In its newest attempt to overhaul biotechnology rules adopted in 1987, the USDA said it would exempt new crop varieties created through techniques such as gene editing from regulatory review, so long as the modifications are similar to those achieved by traditional breeding and pose no plant-pest risks.
“We anticipate that adopting the new framework will result in significant savings for developers of GE organisms,” said the USDA’s biotech agency, the Animal and Plant Health Inspection Service (APHIS), on Wednesday in proposing the new regulatory approach.
Dubbed SECURE, the proposal will be open for public comment for 60 days, until August 5.
The trade group American Seed Trade Association said it would work for regulations that provide “consistent, workable policies that foster continued innovation in the plant-breeding sector.” The seed industry has championed gene editing as a safe and speedy way to improve crop varieties and U.S. officials have agreed, with an eye to maintaining U.S. leadership in the sector internationally.
APHIS said its proposal would facilitate “development of new and novel genetically engineered organisms that are unlikely to pose plant risks.”
Unlike classical biotechnology, which introduces genetic material from an outside source into an organism, genetic engineering technology such as CRISPR manipulates only the genetic makeup of the chosen plant. For years, the USDA has required new genetically modified plants to go through a lengthy and rigorous review to assure they would be safe to grow. Plant companies say the process is unduly expensive and time consuming.
For its new framework, the APHIS pointed to suggestions that federal oversight should be aimed at novel plants that may pose a threat of becoming pests, while backing away from “repetitive analyses” of plants that are similar to those already recognized as safe.
“This common sense approach will ultimately give farmers more choices in the field and consumers more choices at the grocery store,” said Agriculture Undersecretary Greg Ibach.
In a 108-page Federal Register notice, the APHIS said, “We believe that this new approach, which reflects our current knowledge of the field of biotechnology, would enable us to evaluate GE organisms for plant risk with greater precision than the current approach allows. APHIS will continue to regulate GE organisms that are, in and other themselves, plant pests as well as other GE non-plant organisms that pose plant risks.”
Plant developers would have the option of requesting an APHIS review of a new GE plant. They also would have the option of “self-determination” that a new plant belongs to a category of plants that are exempt from regulation. In that case, developers could ask for APHIS for a confirmatory letter or not. They would face disciplinary action if their plants are later proven to require USDA approval.
The Federal Register notice is available here.