Comments Submitted on USDA Biotech Regulations

I’ve just submitted comments in response to the recent notice from the USDA Animal and Plant Health Inspection Service (APHIS) requesting public comment on certain questions relating to the agency’s biotechnology regulations. On February 5, 2016, APHIS published a notice in the Federal Register (81 FR 6225-6229, Docket No. APHIS-2014-0054) stating its decision to complete a programmatic environmental impact statement (EIS) in connection with the revisions and amendments to the biotechnology regulations that are under consideration at the agency. According to APHIS, these proposed revisions primarily consist of amendments to its regulations covering introductions into the environment of genetically modified plants and agricultural microorganisms, in order to address advances in biotechnology and issues raised by stakeholders. The APHIS notice described the range of proposed alternatives that are currently under consideration for evaluation in the EIS, and the agency requested public comment on these and other issues.

The APHIS biotechnology rule (7 CFR Part 340) is the primary U.S. regulation that has governed the agricultural biotechnology industry. Although having its primary impact on agricultural crops, this rule would also potentially apply to any developer of transgenic plants to be used as feedstocks for the production of biofuels or bio-based chemicals. Although not explicitly stated in the agency’s posting, this action is taking place at the same time all federal agencies have been directed by the White House to reexamine their biotechnology regulatory policies under the Coordinated Framework (see my August 5, 2015 post and other recent posts on the blog), and so any changes APHIS may propose to its regulations might be adopted within the overall time frame of the White House effort.

My comments touched on the following points:

  • The existing APHIS regulations under 7 CFR Part 340 have been successful, and there have been no demonstrable adverse effects arising from plants or microorganisms subject to the regulations, in spite of the allegations or concerns of biotech critics and other observers.
  • APHIS has gained a considerable knowledge base and expertise in the review of the environmental impact of modified plants and agricultural microorganisms.
  • Nevertheless, it is appropriate for USDA to review the scope of the Part 340 regulations, and to consider other revisions to the rules, in view of changes in statutory authority, advances in technology, and the agency’s years of experience in regulating agricultural biotechnology.
  • I expressed support for one of the alternative regulatory approaches proposed in the APHIS Federal Register notice, which it appears APHIS would use to establish categories of activities or articles not needing prior APHIS review or notification at any level of use.
  • I further suggested that any revision to the regulations should include a provision under which almost all small-scale research field tests can take place without prior APHIS notification, as long as the test follows accepted performance standards, perhaps subject only to a simple online registration.

It is very hard to predict what will come of this effort. USDA has tried once before to revise the Part 340 regulations, by publishing a proposed revised rule in 2008 which was eventually withdrawn from consideration. The agency received more than 88,000 comments on that proposed rule. Although no detailed explanation was given for the decision to withdraw, my guess is that USDA found itself torn between competing objectives. On the one hand, the agency wanted to strengthen the scientific basis for its reviews of proposed field activities by more formally allowing the consideration of noxious weed risk and other ecological issues, in response to critics and biotech opponents that had questioned the adequacy and scope of APHIS’s environmental reviews. But on the other hand, there was likely strong sentiment within the regulated community that field testing and other activities with the more familiar crop species should be deregulated in whole or in part, based on the significant accumulated experience with such species. I suspect that, especially in view of the avalanche of public comments it received, the agency was not able to navigate between these two competing objectives. The same dynamic may arise in the current attempt as well.

Please contact me to obtain a complete copy of my comments, or with any questions you may have about this process. The comment period has been extended until April 21, 2015, and comments can be submitted at!docketDetail;D=APHIS-2014-0054.

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 and 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.