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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on December 9, 2019, that in advance of the December 10, 2019, public meeting on new chemicals, it is providing the meeting materials and announcing the availability of a new web page detailing cases with completed confidential business information (CBI) determinations under the Toxic Substances Control Act (TSCA).  Materials for the December 10, 2019, meeting include:

The new CBI web page includes a table of all the final CBI determinations under TSCA Section 14(g).  The table contains information from CBI reviews including:

  • Case Number;
  • Submission Type;
  • CBI Review Category (specific chemical identity, other information, or both);
  • Final Determination;
  • Determination Rationale Summary;
  • For CBI Claims for Specific Chemical Identity:
  • EPA Unique Identifier (UID);
  • Accession Number;
  • Generic Name; and
  • Expiration Date for Chemical Identity and Non-Chemical Identity CBI Claims.

EPA states that it plans to update this information on a quarterly basis.


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) will hold a public meeting on December 10, 2019, to engage with interested stakeholders on the implementation of EPA’s Toxic Substances Control Act (TSCA) New Chemicals program.  At the meeting, EPA will:

  • Provide an overview of EPA’s updated “Working Approach” document that builds upon EPA’s November 2017 “New Chemicals Decision-Making Framework:  Working Approach to Making Determinations under Section 5 of TSCA”;
  • Demonstrate how EPA has used concepts in the “Working Approach” document to reach conclusions and make determinations under TSCA Section 5(a)(3) using specific case examples;
  • Provide an update on confidential business information (CBI) process improvements and clarifications; and
  • Discuss its progress on transparency in the TSCA New Chemicals program.

By the end of 2019, EPA intends to announce the availability of the updated “Working Approach” document and provide an opportunity for written public comment.  EPA states that feedback from the public meeting and comments received will help inform its ongoing efforts to improve the way EPA reviews new chemicals under TSCA.  Details regarding the meeting are available in the prepublication version of the Federal Register notice announcing the meeting.

Background

EPA states in the prepublication version of the Federal Register notice that after considering comments received on the 2017 version of the “Working Approach” document and based on additional implementation experience, EPA is updating the “Working Approach” document.  Later in December 2019, EPA will announce the availability of the updated document after the public meeting and will hold a public comment period.  According to the notice, EPA expects the updated document to provide further clarity and detail on EPA’s approach and practices, including:  (1) EPA’s general guiding principles and concepts for making determinations on new chemical notices submitted to EPA under TSCA Section 5; (2) the decision-making logic and the key questions that EPA must address; and (3) a discussion of how EPA might apply the working approach to reach one of the five new chemical determinations allowable under the statute.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on November 13, 2019, that it published “new, easily-searchable” web pages displaying information on:

EPA notes that it is required to publish information pertaining to new chemical submissions under TSCA Section 5.  EPA states that historically, these data have been, and will continue to be, made available monthly in the Federal Register via www.regulations.gov.  According to EPA, the new web pages “are a much easier way for the public to access information about new chemical submissions.”  The web pages provide information, such as the date the notice was received by EPA, the case number, and the chemical substance identity (to the extent that such information is not subject to a confidential business information (CBI) claim).  EPA states that it will update the web pages monthly.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On Wednesday, November 13, 2019, at 3:00 p.m. (EST), the U.S. Environmental Protection Agency (EPA) will hold a webinar on the Green Chemistry Challenge Awards Program.  Participants will learn more about applying for the 2020 Green Chemistry Challenge Awards.  The webinar presentation will cover award eligibility, the application process, and evaluation criteria.  There will also be time for questions from the webinar participants.
 
As reported in our September 20, 2019, blog item, EPA is now accepting nominations for the 2020 Green Chemistry Challenge Awards for companies or institutions that have developed a new process or product that helps protect public health and the environment.  EPA defines green chemistry as the design of chemical products and processes that reduce both the generation and use of chemicals that are hazardous to the environment and people’s health.  Nominations for innovative technologies featuring the design of greener chemicals and products, greener chemical syntheses and reactions, or greener chemical processes are due to EPA by December 31, 2019.  EPA anticipates giving awards to outstanding green chemistry technologies in five categories in June 2020


 

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 and Carla N. Hutton
 
On September 23, 2019, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) announced that it plans to begin fieldwork on EPA’s Safer Choice program.  According to OIG, its objectives are to identify and assess the controls that EPA has in place to verify that the Safer Choice program meets its goals and achieves quality standards through its product qualification, renewal, and required audit process.  OIG states that Safer Choice “is a voluntary labeling program that helps consumers and commercial buyers find chemical-based products that are safer for human health and the environment.”  OIG plans to conduct work at headquarters and at various third-party assessor and auditor locations.  It will use applicable generally accepted government auditing standards in conducting its audit.  The anticipated benefits of the audit “are reducing the use of chemicals of concern and empowering consumers to protect their health.”

Tags: Safer Choice,

 

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
 
The U.S. Environmental Protection Agency (EPA) announced on September 18, 2019, that it is now accepting nominations for the 2020 Green Chemistry Challenge Awards for companies or institutions that have developed a new process or product that helps protect public health and the environment.  EPA defines green chemistry as the design of chemical products and processes that reduce both the generation and use of chemicals that are hazardous to the environment and people’s health.  Nominations for innovative technologies featuring the design of greener chemicals and products, greener chemical syntheses and reactions, or greener chemical processes are due to EPA by December 31, 2019.  EPA states that it anticipates giving awards to outstanding green chemistry technologies in five categories in June 2020.  According to EPA, since the inception of the awards more than two decades ago, it has received more than 1,600 nominations and presented awards to 118 technologies that reduced the use or generation of hundreds of millions of pounds of hazardous chemicals and saved billions of gallons of water and trillions of BTUs in energy.  An independent panel of technical experts convened by the American Chemical Society Green Chemistry Institute will formally judge the 2020 nominations and make recommendations to EPA for the 2020 winners.


 

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

 
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