By Lynn L. Bergeson
Bergeson & Campbell, P.C. (B&C®) has launched the complete suite of TSCA TutorTM regulatory training courses online and on-demand at www.TSCAtutor.com. Professionals seeking expert, efficient, essential training can preview and enroll in on-demand classes to complete at their own pace and timing. In addition to the newly released online e-learning courses, B&C’s TSCA TutorTM training platform offers live in-person training at a company’s site and customized live webinar training, so companies can mix and match training modules and training approaches to provide the most suitable combination for their work needs.
Toxic Substances Control Act (TSCA) awareness is a critically important element in the 21st century work environment for any business that involves industrial chemicals. The new normal requires awareness of TSCA’s application to a company’s operations to ensure consistent compliance with TSCA regulations and, importantly, to understand and anticipate how the U.S. Environmental Protection Agency’s (EPA) ongoing implementation of new TSCA will impact a company’s industrial chemical selection and use processes.
TSCA TutorTM online training courses include:
- Video lessons.
- Detailed hand-out materials, including copies of all presentations and relevant course materials from EPA and other sources.
- Customizable, yet detailed and ready-to-use Standard Operating Procedures (SOP) for the regulatory topic covered in the session.
The courses were developed and are presented by members of B&C’s renowned TSCA practice group, which includes five former senior EPA officials; an extensive scientific staff, including seven Ph.D.s; and a robust and highly experienced team of lawyers and non-lawyer professionals extremely well versed in all aspects of TSCA law, regulation, policy, compliance, and litigation.
By Lynn L. Bergeson
On January 2, 2020, EPA published a Federal Register notice announcing the availability of the updated “Working Approach” document for a 45-day comment period. As reported in the Bergeson & Campbell, P.C. (B&C®) December 20, 2019, blog item, EPA released an updated version of the “Working Approach” document that builds upon EPA’s November 2017 “New Chemicals Decision-Making Framework: Working Approach to Making Determinations under Section 5 of TSCA.” Comments are due on or prior to February 18, 2020. The updated document explains its approach for making one of the five affirmative determinations on new chemical notices under the Toxic Substances Control Act (TSCA):
- The chemical or significant new use presents an unreasonable risk of injury to health or the environment;
- Available information is insufficient to allow EPA to make a reasoned evaluation of the health and environmental effects associated with the chemical or significant new use;
- In the absence of sufficient information, the chemical or significant new use may present an unreasonable risk of injury to health or the environment;
- The chemical is or will be produced in substantial quantities and either enters or may enter the environment in substantial quantities or there is or may be significant or substantial exposure to the chemical; or
- The chemical or significant new use is not likely to present an unreasonable risk of injury to health or the environment.
EPA notes that the updated document reflects feedback from a 2017 public meeting and comment period and EPA’s additional experience implementing the 2016 amendments to TSCA Section 5, and includes:
- Additional clarification and detail throughout;
- General guiding principles and concepts for making determinations;
- Decision-making logic and key questions that EPA must address; and
- Example applications of the Working Approach to reach each of the affirmative determinations under TSCA Section 5(a)(3).
EPA has posted a document summarizing public comments received on the 2017 document and its responses. More information is available in B&C’s December 20, 2019, memorandum, “EPA Releases Updated Version of ‘Working Approach’ Document for New Chemicals Review.”
By Lynn L. Bergeson
On December 13, 2019, EPA announced that it has contracted the National Academies of Science (NAS) to conduct a peer review of its Application of Systematic Review in TSCA Risk Evaluations. According to EPA, this review will help provide it with important feedback on its approach to selecting and reviewing the scientific studies that are used to inform Toxic Substances Control Act (TSCA) risk evaluations. EPA states that “integrating systematic review principles into the TSCA risk evaluation process is critical to developing transparent, reproducible and scientifically credible risk evaluations.” EPA will provide NAS with the document published in June 2018, “as well as additional publicly available information” that can inform its review, including previously received public comments on this method. NAS will use their study process to conduct an objective and independent peer review, including convening a public meeting and issuing a final report, by June 2020. EPA notes that it will continue its work on the risk evaluations currently underway using the established systematic review process. EPA will incorporate NAS’s recommendations “as appropriate into our systematic review methods and use the updated process in future risk evaluations as timing allows.”
By Lynn L. Bergeson
The U.S. Environmental Protection Agency (EPA) announced on December 9, 2019, that in advance of its December 10, 2019, public meeting on new chemicals, it is providing the meeting materials and announcing the availability of a new web page detailing cases with completed confidential business information (CBI) determinations under the Toxic Substances Control Act (TSCA). Materials for the December 10, 2019, meeting include:
The new CBI web page includes a table of all the final CBI determinations under TSCA Section 14(g). The table contains information from CBI reviews including:
- Case Number;
- Submission Type;
- CBI Review Category (specific chemical identity, other information, or both);
- Final Determination;
- Determination Rationale Summary;
- For CBI Claims for Specific Chemical Identity:
- EPA Unique Identifier (UID);
- Accession Number;
- Generic Name; and
- Expiration Date for Chemical Identity and Non-Chemical Identity CBI Claims.
EPA states that it plans to update this information on a quarterly basis.
By Lynn L. Bergeson
On November 20, 2019, the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) announced a public meeting to engage with stakeholders interested on the implementation of the Toxic Substances Control Act (TSCA) New Chemicals Program. The meeting will be held on December 10, 2019, from 10:00 a.m. to 3:00 p.m. (EST), and will include:
- An overview of EPA’s updated “Working Approach” document that builds on EPA’s “New Chemicals Decision Making Framework: Working Approach to Making Determinations under Section 5 of TSCA”;
- A demonstration of how EPA uses key concepts in the Working Approach to reach certain conclusions and/or make determinations under TSCA Section 5(a)(3) using case examples;
- An update on confidential business information (CBI) process improvements and clarifications; and
- A discussion of EPA’s ongoing efforts and progress to increase transparency.
During the meeting, EPA will provide an opportunity for stakeholders to provide input on the topics mentioned above. Feedback can also be submitted via the docket on or prior to January 24, 2020.
By the end of 2019, EPA expects to make the “Working Approach” document available for written public comments
By Lynn L. Bergeson
On October 30, 2019, EPA announced that in response to an April 2019 court decision on the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements Final Rule, EPA will publish a supplemental notice of proposed rulemaking that includes two additional questions about “reverse engineering” that manufacturers and processors would be required to answer when making confidential business information (CBI) claims. According to EPA, these questions would help provide additional information on CBI claims for specific chemical identities and would ensure that chemical companies are fully supporting their CBI claims. EPA is also proposing a process for manufacturers and processors to use to amend and update certain previously submitted claims to include responses to these additional questions, as required to be addressed by federal circuit court decision. EPA notes that the supplemental notice is limited in scope and that “it impacts only the universe of CBI claims made for specific chemical identities for chemicals reported as ‘active’ in response to the Active-Inactive Rule.” Publication of the supplemental notice in the Federal Register will begin a 30-day comment period.
By Lynn L. Bergeson
On August 29, 2019, an article titled Population susceptibility: A vital consideration in chemical risk evaluation under the Lautenberg Toxic Substances Control Act was published in the PLOS Biology Journal. The article, written by academics, criticizes EPA for not identifying pregnant women, infants, children, families near industrial sites, and other susceptible and highly exposed populations in its risk evaluations. This lack of consideration for vulnerable populations, according to the article, is the lead cause of EPA’s future challenge to incorporate current scientific principles and address data deficits in the process of identifying, evaluating, and mitigating unreasonable risks. Given this challenge, Koman et al. urge EPA to act quickly to identify potentially highly exposed or susceptible populations and subpopulations, evaluate risks, and safeguard health through primary prevention
By Lynn L. Bergeson
The U.S. Environmental Protection Agency (EPA) announced on August 1, 2019, that it is making additional information about new chemical notices available on its website. The new web page, “Statistics for the New Chemicals Review Program under TSCA,” allows users to view and search monthly updates for any active Premanufacture Notice (PMN), Significant New Use Notice (SNUN), and Microbial Commercial Activity Notice (MCAN) of interest by case number. Users can also download a spreadsheet with a list of all active cases and each case’s status.
As reported in Bergeson & Campbell, L.L.C.’s (B&C) May 16, 2019, TSCA blog item, “EPA Updates Its New Chemical Statistics Web Page to Increase Transparency,” EPA previously presented only the number of cases in each step of the review process without identifying case numbers. According to EPA, this enhancement supplements the existing status tables describing the received date, the interim status, and final determinations for each case reviewed by EPA since the amendments to the Toxic Substances Control Act (TSCA) were passed in 2016. The update also supports EPA’s ongoing efforts to review new chemicals submissions more efficiently “by proactively providing status updates to submitters.” EPA notes that the tool will continue to keep confidential business information confidential. B&C has prepared a memorandum on EPA’s new web page, which can be accessed here.
By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.
On July 25, 2019, Bergeson & Campbell, P.C. (B&C®) hosted a webinar titled “New TSCA at 3: Key Implementation Issues” led by B&C’s Managing Partner, Lynn L. Bergeson. Webinar speakers included the U.S. Environmental Protection Agency’s (EPA) Assistant Administrator, Alexandra Dapolito Dunn, and B&C’s Director of Chemistry and former EPA staff, Richard E. Engler, Ph.D. Assistant Administrator Dunn’s presentation outlined EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) accomplishments and priorities three years after the amendment of the Toxic Substances Control Act (TSCA). Some of the most recent accomplishments highlighted by Assistant Administrator Dunn included OCSPP’s update to the TSCA Chemical Substance Inventory in designating substances as “active” in commerce, the selection of the first 40 chemicals for prioritization, and consumer protection measures, among others. In addition, Dunn also highlighted OCSPP’s priorities for the future implementation of TSCA:
- Publication of the draft dossiers for substances designated as high- and low-priority in the Federal Register for public comment expected as follows:
- Early August 2019, for low-priority substances; and
- End of August 2019, for high-priority substances;
- Initiation of the risk evaluations on the 20 high-priority chemicals and designation of the 20 low-priority chemicals by December 22, 2019; and
- Issue of draft scopes for public comment prior to issuing statutorily required final scopes six months after initiating the risk evaluation.
Assistant Administrator Dunn’s remarks also included EPA’s efforts for increased transparency through the publishing of information about new chemicals’ TSCA Confidential Business Information (CBI) claim reviews, which began in early July 2019. Bergeson and Engler commended Dunn’s efforts in implementing TSCA, and especially EPA’s efforts in increasing new chemical transparency. Engler urged businesses submitting new chemical notices to EPA to review carefully its submission prior to providing it to EPA to ensure that no CBI is made publicly available when new chemical notices are published. Following these discussions, questions from webinar attendees were accepted until the very last minute of the webinar. The full recording of the webinar can be accessed here.
Bergeson & Campbell, P.C. (B&C®) would like to thank all of the participants that made “TSCA: Three Years Later” such a success. Speakers, including Alexandra Dapolito Dunn, Assistant Administrator, OCSPP, EPA, and Lynn R. Goldman, M.D., M.S., M.P.H., Michael and Lori Milken Dean and Professor of Environmental and Occupational Health at Milken Institute School of Public Health, George Washington University, provided timely insights into EPA’s implementation of the Toxic Substances Control Act (TSCA) now and what should be expected going forward. If you missed the conference on Monday, it is not too late to catch up! A full recording and copies of all presentations are available now on the Environmental Law Institute (ELI) website.