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.
By Lynn L. Bergeson
The Environmental Defense Fund (EDF) announced on June 17, 2019, a report entitled Toxic Consequences: Trump’s attacks on chemical safety put our health at risk. EDF notes that “[c]oncern over toxic exposures and a lack of confidence in the badly outdated chemical safety system” led to Congress passing the Frank R. Launtenberg Chemical Safety for the 21st Century Act (Launtenberg Act) to reform the Toxic Substances Control Act (TSCA). The bipartisan bill “finally” gave EPA “the power to strengthen health protections for American families and the environment.” EDF claims that the Trump Administration “is seeking to dismantle the new authorities and mandates under the law with the goal of shifting policies to serve the chemical industry’s agenda,” however. According to EDF, EPA has taken the following actions that undermine the Launtenberg Act:
- Approving new chemicals without regard for the law or public health;
- Ignoring real-life exposures when evaluating risks of existing chemicals; and
- Blocking or weakening bans of toxic chemicals.
EDF concludes that “without a drastic change to EPA’s current direction on chemical safety, we will be forced to endure the toxic consequences of its mistakes for decades to come.”
By Lynn L. Bergeson
On May 28, 2019, Bergeson & Campbell, P.C. (B&C®) posted a podcast “Inside OCSPP with EPA Assistant Administrator Alexandra Dapolito Dunn” to its All Things Chemical™ web page. In its podcast, Lynn L. Bergeson, Managing Partner of B&C, presented a very special guest, the Assistant Administrator for the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP): Alexandra Dapolito Dunn.
As Assistant Administrator Dunn has spent just over five months in office, she and Lynn sat down and talked about what it has been like to take over OCSPP at this crucial time when the amended Toxic Substances Control Act (TSCA), post-Lautenberg, is just coming into its maturity. They discussed the challenges OCSPP is currently facing, and how Alex and her team have kept morale up while managing to meet all of the many deadlines imposed on OCSPP thus far. This was a fantastic opportunity to gain insight into what has been going on inside the OCSPP over the last few months, and what to expect from it in the next few months.
By Lynn L. Bergeson
On May 20, 2019, the U.S. Environmental Protection Agency (EPA) announced that on May 30, 2019, it will begin publishing Toxic Substances Control Act (TSCA) Section 5 notices, including premanufacture notices (PMN), microbial commercial activity notices (MCAN), and significant new use notices (SNUN), their attachments, including any health and safety studies, any modifications thereto, and all other associated information in ChemView -- in the form they are received by EPA, without review by EPA. EPA states that it will not be reviewing confidential business information (CBI)-sanitized filings before publishing. EPA states that this announcement will be the first of several reminders that EPA sends and, in addition, EPA has incorporated a reminder to check accompanying sanitized submissions as part of the Central Data Exchange (CDX) reporting module for TSCA Section 5 notices.
EPA’s announcement states the following as guidance for submitters to take heed of before submitting their TSCA Section 5 notices:
- Verify the asserted CBI claims are correct and consistent; and
- Verify the sanitized versions of the form, attachments, and file names are checked for proper and consistent CBI redactions and that watermarks or stamps indicating CBI are removed.
Bergeson & Campbell, P.C. (B&C®), the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health are pleased to present the one day conference “TSCA: Three Years Later” on June 24, 2019. Panelists Alexandra Dunn, Assistant Administrator, Office of Chemical Safety and Pollution Prevention (OCSPP), EPA, and Lynn R. Goldman, Michael and Lori Milken Dean and Professor, Environmental and Occupational Health, Milken Institute School of Public Health, George Washington University, will dive into a host of topics, including the current impacts of TSCA on science policies, challenges faced by industry, and the impacts of TSCA on regulatory policies, especially those concerning ensuring compliance and enforcement. This conference (in-person and webinar) is free and open to the public, but registration is required by June 21, 2019, at the ELI website.
By Lynn L. Bergeson
On April 26, 2019, the U.S. Court of Appeals for the D.C. Circuit (D.C. Circuit) issued its order on the petition for review of the U.S. Environmental Protection Agency’s (EPA) final rule on the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements (82 Fed. Reg. 37520 (Aug. 11, 2017)), which denied the petition for review on all but one claim. Petitioner Environmental Defense Fund (EDF) challenged five distinct features of the Inventory final rule: (i) EPA’s exclusion of substantiation questions regarding reverse engineering; (ii) the final rule’s criteria for “maintaining” a confidentiality claim; (iii) EPA’s choice not to incorporate certain regulatory requirements into the final rule; (iv) EPA’s failure to implement the Act’s “unique identifier” requirements in this rulemaking; and (v) the final rule’s exemption of exported chemicals from its notification requirements.
The D.C. Circuit’s order states that only the first claim succeeds past the standard of review required under both the Administrative Procedure Act (APA) and TSCA, however; specifically, EPA acted arbitrarily and capriciously via its “omission of any inquiry into a chemical identity’s susceptibility to reverse engineering [which] effectively excised a statutorily required criterion from the substantiation process.” Even though EPA included several substantiation questions to address reverse engineering in the proposed rule, EPA did not include any “substantiation questions related to the requirement that a substance’s chemical identity not be susceptible to reverse engineering” and declined altogether to “‘secure answers’ substantiating a company’s ‘assertion’ that its chemical product cannot be reverse engineered.” The court states that this error was “fatal” and remands this issue back to EPA for EPA to “address its arbitrary elimination of substantiation questions regarding reverse engineering.” For further details, see Bergeson & Campbell, P.C.’s (B&C®) TSCAblog™ article.