By MATTHEW D. ERNST

Missouri Correspondent

ST. LOUIS, Mo. — Agricultural, biotechnology and consumer groups issued mixed reviews to a November announcement from the Animal Plant Health and Inspection Service that APHIS would withdraw a proposed rule amending regulations about the import, transport and environmental release of some genetically engineered (GE) organisms.

The rule, proposed in January, represented a shift in the APHIS approach to regulating new GE organisms, according to an agency statement published Nov. 7 in the Federal Register.

The existing approach was described as “regulate first/analyze later.” Under the existing approach, most GE genetic material is regulated and must be approved by APHIS. The agency issued 356 release authorizations during fiscal year 2016 that added up to more than 45,000 crop-trait combinations authorized, according to an APHIS report on Nov. 15.

The January rule proposal stated that APHIS would first assess new GE organisms to determine if they posed plant pest or noxious weed risks. The agency would then only regulate organisms that were determined to pose risks.

Public comments on the proposed rule, during a comment period extending from January to June, showed many parties unsatisfied with the proposal. “Some commenters expressed concern that the proposed risk assessment process could prove lengthy, cumbersome, and confusing, thereby hindering innovation and preventing GE products from getting to market in a timely manner,” stated APHIS, in its withdrawal of the rule.

Many commenters applauded that the proposed rule excluded some classes of gene editing from requiring APHIS approval. This includes newer technologies which do not introduce genes from another organism into a crop (transgenics), but use new gene editing technologies to modify genes in an organism for some desired end. “We support USDA’s science-based exclusion of some classes of gene editing, and the recognition of the safety of familiar crop-trait combinations with which they have years of experience,” stated BIO, the largest biotechnology trade organization, in its response to the APHIS announcement this month.

Agricultural producer groups, including the American Soybean Assoc. and American Farm Bureau Federation, expressed favor toward the decision, even while sharing concerns about how APHIS might handle future GE regulation.

“There were some positives, especially how USDA was viewing new breeding techniques such as genome editing, but there was also some concerns on how traditional biotechnology production practices might be regulated in the future and what that means for innovation and research and development,” said Andrew Walmsley, American Farm Bureau Federation congressional relations director, in a Farm Bureau update on Nov. 8.

Ron Moore, ASA President, echoed that assessment. “On the plus side, there were a considerable number of aspects about the rule that would have stifled innovation and created additional regulatory uncertainty and ambiguity,” said Moore.

But the ASA also hoped the rule withdrawal would not result in complicating GE crop approvals. “In this regard, we do not want the withdrawal of the rule to lengthen the existing lag between efforts to craft smarter regulations for new technologies and the need to convince consumers of their benefits, both at home and abroad,” Moore said.

Many said the rule did not go far enough with regulation, APHIS stated. “These commenters objected to our proposed exemption from the risk assessment process of products having plant/trait combinations corresponding to specific organisms that had been granted non-regulated status based on previous risk assessments,” stated APHIS. Some commenters opposed a proposal that would no longer require submission of field test data as part of the APHIS assessment process.

Others, especially groups opposing GE food crops, advocated much stricter government approval standards for GE crops. “It’s not just that we’re going to have unlabeled, untested GMOs, we’re going to have GMOs that are totally under the radar which is going to completely blur the lines between what is genetically engineered and what is not. Not in a scientific way, but in a way that resulting from this deregulation,” said Alexis Baden-Meyer, political director at the Organic Consumers Assoc., in her comments on the APHIS rule.

Baden-Meyer’s comments came at a public forum APHIS in Maryland in June, after the agency extended the public comment period on the proposed rule. There were also public forums in Kansas City, Mo., and at the University of California-Davis.

APHIS received 208 comments on the proposed rule, according to a report given Nov. 15 by Michael Firko, APHIS deputy administrator, Biotechnology Regulatory Services, at a meeting in Kansas City.