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.

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) announced on September 23, 2019, that it plans to begin an evaluation of EPA’s implementation of the 2009 Toxic Substances Control Act (TSCA) premanufacture notice (PMN) consent order with DuPont [Chemours].  According to OIG, its objective is to determine what actions EPA took to verify compliance with the requirements of the consent order to prevent release of the chemical GenX into the Cape Fear River basin.  OIG states that it plans to conduct work in headquarters within the Office of Enforcement and Compliance Assurance and the Office of Chemical Safety and Pollution Prevention, as well as Region 4.  The anticipated benefits of the project are to improve controls over TSCA PMN consent orders.

Tags: PMN, DuPont, Chemours,

 

By Lynn L. Bergeson, Charles M. Auer, and Carla N. Hutton
 
On September 25, 2019, the U.S. Environmental Protection Agency (EPA) submitted a proposed significant new use rule (SNUR) on long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate (PFAS) chemical substances to the Office of Management and Budget (OMB) for review.  The item on the rulemaking in EPA’s Spring 2019 Regulatory Agenda states that in 2015, EPA proposed amending the SNURs under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for LCPFAC chemical substances and for perfluorooctanoic acid (PFOA) or its salts.  80 Fed. Reg. 2885 (Jan. 21, 2015).  Specifically, EPA proposed to amend the SNUR for LCPFAC chemical substances by designating as a significant new use manufacturing (including importing) or processing of an identified subset of LCPFAC chemical substances for any use that will not be ongoing after December 31, 2015, and all other LCPFAC chemical substances for which there are currently no ongoing uses.  EPA also proposed to make inapplicable the exemption for persons who import LCPFAC chemical substances as part of articles.  In addition, EPA proposed to amend the SNUR for PFAS chemical substances that would make inapplicable the exemption for persons who import PFAS chemical substances as part of carpets.  Persons subject to these SNURs would be required to notify EPA at least 90 days before commencing such manufacture or processing.  The required notifications would initiate EPA’s evaluation of the intended use within the applicable review period.  Manufacture and processing for the significant new use would be unable to commence 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.
 
EPA states that it is developing a supplemental proposal for the LCPFAC SNUR amendments to make inapplicable the exemption for persons who import a subset of LCPFAC chemical substances as part of certain articles.  According to EPA, this supplemental proposal is necessary to be responsive to the article consideration provision in TSCA Section 5(a)(5) that was added with the 2016 amendments to TSCA.  Under the provision, articles can be subject to notification requirements as a significant new use provided that EPA makes an affirmative finding in a rule that the reasonable potential for exposure to a chemical from an article or category of articles justifies notification.  Insofar as this new provision has not been used previously for chemical substances with a history of prior import in articles, EPA’s approach to and its arguments in making this required affirmative finding will be important for all stakeholders to consider carefully.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On September 25, 2019, the U.S. Environmental Protection Agency (EPA) recognized 14 Safer Choice Partner of the Year award winners for outstanding achievement in 2018 for the design, manufacture, selection, and use of products with safer chemicals for use in households and facilities nationwide.  The Safer Choice program partners with businesses and others to help consumers and commercial buyers identify products with safer chemical ingredients, without sacrificing quality or performance.  According to EPA’s press release, the 2019 Partner of the Year award winners represent businesses -- including woman-owned and small- and medium-sized -- local government, and associations.  The following organizations from seven EPA regions are being awarded this year:


 

By Lynn L. Bergeson and Carla N. Hutton

On September 3, 2019, Earthjustice filed with the U.S. Environmental Protection Agency (EPA) a notice of intent to sue EPA under Section 20(a)(2) of the Toxic Substances Control Act (TSCA) for “EPA’s repeated and ongoing failures to comply with TSCA’s nondiscretionary mandates to disclose to the public information about new chemical substances reviewed by EPA.”  According to Earthjustice, EPA “routinely fails to disclose” certain information regarding the submission and review of new chemical applications under the premanufacture notification (PMN) and test marketing exemption (TME) provisions.  Earthjustice states that these violations impede the ability of the listed parties -- the Environmental Defense Fund, Center for Environmental Health, Environmental Health Strategy Center, Natural Resources Defense Council, Sierra Club, and the United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial Service Workers International Union, AFL-CIO/CLC -- “to be meaningfully informed of and able to participate in EPA’s review of new chemicals.”  Earthjustice asks that EPA immediately cease further violations of TSCA’s disclosure requirements for new chemicals and disclose the information to which the listed parties are legally entitled in the mandated time frames. A detailed analysis and commentary on the notice are available in our September 17, 2019, memorandum, “Earthjustice Notifies EPA of Intent to Sue for Failure to Disclose Information about New Chemical Substances.”

Tags: NOI, PMN, TME

 

By Lynn L. Bergeson and Carla N. Hutton

On August 20, 2019, the U.S. Environmental Protection Agency (EPA) published in the Federal Register final significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 145 chemical substances that are the subject of premanufacture notices (PMN).  84 Fed. Reg. 43266.  According to EPA, the chemical substances are subject to orders issued by EPA pursuant to TSCA Section 5(e).  The final SNURs require persons who intend to manufacture (defined by statute to include import) or process any of the 145 chemical substances for an activity that is designated as a significant new use by the rule to notify EPA at least 90 days before commencing that activity.  The required notification initiates EPA’s evaluation of the use, under the conditions of use for that chemical substance, within the applicable review period.  Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required by that determination.  The final SNURs will take effect October 21, 2019.

EPA notes that the final SNURs may also affect certain entities through pre-existing import certification and export notification rules under TSCA.  Chemical importers are subject to TSCA Section 13 import certification requirements.  Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA.  Importers of chemicals subject to the SNURs must certify their compliance with the SNUR requirements. Any persons who export or intend to export a chemical substance that is the subject of the SNURs on or after September 19, 2019, are subject to the export notification provisions of TSCA Section 12(b) and must comply with export notification requirements.

Tags: SNUR

 

By Lynn L. Bergeson and Carla N. Hutton
 
Section 5(g) of the Toxic Substances Control Act (TSCA) requires the U.S. Environmental Protection Agency (EPA) to publish a statement of its findings after its review of TSCA Section 5(a) notices when EPA makes a finding that a new chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment.  On August 12, 2019, EPA published a statement of its findings for June 2019.  84 Fed. Reg. 39828.  EPA notes that such statements apply to premanufacture notices (PMN), microbial commercial activity notices (MCAN), and significant new use notices (SNUN) submitted to EPA under TSCA Section 5.  In the Federal Register notice, EPA provides the following information (to the extent that such information is not claimed as confidential business information (CBI)) on the PMNs, MCANs, and SNUNs for which, during this period, EPA has made findings under TSCA Section 5(a)(3)(C) that the new chemical substances or significant new uses are not likely to present an unreasonable risk of injury to health or the environment:  EPA case number assigned to the TSCA Section 5(a) notice; chemical identity (generic name, if the specific name is claimed as CBI); and website link to EPA’s decision document describing the basis of the “not likely to present an unreasonable risk” finding made by EPA under TSCA Section 5(a)(3)(C). 


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on August 1, 2019, that it is making additional information about new chemical notices available on its website.  The new web page, “Statistics for the New Chemicals Review Program under TSCA,” allows users to view and search monthly updates for any active Premanufacture Notice (PMN), Significant New Use Notice (SNUN) and Microbial Commercial Activity Notice (MCAN) of interest by case number.  Users can also download a spreadsheet with a list of all active cases and each case’s status.  More information and commentary is available in our August 5, 2019, memorandum, "EPA Improves Transparency for New Chemicals Review Program under TSCA."


 

Bergeson & Campbell, P.C. (B&C®) is pleased to present the complimentary webinar “New TSCA at 3: Key Implementation Issues.” The webinar will drill down on key implementation challenges facing industry and the U.S. Environmental Protection Agency (EPA) three years into navigating the legal, regulatory, and science policy issues arising under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act). Alexandra Dapolito Dunn, Assistant Administrator, EPA Office of Chemical Safety and Pollution Prevention (OCSPP); Lynn L. Bergeson, Managing Partner, B&C; and Richard E. Engler, Ph.D., Director of Chemistry, B&C, will present. Register online now.


 

By Lynn L. Bergeson and Emily A. Scherer
As reported in our June 28, 2019, memorandum, on June 24, 2019, Bergeson & Campbell, P.C.(B&C®), the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health (GWU) presented “TSCA: Three Years Later,” a day-long conference with leading experts exploring the current impacts of the Toxic Substances Control Act (TSCA) on science policies, challenges faced by industry, and the impacts of TSCA on regulatory policies, especially those concerning ensuring compliance and enforcement. A recording of the full conference is available online.  Our memorandum provides details regarding the session topics and presenters, including copies of the presentation where available.


 

By Lynn L. Bergeson, Charles M. Auer, Oscar Hernandez, Ph.D., Richard E. Engler, Ph.D., and Carla N. Hutton

On March 4, 2019, the U.S. Government Accountability Office (GAO) published a report titled Chemical Assessments:  Status of EPA’s Efforts to Produce Assessments and Implement the Toxic Substances Control Act.  The report describes the extent to which the U.S. Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS) Program has addressed identified challenges and made progress toward producing chemical assessments; and assesses whether EPA has demonstrated progress implementing the Toxic Substances Control Act (TSCA).  GAO reviewed documents from the National Academy of Sciences (NAS) and EPA and interviewed EPA officials and representatives from two environmental and two industry stakeholder organizations.  GAO found that while EPA made improvements in the IRIS Program, between June and December 2018, EPA leadership directed the Program to stop the assessment process during discussions about program priorities.  GAO states that while EPA has responded to initial statutory deadlines in TSCA, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), challenges remain.  Read the full memorandum for more information on the report including why GAO did the study, GAO’s findings, and an insightful commentary.


 
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