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 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 Margaret R. Graham

On April 24, 2018, the U.S. Environmental Protection Agency (EPA) is scheduled to publish a notice in the Federal Register that it will be adding a supplemental analysis, “Supplemental Analysis of Alternative Small Business Size Standard Definitions and their Effect on TSCA User Fee Collection,” to the rulemaking docket for the User Fees for the Administration of the Toxic Substances Control Act (TSCA) proposed rule published on February 26, 2018.  EPA will also be extending the comment period for the proposed rule for an additional 30 days “to give interested parties the opportunity to consider this additional analysis and prepare meaningful comments.”  Comments will be due within 30 days of publication (by May 24, 2018).  The original comment deadline was April 27, 2018.

Regarding the supplemental analysis, EPA states that it “provides additional estimates for the impact of setting the small business definition based on an employee-based threshold.”  More information on the proposed rule is available in our February 9, 2018, memorandum “Administrator Pruitt Signs TSCA User Fee Proposal.”


 

By Lynn L. Bergeson and Margaret R. Graham

On February 26, 2018, the U.S. Environmental Protection Agency (EPA) published its proposed fees rule entitled User Fees for the Administration of the Toxic Substances Control Act (TSCA), as permissible under TSCA Section 26(b).  83 Fed. Reg. 8212.  The rule as proposed will set user 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 the Administrator 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).  The notice of proposed rulemaking provides a description of proposed TSCA fees and fee categories for fiscal years 2019, 2020, and 2021, and explains the methodology by which the proposed TSCA user fees were determined and would be determined for subsequent fiscal years.  In proposing these new TSCA user fees, EPA also proposes amending long standing user fee regulations governing the review of premanufacture notices, exemption applications and notices, and significant new use notices.  Comments on the proposed rule are due April 27, 2018.

An in-depth analysis prepared by Bergeson & Campbell, P.C. (B&C®) is available in our memorandum “Administrator Pruitt Signs TSCA User Fee Proposal.”


 

By Lynn L. Bergeson and Margaret R. Graham

 


 

By Lynn L. Bergeson and Margaret R. Graham

On February 8, 2018, the U.S. Environmental Protection Agency (EPA) issued the prepublication version of its long-anticipated fees rule under amended Toxic Substances Control Act (TSCA) Section 26(b) entitled User Fees for the Administration of the Toxic Substances Control Act.  EPA states that the proposed rule will set user 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 the Administrator 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’s notice of proposed rulemaking provides a description of proposed TSCA fees and fee categories for fiscal years 2019, 2020, and 2021, and explains the methodology by which the proposed TSCA user fees were determined and would be determined for subsequent fiscal years.  In proposing these new TSCA user fees, the Agency also proposes amending long standing user fee regulations governing the review of premanufacture notices, exemption applications and notices, and significant new use notices.  

EPA states the proposed fees on certain chemical manufacturers, including importers, would go towards developing risk evaluations for existing chemicals; collecting and reviewing toxicity and exposure data and information; reviewing Confidential Business Information (CBI); and making determinations regarding the safety of new chemicals before they enter the marketplace.

Comments on the proposed rule will be due 60 days after its publication in the Federal Register.

An in-depth analysis prepared by Bergeson & Campbell, P.C. (B&C®) will soon be available on our Regulatory Developments webpage.


 

By Lynn L. Bergeson and Margaret R. Graham

On January 31, 2018, the U.S. Environmental Protection Agency (EPA) announced the release of its 2018 Annual Report on Risk Evaluations.  Pursuant to Section 26(n)(2) of the amended Toxic Substances Control Act (TSCA), EPA is directed to publish an annual plan at the beginning of each calendar year identifying the chemical substances that will undergo risk evaluations during that year. The plan is to include both risk evaluations that will be initiated and that will be completed, the resources necessary for completion, and the status and schedule for ongoing evaluations.  The 2018 annual plan identifies the next steps for the first ten chemical reviews currently underway and describes EPA’s work in 2018 to prepare for future risk evaluations.

EPA issued scoping documents on the first ten chemical reviews in June 2017.  The plan states that in early calendar year 2018, EPA will be making refinements to these scope documents in the form of “problem formulation documents” that will include additional elements such as conceptual models.  EPA will publish a notice in the Federal Register announcing the release of these problem formulation documents and will invite comments for 45 days.  

The plan also states that EPA will initiate prioritization for 40 chemicals (at least 20 Low-Priority and 20 High-Priority candidates) by the end of calendar year 2018.  By December 22, 2019, EPA plans to have designated 20 substances as Low-Priority and initiated risk evaluations on 20 High-Priority substances.  Further, EPA will be proposing the much-anticipated TSCA Fees Rule in early-mid fiscal year (FY) 2018, and anticipates issuing a final rule in late FY2018.

Information on EPA’s 2017 Annual Report is available in our blog item EPA Publishes 2017 Annual Report on Chemical Risk Evaluations.


 

By Lynn L. Bergeson and Margaret R. Graham

On December 22, 2017, the U.S. Environmental Protection Agency (EPA) sent to the Office of Management and Budget (OMB) a proposed rule establishing fees on certain submissions under amended Toxic Substances Control Act (TSCA) Sections 4, 5, and 6.  EPA has indicated that it expects to propose the rule in the early part of the New Year:  EPA’s regulatory agenda lists February 2018 for the proposed rule and September 2018 for the final rule.

More information on the TSCA fees rulemaking and requirements is available in our blog item “EPA Hosts August 11, 2016, Public Meeting on Proposed Rule for Revised TSCA Fees,” in our memorandum “TSCA Reform:  An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA,” and in our September 20, 2016, webinar “‘The New TSCA’ Webinar 4: Administration of the Act, Preemption, Fees, and Green Chemistry.”

Tags: TSCA fees, OMB

 

By Zameer Qureshi

On October 4, 2016, Bergeson & Campbell, P.C. (B&C®) hosted its fourth and final webinar in its series of webinars on the new Toxic Substances Control Act (TSCA) in collaboration with Chemical Watch.  The webinar addressed numerous important issues for a wide array of stakeholders.  The webinar was moderated by Lynn L. Bergeson, Managing Partner at B&C, and the expert panel included Charles M. Auer, Richard E. Engler, Ph.D., Lisa R. Burchi, and Sheryl L. Dolan.

Mr. Auer, Senior Regulatory and Policy Advisor at B&C, addressed “Administration of the Act” and described important changes between old and new TSCA.  Mr. Auer’s presentation consisted of three segments:  (1) “Section 26 Science Requirements”; (2) “Section 26 Information and Guidance”; and (3) “Section 26 ‘Savings’ Provision.”  

Mr. Auer addressed the “Scientific Standards” requirements of new TSCA Section 26(h), the “Weight of Scientific Evidence” requirements of Section 26(i), and the Section 26(o) provisions of new TSCA relating to Consultation with the Science Advisory Committee on Chemicals (SACC).  Mr. Auer addressed a number of additional rules and requirements in Section 26, including the U.S. Environmental Protection Agency’s (EPA) obligation to submit a report to Congress and issue an Annual Plan under Sections 26(m)-(n).

Ms. Burchi, Of Counsel at B&C, discussed “Preemption” under Section 18 of new TSCA. Ms. Burchi described preemption as “one of the most debated subjects in [the TSCA reform] debate” and stated that she had heard it referred to as a “linchpin” in terms of reaching agreement on provisions for TSCA reform to occur.  Ms. Burchi stated “Everything in the new Section 18 is new or very significantly changed from what we were used to with regard to preemption … The final provisions are fairly complicated … It will remain to be seen whether states continue to act with regard to chemical substances in the way that they have been.”

Ms. Burchi addressed the three “main” provisions related to preemption under new TSCA Sections 18(a)(1)(A)-(C), and analyzed more specific issues (e.g., pause preemption) and the related exceptions.  Ms. Burchi described the TSCA Section 18(d)-(e) provisions relating to “Exceptions” and “Preservation of Certain Laws.”  Ms. Burchi also addressed new TSCA’s Section 18(f) “Waivers” provisions and concluded her segment of the presentation with the following statement:  “It remains to be seen whether states are going to be jumping in to [take action] when EPA has already identified a chemical for prioritization and review … [There will be some interesting provisions and interplay] to be seen as we move forward under new TSCA.” 

Ms. Dolan, Senior Regulatory Consultant at B&C, analyzed “Fees” under new TSCA and addressed EPA’s obligations to:  (1) set lower fees for small business concerns; (2) consider balance between manufacturers and processors; and (3) consult with the regulated community.  Ms. Dolan stated “new TSCA directs EPA to review its fee program on a three-year cycle and revise it as needed to raise the target fees … While new TSCA did not set a deadline for developing the fees program, it really didn’t have to -- EPA, of course, has every incentive to knock this rulemaking out quickly.” 

Ms. Dolan indicated that a final rule is expected on fees under new TSCA by June 2017, and provided an overview of comments received on the proposed rule.  Ms. Dolan stated that “overarching themes” in the comments included that:  (1) fees should be tied to the level of required effort; (2) fees should encourage innovation; and (3) fees should not be overly complex or difficult to administer.  In relation to (3), Ms. Dolan quoted a commenter that stated “don’t give us the [Internal Revenue Service (IRS)] Code.” 

Ms. Dolan stated “everyone seems to want to know how much will a [pre-manufacture notice (PMN)] cost in the future … I think the answer to that [will come with a big red bow] in December.  Specifically, EPA states that it will send a proposal to [the Office of Management and Budget (OMB)] in mid-October … EPA may well set a comment period of at least 60 days for this proposed rule.”

Dr. Engler, Senior Chemist at B&C, discussed Sustainable Chemistry (i.e., Green Chemistry) under new TSCA.  Dr. Engler stated “new TSCA is largely silent on sustainability” and indicated that the “primary benefit” to Sustainable Chemistry under new TSCA is the abbreviated review period when EPA determines that a new chemical is “not likely to present” an unreasonable risk (i.e., 90-day period waived and manufacturers can commence manufacturing immediately).  Dr. Engler addressed chemicals that EPA considers to present low hazard for health and ecotoxicity (“low/low” chemicals) and stated that new TSCA could be “more of a driver for Sustainable Chemistry,” if only low/low chemicals escape regulation.

Dr. Engler addressed “Relative Risk under New TSCA” and EPA’s “Safer Choice Program” (SCP).  Dr. Engler discussed the Senate Report on S. 697, which suggested that EPA should consider “private sector voluntary consensus standards as an alternative” to SCP.  Dr. Engler indicated that as the relevant section of the Senate report concerns Section 23, the Sustainable Chemistry Section that was not included in the enacted new TSCA, it is unclear how it applies to new TSCA as enacted.  Dr. Engler stated that EPA is proceeding with SCP and hosting a summit in November on this topic.

The webinar concluded with a Questions and Discussion (Q&D) session, and B&C’s expert panel provided useful answers and analyses in response to attendees’ questions.  Ms. Bergeson moderated the Q&D session, which was organized by topic. 

In the Q&D session, Ms. Bergeson stated and asked Ms. Dolan: “Fees are super important … [small businesses and startups] might have a hard time mustering any type of financial liquidity to get their notifications through the gauntlet of EPA -- so how would you expect EPA to be defining lower fees for purposes of small business provision?”

Ms. Dolan responded by stating “[currently, the ratio is $2,500 and $100 for small businesses.  I would imagine there will be some kind of comparable proportionality and currently there are other submissions (e.g., Low Volume Exemptions) that don’t require any fees.  EPA has got to raise the money somewhere -- the more they put it on something else or the more they try to avoid charging fees for things, the more it’s going to jack up the cost and other things.  I would imagine that they are going to charge something for everything.  Whether they maintain that proportionality of 100:2500 remains to be seen.  Another consideration is what constitutes a small business.  There is a lot of conversation about that and the fact that definition hasn’t been updated in quite a while … This might be something that is the focus of a lot of attention in the proposed rule.]”

Ms. Bergeson drew on Mr. Auer’s extensive experience with EPA on several occasions during the Q&D session, starting questions with “If you were back at EPA,” and Mr. Auer’s responses were comprehensive.   Dr. Engler responded to questions regarding Green Chemistry and discussed Persistent, Bioaccumulative, and Toxic (PBT) substances under new TSCA, and Ms. Burchi answered questions on California’s Safer Consumer Products Regulation (SCPR) and preemption under new TSCA.

More information on TSCA reform and B&C’s “The New TSCA: What You Need to Know” webinar series is available online.


 
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