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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.”


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) released on August 9, 2019, the draft risk evaluation for 1-bromopropane (1-BP), the fourth of the first ten chemicals undergoing risk evaluation under the amended Toxic Substances Control Act (TSCA).  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 states that these initial determinations may change as its evaluation becomes more refined through the public and peer review process.  The draft risk evaluation, including initial risk determinations as to whether the chemical under the conditions of use presents an unreasonable risk to human health or the environment, is not final.  If unreasonable risk is found for one or more conditions of use in a final risk evaluation, EPA will propose actions to address those risks within the timeframe required by TSCA.

The TSCA Science Advisory Committee on Chemicals (SACC) will peer review the draft risk evaluation at a September 10-12, 2019, meeting.  EPA will hold a preparatory virtual meeting on August 21, 2019, to discuss the scope and clarity of the draft charge questions to SACC.  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."


 

By Lynn L. Bergeson and Carla N. Hutton

On June 28, 2019, the U.S. Environmental Protection Agency (EPA) released the draft risk evaluations for cyclic aliphatic bromide cluster (HBCD) and 1,4-dioxane, two of the first ten chemicals undergoing risk evaluation under the amended Toxic Substances Control Act (TSCA).  In its June 28, 2019, press release, EPA states in the draft risk evaluation for HBCD, it did not find unreasonable risk to the general population, consumers, workers, or the environment.  According to EPA, in the draft risk evaluation for 1,4-dioxane, EPA did not find unreasonable risk to the environment, but the data “show there could be unreasonable risks to workers in certain circumstances.”  EPA states:  “It is important to note that for the general population, including children, environmental statutes administered by EPA such as the Clean Air Act, the Safe Drinking Water Act, the Clean Water Act, and the Resource Conservation and Recovery Act, adequately assess and effectively manage risks from 1,4-dioxane.”

On Monday, July 1, 2019, EPA will publish a Federal Register notice announcing the availability of the draft risk evaluations and beginning a 60-day comment period.  The draft risk evaluations will be peer reviewed by the Science Advisory Committee on Chemicals (SACC) on July 29- August 2, 2019.  SACC will hold a preparatory virtual meeting to discuss the scope and clarity of the draft charge questions on July 10, 2019.


 

By Lynn L. Bergeson and Margaret R. Graham, M.S.

On May 9, 2019, the U.S. Environmental Protection Agency (EPA) announced it will hold the first meeting of the Science Advisory Committee on Chemicals (SACC) under the Toxic Substances Control Act (TSCA), for Pigment Violet 29 (PV29), the first chemical of the initial ten chemicals undergoing review, on June 18-21, 2019, from 9:00 a.m. to 5:30 p.m. (EDT) at the Holiday Inn Rosslyn at Key Bridge, Rosslyn Ballroom, 1900 North Fort Myer Drive, Arlington, Virginia.  84 Fed. Reg. 20354.  The meeting may also be available via webcast.

EPA states that the purpose of the SACC meeting is for EPA “to get the independent review of the science underlying the PV29 risk assessment, including the hazard assessment, assessment of dose-response, exposure assessment, and risk characterization.”  Additionally, this meeting will include an orientation on TSCA and how EPA is evaluating chemicals in commerce as prescribed in amended TSCA.  EPA states that it will use the scientific advice, information, and recommendations from the SACC, as well as public comments, to inform the final risk evaluation.  Comments are still being collected on the PV29 risk assessment until May 17, 2019, in Docket No. EPA-HQ-OPPT-2018-0604 on www.regulations.gov.

More information about the June SACC meeting and peer review of PV29 is available on EPA’s website.


 

By Lynn L. Bergeson and Margaret R. Graham

On December 31, 2018, the U.S. Environmental Protection Agency (EPA), even though they had already shut down due to funding issues, announced that if the government shutdown continues through 5:00 p.m. (EST) January 4, 2019, the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals’ (SACC) January 8, 2019, Preparatory Virtual Meeting for the January 29 through February 1, 2019, meeting on Colour Index (C.I.) Pigment Violet 29 will be cancelled, and discussion of charge questions will be folded into the face-to-face meeting scheduled for January 29 through February 1, 2019.  Further, if the shutdown continues through 5:00 p.m. (EST) January 11, 2019, the TSCA SACC’s January 29 through February 1, 2019, Peer Review of the draft risk evaluation for C.I. Pigment Violet 29 will be postponed.  More information on the draft risk evaluation of C.I. Pigment Violet 29 is available in our memorandum EPA Publishes First Draft TSCA Chemical Risk Evaluation.


 

By Lynn L. Bergeson and Margaret R. Graham

On November 29, 2019, the U.S. Environmental Protection Agency (EPA) announced that it has scheduled the first public meetings of the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC).  The first meeting, a preparatory virtual meeting, and will be held on January 8, 2019, from 2:00 p.m. to 4:00 p.m. (EST).  The second meeting, a four-day in-person meeting, will be held on January 29, 2019, from 1:00 p.m. (EST) to 5:30 p.m. and on January 30, 31, and February 1, 2019, from 9 a.m. to 5:30 p.m. (EST).  The official announcement is scheduled to be published in the Federal Register on November 30, 2018.  Further information, including the location of the in-person meeting and how to register, will be posted on EPA’s TSCA Scientific Peer Review Committees website.

The topic for this first series of meetings is the peer review of the draft risk evaluation for Colour Index (C.I.) Pigment Violet 29 and associated documents developed under EPA’s existing chemical substance process under TSCA.  EPA states that the two-hour preparatory virtual meeting on January 8, 2019, will consider the scope and clarity of the draft charge questions for this peer review -- included with EPA’s Transmission of Background Materials and Charge to the Panel for the TSCA SACC Reviewing the Draft Risk Evaluation for C.I. Pigment Violet 29 (Attachment 23).  The 4-day, in-person, public meeting will be comprised of the peer review panel deliberations and a general TSCA orientation for the TSCA SACC.  A portion of the in-person meeting will be closed to the public, however, for the discussion of information claimed as confidential business information (CBI).

During these upcoming meetings, EPA states that the public is invited to provide oral comments for the peer review on the draft risk evaluation for C.I. Pigment Violet 29 and related documents; comments submitted by January 14, 2019, on the draft risk evaluation will be provided to the peer review panel members before the in-person meeting.  Comments on the draft charge questions will be accepted prior to and during the 2-hour preparatory virtual meeting (but preferably by January 7, 2019); the TSCA SACC peer review panel will consider these comments during their discussions. 

More information on the draft risk evaluation for C.I. Pigment Violet 29 is available in our memorandum EPA Publishes First Draft TSCA Chemical Risk Evaluation.


 

By Lynn L. Bergeson, Charles M. Auer, Oscar Hernandez, Ph.D., and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on November 15, 2018, announcing the availability of and seeking public comment on the first draft chemical risk evaluation under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg).  The draft risk evaluation for Colour Index (C.I.) Pigment Violet 29 is intended to determine whether C.I. Pigment Violet 29 presents an unreasonable risk to health or the environment under the conditions of use, including an unreasonable risk to a relevant potentially exposed or susceptible subpopulation.  According to the notice, EPA is also submitting these same documents to the TSCA Science Advisory Committee on Chemicals (SACC) to peer review the draft risk evaluation.  EPA intends to publish a separate Federal Register notice containing the peer review meeting details.  Comments on the draft risk evaluation are due January 14, 2019.  EPA will provide all comments submitted on the draft risk evaluation to the TSCA SACC peer review panel, which will have the opportunity to consider the comments during its discussions.  More information is available in the full memorandum.


 

By Lynn L. Bergeson and Margaret R. Graham

On September 13, 2018, EPA announced it was requesting public nominations of scientific experts to be considered for ad hoc participation and possible membership on the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC).  83 Fed. Reg. 46487.  The notice states that all nominees will be considered for ad hoc participation in the TSCA SACC’s peer reviews of the EPA’s risk evaluations for the first ten chemical substances addressed under TSCA.  Further, all nominees may be considered for TSCA SACC membership to fulfill short term needs when a vacancy occurs on the chartered Committee.  As part of a broader process for developing a pool of candidates, EPA staff solicits from the public and stakeholder communities nominations of prospective candidates for service as ad hoc reviewers and possibly members of TSCA SACC. 

EPA states in the notice that any interested person or organization may nominate qualified individuals to be considered as prospective candidates, including themselves.  It is requested for individuals nominated to have expertise in one or more of the following areas:  women's health; children’s health; genetic variability; disproportionately exposed populations; aging; other susceptible populations; biochemistry; chemistry; epidemiology; human health risk assessment; pathology; physiologically based pharmacokinetic (PBPK) modeling; pharmacology; ecological risk assessment; environmental fate; environmental toxicology; occupational, consumer, and general exposure assessment; toxicology; dose response modeling; environmental engineering; biostatistics; computational toxicology; fiber science; inhalation toxicology; volatile organics; and systematic review.  Nominations are due by October 29, 2018.


 
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