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

On March 10, 2020, EPA announced that it issued a final rule to add two strains of microorganisms to the list of microorganisms eligible for an exemption from certain reporting requirements under the Toxic Substances Control Act (TSCA). EPA states that manufacturers of new intergeneric Trichoderma reesei (strain QM6a) and Bacillus amyloliquefaciens (subspecies amyloliquefaciens) may now be eligible to undergo a streamlined review process under TSCA’s new chemicals review program with reduced TSCA fees. The final rule is intended to ensure the safety of human health and the environment while reducing regulatory burden for the biotechnology industry.

EPA states that after reviewing all relevant health and safety data, it determined that the two microorganisms can be added to the list of microorganisms eligible for exemption. Under TSCA, manufacturers of a new intergeneric microorganism may be eligible to submit an exemption request in lieu of a microbial commercial activity notice (MCAN) if the organism is on the list of species eligible for an exemption and meets other criteria. EPA is including these two microorganisms on the list because it determined that the microorganisms “will not present an unreasonable risk of injury to health or the environment provided that the other criteria relating to the introduced genetic material and the physical containment of the new microorganisms have been met.”

According to EPA, both microorganisms have a long history of safe use to produce a variety of commercial enzymes used in industrial and food-related industries. Trichoderma reesei is used by the animal feed, baking, beverages, textile processing, detergent, pulp and paper, industrial chemicals, and biofuels industries. Bacillus amyloliquefaciens has been used to produce commercial enzymes for more than 50 years. It produces carbohydrases, proteases, nucleases, xylanases, and phosphatases that have applications in the food, brewing, distilling, and textile industries.

The final rule will be effective April 9, 2020.


 

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 October 21, 2014, the Biobased and Renewable Products Advocacy Group (BRAG®) submitted petitions to the U.S. Environmental Protection Agency (EPA) requesting that biodiesel fuel manufacturers be granted the same Chemical Data Reporting (CDR) exemptions that petroleum-based diesel manufacturers already receive. BRAG made its petitions through two mechanisms allowed under Toxic Substances Control Act (TSCA) rules. BRAG's petitioning of EPA was reported in the Bloomberg BNA Daily Environment Report story "Biobased Diesel Companies Petition EPA For Rules Comparable To Traditional Diesel."

One petition, "Section 21 Petition for Section 8(a) Partial Exemption in Chemical Data Reporting for Biodiesel Products," was submitted to EPA Administrator Gina McCarthy requesting that EPA initiate a rulemaking to amend the TSCA Section 8 CDR partially exempted chemical list set forth in the EPA regulations at 40 C.F.R. Section 711.6(b)(1), referred to as the (b)(1) List. Specifically, BRAG petitioned EPA to add "biodiesel" as a chemical category for partial exemption for the same reasons as those given for petroleum chemicals already included, which occurred via a rulemaking process based on proposals submitted by the American Petroleum Institute (API). BRAG contends that biodiesel products should be treated similarly to the petroleum products included in the (b)(1) List due to the conditions of manufacture and the properties and uses of the substances.

The second petition, "Petition for Partial Exemption of Biodiesel Products," was submitted to the CDR Coordinator of EPA's Office of Chemical Safety and Pollution Prevention (OCSPP). In it, BRAG petitions to add "biodiesel" as a chemical category in the partially exempted chemical list at 40 C.F.R. Section 711.6(b)(2)(iv), referred to as the (b)(2) List. EPA has stated that CDR processing and use information for chemicals on the (b)(2) List is of "low current interest" and has established a petition process to enable stakeholders to add chemicals to the (b)(2) list.

BRAG believes biodiesel belongs on the (b)(1) List but because there is no formal petition process to amend the (b)(1) List, it decided to proceed with the "low current interest" petition process to amend the (b)(2) List as well.

Amending the CDR partial exemption list to include biodiesels is necessary to ensure equitable regulatory treatment of chemical substances of comparable release and exposure potential, and to avoid EPA providing regulatory relief to one subset of diesel products over another -- even though both meet the decision conditions identified by EPA in its final rulemaking to amend the (b)(1) List, especially in light of EPA's stated objectives and interest in sustainable technologies in general, and ongoing programs that engage biodiesel producers in particular.

Regarding the petitions, BRAG's Executive Director Kathleen M. Roberts stated: "We hope EPA recognizes that these petitions only seek to level the playing field for biodiesel and petroleum-derived diesel manufacturers. Under current regulation, biodiesel producers are required to spend significant amounts of time and money gathering and providing CDR information to EPA while petroleum-derived producers are not, for chemicals that are very similar, serve the same purpose, and are managed in equivalent ways."

BRAG provides a platform for organizations engaged in biobased chemistries to identify regulatory barriers for their unique products and to work collectively to address them. BRAG tackles regulatory hindrances related to commercialization of biobased products and works to improve public awareness of the benefits of these products. For more information or to join BRAG, contact Kathleen M. Roberts at .(JavaScript must be enabled to view this email address) or (443) 964-4653. BRAG is managed by B&C® Consortia Management, L.L.C. (BCCM).


 

On December 4, 2013, EPA published a final rule requiring the electronic submission of certain documents under the Toxic Substances Control Act (TSCA). EPA is promulgating amendments to reporting requirements under TSCA Section 4 (including test rules and Enforceable Consent Agreements (ECA)), TSCA Section 5, TSCA Section 8(a) Preliminary Analysis Information Rule (PAIR) at 40 C.F.R. Part 712, and TSCA Section 8(d) Health and Safety Data Reporting Rules at 40 C.F.R. Part 716. A copy of the rule, including a more detailed description of the new reporting requirements, is available online. The rule will become effective on March 4, 2014.