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.

By Lynn L. Bergeson

EPA announced on November 13, 2019, that it published “new, easily-searchable” web pages displaying information on:

EPA notes that it is required to publish information pertaining to new chemical submissions under TSCA Section 5. EPA states that historically, these data have been, and will continue to be, made available monthly in the Federal Register via www.regulations.gov. According to EPA, the new web pages “are a much easier way for the public to access information about new chemical submissions.” The web pages provide information, such as the date the notice was received by EPA, the case number, and the chemical substance identity (to the extent that such information is not subject to a confidential business information (CBI) claim. EPA states that it will update the web pages monthly.

Tags: PMN, SNUN, MCAN, NOC

 

On August 12, 2015, the U.S. Environmental Protection Agency (EPA) announced three webinars to review the new features of the updated online Premanufacture Notifications (PMN) Submission System. The new web-based submission system for the Toxic Substances Control Act (TSCA) Section 5 submissions is replacing the ePMN reporting software that is currently in use. The first webinar is on August 26, 2015, from 1:00 p.m. - 4:00 p.m., and will cover the process of registering with the Central Data Exchange (CDX) and user roles. The second webinar is on September 16, 2015, from 1:00 p.m. - 4:00 p.m., and will review the PMN form, support form, and joint submissions. The final webinar will occur on September 30, 2015, from 1:00 p.m. - 4:00 p.m., and will include a discussion of Notice of Commencement (NOC), biotech, "bona fide," and Significant New Use Rules (SNUR) Alternate Control Measures electronic submissions.

The inclusion of biotechnology algae in the third and final webinars was previously mentioned in the announcement of the "US Environmental Protection Agency Biotechnology Algae Project." The biotechnology algae project will result in the development of a stand-alone document that will assist innovators who are developing new microbial technology applications under TSCA. EPA will develop the algae guidance in conjunction with the update of the Points to Consider in the Preparation of TSCA Biotechnology Submissions for Microorganisms (Points to Consider) document. The webinar will allow the public to submit questions on both technical issues relating to the development of a biotechnology algae considerations document, as well as on the societal implications of the development of biotechnology algae. This invitation for stakeholder input is a key opportunity to explain the steps that are being taken to ensure responsible development and use of biotechnology, and to provide comment on how EPA can improve and update the Points to Consider document. More information regarding the biotechnology algae project is available in Bergeson & Campbell, P.C.'s (B&C®) memorandum EPA Posts Information on Biotechnology Algae Project.


 

The July 20, 2015, Federal Register includes a notice for direct final action to amend the electronic reporting regulations for Section 5 under the Toxic Substances Control Act (TSCA). The U.S. Environmental Protection Agency (EPA) action goes into effect on January 19, 2016, unless adverse comments are received by August 19, 2015. The rule requires the use of new electronic premanufacture notice (e-PMN) software that is reportedly easier to use. The rule also adds the requirement that "bona fide intents to manufacture" submissions be made electronically, and changes the procedure for notifying EPA of any new manufacturing site of a chemical substance for which an exemption was granted by EPA. This action is intended to further streamline and reduce the administrative costs and burdens of TSCA Section 5 notifications for both industry and EPA.


 

On May 8, 2015, the U.S. Environmental Protection Agency (EPA) issued a direct final rule for 25 chemical substances that were the subject of premanufacture notices (PMN), including several biobased chemical substances. The rulemaking under Section 5, known as a significant new use rule or SNUR, requires persons who intend to manufacture (including import) or process any of these 25 chemical substances for an activity that is designated in the SNUR as a significant new use to notify EPA at least 90 days before commencing that activity. The required notification provides EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. The rule will be effective July 7, 2015.

Bergeson & Campbell, P.C. (B&C®) has posted an analysis of the restrictions and testing included in the SNURs for the biobased chemicals.


 

Learn How to Pre-Screen New Chemicals Using EPA's Models and Methods at Sustainable Futures Training Workshop


Co-hosted by the Biobased and Renewable Products Advocacy Group (BRAG®), the U.S. Environmental Protection Agency (EPA), and George Washington University (GWU)

August 5-7, 2014, at the GWU Campus in Washington, D.C.


During this hands-on three-day workshop, you will learn about a variety of tools, methods, and models that can be used to assess the hazard and potential exposure of chemicals. Methods addressed will include hazard and risk screening for human health, ecotoxicity, and environmental fate.


The workshop includes in-depth presentations and hands-on sessions with EPA's computer-based models. Using these models, companies can identify potentially risky chemicals early in the development process and reduce risk by finding safer substitutes and/or processes before submitting them to EPA. They can also be used to help stakeholders identify potential chemicals of concern from existing chemical inventories or supply chains.


Invited presenters include EPA Office of Pollution Prevention and Toxics (OPPT) staff with experience in the EPA New Chemicals Program and Premanufacture Notification (PMN) review process.


Companies that complete the training can be eligible to receive reduced regulatory review time for dual PMN/Test Market Exemption Application (TMEA) submissions.


More information is available online.
 


 

On Thursday, May 29, 2014, Biofuels Digest published an article by Biobased and Renewable Products Advocacy Group (BRAG™) Executive Director Kathleen Roberts titled “How to Make Friends and Win EPA Approvals: tips for biobased chemicals.” A copy of the article is available online.

The article highlights the B&C© affiliate BRAG™ and the session it co-presented with B&C during the Biotechnology Industry Organization’s World Congress on Industrial Biotechnology, which was held in Philadelphia, Pennsylvania May 12-15, 2014. The session titled “Commercializing Renewable Chemicals and Biobased Products: The Importance of Successfully and Efficiently Navigating the Regulatory Process,” was moderated by Lynn Bergeson of Bergeson & Campbell and included the following speakers: David Widawsky, U.S. Environmental Protection Agency; Tracy Williamson, U.S Environmental Protection Agency; Frank Pacholec, Stepan Company; and, Nancy Clark, DuPont Industrial Biosciences. The article published in Biofuels Digest includes summaries of the top tips for successfully navigating the regulatory process presented by Drs. Tracy Williamson and David Widawsky.
 


 

In an article appearing in the January/February 2014 issue of The Environmental Forum, a publication of the Environmental Law Institute, the Biobased and Renewable Products Advocacy Group's (BRAG™) Lynn L. Bergeson and Kathleen M. Roberts discuss the latest developments in the U.S. Environmental Protection Agency's (EPA) approach under the Toxic Substances Control Act (TSCA) to biobased chemicals, and offer strategies on how biobased chemical manufacturers can best navigate current TSCA requirements.


"Sustainability is a watchword for many brand owners, especially those that market to consumers, and renewable chemicals can facilitate the marking off of many boxes on the 'environmentally preferred' checklist. One big box that remains unchecked and curiously sometimes unnoticed altogether is an understanding of the application of TSCA to renewable chemicals. We discuss here TSCA's requirements and restrictions, offer a few thoughts for stakeholders to assure the successful marketing of these chemical products, and explain why there is an urgent need for an even playing field within TSCA and its implementing regulations that will promote and not discourage the development of new, greener chemical substances."


The full article can be found here.