Source: https://www.bdlaw.com/alan-j-sachs/publications/usda-declares-do-over-on-overhaul-of-biotechnology-regulations/
Timestamp: 2019-06-25 17:30:16
Document Index: 134060573

Matched Legal Cases: ['art 340', 'art 340', 'art 340', 'art 340', 'art 340', 'art 340', 'arts 330']

USDA Declares “Do-Over” on Overhaul of Biotechnology Regulations | Alan J. Sachs
February 8, 2016News Alert
Beveridge & DiamondJamie Auslander, Alan Sachs, Kathy Szmuszkovicz
The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Information Service (APHIS) is renewing efforts to amend or replace its existing rules governing plant-based biotechnology while highlighting possible changes to its regulations that may significantly expand the scope of biotechnology products and processes subject to APHIS jurisdiction. Akin to an advance notice of proposed rulemaking, APHIS’s Notice of Intent seeks public input on scoping for a Programmatic Environmental Impact Statement (PEIS) under the National Environmental Policy Act (NEPA). APHIS’s non-exclusive proposals range from status quo to transformative, and its notice provides a rare opportunity for agriculture and biotechnology stakeholders to help shape what may become a wholly new regulatory program to replace APHIS’s three-decades-old regulations at 7 C.F.R. Part 340.
Comments are due by April 21, 2016.
Consistent with its authority to regulate “plant pests” under the Plant Protection Act (PPA), APHIS regulates the introduction of certain genetically engineered (GE) organisms that may cause injury or harm to plants. When originally issued in 1987, APHIS’s implementing regulations at 7 C.F.R. Part 340 addressed nearly all GE plants, since most of the then-existing plant-based GE technologies involved the use of modified plant pests such as Agrobacterium to transfer new genes to plants.
Accordingly, APHIS proposed to expand the scope of its regulatory program beyond plant pests, consistent with its additional PPA authority over noxious weeds. APHIS’s 2008 proposal did not suggest any changes to the definition of the term “genetic engineering” itself, which is defined under Part 340 to mean “the genetic modification of organisms by recombinant DNA techniques.” Seven years and thousands of comments later, APHIS in 2015 formally withdrew its proposed rule, and instead initiated a series of public webinars and outreach to more broadly evaluate alternative approaches to the regulation of biotechnology under the PPA.
Analyze first, regulate as needed;
Regulate all products of biotechnology that pose plant pest or noxious weed risks; or
Withdraw APHIS’s Part 340 regulations.
As required in any NEPA analysis, APHIS must consider doing nothing, which here would leave its current Part 340 rules in place. Companies would continue to file permit applications or notifications in connection with the movement and field testing of GE organisms, and petitions to deregulate their products for widespread environmental release, according to existing APHIS definitions and rules now in place.
Analyze First, Regulate as Needed
This alternative would introduce a two-step evaluation process for new biotechnology products. First, the agency would determine whether a plant pest or noxious weed risk exists for a particular product of biotechnology. According to APHIS, certain products that lack any “realistic potential” to pose such risks (for example, nucleotide deletions, single base pair substitutions, or other modifications that could reasonably be expected to be obtained through mutagenic techniques) would be exempt from regulation. For other products that do not meet these criteria, APHIS would employ a plant pest or noxious weed risk analysis and issue permits with “risk-appropriate” conditions to mitigate risks.
Regulate All Products of Biotechnology that Pose Plant Pest or Noxious Weed Risks
Under this alternative, all products of biotechnology that are developed using a plant pest or that pose a noxious weed risk would be subject to permit requirements, without exception. Here, APHIS anticipates retaining jurisdiction over many more products as regulated articles, fundamentally expanding the reach of APHIS’ program and multiplying its responsibilities. It is unclear from the Notice of Intent whether or how APHIS would revisit existing approvals of non-regulated status. How the “mitigation” required for APHIS permits under this alternative would differ from the conditions APHIS contemplates under the second alternative above also is uncertain.
Withdraw APHIS’s Part 340 Regulations
In contrast, APHIS also is weighing whether to regulate GE plant pests and noxious weeds no differently than conventional (non-GE) ones, under its existing regulations at 7 C.F.R. Parts 330 and 360. Under this alternative, APHIS envisions still providing consultative services to developers, upon request, to help analyze plant pest and noxious weed risks and facilitate the movement and release of biotechnology products that do not pose risks regulated by the PPA.