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 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).


 

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

Register Today

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.

Register Online

Speakers:

  • 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

Register Today

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
       
    • Nomenclature.
       
  • 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.

 

Monday, September 12, 2016
8:00 a.m. Pacific Daylight Time/11:00 a.m. Eastern Daylight Time/16:00 British Summer Time

Register Today

Biobased and Renewable Products Advocacy Group (BRAG®) affiliate Bergeson & Campbell, P.C. (B&C®) and Chemical Watch have collaborated to present a series of complimentary webinars on the reformed Toxic Substances Control Act (TSCA). 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
       
    • Nomenclature.
       
  • 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.

Previous webinars in the series:

Webinar 1 -- The New TSCA -- Overview and Summary of Major Changes: What to Expect and When to Expect It, June 13, 2016; and

Webinar 2 -- Impacts on New and Existing Chemicals Programs (TSCA Sections 4, 5, and 6), July 14, 2016.

To request materials from previous webinars, please contact .(JavaScript must be enabled to view this email address).


 

On September 12, 2016, Lynn L. Bergeson, Managing Partner of Biobased and Renewable Products Advocacy Group (BRAG®) affiliate Bergeson & Campbell, P.C. (B&C®); Richard E. Engler, Ph.D., B&C Senior Chemist; and Kathleen M. Roberts, Vice President of B&C Consortia Management, L.L.C. (BCCM), will present "The New TSCA: Information and Reporting (Sections 8 & 14)" in conjunction with Chemical Watch. This free webinar is the third in Chemical Watch's Toxic Substances Control Act (TSCA) reform series, and will focus on reporting and recordkeeping obligations, confidential business information (CBI) considerations, nomenclature, the "reset" of the TSCA inventory, and obligations for processors. The first two webinars in this series, "Summary of major changes: what to expect and when to expect it" and "Impacts on new and existing chemicals programs" are available on the Chemical Watch website.


 

On August 2, 2016, Lynn L. Bergeson, Managing Partner of B&C, presented the webinar "New TSCA's Impact on Biotechnology," with the National Academies of Sciences, Engineering, and Medicine (NAS). This webinar, available for free on the NAS website, includes an overview of TSCA updates resulting from the passage of the Frank R. Lautenberg Chemical Safety for the 21st Century Act. Ms. Bergeson focused specifically on how these updates could impact the regulation of biotechnology, especially under Sections 3, 4, 5, and 26. Changes include: how EPA defines "conditions of use" and "potentially exposed or susceptible subpopulations," and applies them to intergeneric microorganisms; an expansion of EPA's authority to compel testing; and a requirement for EPA to provide an affirmative determination when reviewing Section 5 notifications.


 

On July 15, 2016, Environmental Leader published "What Does the Loss of 'Green Chemistry' Provision from Amended TSCA Mean for Biochemicals?," featuring comments by Lynn L. Bergeson, Managing Partner of Biobased and Renewable Products Advocacy Group (BRAG®) affiliate Bergeson & Campbell, P.C. (B&C®). Ms. Bergeson expanded on a previous blog post titled "Inside EPA Reports On Loss Of Green Chemistry Provision From TSCA Reform," stating:

"While regrettable, the absence of the green chemistry provisions in the amended Toxic Substances Control Act (TSCA) is a setback, not a deal breaker," Bergeson told Environmental Leader. "The green chemistry provisions in Section 24 of H.R. 2576 were taken from Senator Chris Coons' (D-DE) Sustainable Chemistry Research and Development Act. Section 24 was eliminated reportedly because its inclusion would have been subject to review by the House Science, Space, and Technology Committee, a different House Committee from the House Energy and Commerce Committee that had primary jurisdiction over TSCA reform, potentially complicating and delaying an already complicated and time-sensitive Congressional review process. The decision to forego this review and eliminate the green chemistry provisions is disappointing, but a failed TSCA reform effort would have been more so."

Bergeson notes that the provision's absence in the updated chemical safety law eliminates -- for now -- the development of and funding for a green chemistry strategy at the federal level. Senator Coons is expected to introduce a similar bill next year.

Senators Coons, Susan Collins (R-ME), and Ed Markey (D-MA) have asked the U.S. Government Accountability Office (GAO) for a technology review of sustainable chemistry. "The report, expected to be complete in the spring of 2017, can help illuminate the options available to the federal government to promote green chemistry whether by instigating new legislation or by serving as a resource which existing legal authorities can use to support this field that is so vital to economic competitiveness and/or use to diminish the less positive impacts of chemistry throughout our economy," Bergeson stated.


 

On July 1, 2016, Inside EPA published "Committee Jurisdiction Issues Blocked Green Chemistry From TSCA Reform," an article discussing the passage of the Toxic Substances Control Act (TSCA) law and the lack of language from previous versions boosting federal support of green chemistry. The majority of the bill was reviewed by the House Energy and Commerce Committee, but the green chemistry provision would have needed to be reviewed by the House Science, Space, and Technology Committee, further complicating the fragile House and Senate negotiations. Inside EPA's source stated: "Nobody wanted to step on anybody's toes. [...] Pretty much everything else [was] in [Energy and Commerce's] jurisdiction or was sufficiently small enough [to not raise concerns.] There were a lot of concessions on all sides." The green chemistry provision was originally added to the Senate version of the TSCA Reform, the Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697), by Senator Chris Coons (D-DE), and was primarily focused on funding the research and development of green chemistry.

The green chemistry provision of S. 697 called for a study of how to best incentivize sustainable chemistry research and development, as well as support "economic, legal and other appropriate social science research to identify barriers to commercialization and methods to advance commercialization of sustainable chemistry." The bill also created a working group to coordinate federal sustainable chemistry activities that would be lead by EPA's research chief and the National Science Foundation (NSF) director, as well as an advisory council to coordinate with the working group. Although green chemistry language in S. 697 did not remain in the final version of the bill, there are still supporters in Congress who are prepared to work to get the programs outlined in S. 697 into law.


 
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