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Biotech Regs Proposed
Friday, February 5, 2016 11:01AM CST

By Todd Neeley
DTN Staff Reporter

OMAHA (DTN) -- USDA is asking for the public's input on whether the agency should draw up new rules to regulate biotechnology products, according to a notice filed in the Federal Register this week.

The Animal Plant Health Inspection Service has faced heavy criticism from environmental and food groups for not conducting a complete environmental assessment on the potential effects of biotechnology crops. The APHIS announcement is part of an overall reexamination of the "coordinated framework" of regulations on biotechnology by USDA, the Environmental Protection Agency and the Food and Drug Administration. The White House ordered a review of the rules last summer.

APHIS is asking for public comment on a number of fronts, including proposed definitions of biotechnology and regulated organisms. APHIS proposes a number of regulatory and non-regulatory options on biotechnology, including genetically engineered organisms, and to safeguard agricultural plants and natural resources from plant pests or noxious weed damage caused by biotechnology.

Nathan Fields, director of biotechnology and crop inputs for the National Corn Growers Association, told DTN there are concerns APHIS will broaden the definition of biotechnology.

He said NCGA would rather limit the definition to transgenic crops. Transgenic crops include plant genes that have been artificially inserted instead of plants acquiring them through pollination, such as Bt corn.

Fields said NCGA may ask for an extension of the 30-day public comment period.

"There are some concerns we have," he said. "First and foremost, it's kind of odd we only have a 30-day comment on this. I'm not sure that's adequate time to address. USDA seems to be broadening the definition."

Jacque Matsen, public affairs manager for DuPont Pioneer, told DTN the company is watching the process closely.

"I can tell you we are closely following and engaging in USDA's efforts to update its biotech regulations," she said. "We will review and provide feedback on this latest development as well, but don't have anything specific yet."

Karen Batra, director of food and agriculture communications for the Biotechnology Innovation Organization, or BIO, said the group will be providing public comment to APHIS at some point.

"We are currently reviewing the proposal, but we are not able to comment yet," Batra told DTN. "We need to have a number of discussions first to outline the key issues we need to address."

Patty Lovera, assistant director of Food and Water Watch, said APHIS is taking a good first step. Food and Water Watch will be urging APHIS to include in their environmental impact statements the full list of impacts from adoption of biotech crops, including associated herbicide use, potential for contamination of organic and identity-preserved crops, development of resistance and any other potential impacts. "It is long overdue for APHIS to consider all of the ways that biotechnology impacts the environment," Lovera said. "The extremely limited scope of what is evaluated in APHIS' current process needs to be addressed in any update to their regulations."

PROPOSED OPTIONS

The APHIS notice said there are a number of options including taking no action to change existing regulations for certain organisms developed through biotechnology that could pose a plant-pest risk, but would continue to regulate those potential biotech organisms as the agency does now.

A second alternative is to revise current APHIS regulations on biotechnology. That would include creating a review process to regulate certain biotech products to protect plant health, analyze potential plant pest and/or noxious weed risks first, and "thereafter regulate only when appropriate and necessary."

The second option calls for setting a procedure to first analyze which biotech products would require an agency review. In addition, APHIS is asking for input on possible "justifiable exceptions or exemptions" that would exclude certain biotech products from regulatory review.

APHIS would propose to eliminate the notification procedure, as "APHIS anticipates that many GE organisms currently regulated under the notification procedures would not be regulated nor subject to further review under this alternative," the agency said in the notice.

The second option would eliminate the current petition process for non-regulated status and conduct new risk analyses when new information is made available.

A third alternative would be for APHIS to regulate biotech products as either plant pests or noxious weeds using an existing plant pest or noxious weed "analysis trigger."

"Under this third alternative, APHIS' proposed regulations would substantially increase oversight and resources over those currently used to regulate GE organisms," the notice said. In addition, the third alternative would not exempt certain biotech products and would eliminate notification and petition procedures.

The fourth option put forward in the notice would be to withdraw the current regulations completely and implement a voluntary, non-regulatory "consultative" process for certain biotech products.

With the fourth alternative, biotech developers would be responsible for ensuring their products "do not pose risks" as a plant pest or noxious weeds.

Despite the complexity of the proposed changes for the biotechnology industry, companies or others wanting to weigh in need to have their comments sent in before March 7. Full details can be found in the Federal Register notice: http://dld.bz/…

Todd Neeley can be reached at todd.neeley@dtn.com

Follow him on Twitter @ToddNeeleyDTN

(CC/AG)


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