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.

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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.

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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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By Lynn L. Bergeson and Margaret R. Graham

On September 6, 2017, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register extending the period for public comments on the candidates for consideration for the Science Advisory Committee on Chemicals from September 5, 2017, to September 17, 2017.  Comments can be submitted online in Docket Identification Number EPA-HQ-OPPT-2016-0713.

EPA is considering candidates for SACC membership listed in the August 26, 2016, Federal Register notice pool of requested nominees; the 29 candidates for membership identified in the December 9, 2016, Federal Register notice; and the additional candidates provided in the August 3, 2017, Federal Register notice.  More information on the background, qualification of members, and the process of obtaining nominees is available in our memorandum EPA Seeks Comment on Nominations to “Augmented” Science Advisory Committee on Chemicals.

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By Lynn L. Bergeson and Margaret R. Graham

On August 3, 2017, the U.S. Environmental Protection Agency (EPA) published a notice on further nominations to the Science Advisory Committee on Chemicals (SACC).  EPA’s notice provides the names and affiliations of 64 additional candidates currently under consideration for appointment to SACC.  Biographical sketches for these candidates will be are posted on EPA’s website. 

EPA will also be considering the 29 candidates for membership previously identified in the December 9, 2016, Federal Register notice -- their biographical sketches are available here.  EPA states that it “anticipates selecting approximately six additional SACC members with specific expertise and perspectives representing industry, labor, animal protection, government, public health, and public interest groups.”  EPA is inviting comments on the candidates to be used to assist in the selection process.  Comments are due September 5, 2017.

More information on these new nominations is available in our memorandum EPA Seeks Comment on Nominations to “Augmented” Science Advisory Committee on Chemicals.  More information on the SACC is available on our blog under key word SACC.

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Charles M. Auer and Oscar Hernandez, Ph.D. 

The U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) announced on its website on February 9, 2017, that it has established the Science Advisory Committee on Chemicals (SACC).  EPA was required to form the SACC within one year after enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act.  The timing is interesting given that the deadline for public comments on the nominees was January 9, 2017, and the EPA Administrator appointed the 18 experts a mere eight days later on January 17 (a full five months ahead of the Congressional deadline), yet the announcement was held until its posting, over three weeks later, on February 9.  It thus is the case that the Obama Administration took very prompt steps to ensure that formation was completed during its period in office, perhaps in an effort to select a membership more to its liking and preferences. 

Based on our quick review of the affiliations of the 18 experts selected for the SACC, this seems to be the case.  Of the members, nine are associated with academic institutions, four with industry (with two from the pharmaceutical industry, one from a trade association (Toy Industry Association), and one a former Dow Chemical Company employee currently with Underwriters Laboratories), two with non-governmental institutions (American Cancer Society and the Humane Society), and three with federal and state government.  While there are no members hailing from an environmental advocacy group, similarly there are no members currently affiliated with a chemical company.

Regarding backgrounds, there is an emphasis on expertise associated with exposure and response research on susceptible populations, with nine members having explicit or related expertise on this topic, six of which are experts from academia.  In contrast, the panel does not seem to include a breadth of experience in exposure or risk assessment.  There are two members who previously chaired EPA’s Children’s Health Protection Advisory Committee, a group that in our view is better known for advocacy than rigorous science.    

As many readers will know, the chemical industry had offered critical comments on the slate of nominees that was announced by EPA in the December 9, 2016, Federal Register notice, but little consideration seems to have been given to those comments.  At a minimum, it seems self- evident that the current membership would not have been the selection made under the Trump Administration.  How all of this will play through under the new Trump Administration is yet to be seen but could get interesting.

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By Lynn L. Bergeson and Margaret R. Graham

On August 26, 2016, the U.S. Environmental Protection Agency (EPA) issued a notice of the establishment of a Science Advisory Committee on Chemicals (SACC) under Section 9(a) of the Federal Advisory Committee Act and pursuant to Section 26(o) of the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act.  The notice also solicits comments and requests nominations for new members of the SACC.  The SACC expects to meet in person or by electronic means (e.g., via webinar) approximately three to four times a year, or as needed and approved by the Designated Federal Officer (DFO) and its meetings will be held in the Washington, D.C. metropolitan area.

EPA’s notice states that the purpose of the SACC is to “provide independent advice and expert consultation, at the request of the EPA Administrator, with respect to the scientific and technical aspects of risk assessments, methodologies, and pollution prevention measures or approaches supporting implementation of [amended TSCA].”  The SACC will be composed of approximately 14 members who will serve as Special Government Employees or Regular Government Employees (RGE).  Nine of the 14 members of the SACC will most likely be selected from existing EPA Chemical Safety Advisory Committee (CSAC) members, and EPA will select five new members from among the candidates nominated via this notice and other sources.

CSAC members who are interested and available for the SACC include:

• Holly Davies, Ph.D., Senior Toxicologist, Department of Ecology, State of Washington, Olympia, WA;
• William Doucette, Ph.D., Professor, Department of Civil and Environmental Engineering, Utah State University, Logan, UT;
• Panos G. Georgopoulos, Ph.D., Professor of Environmental and Occupational Health, Rutgers Biomedical and Health Sciences—School of Public Health, Rutgers, The State University of New Jersey, Piscataway, NJ;
• Kathleen Gilbert, Ph.D., Professor, Department of Microbiology and Immunology, University of Arkansas for Medical Sciences, Little Rock, AR;
• John Kissel, Ph.D., Professor of Environmental and Occupational Health Sciences, University of Washington, Seattle, WA;
• Jaymie Meliker, Ph.D., Associate Professor, Program in Public Health, Department of Family, Population, & Preventive Medicine, Stony Brook University, Stony Brook, NY;
• Kenneth Portier, Ph.D., Vice President, Statistics and Evaluation Center, American Cancer Society, Atlanta, GA;
• Daniel Schlenk, Ph.D., Professor of Aquatic Ecotoxicology and Environmental Toxicology, University of California, Riverside, Riverside, CA; and
• Kristina Thayer, Ph.D., Deputy Division Director of Analysis and Director, Office of Health Assessment and Translation, National Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, NC.

EPA states that nominated candidates should have:

• [D]emonstrated high levels of competence, knowledge, and expertise in scientific/technical fields relevant to chemical risk assessment and pollution prevention and in particular, the nominees should include representation of the following disciplines, including, but not limited to: Human health and ecological risk assessment, biostatistics, epidemiology, pediatrics, physiologically-based pharmacokinetics (PBPK), toxicology and pathology (including neurotoxicology, developmental/reproductive toxicology, and carcinogenesis), and chemical exposure to susceptible life stages and subpopulations (including women, children, and others).

EPA is also considering the differing perspectives and breadth of collective experience needed to address EPA's charge to the SACC, as well as the following:

1. Background 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., geographical location; social and cultural backgrounds; and professional affiliations);
2. Skills and experience working on committees and advisory panels, including demonstrated ability to work constructively and effectively in a committee setting;
3. Absence of financial conflicts of interest or the appearance of a loss of impartiality;
4. A willingness to commit adequate time for the thorough review of materials provided to the committee; and
5. Availability to participate in committee meetings.

EPA will publish the names, affiliations, and brief biographical sketches of the interested and available nominees in the Federal Register for a 30-day public comment period.  Comments and nominations are due by October 11, 2016.  Updates concerning the SACC will be available on EPA’s CSAC website.

The SACC needs to be populated with a diversity of skill sets and individuals who know how TSCA operates in real time.  Qualified industry representatives with solid TSCA credentials are urged to consider becoming a nominee to ensure the SACC represents the full spectrum of interests it was intended to reflect. 

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