Regulatory Developments

EPA Posts Information on Biotechnology Algae Project

August 3, 2015

The U.S. Environmental Protection Agency (EPA) has posted a document concerning its development of a project intended to support public dialog concerning the development and use of biotechnology.  EPA has oversight responsibility for the production and use of intergeneric cyanobacteria, eukaryotic microalgae, and their products by application of genetic engineering approaches.  EPA’s recently posted document, US Environmental Protection Agency Biotechnology Algae Project, states that it is focusing its project around these biotechnology algae applications.

As part of its efforts to implement the Toxic Substances Control Act (TSCA), EPA provides technical support for reporting on new chemical substances and microorganisms that are not yet in commerce.  EPA’s 1997 document Points to Consider in the Preparation of TSCA Biotechnology Submissions for Microorganisms (Points to Consider) assists those who intend to submit pre-manufacture microbial commercial activity notices (MCAN) or TSCA experimental release applications (TERA) for various commercial products.  According to EPA, the Points to Consider document helps submitters identify and organize the information and data they provide to inform EPA’s required risk assessments.  An important component of EPA’s recent announcement is a somewhat muted statement that it is “currently updating the Points to Consider to accommodate the development of new information relevant to risk assessment of biotechnology products regulated under TSCA.”  According to EPA, the Points to Consider document does not currently provide specific support for those using the emerging technologies of algae production and biotechnology.  EPA states that to keep its risk assessment process for biotechnology algae open and transparent, it intends “to develop a separate document on the scientific and technological issues it currently understands to be key and unique for evaluating risks from the production and use of biotechnology algae.”  EPA will develop its “Considerations for Biotechnology Algae” document in parallel with updating the Points to Consider.

According to EPA, the updates to the Points to Consider “will be enhancements of the current detailed, how-to content for submitters to think about as they prepare submissions.”  EPA notes that the current document is organized to reflect the components of risk assessments for microorganisms, but this format is not optimally designed to address specific considerations informing the evaluation of biotechnology or algal technologies submitted under TSCA.  The “Considerations for Biotechnology Algae,” as a separate, stand-alone document, can organize the information in a consolidated manner that can assist those developing new microbial technology applications that have emerged since EPA last revised the Points to Consider.  EPA notes that “[e]ven those applications that employ both algal and genetic engineering technologies simultaneously can be highlighted in a way that the current Points to Consider cannot readily do.”  According to EPA, the separate biotechnology algae document can serve other purposes, unlike the Points to Consider.  EPA states that the “Considerations for Biotechnology Algae” document “can also -- through its use as an example of an actual, practical governance tool -- help advance discourse around broader societal implications of biotechnology.  Once fully developed, it will be a source of information that could be folded into the Points to Consider, within its current structure or in other ways, such as an addendum, or it could remain as a stand-alone complement to the Points to Consider.”

EPA states that it expects that the process of revising the Points to Consider and developing a companion document on considerations for biotechnology algae will lead to the identification of technical, environmental, and social science research needs related to the introduction of such products into society.  According to EPA, addressing these research needs may directly or indirectly support its evaluation of such products under TSCA, as well as more broadly help advance the responsible development and application of biotechnology.  Therefore, as EPA develops its considerations document for biotechnology algae, EPA states that it “welcomes public input not only on technical environmental assessment issues, but also on the societal benefits and implications of biotechnology algae products.”

EPA intends to facilitate such engagement by holding an expert workshop, open to the public, during the week of September 28, 2015.  While the workshop will focus on the technical questions that EPA believes are important to its development of a biotechnology algae considerations document, EPA states that it will also provide an opportunity to stakeholders and the general public to comment on any aspects of biotechnology algae they believe are relevant to EPA’s mission.

Following the workshop, EPA will consider the public input as it begins to draft its biotechnology algae considerations document.  EPA expects that feedback on the biotechnology algae document will also inform its update of the Points to Consider document.  EPA recognizes that some input may relate to issues that fall outside the scope of the document and EPA’s premanufacture review authority under TSCA.  EPA expects that public awareness of its biotechnology algae document will lead to broader questions about the introduction of genetically modified organisms and other biotechnology products into society.  EPA states:  “While the discussion of such questions likely will have to occur outside EPA’s document-development process, and be facilitated by entities other than EPA, the Agency welcomes this discourse as important to democratic engagement in the development and introduction of new technologies into society.”

EPA notes that the number of TSCA biotechnology submissions is increasing rapidly.  As of June 2015, the number of submissions had already surpassed previous years’ totals.  According to EPA, most newer cases employ some form of biotechnology, such as the use of chemically synthesized, codon optimized genes.  Importantly, EPA notes its appreciation that some of the algae submissions are from companies that “have had little or no experience with new substance review under TSCA.”  EPA expects that for these companies in particular, it will be useful to have guidance on how to submit an MCAN or TERA that includes information to help answer the questions that EPA will ask in its evaluation of their submissions.  Consolidating information on emerging technologies will make it easier for interested parties to understand both what information is needed to support risk assessments, as well as why such information is needed.

EPA states that it recognizes the potential of biotechnology to create new benefits for society, and, therefore, supports its development in the U.S.  According to EPA, the biotechnology algae considerations document “will increase the likelihood that MCAN and TERA submitters receive expeditious EPA review of their submissions, and that any products that are approved, and ultimately commercialized, maximize their benefits to society by minimizing their potential for negative impacts on human health and the environment.”  EPA “understands that the development and evolution of any technology, including biotechnology, is subject to debate within democratic societies.”  EPA states that as with other emerging technologies, it “believes that the responsible development of biotechnology should include discourse around introducing biotechnology applications and products into society.  EPA’s creation of a biotechnology algae considerations document can play a positive role in advancing public discourse and supporting the responsible development of biotechnology products.”

Commentary

EPA’s posting of the biotechnology algae project is hugely important for the industrial biotechnology communities.  EPA’s announcement suggests a broader Agency initiative is underway, and is best read in the context of other relevant developments.

First, on July 2, 2015, the White House Office of Science and Technology Policy (OSTP), the Office of Management and Budget (OMB), the U.S. Trade Representative, and the Council on Environmental Quality issued a memorandum directing EPA, the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) to update the Coordinated Framework for the Regulation of Biotechnology.  The memorandum reflects the Administration’s acknowledgement that the Framework needs to be updated to reflect the tremendous explosion of new technologies addressed by the federal family or regulatory agencies and the lack, in some instances, of a coherent regulatory framework that innovators and others can anticipate and follow in commercializing their products.  More information on the update to the coordinated framework in available in our memoranda “Biotechnology:  White House Directs EPA, FDA, and USDA to Update the Coordinated Framework for the Regulation of Biotechnology.”

Second, EPA has been mentioning since at least last October that it is updating it Points to Consider document, which was already in need of a do-over since its last revision almost two decades ago.  EPA’s acknowledgement, in writing, that this process is underway is significant.  More information is needed, however, so stakeholders can assist EPA with this process.  For those of us assisting innovators with preparing MCANs and TERAs, we appreciate that the regulated community and academic research organizations have much to offer EPA with improving and updating the Points to Consider document.  The sharp spike in MCAN submissions reflects the tremendous commercial activity in this area, and the need for more clarity, more EPA staff, and more EPA resources to manage the demand.

Third, EPA’s stand-alone biotechnology algae project confirms what we have predicted:  namely that most recent biotechnology submissions involve some aspect of synthetic biology.  EPA expects many more down the road.  The biotechnology algae project presumably will capture aspects unique to these applications and focus on algal technologies.  That EPA is convening an expert workshop that will provide an opportunity for stakeholder input during the week of September 28 means there is not a lot of time to identify and prioritize issues in a way most helpful to assist EPA’s much needed efforts.  As EPA recognizes and “welcomes” public input at the workshop, the workshop discussion is likely to include aspects that fall outside of EPA’s TSCA responsibilities, such as the societal implications of biotechnology algae.  This point highlights the need for the developers and the commercial innovators using this technology to be prepared to explain the steps they are taking to ensure responsible commercial development and use of biotechnology.

On the whole, these activities are a big deal and offer huge opportunities for innovators and interested others.  We are organizing consortia now to make the most of this opportunity, and urge stakeholders to engage quickly to make the most of this development.


 
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