By Lynn L. Bergeson
On August 17, 2020, EPA’s Office of Inspector General (OIG) published a report entitled Lack of Planning Risks EPA’s Ability to Meet Toxic Substances Control Act Deadlines. OIG conducted an audit to determine whether EPA met the deadlines already imposed by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) in 2016, which amended the Toxic Substances Control Act (TSCA), and whether EPA has the staff, resources, and management controls in place to meet future statutory deadlines. OIG found that while EPA met several of its TSCA deadlines, it did not complete all ten required existing chemical risk evaluations by the June 19, 2020, deadline. OIG recommends that the assistant administrator for Chemical Safety and Pollution Prevention publish the annual existing chemical plan, including the anticipated implementation efforts and required resources; conduct a workforce analysis to assess the Office of Pollution Prevention and Toxics’ (OPPT) capability to implement the TSCA requirements; and specify what skill gaps must be filled in fiscal year 2021 to meet the TSCA requirements. More information is available in our August 18, 2020, blog item.
By Lynn L. Bergeson
From June 15-19, 2020, the American Chemical Society (ACS) will be hosting its annual Green Chemistry and Engineering (GC&E) Conference virtually. On June 15, 2020, from 1:00 p.m. to 4:30 p.m. (EDT), during the “Enabling a Circular Economy for Materials in the Consumer Goods Industry,” Richard E. Engler, Ph.D., B&C’s Director of Chemistry, will proudly present his abstract titled “Road-map for Innovators - Commercialization in a Circular Economy.”
In addition, Engler will present a poster titled “TSCA Tutor -- The Importance of Regulatory Awareness and Applications” on each day of the conference, from 12:00 p.m. to 12:55 p.m. (EDT). The poster presentation will highlight B&C’s complete suite of TSCA Tutor® regulatory training courses online and on-demand. This year’s conference registration is free, so check out Engler’s abstract and poster presentations!
B&C will also have a virtual exhibitor booth concurrent with the poster session mentioned above where attendees can learn more about B&C’s services, BRAG, and B&C’s affiliates The Acta Group and BCCM. Join us during our live sessions to discover more! If those times do not work for you, check us out during one of the conference’s networking breaks daily from 2:45 p.m. to 3:05 p.m. (EDT).
By Lynn L. Bergeson
EPA announced on June 1, 2020, the availability of the latest Toxic Substances Control Act (TSCA) Inventory. EPA notes that this biannual update to the public TSCA Inventory is part of its regular posting of non-confidential TSCA Inventory data. EPA plans the next regular update of the Inventory for early 2021. According to EPA, the Inventory contains 86,405 chemicals, of which 41,587 are active in the United States commerce. Other updates to the TSCA Inventory include updates to commercial activity data and regulatory flags, such as consent orders and significant new use rules (SNUR).
From the current impacts of the Toxic Substances Control Act (TSCA) on science policies to challenges faced by industry, Lautenberg Implementation continues to evolve even four years after becoming law. B&C, The Environmental Law Institute (ELI), and the George Washington University (GWU) Milken Institute School of Public Health are pleased to present “TSCA Reform -- Four Years Later,” a complimentary virtual seminar bringing together government and industry officials to reflect on the accomplishments and challenges since the implementation of the 2016 Lautenberg Amendments and where TSCA stands today.
Panelists will dive into a host of topics, including the current impacts of TSCA on science policies, challenges faced by industry, and regulatory policies, especially those concerning ensuring compliance and enforcement. Confirmed speakers include:
- Eve C. Gartner, Managing Attorney, Toxic Exposure & Health Program, Earthjustice
- Lynn R. Goldman, Michael and Lori Milken Dean and Professor, Environmental and Occupational Health, Milken Institute School of Public Health, GWU
- Jennifer Sass, Senior Scientist, Healthy People & Thriving Communities Program, Natural Resources Defense Council (NRDC)
Mark your calendar for Wednesday, June 24, 2020, 9:30 a.m. - 4:30 p.m. (EDT),to join ELI, B&C, the GWU Milken Institute School of Public Health, leading experts, and distinguished keynote speakers in a day-long exploration of the issues and regulations surrounding TSCA. Registration is free and open to the public, but an ELI account (no charge) is required.
By Lynn L. Bergeson
One of several changes to the Toxic Substance Control Act (TSCA) Chemical Data Reporting (CDR) rule, issued in final on April 9, 2020, is that in the 2020 cycle, EPA has changed the way that toll manufacturing must be reported. In this cycle, EPA will not accept reporting from only the contracting manufacturer in situations where a company contracts with another company (i.e., a toll manufacturer) for the production of chemicals. As in years’ past, EPA states in its final rule that if no report is filed, both the contracting and producing companies will be held liable if no reporting occurs. Under past CDR cycles, EPA would accept reporting from either the contracting manufacturer or the producing (formerly referred to as “toll”) manufacturer. In 2020, EPA has stated in multiple fora that for the 2020 reporting period, EPA will only accept manufacturing details from the actual producers, even if manufacturing was contracted by another company. This change may come as a surprise, especially to producing companies that heretofore may not have reported under the CDR rule and instead relied on the contracting company to do so.
EPA stated in the preamble to the final CDR rule that it chose to include two different reporting methodologies for a co-manufacturing situation, indicating that the methodologies are based on a desire to reduce reporting burden and maintain flexibility for both the contracting and producing company. EPA noted that the companies must work together to select between the methodologies for preparing their CDR methodologies. The two methodologies for reporting, codified at 40 C.F.R. Section 711.22(c), are:
(1) The contracting company initiates the required report for that site [defined by EPA at 40 C.F.R. §711.3 as the location where the chemical substance is physically manufactured for chemical substances co-manufactured] as the primary submitter. The contracting company must indicate on the report that this is a co-manufacturing situation, notify the producing company, and record the production volume domestically co-manufactured as set forth in §711.15(b)(3) and processing and use information set forth in §711.15(b)(4). Upon notification by the contracting company, the producing company must also record the production volume domestically co-manufactured and complete the rest of the report as prompted by e-CDRweb.
(2) Upon written agreement between the contracting company and the producing company, the producing company completes the full report for the co-manufactured chemical. The contracting company supplies the information not otherwise known to or reasonably ascertainable by the producing company.
In both cases, the producing company (toll manufacturer) must provide the manufacturing details. There is no mechanism for the contracting company to submit the entire Form U.
More information on the final CDR rule is available in our March 19, 2020, memorandum, “EPA Releases Final Amendments to CDR Rule, Extends Reporting Period.”
By Lynn L. Bergeson
On May 12, 2020, EPA released the signed final rule updating the definition of small manufacturers, including a new definition of what is considered a small government, used to determine reporting and recordkeeping requirements under TSCA. According to EPA, the updated definitions will reduce reporting burdens on chemical manufacturers and small governments while maintaining the Agency’s ability to receive the information it needs to understand exposure to chemical substances manufactured in the United States. The final rule makes a technical correction to the small manufacturer reference at 40 C.F.R. Section 704.104 for hexafluoropropylene oxide, which only includes a rule-specific small processor definition and not a small manufacturer definition. When reviewing the small manufacturer size standards, EPA found this to be an “inadvertent error.” The final rule also updates the current small manufacturer definition in the Preliminary Assessment Information Rule (PAIR) at 40 C.F.R. Section 712.25 to align it with the updated small manufacturer definition at 40 C.F.R. Section 704.3.
EPA notes that the updated definitions will apply to the CDR rule reporting period beginning June 1, 2020, and will impact certain reporting and recordkeeping requirements for TSCA Section 8(a) rules. EPA states that the final rule is based on 2018 dollars to ensure that the definition is as up to date as possible at the time of promulgation. The final rule will be effective 30 days after publication in the Federal Register. EPA has posted the pre-publication version of the final rule on its website.
More information on CDR reporting is available in our May 13, 2020, blog item, “New Reporting Procedure for Co-Manufacturers under TSCA CDR Rule May Catch Certain Manufacturers Off Guard,” and our March 19, 2020, memorandum, “EPA Releases Final Amendments to CDR Rule, Extends Reporting Period.”
By Lynn L. Bergeson
EPA will host a webinar on May 19, 2020, from 1:00 p.m. to 3:00 p.m. (EDT) to provide an overview of the 2020 CDR requirements. The webinar will include information about the revised reporting requirements, including:
- New requirements for making confidential business information (CBI) claims;
- Reporting refinements related to byproducts, including exemptions;
- Phasing in certain processing and use data codes; and
- Process improvements for reporting co-manufacturing.
The webinar will also introduce the updated e-CDRweb reporting tool. EPA notes that the presentation will be similar to the webinars EPA hosted on March 31, and April 9, 2020.
EPA states that although registration is not required, it is preferred. Details on how to access the webinar and slides will be sent to participants after registering. Participants should follow along with the webinar slides and use the following call-in number to access the audio: (866) 609-6049; Conference ID: 2499985. EPA will provide webinar materials, including transcripts and recordings, on its CDR website following the webinar.
By Lynn L. Bergeson
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, U.S. Environmental Protection Agency (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 (ACC); 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.
By Lynn L. Bergeson
B&C, the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health are pleased to present "TSCA Reform -- Four Years Later," on June 24, 2020. This complimentary virtual conference marks the fourth Toxic Substances Control Act (TSCA) Annual Conference, reflecting on the accomplishments and challenges since the implementation of the 2016 Lautenberg Amendments and where TSCA stands today.
- Lynn L. Bergeson, Managing Partner, B&C;
- Yvette T. Collazo, Director, OPPT, EPA;
- Thomas M. Connelly, Jr., Executive Director and CEO, American Chemical Society (ACS);
- Alexandra Dapolito Dunn, Assistant Administrator, OCSPP, EPA;
- Richard A. Denison, Ph.D., Lead Senior Scientist, Environmental Defense Fund (EDF);
- Scott Fulton, President, ELI;
- Eve Gartner, Managing Attorney, Toxic Exposure & Health Program, Earthjustice;
- Lynn R. Goldman, Michael and Lori Milken Dean and Professor, Environmental and Occupational Health, Milken Institute School of Public Health, George Washington University;
- Jennifer Sass, Senior Scientist, Healthy People & Thriving Communities Program, Natural Resources Defense Council; and
- Hon. Tom Udall, U.S. Senator, New Mexico (invited).
Panelists will dive into a host of topics, including the current impacts of TSCA on science policies, challenges faced by industry, and regulatory policies, especially those concerning ensuring compliance and enforcement. Mark your calendar to join ELI, B&C, the George Washington University Milken Institute School of Public Health, leading experts, and distinguished keynote speakers in a day-long exploration of the issues and regulations surrounding TSCA.