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.

On June 18, 2018, Richard E. Engler, Ph.D., Director of Chemistry, Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®), presented “New TSCA and Green Chemistry Innovation” at the American Chemical Society’s (ACS) Green Chemistry & Engineering Conference in Portland, Oregon. This presentation covered specific changes to the Toxic Substances Control Act (TSCA) and the impact of those changes for new chemicals, including innovative “green” chemicals. In line with the conference theme, “product innovation using greener chemistries,” Dr. Engler outlined key steps to take when preparing to submit a new chemical for review, including the following items that a robust Premanufacture Notice (PMN) should include: 

  • Detailed descriptions of all potential releases and exposures throughout the supply chain, including container and equipment cleaning activities 
  • Identities of analogs that have measured data
  • All data on physical-chemical properties
     



For more information and a full copy of the presentation, contact Richard E. Engler, Ph.D., at .(JavaScript must be enabled to view this email address).


 

By Kathleen M. Roberts 

On June 13, 2018, representatives of the Biobased and Renewable Products Advocacy Group (BRAG®) and representatives of the Biotechnology Innovation Organization (BIO) met with U.S. Environmental Protection Agency (EPA) staff to discuss the two groups’ white paper, “Proposal for a Toxic Substances Control Act (TSCA) Inventory Representation and Equivalency Determinations for Renewable and Sustainable Bio-based Chemicals.”  BRAG and BIO members provided a presentation for EPA staff that outlined the regulatory challenges and market impendence facing the biobased industry related to current naming conventions.  BRAG and BIO look forward to further dialogue with EPA on this crucial issue.


 

By Lynn L. Bergeson

On June 18, 2018, Richard E. Engler, Ph.D., Director of Chemistry, Bergeson & Campbell, P.C. (B&C®), will present “New TSCA and Green Chemistry Innovation” at the 22nd Annual Green Chemistry & Engineering Conference (GC&E), hosted by the American Chemical Society’s (ACS) Green Chemistry Institute®. GC&E will highlight product innovation using greener chemistries and provide an opportunity for a diverse group of academic, industrial, and government stakeholders to network and learn about the newest ideas in sustainable approaches to chemistry, chemicals, processes, and products. The conference will be held in Portland, Oregon, from June 18 - 20, 2018, and online registration is now open. B&C is a proud sponsor.


 

On March 2, 2018, Lauren M. Graham, Ph.D., Manager of the Biobased and Renewable Products Advocacy Group (BRAG®), presented “Advocating for Commercialization of Biobased Products” at the 2018 Advanced Bioeconomy Leadership Conference (ABLC2018).  Dr. Graham presented as part of the “Federal Perspective & Programs Forum” alongside four other panelists.  Dr. Graham provided an overview of the Toxic Substances Control Act (TSCA) regulation impacting biobased chemicals and the regulatory barriers to the commercialization of such chemicals.  The presentation highlighted issues with the TSCA nomenclature system, as well as the work being done by BRAG to address the obstacles to commercialization and to engage in the implementation of new TSCA. If companies wish to ensure equitable regulations for biobased chemicals and products, they should consider joining BRAG to assist with future engagement with the U.S. Environmental Protection Agency (EPA).  For a copy of this presentation or for more information on BRAG, please contact Dr. Graham at .(JavaScript must be enabled to view this email address).
 
On March 1, 2018, Richard E. Engler, Ph.D., Senior Chemist for Bergeson & Campbell, P.C. (B&C®), presented “New TSCA and Biobased Innovation” at ABLC2018.  Dr. Engler presented as part of the Renewable Chemicals Summit and provided an overview of the impact new TSCA has had on EPA’s review of new chemicals under TSCA Section 5.  Pursuant to new TSCA Section 5, EPA must make an affirmative determination on every new chemical review, which has resulted in significant delays in the review process and increased regulation of new chemicals.  For a copy of this presentation, please contact Dr. Engler at .(JavaScript must be enabled to view this email address).

Tags: ABLC, TSCA

 

By Lauren M. Graham, Ph.D.

Industrial Biotechnology recently published a special issue to highlight the advances and challenges in algae-based products and applications.  The article, written by B&C® Consortia Management, L.L.C. (BCCM) affiliate Bergeson & Campbell, P.C. (B&C®) Managing Partner, Lynn L. Bergeson; B&C Senior Chemist, Richard E. Engler, Ph.D.; and BCCM Manager, Lauren M. Graham, Ph.D., examines the complex regulatory domain and discusses the significance and implications of the Toxic Substances Control Act (TSCA) for industrialized microorganisms, such as algae.  The article titled “TSCA Affects on Algae, Other Novel Biosources, and Bioprocesses” provides an overview of the fundamentals of TSCA, the U.S. Environmental Protection Agency’s (EPA) review of new substances, the impact that chemical identity has on EPA’s regulation of new substances, and available reporting exemptions.  In the article, the authors highlight the need for chemical product innovators “to understand how TSCA, significantly amended in 2016, applies to biomass starting material, including industrial microorganisms (such as algae); intermediates; and commercial products, and build TSCA compliance into business timelines and budgets.”  While the products of industrial microbes have the potential to reduce toxicity, greenhouse gas (GHG) emissions, and dependence on non-renewable resources, companies must comply with TSCA and the Federal Food, Drug, and Cosmetic Act (FFDCA) to ensure that such products successfully enter the market.


 

By Lauren M. Graham, Ph.D.

On June 15, 2017, Richard E. Engler, Ph.D., Senior Chemist at Bergeson & Campbell, P.C. (B&C®), presented at Products as Solutions to Real-World Sustainability Challenges: Incentives & Barriers, a session at the 2017 Green Chemistry & Engineering Conference (GC&E).  Dr. Engler’s presentation, “TSCA, its effects on renewable feedstocks, and how TSCA reform has changed things,” provided an overview of the Toxic Substances Control Act (TSCA) and aspects of TSCA reform that impact green chemistry, including both biobased materials and sourcing from byproducts or other wastes.  The presentation discussed how the use of a chemical substance determines TSCA regulatory requirements for the entire supply chain, including starting materials, intermediates, and catalysts (including enzymes and microbes).  To demonstrate this point, Dr. Engler reviewed scenarios under which TSCA reporting requirements for byproduct generators and processors would change based on how the byproduct is processed and used.  Dr. Engler highlighted the need for communication on TSCA reporting throughout the supply chain to ensure compliance and minimize potential commercial disruptions.
 
For more information or to request copies of the presentation materials, please contact .(JavaScript must be enabled to view this email address).


 

On March 2, 2017, Kathleen M. Roberts, Executive Director of the Biobased and Renewable Products Advocacy Group (BRAG®), participated as a panelist alongside four other trade associations in the “Domestic Policy Forum” at the 2017 Advanced Bioeconomy Leadership Conference (ABLC2017).  Ms. Roberts discussed the challenges facing the bioeconomy, including the implementation of the amendments to the Toxic Substances Control Act (TSCA), issues with the TSCA nomenclature system, and the potential for increased scrutiny of renewable products under the current Administration, as well as the work being done by BRAG to address these challenges and to level the playing field for biobased chemicals.  If companies wish to ensure equitable regulations for biobased chemicals and products, they should consider joining BRAG to assist with future engagement with EPA.

On March 2, 2017, Richard E. Engler, Ph.D., Senior Chemist for Bergeson & Campbell, P.C. (B&C®), presented “New TSCA: How Renewable Chemicals Survive and Thrive” at ABLC2017.  Dr. Engler presented as part of the Renewable Chemicals Summit and provided an overview of amended TSCA with a focus on the fundamental changes that will impact the bioeconomy.  Amendments to TSCA Section 5 require EPA to make an affirmative determination on every new chemical review, which has resulted in significantly more regulations for new chemicals.  Additionally, under amended TSCA, Congress has the authority to preempt state action, and EPA has increased testing authorities, as well as the authority to determine chemical substances as equivalent and the authority to increase fees under Sections 4, 5, 6, and 14.  For a copy of this presentation, please contact Dr. Engler at .(JavaScript must be enabled to view this email address).

Tags: ABLC, TSCA, B&C, BRAG

 

Lynn L. Bergeson, Managing Partner of Bergeson & Campbell, P.C. (B&C®), and Charles M. Auer, Senior Regulatory and Policy Advisor with B&C, have published “An Analysis of TSCA Reform Provisions Pertinent to Industrial Biotechnology Stakeholders,” in Industrial Biotechnology. This article discusses how the “New [Toxic Substances Control Act (TSCA)] fundamentally changes the U.S. Environmental Protection Agency's (EPA) approach to evaluating and managing industrial chemicals, including genetically engineered microorganisms. The body of changes, the careful balancing of countless competing needs and interests, and artful drafting yield a statute that has been greatly strengthened and addresses virtually all of the deficiencies that have impeded TSCA's effectiveness over the years.  The changes are consequential, and stakeholders in the industrial biotechnology community could be greatly impacted by them, depending upon how EPA interprets and discharges its new authorities. This article highlights key changes of which stakeholders should be aware, sets forth the law's schedule by which EPA is to implement the changes, and identifies opportunities for stakeholders to engage in rulemaking or other activities to help influence the implementation process to ensure that it is firmly rooted in a clear understanding of the science, and of the risks and benefits offered by products of industrial biotechnology.”


 

On November 9, 2016, Inside EPA published “ New TSCA Requirements Raise Challenges To EPA Biotech Review Staff” (subscription required), outlining what EPA has done to adapt to revised Toxic Substances Control Act (TSCA) requirements for engineered microorganisms.   Richard E. Engler, Ph.D., Senior Chemist with Bergeson & Campbell, P.C. (B&C®), was quoted in the article discussing what to expect from approaching biotechnology regulations:  

Richard Engler, a former EPA toxics official now a senior chemist with environmental law firm Bergeson & Campbell, attended the [Second Public Meeting and Opportunity for Public Comment on EPA's Draft Algae Guidance for the Preparation of TSCA Biotech Submissions] and said in a Nov. 3 interview with Risk Policy Report, "I think EPA's still figuring out what 'reasonably foreseeable' means.  It's a challenge for chemicals as well as microorganisms.
 
Noting that the Lautenberg Chemical Safety Act, which reformed TSCA, "is silent on microorganisms," Engler adds that the "effect of Lautenberg is parallel for chemicals and microorganisms."  A key change in the updated law, Engler says, is the new requirement that EPA make an affirmative decision on whether new chemicals or microorganisms meet TSCA's risk standard of "will not present an unreasonable risk of injury to health or the environment," which is "true for chemicals and microorganisms."
 
One difference that Engler notes is that if a newly submitted chemical "is a new microbe, it increases the data need for EPA to show not likely to present" unreasonable risk.
 
[…]
 
Engler said that what Segal described is "what [significant new use rules (SNURs)] do.  They limit releases of substances or an organism so the commercial activity in the notice is permitted but if another company wanted to use [it] in a different manner a significant new use notice is required."
 
As an example, Engler said that "if a [microbial commercial activity notices (MCAN)] submitter had a contained use [of a microorganism] with complete destruction of the organism but if EPA was unsure . . . they might place a SNUR on the microorganism that the submitter or anyone else would have to abide by."
 
In this example, as in other cases, Engler said, EPA would treat a new organism and the decision on whether to place a SNUR on other uses of that microorganism as it would a new chemical.  "It's the same rules," he said.  "The hazards are different, there are other risks because they're living organisms.  There are concerns about gene transfer between the MCAN organism and whatever's in the wild.  But the criteria is the same and the regulatory tools they use to contain are the same."
 
One change that Engler noticed is that all SNURs will now be accompanied by a consent order.  "EPA said that their interpretation of Lautenberg is that if they make a 'may present' finding, they must also impose a Section 5(e) consent order.  In the past we could do a non 5(e) SNUR."
 
"Their new interpretation is they have to do a consent order" with a SNUR," Engler said.  "The effect depends on what the consent order says.  It may say, 'SNUR is in effect until the SNUR is published'" once the commercial activity commences.  "In the past, [5e orders] were typically used to impose testing" requirements.
 
Like other elements of changes to TSCA, Engler said that the consent order changes will apply equally to chemicals and microorganisms.  "With TSCA reform in place, I'm not sure what consent orders will look like," he said.  "But that will be the same for chemicals and microbes."

 

On October 25, 2016, Richard E. Engler, Ph.D., Senior Chemist with Bergeson & Campbell, P.C. (B&C®), presented “Under-appreciated Regulatory Barriers to Commercialization of Algae and Algal Products” at the Algae Biomass Summit in Phoenix, Arizona. Dr. Engler’s presentation was part of the Legal, IP and Regulatory Issues -- Challenges and Opportunities track of the summit, and explored how algae processing and use is regulated by the Federal Food, Drug, and Cosmetic Act (FFDCA) and the Toxic Substances Control Act (TSCA). The TSCA Inventory lists all chemical substances that may be manufactured or imported into the U.S. for TSCA purposes, and all chemicals in commerce must be on the TSCA Inventory or eligible for exemption. Intergeneric algae are reportable under TSCA, as well as spent biomass byproduct, depending on use. Algae and algal products have similar requirements to demonstrate safety under FFDCA, but this is done mainly through scientific studies as there is no list (or inventory) published by the U.S. Food and Drug Administration (FDA) of approved ingredients. Dr. Engler ended the presentation by emphasizing the need to understand regulatory burdens and seek assistance in preparation, review, and communication with regulators to bring a product to market. For a copy of this presentation, contact Dr. Engler at .(JavaScript must be enabled to view this email address).


 
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