The USDA's Animal and Plant Health Inspection Service (APHIS) has initiated a review to examine current regulation and definitions covering how biotech or genetically engineered crops and products are introduced.
The National Grain and Feed Association (NGFA) along with the Corn Refiners Association, North American Export Grain Association and North American Millers Association, have asked regulators in submitted comments to develop a process that supports innovation and considers export markets.
“We urged APHIS to slow this process down,” said Randall Gordon, NGFA president in a previous interview. “We don’t want the US regulatory system to be further out of kilter – we are not in alignment in with other countries in how we regulate biotech, so rather than hastening its action, [we] should take the time to consult with other countries.”
Economic concerns
The organizations are advocating that consideration be given to the economic concerns of regulating biotech crops, members said.
Economic interests can be damaged if biotech crops are commercialized in the US before being approved in export markets, said the groups. “Grain supplies that can be comingled without concern over regulatory status can be accessed in a timely and efficient manner in response to buyer demands, providing time-and-space utility that is essential to achieving supply integrity and food security,” they added.
However, the feed and grain organizations do support the idea of ‘conditional deregulation,’ they said. The plan would allow APHIS to give a type of approval for new biotech products that have been found safe, but that have not been approved in export markets or have specific output traits, they added.
“Biotechnology enhanced events subject to ‘conditional deregulation,’ technology owners would be required to implement sufficiently robust and appropriate trait-specific stewardship plans and assume associated risk-responsibility if their defined risk-management plans fail to protect the value of US crops until such approvals are granted,” they said.
However, the group is leery of a proposal to issue a risk assessment for a common trait and then determine it safe and no longer subject to review when it is included in a new submission, said Gordon.
“They would do a risk assessment and issue guidance and certain technologies that have a long history of safety wouldn’t be reviewed,” he said. “But that may not go over well. If you have a number of traits that would have gone through at least an initial review, like glyphosate resistance, [then the view would be] we’ve looked at this many times and [so] it’s automatically approved – that lack of transparency again is troubling.”
Regulatory oversight
The revisions being suggested seek to address biotechnology developments and concerns raised by stakeholders while protecting the environment and increasing transparency of the regulatory process, said the APHIS.
Four regulatory scenarios are being looked it.
The potential alternatives include maintaining the current regulation system and definitions, said the USDA agency.
Another approach would be to revise regulation and provide “a process to review and regulate certain products of biotechnology to protect plant health; analyze potential plant pest and/or noxious weed risks first; and thereafter regulate only when appropriate and necessary,” it added.
This scenario would involve first establishing if a biotech product actually offers a threat to generate plant pests or noxious weed risks and then the regulatory process would start, it said. “APHIS is considering and would like public input on potential justifiable exceptions or exemptions that would exclude certain ‘products of biotechnology’ from APHIS' regulatory review and oversight because they lack the realistic potential to pose documented plant pest or noxious weed risks,” it added.
The third potential revision would increase oversight and require permits for GE organisms: “APHIS would use its plant pest and/or noxious weed risk analyses to inform the establishment of appropriate permit conditions to protect agricultural plants and agriculturally important natural resources.”
The last option would be to replace the current review system with a voluntary, non-regulatory process for biotech products, the agency said. “Developers would be responsible for ensuring their respective products of biotechnology do not pose risks as a plant pest or noxious weed pursuant to their respective PPA definitions, and that their activities related to the importation, interstate movement, or release into the environment of their respective products of biotechnology are not in violation of any existing statutes or Federal regulations that relate to plant pests or noxious weeds,” it added.
The comment period for the proposed review options closed at the end of April.