By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) recently published its 2020 Annual Plan for Chemical Risk Evaluations under TSCA (Annual Plan).  Section 26(n) of the Toxic Substances Control Act (TSCA) requires EPA to publish an annual plan at the beginning of each calendar year that identifies the chemical substances for which EPA expects to initiate or complete risk evaluations that year and the resources necessary for their completion, describes the status of each risk evaluation that has been initiated but not yet completed, and includes an updated schedule for completion of risk evaluations, if appropriate.  The Annual Plan states that in fiscal year (FY) 2020, EPA intends to complete final risk evaluations for the first ten chemicals.  As reported in our April 7 and April 20, 2020, blog items, EPA has published the draft scope documents for the risk evaluations to be conducted for the 20 high-priority substances designated in December 2019.  According to the Annual Plan, EPA expects to issue final draft scope documents in June 2020.  In accordance with statutory timelines, EPA states that it will publish final risk evaluations within three years of initiation, with a possible six-month extension.  In May 2019, EPA received manufacturer requests to conduct risk evaluations of diisodecyl phthalate (DIDP) and diisononyl phthalate (DINP).  EPA expects to release draft scope documents in the third quarter of FY 2020, complying with statutory timelines.  In March 2020, EPA received a facially complete manufacturer request to conduct a risk evaluation on octamethylcyclotetrasiloxane (D4).  EPA expects to ask for public comment on this request and make a final determination as to whether to grant this request within FY 2020.  EPA notes that it may receive additional requests in FY 2020 and will conduct the process to review these requests as directed in the Risk Evaluation Process Rule.  TSCA requires EPA to review fees and consider updating the fees rule every three years to ensure fees are adequate to defray 25 percent of the costs for implementing TSCA Sections 4, 5, 6, and 14, and to consult with stakeholders again if fees change.  In 2020, EPA expects to begin this process to review fees and propose certain exemptions to the current rule’s self-identification requirements associated with EPA-initiated risk evaluations for manufacturers that import the chemical substance in an article, produce the chemical substance as a byproduct, and produce or import the chemical substance as an impurity.

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Bergeson & Campbell, P.C. (B&C^®) is pleased to announce the release of the complete suite of TSCA Tutor™ regulatory training courses online and on-demand at www.TSCAtutor.com.  Professionals seeking expert, efficient, essential training can preview and enroll in on-demand classes to complete at their own pace and timing.  In addition to the newly released online e-learning courses, B&C’s TSCA Tutor™ training platform offers live in-person training at a company’s site and customized live webinar training, so companies can mix and match training modules and training approaches to provide the most suitable combination for their work needs.
 
Toxic Substances Control Act (TSCA) awareness is a critically important element in the 21st century work environment for any business that involves industrial chemicals.  The new normal requires awareness of TSCA’s application to a company’s operations to ensure consistent compliance with TSCA regulations and, importantly, to understand and anticipate how the U.S. Environmental Protection Agency’s (EPA) ongoing implementation of new TSCA will impact a company’s industrial chemical selection and use processes.
 
TSCA Tutor™ online training courses include:

• Video lessons.
• Detailed hand-out materials, including copies of all presentations and relevant course materials from EPA and other sources.
• Customizable, yet detailed and ready-to-use Standard Operating Procedures (SOP) for the regulatory topic covered in the session.

ONE-HOUR SESSIONS:

• An Overview of TSCA (Course number T101)
• New TSCA at a Glance (Course number T102)
• Import Requirements, TSCA Section 13 (Course number T103)
• Export Requirements, TSCA Section 12 (Course number T104)
• Confidential Business Information (CBI) (Course number T105)
• Reporting and Retention of Information, TSCA Section 8 (Course number T106)

TWO-HOUR SESSIONS:

• Inspections and Audits (Course number T201)
  • Preparing for a TSCA Audit
  • TSCA Penalties/Overview of Self-Confession Policy
• TSCA Section 5, Part 1:  TSCA Chemical Inventory, Exemptions (Course number T202)
  • TSCA Inventory
  • Exemptions
• TSCA Section 5, Part 2:  New Chemicals/New Use (Course number T203)
  • New Chemicals/New Use
  • SNURs
• Chemical Data Reporting (CDR) (Course number T204)
  • CDR Overview
  • Byproduct Reporting under CDR
• Chemical Testing (Regulatory)/Animal Welfare, TSCA Section 4 (Course number T205):
  • Chemical Testing
  • How to Prepare/Engage If a Chemical of Interest Is Listed under TSCA Section 4
• Prioritization and Risk Evaluation, TSCA Section 6 (Course number T206)
  • Overview of Section 6 Risk Framework -- Prioritization, Evaluation, and Management
  • How to Prepare/Engage If a Chemical of Interest Is Listed under Section 6

Bergeson & Campbell, P.C. is a Washington, D.C., law firm focusing on conventional, biobased, and nanoscale industrial, agricultural, and specialty chemical product approval and regulation, and associated business issues.  B&C represents clients in many businesses, including basic, specialty, and agricultural and antimicrobial chemicals; biotechnology, nanotechnology, and emerging transformative technologies; paints and coatings; plastic products; and chemical manufacturing, formulation, distribution, and consumer product sectors.  Visit www.lawbc.com for more information.

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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.

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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.

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On April 14, 2017, Lynn L. Bergeson’s article “TSCA Reform: Key Provisions and Implications,” was published in Volume 26, Issue 2, of Environmental Quality Management.  On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act which substantially amended the Toxic Substances Control Act (TSCA), and, in so doing, fundamentally altered the domestic management of industrial chemicals -- the lifeblood of many manufacturing processes.  This article summarizes key changes to TSCA and explains their likely impacts on the manufacturing sector.

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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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By Sheryl L. Dolan, Kathleen M. Roberts, James V. Aidala, and Lynn L. Bergeson

On August 11, 2016, the U.S. Environmental Protection Agency (EPA) convened a public meeting to solicit comments prior to development of a proposed rule to implement the revised Section 26 fees provision under the new Toxic Substances Control Act (TSCA).  Public comments may be submitted through regulations.gov in docket EPA-HQ-OPPT-2016-0401 until August 24, 2016.

During the meeting, EPA solicited public comment in particular on the following five issues:

1. To be able to defray 25 percent of costs of administering Sections 4, 5 and 6, and Confidential Business Information (CBI), does industry have considerations of weight amongst the three areas of fee collection?
2. Does industry have thoughts on the types of factors (types of submissions, numbers of submissions, level of difficulty, etc.) that EPA should consider when structuring the fees?
3. Has industry considered how to distribute payment amongst multiple manufacturers and/or processors?
4. Does industry have thoughts on how to identify the whole universe of manufacturers, including importers and processors affected?
5. Does industry have thoughts on how to arrive at an appropriate balance between manufacturers and processors?

In its presentation, EPA stated that it intends to publish a proposed rule by mid-December 2016, and a final rule in time for its statutory June 22, 2017, deadline.

Four industry trade associations gave prepared remarks during the meeting:  the American Chemistry Council; the American Petroleum Institute; the Society of Chemical Manufacturers and Affiliates; and the American Fuel & Petrochemical Manufacturers.  Their comments reflected several common but competing themes, including:

• EPA needs to share its expectations of internal costs as a starting point for discussions of the fee structure.
• The fee system should be straightforward to implement.
• EPA should be mindful in developing a fee structure so as not to stifle innovation; for example, placing too high of fees for review of new chemistries under Section 5 or confidentiality claims under Section 14.
• Not all sections should be given equal weight; in particular, as industry will pay for Section 4 data development, it should not be double-charged by assessing a fee for EPA’s review of these data.
• EPA must provide adequate consideration for the effect on small businesses.
• Consideration should be given to incremental fees, tied to EPA milestones.
• A business should have a way to exit from a Section 6 risk evaluation process if it elects to exit the market.

Commentary

Congress recognized that the new TSCA tasks EPA with significant additional responsibilities, and included Section 26 as a venue to ensure adequate resources would be available to develop the infrastructure to meet these responsibilities according to the specified timelines and in conformity with sound science.  Input from all affected stakeholders will be needed to devise a workable TSCA fee system, particularly in the compressed timeframe for rule development. 

EPA and industry stakeholders are supportive of a simple framework, but the complexities and current unknowns of how new TSCA will operate will make this goal challenging.  Many questions exist that will not be answered before next week’s comment deadline:

1. Should a company have to pay fees for a Section 6 risk evaluation on uses that it does not support? 
2. Should there be fees associated with Section 6 prioritization actions?  If not, does that mean that only high priority chemicals will have Section 6 fees assessed on them? 
3. Given the new threshold for affirmative findings under Section 5, will EPA complete the same number of new chemical notifications that it has in the past?  If not, should that anticipated reduction in notification reviews be reflected in the fees proposal? 
4. Most industry stakeholders recognize that the current PMN fee of $2,500 will be increased, but how much is too much?   
5. As previously noted, is it appropriate to require industry to pay for testing under Section 4, and then charge for EPA review of that test data? 
6. To ensure that sufficient funds are raised, will we need to assess a fee for every “touch” that EPA has within Sections 4, 5, and 6?  How can that cost be fairly allocated among all industry players, including small businesses?

While EPA did not offer to share information on budgets at the August 11, 2016, meeting, the Office of Pollution Prevention and Toxics (OPPT) presumably has pertinent information supporting its annual budgets that must be shared in the near term if it hopes to receive any meaningful ideas on a proposed fee structure.  Although past program outputs done under old TSCA may bear little resemblance to the duties EPA now has under new TSCA, EPA’s new policies and responsibilities will be some scale of past program capabilities and budget.

Of more relevance will be the experience of OPPT’s sister program, the Office of Pesticide Programs (OPP).  OPP has had a dedicated stream of user fees since the 1988 amendments to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and additional fees were imposed in 2004 with enactment of the Pesticide Registration Improvement Act (PRIA) fee-for-service program.  While the FIFRA product licensing program is different in many respects from TSCA, there are relevant commonalities that OPPT should find helpful.  OPP has a time accounting system, for example, that provides a principled basis on which to estimate the time required for study report review and risk evaluation. 

With estimates derived from the time accounting system, OPP (and presumably OPPT) can estimate how much it costs EPA to review toxicity studies individually.  For example, there is an estimate of how much it costs EPA to review a 90-day subchronic study, or how much to review a genotoxicity study. These calculations form the basis of the PRIA fee scheme, as PRIA is designed to generate one-third of the program costs involved.  The “simple” general rule underlying a now elaborate fee schedule with almost 200 categories is that the more science review involved, the greater the required fee.  The new law may not need or want to have so many different categories, but the operating principle can remain the same.

For OPPT, the dollar amounts could vary from OPP given the statutory limitation of the maximum amount to be generated, but the more difficult question will be how OPPT calculates its expected workload under the new law.  Given the wealth of information available through OPP’s experience, sharing this information would further inform the public about what to expect in, or options for how to fashion, a fee scheme.

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