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USDA Will Try Again on Update of Biotechnology Regulations

For the third time in a decade, the Agriculture Department is starting anew on a modernization of its regulation of biotech plants. As part of the new search for “the most effective, science-based approach” to regulation, the USDA ditched a proposal that would have covered genome-editing techniques, such as CRISPR, if the products created posed a plant pest or noxious weed risk.

The Biotechnology Innovation Organization, a trade group, said that the latest USDA proposal, unveiled in January just before President Trump took office, “had significant flaws that would have rendered the proposed system difficult to implement and created greater uncertainty for developers.”

“It’s critical that our regulatory requirements foster public confidence and empower American agriculture while also providing industry with an efficient and transparent review process that doesn’t restrict innovation,” said Agriculture Secretary Sonny Perdue in announcing that the USDA will “take a fresh look, explore policy alternatives, and continue the dialogue with all interested stakeholders, both domestic and international.”

At present, the USDA regulates only crops and other plants developed through classical biotechnology. Genetically engineered plants produced without the use of genetic sequences from plant pests are not subject to federal biotechnology rules. The development of gene editing and other techniques led to calls for broader federal oversight of biotech and arguments that gene editing was inherently safe and there was no need for government regulation.

The USDA proposed a major change in its approach to biotech regulation in January, from a “regulate first, analyze later” format to one that would assess new GE organisms and regulate only those deemed to present a risk. In explaining the proposal, the USDA said it “regulates the products of biotechnology and not specific biotech techniques. Products of so-called ‘new genome-editing techniques’ would be regulated … only if they pose plant pest or noxious weed risk.”

“Many commenters objected to the scope of the proposed rule,” said the USDA in a four-page Federal Register notice of withdrawal. “Some thought that our criteria for designating GE organisms as regulated organisms was too expansive, potentially resulting in our regulating a wider range of GE organisms than necessary and thereby increasing, rather than reducing, the regulatory burden on the biotechnology industry. Other commenters, however, thought that certain exemptions and exclusions contained in the proposed rule would narrow the scope of our regulatory authority over GE organisms and increase the risk of unintended presence of GE crops in organic and non-GE crops.”

The USDA received 200,000 comments after it began the process in 2015 of updating its biotech rules, resulting in the January 2017 proposed rule. Some 203 comments were filed on the January proposal by a panorama of interested parties. When the USDA proposed a regulatory update in 2008, it got 83,000 comments and withdrew that iteration in 2015, so it could try again. It said the 2017 approach would have resulted in a reduced requirement for data from field tests, fewer reporting requirements, and lower management costs compared to the current system of applying for permits and filing petitions.

Biotech companies say it can cost tens of millions of dollars and years of work to develop a GE variety and carry out tests to prove it is safe for commercial cultivation.

Science magazine said more than 100 biotech and ag trade groups wrote the USDA during the summer to say they feared there would be a lengthy risk assessment simply to learn whether or not a GE product would be regulated, which would slow the early development of new crop varieties by creating a hurdle to even small-scale field trials.

The FDA is considering an update to its regulations for GE animals.

To read the Federal Register notice of withdrawal of the proposed rule, click here.

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