By Lynn L. Bergeson and Carla N. Hutton
On March 23, 2022, the U.S. Environmental Protection Agency (EPA) held a webinar on “Biofuel Premanufacture Notices: New Chemical Risk Assessment and Applications of Tools and Models.” As reported in our January 24, 2022, blog item, in January 2022, EPA announced an effort to streamline the review of new biobased or waste-derived chemicals that could displace current, higher greenhouse gas (GHG)-emitting transportation fuels. EPA states that to support this effort, it is offering outreach and training to stakeholders interested in biofuels. According to EPA, the bi-weekly webinar series includes reviewing requirements under the Toxic Substances Control Act (TSCA), outlining the streamlined approaches for risk assessments and risk management actions, and providing information on how to navigate the new chemicals premanufacture notice (PMN) process. EPA provided background and outlined the following challenges for each risk assessment conducted:
- Chemistry Assessment:
- Fuel stream and related substances are broad in number and scope, especially with the addition of current biobased and waste feedstock blends; they can be class 1, class 2, or chemical substances of unknown or variable composition, complex reaction products, and biological materials (UVCB) substances;
- Many petroleum-derived fuel streams are on the original TSCA Inventory and there are very little data associated with them; and
- Complete characterization of the new chemical substance is often unavailable;
- Environmental Fate and Transport Assessment:
- Analysis of constituents may not represent the properties of the new chemical substance;
- Engineering Assessment: Environmental Releases:
- EPA’s release assessment analyzes each manufacturing, processing, and use operation and determines the sources/activities that can result in releases to the environment. These release estimates are used to estimate exposure estimates for ecological and human receptors;
- Examples of release data: (1) Measured release data; (2) Measured release data for a “surrogate” chemical; (3) Modeled release estimates; and
- Release estimates have limitations -- examples:
- Lack of appropriate model/method to estimate releases from specific industrial activities (e.g., storage tank emissions); and
- Limitation in certain release models (e.g., limited to a vapor pressure threshold of 35 torr);
- Engineering Assessment: Occupational Exposures:
- The occupational exposure assessment estimates the magnitude, frequency, and duration of exposures to the new chemical substance at the workplace;
- Worker inhalation and dermal exposures are expected throughout the lifecycle of the new chemical substance (e.g., manufacturing, processing, use); and
- Exposure models do not account for some engineering controls (vapor capture/reduction);
- Exposure Assessment: General Population and Consumer Exposures:
- The occupational exposure assessment estimates the magnitude, frequency, and duration of exposures to the new chemical substance for the general population and consumers via inhalation and drinking water pathways; and
- The confidence of the exposure estimates are affected by:
- Assumptions, limitations, and areas of uncertainty in the fate and engineering analyses; and
- Inherent uncertainties of the exposure parameters and assumptions for the estimation of the general population and consumer exposures;
- Hazard Assessment:
- Data on the new chemical substance or an analogous biofuel are preferred, but few submissions include toxicological or composition data;
- EPA often lacks acute/chronic environmental test data on the new chemical substance and the analogous substances; and
- There are challenges in performing read-across approaches and route-to-route extrapolations with analogous substances of variable composition.
For biofuel PMNs, EPA has started generating one report that combines the results of each of the above assessments. The final webinar in the series will be held April 6, 2022, on new chemicals risk management actions, including TSCA Section 5 orders and significant new use rules (SNUR).
By Lynn L. Bergeson and Carla N. Hutton
On February 25, 2022, the U.S. Environmental Protection Agency (EPA) announced that it is revoking the 1980 guidelines and associated procedures for correcting the specific chemical identities of incorrectly described chemical substances submitted to EPA in 1978 using the original reporting form for inclusion on the Toxic Substances Control Act (TSCA) Inventory. 87 Fed. Reg. 10781. EPA states that it is providing a final opportunity to use the 1980 guidelines and form to request corrections of Inventory listings to address errors with the chemical identities submitted in the original reporting forms. The regulated community will have until April 26, 2022, to submit any final Inventory corrections. EPA also announced the discontinuation of the related form and associated approval of the collection activities under the Paperwork Reduction Act (PRA). The revocation will be effective May 31, 2022. All final Inventory corrections must be received on or before April 26, 2022.
After April 26, 2022, EPA does not intend to accept requests to correct original Inventory reporting forms. If, after April 26, 2022, a person discovers for any reason an error in the specific chemical identity of a chemical substance submitted on an original Inventory reporting form, a premanufacture notice (PMN) or exemption notice may need to be filed if the chemical substance is not already listed on the TSCA Inventory.
EPA notes that this action does not impact its authority for initiating, at its discretion, corrections to the Inventory should EPA determine on its own that, for example, a chemical substance listed on the Inventory has been unintentionally misidentified. EPA states that only in this situation will it, at its discretion, request and accept documentation from a company to support an Inventory correction in lieu of requiring a PMN or exemption notice. This action also does not impact EPA’s regular maintenance of the Inventory that can include nomenclature updates and correcting minor errors to listings.
EPA’s unilateral decision seems ill-considered and unwise. At the least, EPA should seek comment from the TSCA stakeholder community to inform its judgment.
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency’s (EPA) New Chemicals Program will hold a webinar on Wednesday, February 23, 2022, from 2:00 to 3:00 p.m. (EST) to learn about requirements under the Toxic Substances Control Act (TSCA) and the premanufacture notice (PMN) process for biofuels. As reported in our January 24, 2022, blog item, in January 2022, EPA announced an effort to streamline the review of new biobased or waste-derived chemicals that could displace current, higher greenhouse gas (GHG)-emitting transportation fuels. EPA states that to support this effort, it is offering outreach and training to stakeholders interested in biofuels. According to EPA, the bi-weekly webinar series includes reviewing TSCA requirements, outlining the streamlined approaches for risk assessments and risk management actions, and providing information on how to navigate the new chemicals PMN process. Future webinars will include:
Registration is required for the February 23, 2022, webinar.
By Lynn L. Bergeson and Carla N. Hutton
On January 21, 2022, the U.S. Environmental Protection Agency (EPA) announced a new effort under the Toxic Substances Control Act (TSCA) to streamline the review of new chemicals that could be used to displace current, higher greenhouse gas (GHG) emitting transportation fuels. The Office of Chemical Safety and Pollution Prevention’s (OCSPP) New Chemicals Division (NCD) has implemented a “robust, consistent, and efficient process to assess the risk and apply mitigation measures, as appropriate, for substitutes to petroleum-based fuels and fuel additives that use biobased or waste-derived sources to produce biofuels.” EPA states that this effort supports its goals under the Renewable Fuel Standard (RFS) program, as well as its 2021 Climate Adaptation Action Plan. According to the announcement, EPA has received over 30 biofuel premanufacture notices (PMN) “that collectively describe plans for close to 800 million gallons per year of production of advanced biofuels, that could contribute to annual volume mandates under the RFS program and help support the goals of energy security through increasing domestic production” within the United States.
The announcement includes:
New Chemicals Division Integrated Approach to Biofuels
Under this effort, NCD formed a dedicated team to collaborate on the review of PMNs for biobased or waste-derived feedstocks used to make transportation fuel substitutes with the goals to use the best available science while creating a consistent and efficient review process. EPA states that NCD developed a standardized process for the way biofuel PMNs are reviewed. For example, the same dedicated team will be conducting reviews for all biofuels PMNs, helping to ensure the assessments and determinations are consistent and aligned with requirements. Further, NCD will generate one report for biofuels PMNs that combines the six different risk assessments typically conducted for PMNs, helping to provide a clearer summary explanation of how EPA conducted its assessment and made its determination.
For risk management actions, NCD will apply appropriate mitigation measures to address any potential for unreasonable risk identified in an efficient and consistent manner within TSCA consent orders and significant new use rules (SNUR).
Outreach and Training
According to the announcement, OCSPP is launching outreach and training for interested stakeholders in the biofuels sector to review TSCA requirements, outline the streamlined approaches for risk assessments and risk management actions, and provide information on how to navigate the new chemicals PMN process.
OCSPP will hold a kick-off meeting on February 9, 2022, to provide an overview of this initiative and answer questions from stakeholders. Registration for the meeting is open.
Other planned outreach and training related to this biofuels initiative include webinars on:
- TSCA requirements and the PMN process;
- The TSCA Inventory, nomenclature, and Bona Fide process;
- New chemicals risk assessments, including applications of the tools, models, and databases; and
- New chemicals risk management actions, including TSCA Section 5 orders and SNURs.
EPA states that it may add additional outreach and training sessions, including training opportunities applicable to all new chemical submitters, based on stakeholder interest and feedback.
Bergeson & Campbell, P.C. (B&C®) is pleased to provide our Forecast 2022 to TSCAblog® readers, offering our best informed judgment as to the trends and key developments we expect to see in the new year. In 2022, the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) will continue to focus on implementing the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) amendments to the Toxic Substances Control Act (TSCA), including the development of required risk evaluations and risk management actions on certain existing chemicals, review of and determinations on new chemical premanufacture notices (PMN), and issuance of a final rule requiring the reporting of hazard and exposure information on per- and polyfluoroalkyl substances (PFAS). In 2022, OPPT is also expected to initiate the prioritization for risk evaluation of certain chemicals to replace in the TSCA risk evaluation pipeline those “high-priority” chemicals for which risk evaluations may be completed in late 2022 or 2023. More details on this, and expected regulatory changes of all varieties, are available in our Forecast for U.S. Federal and International Chemical Regulatory Policy 2022.
“What to Expect in Chemicals in 2022”
January 26, 2022, 12:00 p.m. EST
B&C will be presenting a complimentary webinar, “What to Expect in Chemicals in 2022,” focusing on themes outlined in the forecast. Join Lynn L. Bergeson, Managing Partner; Richard E. Engler, Ph.D., Director of Chemistry; and James V. Aidala, Senior Government Affairs Consultant, for this informative and forward-looking webinar.
By Lynn L. Bergeson, Carla N. Hutton, and Holly M. Williams
On June 30, 2020, the Trump Administration released the Spring 2020 Unified Agenda of Regulatory and Deregulatory Actions for the U.S. Environmental Protection Agency (EPA.) According to the Unified Agenda, the Office of Chemical Safety and Pollution Prevention (OCSPP) is working on several rulemakings under the Toxic Substances Control Act (TSCA). Rulemakings at the proposed stage are listed below:
- Review of Dust-Lead Post-Abatement Clearance Levels. On June 24, 2020, EPA published a proposed rule that would lower the amount of lead that can remain in dust on floors and windowsills after lead removal activities (dust-lead clearance levels (DLCL)) from 40 micrograms (µg) of lead in dust per square foot (ft2) to 10 µg/ft2 for floor dust and from 250 µg/ft2 to 100 µg/ft2 for window sill dust. 85 Fed. Reg. 37810. Comments on the proposed rule are due August 24, 2020. EPA intends to publish a final rule in September 2020.
- Reporting and Recordkeeping for Certain Chemicals under TSCA Section 8(a). EPA is developing a rulemaking under TSCA Section 8(a) to add certain chemicals that are on the TSCA Work Plan to the Chemical-Specific Reporting and Recordkeeping rules in 40 C.F.R. Part 704, Subpart B. EPA is developing this rule to obtain information about potential hazards and exposure pathways related to certain chemicals on the TSCA Work Plan, particularly occupational, environmental, and consumer exposure information. EPA states that this information is needed to inform prioritization and risk evaluation of the chemical substances, as mandated under TSCA Section 6. EPA intends to issue a notice of proposed rulemaking (NPRM) in November 2020 and a final rule in June 2021.
- Revisions to the Fees Rule under TSCA. EPA is reviewing its 2018 final rule that established the requirements and procedures for setting and collecting fees from chemical manufacturers (including importers) and, in some cases, processors, submitters of new chemical substances, and others. TSCA Section 26(b)(4)(F) requires EPA to review and adjust the fees every three years and to consult with parties potentially subject to fees when the fees are reviewed and updated to reflect changes in program costs. EPA states that in addition to possible revisions resulting from this review, consistent with its announcement in March 2020, it will also consider proposing exemptions to the current rule’s self-identification requirements associated with EPA-initiated risk evaluations for manufacturers that: (1) import the chemical substance in an article; (2) produce the chemical substance as a byproduct; and (3) produce or import the chemical substance as an impurity. EPA intends to issue an NPRM in December 2020 and a final rule in October 2021. More information on EPA’s March 2020 announcement is available in our April 17, 2020, blog item.
- Updates to New Chemicals Procedural Regulations to Reflect the 2016 TSCA Amendments: EPA states that the 2016 amendments impacted how it reviews and makes determinations on new chemical notices under TSCA Section 5. EPA acknowledges that as a result of these increased responsibilities, “it has become more challenging for EPA to complete reviews within 90 days.” This rulemaking seeks to revise the procedural regulations in 40 C.F.R. Part 720 to improve the efficiency of EPA’s review process and to align its processes and procedures with the new statutory requirements. EPA intends to increase the quality of information initially submitted in new chemicals notices and improve its processes to reduce unnecessary rework in the risk assessment and, ultimately, the length of time that new chemicals are under review. EPA intends to publish an NPRM in September 2020 and a final rule in July 2021.
Rulemakings at the final stage include:
- Significant New Uses of Chemical Substances; Updates to the Hazard Communication Program and Regulatory Framework; Minor Amendments to Reporting Requirements for Premanufacture Notices. On July 28, 2016, EPA proposed amending components of the Significant New Uses of Chemical Substances regulations at 40 C.F.R. Section 721, specifically the “Protection in the Workplace” (40 C.F.R. Section 721.63) and “Hazard Communication Program” (40 C.F.R. Section 721.72). The proposed changes are intended to align, where possible, EPA’s regulations with the revised Occupational Safety and Health Administration (OSHA) regulations at 29 C.F.R. Section 1910.1200. EPA intends to issue a final rule in August 2020. More information on the proposed rule is available in our July 29, 2016, memorandum, “: TSCA: Proposed Revisions to Significant New Use Rules Reflect Current Occupational Safety and Health Standards.”
- Long-Chain Perfluoroalkyl Carboxylate (LCPFAC) and Perfluoroalkyl Sulfonate Chemical Substances (PFAS); Significant New Use Rule (SNUR). In a January 21, 2015, proposed SNUR for LCPFAC and PFAS chemical substances, EPA proposed to require notification of significant new uses from persons who import a subset of LCPFAC chemical substances as part of any article. 80 Fed. Reg. 2885. EPA proposed to make the exemption from notification requirements for persons who import the chemical substance as part of an article inapplicable for the import of a subset of LCPFAC chemical substances in all articles. As reported in our February 28, 2020, memorandum, “Proposed Supplemental SNUR Would Remove Exemption for LCPFAC Chemical Substances Used as Surface Coatings on Articles,” EPA issued a supplemental proposal that would make inapplicable the exemption for persons who import a subset of LCPFAC chemical substances as part of surface coatings on articles. EPA intended to issue a final rule in June 2020.
- Decabromodiphenyl Ether (DecaBDE); Regulation of Persistent, Bioaccumulative, and Toxic (PBT) Chemicals under TSCA Section 6(h). TSCA Section 6(h) directs EPA to issue regulations under Section 6(a) for certain PBT chemical substances identified in the 2014 update of the TSCA Work Plan. EPA states that it is selecting among the available prohibitions and other restrictions in TSCA Section 6(a) to address risks of injury to health or the environment that the Administrator determines are presented by the chemical substances and reduce exposure to the chemical substances to the extent practicable. Since the statute states that a risk evaluation is not required for these chemical substances under TSCA Section 6(h), EPA developed an exposure and use assessment. According to the Unified Agenda item, EPA intends to take final action on all of the chemicals that were addressed in the July 29, 2019, proposed rule (i.e., the following PBT chemicals identified in TSCA Section 6(h): DecaBDE; phenol, isopropylated phosphate (PIP) (3:1); 2,4,6-tris(tert-butyl)phenol (TTBP); pentachlorothiophenol (PCTP); and hexachlorobutadiene (HCBD). Although addressed in a single proposed rule, EPA intends to issue separate final rules. EPA proposed to prohibit the manufacture (including import), processing, and distribution in commerce of DecaBDE, and articles and products to which DecaBDE has been added with several exceptions, and proposed to require affected persons to maintain, for three years from the date the record is generated, ordinary business records that demonstrate compliance with the restrictions, prohibitions, and other requirements. EPA intends to issue a final rule in December 2020. More information is available in our June 24, 2019, memorandum, “EPA Publishes Proposed PBT Chemicals Rule under TSCA.”
- PIP (3:1); Regulation of PBT Chemicals under TSCA Section 6(h). EPA proposed to prohibit the processing and distribution in commerce of PIP (3:1), and products containing the chemical substance with several exceptions; prohibit releases to water from the non-prohibited processing, distribution in commerce, and commercial use activities. Persons manufacturing, processing, and distributing PIP (3:1), and products containing PIP (3:1), in commerce would be required to notify their customers of these restrictions, and EPA proposed to require affected persons to maintain, for three years from the date the record is generated, ordinary business records that demonstrate compliance with the restrictions, prohibitions, and other requirements. EPA intends to issue a final rule in December 2020.
- TTBP; Regulation of PBT Chemicals under TSCA Section 6(h.). EPA proposed to prohibit the distribution in commerce of 2,4,6-TTBP and products containing 2,4,6-TTBP in any container with a volume of less than 55 gallons for any use to prevent the use of 2,4,6-TTBP as a fuel additive or fuel injector cleaner by consumers and small commercial operations (e.g., automotive repair shops, marinas). The proposed restriction also would prohibit processing and distribution in commerce of 2,4,6-TTBP, and products containing 2,4,6-TTBP, for use as an oil or lubricant additive, regardless of container size. EPA also proposed to require affected persons to maintain, for three years from the date the record is generated, ordinary business records that demonstrate compliance with the restrictions, prohibitions, and other requirements. EPA intends to issue a final rule in December 2020.
- PCTP; Regulation of PBT Chemicals under TSCA Section 6(h). EPA proposed to prohibit the manufacture (including import), processing, and distribution in commerce of PCTP, and products containing PCTP, unless in concentrations at or below one percent by weight; and proposed to require affected persons to maintain, for three years from the date the record is generated, ordinary business records that demonstrate compliance with the restrictions, prohibitions, and other requirements. EPA intends to issue a final rule in December 2020.
- HCBD; Regulation of PBT Chemicals under TSCA Section 6(h). For HCBD, EPA proposed no regulatory action. EPA intends to issue a final rule in December 2020.
By Lynn L. Bergeson and Carla N. Hutton
On May 28, 2020, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) issued a report entitled EPA Toxic Substances Control Act Consent Orders Need Better Coordination. OIG conducted the evaluation to determine what actions EPA took to verify compliance with the requirements of the 2009 Toxic Substances Control Act (TSCA) Premanufacture Notice Consent Order with DuPont (responsibilities transferred to The Chemours Company in 2015) to prevent the release of GenX chemicals in the Cape Fear River in North Carolina. OIG notes that GenX chemicals are a type of per- and polyfluoroalkyl substances (PFAS) found in surface water, groundwater, drinking water, rain water, and air emissions. OIG found insufficient communication and coordination between the two EPA offices responsible for developing and enforcing the consent order requirements designed to reduce risks in the manufacture of GenX chemicals. Under the 2009 Consent Order, EPA required DuPont to determine how to recover and capture 99 percent of GenX’s manufacturing discharges and air emissions. The Consent Order was not reviewed or approved by the Office of Enforcement and Compliance Assurance (OECA), which is responsible for conducting inspections to verify compliance, however. Until June 2017, EPA’s actions to verify compliance with the 2009 Consent Order and new chemicals testing requirements consisted of tracking and reviewing information provided by the manufacturer. According to OIG, following the local media coverage of the presence of GenX chemicals in the Cape Fear River in 2017, Region 4 and EPA contractors conducted EPA’s first on-site compliance monitoring inspection at the Fayetteville Works facility, which manufactures GenX. OIG found that the Region 4 inspectors were unaware of the 2009 Consent Order and its requirements until the inspection was requested by EPA headquarters.
OIG recommends that EPA establish and implement processes:
- For OECA to review and approve the terms and conditions of TSCA Section 5(e) Consent Orders that it is responsible for verifying during compliance monitoring and enforcement activities; and
- To provide final TSCA Section 5(e) Consent Orders to regions and verify that the regions have the final consent orders.
OIG states that EPA “did not provide an acceptable corrective action for Recommendation 1, and we consider this recommendation unresolved.” For Recommendation 2, EPA provided an alternative course of action that OIG finds acceptable. OIG considers Recommendation 2 resolved with corrective action pending.
By Lynn L. Bergeson and Carla N. Hutton
On May 20, 2020, the U.S. Environmental Protection Agency (EPA) issued a press release announcing a final agreement with Swix Sport USA (Swix) resolving Toxic Substances Control Act (TSCA) violations associated with the importation of noncompliant ski wax products containing per- and polyfluoroalkyl substances (PFAS). According to the press release, Swix agrees to pay a fine and develop a $1 million educational program to raise awareness in ski communities about PFAS chemicals in ski waxes. EPA states that Swix violated the TSCA Premanufacturing Notice requirements and Import Certification requirements when it imported ski wax products containing six different PFAS chemicals on at least 83 occasions that were not included on the TSCA Inventory or otherwise exempt for commercial purposes. Once the chemicals were identified, Swix immediately ceased importation of the products containing the PFAS substances and quarantined products in its control in the United States.
Under the terms of the settlement, Swix has agreed to spend approximately $1 million to develop and implement an outreach and training program referred to as a Responsible Waxing Project (RWP) and pay a $375,625 civil penalty. The RWP is aimed at: (1) educating the ski racing community about PFAS chemicals in racing waxes and their impact on the environment; and (2) promoting the use of wax alternatives with lower environmental impact, including but not limited to racing waxes that are PFAS-free. Another objective of the RWP is to educate and motivate the ski racing community to phase out (and ultimately eliminate) the use of PFAS-containing waxes in ski racing beginning with the 2020 ski season.
EPA notes that the RWP has several elements, including an education and training component for ski wax technicians on the proper disposal of racing wax shavings and the use of appropriate personal protective equipment (PPE) during the waxing process. Other RWP elements include:
- PFAS ski wax education program, including two on-site presentations at a major ski event that attracts more than 10,000 participants;
- Training for wax technicians on the proper use of PPE, proper ventilation, and proper disposal of wax shavings;
- Program for ski wax coaches available online and used at on-site presentations at a minimum of ten events designed for coach certifications;
- Additional outreach to college racing teams and clubs that educates high school and college level skiers about the RWP content;
- A dedicated Swix project manager who oversees the project to completion;
- Website development for all videos created as part of the settlement for technicians, coaches, and teams; and
- Distribution of PFAS alternative wax information materials at a minimum of 50 ski sites.
EPA’s Environmental Appeals Board approved the consent agreement and final order on May 13, 2020.
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on November 13, 2019, that it published “new, easily-searchable” web pages displaying information on:
EPA notes that it is required to publish information pertaining to new chemical submissions under TSCA Section 5. EPA states that historically, these data have been, and will continue to be, made available monthly in the Federal Register via www.regulations.gov. According to EPA, the new web pages “are a much easier way for the public to access information about new chemical submissions.” The web pages provide information, such as the date the notice was received by EPA, the case number, and the chemical substance identity (to the extent that such information is not subject to a confidential business information (CBI) claim). EPA states that it will update the web pages monthly.
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) announced on September 23, 2019, that it plans to begin an evaluation of EPA’s implementation of the 2009 Toxic Substances Control Act (TSCA) premanufacture notice (PMN) consent order with DuPont [Chemours]. According to OIG, its objective is to determine what actions EPA took to verify compliance with the requirements of the consent order to prevent release of the chemical GenX into the Cape Fear River basin. OIG states that it plans to conduct work in headquarters within the Office of Enforcement and Compliance Assurance and the Office of Chemical Safety and Pollution Prevention, as well as Region 4. The anticipated benefits of the project are to improve controls over TSCA PMN consent orders.