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 a Federal Register notice on March 23, 2020, announcing that the EPA Safer Choice program is accepting submissions for its 2020 Safer Choice Partner of the Year Awards.  85 Fed. Reg. 16334.   EPA states that it developed the Partner of the Year Awards to recognize the leadership contributions of Safer Choice partners and stakeholders who, over the past year, have shown achievement in the design, manufacture, selection, and use of products with safer chemicals, furthering outstanding or innovative source reduction.  All Safer Choice stakeholders and program participants in good standing are eligible for recognition.  Interested parties who would like to be considered for this award should submit to EPA information about their accomplishments and contributions during 2019.  EPA notes that there is no form associated with this year’s application.  EPA will recognize award winners at a Safer Choice Partner of the Year Awards ceremony that is being planned for fall 2020.  Submissions are due May 31, 2020.


 

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
 

The U.S. Environmental Protection Agency (EPA) announced on March 11, 2020, the availability of the latest Toxic Substances Control Act (TSCA) Inventory.  EPA states that this biannual update to the public TSCA Inventory is part of its regular posting of non-confidential TSCA Inventory data.  According to EPA, this update adds 81 new chemicals, and the Inventory as a whole now contains 86,405 chemicals of which 41,484 are active in U.S commerce.  Other updates to the TSCA Inventory include:

  • Updates to commercial activity data, or active/inactive status;
  • Updated regulatory flags, such as consent orders and significant new use rules (SNUR); and
  • Additional unique identifiers.

EPA notes that the TSCA inventory is a list of all existing chemical substances manufactured, processed, or imported in the United States that do not qualify for an exemption or exclusion under TSCA.  More information on the TSCA Inventory is available on EPA’s website.

 

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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 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.


 

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
 
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.

 

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


 

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.
 
The courses were developed and are presented by members of B&C’s renowned TSCA practice group, which includes five former senior EPA officials; an extensive scientific staff, including seven Ph.D.s; and a robust and highly experienced team of lawyers and non-lawyer professionals extremely well versed in all aspects of TSCA law, regulation, policy, compliance, and litigation.
 
Online courses are offered at $100 for one-hour modules and $200 for 2-hour modules, or $1,400 for the full 12-module training.  Courses can be completed at the learner’s own pace, and enrollment is valid for one full year.  Interested professionals should visit www.TSCAtutor.com to view sample course segments and purchase modules.  Volume discounts are available for companies wishing to purchase courses for multiple employees.  Companies interested in live in-person or customized live webinar training should contact .(JavaScript must be enabled to view this email address) to schedule.
 
For more information about TSCA Tutor™, contact Heidi Lewis at .(JavaScript must be enabled to view this email address), or read our full course descriptions here.
 
TSCA Tutor -- Curriculum


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.


 

By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our December 20, 2019, blog item, the U.S. Environmental Protection Agency (EPA) released on December 20, 2019, an updated version of the “Working Approach” document that builds upon EPA’s November 2017 “New Chemicals Decision-Making Framework:  Working Approach to Making Determinations under Section 5 of TSCA.”  On January 2, 2020, EPA published a Federal Register notice announcing the availability of the updated document and beginning a 45-day comment period.  85 Fed. Reg. 99.  Comments are due February 18, 2020.
 
The updated document explains its approach for making one of the five affirmative determinations on new chemical notices under the Toxic Substances Control Act (TSCA):

  • The chemical or significant new use presents an unreasonable risk of injury to health or the environment;
  • Available information is insufficient to allow EPA to make a reasoned evaluation of the health and environmental effects associated with the chemical or significant new use;
  • In the absence of sufficient information, the chemical or significant new use may present an unreasonable risk of injury to health or the environment;
  • The chemical is or will be produced in substantial quantities and either enters or may enter the environment in substantial quantities or there is or may be significant or substantial exposure to the chemical; or
  • The chemical or significant new use is not likely to present an unreasonable risk of injury to health or the environment.

EPA notes that the updated document reflects feedback from a 2017 public meeting and comment period and EPA’s additional experience implementing the 2016 amendments to TSCA Section 5, and includes:

  • Additional clarification and detail throughout;
  • General guiding principles and concepts for making determinations;
  • Decision-making logic and key questions that EPA must address; and
  • Example applications of the Working Approach to reach each of the affirmative determinations under TSCA Section 5(a)(3).

EPA has posted a document summarizing public comments received on the 2017 document and its responses.  More information is available in our December 20, 2019, memorandum, “EPA Releases Updated Version of ‘Working Approach’ Document for New Chemicals Review.”


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) released on December 20, 2019, an updated version of the “Working Approach” document that builds upon EPA’s November 2017 “New Chemicals Decision-Making Framework:  Working Approach to Making Determinations under Section 5 of TSCA.”  EPA discussed the updated document, “TSCA New Chemical Determinations:  A Working Approach for Making Determinations under TSCA Section 5,” at a public meeting on December 10, 2019.  EPA states that the updated document explains its approach for making one of the five affirmative determinations on new chemical notices under the Toxic Substances Control Act (TSCA):

  • The chemical or significant new use presents an unreasonable risk of injury to health or the environment;
  • Available information is insufficient to allow EPA to make a reasoned evaluation of the health and environmental effects associated with the chemical or significant new use;
  • In the absence of sufficient information, the chemical or significant new use may present an unreasonable risk of injury to health or the environment;
  • The chemical is or will be produced in substantial quantities and either enters or may enter the environment in substantial quantities or there is or may be significant or substantial exposure to the chemical; or
  • The chemical or significant new use is not likely to present an unreasonable risk of injury to health or the environment.

EPA notes that the updated document reflects feedback from a 2017 public meeting and comment period and EPA’s additional experience implementing the 2016 amendments to TSCA Section 5, and includes:

  • Additional clarification and detail throughout;
  • General guiding principles and concepts for making determinations;
  • Decision-making logic and key questions that EPA must address; and
  • Example applications of the Working Approach to reach each of the affirmative determinations under TSCA Section 5(a)(3).

EPA has posted a document summarizing public comments received on the 2017 document and its responses.  Upon publication in the Federal Register, EPA will accept comment on the updated document for 45 days in docket EPA-HQ-OPPT-2019-0684 at https://www.regulations.gov.  More information will be available in a forthcoming memorandum that will be posted on our website.


 
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