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

The U.S. Environmental Protection Agency (EPA) announced on March 26, 2020, a temporary policy regarding enforcement of environmental legal obligations during the COVID-19 pandemic.  EPA states that its temporary enforcement discretion policy applies to civil violations during the COVID-19 outbreak.  The policy addresses different categories of noncompliance differently.  For example, according to EPA, it “does not expect to seek penalties for noncompliance with routine monitoring and reporting obligations that are the result of the COVID-19 pandemic but does expect operators of public water systems to continue to ensure the safety of our drinking water supplies.”  The policy describes the steps that regulated facilities should take to qualify for enforcement discretion.  To be eligible for enforcement discretion, the policy requires facilities to document decisions made to prevent or mitigate noncompliance and demonstrate how the noncompliance was caused by the COVID-19 pandemic. 

EPA notes that its policy does not provide leniency for intentional criminal violations of law and that it does not apply to activities that are carried out under Superfund and Resource Conservation and Recovery Act (RCRA) Corrective Action enforcement instruments.  EPA states that it will address these matters in separate communications.  The policy states that it does not apply to imports.  According to the policy, EPA is “especially concerned about pesticide products entering the United States, or produced, manufactured, distributed in the United States, that claim to address COVID-19 impacts.”  EPA “expects to focus on ensuring compliance with requirements applicable to these products to ensure protection of public health.”

The policy will apply retroactively beginning on March 13, 2020.  EPA will assess the continued need for and scope of this temporary policy on a regular basis and will update it if EPA determines modifications are necessary.  To provide fair and sufficient notice to the public, EPA states that it will post a notification on its website at least seven days prior to terminating the temporary policy.


 
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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.”


 
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By Lynn L. Bergeson and Carla N. Hutton
 
Effective March 29, 2020, Yvette T. Collazo will be the new Director of the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT).  Ms. Collazo previously worked for the U.S. Department of Energy (DOE), where she led activities related to federal contracts and agreements of more than $250 million for the cleanup of radiological, industrial, and groundwater hazards resulting from decades of nuclear material production at DOE’s Savannah River facility.  Ms. Collazo also served as Senior Advisor and Director for the Office of Technology Innovation and Development at DOE’s Office of Environmental Management.  In this capacity, she led the identification and advancement of technologies, processes, and technical practices that improved the performance of waste processing, groundwater and soil, facility decontamination and decommissioning, and nuclear materials projects over their life cycles, from planning to disposal.  Starting in 2013, Ms. Collazo served as District Director of the U.S. Small Business Administration (SBA) Puerto Rico and Virgin Islands District Office.  As District Director, she was responsible for the delivery of the SBA’s financial assistance, business counseling, entrepreneurial training, and federal contracting programs throughout the District.  Ms. Collazo has a Master of Science in Environmental Management from the Illinois Institute of Technology and a Bachelor of Science in Mechanical Engineering from the University of Puerto Rico, Mayagüez Campus.

Tags: OPPT, Collazo

 
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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.


 
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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on March 20, 2020, inviting the public to nominate scientific experts from a diverse range of disciplines to be considered for appointment to the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC).  85 Fed. Reg. 16094.  EPA is seeking nominations of individuals who have demonstrated high levels of expertise in scientific and/or technical fields relevant to chemical safety and risk assessment, including, but not limited to:  human health and ecological risk assessment, biostatistics, epidemiology, pediatrics, physiologically based pharmacokinetics, toxicology and pathology, and the relationship of chemical exposures to women, children, and other potentially exposed or susceptible subpopulations.  In addition, nominees should have backgrounds and experiences that would contribute to the diversity of scientific viewpoints on the committee, including professional experiences in government, labor, public health, public interest, animal protection, industry, and other groups, as the EPA Administrator determines to be advisable (e.g., geographic location, social and cultural backgrounds, and professional affiliations).  Any interested person or organization may nominate qualified persons to be considered for appointment to SACC.  Individuals also may self-nominate.  The preferred method for submitting nominations is via e-mail to Steven Knott, the SACC’s Designated Federal Officer (.(JavaScript must be enabled to view this email address)).  Nominations are due no later than April 20, 2020.

Background
 
SACC serves as a primary scientific peer review mechanism of EPA’s Office of Chemical Safety and Pollution Prevention and is structured to provide independent scientific advice and recommendations to EPA on the scientific basis for risk assessments, methodologies, and pollution prevention measures and approaches for chemicals regulated under TSCA.

 
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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.


 
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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.

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


 
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By Lynn L. Bergeson and Carla N. Hutton
 
On March 17, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of a final rule amending the Chemical Data Reporting (CDR) rule.  According to EPA, the amendments are intended to reduce the burden for certain CDR reporters, improve the quality of CDR data collected, and align reporting requirements with the Frank R. Lautenberg Chemical Safety for the 21st Century Act’s (Lautenberg Act) amendments to the Toxic Substances Control Act (TSCA).  EPA states that some of the key revisions include:

  • Simplifying reporting, including allowing manufacturers to use certain processing and use data codes already in use by many chemical manufacturers as part of international codes developed through the Organization for Economic Cooperation and Development (OECD);
     
  • Updating requirements for making confidentiality claims to align with the requirements in amended TSCA; and
     
  • Adding reporting exemptions for specific types of byproducts manufactured in certain equipment.

Additionally, EPA is extending the reporting period for CDR data submitters from September 30, 2020, to November 30, 2020, to provide additional time for the regulated community to familiarize themselves with the amendments and to allow time for reporters to familiarize themselves with an updated public version of the reporting tool.  The reporting period will still begin on June 1, 2020.  EPA will host a webinar on Tuesday, March 31, 2020, to discuss the revised reporting requirements, provide an overview of the 2020 CDR submission period, and to give an introduction to the updated e-CDRweb reporting tool.  EPA has posted pre-publication versions of the final rules amending the CDR rule and extending the reporting period.  More information will be available in a forthcoming memorandum that will be posted on our website.

Tags: CDR, Reporting

 
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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 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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