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
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 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.
By Lynn L. Bergeson
On September 27, 2018, the U.S. Environmental Protection Agency (EPA) announced the user fees final rule for the administration of the Toxic Substances Control Act (TSCA), the fourth and remaining framework rule to be issued in final under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg).
This final rule, that amends 40 C.F.R. Parts 700, 720, 723, 725, 790, and 791, “describes the final TSCA fees and fee categories for fiscal years 2019, 2020, and 2021”; “explains the methodology by which the final TSCA fees were determined”; “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.” The final rule has not been published yet in the Federal Register so an effective date is not yet available; a pre-publication version is available here.
Specifically, EPA is establishing fees applicable to any person required to submit information to EPA under TSCA Section 4; or a notice, including an exemption or other information, to be reviewed by EPA under TSCA Section 5; or who manufactures (including imports) a chemical substance that is the subject of a risk evaluation under TSCA Section 6(b). EPA is also establishing standards for determining which persons qualify as "small business concerns" and thus would be subject to lower fee payments.
In the press release announcing the rule, EPA Acting Administrator Andrew Wheeler states that this rule will “provide resources needed to support the valuable work EPA does to review chemicals for safety, manage risk as required, and make chemical information available as appropriate.” During fiscal years 2019-2021, EPA states it will “work to track costs and will use that information to adjust future fees, if appropriate.”
EPA also announced that it will be 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. Two other webinars are scheduled for October 24, 2018, from 1:00 p.m. - 2:30 p.m. (EDT); and November 7, 2018, from 1:00 p.m. - 2:30 p.m. (EST).
More information on TSCA implementation is available on our website under key phrase Lautenberg Implementation. More information on the TSCA user fees final rule is available in Bergeson & Campbell, P.C.’s (B&C®) detailed memorandum, “EPA Issues Final TSCA Fees Rule.”
Borrowing from William Shakespeare … WHAT’S IN A NAME? That which we call a biobased chemical. By any other name would stand as sustainable. And yet, it is the mere name of the biobased chemical that hinders its ability to go to market!
Did you know that the Toxic Substances Control Act (TSCA) is interpreted and applied in ways that often cause new biobased chemicals and their derivatives to be subject to stringent premarket review by EPA? This review often results in the application of restrictions that are not applicable to older chemical substances already in commerce. This lack of consistency results in regulatory and commercial challenges for new biobased chemical products that hamper commercialization pathways and invite considerable delays to market entry. This oddity of the current EPA naming system results in newer biobased technologies that offer the same, if not greater, benefits than existing chemicals now being commercialized. Any company or organization intending to market biobased products -- whether they come from plants, algae, or industrial waste -- should be aware of this situation and join the effort to create a more sensible regulatory approach.
As a company focused on creating chemistry for a sustainable future, we invite your organization to join BRAG as a member in 2019. BRAG is a group of international and well respected member organizations and companies engaged in the development of biobased or renewable chemical products. BRAG members recognize the importance of advocacy, education, and communication.
BRAG is helping its members understand and comply with the application of TSCA to their products and operations, educating regulatory officials on biobased chemical production and the application of TSCA to these products, and developing strong and compelling advocacy platforms to ensure the robust commercialization and growth of biobased and renewable chemical feedstocks. No other biobased chemical industry consortium focuses on TSCA in this way or on biobased chemical commercialization and associated regulatory inequities. Because BRAG is managed by B&C® Consortia Management, L.L.C. (BCCM), a group that has regulatory compliance advisors, legal counsel, and science policy experts available for consultation and strategy development, we have the legal, technical, and management capacity to identify, develop, and implement successfully strategic plans to modify current EPA approaches or policies.
BRAG is expanding its membership to include more companies that have already been or may be adversely impacted by EPA’s current policies. As the leader in TSCA compliance issues, BRAG provides strength in numbers, which allows for more efficient engagement with EPA on these critical issues for less cost.