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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) is accepting public comments on candidates under consideration for selection as ad hoc reviewers assisting the Science Advisory Committee on Chemicals (SACC) with their review of the draft EPA Toxic Substances Control Act (TSCA) Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities. EPA will use the comments to assist it in selecting approximately six to eight ad hoc reviewers to assist the SACC with its review. Biographies of the candidates are available online. Comments are due January 5, 2022. Comments can be submitted through Docket ID EPA-HQ-OPPT-2021-0415. Information considered to be confidential business information (CBI) or other information whose disclosure is restricted by statute should not be submitted electronically. EPA notes that it will not post copyrighted material without explicit permission of the copyright holder.
 
EPA notes that it published ten final risk evaluations between 2020 and 2021 under TSCA as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act. During the course of preparing many of these final risk evaluations, the previous Administration made a policy decision that EPA not assess air and water exposure pathways that fall under the jurisdiction of other EPA-administered laws. This policy decision was reversed in June 2021. EPA states that it is presenting Version 1.0 of a screening level methodology for assessing potential air and water pathway chemical exposures to fenceline communities. Along with presenting this methodology, EPA will also present results of applying the screening methodology (case studies) to 1-bromopropane (air pathway), N-methylpyrrolidone (water pathway), and methylene chloride (air and water pathway). The review will take place during a public meeting anticipated for March 15-17, 2022. Registration instructions will be announced on the SACC website in early February 2022.


 
By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced the availability of the Draft Systematic Review Protocol Supporting TSCA Risk Evaluations for Chemical Substances (Draft Protocol) on December 20, 2021. 86 Fed. Reg. 71891. According to EPA, the Draft Protocol includes a revised generic approach for Toxic Substances Control Act (TSCA)-related approaches accounting for previous peer review comments from the Science Advisory Committee on Chemicals (SACC) reviews of risk evaluations on the first ten chemical assessments and more recent recommendations from the National Academies of Sciences, Engineering, and Medicine (NASEM) review of the Application of Systematic Review in TSCA Risk Evaluations. EPA states that in addition to the revised, generic approach, the peer review package will include appendices containing chemical-specific information that is relevant for search strings and screening statements and data evaluation criteria for the next chemical risk evaluations being conducted by the Office of Pollution Prevention and Toxics (OPPT). The Draft Protocol provides specific details of the systematic reviews for the individual chemicals listed below:

o-Dichlorobenzene
p-Dichlorobenzene
1,2-Dichloroethane
trans-1,2- Dichloroethylene
1,1,2-Trichloroethane
1,2-Dichloropropane
1,1-Dichloroethane
Ethylene dibromide
1,3-Butadiene
1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-2-benzopyran (HHCB)
4,4'-(1-Methylethylidene)bis[2, 6-dibromophenol] (TBBPA)
Tris(2-chloroethyl) phosphate (TCEP)
Phosphoric acid, triphenyl ester (TPP)
Formaldehyde
Phthalic anhydride
Dibutyl phthalate (DBP) (1,2-Benzene-dicarboxylic acid, 1,2- dibutyl ester)
Butyl benzyl phthalate (BBP) -- 1,2-Benzene-dicarboxylic acid, 1-butyl 2(phenylmethyl) ester
Di-ethylhexyl phthalate (DEHP) -- (1,2-Benzene-dicarboxylic acid, 1,2-bis(2-ethylhexyl) ester)
Di-isobutyl phthalate (DIBP) -- (1,2-Benzene-dicarboxylic acid, 1,2-bis-(2-methylpropyl) ester)
Dicyclohexyl phthalate
Diisodecyl phthalate (DIDP)
Diisononyl phthalate (DINP)
Octamethylcyclotetra-siloxane (Cyclotetrasiloxane, 2,2,4,4,6,6,8,8-octamethyl-) (D4)
Asbestos 2 (including Libby Amphibole Asbestos [LAA] and its tremolite, winchite, and richterite constituents)
1,4-Dioxane supplement
 
EPA invites the public to provide input on the Draft Protocol via Docket No. EPA-HQ-OPPT-2021-0414. Comments are due February 18, 2022.
SACC will hold a virtual three-day peer review public meeting to consider and review the Draft Protocol on April 19-21, 2022. Stakeholders must register online to receive the webcast meeting link and audio teleconference information. Registration instructions will be announced on the SACC website by early March 2022. After the public meeting, SACC will prepare meeting minutes summarizing its recommendations to EPA. The meeting minutes will be posted on the SACC website and in the relevant docket.
 
More information and a detailed commentary will be available in a forthcoming memorandum that will be posted on our website.

 

By Lynn L. Bergeson and Carla N. Hutton
 
On October 27, 2021, the U.S. Environmental Protection Agency (EPA) requested public nominations of scientific experts to consider for service as ad hoc reviewers assisting the Science Advisory Committee on Chemicals (SACC) with two peer review topics anticipated for early 2022: the draft EPA Toxic Substances Control Act (TSCA) Systematic Review Protocol and the draft EPA TSCA Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities. 86 Fed. Reg. 59382. EPA states that individuals nominated should have expertise in one or more of the following areas:

  • Systematic review: Individuals nominated for peer review of the draft systematic review protocol should have expertise in one or more of the following areas: systematic review approaches of human health and ecological hazard, exposure topics, and fate. All experts, including those representing other fields of interest, who have experience with engineering, machine learning, artificial intelligence techniques, and natural language processing approaches as applied to systematic review are also needed. EPA states that understanding the TSCA risk evaluation process “is highly desirable for the context of this peer review.”
  • Exposures to fenceline communities: Individuals nominated for peer review of the draft EPA TSCA Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities should have expertise in one or more of the following areas: chemical fate and transport via ambient air and water pathways; atmospheric modeling of fate, transport, and human exposures; human health, exposure, and risk assessment for airborne and/or waterborne chemicals; expertise estimating environmental air releases of chemicals from a variety of sources and databases such as Chemical Data Reporting (CDR); experience developing air dispersion methodologies and/or models to estimate ambient air concentrations and impacts to human populations; expertise estimating environmental water releases of chemicals from a variety of sources and databases such as CDR, Toxics Release Inventory (TRI), and Discharge Monitoring Report; experience developing methodologies and/or models to estimate chemical concentrations in ambient/source/drinking water and impacts to human populations; and public health protection for at-risk communities.

EPA states that any interested person or organization may nominate qualified individuals to be considered prospective candidates for these reviews. Individuals may also self-nominate. Nominations are due November 17, 2021.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On June 15, 2021, the U.S. Environmental Protection Agency (EPA) appointed nine new members to serve on the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC). Additionally, EPA appointed a new Chair and reappointed seven existing members. In EPA’s July 13, 2021, announcement, EPA notes that members of the TSCA SACC serve staggered terms of appointment, generally of three years. They possess expertise in scientific and technical fields relevant to chemical risk assessment and pollution prevention, including human health and ecological risk assessment and chemical exposure to susceptible life stages and subpopulations. EPA states that in addition to scientific expertise, members also have backgrounds and experiences that will contribute to the diversity of scientific viewpoints, including professional experiences in government, public health, industry, and other groups. According to EPA, TSCA SACC serves as a primary scientific peer review mechanism of EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) 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
 
The U.S. Environmental Protection Agency (EPA) is accepting public comments for all candidates under consideration for membership on the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC).  Biographies for all candidates are available in Docket ID EPA-HQ-OPPT-2020-0135.  When providing comments, EPA states that stakeholders should not submit electronically any information considered to be confidential business information (CBI) or other information whose disclosure is restricted by statute.  Comments are due October 30, 2020.  EPA will use public comments to assist in selecting multiple members of the SACC over the next year. 
 
EPA anticipates appointing approximately 15 members to the SACC by March 2021.  EPA notes that current SACC members are eligible for reappointment during this period.  Therefore, the appointments completed by March 2021 may include a mix of newly appointed and reappointed members.


 

By Lynn L. Bergeson and Carla N. Hutton
 

The U.S. Environmental Protection Agency (EPA) is extending the nomination and public comment periods for the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) to receive additional nominees and input on prospective candidates for membership.  EPA states that it will use public comments to assist it in selecting multiple members of SACC over the next year.  EPA anticipates appointing approximately 15 members to SACC by March 2021.  EPA notes that current members of SACC are eligible for reappointment during this period.  Therefore, the approximately 15 member appointments completed by March 2021 may include a mix of newly appointed and reappointed members.  Biographies of the candidates are available in Docket ID EPA-HQ-OPPT-2020-0135.  Comments are due September 1, 2020.

Tags: SACC

 

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.


 
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