Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.
On September 21, 2016, the U.S. Environmental Protection Agency (EPA) Office of Pollution Prevention and Toxics (OPPT) announced its regulatory determinations for a batch of Microbial Commercial Activity Notices (MCAN) and premanufacture notices (PMN).
The announcement by EPA consisted of ten new microorganisms submitted as MCANs and seven new chemicals submitted as PMNs. All microorganisms and chemical substances were determined “not likely to present an unreasonable risk” (per Toxic Substances Control Act (TSCA) Section 5(a)(3)(C)). This determination was based in all cases on the low hazard of the microorganism or the chemical substance. The microorganisms and chemical substances are:
In both types of submissions, the EPA reports are facilitated by the use of templates. The footnotes in the template describe the approach and methodology followed to identify uses and to determine persistence, bioaccumulation, human health hazard, and environmental hazard.
The MCAN template includes three footnotes that describe: (1) identification of “known” and “reasonably foreseen” uses; (2) criteria for human health hazard; and (3) criteria for ecological hazard.
The PMN template includes seven footnotes that describe: (1) identification of “known” and “reasonably foreseen” uses; (2) criteria for persistence; (3) criteria for bioaccumulation; (4) criteria for human health hazard ranking; (5) criteria for ecological hazard ranking; (6) link to the TSCA New Chemicals Program Chemical Categories; and (7) link to the Organization for Economic Cooperation and Development’s (OECD) 2014 Guidance on Grouping of Chemicals. The OECD link and a link to the Sustainable Futures Manual within footnote 5 are obsolete.
The ecological hazard ranking criteria are consistent with OPPT’s past practice. The human health ranking criteria departs from practice by using a single descriptor for all endpoints. Other approaches that EPA has used for several years utilize criteria that address specific end points. Examples include the ChAMP (Chemical Assessment and Management Program) Methodology and the section 8(e) program.
For the MCANs, the “unlikely to present” determination is based on the human health hazard criteria identified in the template for human health hazard: “a microorganism is considered to have low human health hazard if it is not known to be a frank human pathogen that causes disease in healthy adults, and/or animal studies have demonstrated a lack of pathogenicity or toxicity”; and “a microorganism is considered to be of low ecological hazard if it is not known to be an animal or plant pathogen, and the genetic modifications do not impart pathogenic or toxigenic traits, and the introduced genetic material does not provide a selective growth advantage in outcompeting indigenous microbial communities in the environment.”
For the chemical substances, estimates indicated that the majority of these chemicals were persistent or very persistent and bioaccumulation potential was low for all chemicals. Human health hazard was determined by using a combination of physicochemical properties and structural analogs. Ecological hazard determinations utilized analog information and, as appropriate, estimates made by the Ecological Structure Activity Relationships (ECOSAR) Class Program. Exposure estimates were not conducted based of the low hazard concern from which followed the “not likely to present an unreasonable risk” determination.
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:
On September 19, 2016, the U.S. Environmental Protection Agency (EPA) posted a notice on the Chemical Data Reporting website that it has amended the CDR regulations to extend the 2016 submission deadline from September 30, 2016, to October 31, 2016. According to the pre-publication version of the Federal Register notice for the final rulemaking, EPA received a request for an extension, citing problems with certain aspects of the electronic reporting system that impact a business’s ability to submit within the required timeframe, and agreed that additional time should be afforded. EPA clearly states, however, that the extension is a one-time extension for the 2016 reporting period only. The action does not impact the reporting timeframe for the 2020 CDR.
Because the original reporting deadline of September 30, 2016, was imminent, EPA will utilize discretion under the Administrative Procedure Act that allows it to issue a final rule if standard public review and comments are impracticable (Section 553(b)(3)(B)) and for “good cause” (Section 553(d)).
The rulemaking will be effective upon publication in the Federal Register.
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:
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:
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.
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 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:
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.
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:
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.
The American Chemical Society (ACS), together with the Johns Hopkins Bloomberg School of Public Health (JHSPH) and Honorary Co-Hosts Representatives Ken Calvert (R-CA) and Earl Blumenauer (D-OR), through ACS’ Science & the Congress Project have announced that they will be hosting a panel on “Alternatives to Animal Testing: Emerging Uses and Policy Implications” on Tuesday, September 13, 2016, from Noon - 1:30 p.m. on Capitol Hill at the Cannon House Office Building in Room 340. The panel will cover new and evolving non-animal based technologies and science that are being used to advance toxicology and safety testing and improve prospects in biomedical research, and will discuss how to robustly develop and incentivize adoption of these new methods, followed by an audience Q&A. Lunch will be provided. The moderator and panelists include:
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:
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
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)
Additional Webinars in "The New TSCA" Series:
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:
EPA states that nominated candidates should have:
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:
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.
Section 6(h) of new TSCA addresses persistent, bioaccumulative, and toxic (PBT) chemical substances listed in the 2014 TSCA Work Plan. For such chemicals, 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 will 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, or three years from enactment of new TSCA, and issue the final rules six months thereafter.
Importantly, manufacturers or other stakeholders of potential Section 6(h) chemicals can request that EPA conduct a risk evaluation prior to risk management decisions. Section 6(h)(5) expressly allows entities to request such risk evaluations, effectively blunting expedited action. The cost of the risk evaluation is borne by the entity requesting the evaluation. Such requests must be received prior to September 22, 2016, a fast-approaching deadline.
This deadline plainly 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 regulation 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. Nonetheless, 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 22 is less than a month away. Reportedly, EPA is preparing interim guidance for companies that wish to nominate a PBT for risk evaluation, and expects to issue it soon.
On August 11, 2016, the U.S. Environmental Protection Agency (EPA) convened a public meeting to solicit comments prior to development of a proposed rule to implement the revised Section 26 fees provision under the new Toxic Substances Control Act (TSCA). Public comments may be submitted through regulations.gov in docket EPA-HQ-OPPT-2016-0401 until August 24, 2016.
During the meeting, EPA solicited public comment in particular on the following five issues:
In its presentation, EPA stated that it intends to publish a proposed rule by mid-December 2016, and a final rule in time for its statutory June 22, 2017, deadline.
Four industry trade associations gave prepared remarks during the meeting: the American Chemistry Council; the American Petroleum Institute; the Society of Chemical Manufacturers and Affiliates; and the American Fuel & Petrochemical Manufacturers. Their comments reflected several common but competing themes, including:
Congress recognized that the new TSCA tasks EPA with significant additional responsibilities, and included Section 26 as a venue to ensure adequate resources would be available to develop the infrastructure to meet these responsibilities according to the specified timelines and in conformity with sound science. Input from all affected stakeholders will be needed to devise a workable TSCA fee system, particularly in the compressed timeframe for rule development.
EPA and industry stakeholders are supportive of a simple framework, but the complexities and current unknowns of how new TSCA will operate will make this goal challenging. Many questions exist that will not be answered before next week’s comment deadline:
While EPA did not offer to share information on budgets at the August 11, 2016, meeting, the Office of Pollution Prevention and Toxics (OPPT) presumably has pertinent information supporting its annual budgets that must be shared in the near term if it hopes to receive any meaningful ideas on a proposed fee structure. Although past program outputs done under old TSCA may bear little resemblance to the duties EPA now has under new TSCA, EPA’s new policies and responsibilities will be some scale of past program capabilities and budget.
Of more relevance will be the experience of OPPT’s sister program, the Office of Pesticide Programs (OPP). OPP has had a dedicated stream of user fees since the 1988 amendments to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and additional fees were imposed in 2004 with enactment of the Pesticide Registration Improvement Act (PRIA) fee-for-service program. While the FIFRA product licensing program is different in many respects from TSCA, there are relevant commonalities that OPPT should find helpful. OPP has a time accounting system, for example, that provides a principled basis on which to estimate the time required for study report review and risk evaluation.
With estimates derived from the time accounting system, OPP (and presumably OPPT) can estimate how much it costs EPA to review toxicity studies individually. For example, there is an estimate of how much it costs EPA to review a 90-day subchronic study, or how much to review a genotoxicity study. These calculations form the basis of the PRIA fee scheme, as PRIA is designed to generate one-third of the program costs involved. The “simple” general rule underlying a now elaborate fee schedule with almost 200 categories is that the more science review involved, the greater the required fee. The new law may not need or want to have so many different categories, but the operating principle can remain the same.
For OPPT, the dollar amounts could vary from OPP given the statutory limitation of the maximum amount to be generated, but the more difficult question will be how OPPT calculates its expected workload under the new law. Given the wealth of information available through OPP’s experience, sharing this information would further inform the public about what to expect in, or options for how to fashion, a fee scheme.
EPA’s August 9 and August 10 Public Meetings on Proposed Rules Concerning Chemical Risk Evaluation and Prioritization
On August 9 and August 10, the U.S. Environmental Protection Agency (EPA) held two public meetings to obtain input prior to development of a proposed rule for chemical risk evaluation (August 9) and a proposed procedural rule regarding prioritization of chemicals for further risk evaluation (August 10) under the new Toxic Substances Control Act (TSCA). Bergeson & Campbell, P.C.’s (B&C®) Oscar Hernandez, Ph.D. and Richard E. Engler, Ph.D. were in attendance, and offer the following highlights.
On August 9, many speakers across different stakeholder groups flagged issues in terms of how EPA should conduct the chemical risk evaluation process:
As for the content of the actual chemical risk evaluation rule, stakeholders made the following comments:
On August 10, comments made during the prioritization procedural rule meeting sessions were similar to those made at the August 9 meeting, with an emphasis on the application of Section 26 scientific standards. A few speakers expressed reservations about the prioritization methodology that EPA currently uses and suggested some alternative approaches.
Bloomberg BNA Daily Environment Report Article, “Fees Must Not Stymie Innovation, Chemical Makers Tell EPA,” Includes Comments From Kathleen M. Roberts
On August 11, 2016, the Bloomberg BNA Daily Environment Report quoted Kathleen M. Roberts, Vice President of B&C® Consortia Management, L.L.C. (BCCM), an affiliate of Bergeson & Campbell, P.C. (B&C®), on the implication of additional fees created by Toxic Substance Control Act (TSCA) reform.