November 30, 2015
Those tuned into the biotechnology regulatory landscape will have noticed quite a few changes and announcements from the federal government lately. Several agencies have been asking for public comments, announcing proposed rules, releasing guidance, and taking other actions related to biotechnology, or genetic engineering (“GE”).
The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) solicited comments in June 2015 on the withdrawal of a proposed rule on biotechnology regulation. And APHIS’ Biotechnology Regulatory Services (BRS) held a stakeholder meeting last week to discuss a new proposed rule, which is expected to be released next summer.
In the midst of these macro-level changes, APHIS requested comments on a petition to deregulate a new variety of herbicide tolerant corn. Meanwhile, the Food and Drug Administration (FDA) gave the green light to GE salmon — the first genetically engineered animal intended for food — and denied a petition to label GE foods, despite strong support for such labels from the public and Members of Congress.
Amid this flurry of activity, the White House Office of Science and Technology Policy (OSTP) is updating the Coordinated Framework for the Regulation of Biotechnology, which was written in 1986 and updated once in 1992. This document sets out how the USDA, FDA, and Environmental Protection Agency (EPA) are to coordinate with one another in their shared oversight of biotechnology. OSTP recently asked the public to submit comments on updating the Coordinated Framework.
In our view, this recent suite of federal actions – taken without providing the public with any clue to how the various actions relate to each other, or any strategy to explain how the public’s comments will be integrated and considered across the related actions – demonstrates a clear and urgent need for improved coordination and transparency across the several agencies tasked with the oversight of GE products.
As NSAC recently noted in our comments to OSTP on the Coordinated Framework, the public needs clear information regarding the multiple Administrative actions recently taken on biotechnology and their relation to one another. This should include an overarching process by which the impacts of each action — and the public comments submitted on each — will be considered in a thoughtful and comprehensive manner.
The recent BRS stakeholder meeting showcased just how uncoordinated biotechnology regulations really are, and evidences the need for a more transparent and streamlined approach as the Administration considers updating GE regulations.
USDA To Propose New Biotechnology Rule
The Biotechnology Regulatory Services (BRS) enticed individuals to its annual Stakeholder Meeting on November 18 with a teaser involving discussion of a “possible new proposed rule.”
That new proposed rule would completely change BRS’ operations, according to APHIS Deputy Administrator for BRS Mike Firko. A division of APHIS, BRS aims to move from a “regulate first, analyze later” framework to “analyze first, only regulate if it presents a risk.”
Administrator Firko said BRS would only regulate if there is a documented risk after completing a plant pest assessment. BRS developed a new Weed Risk Assessment tool for this purpose that is currently being peer reviewed. It is unclear whether the public will have an opportunity to provide input on the tool before it is finalized.
BRS is currently finishing a draft of the proposed rule, which will likely be released next summer. Accompanying the proposed rule will be a “regulated status registry” listing the products that BRS will and will not regulate. Firko expects that by the time the final rule is out, the list of things they will not regulate will be “very well populated.”
He does not foresee the rule being finalized, however, for three to four years, due to the change of Administration in 2017.
The (Un)Coordinated Framework
In response to questions at the BRS meeting on how the new rule relates to the Coordinated Framework update, Administrator Firko said the Coordinated Framework is not focused on changing regulations so there is only a little overlap, but BRS is moving “in concert with” the Coordinated Framework update and OSTP supports BRS’ proposed rule.
But BRS moving forward with the new rule before the Coordinated Framework has been updated makes it seem as though this action and the other actions involving biotechnology regulation are not very coordinated at all.
What’s more, the agency does not seem to be listening to the thousands of public comments expressing concern about the Administration’s continued deregulation of new GE products.
During the November 18 meeting, Administrator Firko referenced some of APHIS’ most recent requests for public comment. For example, after BRS’ webinars last summer BRS received 221,000 public comments, the majority of which said BRS should never deregulate biotechnology products.
Additionally, BRS received 167 comments representing 11,088 commenters after soliciting public comment on GE wheat trials this year: 11,029 were in support of banning trials altogether, 35 supported the permit proposal, 15 supported the continued use of notification, and 9 were outside of those categorizations.
Administrator Firko also mentioned that OSTP received over 900 comments after soliciting public comments on the Coordinated Framework.
We believe these public comments — as well as the public comments submitted to USDA’s recent “coexistence” dockets — should be thoroughly reviewed and carefully considered before moving forward with any other actions related to the regulation of biotechnology.
Increased transparency and coordination across agencies is essential to facilitating public understanding and engagement around these complex biotechnology issues. At a time when consumers nationwide are demanding transparency in the marketplace — and the Administration has acknowledged that changes are needed in our approach to biotechnology regulation — we need a process that:
Nothing to date inspires a great deal of confidence, but we hope that OSTP and the President will insist that the current uncoordinated and illogical framework be replaced with a rational and coherent regime that serves the public interest.