By Lynn L. Bergeson
On April 26, 2019, the U.S. Court of Appeals for the D.C. Circuit (D.C. Circuit) issued its order on the petition for review of the U.S. Environmental Protection Agency’s (EPA) final rule on the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements (82 Fed. Reg. 37520 (Aug. 11, 2017)), which denied the petition for review on all but one claim. Petitioner Environmental Defense Fund (EDF) challenged five distinct features of the Inventory final rule: (i) EPA’s exclusion of substantiation questions regarding reverse engineering; (ii) the final rule’s criteria for “maintaining” a confidentiality claim; (iii) EPA’s choice not to incorporate certain regulatory requirements into the final rule; (iv) EPA’s failure to implement the Act’s “unique identifier” requirements in this rulemaking; and (v) the final rule’s exemption of exported chemicals from its notification requirements.
The D.C. Circuit’s order states that only the first claim succeeds past the standard of review required under both the Administrative Procedure Act (APA) and TSCA, however; specifically, EPA acted arbitrarily and capriciously via its “omission of any inquiry into a chemical identity’s susceptibility to reverse engineering [which] effectively excised a statutorily required criterion from the substantiation process.” Even though EPA included several substantiation questions to address reverse engineering in the proposed rule, EPA did not include any “substantiation questions related to the requirement that a substance’s chemical identity not be susceptible to reverse engineering” and declined altogether to “‘secure answers’ substantiating a company’s ‘assertion’ that its chemical product cannot be reverse engineered.” The court states that this error was “fatal” and remands this issue back to EPA for EPA to “address its arbitrary elimination of substantiation questions regarding reverse engineering.” For further details, see Bergeson & Campbell, P.C.’s (B&C®) TSCAblog™ article.
By Lynn L. Bergeson
On April 25, 2019, EPA issued a proposed rule that would amend the TSCA Section 8(a) Chemical Data Reporting (CDR) requirements and the TSCA Section 8(a) size standards for small manufacturers. The current CDR rule requires manufacturers (including importers) of certain chemical substances listed on the TSCA Inventory to report data on chemical manufacturing, processing, and use every four years. EPA is proposing several changes to the CDR rule to make regulatory updates to align with new statutory requirements of TSCA, improve the CDR data collected as necessary to support the implementation of TSCA, and potentially reduce the burden for certain CDR reporters. Proposed updates to the definition for small manufacturers, including a new definition for small governments, are being made in accordance with TSCA Section 8(a)(3)(C) and impact certain reporting and recordkeeping requirements. Overall, according to EPA, the regulatory modifications may better address EPA and public information needs by providing additional information that is currently not collected; improve the usability and reliability of the reported data; and ensure that data are available in a timely manner. Comments are due by June 24, 2019. See B&C’s full memorandum for more information on the proposed rule.
By Lynn L. Bergeson
On March 21, 2019, the U.S. Environmental Protection Agency (EPA) announced it was releasing a list of 40 chemicals to begin the prioritization process required by the amended Toxic Substances Control Act (TSCA). 84 Fed. Reg. 10491. New TSCA requires EPA to designate 20 chemicals as “high-priority” for subsequent risk evaluation and 20 chemicals as “low-priority,” meaning that risk evaluation is not warranted at this time. The 20 high priority candidate chemicals include:
- Seven chlorinated solvents;
- Six phthalates;
- Four flame retardants;
- Formaldehyde (which has been studied by EPA’s Integrated Risk Information System (IRIS) program for many years);
- A fragrance additive; and
- A polymer pre-curser.
EPA is also currently determining whether to conduct a risk evaluation of two additional phthalates. The 20 low priority candidate chemicals have been selected from EPA’s Safer Chemicals Ingredients List, which includes chemicals that have been evaluated and determined to meet EPA's safer choice criteria.
Alexandra Dapolito Dunn, Assistant Administrator for EPA’s Office of Chemical Safety and Pollution Prevention, stated that initiating a chemical for high or low prioritization “does not mean EPA has determined it poses unreasonable risk or no risk to human health or the environment,” however. EPA states that is it releasing this list “to provide the public an opportunity to submit relevant information such as the uses, hazards, and exposure for these chemicals.” Comments are due June 19, 2019. EPA has opened a docket for each of the 40 chemicals; the dockets numbers are listed in the Federal Register notice. EPA is directed to complete the prioritization process in the next nine to 12 months.
Please be on the lookout for the Bergeson & Campbell, P.C.’s (B&C®) memorandum that will contain more information regarding EPA’s list. It will be posted on our Regulatory Developments webpage.
By Lynn L. Bergeson
On January 8, 2019, B&C and its consulting affiliate The Acta Group (Acta®) published the 2019 Forecast. The document details the legal, scientific, and regulatory trends in U.S. and global chemical law, providing informed judgment as to the shape of key developments we are likely to see in 2019. Sections on biobased products and biotechnology are included in the document. The full document can be accessed here.
By Lynn L. Bergeson
On December 21, 2018, the U.S. Environmental Protection Agency (EPA) announced in the Federal Register that the Syracuse Research Corporation (SRC) will be assisting the EPA Office of Pollution Prevention and Toxics (OPPT) in the creation of a database that will cover key data from past biotechnology submissions, and the creation of a biotechnology literature database with documents provided or referenced in Toxic Substances Control Act (TSCA) biotechnology submissions. The databases may include Confidential Business Information (CBI) and SRC will be given access to information submitted to EPA under all sections of TSCA. Under this contract, EPA may provide SRC access to CBI materials on a need-to-know basis only. All access to CBI will take place at EPA Headquarters and SRC sites in Arlington, Virginia, and Syracuse, New York, in accordance with EPA’s TSCA CBI Protection Manual. The contract will be effective until April 2, 2022, unless it is extended. SRC personnel will be required to sign nondisclosure agreements and will be briefed on security procedures prior to gaining access to CBI.
By Kathleen M. Roberts
Is your company engaged in Class 2 chemistries that are similar to existing Class 2 chemicals but are derived from an innovative bio-source? We are looking for pioneering companies working on new biobased Class 2 chemicals to assist in advancing an important project with the U.S. Environmental Protection Agency (EPA).
ISSUE: While EPA sustainability goals would seemingly include adoption of improved biobased technologies, EPA’s policies under the Toxic Substances Control Act (TSCA) mean that many novel, sustainable technologies are considered “new chemicals” requiring EPA to conduct new chemical assessments. If these new chemicals are converted to other substances by downstream customers, those substances are likely also new, requiring additional new chemical submissions and assessments. Each new chemical submission and assessment represents a cost and a commercial delay and each is a barrier to adoption of what may be a promising sustainable technology. These reviews can and do result in EPA applying risk management conditions on the production and distribution in commerce of the novel, renewable chemicals -- restrictions that may not apply to older chemistries even though they may be functionally identical in performance, hazard, and risk. Ironically, the new chemical may offer a more benign environmental footprint but nonetheless be subject to stricter controls.
POTENTIAL SOLUTION: To address these issues, the Biobased and Renewable Products Advocacy Group (BRAG®) has submitted to EPA, in partnership with the Biotechnology Innovation Organization (BIO), a BRAG member, a White Paper proposing a TSCA Inventory representation and equivalency determinations for renewable and sustainable biobased chemicals. EPA’s initial response to the White Paper has been positive and staff has indicated a willingness to conduct equivalency determinations if submitted.
REQUEST: BRAG is now seeking companies interested in participating in a pilot project to prepare and submit such requests. Specifically, we are looking for companies that manufacture or plan to manufacture a Class 2 chemical substance that is functionally equivalent to another Class 2 chemical, but due to existing naming conventions, the two chemicals are not listed as equivalent. If your company fits this description and you wish to support an effort to alleviate commercial burden for yourself and others in the future, please consider working with BRAG on this important project so we present impactful equivalency cases to EPA.
BRAG and Bergeson & Campbell, P.C. (B&C®) are committed to this project. As such, we will evaluate all candidate chemicals submitted, select what we believe is a good test case for the project, and prepare as a courtesy the necessary submission paperwork and equivalency arguments, in conjunction with the nominating company.
By Lynn L. Bergeson
On October 17, 2018, the U.S. Environmental Protection Agency (EPA) issued its final fees rule under the Toxic Substances Control Act (TSCA) in the Federal Register
. 83 Fed. Reg. 52694. The final rule largely tracks the proposed rule. EPA is establishing fees applicable to any person required to submit information to EPA; or a notice, including an exemption or other information, to be reviewed by EPA; or who manufactures (including imports) a chemical substance that is the subject of a risk evaluation. This final rulemaking describes the final TSCA fees and fee categories for fiscal years 2019
, and 2021
, and explains the methodology by which the final TSCA fees were determined. It identifies some factors and considerations for determining fees for subsequent fiscal years; and includes amendments to existing fee regulations governing the review of premanufacture notices, exemption applications and notices, and significant new use notices. As required in TSCA, EPA is also establishing standards for determining which persons qualify as “small business concerns” and thus would be subject to lower fee payments. Small businesses will be eligible to receive a substantial discount of approximately 80 percent on their fees. EPA has been hosting a series of webinars focusing on making TSCA submissions and paying fees under the final rule. The first webinar was held on October 10, 2018, and the second was held on October 24, 2018.
The third webinar will be held on November 7, 2018, from 1:00 p.m. to 2:30 p.m. (EST)
. The final rule became effective on October 18, 2018. For an overview of the rule, see Bergeson & Campbell, P.C.’s regulatory developments update
By Lynn L. Bergeson
On October 16, 2018, the Office of Information and Regulatory Affairs released the Trump Administration’s Fall 2018 Unified Agenda of Regulatory and Deregulatory Actions (Agenda). The Agenda aims to report on actions that administrative agencies, such as EPA, plan to put forward in the near- and long-terms. As its name implies, the Agenda includes both regulatory and deregulatory actions and attempts to justify any burden associated with these actions. According to its announcement, it should reflect four broad regulatory reform priorities: advancing regulatory reform, public notice of regulatory development, transparency, and consistent practice across the Federal Government.
Included in the Agenda are the Administration’s estimated timelines for the rulemakings on year-round sales of 15 percent ethanol (E15) sales and the Renewable Fuel Standard (RFS) resetting renewable volume obligations (RVO). It is expected that EPA will release a proposed rule on permitting E15 sales year-round in February 2019, with a final rulemaking expected in May 2019. While the final rulemaking on RFS Biomass-Based Diesel (BBD) volume is expected to be announced in November 2018, the rulemaking on the RFS modification of applicable volumes is predicted to be announced in 2019. According to the Agenda, the proposed rule will be announced in January 2019 and the final rule should follow in December 2019.