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 Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published the draft risk evaluation of asbestos on March 30, 2020.  EPA reviewed a suite of potential asbestos exposures and made the following initial determinations on risk:

  • EPA did not find risk to the environment.  For all the conditions of use included in the draft risk evaluation, EPA has preliminarily found no unreasonable risks to the environment under any of the conditions of use.
     
  • EPA’s draft risk evaluation preliminarily found unreasonable risk to workers, occupational non-users, consumers, and bystanders.  EPA found that workers, occupational non-users, consumers, and bystanders could be adversely affected by asbestos under certain conditions of use.

EPA states that these initial determinations are based on a draft risk evaluation of the reasonably available information and are not final determinations on whether asbestos presents unreasonable risks under the conditions of use.  EPA will use feedback received from the public comment and peer review processes to inform the final risk determinations.


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on March 25, 2020, that it will consider a proposed rule that would look at potential exemptions to the Toxic Substances Control Act (TSCA) fees rule in response to stakeholder concerns about implementation challenges.  EPA states that by considering a proposal to narrow the broad scope of the current requirements, it “could significantly reduce burden on potentially thousands of businesses across the country while maintaining the ability to successfully implement the Lautenberg Act amendments” to TSCA to protect human health and the environment.  According to EPA, it plans to initiate a new rulemaking process to consider proposing 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; or
  • Produce or import the chemical substance as an impurity.

EPA states that it may also consider proposing other changes to the rule during this process consistent with TSCA’s requirement to reevaluate the fees rule every three years.  EPA notes that it believes that considering exempting certain entities from self-identification requirements will not impede the ability to collect fully the necessary fees and will still allow it to achieve the ultimate objective of the TSCA fees rule and the statute -- “to defray a portion of EPA’s TSCA implementation costs.”  EPA intends to issue proposed amendments to the current fees rule later in 2020, with the goal of promulgating the amendments in 2021.

EPA states that additionally, “in light of the extremely unusual circumstances of this situation and the undue hardship imposed on certain businesses who would be required to collect and report information” under the TSCA fees rule, EPA issued a “no action assurance” for the three categories of manufacturers at this time.  More specifically, EPA “will exercise its enforcement discretion regarding the self-identification requirement for the three categories of manufacturers” for which EPA intends to propose an exemption.

EPA suggests that businesses that are erroneously on the preliminary lists of fee payers or fall into one of the three categories discussed above should see its frequently asked questions (FAQ) for more information about how to certify as such to EPA and to avoid fee obligations.  EPA posted more information on its announcement, as well as a copy of the no-action assurance, on its website.  More information is available in our March 9, 2020, blog item, “EPA Extends Deadline to Self-Identify as a Manufacturer or Importer of a High-Priority Chemical to May 27.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
In a Federal Register notice published on March 20, 2020, the U.S. Environmental Protection Agency (EPA) announced that the March 24-26, 2020, Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) meeting to review the draft risk evaluation for trichloroethylene (TCE) is being changed to a virtual public meeting.  85 Fed. Reg. 16096.  Participation will be by telephone and webcast only.  EPA states the meeting times and dates have been adjusted, and that the meeting will be held on March 24-27, 2020, from 10:00 a.m. to approximately 5:00 p.m. (EDT).  EPA asks that stakeholders who want to make oral comments register by noon on March 20, 2020.  Stakeholders must register online to receive the webcast meeting link and audio teleconference information for participation.


 

Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®), sat down with Dr. Richard Engler, Director of Chemistry at B&C, to bring everyone up to date on the U.S. Environmental Protection Agency’s (EPA) implementation of the Toxic Substances Control Act (TSCA) fee rule and how it applies to entities obligated to pay a portion of the $1,350,000 per chemical fee for preparing an EPA-initiated risk evaluation, the legal and regulatory significance of the supplemental rulemaking on long-chain perfluoroalkyl carboxylate (LCPFAC) chemicals and the precedent it sets for eliminating the article exemption for imported articles containing these substances, and the significance of the recently updated TSCA Chemical Inventory with regard to the fast-approaching Chemical Data Reporting (CDR) cycle.  As always, Rich is a font of information on these topics, and he does a great job of contextualizing this information for busy business people working in the chemical space.

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

©2020 Bergeson & Campbell, P.C.  All Rights Reserved


 

By Lynn L. Bergeson and Carla N. Hutton

On March 9, 2020, the U.S. Environmental Protection Agency (EPA) announced that it has extended the deadline to self-identify as a manufacturer or importer of a high-priority chemical to May 27, 2020.  EPA states that it is working to address issues identified with implementation of the Toxic Substances Control Act (TSCA) Fees Rule and EPA-initiated risk evaluations.  EPA “is actively seeking ways to address the many implementation impracticalities that have been brought to our attention and to reduce concerns by affected entities.”  During the extended comment period extension, EPA “will continue to receive input from the regulated community and analyze options to address some of the implementation challenges with the final rule and reduce stakeholder concerns.”  EPA will publish a Federal Register notice announcing the extension of the comment deadline.  A pre-publication version of the notice is available.

Background

As reported in our February 26, 2020, memorandum, on February 24, 2020, EPA hosted a conference call to review certain provisions of the final rule on fees for the administration of TSCA, particularly those related to EPA-initiated risk evaluations.  EPA published a Federal Register notice on January 27, 2020, identifying the preliminary lists of manufacturers (including importers) of the 20 high-priority chemical substances for risk evaluation for which fees will be charged.  85 Fed. Reg. 4661.  During the comment period, manufacturers (including importers) are required to self-identify as manufacturers of a high-priority substance irrespective of whether they are included on the preliminary lists identified by EPA.

Resources

Our March 4, 2020, memorandum, “EPA Plans to Provide Additional Clarification on Self-Identifying as a Manufacturer or Importer of a High-Priority Chemical,” suggests that industry stakeholders that believe they may be impacted by the January 27 notice may wish to consider suspending ongoing internal deliberations on self-reporting obligations until EPA provides additional guidance.

Information on forming a consortium is available in our March 2, 2020, memorandum, “The Essential Value of Forming TSCA Consortia.”

More information on the 20 substances designated as high-priority substances is available in our December 20, 2019, memorandum, “Final List of High-Priority Chemicals Will Be Next to Undergo Risk Evaluation under TSCA.”

More information on the final TSCA fees rule is available in our September 28, 2018, memorandum, “EPA Issues Final TSCA Fees Rule.”


 

On March 2, 2020, at ChemCon The Americas 2020 in Philadelphia, Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®), and Alexandra Dapolito Dunn, Assistant Administrator, EPA Office of Chemical Safety and Pollution Prevention, sat down with Tjeerd Bokhout to discuss the implementation of Lautenberg and what can be expected through 2020.  Ms. Dunn started off the discussion, noting that EPA is “getting our sea legs under us; we spent the first two or three years after enactment, really through 2019, setting up the bones of the program, the regulations, the structure, the fees rule, and now we’ve begun the deep process of looking at each chemical [for risk evaluation].” The conversation continued with discussion regarding how chemicals are selected for evaluation, surprises EPA encountered while making low-priority determinations, and what can be expected through the remainder of 2020.  Ms. Dunn and Ms. Bergeson agreed that as more chemicals go through this review process, the quantity and type of information needed will standardize, leading to more predictability for all stakeholders.  Now that a system is evolving, EPA plans to identify data gaps early to provide time to strategize how to acquire as much information as is required to evaluate properly a chemical on schedule and with minimal additional costs.

A full video of this informative interview, drawing back the curtain on both EPA and industry’s experience with the implementation of TSCA and details on what to prepare for in the near future, is available to stream now.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register on February 26, 2020, announcing the availability of the draft risk evaluation for trichloroethylene (TCE), “a chemical used as a solvent and an intermediate for refrigerant manufacture in industrial and commercial processes, and with limited consumers uses like as a spot cleaner in dry cleaning facilities.”  85 Fed. Reg. 11079.  EPA assessed 54 conditions of use of TCE, and the draft risk evaluation includes the following findings:

  • EPA did not find risk to the environment; and
  • EPA’s draft risk evaluation preliminarily found unreasonable risk associated with dermal and inhalation exposure for workers, occupational non-users, consumers, and bystanders.

EPA notes that the draft risk evaluation and the initial risk determinations are not a final action.  The draft represents EPA’s preliminary conclusions, findings, and determinations on TCE and will be peer reviewed by independent scientific experts.  According to EPA, the draft risk evaluation includes input from other EPA offices, as well as other federal agencies.
 
The TSCA Science Advisory Committee on Chemicals (SACC) will meet March 24-26, 2020, to peer review the draft risk evaluation of TCE’s conditions of use.  EPA asks that comments on the draft risk evaluation be submitted by March 18, 2020, to allow SACC time to review and consider them before the peer review meeting.  EPA states that comments received after March 18, 2020, and prior to the end of the oral public comment period during the meeting will still be provided to SACC for their consideration.  EPA will hold a preparatory virtual meeting on March 3, 2020, for SACC and the public to comment on the clarity and scope of the draft charge questions for the March 24-26, 2020, meeting.
 
Comments on the draft risk evaluation are due April 27, 2020.  More information on the draft risk evaluation is available in our February 26, 2020, memorandum, “EPA Releases Draft Risk Evaluation for TCE, Announces SACC Peer Review Meeting.”

 

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) released on February 21, 2020, the draft risk evaluation for trichloroethylene (TCE), “a chemical used as a solvent and an intermediate for refrigerant manufacture in industrial and commercial processes, and with limited consumers uses like as a spot cleaner in dry cleaning facilities.”  EPA assessed 54 conditions of use of TCE, and the draft risk evaluation includes the following findings:

  • EPA did not find risk to the environment; and
  • EPA’s draft risk evaluation preliminarily found unreasonable risk associated with dermal and inhalation exposure for workers, occupational non-users, consumers, and bystanders.

EPA notes that the draft risk evaluation and the initial risk determinations are not a final action.  The draft represents EPA’s preliminary conclusions, findings, and determinations on TCE and will be peer reviewed by independent scientific experts.  According to EPA, the draft risk evaluation includes input from other EPA offices, as well as other federal agencies.
 
The TSCA Science Advisory Committee on Chemicals (SACC) will meet on March 24-26, 2020, to peer review the draft risk evaluation of TCE’s conditions of use.  EPA asks that comments on the draft risk evaluation be submitted by March 18, 2020, to allow SACC time to review and consider them before the peer review meeting.  EPA states that comments received after March 18, 2020, and prior to the end of the oral public comment period during the meeting will still be provided to SACC for their consideration.  EPA will hold a preparatory virtual meeting on March 3, 2020, for SACC and the public to comment on the clarity and scope of the draft charge questions for the March 24-26, 2020, meeting.
 
EPA will publish a notice in the Federal Register announcing the availability of the draft risk evaluation and beginning a 60-day comment period.  More information on the draft risk evaluation will be available in a forthcoming memorandum that will be posted on our website.

 

Try our new TSCA Tutor™ online e-training platform, offering expert, efficient, essential TSCA training.


 

By Lynn L. Bergeson and Carla N. Hutton

On February 20, 2020, the U.S. Environmental Protection Agency (EPA) published a list of 20 chemical substances identified as low-priority for risk evaluation under the amended Toxic Substances Control Act (TSCA), completing another TSCA requirement.  EPA notes that a final designation as “low-priority” means that risk evaluations are not warranted at this time.  EPA states that it considered reasonably available information for each chemical substance under its conditions of use as specified in TSCA.  Additionally, according to EPA, these 20 low-priority chemicals are on its Safer Chemical Ingredients List, which includes chemicals that meet strict criteria for both human health and the environment.  The 20 chemicals are

  1. 1-Butanol, 3-methoxy-, 1-acetate;
  2. D-gluco-Heptonic acid, sodium salt (1:1), (2.xi.)-;
  3. D-Gluconic acid;
  4. D-Gluconic acid, calcium salt (2:1);
  5. D-Gluconic acid, .delta.-lactone;
  6. D-Gluconic acid, potassium salt (1:1);
  7. D-Gluconic acid, sodium salt (1:1);
  8. Decanedioic acid, 1,10-dibutyl ester;
  9. 1-Docosanol;
  10. 1-Eicosanol;
  11. 1,2-Hexanediol;
  12. 1-Octadecanol;
  13. Propanol, [2-(2-butoxymethylethoxy)methylethoxy]-;
  14. Propanedioic acid, 1,3-diethyl ester;
  15. Propanedioic acid, 1,3-dimethyl ester;
  16. Propanol, 1(or 2)-(2-methoxymethylethoxy)-, acetate;
  17. Propanol, [(1-methyl-1,2-ethanediyl)bis(oxy)]bis-;
  18. 2-Propanol, 1,1'-oxybis-;
  19. Propanol, oxybis-; and
  20. Tetracosane, 2,6,10,15,19,23-hexamethyl-.

EPA has posted a pre-publication version of the Federal Register notice announcing the final designation of low-priority substances.  As reported in our December 20, 2019, blog item, in December 2019, EPA designated 20 chemicals as high-priority under TSCA, and those chemicals are now in the risk evaluation process.  More information on the final list of low-priority chemicals 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 host a conference call on February 24, 2020, from 12:30 to 1:00 p.m. (EST) to review certain provisions of the final rule on fees for the administration of the Toxic Substances Control Act (TSCA).  In light of the recent publication of the preliminary list of manufacturers/importers subject to risk evaluation fees, as reported in our January 29, 2020, blog item, EPA states that it will give a brief overview of the fees associated with an EPA-initiated risk evaluation, the entities subject to fees, requirements for self-identification, and how fees will be divided among those identified on final lists.  The publication of the lists has inspired considerable confusion and the call is intended to address as many as possible of them.  Questions can be submitted in advance to Ryan Schmit at .(JavaScript must be enabled to view this email address).  Additional questions will be answered as time permits.  To attend, call the following number and enter the conference ID:

Call-in Number: (877) 317-0679
Conference ID: 3372249

The preliminary list of manufacturers/importers subject to risk evaluation fees is available in Docket EPA-HQ-OPPT-2019-0677.  Reference 9 from the final rule on fees, TSCA Fee Reporting Notice (Sept. 2018), is available in the docket for the final rule at https://www.regulations.gov/document?D=EPA-HQ-OPPT-2016-0401-0079.  More information about TSCA fees is available on EPA’s website at http://www.epa.gov/TSCA-fees.


 
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