Grain trade groups caution APHIS on 'premature' changes to biotech regulations

by Jay Sjerven
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WASHINGTON — Five national grain trade organizations have cautioned the U.S. Department of Agriculture's Animal and Plant Health Inspection Service (APHIS) not to make “premature and ill-advised” changes to its biotechnology regulations that may result in increased domestic and international market disruptions for grain and grain products.

The statement, composed by the National Grain and Feed Association, was in response to APHIS’s notice announcing its intent to prepare an Environmental Impact Statement concerning potential revisions to its Part 340 biotechnology regulations. Under these regulations, APHIS makes science-based determinations of whether bioengineered traits pose a plant pest or noxious weed risk.

The North American Export Grain Association, the Corn Refiners Association, the North American Millers’ Association and the National Oilseed Processors Association joined the N.G.F.A. in stating that the outcome of any revision to APHIS’s biotechnology regulations should be either acceptable to or comparable and compatible with regulatory approaches used by competent government authorities in important U.S. markets so as to minimize or prevent the risk of market and trade disruptions.

“To create a truly workable biotech regulatory framework for the future, APHIS must take the necessary time and make the necessary effort to address the challenge of achieving regulatory coherence and compatibility in the global market,” the organizations stated. “We believe that any changes to U.S. biotech regulatory processes — including Part 340 — should be considered only after advance, robust and thorough discussions with competent government authorities in countries that represent important U.S. export markets, during which alignment in regulatory approaches is achieved to the maximum extent possible.... This is even more important currently, given ongoing and potentially productive discussions occurring between the private sector and various foreign governments on whether and how to address the regulatory treatment of important new breeding technologies,” such as gene-editing techniques.

The groups said to date there was no indication that adequate consultations or buy-in from foreign governments has occurred.

The statement also referred to the need for APHIS to develop a clearly defined, specific regulatory process for bioengineered agricultural products that have unique functional characteristics (e.g., output traits) 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.

The organizations also faulted APHIS for seemingly divorcing the review of its regulations that determine whether a biotechnology trait poses a plant pest or noxious weed risk from the Obama administration’s ongoing review of the so-called Coordinated Framework for biotechnology that involves other federal agencies like the Food and Drug Administration and the Environmental Protection Agency, which have oversight of other aspects of pre-market reviews of biotech-enhanced products.

Further, the joint statement urged 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 biotechnology owners/providers to minimize the potential for traits that may pose market disruptions from becoming commingled in the fungible commodity supply stream.

The groups noted that the “conditional deregulation” concept was consistent with the U.S.D.A.’s obligation to consider the potential economic impacts on U.S. agriculture of commercialization of biotech-enhanced traits.  It also would contribute to preserving the efficiencies and cost-competitiveness of the fungible, commingled U.S. and global grain and oilseed supply, in which commodities from various regions of the world may be sourced in a timely and efficient manner in response to customer demand without concern over regulatory status, thereby enhancing food security.  
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