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By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our December 20, 2019, blog item, the U.S. Environmental Protection Agency (EPA) released on December 20, 2019, an updated version of the “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.”  On January 2, 2020, EPA published a Federal Register notice announcing the availability of the updated document and beginning a 45-day comment period.  85 Fed. Reg. 99.  Comments are due February 18, 2020.
 
The updated document explains its approach for making one of the five affirmative determinations on new chemical notices under the Toxic Substances Control Act (TSCA):

  • The chemical or significant new use presents an unreasonable risk of injury to health or the environment;
  • Available information is insufficient to allow EPA to make a reasoned evaluation of the health and environmental effects associated with the chemical or significant new use;
  • In the absence of sufficient information, the chemical or significant new use may present an unreasonable risk of injury to health or the environment;
  • The chemical is or will be produced in substantial quantities and either enters or may enter the environment in substantial quantities or there is or may be significant or substantial exposure to the chemical; or
  • The chemical or significant new use is not likely to present an unreasonable risk of injury to health or the environment.

EPA notes that the updated document reflects feedback from a 2017 public meeting and comment period and EPA’s additional experience implementing the 2016 amendments to TSCA Section 5, and includes:

  • Additional clarification and detail throughout;
  • General guiding principles and concepts for making determinations;
  • Decision-making logic and key questions that EPA must address; and
  • Example applications of the Working Approach to reach each of the affirmative determinations under TSCA Section 5(a)(3).

EPA has posted a document summarizing public comments received on the 2017 document and its responses.  More information is available in our December 20, 2019, memorandum, “EPA Releases Updated Version of ‘Working Approach’ Document for New Chemicals Review.”


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) released on December 20, 2019, an updated version of the “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.”  EPA discussed the updated document, “TSCA New Chemical Determinations:  A Working Approach for Making Determinations under TSCA Section 5,” at a public meeting on December 10, 2019.  EPA states that the updated document explains its approach for making one of the five affirmative determinations on new chemical notices under the Toxic Substances Control Act (TSCA):

  • The chemical or significant new use presents an unreasonable risk of injury to health or the environment;
  • Available information is insufficient to allow EPA to make a reasoned evaluation of the health and environmental effects associated with the chemical or significant new use;
  • In the absence of sufficient information, the chemical or significant new use may present an unreasonable risk of injury to health or the environment;
  • The chemical is or will be produced in substantial quantities and either enters or may enter the environment in substantial quantities or there is or may be significant or substantial exposure to the chemical; or
  • The chemical or significant new use is not likely to present an unreasonable risk of injury to health or the environment.

EPA notes that the updated document reflects feedback from a 2017 public meeting and comment period and EPA’s additional experience implementing the 2016 amendments to TSCA Section 5, and includes:

  • Additional clarification and detail throughout;
  • General guiding principles and concepts for making determinations;
  • Decision-making logic and key questions that EPA must address; and
  • Example applications of the Working Approach to reach each of the affirmative determinations under TSCA Section 5(a)(3).

EPA has posted a document summarizing public comments received on the 2017 document and its responses.  Upon publication in the Federal Register, EPA will accept comment on the updated document for 45 days in docket EPA-HQ-OPPT-2019-0684 at https://www.regulations.gov.  More information will be available in a forthcoming memorandum that will be posted on our website.


 

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, 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
 
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 Margaret R. Graham

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, 2020, 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 will host 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.  The other two webinars will be held on October 24, 2018, from 1:00 p.m. to 2:30 p.m. (EDT) and on November 7, 2018, from 1:00 p.m. to 2:30 p.m. (EDT).  Our memorandum provides an overview of the final rule with specific information about final fee amounts and timing and a commentary.  The final rule is effective on October 18, 2018.


 

By Lynn L. Bergeson and Margaret R. Graham

On September 27, 2018, the U.S. Environmental Protection Agency (EPA) issued 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 webinars are scheduled for October 10, 2018, from 1:00 p.m. - 2:30 p.m. (EST); October 24, 2018, from 1:00 p.m. - 2:30 p.m. (EST); 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.  A detailed Bergeson & Campbell, P.C. (B&C®) memorandum on the TSCA user fees final rule is forthcoming.


 

By Lynn L. Bergeson and Carla N. Hutton

On August 31, 2018, the U.S. Environmental Protection Agency (EPA) submitted to the Office of Management and Budget (OMB) for review a final rule regarding user fees for the administration of the Toxic Substances Control Act (TSCA).  As reported in our February 9, 2018, memorandum, “Administrator Pruitt Signs TSCA User Fee Proposal,” as amended by the Frank Lautenberg Chemical Safety for the 21st Century Act, TSCA provides EPA the authority to levy fees on certain chemical manufacturers, including importers and processors, to “provide a sustainable source of funding to defray resources that are available for implementation of new responsibilities under the amended law.”  Under the amendments to TSCA, EPA has authority to require payment from manufacturers and processors who:

  • Are required to submit information by test rule, test order, or enforceable consent agreement (ECA) (TSCA Section 4);
  • Submit notification of or information related to intent to manufacture a new chemical or significant new use of a chemical (TSCA Section 5); or
  • Manufacture or process a chemical substance that is subject to a risk evaluation, including a risk evaluation conducted at the request of a manufacturer (TSCA Section 6(b)).

EPA’s February 26, 2018, proposed rule described the proposed TSCA fees and fee categories for fiscal years (FY) 2019, 2020, and 2021, and explained the methodology by which the proposed TSCA user fees were determined and would be determined for subsequent FYs.  In proposing the new TSCA user fees, EPA also proposed amending long-standing user fee regulations governing the review of Section 5 premanufacture notices (PMN), exemption applications and notices, and significant new use notices (SNUN).  Under the proposed rule, after implementation of final TSCA user fees regulations, certain manufacturers and processors would be required to pay a prescribed fee for each Section 5 notice or exemption application, Section 4 testing action, or Section 6 risk evaluation for EPA to recover certain costs associated with carrying out certain work under TSCA.  EPA did not propose specific fees for submission of confidential business information (CBI).


 

By Lynn L. Bergeson and Carla N. Hutton

On August 27, 2018, the Natural Resources Defense Council (NRDC) filed a motion in the U.S. Court of Appeals for the Second Circuit asking to dismiss voluntarily its petition for review of the U.S. Environmental Protection Agency’s (EPA) “New Chemicals Decision-Making Framework:  Working Approach to Making Determinations under Section 5 of TSCA.”  NRDC v. EPA, No. 18-25.  NRDC petitioned the court on January 5, 2018, for review of EPA’s November 2017 Framework Document.  In its petition for review, NRDC described the Framework Document as a final rule, and argued in its May 1, 2018, opening brief that, based on the Framework Document, EPA “limits its review of a new chemical substance to the manufacturer’s intended conditions of use and disregards Congress’s instruction to address risk concerns through enforceable orders and regulations.”  On July 31, 2018, EPA filed its opening brief, which included a declaration from Dr. Jeffery Morris, Director of EPA’s Office of Pollution Prevention and Toxics (OPPT).  According to Morris, EPA considers the “conditions of use” of the premanufacture notice (PMN) when making determinations under TSCA Section 5(a)(3).  Morris notes that under TSCA Section 3(4), the term “conditions of use” means “the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of.”  Since EPA issued the Framework Document for comment, it has made 150 determinations on PMNs under TSCA Section 5(a)(3), but “has not yet followed the SNUR approach described in the Framework.”  For 19 PMNs, EPA determined that the new chemical substance was not likely to present an unreasonable risk.  According to EPA, “[f]or none of these determinations did EPA consider whether a significant new use rule had been issued in concluding that unreasonable risk was unlikely.”  Additionally, for 131 determinations, EPA made a determination under TSCA Section 5(a)(3)(B) related to the sufficiency of information regarding the substance, and then issued orders under TSCA Section 5(e).  The basis for a significant number of these determinations was related to the reasonably foreseen conditions of use of the new chemical substance at issue.  Notwithstanding EPA’s pronouncement in the Framework Document that it anticipated using significant new use rules in similar cases, “none of these determinations followed that approach.”  NRDC states that, in light of these representations, it “has elected to move for voluntary dismissal of this petition for review.”


 
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