September 23, 2016
The ever-evolving biotechnology sector continues to be an important topic among farmers and consumers, and business and the government. However, the process has been criticized for being convoluted and uncoordinated in its nature, with unclear boundaries of where each federal agencies’ jurisdiction lies, and how stakeholder input is obtained and utilized across agency functions.
In response to the White House Office of Science and Technology Policy (OSTP) Memorandum – directing the U.S. Department of Agriculture (USDA), the Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA) to streamline the biotechnology regulatory and review process – the inter-agency Biotechnology Working Group (including USDA, FDA and EPA) released three important documents in the past month:
Context for the Biotechnology Regulatory and Coordination Landscape
It has been over twenty years since the last update to the Coordinated Framework for Biotechnology Regulations. Since its initial enactment in 1986, during a time that marked the beginning of the biotechnology era, 1992 was the only year the document was updated – hence the need for the 2015 Memorandum. This Memorandum stated that while biotechnology regulation “effectively protects health and the environment,” the framework lacks the coordination needed for transparency and efficiency. Additionally, the Memorandum solicited the need for “expert analysis” on biotechnology products.
Following the release of the memorandum, the National Science and Technology Council (NSTC) issued a request for information from stakeholders and generally vested parties, in order to update the framework based on these suggestions.
NSAC submitted comments that identified areas in which enhanced coordination and more robust oversight would improve not only the framework, but the process through which the agencies involved in biotechnology oversight engage with the public. NSAC urged increased transparency and coordination of the biotechnology overview process, in particular by aligning USDA and EPA’s approval processes of new biotechnology traits and their accompanying pesticides in order to ensure that the products are viewed, assessed, and regulated as full technology packages.
NSAC also recommended that the agencies better communicate to stakeholders how the various actions currently underway regarding changes to biotechnology regulation were connected, and how stakeholder input on each individual action would be considered in an integrated manner. This was important because, at the time the memo was issued, USDA had also decided to withdraw and revisit an older proposed rule on governing crop biotechnology approval processes.
NSAC argued that these actions needed to consider each other, and that stakeholders deserved to have complete information regarding the timeline for each action to manage the time and energy necessary to understanding what was being proposed and providing feedback on the multiple calls for comment from various agencies.
Given that the USDA’s new proposed rule governing biotechnology regulation is currently under administrative review before being published for public comment, and that the public has no clear indication of when that will occur, we are disappointed that these related actions continue to operate as if in isolation, despite the good intentions of the coordinated framework.
Below, we provide more analysis of the good, bad, and ugly of the Updated Coordinated Framework.
The Updated Draft and Strategy: Positives and Pitfalls
The National Strategy serves to give an overview of the aim of the updated Framework, highlighting its three main foci as: (1) increasing transparency, (2) increasing predictability and efficiency, and (3) supporting the science that reinforces the biotechnology regulatory system. Along with each issue area, it highlights programs that already exist to bolster these three initiatives in addition to programs and activities to be implemented in the future to further serve these goals.
In terms of increasing transparency, a large portion of the efforts are directed towards stakeholder engagement through public meetings, workshops and social media/website efforts to help better explain the different jurisdictions and functions of the USDA, FDA, and EPA. The Updated Coordinated Framework details these roles, including the varying enforcement authority, of each agency.
The goals of improving predictability and efficiency and ensuring science-based regulations are closely linked. In achieving these goals, the National Strategy notes that the three agencies have commissioned an independent study by the National Academy of Sciences (NAS). NAS’ study will identify opportunities in biotechnology, related risks that may come with a product, and the necessary mechanisms and expertise to continue to seek new biotechnologies. Other initiatives are based on expanding sources of research within and outside of the agencies, as well as better coordinating regulation and research.
However, certain areas go unmentioned in both the National Strategy and the Updated Framework itself, that perhaps can be emphasized in this round of public comments due in November. For example, while the Strategy makes a commitment to using the best available science related to health and the environment, it makes no mention of contamination prevention. NSAC strongly believes that a robust regulatory framework requires a compensation mechanism for non-GE producing farmers who have experienced crop contamination, and considers this an important addition to the responsibilities of the governing bodies.
Additionally, as mentioned above, USDA-APHIS’ proposed rule governing GE crops is currently pending interagency review. The fact that the request for comments on the updated draft Framework and National Strategy comes before the proposed rule is made public once again begs the question as to how all of these moving parts will fit together under one, truly coordinated framework.
This comes at a particularly poignant time, as a series of mergers in agricultural input companies – who all heavily rely on GE technologies – have caused alarm in the farming industry due to the increasing consolidation in the seed industry and the detrimental impacts it has on farmer choice and research. Clearly, the need for true coordination in our nation’s approach to biotechnology oversight is strong. Whether the Coordinated Framework is the vehicle for achieving a robust and comprehensive approach to biotechnology remains to be seen.
Categories: General Interest