USDA's Proposed Genetically Engineered (GE) Organisms Rule

On October 9, the U.S. Department of Agriculture’s (USDA), Animal and Plant Health Inspection Service (APHIS) and its Biotechnology Regulatory Services (BRS), which is responsible for regulating the importation, interstate movement, and environmental release of certain genetically engineered (GE) organisms, published its proposed rule revisions to its existing biotechnology regulations. APHIS indicated that the changes are being proposed in light of advances in science and technology, and are based on prior public input and BRS’ extensive experience in implementing the current regulations. Cindy Smith, administrator of APHIS said, "This is the most comprehensive review and revision of our biotechnology regulations since they were first developed in 1987. Revising these regulations now will allow us to ensure effective oversight for years to come.”

According to the FR announcement APHIS proposes to revise the regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered organisms in order to bring the regulations into alignment with provisions of the Plant Protection Act (PPA) of 2000. The revisions would also update the regulations in response to advances in genetic science and technology and our accumulated experience in implementing the current regulations. APHIS indicates that this is the first comprehensive review and revision of the regulations since they were established in 1987. The rule would affect persons involved in the importation, interstate movement, or release into the environment of genetically engineered plants and certain other genetically engineered organisms. APHIS will consider all comments received on or before November 24, 2008, and is holding three public forums to be held in Davis, CA; Kansas City, MO; and Riverdale, MD.

APHIS is also proposing to expand its regulatory oversight to include the regulation of GE biological control macroorganisms, such as insects genetically engineered to control plant pests or noxious weeds. APHIS is not proposing, however, to regulate biological control microorganisms, such as bacteria and fungi, which are already regulated by U.S. EPA. In addition, APHIS is proposing to include nonviable GE plant material originating from field tests to the Agency’s oversight. Currently, nonviable materials, like plant stems and leaves that cannot propagate, are not regulated by APHIS.

The Center for Food Safety responded to the proposal with a lengthy release indicating that while it believes that stricter regulation of growing and field testing GE crops is needed, the USDA's proposal "fails to fully protect the public's safety or the environment." The Center contends that the proposed regulations "may set in motion a process that would put many GE crops completely beyond the bounds of regulation, and outside the safety net designed to protect the American public." Bill Freese, Science Policy Analyst for the Center for Food Safety said, "The USDA has missed a golden opportunity to improve its oversight of genetically engineered crops. This USDA proposal has the same gaping holes as the policy it is replacing, and creates a few new ones, as well."

According to the Center, the biggest concern is that the proposed rules "remove established criteria vital in determining the very scope of regulation. Previously, regulation of GE crops was based on the presence of genetic elements from a list of 'plant pests' codified under Section 340.2. This fairly comprehensive list covered almost all of the genetic elements companies used to engineer crops. However, under the new policy, the USDA proposes 'deleting the list of organisms which are or contain plant pests,' effectively removing triggers to regulation and leaving the decision to the discretion of the USDA or even biotech companies themselves.

Freese said, "Whether a GE crop falls within the scope of regulation or not will now be much more open to interpretation. We can expect the range of GE organisms subject to oversight to decrease over time, allowing for future food safety regulatory failures." The Center also indicates that USDA also "failed to address the epidemic of herbicide-resistant weeds associated with ubiquitous herbicide-tolerant GE crops. Resistant weeds have led to increased use of chemical weed killers, rising production costs for growers, and in some cases accelerated soil erosion caused by the additional mechanical tillage required to remove resistant weeds."

Sharon Bomer Lauritsen, executive vice president, food and agriculture for the Biotechnology Industry Organization (BIO), issued a statement in response to the USDA proposal saying, “Rigorous science-based regulations provide the best environment for the development of valuable agricultural biotechnology products. Revision of these rules in a timely and transparent manner will enable ag biotech companies to continue to provide solutions to a number of challenges facing both farmers and consumers.

“Biotech plant products are safe, and the existing regulatory process for regulating, permitting and approving these products is effective. But it's essential to ensure that the regulatory system reflects the latest technological advances within the biotechnology industry as well as the wealth of scientific knowledge gained over the years about the safe development and use of agricultural biotech products. We look forward to reviewing the proposed rule with this in mind and providing our input.

"The original regulations for plant biotechnology were promulgated by USDA-APHIS in 1987, and the rules underwent minor revisions in 1993 and 1997. In late 2003, the White House Office of Science and Technology Policy directed USDA-APHIS to undertake a major revision of its rules governing biotechnology, and the department announced its intent to revise the regulations after completion of a programmatic environmental impact statement (EIS). It is anticipated that the final EIS will be published together with a final rule.

“Since the release of the EIS in July of last year, plant biotechnology has continued to advance, biotech industries have grown to become a major force in the U.S. economy, and hundreds of scientific studies have been published, documenting both the safety of the current technologies and the promise of technologies under development. BIO and its member companies are reviewing the agency’s proposed revisions and will submit comments. Science-based regulations, implemented in a timely and transparent manner with adequate input from stakeholders, will help farmers use agriculture biotechnology to produce high quality crops to provide solutions for the world’s growing population.”

Access the USDA-APHIS release (click here). Access an APHIS Q&A document on the proposed rules (click here). Access USDA's Biotechnology website for additional information (click here). Access a release from the Center (click here). Access the Center's GE Food website (click here). Access a release from BIO (click here). Access the BIO website for additional information (click here). Access the docket for this rulemaking to submit comments and link to background information, the proposed rule and submitted comments (click here). [*Toxics, *Agriculture]