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.


 

Part 3 of Biofuels Digest's "Thought Leadership" series highlighting some of the ways the Toxic Substances Control Act (TSCA) applies to biobased products was published May 18, 2015. Summaries of the first two "TSCA and the Bioeconomy" articles, written by Biobased and Renewable Products Advocacy Group (BRAG®) Senior Policy Advisor and former head of the U.S. Environmental Protection Agency's (EPA) Green Chemistry program, Richard E. Engler, Ph.D., were summarized in the May 7, 2015, BRAG report.

"The Toxic Substances Control Act and the Bioeconomy: Part 3, Call to Action," presents options for reforming TSCA and the related implementing regulations to put novel, biobased chemistry on an even footing with incumbent products and processes that were grandfathered under the original TSCA Inventory. Among the suggestions and options offered is the expansion of the Soap and Detergent Association (SDA) nomenclature system to cover more sources related to biobased products:

Opening the 40-year-old list of organisms eligible to use SDA nomenclature would go a long way towards enabling novel triglyceride sources to enter commerce without triggering new chemical substance notifications throughout the supply chain. Right now, EPA has no mechanism for adding sources without conducting a full rulemaking. A mechanism that enables EPA to add sources to the SDA list as part of the premanufacture notice (PMN) review of a new source would maintain EPA's ability to ensure new sources do not present unreasonable risk to human health and the environment, as well as lower the barrier to market adoption of these new sources.

The article closes with a call for the regulated community, both producers and their customers to:

[E]ngage with EPA to seek broad solutions, as a group, rather than individual companies seeking individual solutions. These solutions may require rulemaking and a collective approach could bring the issue to a high enough priority to justify the effort and expense for EPA to undertake rulemaking.

Dr. Engler will be speaking about opportunities and challenges presented by TSCA for the biobased products community at the 19th Annual American Chemical Society (ACS) Green Chemistry & Engineering Conference, July 14 - 16, Bethesda, Maryland, and at BIO World Congress on Industrial Biotechnology, July 19 - 22, Montreal, Canada. .(JavaScript must be enabled to view this email address) if you plan on attending either of these events and would like to speak further about these issues while at the conferences.


 

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.


 

By Lynn L. Bergeson

 

The American Sustainable Business Council (ASBC) and the Green Chemistry & Commerce Council (GC3) recently released a report that evaluates the potential business and economic value of “safer chemistry.”  The report, Making the Business & Economic Case for Safer Chemistry, concludes that market growth, capital flows, and market demand show upward trajectories during the past five years.  Large corporations, specifically including Dow, DuPont, and Sigma-Aldrich, have higher sales growth of broadly defined “green chemistry” production portfolios, as compared to sales of conventional chemistry.  Smaller companies whose value proposition is based on safer chemistry, including Seventh Generation or Method, have demonstrated continued growth.  The research also identified examples of sizeable business risk posed by traditional chemistry that safer chemistry could alleviate.  These include expanding regulations, continued non-governmental organization (NGO) and shareholder activism, loss of access to major markets, and chemical mismanagement.

 

The Report offers several recommendations:

  1. Businesses that have not yet evaluated their individual business case for safer chemistry within their specific product portfolio and market segment are strongly encouraged to do so, given the potential for revenue growth and business value at risk.
  2. Safer chemistry metrics that relate to business and economic opportunity (and risk) should be tracked and communicated, to help spur business understanding of safer chemistry and public policy mechanisms for data closure.
  3. The total societal benefits associated with the addressable market for safer chemistry should be quantified and communicated to policy makers and investors.
  4. Existing safer chemistry initiatives should be catalyzed, harmonized, and aligned through a value chain approach and used to leverage capital flows toward safer chemistry innovation.
  5. Stakeholders should work toward a common understanding and communicate with better clarity on the specific aspects of safer chemistry that they are addressing, since the topic can encompass many different production aspects and product attributes.
  6. Priorities for filling data gaps should include gathering more specific market research to quantify the potential for job growth and revenue opportunity for safer chemistry (as more narrowly defined), more specifically by product segment and industry vertical.

 


 

By Lynn L. Bergeson and Richard E. Engler, Ph.D.

 

On May 8, 2015, the U.S. Environmental Protection Agency (EPA) promulgated through a direct final rule significant new use rules (SNUR) for 25 chemical substances that were the subject of premanufacture notices (PMN).  The SNURs require 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.

                                               

The draft final rule includes SNURs for several biobased chemicals.  The SNURs for fatty acids, satd. and unsatd alkyl-, esters with polyol (generic) (PMN Number P-13-139) and fatty acids reaction products with polyethylenepolyamine and naphthenic acids (generic) (PMN Numbers P-14-616 and P-14-617) limit uses of those substances to those in the PMNs, but that aquatic toxicity testing could demonstrate lower hazard and obviate the need for the SNUR.  A SNUR for 1,2,3-propanetriol, homopolymer, dodecanoate (PMN Number P-14-395), which could be a biobased chemical, limits “use of the substance that results in releases to surface waters exceeding 18 ppb.”  Again, aquatic toxicity testing could demonstrate lower hazard and lead to a higher concentration limit or obviate the need for the SNUR.  These SNURs demonstrate what we have stated many times, namely that biobased chemicals are “renewable,” but not necessarily non-toxic.  Esters are a category that triggers concerns according to EPA’s New Chemicals Program Chemical Categories report, so regulations to limit releases of these substances to water should not be a surprise.  When submitting PMNs to EPA for new biobased chemicals, companies should keep in mind that robust pollution prevention statements can offset possible concerns by putting the new biobased substance in a risk context with incumbent technologies that it may replace.  EPA can make a reduced risk determination and forgo regulation if it has sufficient information to substantiate the relative risk of the new substance and the incumbent it will displace.


 

Biofuels Digest is running a "Thought Leadership" series of articles highlighting some of the ways the Toxic Substances Control Act (TSCA) applies to biobased products. The articles, written by Biobased and Renewable Products Advocacy Group (BRAG®) Senior Policy Advisor and former head of the U.S. Environmental Protection Agency's (EPA) Green Chemistry program, Richard E. Engler, Ph.D., cover key points throughout the manufacturing and commercialization process at which biobased companies need to be aware of TSCA requirements.

"The Toxic Substances Control Act and the Bioeconomy: Part 1, The Impact of Nomenclature on the Commercialization of Biobased Chemicals," published April 26, 2015, begins with some common misconceptions about TSCA:

When I meet people from bioeconomy companies, I ask them about their products' status under the Toxic Substances Control Act (TSCA). The most common answers I receive are: "TSCA doesn't apply because our product is not toxic," "TSCA doesn't apply because our product is naturally occurring," and "We are compliant with TSCA because we're making something that's already in commerce." This usually leads to a more in-depth discussion of how TSCA works and its idiosyncrasies with respect to biobased products. I do not ask this to be accusatory, rather I want to be sure that companies understand their obligations so that they do not run afoul of the law. TSCA penalties can add up quickly (maximum $37,500 per violation per day) and can threaten nascent companies if they are not diligent.

The article continues by detailing how the Chemical Abstracts Index name and identity of a substance is determined, how feedstock and production processes can affect identity, and the impact the name has on commercialization prospects since all chemicals in production must be listed on the TSCA Inventory.

"The Toxic Substances Control Act and the Bioeconomy: Part 2, Reportable Substances across the Manufacturing Process," published May 3, 2015, details when feedstocks, intermediates, and catalysts may be reportable under TSCA.

Importantly, in addition to final chemical products, TSCA also applies to the other chemicals used in the manufacturing process. Looking at the various stages of a typical manufacturing process allows us to examine how TSCA applies at each stage.

The article then discusses feedstocks, such as plants, sugars, and municipal wastes; isolated and non-isolated intermediates; and catalysts, such as metals, enzymes, and microoganisms; and how each of those is treated under TSCA.

The final article in the series will be published in Biofuels Digest on May 10, 2015, and we will feature excerpts in next week's BRAG Report.


 

 

Iowa Senate bill SF 350: the Renewable Chemical Production Tax Credit Program was introduced in March 2015, and is awaiting review in the Ways & Means Committee. If passed, the legislation will allow producers of renewable chemicals in Iowa to claim a five cent per pound tax credit, with a maximum credit of $1 million for businesses operating in Iowa for five years or less, and a maximum credit of $500,000 for businesses operating in Iowa for more than five years. Chemicals must have at least a 50 percent biobased content to qualify as renewable chemicals under the bill, and must also be sold and used for purposes other than food, feed, or fuel.


 

 

The Oil Price Information Network (OPIS) spoke with BRAG's Richard E. Engler, Ph.D., Senior Policy Advisor with B&C, regarding the application of the Toxic Substances Control Act (TSCA) to oils made from algae feedstocks and other non-traditional bio-materials. The resulting article, "TSCA Nomenclature May Be Barrier for Advanced Biofuels," from the OPIS Ethanol & Biodiesel Newsletter is excerpted below, and reprinted in full at the link with permission from OPIS.


Any number of complications could trip up the commercial use of an advanced biofuel, but one that should attract attention is the requirement that all fuels be listed on Toxic Substances Control Act (TSCA) Inventory of Chemical Substances.
 
This requirement has the potential to raise reporting requirements that could be a barrier to sales of oils made from algae feedstocks, as well as other non- traditional biomaterials, said Richard Engler, Ph.D., with Bergeson & Campbell, PC.
 
"TSCA is based on identification of what you are making. So if you have a single, defined molecule, like ethanol, it's simple," he told OPIS in a follow- up to his presentation at last month's Advanced Bioeconomy Leadership Conference.
 
Ethanol is a Class 1 chemical on the TSCA list. Its identity does not depend on how it is made. And since one ethanol is chemically the same as another, Engler explained that a new producer of ethanol can use the existing TSCA Inventory registration.
 
But most hydrocarbon-based and bio-based fuels are Class 2 chemicals, which are identified differently, Engler said. Class 2 compounds are defined as having unknown or variable composition, complex reaction products, and biological materials.

The article goes on to explain how Class 2 compounds are named, where there is flexibility in naming plant, animal, and marine sourced oils and where there is not, and solutions for which the advanced biofuels industry should petition EPA.

Tags: biofuels, TSCA

 
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