Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C., law firm providing biobased and renewable chemical product stakeholders unparalleled experience, judgment, and excellence in bringing innovative products to market.

On February 19, 2016, Kathleen M. Roberts, Executive Director of BRAG, presented "Achieving Critical Policy Changes through Consortia" at the 2016 Advanced Bioeconomy Leadership Conference (ABLC2016). Ms. Roberts presented as part of The Bioeconomy R&D Consortia Summit and discussed the work being done by BRAG to level the regulatory playing field for biobased chemicals. BRAG has successfully petitioned the U.S. Environmental Protection Agency (EPA) to make Chemical Data Reporting (CDR) partial reporting exemptions that are already granted to petroleum products available to biodiesel products as well. BRAG is also currently working to resolve the limitations of the Soap and Detergent Association (SDA) nomenclature system for Toxic Substances Control Act (TSCA) Inventory purposes. SDA nomenclature allows for chemical identification by alkyl range rather than source, but is limited to 35 predetermined sources. BRAG petitioned EPA on October 7, 2015, to implement, via rulemaking, a process that would broaden the sources on the SDA nomenclature list. BRAG sought to include such sources as algae and non-traditional plant materials. The petition was denied because, according to EPA, the Agency lacks the authority to initiate rulemaking under TSCA Section 8(b). EPA also claimed that BRAG did not justify the need for regulatory relief, given that the petition lacked a specific example of products experiencing this issue. While BRAG respectfully disagrees with EPA's reasoning, the denial allowed EPA to express its concurrence with BRAG's view that the SDA nomenclature is limited to the predetermined sources, and expressed a willingness to discuss approaches to address the limitation, either through changes to nomenclature guidance, or through rulemaking to establish an exemption under TSCA Section 5(h)(4). If companies wish to ensure that the SDA nomenclature list expands, they should consider joining BRAG and assist with future engagement with EPA.

For a copy of this presentation, please contact .(JavaScript must be enabled to view this email address).


 

On January 12, 2016, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice announcing the availability of EPA’s response to a petition it received from the Biobased and Renewable Products Advocacy Group (BRAG®) under Section 21 of the Toxic Substances Control Act (TSCA). BRAG requested EPA to promulgate a rule pursuant to TSCA Section 8 that would establish a process to amend the list of natural sources of oil and fat in the “Soap and Detergent Association” (SDA) nomenclature system by considering the chemical equivalency of additional natural sources. While EPA denied the TSCA Section 21 petition, EPA left the door open for additional relief in this area and its notice provides useful information regarding options for doing so.

EPA concurred with BRAG that SDA nomenclature is currently limited to the listed sources. In its notice, EPA states, “[t]he petition correctly recognizes the current limitations of certain TSCA Inventory listings (i.e., those listings that incorporate particular assumptions about the natural sources of fats or oils from which the listed substance is derived, because they were named according to the SDA naming convention). Manufacturers of a new chemical substance that clearly falls outside the definitional scope of an existing chemical substance are not allowed to determine that the new chemical substance is nonetheless sufficiently ‘similar’ to the existing chemical substance, and simply deem the new chemical substance to be an existing substance on the basis of that similarity.”

While not providing details as to how it could be accomplished, EPA’s response seems to indicate that there may be opportunities for BRAG to achieve its goal. EPA stated “the petition presumes, without justification, that until a certain preliminary EPA rulemaking has been completed, those same manufacturers lack a meaningful opportunity to request that EPA enlarge the definitional scope of one or more existing chemical substances named according to the SDA naming convention.” “Although the response indicates that the current SDA Nomenclature system is limited to the original 35 sources, it is encouraging that EPA does not see a regulatory barrier to adding additional sources,” stated Richard E. Engler, Ph.D., Senior Chemist with Bergeson & Campbell, P.C. (B&C®) and BRAG advisor. Further, “[t]his language appears to support the contention that there may be an opportunity to request EPA to expand the SDA naming convention beyond the current list of 35 plant and animal sources.”

Similarly, Kathleen M. Roberts, Executive Director of BRAG, stated “BRAG is encouraged by the language in Assistant Administrator James J. Jones’ letter to BRAG, in which he highlighted Section 5(h)(4) as a potential mechanism to achieve BRAG’s goal with the Section 21 petition.” Section 5(h)(4) allows EPA to develop a rulemaking for exemption of certain chemical substances if EPA determines that the manufacture, processing, distribution, use, or disposal will not present an unreasonable risk.

Ms. Roberts also stated that “BRAG members are evaluating next steps, including careful consideration of the potential pathways to achieve the ultimate goal of the petition that EPA identified in its response.” As part of its 2016 efforts, BRAG is expanding its membership to include more companies that have already been or may be adversely impacted by EPA’s current naming convention policies, such as companies looking to produce bio-based chemicals from algae or non-traditional plant materials.


 

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 October 21, 2014, the Biobased and Renewable Products Advocacy Group (BRAG®) submitted two 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.


The Bloomberg BNA Daily Environment Report covered the petitions in an October 22, 2014, feature story that stated "[t]he Biobased and Renewable Products Advocacy Group (BRAG) filed the petitions in an attempt to be exempted through either of two mechanisms allowed under Toxic Substances Control Act rules. Petroleum-derived diesel already is exempt from certain Chemical Data Reporting (CDR) rule requirements, BRAG wrote in both petitions. That means the EPA's current rule provides regulatory relief to petroleum-derived diesel but not to the biobased chemicals that are used in conjunction with or as replacements for the petroleum-based compounds, BRAG's petitions say. If the EPA rejects the petitions, biodiesel manufacturers will be subject to certain Chemical Data Reporting Rule requirements while manufacturers of the petroleum-derived versions of these fuels are not, Kathleen Roberts, BRAG's executive director, told Bloomberg BNA. That means biodiesel producers would have to spend a significant amount of time and money gathering information and providing it to the EPA, she said. The chemicals both types of manufacturers make are very similar, serve the same purpose and are managed in equivalent ways, BRAG's petitions said."


Copies of the two petitions submitted by BRAG are available on the BRAG website:


* Section 21 Petition for Section 8(a) Partial Exemption in Chemical Data Reporting for Biodiesel Products

* Petition for Partial Exemption of Biodiesel Products
 


 

In a letter from Senators Amy Klobuchar (D-MN) and Chuck Grassley (R-IA) to Attorney General Eric Holder and Federal Trade Commission (FTC) Chair Edith Ramirez, the Senators have requested that the U.S. Department of Justice and the FTC investigate the efforts of the oil companies to block market access of renewable fuels in violation of the Sherman Act and the Gasohol Competition Act of 1980, which prohibits discrimination or unreasonable limits against the sale of gasoline or other synthetic motor fuels. A copy of the letter is available online.