Monday marked the close of the comment period for the U.S. Department of Agriculture’s proposed changes to regulations in 7 CFR part 340 in its efforts to modernize biotechnology regulations. Commenters welcomed the new science-based regulatory approach and said it can increase consumer confidence as well as support bringing new products to the market.
It would revise USDA regulations regarding the movement (importation, interstate movement, and environmental release) of certain genetically engineered organisms in response to advances in genetic engineering and our understanding of the plant pest risk posed by them, thereby reducing regulatory burden for developers of organisms that are unlikely to pose plant pest risks.
In comments to USDA, the Biotechnology Innovation Organization (BIO) said it strongly encourages USDA to require developers to notify the agency of their intent to market new plants produced through biotechnology — such as gene editing — even if the plant is similar to conventionally bred plants and does not require pre-market review by USDA under the agency’s new science-based regulatory approach. The notification would then be posted online and available to the public.
BIO president and chief executive officer Jim Greenwood said the group's comments send a strong signal that it is listening to consumers' calls for greater access to information about how food is produced.
“BIO’s member companies are excited about harnessing the potential of biology-based innovation to create sustainable agricultural products that can mitigate climate change, combat hunger, reduce food waste and improve health, and we welcome public dialogue about these efforts,” Greenwood noted. “Although all food is regulated for safety, BIO understands that consumers want to know information about gene-edited and other biotech food products, and our members want to be the driver of that endeavor.
“Science-based regulation and public support must coexist if we are to energize understanding, build trust and foster an environment where technology, companies and consumers together can address our most pressing societal and environmental problems,” Greenwood added.
The National Association of Wheat Growers (NAWG) also submitted comments. NAWG noted that its members believe science-based decisions should be used to develop regulatory framework and that regulations should not burden research investment with unnecessary costs or delays.
In its comments, NAWG said its highest-priority concern is that any rule change contemplated by USDA's Animal & Plant Health Inspection Service (APHIS) needs to consider the impact on countries importing U.S.-produced grain.
“NAWG encourages USDA APHIS to develop and execute an international engagement strategy that defines USDA’s rationale on pre-market regulatory approaches. All foreign customers expect the continued oversight by USDA to ensure consistent food safety, which is fundamental to their confidence in purchases of U.S. wheat,” NAWG president Ben Scholz said in a statement.
In a joint statement, the National Grain & Feed Assn., Corn Refiners Assn., National Oilseed Processors Assn., North American Export Grain Assn. and North American Millers Assn. said the rule, as drafted, is “fundamentally flawed” and could contribute to future trade disruptions.
“If the U.S. government’s regulatory oversight approach to genome editing and other plant breeding innovation is out of step with the domestic food industry or America’s significant export markets, it will have perilous repercussions for the grain and oilseed value chain, including U.S. farmers,” the grain and oilseed groups said.
Under the proposed rule published on June 6, APHIS – which has the authority to determine whether agricultural biotech traits pose a plant pest or noxious weed risk to the environment – would exempt most crops developed with gene editing techniques from regulatory oversight. APHIS’s proposed rule states that such plants can be developed through traditional breeding techniques, making them unlikely to pose a greater plant pest risk than conventionally bred crops. The APHIS proposal also would empower crop developers to make a “self-determination” that their plant is exempt from APHIS regulatory oversight, without providing any notification to the agency. Under the proposed rule, technology providers would have the “option” to request written confirmation from APHIS that their self-determinations are valid.
The agribusiness organizations said such a broad self-determination approach “risks undermining consumer acceptance and international regulatory recognition of APHIS’s regulatory oversight.”
They urged APHIS to amend its proposed rule to require all technology providers to notify the agency in advance before introducing gene-edited or other plant breeding innovation traits for commercialization – even those within APHIS’s expressly exempted categories – to provide needed transparency to the market and to consumers. Doing so would enable the agency to issue an official attestation that the trait does not pose a plant pest risk, “thereby providing an important tool to efficiently market U.S. agricultural products,” the organizations said.
“Further, NAWG encourages USDA APHIS to be vocal about the safety of GE technology, aiming their messaging at every opportunity to earn the trust of every U.S. consumer. Even if the technology is innovative and improves productivity, farmers will not purchase it if the marketplace will not accept it,” Scholz added.
NAWG’s comments also noted that it supported USDA’s approach to focus on the properties of the genetically modified organism itself rather than on the method used to produce it. “NAWG believes it is the end result plant organism needing the assessment of risk, not the process used to develop it,” the group said. In addition, NAWG supports the proposed rule's exemption of GE plants with plant trait-mechanism of action combinations that have already been evaluated.
Regulation of plants for producing industrials and pharmaceuticals are subject to Food & Drug Administration oversight. However, FDA has no regulations governing the planting of such crops, and producers do not have to go to FDA until they are ready to begin clinical trials with the pharmaceutical derived from the plant. “Since this time frame could be years after the first planting of the crop, NAWG prefers USDA APHIS provide oversight of the planting of such crops,” NAWG said in its comments.