Bergeson & Campbell, P.C. (B&C®) Managing Partner Lynn L. Bergeson and Senior Policy and Regulatory Advisor Charles M. Auer have recently published two articles on important issues as related to the amended Toxic Substances Control Act (TSCA):
The concept of “conditions of use” plays an important role in TSCA as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act. Conditions of use is a centralizing concept under which the U.S. Environmental Protection Agency (EPA) determines how a chemical is made, processed, used, and disposed. The term is defined in TSCA Section 3 and also appears one or more times in the following Sections: 5, 6, 9, 14, 18, 21, and 26. The term is not used in Sections 4 and 8. B&C’s BNA article explores the use and application of conditions of use under Sections 5 and 6 and provides insights into the implications of what may be its unusual use in Section 5 in comparison to Section 6.
Among its other requirements and authorities, Section 5 of new TSCA generally requires that a company timely submit to EPA a notice of its intent to manufacture or process a new chemical or significant new use (NC/SNU). EPA is then required to conduct a review of the Section 5(a)(1) notice and make a determination on the NC/SNU and take required additional actions. Questions have been raised as to whether the review period is fixed and requires that EPA determinations and actions be completed within that period, or if the statute can be read to permit a more flexible review period along the lines of how it was interpreted and applied in old TSCA with the use of voluntary suspensions. Charles M. Auer and Lynn L. Bergeson’s September ABA article analyzes that question.
Other B&C articles on amended TSCA and other regulatory issues of interest are available on our website.
By Zameer Qureshi
On October 4, 2016, Bergeson & Campbell, P.C. (B&C®) hosted its fourth and final webinar in its series of webinars on the new Toxic Substances Control Act (TSCA) in collaboration with Chemical Watch. The webinar addressed numerous important issues for a wide array of stakeholders. The webinar was moderated by Lynn L. Bergeson, Managing Partner at B&C, and the expert panel included Charles M. Auer, Richard E. Engler, Ph.D., Lisa R. Burchi, and Sheryl L. Dolan.
Mr. Auer, Senior Regulatory and Policy Advisor at B&C, addressed “Administration of the Act” and described important changes between old and new TSCA. Mr. Auer’s presentation consisted of three segments: (1) “Section 26 Science Requirements”; (2) “Section 26 Information and Guidance”; and (3) “Section 26 ‘Savings’ Provision.”
Mr. Auer addressed the “Scientific Standards” requirements of new TSCA Section 26(h), the “Weight of Scientific Evidence” requirements of Section 26(i), and the Section 26(o) provisions of new TSCA relating to Consultation with the Science Advisory Committee on Chemicals (SACC). Mr. Auer addressed a number of additional rules and requirements in Section 26, including the U.S. Environmental Protection Agency’s (EPA) obligation to submit a report to Congress and issue an Annual Plan under Sections 26(m)-(n).
Ms. Burchi, Of Counsel at B&C, discussed “Preemption” under Section 18 of new TSCA. Ms. Burchi described preemption as “one of the most debated subjects in [the TSCA reform] debate” and stated that she had heard it referred to as a “linchpin” in terms of reaching agreement on provisions for TSCA reform to occur. Ms. Burchi stated “Everything in the new Section 18 is new or very significantly changed from what we were used to with regard to preemption … The final provisions are fairly complicated … It will remain to be seen whether states continue to act with regard to chemical substances in the way that they have been.”
Ms. Burchi addressed the three “main” provisions related to preemption under new TSCA Sections 18(a)(1)(A)-(C), and analyzed more specific issues (e.g., pause preemption) and the related exceptions. Ms. Burchi described the TSCA Section 18(d)-(e) provisions relating to “Exceptions” and “Preservation of Certain Laws.” Ms. Burchi also addressed new TSCA’s Section 18(f) “Waivers” provisions and concluded her segment of the presentation with the following statement: “It remains to be seen whether states are going to be jumping in to [take action] when EPA has already identified a chemical for prioritization and review … [There will be some interesting provisions and interplay] to be seen as we move forward under new TSCA.”
Ms. Dolan, Senior Regulatory Consultant at B&C, analyzed “Fees” under new TSCA and addressed EPA’s obligations to: (1) set lower fees for small business concerns; (2) consider balance between manufacturers and processors; and (3) consult with the regulated community. Ms. Dolan stated “new TSCA directs EPA to review its fee program on a three-year cycle and revise it as needed to raise the target fees … While new TSCA did not set a deadline for developing the fees program, it really didn’t have to -- EPA, of course, has every incentive to knock this rulemaking out quickly.”
Ms. Dolan indicated that a final rule is expected on fees under new TSCA by June 2017, and provided an overview of comments received on the proposed rule. Ms. Dolan stated that “overarching themes” in the comments included that: (1) fees should be tied to the level of required effort; (2) fees should encourage innovation; and (3) fees should not be overly complex or difficult to administer. In relation to (3), Ms. Dolan quoted a commenter that stated “don’t give us the [Internal Revenue Service (IRS)] Code.”
Ms. Dolan stated “everyone seems to want to know how much will a [pre-manufacture notice (PMN)] cost in the future … I think the answer to that [will come with a big red bow] in December. Specifically, EPA states that it will send a proposal to [the Office of Management and Budget (OMB)] in mid-October … EPA may well set a comment period of at least 60 days for this proposed rule.”
Dr. Engler, Senior Chemist at B&C, discussed Sustainable Chemistry (i.e., Green Chemistry) under new TSCA. Dr. Engler stated “new TSCA is largely silent on sustainability” and indicated that the “primary benefit” to Sustainable Chemistry under new TSCA is the abbreviated review period when EPA determines that a new chemical is “not likely to present” an unreasonable risk (i.e., 90-day period waived and manufacturers can commence manufacturing immediately). Dr. Engler addressed chemicals that EPA considers to present low hazard for health and ecotoxicity (“low/low” chemicals) and stated that new TSCA could be “more of a driver for Sustainable Chemistry,” if only low/low chemicals escape regulation.
Dr. Engler addressed “Relative Risk under New TSCA” and EPA’s “Safer Choice Program” (SCP). Dr. Engler discussed the Senate Report on S. 697, which suggested that EPA should consider “private sector voluntary consensus standards as an alternative” to SCP. Dr. Engler indicated that as the relevant section of the Senate report concerns Section 23, the Sustainable Chemistry Section that was not included in the enacted new TSCA, it is unclear how it applies to new TSCA as enacted. Dr. Engler stated that EPA is proceeding with SCP and hosting a summit in November on this topic.
The webinar concluded with a Questions and Discussion (Q&D) session, and B&C’s expert panel provided useful answers and analyses in response to attendees’ questions. Ms. Bergeson moderated the Q&D session, which was organized by topic.
In the Q&D session, Ms. Bergeson stated and asked Ms. Dolan: “Fees are super important … [small businesses and startups] might have a hard time mustering any type of financial liquidity to get their notifications through the gauntlet of EPA -- so how would you expect EPA to be defining lower fees for purposes of small business provision?”
Ms. Dolan responded by stating “[currently, the ratio is $2,500 and $100 for small businesses. I would imagine there will be some kind of comparable proportionality and currently there are other submissions (e.g., Low Volume Exemptions) that don’t require any fees. EPA has got to raise the money somewhere -- the more they put it on something else or the more they try to avoid charging fees for things, the more it’s going to jack up the cost and other things. I would imagine that they are going to charge something for everything. Whether they maintain that proportionality of 100:2500 remains to be seen. Another consideration is what constitutes a small business. There is a lot of conversation about that and the fact that definition hasn’t been updated in quite a while … This might be something that is the focus of a lot of attention in the proposed rule.]”
Ms. Bergeson drew on Mr. Auer’s extensive experience with EPA on several occasions during the Q&D session, starting questions with “If you were back at EPA,” and Mr. Auer’s responses were comprehensive. Dr. Engler responded to questions regarding Green Chemistry and discussed Persistent, Bioaccumulative, and Toxic (PBT) substances under new TSCA, and Ms. Burchi answered questions on California’s Safer Consumer Products Regulation (SCPR) and preemption under new TSCA.
More information on TSCA reform and B&C’s “The New TSCA: What You Need to Know” webinar series is available online.
The September 2016 issue of the Pesticides, Chemical Regulation, and Right-to-Know Committee Newsletter is now available. This newsletter is prepared by the American Bar Association’s (ABA) Section of Environment, Energy, and Resources, and edited by Lynn L. Bergeson. Several professionals from Bergeson & Campbell, P.C. (B&C®) contributed articles to this issue of the newsletter.
Articles in this special edition of the September 2016 issue are exclusively focused on Toxic Substances Control Act (TSCA) reform. The articles include:
- From the Chair;
- From the Editor;
- New TSCA and EPA's Enhanced Testing Authority;
- New Chemicals under New TSCA;
- Is the Section 5 Review Period Fixed or Flexible in New TSCA?;
- New TSCA -- Existing Substances;
- Implementing the 2016 TSCA Amendments;
- 2017 “Reset” of New TSCA Inventory Will Affect All Chemical Users, Not Just Manufacturers;
- Changes Regarding Confidential Information in New TSCA;
- Preemption under New TSCA;
- New Fees Provisions in New TSCA;
- Weight of Evidence in New TSCA;
- PBT Actions under New TSCA; and
- New TSCA and “Articles.”
By Sheryl L. Dolan and Kathleen M. Roberts
In anticipation of the second meeting, EPA shared its general observations as to a way forward for fee assessment under TSCA Sections 4, 5, 6, and 14 and some of EPA’s key take aways from the comments submitted to the docket. In its meeting presentation, EPA outlined its estimated annual costs by 2019 (i.e., once the Section 6 risk evaluation schedule is ramped up). While no specific fee proposals emerged from the meeting discussions, the following information was discussed, which provides some insight into EPA’s ongoing process:
- EPA’s projected annual cost for implementing TSCA Sections 4, 5, 6 and 14 includes both direct and indirect/overhead costs, with a 22.75 percent adjustment to cover overhead, consistent with EPA’s overall budget practice.
- In estimating the anticipated number of Section 5 submissions, EPA stated that based on industry comments regarding the effect of fees, it assumed a 30 percent reduction from recent years. EPA essentially stated that 30 percent is an educated guess, noting that Notices of Commencement (NOC) are only filed on approximately 50 percent of premanufacture notices (PMN).
- EPA stated that, consistent with industry’s comments, it most likely will not propose to charge separately for individual confidential business information (CBI) claims, but instead will incorporate that into overhead costs.
- EPA stated that it is implementing a time accounting system, which may support future refinements of its cost estimates; EPA is required to review its fee program every three years under TSCA Section 26(b)(4)(F).
- EPA stated that it is pursuing consultation with the Small Business Administration regarding revisiting the applicable definition of a small business concern. While clarifying that this is not a proposal, EPA noted that if the producer price index is applied to the small business concern definition in 40 C.F.R. § 700.43, the $40 million revenue cap in the definition would increase to $91 million. As reflected in the circulated spreadsheet, EPA plans to propose reduced fees for small businesses as required by TSCA Section 26(b)(4)(A). EPA also stated that approximately 14 percent of TSCA submissions are made by small businesses.
- Section 6 risk evaluation fees remain one of the greater uncertainties. During the September 13, 2016, meeting, suggestions were made that these fees should be assessed incrementally, perhaps tied to milestones, with a schedule that perhaps could allow tying the fees to actual costs. In response, EPA noted that OMB requirements preclude federal agencies from seeking fees in reimbursement for completed activities.
Based on its projected costs, EPA will seek to raise the $25 million annual maximum allowed by new TSCA. Regardless of how these costs are distributed among Sections 4, 5, and 6 (assuming EPA’s proposal does not separately charge for Section 14 activities), it is clear that the proposed rule will be a significant change from the $2,500 PMN fee in place since the 1980’s.
ChemCon The Americas is a global chemical control conference offering authoritative speakers, in-depth sessions, and a global perspective on existing and emerging chemical regulatory schemes. ChemCon The Americas 2016 will be held October 17 - 21, 2016, in Toronto, Canada.
Highlights from the diverse and substantive program planned for Toronto include:
- Workshop on the modernized Toxic Substances Control Act, with speakers including Jeff Morris, Deputy Director, U.S. Environmental Protection Agency (EPA) Office of Pollution Prevention and Toxics (OPPT), and Lynn L. Bergeson, Managing Partner, B&C®, and President, Acta®, Monday, October 17, 2016
- Chemical control legislation in Middle and South America, with speakers including Alberto da Rocha Neto, Ministry of Environment of Brazil, and Michael S. Wenk, M.S., Senior Regulatory Consultant, B&C and Acta, Tuesday, October 18, 2016
- Update on regulatory issues in Asia with speakers including J. Brian Xu, M.D., Ph.D., DABT®, Toxicologist, B&C and Acta, Friday, October 21, 2016
The full ChemCon agenda is available online. A video overview of the ChemCon experience -- the sessions, exhibition, and networking and socializing opportunities -- is available on ChemCon’s YouTube channel. For more information and to register, visit the ChemCon The Americas 2016 website.
By Lynn L. Bergeson and Richard E. Engler, Ph.D.
The topics from Section 8 of TSCA, regarding reporting and retention of information, included: Small Manufacturer Definition; Reporting by Processors; Inorganic Byproduct Rulemaking and Reporting; TSCA Inventory; and Nomenclature. The key points from this portion included:
- The sales thresholds for small manufacturers are likely to rise from the current level that was set in 1986;
- TSCA Inventory “reset” will require companies to report for substances manufactured or imported in the last 10 years and there will be no exemptions for polymers or low volume substances;
- EPA may impose different requirements for CDR reporting by manufacturers and processors;
- EPA must enter into negotiated rulemaking to reduce CDR reporting for recycling and reprocessing inorganic byproducts; and
- Interested parties should be aware of rulemaking on these issues as well as rules that EPA will be promulgating to implement other sections of TSCA.
The topics from Section 14 of TSCA, regarding CBI, included: Information Not Protected; Asserting CBI; Presumptive CBI; Requirements for CBI Claims; Exemptions to Protection from Disclosure; Review and Resubstantiation; Duties of Administrator; and Criminal Penalties. The key points from this portion included:
- Most CBI claims made prior to enactment of TSCA reform will not require substantiation, but claims going forward, including chemical identity for substances notified as “active” on the TSCA Inventory will require substantiation;
- EPA must review all CBI claims for chemical identity;
- CBI protection that requires substantiation will sunset after ten years; claimants may reassert and resubstantiate claims to continue protection for another ten year period;
- EPA must disclose CBI upon request from state, municipal, and tribal officials who demonstrate the need for the information and agree to protect CBI;
- EPA must also disclose CBI upon request from medical professionals if it is reasonable to believe the information is necessary to treat a patient; and
- In most cases, EPA will notify CBI claimants prior to disclosing CBI to persons that are not federal employees or federal contractors.
The panel speakers were, from B&C: Charles M. Auer, Senior Regulatory and Policy Advisor, former Director of the Office of Pollution Prevention and Toxics (OPPT), U.S. Environmental Protection Agency (EPA); Lynn L. Bergeson, Managing Partner; Richard E. Engler, Ph.D., Senior Chemist, former senior staff scientist in OPPT and leader of EPA's Green Chemistry Program; and Kathleen M. Roberts, Vice President, B&C Consortia Management, L.L.C.; and from Chemical Watch: Kelly Franklin, North America Reporter & Editor.
The fourth and final webinar in the series, “Other Provisions -- PBTs, Preemption, and Green/Sustainable Chemistry” will be presented on September 27, 2016.
By Lynn L. Bergeson and Richard E. Engler, Ph.D.
On September 2, 2016, the U.S. Environmental Protection Agency (EPA) released additional guidance on its implementation of the new Toxic Substances Control Act (TSCA) in the form of additional questions and answers (Q&A). EPA added a series of Q&As of particular relevance given the fast-approaching TSCA Section 6(h) deadline of September 19, 2016, for industry to request a risk evaluation for persistent, bioaccumulative, and toxic (PBT) chemicals listed in the 2014 TSCA Work Plan. Section 6(h) outlines a procedure requiring “expedited” regulatory action that is intended to reduce exposures to these chemicals to the “extent practicable.” As written, chemicals subject to Section 6(h) will not undergo a risk evaluation as with other high-priority chemicals. Instead, EPA will proceed immediately to assess and identify appropriate risk management actions for these chemicals that EPA believes achieves the goal of reduced exposure to the “extent practicable.” EPA is required under new TSCA to issue the proposed risk management rules by June 2019, three years from enactment of new TSCA, and issue the final rules six months thereafter.
As we noted in an earlier blog, this deadline poses ups and downs. On the one hand, absent a risk evaluation, fast tracking the process necessarily invites worst-case assumptions and a high degree of probability that regulatory actions will be extensive. On the other hand, in the absence of a defined risk evaluation process and a yet-to-be-defined fee assessment process or schedule, volunteers may be few and far between. Understandably, a potential requester can be expected to want to know what the risk evaluation cost will be before making a commitment to pay that amount. Even with these uncertainties, under some circumstances the election may be worth considering and stakeholders are urged to consider the risks and benefits quickly, as September 19 is only days away.
EPA’s new Q&As pertinent to PBTs relate to:
Interestingly, EPA’s Q&As address some, but not all, questions. Careful review of the questions and EPA’s answers is advised. In short:
- There are seven substances on the Work Plan list that are PBTs;
- There is no formal request form; all that is required is the substance and company identity, along with the contact information of the requesting official;
- Entities requesting the assessment are disallowed from defining the scope and EPA intends to “evaluate the chemical substance in accordance with TSCA section 6(b)” regardless of a more narrowly defined set of uses of interest to the submitter;
- The submitter will be expected to pay for the full assessment; and
- The request is irrevocable and cannot be withdrawn.
While EPA’s interpretation comes as no surprise, reasonable people are likely to disagree as to whether the law must be read as EPA reads it. EPA may find more willing sponsors if, for example, the fee is limited to cover the scope of nominated uses. EPA could evaluate a broader scope, but the additional expense would not be entirely borne by the nominating company.
By Lynn L. Bergeson and Margaret R. Graham
The U.S. Environmental Protection Agency (EPA) posted guidance regarding changes to the requirements for making confidential business information (CBI) claims under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act. The “key changes” that EPA notes are:
New Certification Requirement. Pursuant to TSCA § 14(c), a submitter of information claimed as CBI must now certify agreement with several statements. The certification language is incorporated into electronic reporting tools for TSCA submissions requiring or permitting electronic reporting. Entities who make TSCA submissions on paper must now also include the following statements in the submission:
- I hereby certify to the best of my knowledge and belief that all information entered on this form is complete and accurate.
- I further certify that, pursuant to 15 U.S.C. § 2613(c), for all claims for confidentiality made with this submission, all information submitted to substantiate such claims is true and correct, and that it is true and correct that:
- (i) My company has taken reasonable measures to protect the confidentiality of the information;
- (ii) I have determined that the information is not required to be disclosed or otherwise made available to the public under any other Federal law;
- (iii) I have a reasonable basis to conclude that disclosure of the information is likely to cause substantial harm to the competitive position of my company; and
- (iv) I have a reasonable basis to believe that the information is not readily discoverable through reverse engineering.
- Any knowing and willful misrepresentation is subject to criminal penalty pursuant to 18 U.S.C. § 1001.
Substantiation Requirements. Existing substantiation requirements for certain types of CBI claims continue to remain in effect. EPA notes that it may develop further guidance and require additional requirements in the future.
Generic Names. A structurally descriptive generic name is now required where specific chemical identity is claimed as CBI. EPA will be relying on existing generic name guidance for the creation and approval of generic names until updated guidance is developed.
EPA’s Review of Claims. EPA will be reviewing and approving or denying a CBI claim for specific chemical identity and a proportion of CBI claims for other types of information in accordance with TSCA § 14. EPA states that it may contact submitters of CBI to corroborate their CBI claims to the extent that substantiation has not already been provided.
While the guidance is welcomed and useful, it sheds no light on how best to corroborate a claim of CBI and how best to respond to an EPA allegation that the CBI claim is lacking. These questions will continue to be debated; when in doubt, consult legal counsel.
More information is available on EPA’s website. Please also join Bergeson & Campbell, P.C. (B&C®) and Chemical Watch on September 12, 2016, for the third complementary webinar in the series on “‘The New TSCA -- What You Need to Know,” featuring information on the TSCA Inventory, Chemical Data Reporting (CDR), and CBI.
Monday, September 12, 2016
8:00 a.m. Pacific Daylight Time/11:00 a.m. Eastern Daylight Time/16:00 British Summer Time
With passage by unanimous consent voice vote of the U.S. Senate of the Frank R. Lautenberg Chemical Safety for the 21st Century Act on June 7, 2016, this bill, that profoundly alters the regulation of industrial chemicals in the U.S. under TSCA, has cleared all hurdles and was signed into law by President Obama on June 22, 2016.
All chemical stakeholders doing business in the U.S., as well as foreign entities with business interests in the U.S., will need to understand the fundamental shifts in requirements, and the new concepts and approaches that are introduced by the law.
Bergeson & Campbell, P.C. has collaborated with Chemical Watch in assembling an impressive faculty of TSCA experts representing the perspectives of industry, environmental organizations, and U.S. federal and state regulatory authorities to present a series of complimentary webinars titled "'The New TSCA' -- What You Need to Know."
Webinar 3: Inventory, CDR, and CBI (Sections 8 & 14)
- Charles M. Auer, Charles Auer & Associates, LLC, former Director of the Office of Pollution Prevention and Toxics (OPPT), U.S. Environmental Protection Agency (EPA)
- Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C.
- Richard E. Engler, Ph.D., Senior Chemist, Bergeson & Campbell, P.C., former senior staff scientist in OPPT and leader of EPA's Green Chemistry Program
- Kelly Franklin, Chemical Watch
- Kathleen M. Roberts, Vice President, B&C® Consortia Management, L.L.C.
- Section 8 Reporting and Retention of Information
- Small Manufacturer Definition
- Reporting by Processors
- Byproduct Rulemaking and Reporting
- Toxic Substances Control Act (TSCA) Inventory
- Section 14 Confidential Business Information (CBI)
- Information Not Protected
- Asserting CBI
- Presumptive CBI
- Requirements for CBI Claims
- Exemptions to Protection from Disclosure
- Review and Resubstantiation
- Duties of Administrator
- Criminal Penalties
Additional Webinars in "The New TSCA" Series:
||Webinar 1: Overview and Summary of Major Changes: What to Expect and When to Expect It, presented June 13, 2016.
||Webinar 2: Impacts on New Chemical Programs, presented July 14, 2016.
||Webinar 4: Other Provisions -- PBTs, Preemption, Green/Sustainable Chemistry -- will be presented on September 26, 2016.
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:
- 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);
- Skills and experience working on committees and advisory panels, including demonstrated ability to work constructively and effectively in a committee setting;
- Absence of financial conflicts of interest or the appearance of a loss of impartiality;
- A willingness to commit adequate time for the thorough review of materials provided to the committee; and
- 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.