EPA Extends Deadline To Self-Identify As A Manufacturer Or Importer Of A High-Priority Chemical: On March 13, 2020, EPA announced that it has extended the deadline to self-identify as a manufacturer or importer of a high-priority chemical to May 27, 2020. 85 Fed. Reg. 14677. EPA states that it is working to address issues identified with implementation of the TSCA Fees Rule and EPA-initiated risk evaluations. EPA “is actively seeking ways to address the many implementation impracticalities that have been brought to our attention and to reduce concerns by affected entities.” During the extended comment period extension, EPA “will continue to receive input from the regulated community and analyze options to address some of the implementation challenges with the final rule and reduce stakeholder concerns.” More information is available in our March 9, 2020, blog.

EPA Announces Final List Of Low-Priority Chemicals Under TSCA: EPA issued on February 26, 2020, the final list of 20 chemical substances designated as low-priority substances for which risk evaluation under TSCA is not warranted at this time. 85 Fed. Reg. 11069. The notice includes the final designation for each of the chemical substances and instructions on how to access the chemical-specific information, analysis, and basis used by EPA to make the final designation for each chemical substance. EPA notes in its press release that these 20 low-priority chemicals are on its Safer Chemical Ingredients List, “which includes chemicals that meet strict criteria for both human health and the environment.” EPA released in March 2019 a list of 40 chemicals for which it initiated the prioritization process for risk evaluation. EPA selected 20 chemical substances as candidates for designation as low-priority substances, proposed in August 2019 to designate them as low-priority substances, and has now designated these same 20 chemical substances as low-priority:

EPA states that it used “reasonably available information” to screen each candidate chemical substance against the following criteria and considerations and thereby inform the proposed designation:

• The chemical substance’s hazard and exposure potential;

• The chemical substance’s persistence and bioaccumulation;

• Potentially exposed or susceptible subpopulations;

• Storage of the chemical substance near significant sources of drinking water;

• The chemical substance’s conditions of use or significant changes in conditions of use;

• The chemical substance’s production volume or significant changes in production volume; and

• Other risk-based criteria that EPA determines to be relevant to the designation of the chemical substance’s priority for risk evaluation.

For the final priority designation, EPA states that it considered comments and information submitted by the public during two public comment periods (after initiation and after proposed designation) and incorporated them as appropriate in preparing the final list of 20 chemical substances designated as low-priority substances. EPA notes that as required by TSCA Section 6(b)(1)(B)(ii) and 40 C.F.R. Section 702.11(b), it did not consider cost or other non-risk factors in making a priority designation. For more information, read the full memorandum.

EPA Releases Final Rule On Procedures For Review Of CBI Claims For The Identity Of Chemicals On The TSCA Inventory: On March 6, 2020, EPA published its final rule on procedures for review of confidential business information (CBI) claims made under TSCA. 85 Fed. Reg. 13062. The final rule includes the requirements for regulated entities to substantiate certain CBI claims made under TSCA to protect the specific chemical identities of chemical substances on the confidential portion of the TSCA Inventory, and EPA’s plan for reviewing certain CBI claims for specific chemical identities. EPA sets out the review criteria and related procedures that it will use to complete the reviews within the five-year time frame set in TSCA. The substantiation requirements describe the applicable procedures and provide instructions for regulated entities. The final rule is effective on May 5, 2020. For more information, please read the full memorandum.

Proposed Supplemental SNUR Would Remove Exemption For LCPFAC Chemical Substances Used As Surface Coatings On Articles: EPA published on March 3, 2020, a proposed supplemental significant new use rule (SNUR) for long-chain perfluoroalkyl carboxylate (LCPFAC) chemical substances that would make inapplicable the exemption for persons who import a subset of LCPFAC chemical substances as part of surface coatings on articles. 85 Fed. Reg. 12479. Under the proposed supplemental SNUR, issued under TSCA Section 5(a)(2), this subset of LCPFAC chemical substances also includes the salts and precursors of these perfluorinated carboxylates. The supplemental proposal would require importers to notify EPA at least 90 days before commencing the import of these chemical substances in certain articles for the significant new use described in the proposed SNUR. The required significant new use notification would initiate EPA’s evaluation of the conditions of use associated with the intended significant new use. Manufacturing (including import) or processing for the significant new use would be prohibited from commencing until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination. Comments are due by April 17, 2020. For more information, please read the full memorandum.

EPA Announces Latest UpdateTo TSCA Inventory: EPA announced on March 11, 2020, the availability of the latest TSCA Inventory. EPA states that this biannual update to the public TSCA Inventory is part of its regular posting of non-confidential TSCA Inventory data. According to EPA, this update adds 81 new chemicals, and the Inventory as a whole now contains 86,405 chemicals of which 41,484 are active in U.S commerce. Other updates to the TSCA Inventory include:

• Updates to commercial activity data, or active/inactive status;

• Updated regulatory flags, such as consent orders and SNURs; and

• Additional unique identifiers.

EPA notes that the TSCA Inventory is a list of all existing chemical substances manufactured, processed, or imported in the United States that do not qualify for an exemption or exclusion under TSCA. More information on the TSCA Inventory is available on EPA’s website.

EPA Adds Two Microorganisms To List Of Microorganisms Eligible For Exemption From Certain TSCA Reporting Requirements: On March 10, 2020, EPA announced that it issued a final rule to add two strains of microorganisms to the list of microorganisms eligible for an exemption from certain reporting requirements under TSCA. 85 Fed. Reg. 13760. EPA states that manufacturers of new intergeneric Trichoderma reesei (strain QM6a) and Bacillus amyloliquefaciens (subspecies amyloliquefaciens) may now be eligible to undergo a streamlined review process under TSCA’s new chemicals review program with reduced TSCA fees. The final rule is intended to ensure the safety of human health and the environment while reducing regulatory burden for the biotechnology industry. The final rule is effective April 9, 2020. More information is available in our blog.

EPA OIG Will Audit EPA’s TSCA Service Fee Fund Financial Statements: The Office of Inspector General (OIG) for EPA announced on February 27, 2020, that it plans to begin its audit of the EPA’s TSCA Service Fee Fund financial statements for the period from inception, June 22, 2016, to September 30, 2018. More information is available in our blog.

Madison Le Will Be Director Of EPA’s Chemical Control Division: Effective March 15, 2020, Madison Le joined EPA’s Office of Pollution Prevention and Toxics (OPPT) as Director of the Chemical Control Division (CCD). Ms. Le will replace Acting Director Lynn Vendinello. Ms. Le was Director of the Fuels Compliance Policy Center within the Office of Air and Radiation. In that capacity, Ms. Le managed the implementation of EPA’s national fuels programs, including the Renewable Fuel Standard Program, Tier 3 Gasoline, Ultra-Low Sulfur Diesel, and Fuels and Fuel Additives Registration. Prior to working for EPA, Ms. Le worked for California’s Los Angeles County on engineering design projects for municipal solid waste landfills and wastewater treatment plants, including air quality modeling and permitting for stationary and mobile sources. Ms. Le holds an M.S. and B.S. in Environmental Engineering from the University of Southern California.

EPA Announces Grant Opportunity Supporting Innovative Solutions For Reducing Pollution, Including In The Chemical Manufacturing, Processing, And Formulation Sector: On March 5, 2020, EPA announced that it is seeking grant applications through the Source Reduction Assistance Grant Program from states, federally recognized tribes, universities, local governments, and other groups to support innovative solutions for source reduction or pollution prevention (P2) through research, education, training, or certain other methods. EPA notes that as it highlights chemical safety during the month of March, “these grants support that goal by providing information, training, and tools to improve public health and the surrounding environment, reduce pollutants, and decrease resource use (e.g., water and energy).” EPA anticipates awarding individual grants in the range of $20,000 - $200,000 for a two-year funding period (or between $10,000 - $100,000 per year), though award amounts may vary based on EPA region. EPA anticipates awarding 20 grants in total. EPA states that grant applications should focus on at least one of the following P2 priority areas, also referred to as National Emphasis Areas (NEA) that support several of the EPA’s Smart Sectors. Through these grants, technical assistance and projects should encourage businesses to identify, develop, and adopt P2 practices and reduce waste in the following sectors:

• Food and Beverage Manufacturing and Processing (NEA #1);

• Chemical Manufacturing, Processing, and Formulation (NEA #2);

• Automotive Manufacturing and Maintenance (NEA #3);

• Aerospace Product and Parts Manufacturing and Maintenance (NEA #4); and

• Metal Manufacturing and Fabrication (NEA #5).

Proposals are due by April 30, 2020. Additional information is available on www.grants.gov, under Funding Opportunity Announcement EPA-HQ-OPPT-2020-002.

Comments On Draft Risk Evaluation For Trichloroethylene Due April 27: EPA published a notice in the Federal Register on February 26, 2020, announcing the availability of the draft risk evaluation for trichloroethylene (TCE), “a chemical used as a solvent and an intermediate for refrigerant manufacture in industrial and commercial processes, and with limited consumers uses like as a spot cleaner in dry cleaning facilities.” 85 Fed. Reg. 11079. EPA assessed 54 conditions of use of TCE, and the draft risk evaluation includes the following findings:

• EPA did not find risk to the environment; and

• EPA’s draft risk evaluation preliminarily found unreasonable risk associated with dermal and inhalation exposure for workers, occupational non-users, consumers, and bystanders.

EPA notes that the draft risk evaluation and the initial risk determinations are not a final action. The draft represents EPA’s preliminary conclusions, findings, and determinations on TCE and will be peer reviewed by independent scientific experts. According to EPA, the draft risk evaluation includes input from other EPA offices, as well as other federal agencies.

The TSCA Science Advisory Committee on Chemicals (SACC) will meet March 24-26, 2020, to peer review the draft risk evaluation of TCE’s conditions of use. EPA asks that comments on the draft risk evaluation be submitted by March 18, 2020, to allow SACC time to review and consider them before the peer review meeting. EPA states that comments received after March 18, 2020, and prior to the end of the oral public comment period during the meeting will still be provided to SACC for its consideration. EPA held a preparatory virtual meeting on March 3, 2020, for SACC and the public to comment on the clarity and scope of the draft charge questions for the March 24-26, 2020, meeting.

Comments on the draft risk evaluation are due April 27, 2020. More information on the draft risk evaluation is available in our February 26, 2020, memorandum, “EPA Releases Draft Risk Evaluation for TCE, Announces SACC Peer Review Meeting.”