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APHIS urged to keep trade in mind when revising regulations and to consider concept of "conditional deregulation."

April 26, 2016

3 Min Read

The Corn Refiners Association, National Grain and Feed Association, National Oilseed Processors Association, North American Export Grain Association and North American Millers Association sent a joint comment to the USDA Animal and Plant Inspection Service regarding the agency’s intent to prepare an Environmental Impact Statement concerning potential revisions to the Part 340 biotech regulations.

The letter was sent April 21, the last day comments were accepted. The comment period was extended to April 21 after agricultural organizations, including the NGFA and NAEGA, requested an extension.


“We respectfully submit that a lengthier comment period is needed to allow for adequate public input on the wide-ranging issues described in the February 5 notice, particularly given that the options presented in the NOI include ones that are significantly more complex and a much greater departure from current regulations than the revisions proposed for these same regulations in 2008,” the February 18 letter read.

Related: APHIS extends comment period for proposed changes to biotech rules

In the comments submitted April 21, the groups write that APHIS should take an outcome-based focus when developing its EIS.

“We respectfully submit that the desired outcome should be to develop a sound future regulatory policy that accomplishes the twin goals of encouraging continued innovation of biotechnology as a safe, sustainable and environmentally sound crop production technology, but does so in ways that are comparable and compatible, to the maximum extent possible, with regulatory approaches used by competent government authorizes in important U.S. export markets so as to minimize or avoid the risk of market and trade disruptions,” the joint comment reads.

ASA comments

The American Soybean Association also submitted comments, saying it supports the goal of updating regulations to reflect changes in the environment for the development and commercialization of biotech products.

 “Any changes to the regulations should be tailored to address specific problems in a clear and transparent manner,” ASA states in the comments. “In addition, APHIS must consider the potential impact of changes in its policies on the international as well as the domestic regulatory and commercial environment for biotech products.”

Changes that would disrupt international trade are of particular concern to ASA as more than half of the U.S. soybean crop is exported and more than 90% of the varieties planted in the U.S. are genetically engineered.

Clearly defined process

The Corn Refiners Association, National Grain and Feed Association, National Oilseed Processors Association, North American Export Grain Association and North American Millers Association also cite a need for APHIS to develop a clearly defined, specific regulatory process for biotech-enhanced agricultural products that have unique functional characteristics that may adversely affect the functionality and/or compositional and nutritional integrity of the product and downstream users if the trait becomes present in the commingled, fungible supply chain at levels exceeding certain thresholds.

They fault the agency for seemingly not working with the administration’s ongoing comprehensive review of the Coordinated Framework for Biotechnology that involves other federal agencies that have oversight over other aspects of pre-market reviews of biotech products.

Consider “conditional deregulation”

The joint statement encourages APHIS to consider the concept of “conditional deregulation” in instances where scientific risk assessment has found a given biotech-enhanced trait does not present a plant pest or noxious weed risk, but the trait has not been approved in important U.S. export markets or has a functionally different output trait. Under this concept, APHIS would continue to provide permit-controlled oversight over prudent stewardship and risk-responsibility plans put in place by biotech owners/providers to minimize the potential for traits that could pose market disruptions from becoming commingled in the fungible commodity supply stream.

Sources: NGFA, ASA

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