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.
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By Lynn L. Bergeson and Carla N. Hutton
 
On March 5, 2020, the U.S. Environmental Protection Agency (EPA) announced that it is seeking grant applications through the Source Reduction Assistance Grant Program from states, federally recognized tribes, universities, local governments, and other groups to support innovative solutions for source reduction or pollution prevention (P2) through research, education, training, or certain other methods.  EPA notes that as it highlights chemical safety during the month of March, “these grants support that goal by providing information, training, and tools to improve public health and the surrounding environment, reduce pollutants, and decrease resource use (e.g., water and energy).”  EPA anticipates awarding individual grants in the range of $20,000 - $200,000 for a two-year funding period (or between $10,000 - $100,000 per year), though award amounts may vary based on EPA region.  EPA anticipates awarding 20 grants in total.  EPA states that grant applications should focus on at least one of the following P2 priority areas, also referred to as National Emphasis Areas (NEA) that support several of the EPA’s Smart Sectors.  Through these grants, technical assistance and projects should encourage businesses to identify, develop, and adopt P2 practices and reduce waste in the following sectors:

  • Food and Beverage Manufacturing and Processing (NEA #1);
  • Chemical Manufacturing, Processing, and Formulation (NEA #2);
  • Automotive Manufacturing and Maintenance (NEA #3);
  • Aerospace Product and Parts Manufacturing and Maintenance (NEA #4); and
  • Metal Manufacturing and Fabrication (NEA #5).

Proposals are due by April 30, 2020.  Additional information is available on www.grants.gov, under Funding Opportunity Announcement EPA-HQ-OPPT-2020-002.

 

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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.”


 
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By Lynn L. Bergeson and Carla N. Hutton
 
On March 5, 2020, the U.S. Environmental Protection Agency (EPA) announced that it issued a final rule to add two strains of microorganisms to the list of microorganisms eligible for an exemption from certain reporting requirements under the Toxic Substances Control Act (TSCA).  EPA states that manufacturers of new intergeneric Trichoderma reesei (strain QM6a) and Bacillus amyloliquefaciens (subspecies amyloliquefaciens) may now be eligible to undergo a streamlined review process under TSCA’s new chemicals review program with reduced TSCA fees.  The final rule is intended to ensure the safety of human health and the environment while reducing regulatory burden for the biotechnology industry.
 
EPA states that after reviewing all relevant health and safety data, it determined that the two microorganisms can be added to the list of microorganisms eligible for exemption.  Under TSCA, manufacturers of a new intergeneric microorganism may be eligible to submit an exemption request in lieu of a microbial commercial activity notice (MCAN) if the organism is on the list of species eligible for an exemption and meets other criteria.  EPA is including these two microorganisms on the list because it determined that the microorganisms “will not present an unreasonable risk of injury to health or the environment provided that the other criteria relating to the introduced genetic material and the physical containment of the new microorganisms have been met.”
 
According to EPA, both microorganisms have a long history of safe use to produce a variety of commercial enzymes used in industrial and food-related industries.  Trichoderma reesei is used by the animal feed, baking, beverages, textile processing, detergent, pulp and paper, industrial chemicals, and biofuels industries.  Bacillus amyloliquefaciens has been used to produce commercial enzymes for more than 50 years.  It produces carbohydrases, proteases, nucleases, xylanases, and phosphatases that have applications in the food, brewing, distilling, and textile industries.
 
The final rule will be effective 30 days after publication in the Federal Register.


 
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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.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
On March 3, 2020, the U.S. Environmental Protection Agency (EPA) published in the Federal Register a proposed supplemental significant new use rule (SNUR) issued under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for long-chain perfluoroalkyl carboxylate (LCPFAC) chemical substances to make inapplicable the exemption for persons who import a subset of LCPFAC chemical substances as part of surface coatings on articles.  85 Fed. Reg. 12479.  Under the proposed supplemental SNUR, this subset of LCPFAC chemical substances also includes the salts and precursors of these perfluorinated carboxylates.  The supplemental proposal would require importers to notify EPA at least 90 days before commencing the import of these chemical substances in certain articles for the significant new use described in the proposed SNUR.  The required significant new use notification would initiate EPA’s evaluation of the conditions of use associated with the intended significant new use.  Manufacturing (including import) or processing for the significant new use would be prohibited from commencing 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.  Comments on the proposed supplemental SNUR are due April 17, 2020.  More information is available in our February 28, 2020, memorandum, “Proposed Supplemental SNUR Would Remove Exemption for LCPFAC Chemical Substances Used as Surface Coatings on Articles.”

 

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By Lynn L. Bergeson and Carla N. Hutton
 
Effective March 15, 2020, Madison Le will join the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) as Director of the Chemical Control Division (CCD).  Ms. Le will replace Acting Director Lynn Vendinello.  Ms. Le is currently Director of the Fuels Compliance Policy Center within the Office of Air and Radiation.  In that capacity, Ms. Le manages the implementation of EPA’s national fuels programs, including the Renewable Fuel Standard Program, Tier 3 Gasoline, Ultra-Low Sulfur Diesel, and Fuels and Fuel Additives Registration.  Prior to working for EPA, Ms. Le worked for California’s Los Angeles County on engineering design projects for municipal solid waste landfills and wastewater treatment plants, including air quality modeling and permitting for stationary and mobile sources.  Ms. Le holds an M.S. and B.S. in Environmental Engineering from the University of Southern California.


 
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By Lynn L. Bergeson and Carla N. Hutton

On February 28, 2020, the U.S. Environmental Protection Agency (EPA) announced that, in support of President Trump’s (R) Executive Order to promote transparency, EPA launched a new guidance portal that provides public access to its guidance documents.  According to EPA, the new searchable database will make it easier for the regulated community to find and follow agency guidance.  On October 9, 2019, President Trump issued Executive Order 13891, Promoting the Rule of Law Through Improved Agency Guidance Documents, to promote transparency by ensuring that all active guidance documents are made available to the public.  The portal provides an indexed database that allows the public to search for documents based on a range of criteria that include date of issuance, general subject matter, and summary of contents.  EPA states that prior to the launch of the portal, it conducted an exhaustive review of its current guidance documents and withdrew those documents that it determined to be no longer relevant.  The guidance portal provides a mechanism for the public to request modification or withdrawal of any documents.  EPA notes that it uses guidance documents “to clarify existing obligations for interested parties, but not as a vehicle for implementing new, binding requirements on the public.”  According to EPA, it will release by August 28, 2020, a regulation that establishes the processes and procedures for issuance of new guidance documents.

 

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By Lynn L. Bergeson and Carla N. Hutton
 
The Office of Inspector General (OIG) for the U.S. Environmental Protection Agency (EPA) announced on February 27, 2020, that it plans to begin its audit of the EPA’s Toxic Substances Control Act (TSCA) Service Fee Fund financial statements for the period from inception, June 22, 2016, to September 30, 2018.  According to the Project Notification, the audit objectives are to determine whether:

  1. The financial statements are fairly presented in all material respects in accordance with generally accepted accounting principles;
  2. EPA’s internal control structure over financial reporting related to the financial statements is in place and provides reasonable assurance that:
    • Financial transactions are executed in compliance with applicable laws, regulations, contracts, and grant agreements;
    • Assets are safeguarded against loss from unauthorized acquisition, use, or disposition; and
    • Transactions are properly recorded, processed, and summarized to permit the preparation of reliable financial statements;
  3. EPA has complied with laws and regulations that would have a direct and material effect on the financial statements; and
  4. The information and manner of presentation contained in the Management’s Discussion and Analysis, and any other accompanying information, are materially consistent with the information contained in the principal statements.

OIG states that the Frank R. Lautenberg Chemical Safety for the 21st Century Act requires that the annual audit of the financial statements also include:

  1. An analysis of the fees collected and amounts disbursed;
  2. The reasonableness of the fees in place as of the date of the audit to meet current and projected costs of administering the provisions of the law; and
  3. The number of requests for a risk evaluation made by manufacturers.

OIG notes that since fees have not been collected, however, it does not anticipate work in this area for the financial statements for the period from inception, June 22, 2016, to September 30, 2018.

 

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Tags: Fees, Audit, OIG

 
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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.

 

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) released on February 20, 2020, a proposed supplemental significant new use rule (SNUR) issued under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for long-chain perfluoroalkyl carboxylate (LCPFAC) chemical substances to make inapplicable the exemption for persons who import a subset of LCPFAC chemical substances as part of surface coatings on articles.  Under the proposed supplemental SNUR, this subset of LCPFAC chemical substances also includes the salts and precursors of these perfluorinated carboxylates.  The supplemental proposal would require importers to notify EPA at least 90 days before commencing the import of these chemical substances in certain articles for the significant new use described in the proposed SNUR.  The required significant new use notification would initiate EPA’s evaluation of the conditions of use associated with the intended significant new use.  Manufacturing (including import) or processing for the significant new use would be prohibited from commencing 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 posted a pre-publication version of the proposed supplemental SNUR on its website.  Once EPA publishes the proposed supplemental SNUR in the Federal Register, a 45-day comment period will begin.
 
In a January 21, 2015, proposed LCPFAC SNUR, EPA proposed to require notification of significant new uses from persons who import a subset of LCPFAC chemical substances as part of all articles.  The supplemental proposal narrows the category of articles to which the proposed LCPFAC SNUR would apply to those where the subset of LCPFAC chemicals are part of a surface coating.  EPA states that it is proposing this action to be responsive to the article consideration provision at Section 5(a)(5), added with the passage of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which states that 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.
 
More information on the supplemental proposal will be available in a forthcoming memorandum that will be posted on our website.

 

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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


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) released on February 19, 2020, a final rule concerning the process companies must follow to make certain confidential business information (CBI) claims and EPA’s plan for reviewing those claims.  EPA describes its final rule as creating “an efficient process” for fulfilling the CBI requirements under the Toxic Substances Control Act (TSCA) and providing clarity for affected stakeholders.  Following the procedures set forth in the final rule, EPA states that it will review CBI claims made for chemical substance identity for chemicals on the “active” portion of the TSCA Inventory.  These procedures and requirements are intended to help ensure that when a company claims the identity of a chemical as CBI, that claim meets the criteria laid out in TSCA.
 
The final rule is a follow-on to EPA’s 2017 TSCA Inventory Notification (Active-Inactive) Rule and amends certain substantiation provisions of that rule in response to a recent federal court decision.  The final rule applies to manufacturers and processors who made CBI claims for specific chemical identities for chemicals reported as “active” in response to the TSCA Inventory (Active-Inactive) Notification Rule.  The final rule describes the procedures and deadlines for substantiating these CBI claims, including provisions for supplementing certain previously filed substantiations.
 
The final rule also describes EPA’s plan to review these CBI claims for “active” chemicals, including procedures for its publication of annual review goals and results.  Manufacturers that amend, update, or file new CBI substantiations consistent with the new requirements must do so electronically via EPA’s Central Data Exchange.  According to EPA, providing this information electronically supports more efficient data transmittal, improves data quality, and minimizes respondent burden and EPA administrative costs associated with information submission and recordkeeping.
 
More information on the final rule will be available in a forthcoming memorandum that will be posted on our website.  Information on EPA’s 2017 TSCA Inventory Notification (Active-Inactive) Rule is available in our June 26, 2017, memorandum, “EPA Issues Final TSCA Framework Rules.”

 

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Tags: CBI, Inventory

 
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By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our October 1, 2019, blog item, 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.  According to OMB’s website, OMB completed its review on February 14, 2020.  EPA has not yet publicly released the proposed rule.
 
According to the item on the rulemaking in EPA’s fall 2019 Unified Agenda, EPA is developing a supplemental proposal to its 2015 proposed LCPFAC SNUR amendments.  EPA states that the supplemental proposal would 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 Section 5(a)(5) of the Toxic Substances Control Act (TSCA) 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.

 

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Tags: OMB, SNUR, PFAS, LCPFAC

 
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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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