The Biobased and Renewable Products Advocacy Group (BRAG) helps members develop and bring to market their innovative biobased and renewable chemical products through insightful policy and regulatory advocacy. BRAG is managed by B&C® Consortia Management, L.L.C., an affiliate of Bergeson & Campbell, P.C.

By Lynn L. Bergeson

The U.S. Environmental Protection Agency (EPA) announced on March 25, 2020, that it will consider a proposed rule that would look at providing 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

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 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.

Tags: TSCA, SACC

 

By Lynn L. Bergeson

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-CDR web 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, TSCA

 

By Lynn L. Bergeson

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.


 

By Lynn L. Bergeson

On March 6, 2020, EPA published its final rule on procedures for review of confidential business information (CBI) claims made under TSCA. 85 Fed. Reg. 13062. The final rule includes the requirements for regulated entities to substantiate certain CBI claims made under TSCA to protect the specific chemical identities of chemical substances on the confidential portion of the TSCA Inventory, and EPA’s plan for reviewing certain CBI claims for specific chemical identities. EPA sets out the review criteria and related procedures that it will use to complete the reviews within the five-year time frame set in TSCA. The substantiation requirements describe the applicable procedures and provide instructions for regulated entities. The final rule is effective on May 5, 2020. For more information, please read the full B&C memorandum.

Tags: CBI, TSCA

 

By Lynn L. Bergeson

On March 10, 2020, 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 April 9, 2020.


 

By Lynn L. Bergeson

On March 11, 2020, EPA announced the availability of the latest 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 exemption or exclusion under TSCA. More information on the TSCA Inventory is available on EPA’s website.


 

By Lynn L. Bergeson

On March 6, 2020, EPA announced via the Federal Register its final rule on requirements for regulated entities to substantiate certain confidential business information (CBI) made under TSCA. The substantiation requirements describe the applicable procedures and provide instructions for regulated entities, providing the review criteria and related procedures that EPA will use to complete the reviews within the five-year time frame set in TSCA. The final rule will be effective on May 5, 2020.

Tags: TSCA, CBI

 

By Lynn L. Bergeson

On February 19, 2020, the U.S. Environmental Protection Agency (EPA) released its review plan for certain confidential business information (CBI) claims under the Toxic Substances Control Act (TSCA). Aiming to provide clarity for affected stakeholders and efficiently fulfill CBI requirements under TSCA, EPA will review CBI claims made for chemical substance identity for chemicals on the “active” portion of the TSCA Inventory. The final rule is a follow-on to the 2017 TSCA Inventory Notification (Active-Inactive) Rule, amending certain substantiation provisions in response to a federal court decision. Chemical manufacturers and/or processors who have made CBI claims for specific chemical identities listed as “active” substances must follow the final process released by EPA. The final review plan describes the procedures and deadlines for substantiating CBI claims, including provisions for supplementing certain previously filed substantiations. It is important to note that manufacturers that amend, update, or file new CBI substantiations consistent with the new requirements must do so electronically via EPA’s Central Data Exchange (CDX) system.

Tags: CBI, TSCA

 

By Lynn L. Bergeson

Federal enforcement of chemical product laws is alive and well, despite a broadly held misconception to the contrary. We have seen over the past 18 months or so an uptick in federal enforcement under the Toxic Substances Control Act (TSCA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Bergeson & Campbell, P.C. (B&C®) writes to alert stakeholders of this fact. B&C believes that this trend will continue in 2020. Check out its memorandum on the topic here.

Tags: TSCA, FIFRA

 
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