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.
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.
By Lynn L. Bergeson and Margaret R. Graham
The U.S. Environmental Protection Agency (EPA) proposed on July 28, 2016, revisions to the regulations governing significant new uses of chemical substances under the Toxic Substances Control Act (TSCA) with revisions to the Occupational Safety and Health Administration’s (OSHA) Hazard Communications Standard (HCS) occasioned by OSHA’s March 2012 final rule modifying the HCS to conform to the United Nations’ (U.N.) Globally Harmonized System of Classification and Labelling of Chemicals (GHS), changes to OSHA’s Respiratory Protection Standard, and the National Institute for Occupational Safety and Health (NIOSH) respirator certification requirements pertaining to respiratory protection of workers from exposure to chemicals. EPA states that it is also proposing changes to regulations based on issues that it identified, as well as issues raised by public commenters, for significant new use rules (SNUR) previously proposed and issued under these regulations. Additionally, EPA claims to propose a “minor” change to reporting requirements for premanufacture notices (PMN) and other TSCA Section 5 notices. EPA states that it expects the changes “to have minimal impacts on the costs and burdens of complying, while updating the significant new use reporting requirements to assist in addressing any potential effects to human health and the environment.” Comments are due September 26, 2016.
The revisions include:
- Proposed Changes to 40 C.F.R. Section 721.63, Protection in the Workplace;
- Proposed Changes to 40 C.F.R. Section 721.72, Hazard Communication Program;
- Clarification of the Use of 40 C.F.R. Section 721.80, Industrial Commercial and Consumer Activities;
- Proposed Changes to 40 C.F.R. Section 721.91, Computation of Estimated Surface Water Concentrations: Instructions;
- Proposed Changes to 40 C.F.R. Section 721.11, Determining Whether a Chemical Substance or a Specific Use Is Subject to This Part When the Chemical Substance Identity or Significant New Use Is Confidential;
- Proposed Changes for Submission of SDS(s) with PMNs, SNUNs, Low Volume Exemptions (LVE), Low Release and Exposure Exemptions (LoREX), and Test Marketing Exemption (TME) Applications; and
- Fixing Typographical Errors and Other Non-Substantive Changes.
Although the notice downplays them, the proposal raises significant and complex issues. There may well be good reasons for several of the proposed changes. The minimal discussion provided in the notice and the lack of adequate public debate having occurred prior to its issuance raise troubling questions about the legal basis for, scope of, and complexity of the proposed changes, some of which may apply retroactively. The confusion the proposal can be expected to cause could have been avoided had adequate discussion preceded its publication, or at the least EPA could have raised these issues in the proposed rule’s preamble to focus stakeholders’ attention appropriately.
More information is available in our memorandum TSCA: Proposed Revisions to Significant New Use Rules Reflect Current Occupational Safety and Health Standards.
By Lynn L. Bergeson and Margaret R. Graham
On July 25, 2016, the U.S. Environmental Protection Agency (EPA) announced its intention to hold two public meetings on August 9, and August 10, 2016, to obtain input on the processes that will be used to prioritize and evaluate chemicals under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act:
- August 9, 2016: EPA states that this public meeting will inform its proposed rule on conducting risk evaluations to determine whether a chemical presents an unreasonable risk of injury to health or the environment; and
- August 10, 2016: EPA states that this public meeting will inform its proposed rule to establish a risk-based process for chemical prioritization.
The public meetings are scheduled for 9:30 a.m. to 4:30 p.m., and will be held at the Ronald Reagan Building and International Trade Center, Horizon Ballroom, 1300 Pennsylvania Avenue, N.W., Washington, D.C. EPA states that the input obtained during these meetings will be considered as the EPA develops its proposed procedural regulations for risk evaluation and chemical prioritization. EPA is recommending that any interested participants register in advance.
More information concerning EPA’s implementation of the amended TSCA is available in our memorandum EPA Publishes First Year Implementation Plan, as well as on the Bergeson & Campbell, P.C. (B&C®) website under Regulatory Developments: TSCA.
It is critically important that stakeholders attend and participate in these meetings. While the timing is regrettable in light of vacation schedules, EPA is under intense pressure to issue rules later this year and EPA has no choice other than to keep the process moving. EPA is to be commended for scheduling these opportunities as quickly as it has, and its efforts should be acknowledged by robust stakeholder engagement.
By Lynn L. Bergeson
On Friday, July 22, 2016, the U.S. Environmental Protection Agency (EPA) posted the first four Toxic Substances Control Act (TSCA) Section 5(a) determinations made following review of pre-manufacture notifications (PMN) according to TSCA as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century law, Pub. L. No. 114-182 (Lautenberg). EPA’s determination on all four chemical substances was “not likely to present and unreasonable risk,” under new TSCA Section 5(a)(C)(3). The PMN Case Numbers, Chemical Identities, a summary of the determination, the decision dates, as well as the links to the determinations themselves are below. The review start date for all of these determinations was the date of Lautenberg’s enactment, June 22, 2016. Bergeson & Campbell, P.C. (B&C®) is reviewing these determinations and will provide an analysis.
- P-16-0281: Generic: Fatty Alcohols-Dimers, Trimers, Polymers. EPA determined that “[t]he chemical substance is not likely to present an unreasonable risk based on low health hazard concern and low environmental toxicity.” The decision was issued on July 15, 2016.
- P-16-0292: Generic: Depolymerized Waste Plastics. EPA determined that “[t] he chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard. Although EPA estimated that the new chemical substance would be very persistent, this did not indicate a likelihood that the chemical substance would present an unreasonable risk, given that the chemical substance has low potential for bioaccumulation, low human health hazard, and low environmental hazard.” The decision was issued on July 20, 2016.
- P-16-0301: Generic: Propyl Silsesquioxanes, Hydrogen-Terminated. EPA determined that “[t]he chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard.” The decision was issued on July 20, 2016.
- P-16-0302: Generic: Organic Modified Propyl Silsesquioxane. EPA determined that “[t]he chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental toxicity. Although EPA estimated that the new chemical substance would be very persistent, this did not indicate likelihood that the chemical substance would present an unreasonable risk, given that the chemical substance has low potential for bioaccumulation, low human health hazard, and low environmental hazard.” The decision was issued on July 20, 2016.
Bergeson & Campbell, P.C. (B&C®) has learned that the U.S. Environmental Protection Agency (EPA) is planning to convene a stakeholder workshop in Washington, D.C. on August 9-10, 2016, for a public dialogue on prioritization and risk evaluation. We also understand that EPA may host an industry meeting on August 11-12, 2016, to consult on fees. The dates and topics will be confirmed when EPA makes announcements in the Federal Register.
On June 30, 2016, from 2:00 p.m. to 3:00 p.m. (EDT), the U.S. Environmental Protection Agency (EPA) hosted an informational webinar on the Frank R. Lautenberg Chemical Safety for the 21st Century Act, Public Law No. 114-182. A link to the presentation is available online. The topics from the webinar included:
- Major Improvements over Current Law;
- Specific Requirements for Existing Chemicals;
- Testing Authority;
- Confidential Business Information;
- Source of Funding; and
- State-Federal Partnership, among others.
More information concerning EPA’s implementation of the Act is available on EPA’s website.
On June 22, 2016, the U.S. Environmental Protection Agency (EPA) rolled out its new Frank R. Lautenberg Chemical Safety for the 21st Century Act Frequent Questions webpage. This webpage will be a resource for Toxic Substances Control Act (TSCA) reform-related updates and implementation plans. EPA has also posted a summary of key provisions, its six essential principles for reform of chemicals management legislation, the presentation from its informational webinar on June 30, 2016, in which EPA provided an overview of the new TSCA, and an unofficial version of TSCA as recently amended.
By Lynn L. Bergeson and Margaret R. Graham
On June 29, 2016, the U.S. Environmental Protection Agency (EPA) posted an Implementation Plan that outlines EPA’s plans for early activities and actions under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, legislation that significantly amends many of the provisions of the Toxic Substances Control Act (TSCA). The amended TSCA has been identified as Public Law Number (Pub. L. No.) 114-182. EPA notes that the new law imposes new responsibilities on EPA, while providing “comparatively short” deadlines to implement them. EPA “takes these responsibilities and deadlines seriously,” and intends for the Implementation Plan to be a roadmap of the major activities on which EPA will focus during the initial year of implementation. EPA organizes the Implementation Plan by the statutory timeframes during which the activities must be completed, rather than by what is of importance to EPA. EPA states that the Implementation Plan is a living document, and EPA will further develop it over time. EPA cautions that the Implementation Plan “is NOT intended to be a comprehensive listing of all requirements in the new law.”
Bergeson & Campbell, P.C. (B&C®) is pleased that EPA is making strong early efforts to communicate and engage with stakeholders about its early implementation of the new TSCA and its thinking regarding specific provisions. Completing the items listed in the Implementation Plan represents a prodigious amount of work for EPA over the coming months and years. Stakeholders will need to be prepared to respond thoughtfully to rules, lists, and process descriptions as they appear in the Federal Register, or as they are posted.
More information on EPA’s Implementation Plan is available in our memorandum TSCA Reform: EPA Publishes First Year Implementation Plan.
In a June 22, 2016, blog post on The Hill's Congress Blog, Lynn L. Bergeson laid out four reasons why the American public has reason to celebrate the signing into law of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, “a comprehensive and vastly improved domestic chemical management law”:
- Reformed Toxic Substances Control Act (TSCA) strikes the requisite balance between Congressional specificity and Agency discretion.
- Reformed TSCA addresses the law’s most celebrated deficits.
- Reformed TSCA gives the U.S. Environmental Protection Agency (EPA) authority to do its job: manage chemical risks.
- Reformed TSCA ensures greater transparency and public engagement in the chemical evaluation process.
Read the full blog post at The Hill: TSCA reform: renewing public confidence in chemical control.