The Biobased and Renewable Products Advocacy Group (BRAG) helps members develop and bring to market their innovative biobased and renewable chemical products through insightful policy and regulatory advocacy. BRAG is managed by B&C® Consortia Management, L.L.C., an affiliate of Bergeson & Campbell, P.C.

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 EDF notes that “[c]oncern over toxic exposures and a lack of confidence in the badly outdated chemical safety system” led to Congress passing the Frank R. Launtenberg Chemical Safety for the 21st Century Act (Launtenberg Act) to reform the Toxic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.”
Tags: EDF, TSCA

 

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 Chemicalweb 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.

Tags: Podcast, TSCA

 

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:

  1. Verify the asserted CBI claims are correct and consistent; and
     
  2. 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.
Tags: EPA, TSCA

 

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.

Tags: ELI, B&C, GWU, TSCA

 

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.

Tags: TSCA

 

By Lynn L. Bergeson

On April 23, 2019, the U.S. Environmental Protection Agency (EPA) issued a proposed rule regarding its plan to review certain confidential business information (CBI) claims to protect the specific chemical identities of substances on the confidential portion of the Toxic Substances Control Act (TSCA) Inventory.  84 Fed. Reg. 16826.  The CBI claims that would be reviewed under this plan are those that were asserted on Notice of Activity (NOA) Form A’s filed in accordance with the requirements in the Active-Inactive rule.  Comments are due June 24, 2019. See Bergeson & Campbell, P.C.’s (B&C®) full memorandum for more information on the proposed rule.

Tags: TSCA, CBI

 

By Lynn L. Bergeson

On April 25, 2019, EPA issued a proposed rule that would amend the TSCA Section 8(a) Chemical Data Reporting (CDR) requirements and the TSCA Section 8(a) size standards for small manufacturers. The current CDR rule requires manufacturers (including importers) of certain chemical substances listed on the TSCA Inventory to report data on chemical manufacturing, processing, and use every four years.  EPA is proposing several changes to the CDR rule to make regulatory updates to align with new statutory requirements of TSCA, improve the CDR data collected as necessary to support the implementation of TSCA, and potentially reduce the burden for certain CDR reporters.  Proposed updates to the definition for small manufacturers, including a new definition for small governments, are being made in accordance with TSCA Section 8(a)(3)(C) and impact certain reporting and recordkeeping requirements.  Overall, according to EPA, the regulatory modifications may better address EPA and public information needs by providing additional information that is currently not collected; improve the usability and reliability of the reported data; and ensure that data are available in a timely manner.  Comments are due by June 24, 2019See B&C’s full memorandum for more information on the proposed rule.

Tags: TSCA

 

By Lynn L. Bergeson

On March 21, 2019, the U.S. Environmental Protection Agency (EPA) announced it was releasing a list of 40 chemicals to begin the prioritization process required by the amended Toxic Substances Control Act (TSCA).  84 Fed. Reg. 10491.  New TSCA requires EPA to designate 20 chemicals as “high-priority” for subsequent risk evaluation and 20 chemicals as “low-priority,” meaning that risk evaluation is not warranted at this time.  The 20 high priority candidate chemicals include:

  • Seven chlorinated solvents;
  • Six phthalates;
  • Four flame retardants;
  • Formaldehyde (which has been studied by EPA’s Integrated Risk Information System (IRIS) program for many years);
  • A fragrance additive; and
  • A polymer pre-curser.

EPA is also currently determining whether to conduct a risk evaluation of two additional phthalates.  The 20 low priority candidate chemicals have been selected from EPA’s Safer Chemicals Ingredients List, which includes chemicals that have been evaluated and determined to meet EPA's safer choice criteria. 

Alexandra Dapolito Dunn, Assistant Administrator for EPA’s Office of Chemical Safety and Pollution Prevention, stated that initiating a chemical for high or low prioritization “does not mean EPA has determined it poses unreasonable risk or no risk to human health or the environment,” however.  EPA states that is it releasing this list “to provide the public an opportunity to submit relevant information such as the uses, hazards, and exposure for these chemicals.”  Comments are due June 19, 2019.  EPA has opened a docket for each of the 40 chemicals; the dockets numbers are listed in the Federal Register notice.  EPA is directed to complete the prioritization process in the next nine to 12 months. 

Please be on the lookout for the Bergeson & Campbell, P.C.’s (B&C®) memorandum that will contain more information regarding EPA’s list.  It will be posted on our Regulatory Developments webpage.

Tags: EPA, TSCA

 

By Lynn L. Bergeson

B&C is pleased to announce an exciting and important new component to our suite of Toxic Substances Control Act (TSCA) offerings. Our TSCA Tutor™ training platform provides live in-person training at a company’s site, live online training, and pre-recorded webinar training modules -- all designed to offer expert, efficient, and essential TSCA training. Companies can mix and match training modules and training approaches to provide the most suitable combination for their work needs. B&C developed TSCA Tutor in recognition that 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 EPA ongoing implementation of new TSCA will impact a company’s industrial chemical selection and use processes. B&C is now scheduling its TSCA Tutor sessions with a full schedule available online. Companies interested in finding out more, or those ready to sign up for TSCA Tutor sessions, should contact .(JavaScript must be enabled to view this email address) for pricing and scheduling information.


 
 1 2 3 >  Last ›