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 July 29, 2016, President Obama signed into law Senate Bill 764 (S. 764), creating a national bioengineered food disclosure standard. This law requires companies to provide information on food packaging directing customers to a website or phone line for more information about genetically modified organisms (GMO) that are present in the food product. S. 764 also contains specific language preempting State regulations on "labeling of whether a food (including food served in a restaurant or similar establishment) or seed [in interstate commerce] is genetically engineered ... or was developed or produced using genetic engineering."
In addition to requiring companies to disclose the presence of bioengineered ingredients, S. 764 creates an official definition of bioengineering as "a food -- (A) that contains genetic material that has been modified through in vitro recombinant [DNA] techniques; and (B) for which the modification could not otherwise be obtained through conventional breeding or found in nature." The law also creates a "non-GMO" label that can be displayed on products that are U.S. Department of Agriculture (USDA) "certified organic." While harmful effects of GMOs have not been proven, this law allows consumers to educate themselves on the ingredients in their food while creating consistent national language and requirements for bioengineered foods. More information about this bill is available in the Biobased and Renewable Products Advocacy Group's (BRAG®) article "Senate Passes GMO Bill Creating A National Bioengineered Food Disclosure Standard With Federal Preemption And Exclusion Information."
On July 7, 2016, the Senate passed a bill, An Act to Reauthorize and Amend the National Sea Grant College Program Act, and for Other Purposes (S. 764), through agreement to the House's amendment to S. 764, with further amendment. While the bill is being referred to as a genetically modified organism (GMO) labeling bill, there is no actual requirement to print GMO ingredients on labels. Instead, companies would be required to print information on the packaging (through text, a symbol such as a QR code, or an electronic link) directing consumers to a website or phone line for more information. The national bioengineered food disclosure standard includes a definition for "bioengineering": "a food - (A) that contains genetic material that has been modified through in vitro recombinant [DNA] techniques; and (B) for which the modification could not otherwise be obtained through conventional breeding or found in nature," as well as specifics on how the new standard will be established through requirements and procedures. The new requirements and procedures include the following:
- Prohibition of a food derived from an animal to be considered a bioengineered food solely because the animal consumed feed produced from, containing, or consisting of a bioengineered substance;
- Determination of the amounts of a bioengineered substance that may be present in food for the food to be a bioengineered food;
- Establishment of a process for requesting and granting a determination by the Secretary regarding other factors and conditions under which a food is considered a bioengineered food;
- Provision of alternative reasonable disclosure options for food contained in small or very small packages; and
- Requirements and procedures specific to small food manufacturers.
Subtitle F includes a section on federal preemption, which states that any state regulations on "labeling of whether a food (including food served in a restaurant or similar establishment) or seed [in interstate commerce] is genetically engineered ... or was developed or produced using genetic engineering," and also a section on exclusion from federal preemption -- that nothing in the subtitle, or in Subtitle E, "shall be construed to preempt any remedy created by a State or Federal statutory or common law right." The bill will allow producers with a U.S. Department of Agriculture "certified organic" designation to display an additional "non-GMO" label on their products. S. 764 is now back in the House and is expected to be taken up before Congress's seven week recess beginning July 15, 2016.
The U.S. Environmental Protection Agency (EPA) announced last week that it is developing a project intended to support public dialog concerning the development and use of synthetic biology (Synbio) algae. EPA has oversight responsibility for the production and use of intergeneric microorganisms, including cyanobacteria, eukaryotic microalgae (genetically modified (GM) algae), and their products by application of genetic engineering approaches, including those called Synbio. EPA's recently posted document, US Environmental Protection Agency GM/Synbio Algae Project, states that it is focusing its project around GM/Synbio algae applications.
EPA intends to facilitate the development of the GM/Synbio algae project by holding an expert workshop, open to the public on September 30, 2015. While the workshop will focus on the technical questions that EPA believes are important to its development of a GM/Synbio algae considerations document, EPA states that it will also provide an opportunity to stakeholders and the general public to comment on any aspects of GM/Synbio algae that they believe are relevant to EPA's mission.
EPA's posting of the GM/Synbio algae project is hugely important for the industrial biotechnology and synthetic biology communities. EPA's announcement suggests a broader Agency initiative is underway, and is best read in the context of other relevant developments. Full details on this announcement and related developments are available in Biobased and Renewable Products Advocacy Group (BRAG®) affiliate Bergeson & Campbell P.C. (B&C®)'s memorandum EPA Posts Information on GM/Synbio Algae Project.
The National Research Council (NRC) of the National Academies hosted the first public meeting for the Committee on Genetically Engineered Crops: Past Experience and Future Prospects on September 15-17, 2014. This public meeting was the first of a series of events that are part of NRC's ongoing study to determine the benefits and risks of genetically engineered crops. A webinar related to this study has been scheduled for October 1, 2014, and more information is available online. A transcript of the public meeting held September 15-17, 2014, is available online.