Recent Developments in U.S. Biotechnology Regulation

There have been two recent developments in U.S. federal government biotechnology regulation that may affect industrial biotechnology activities. I’m writing with some brief comments about these two recent announcements, to be followed in the days to come by more comprehensive analysis and discussion.

EPA Biotechnology Regulation

Of most significance to companies developing fuels, chemicals or enzymes using modified microorganisms, last week EPA quietly posted on their website a document entitled “US Environmental Protection Agency GM/Synbio Algae Project”. In this document (dated June 15 but apparently not posted until July 30), EPA announced that it was initiating a project to examine and promote “public dialog” about the development and use of genetically modified algae and cyanobacteria, including organisms modified by synthetic biology, intended for industrial purposes including those subject to EPA’s TSCA biotechnology regulations. The centerpiece of this process will be an updating of EPA’s 1997 “Points to Consider” guidance document for companies submitting notices under the TSCA regulations, to reflect new technologies that are not reflected in the guidance document. The document describes the project as follows:

EPA is currently updating the Points to Consider to accommodate the development of new information relevant to risk assessment of biotechnology products regulated under TSCA. This document currently identifies a broad range of risk assessment topics relevant to TSCA biotechnology submissions, providing technical support to assist those who must prepare microorganism premanufacturing notifications to EPA under TSCA. Those Points to Consider do not currently provide specific support for those using the emerging technologies of algae production and synthetic biology. To keep its risk assessment process for GM/synbio algae open and transparent, EPA 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 GM/synbio algae. EPA will develop its “Considerations for GM/Synbio Algae” document in parallel with updating the Points to Consider document.

So, in addition to merely updating the Points to Consider document to account for new technology developments, the agency intends to create a new guidance document specific for submissions involving algae or cyanobacteria, as well as for organisms created using synthetic biology technologies. As part of this process, EPA is hoping to convene a public meeting during the week of September 28, 2015, possibly co-located with the Algae Biomass Summit taking place that week in Washington, DC.

It happens that I’ve just recently given two presentations at the 2015 BIO World Congress on Industrial Biotechnology, that touch on both issues raised by EPA’s action — regulation of synthetic biology and regulation of modified algae. In these talks, I make the arguments that existing biotechnology regulations and risk assessment methods are sufficient to regulate industrial uses of synthetic biology,and that a roadmap exists under current EPA regulations for companies to obtain straightforward approvals of uses of modified algae and cyanobacteria. Both presentations can be downloaded from my SlideShare site, at the following links:

Government Regulation of Synthetic Biology: is the existing framework sufficient to address uses of SynBio in industrial biotechnology?

The Emerging Roadmap to Gain Regulatory Approvals for Uses of Genetically Modified Algae in Biofuel or Bio-Based Chemical Production

As I learn more about EPA’s intentions, I’ll post a more comprehensive summary and analysis of the project and its goals. Among the questions that come to mind are how will EPA define “synthetic biology” (a term which has been defined in many different ways by different observers in recent years) and what extra data might the agency require in the new guidance document for organisms falling into that category; why are they singling out algae/cyanobacteria and what additional data requirements might there be; and whether EPA’s concerns for algae relate primarily to possible open-pond uses of GM algae rather than contained uses.

White House Initiative to Update the Coordinated Framework

One thing that seems clear is that this action by EPA was triggered, at least in part, by the other recent development on the U.S. federal biotechnology scene. On July 2, 2015, the White House announced that it had issued a memorandum to the heads of the EPA, the U.S. Department of Agriculture, and the Food and Drug Administration, directing these agencies to begin a review of their biotechnology regulations under the 1986 “Coordinated Framework”, to determine whether revisions, updating, or other changes might be needed in view of new technologies and other developments since the adoption of the framework. As stated in the memorandum, the goals are “to modernize the Federal regulatory system for the products of biotechnology and to establish mechanisms for periodic updates of that system”.

This announcement is described in a page on an OSTP blog, and the agency memorandum itself can be found here. The memorandum, while asserting that the federal framework has provided effective management of health and safety risks, cites “unnecessary costs and burdens” that have in some cases arisen from jurisdictional uncertainty and unpredictable review timeframes, and that these have particularly disadvantaged small to mid-size companies. The memo also mentions the need to update the Framework in view of advances in science and technology that have been developed since its publication and 1992 revision.

The memorandum describes the formation of a new Biotechnology Working Group under the Emerging Technologies Interagency Policy Coordination Committee (ETIPC), which will carry out the activities mandated by the memo. Specifically, the Working Group has been tasked with developing an updated and clarified Coordinated Framework within one year, including a mechanism for regular reviews and updates of the Framework; developing a long-term strategy to ensure that the Framework is equipped to adequately assess risks without undue burdens on the regulated community; and producing annual reports on its activities for at least the first five years. The memo also directs EPA, USDA and FDA to commission an external, independent assessment of the possible future landscape of biotech products, to be sure that the Framework is equipped to deal with any potential risks posed by such developments.

The specific responses and actions of the agencies and the new Working Group will become more clear in the coming weeks. However, it appears that EPA’s action of last week is one component of that agency’s response to the White House directive. Even earlier, the USDA announced its intention to again revisit the scope of its biotechnology regulations, by formally abandoning a proposed rule for this purpose issued in 2008 and soliciting public comment on ideas for restarting such an effort, in a comment period that closed earlier this summer. That ongoing effort will presumably also take place under the new White House directive.

It’s hard to argue against the idea that, after almost 30 years under the original Coordinated Framework, it’s time for a review of its suitability and relevance in view of the significantly-improved and more powerful genetic technologies now available and in light of how biotechnology-dependent industries have evolved during that time. However, there is always the risk that opening such a comprehensive review of the existing framework might have unintended consequences or give rise to a new round of public concerns (whether or not promoted by activist groups) over the safety of the technology, especially when most observers agree that the existing framework largely continues to operate as originally intended and is doing a good job of assessing and managing risks. Here too, I plan to shortly post a more comprehensive summary of the White House’s action and an analysis of its implications for biofuel and bio-based chemical manufacture.

D. Glass Associates, Inc. is a consulting company specializing in government and regulatory affairs support for renewable fuels and industrial biotechnology. David Glass, Ph.D. is a veteran of over thirty years in the biotechnology industry, with expertise in industrial biotechnology regulatory affairs, U.S. and international renewable fuels regulation, patents, technology licensing, and market and technology assessments. More information on D. Glass Associates’ regulatory affairs consulting capabilities, and copies of some of Dr. Glass’s prior presentations on biofuels and biotechnology regulation, are available at at The views expressed in this blog are those of Dr. Glass and D. Glass Associates and do not represent the views of any other organization with which Dr. Glass is affiliated. Please visit our other blog, Biofuel Policy Watch.