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.
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.
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 12, 2016, the U.S. Environmental Protection Agency (EPA) announced a public meeting on the draft Algae Guidance for the Preparation of [Toxic Substances Control Act (TSCA)] Biotechnology Submissions (Algae Guidance) in the Federal Register. This meeting will receive public input and comments on the draft Algae Guidance that describes EPA’s data needs for supporting risk assessments of genetically engineered algae and cyanobacteria that are manufactured, imported, or processed, and are subject to regulations under Section 5 of TSCA. The meeting will be held in Tempe, Arizona on October 27, 2016. Only 120 people will be able to attend the meeting in person, however, due to space limitations. Registrants not able to attend in person can access the meeting through a live web stream and teleconference capabilities. Registration is available through the Eastern Research Group (ERG) website.
Tuesday, September 27, 2016
8:00 a.m. Pacific Daylight Time/11:00 a.m. Eastern Daylight Time/16:00 British Summer Time
Three months have passed since Toxic Substances Control Act (TSCA) reform was enacted, and now implementation trends are starting to take shape. Rather than waiting to see what TSCA reform's impact on your business might be, take control of your approach to "new" TSCA with the information and insight shared in "The New TSCA: What You Need To Know" webinar series presented by Chemical Watch and B&C.
Webinar 4 will cover:
- Section 6(h) -- Chemicals That Are Persistent, Bioaccumulative, and Toxic (PBT);
- Section 18 -- State-Federal Relationship and Preemption;
- Section 19 -- Judicial Review; and
- Section 26 -- Fees.
- Moderator -- Lynn L. Bergeson, Managing Partner, B&C;
- Charles M. Auer, Senior Regulatory and Policy Advisor, B&C, former Director of the Office of Pollution Prevention and Toxics (OPPT), U.S. Environmental Protection Agency (EPA);
- Richard E. Engler, Ph.D., Senior Chemist, B&C, former senior staff scientist in OPPT and leader of EPA's Green Chemistry Program;
- Lisa R. Burchi, Of Counsel, B&C; and
- Sheryl Lindros Dolan, Senior Regulatory Consultant, B&C.
Additional Webinars in "The New TSCA: What You Need To Know" Series:
- Webinar 1: Overview and Summary of Major Changes: What to Expect and When to Expect It, presented June 13, 2016.
- Webinar 2: Impacts on New Chemical Programs, presented July 14, 2016.
- Webinar 3: Inventory, CDR, and CBI (Sections 8 & 14), presented September 12, 2016.
- For a copy of any of these webinar recordings, click here.
Read B&C's TSCA blog for the latest news and analysis regarding TSCA reform, implementation, and related legal and administrative developments.
Monday, September 12, 2016
8:00 a.m. Pacific Daylight Time/11:00 a.m. Eastern Daylight Time/16:00 British Summer Time
Three months have passed since Toxic Substances Control Act (TSCA) reform was enacted and now implementation trends are starting to take shape. Rather than waiting to see what TSCA reform's impact on your business might be, take control of your approach to "new" TSCA with the information and insight shared in the "The New TSCA: What You Need To Know" webinar series presented by Chemical Watch and Bergeson & Campbell, P.C. (B&C®).
Webinar 3, "Inventory, CDR, and CBI" will cover:
- Section 8 Reporting and Retention of Information:
- Small Manufacturer Definition;
- Reporting by Processors;
- Byproduct Rulemaking and Reporting;
- TSCA Inventory; and
- Section 14 Confidential Business Information (CBI):
- Information Not Protected;
- Asserting CBI;
- Presumptive CBI;
- Requirements for CBI Claims;
- Exemptions to Protection from Disclosure;
- Review and Resubstantiation;
- Duties of Administrator; and
- Criminal Penalties.