On June 24, 2020, Bergeson & Campbell, P.C. (B&C®), The Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health presented “TSCA Reform -- Four Years Later.” A full recording of the seminar, including a keynote address by Alexandra Dapolito Dunn, Assistant Administrator, Office of Chemical Safety and Pollution Prevention, U.S. Environmental Protection Agency (EPA), and comments by the Hon. John Shimkus U.S. Representative, 15th District of Illinois, is available to watch now.
This complimentary all-day virtual seminar marked the fourth Toxic Substances Control Act (TSCA) Annual Conference, with top EPA officials and industry leaders reflecting on the accomplishments and challenges since the implementation of the 2016 Lautenberg Amendments and where TSCA stands today. Panelists covered “TSCA Implementation: Where Are We Now?,” “Science Policy Issues,” and “Regulatory and Policy Issues” while offering unique insights into the decision-making process of EPA.
Building on the timely information shared during this event, B&C’s All Things Chemical ™ podcast has released an exclusive interview with Alexandra Dunn focusing on the current state of TSCA, “TSCA at Four — A Conversation with Alexandra Dunn, OCSPP AA.” Lynn L. Bergeson and Alexandra Dunn focused their discussion on the implementation of the amendments to TSCA, which Congress enacted in 2016. As pollution prevention is an integral part of EPA’s mission, this episode also focuses on initiatives under way to introduce safer and greener chemicals. Finally, the discussion includes a look ahead to what is on EPA’s agenda for the remainder of the year, which promises to be extraordinarily busy.
By Lynn L. Bergeson and Carla N. Hutton
The Consumer Product Safety Commission (CPSC) will hold a public webinar on July 1, 2020, to receive information from interested parties about changes to CPSC’s Publicly Available Consumer Product Safety Information Database, www.SaferProducts.gov, that are in development to improve the website’s usefulness and navigability. CPSC states in its June 18, 2020, Federal Register notice that based, in part, on input from a March 2019 public hearing, CPSC is holding the webinar to show the changes to the website that are in development. 85 Fed. Reg. 36838. According to CPSC, these changes seek to improve usability and navigability on the website; make the website more mobile friendly with other devices, including smartphones and tablets; and improve cross-browser compatibility. Participants who register for the webinar will have an opportunity to see these changes and provide feedback to CPSC through a moderated discussion. All attendees should pre-register for the webinar.
By Lynn L. Bergeson and Carla N. Hutton
On June 16, 2020, the U.S. Environmental Protection Agency (EPA) announced the winners of the 2020 Green Chemistry Challenge Awards. EPA states that this year’s winners “have developed new and innovative green chemistry technologies that turn potential environmental challenges into business opportunities, spurring innovation and economic development.” The 2020 winners and their innovative technologies are:
- Genomatica, San Diego, California, for creating Brontide™, a new brand of 1,3-butylene glycol, commonly used in cosmetics for moisture retention and as a carrier for plant extracts. Butylene glycol is traditionally produced from fossil fuels. Brontide™ is produced by fermenting E. coli using renewable sugars in a one-step production process, however. This method reduces greenhouse gas emissions and avoids the use of hazardous chemicals in the production process.
- Merck, Rahway, New Jersey, for improving the process used to produce certain antiviral drugs used for the treatment of diseases including hepatitis C and HIV. According to EPA, the new process improved manufacturing efficiency and sustainability of one important antiviral by more than 85 percent. This method reduces waste and hazards associated with the existing process and results in substantial cost savings.
- Johns Manville, Littleton, Colorado, for developing a biobased, formaldehyde-free thermoset binder for fiberglass reinforcement applications. Thermoset binders are used to bind glass fibers of fiberglass mats used in carpet tile backing. EPA states that this technology eliminates the use of hazardous chemicals, reduces water and energy use, and produces a product with a longer shelf life.
- Professor Steven Skerlos, University of Michigan and Fusion Coolant Systems, for creating Pure-Cut™, an alternative to traditional metalworking fluids that uses high-pressure carbon dioxide instead of oil-based lubricants. According to EPA, Pure-Cut™ can improve performance and machining tool life span compared to traditional metalworking fluids, while greatly reducing hazards to the environment and worker health.
- Vestaron, Kalamazoo, Michigan, for producing a new biopesticide called Spear®. This pesticide is based on a naturally occurring component inspired by spider venom that can effectively control target pests while showing no adverse effects on people, the environment, and non-target wildlife, such as fish and bees. EPA notes that Spear® should provide growers with a new pest management tool that also lessens environmental impacts.
EPA plans to recognize the winners at a ceremony in Washington, D.C., later this year. EPA and the American Chemical Society co-sponsor the awards. An independent panel of technical experts convened by the American Chemical Society Green Chemistry Institute formally judged the 2020 submissions and made recommendations to EPA for the 2020 winners.
By Lynn L. Bergeson and Carla N. Hutton
On June 3, 2020, the U.S. Environmental Protection Agency (EPA) submitted to the Office of Management and Budget (OMB) a final significant new use rule (SNUR) on long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate (PFAS) chemical substances. On March 3, 2020, EPA published a proposed supplemental SNUR for LCPFAC chemical substances that would 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, issued under Section 5(a)(2) of the Toxic Substances Control Act (TSCA), 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. As noted in our February 28, 2020, memorandum, “Proposed Supplemental SNUR Would Remove Exemption for LCPFAC Chemical Substances Used as Surface Coatings on Articles,” one of the goals of the proposed supplemental SNUR is to establish the ground rules for EPA’s consideration of the article exemption in future SNUR actions. The final SNUR that is under OMB review is not publicly available, so it remains to be seen whether EPA has successfully established policies and procedures that both align with statutory requirements and also are workable, effective, predictable, transparent, and justified scientifically.
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.
The 2020 GlobalChem webinar series addresses major developments in chemicals management and provides participants a chance to engage with policymakers and other key experts throughout the chemical industry value chain. On May 13, 2020, at 12:00 p.m. (EDT), Richard E. Engler, Ph.D., Director of Chemistry, Bergeson & Campbell, P.C. (B&C®), will present during the "TSCA New Chemicals" webinar. Other presenters include Lynn Dekleva, Ph.D., Associate Deputy Assistant Administrator for New Chemicals, EPA Office of Chemical Safety and Pollution Prevention (OCSPP), Tala Henry, Ph.D., Deputy Director, EPA Office of Pollution Prevention and Toxics (OPPT); Mike Walls, Vice President, Regulatory and Technical Affairs, American Chemistry Council; and Ritesh Tiwari, Chemical Engineer, EPA. The webinar will address key changes in the Section 5 program and challenges faced by EPA and submitters, including information requirements, assessment of risks, and practical tips. Register for the 10-part webinar series online. B&C is a proud sponsor.
Bergeson & Campbell, P.C. (B&C®) is pleased to release a timely episode of the All Things Chemical™ podcast, “Chemical Distribution in the Time of COVID-19 — A Conversation with Eric R. Byer, NACD.” In this episode, Lynn L. Bergeson, Managing Partner, B&C, and Eric Byer, President and CEO of the National Association of Chemical Distributors (NACD), sat down to discuss current challenges facing small and large chemical distributors, and how NACD member companies are able to continue to distribute much needed chemical products, including sanitizers and other cleaning products, in response to the pandemic.
Lynn and Eric’s conversation focuses on unique “in the moment” issues and a broad range of federal, state, and international issues on which NACD is focused, including extending the Chemical Facility Anti-Terrorism Standards (CFATS) program, Toxic Substances Control Act (TSCA) implementation initiatives, and the impact of tariffs on imports from China on NACD member companies. Eric is an amazing leader of an essential trade association, and this conversation provides insights into his success as President and CEO of NACD.
The full podcast episode is available to stream online, where listeners can also find the recent podcast “COVID-19, FIFRA, and EPA — A Conversation with Lisa Campbell” Additional updates on chemical regulatory activity related to COVID-19 can be found on B&C’s Pesticide Law and Policy Blog® and on the Regulatory Developments page of B&C's website, including these recent updates:
All Things Chemical™ engages listeners in intelligent, insightful conversation about everything related to industrial, pesticidal, and specialty chemicals and the law and business issues surrounding chemicals. B&C’s talented team of lawyers, scientists, and consultants will keep listeners abreast of the changing world of both domestic and international chemical regulation and provide analysis of the many intriguing and complicated issues surrounding this space. All Things Chemical™ is available now on iTunes, Spotify, Stitcher, and Google Play Music. Subscribe so you never miss an episode.
The Acta Group (Acta®) announced today the launch of CDR Cross-Check™, an ingenious yet simple tool developed and offered by Acta to assist companies in preparing for the 2020 Chemical Data Reporting (CDR) required by the U.S. Environmental Protection Agency (EPA). CDR Cross-Check utilizes the most recent CDR listing information publicly available provided by EPA (currently, 2016 lists) to identify whether all or some of a company’s inventory of chemical substances are subject to CDR under the Toxic Substances Control Act (TSCA) and, if so, at what reporting threshold. CDR Cross-Check will make CDR reporting easier.
CDR Cross-Check will identify whether chemicals are listed on the TSCA Inventory and, if so,
- whether they are listed as active or inactive;
- whether they were subject to specific TSCA regulatory actions in 2016;
- whether they are exempt; and
- what the 2020 reporting thresholds would be based on the 2016 data.
Sample CDR Cross-Check™ Report:
(Click image to enlarge.)
A CDR Cross-Check report prepared at this time will be extremely useful as a preliminary check in preparation for the 2020 CDR reporting. It will confirm regulatory statuses from the 2016 reporting cycle, so for those chemicals, users will know what the reporting threshold will be for 2020 and can determine now whether reporting is needed. It will also give users time to address potential issues well before the 2020 reports are due.
To access CDR Cross-Check, a customer will upload the list of chemicals to be evaluated by the CDR Cross-Check tool and pay the appropriate fee based on the number of chemicals to be evaluated. Fees are $3.00 (USD) per chemical for the first 750 chemicals plus $2.00 (USD) per chemical for additional chemicals over 750. The minimum fee is $400 (USD).
Acta anticipates that additional chemicals will be added to the regulatory lists in June 2020 that may result in lower reporting thresholds. The CDR Cross-Check will be updated at that time to include the new lists. Customers that have already used the CDR Cross-Check prior to the 2020 updates will receive a 50% discount for an updated list.
Visit the CDR Cross-Check website, https://cdr-cross-check.actagroup.com/, for more information and to order a CDR Cross-Check report.
More information on recent CDR developments is available in Acta’s March 19, 2020, memorandum “EPA Releases Final Amendments to CDR Rule, Extends Reporting Period.”
The Acta Group is a global scientific and regulatory consulting firm that assists companies with strategic commercialization planning and complex product registration and compliance matters in North America, South America, Europe, the Middle East, and Asia. Acta is the consulting affiliate of Washington, D.C., law firm Bergeson & Campbell, P.C.
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.
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