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 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, Charles M. Auer, Richard E. Engler, Ph.D., and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) issued on October 16, 2018, a proposed rule that would establish significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 13 chemical substances that are the subject of premanufacture notices (PMN).  83 Fed. Reg. 52179.  The proposed rule is significant.  Unlike other recent SNURs (i.e., those enacted since entry into force of amended TSCA), the 13 chemical substances are not also subject to consent orders.  For this reason, the preamble contains novel language to address the new circumstances and legal issues encountered in the proposed rule.  The proposed SNURs would require persons who intend to manufacture (defined by statute to include import) or process any of the 13 chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity.  The required notification will initiate EPA’s evaluation of the intended use within the applicable review period.  Persons may not commence the 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 has taken such actions as are required with that determination.  Comments on the proposed SNURs are due November 15, 2018.

Please see the full memorandum for more information on the proposed rule and an illuminating commentary.


 

By Lynn L. Bergeson and Margaret R. Graham

On October 5, 2018, the U.S. Environmental Protection Agency (EPA) issued the general approaches that the Office of Pollution Prevention and Toxics (OPPT) may use to identify potential candidate chemicals for prioritization under TSCA.  83 Fed. Reg. 50366.  EPA notes that it will seek public comment on the approach document and on which chemicals should be identified as potential candidates for the initial 20 high-priority and 20 low-priority chemicals that must be identified pursuant to TSCA Section 6(b)(2)(B).  Comments are due by November 15, 2018

The document, A Working Approach for Identifying Potential Candidate Chemicals for Prioritization, lays out EPA’s thinking regarding a near-term approach for identifying potential chemicals for prioritization, the initial step in evaluating the safety of existing chemicals under TSCA.  The approach document also includes a longer-term risk-based strategy for managing the larger TSCA chemical landscape that, according to the portion of the TSCA Chemical Substance Inventory (Inventory) that includes the substances designated as active (TSCA Active Inventory), is expected to include over 38,000 chemicals reported as “active” under the TSCA Inventory Notification (Active-Inactive) Requirements final rule.  More information is available in our memorandum “EPA Releases Working Approach for Identifying Potential Candidate Chemicals for Prioritization under TSCA.”


 

By Lynn L. Bergeson and Margaret R. Graham

On September 28, 2018, the U.S. Environmental Protection Agency (EPA) announced it was releasing the approach it will use to identify chemicals that could be included in the next group of risk evaluations under the Toxic Substances Control Act (TSCA) titled “A Working Approach for Identifying Potential Candidate Chemicals for Prioritization” (Working Approach).  EPA states that the information set forth in this document is “intended to describe the general approaches EPA may consider to identify existing chemicals as potential candidates for prioritization,” and the ultimate goal of these approaches “is to identify potential candidates from which EPA will select candidates for prioritization, consistent with its regulations at 40 C.F.R. § 702.5.” 

EPA also released the pre-publication version of the Federal Register notice of availability of the Working Approach and “A Summary of Public Comments By Topic” (Summary).  The pre-publication notice states that EPA will be opening a public docket to accept comments on the Working Approach until November 15, 2018.  These comments will inform a public meeting to be held in early 2019.  Upon publication of the Federal Register notice, EPA will open 74 chemical-specific public dockets, one for each of the 73 remaining chemicals on the 2014 Update to the TSCA Work Plan for Chemical Assessments that have not received manufacturer requests for EPA evaluation and an additional general docket for chemicals not on the Work Plan.  These dockets will be open until December 1, 2019.  A link to the list of these dockets is available here

More information on TSCA implementation is available on our website under key phrase Lautenberg Implementation


 

By Lynn L. Bergeson and Margaret R. Graham

On September 13, 2018, EPA announced it was requesting public nominations of scientific experts to be considered for ad hoc participation and possible membership on the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC).  83 Fed. Reg. 46487.  The notice states that all nominees will be considered for ad hoc participation in the TSCA SACC’s peer reviews of the EPA’s risk evaluations for the first ten chemical substances addressed under TSCA.  Further, all nominees may be considered for TSCA SACC membership to fulfill short term needs when a vacancy occurs on the chartered Committee.  As part of a broader process for developing a pool of candidates, EPA staff solicits from the public and stakeholder communities nominations of prospective candidates for service as ad hoc reviewers and possibly members of TSCA SACC. 

EPA states in the notice that any interested person or organization may nominate qualified individuals to be considered as prospective candidates, including themselves.  It is requested for individuals nominated to have expertise in one or more of the following areas:  women's health; children’s health; genetic variability; disproportionately exposed populations; aging; other susceptible populations; biochemistry; chemistry; epidemiology; human health risk assessment; pathology; physiologically based pharmacokinetic (PBPK) modeling; pharmacology; ecological risk assessment; environmental fate; environmental toxicology; occupational, consumer, and general exposure assessment; toxicology; dose response modeling; environmental engineering; biostatistics; computational toxicology; fiber science; inhalation toxicology; volatile organics; and systematic review.  Nominations are due by October 29, 2018.


 

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 29, 2018, the Democrats on the House Committee on Energy and Commerce issued a press release announcing that they have renewed their request for a hearing on the U.S. Environmental Protection Agency’s (EPA) implementation of the amendments made by the Frank R. Lautenberg Chemical Safety for the 21st Century Act to the Toxic Substances Control Act (TSCA).  The Democrats note this is the fourth request they have made for hearings to be held on EPA’s management of toxic chemicals.  According to the press release, the Democrats “remain concerned that EPA’s implementation of the reformed TSCA program contradicts the new law’s language and intent and undermines public confidence in the program.”  The press release states that the Democrats “are concerned that EPA is ignoring its own scientific evidence and the recommendations of its experienced career staff regarding TSCA implementation at the expense of public health.  They point to a recent report from the New York Times that found EPA officials proposed a rulemaking to review applications for use of asbestos in consumer products over the objections of EPA attorneys and scientists.”  The Democrats “also charge that EPA has abandoned its statutory mandate to review all new and existing chemicals known or foreseeable uses and exposure putting human health and the environment at risk,” possibly resulting in an incomplete evaluation of the health and environmental risk of a number of “extremely toxic chemicals, including asbestos, perchloroethylene (PERC), methylene chloride, and trichloroethylene (TCE).”  The letter was signed by Ranking Member Frank Pallone, Jr. (D-NJ), Environment Subcommittee Ranking Member Paul Tonko (D-NY), Raul Ruiz (D-CA), Scott Peters (D-CA), Gene Green (D-TX), Diana DeGette (D-CO), Jerry McNerney (D-CA), Tony Cardenas (D-CA), Debbie Dingell (D-MI), and Doris Matsui (D-CA).


 

By Lynn L. Bergeson and Margaret R. Graham

On July 24, 2018, the U.S. Environmental Protection Agency (EPA) announced it was extending the comment periods for all ten problem formulation documents and the systematic review approach document in Toxic Substances Control Act (TSCA) risk evaluations that were published on June 11, 2018, by 21 days;  comments on these documents are now due by August 16, 2018.  EPA states that although the comment period will end in 21 days (August 16, 2018), “EPA will try to consider any additional comments received after this date.  However, incorporation of late comments may not be included in the documents for peer review.  There will be an additional comment period following the publication of each of the draft risk evaluations.”

Links to the problem formulation dockets are available in our blog item “EPA Releases Problem Formulations Documents on First Ten Chemicals; Systematic Review Approach Document; and Asbestos SNUR” and a more detailed analysis is available in our memorandum “EPA Takes ‘Three Important Steps’ Intended to Ensure Chemical Safety.”


 

By Charles M. Auer, Oscar Hernandez, Ph.D., and Lynn L. Bergeson

On June 22, 2018, the U.S. Environmental Protection Agency (EPA) released its Strategic Plan to Promote the Development and Implementation of Alternative Test Methods Within the TSCA Program.  Development of the Strategic Plan was required under Section 4(h)(2)(A) of the Frank R. Lautenberg Chemical Safety for the 21st Century Act with a deadline of not later than two years after enactment.  Release of the final Strategic Plan occurred on the second anniversary of enactment of amendments to the Toxic Substances Control Act (TSCA).

The goal of the strategy is to reduce the level of testing in vertebrates for chemicals regulated under TSCA.  EPA describes alternative test methods and strategies as different descriptors that have a common goal.  The former is based on reduction, refinement, and replacement of animal test methods (the 3Rs), while strategies incorporate more than just toxicity test methods to characterize hazard.  The strategy as proposed relies on a range of applications and testing approaches to characterize human health and environmental endpoints. 

Collectively, alternative test methods and strategies combine to define a new term: new approach methodologies (NAM).  The NAM designation is used as a broadly descriptive reference to any technology, methodology, approach, or combination thereof that can be used to provide information on chemical hazard and risk assessment that avoids the use of vertebrates. For the purposes of TSCA, EPA recognizes this new term (i.e., NAM) as encompassing any “alternative test methods and strategies to reduce, refine or replace vertebrate animals.”

A much more detailed summary and analysis of this important issue is available in our memorandum.


 

By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Molly R. Blessing

Bergeson & Campbell, P.C. (B&C®) will present a webinar regarding confidential business information (CBI) as related to chemical regulation on September 18, 2018.  Register for “TSCA Confidential Business Information and Generic Naming: Analyzing the New Rules” online.  This webinar is part of the 2018 Chemical Policy Summit Series presented by B&C and Bloomberg Next.

On June 21, 2018, the U.S. Environmental Protection Agency (EPA) issued guidance intended to “assist companies in creating structurally descriptive chemical names for chemical substances whose specific chemical identities are claimed confidential, for purposes of protecting the specific chemical identities from disclosure while describing the chemical substances as specifically as practicable, and for listing substances on the Toxic Substances Control Act (TSCA) Chemical Substance Inventory.”  EPA states that the guidance, Guidance for Creating Generic Names for Confidential Chemical Substance Identity Reporting under the Toxic Substances Control Act, was developed in response to the requirement under new TSCA Section 14(c)(4) that EPA “develop guidance regarding – (A) the determination of structurally descriptive generic names, in the case of claims for protection from disclosure of specific chemical identity…” and the requirement under new TSCA Section 14(c)(1)(C) that submitters who assert a confidentiality claim for a specific chemical identity must include a structurally descriptive generic name developed consistent with EPA guidance.  The guidance updates and replaces the 1985 guidance published in the TSCA Inventory, 1985 Edition (Appendix B: “Generic names for Confidential Chemical Substance Identities”).  EPA states that, also consistent with Sections 14(c)(4) and 14(c)(1)(C), EPA will be reviewing generic names upon receipt in TSCA filings where chemical identity is claimed as confidential for consistency with the guidance.  EPA encourages companies to consult the Agency’s Office of Pollution, Prevention, and Toxics (OPPT) if they feel that it will be necessary to mask more than one structural element of a specific chemical name to mask a confidential chemical identity.  More information on this guidance is available in our full memorandum


 
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