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."

 

Richard E. Engler, Ph.D., Senior Chemist at Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®), made two presentations at the Chemical Watch Global Business Summit held in Brussels, Belgium from February 22-25, 2016. Dr. Engler presented during the "Green (Sustainable) Chemistry: The business and economic case for sustainable chemistry" seminar. His presentations are described below. For a full copy of either of these presentations, please contact Dr. Engler at .(JavaScript must be enabled to view this email address).

"Latest Developments in Green Chemistry in the US and possible applications in the EU"

Dr. Engler's first presentation covered the progress made by EPA and the Organization of Economic Cooperation and Development (OECD) in defining and promoting the adoption of Green Chemistry (GC). Both EPA and OECD's definitions of GC do the following:

  • Incorporate design;
     
  • Concern products and processes;
     
  • Concern health and environmental endpoints;
     
  • Include material and energy efficiency; and
     
  • Recognize incremental improvements.

The presentation explored drivers for green chemistry and barriers to adoption, as well as examples of green chemistry from the U.S. Presidential Green Chemistry Challenge Awards (PGCCA).


 

"California's Approach to Green Chemistry"

Dr. Engler began his second presentation with an overview of the history of GC in California. California has historically been forward-thinking in regards to sustainability, and its approach to GC is no exception. In the mid-2000's, California began debating the Green Chemistry Initiative (GCI), a program to increase the development of GC through statewide incentives. The California GCI current initiatives are:

  • Reviewing the high priority products:
     
    • Spray polyurethane with unreacted methylene diphenyl diisocyanate (MDI);
       
    • Paint strippers with dichloromethane; and
       
    • Children's foam-padded sleep products with flame retardants tris-(1,3-dichloro-2-propyl) phosphate (tris or TDCPP) or tris-(2-chloroethyl) phosphate (TCEP);
       
  • Developing Alternative Assessment (AA) Framework; and
     
  • Participating in the Interstate Chemical Clearing House that will contain information about hazardous chemicals used in California.

Dr. Engler also discussed differences and similarities between requirements of the Toxic Substances Control Act (TSCA) and California GCI, and how other GC programs function.


 

For more information or a copy of either of these presentations, please contact Dr. Engler at .(JavaScript must be enabled to view this email address).