACC will hold an in-person public meeting to consider and review the draft risk evaluation on December 3-4, 2019.  Preceding the in-person meeting, there will be a preparatory virtual public meeting on November 12, 2019, for SACC to consider the scope and clarity of the draft charge questions for the peer review.  Registration for the preparatory virtual meeting must be completed on or before November 12, 2019, to receive the webcast meeting link and audio teleconference information.  Written comments for the preparatory virtual meeting and requests for time to present oral comments are due by 12:00 p.m. on November 8, 2019.  Written comments on the draft risk evaluation that are submitted to EPA on or before November 26, 2019, will be provided to SACC for review and consideration before the December 3-4, 2019, meeting.  Requests to present oral comments at the in-person meeting are due December 3, 2019.  Publication of the Federal Register notice on October 29, 2019, will begin a 60-day comment period on the draft risk evaluation.  The draft risk evaluation is not yet publicly available and is not expected to be until the notice is published on October 29, 2019, and Docket ID EPA-HQ-OPPT-2019-0437 is created at http://www.regulations.gov.  More information is available in our October 25, 2019, memorandum, “EPA Will Publish Draft Risk Evaluation of Methylene Chloride on October 29.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
Alexandra Dapolito Dunn, Assistant Administrator for the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) stated on October 11, 2019, that EPA will provide more time for public comment on its draft risk evaluations before the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) meets to peer review the draft documents.  According to Dunn, the new schedule will include a comment period of at least 30 days before SACC meets.  EPA plans to complete ten chemical risk evaluations by June 22, 2020.  To date, EPA has released four draft chemical risk evaluations, and SACC has peer reviewed them.  For the remaining six chemicals, EPA intends to release four of the draft risk evaluations for public comment by the end of 2019 and the other two in January 2020.  SACC will peer review two of the draft risk evaluations in 2019 and the remaining four in 2020.  Dunn stated that EPA will meet the Lautenberg Act’s deadline to release all ten risk evaluations by June 2020.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On September 30, 2019, the U.S. Environmental Protection Agency (EPA) announced the availability of the meeting minutes and final report for the June 18-21, 2019, meeting of the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) on the draft risk evaluation for Pigment Violet 29 (PV29).  SACC’s report addresses the scientific issues being considered by EPA regarding the peer review for the draft risk evaluation.  As reported in our November 16, 2018, memorandum, “EPA Publishes First Draft TSCA Chemical Risk Evaluation,” the draft risk evaluation states that EPA considered all reasonably available data for PV29 to make a determination of whether the risk it poses is unreasonable.  EPA “concludes that C.I. Pigment Violet 29 does not present an unreasonable risk of injury to human health or the environment, without considering costs or other non-risk factors, including no unreasonable risk to potentially exposed and susceptible subpopulations identified as relevant, under the conditions of use.”  EPA requested SACC to provide advice and recommendations on questions concerning:

  • The overall content, organization, and presentation of the draft risk evaluation;
  • Systematic review;
  • Physical chemical properties/environmental fate;
  • Exposure and releases;
  • Environmental effects;
  • Human health;
  • Risk characterization/risk determination; and
  • Supplemental analysis.

The report notes that this first SACC peer review is the first time the TSCA program is making non-TSCA confidential business information (CBI) available to peer reviewers.  According to the report, EPA requested comment on the process, integration, and clarity related to the use of the CBI that was provided.  EPA provided SACC members TSCA CBI training, and they were permitted to review the full studies as part of their peer review.  The report states that upon a comparison of the full (unredacted) studies with the redacted studies, SACC reached consensus that the nature of the redactions do not materially impact the draft risk characterization.  SACC agreed that the summary statistics provided in the unredacted version of the reproduction/development study were consistent with the animal data in the redacted version of the study.  SACC made recommendations to EPA about how to process CBI information for use by SACC and the public for future assessments.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency’s (EPA) Toxic Substances Control Act Science Advisory Committee on Chemicals (TSCA SACC) will peer review EPA’s draft risk evaluation for 1-bromopropane (1-BP) on September 10-12, 2019.  The meeting will be held at the Hyatt Regency Crystal City at Reagan National Airport, 2799 Jefferson Davis Highway, Arlington, Virginia.  As reported in our August 9, 2019, blog item, EPA released the draft risk evaluation for 1-BP on August 9, 2019.  EPA made the following initial determinations on risk:

  • Unreasonable risks to workers, occupational non-users, and consumers under certain conditions of use.  EPA notes that these initial determinations are not its final determinations on whether 1-BP presents unreasonable risks under the conditions of use.  EPA states that it will use feedback received from the public and peer review processes to inform the final risk evaluations.
     
  • No unreasonable risk to the environment.  For all the conditions of use included in the draft risk evaluation, EPA found no unreasonable risks to the environment from 1-BP.

EPA requests comments on the draft risk evaluation by August 30, 2019, to allow SACC time to review and consider them before the peer review meeting.  Comments received after August 30, 2019, and prior to the end of the oral public comment period during the meeting will still be provided to the SACC for their consideration.  EPA will continue to accept comments on the draft risk evaluations until October 11, 2019.  EPA will consider all comments received on the draft risk evaluations by the October 11, 2019, deadline when developing the final risk evaluation.  More information is available in our August 12, 2019, memorandum, “EPA Draft Risk Evaluation for 1-BP Finds Unreasonable Risks to Workers, Occupational Non-Users, Consumers, and Bystanders under Certain Specific Uses.”


 
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