The U.S. Department of Agriculture has withdrawn a proposed rule that would have revised regulations regarding the importation, interstate movement and environmental release of certain genetically engineered organisms. The U.S.D.A.’s Animal and Plant Health Inspection Service plans to re-engage with stakeholders to determine the most cost-effective, science-based approach for regulating the products of modern biotechnology while protecting plant health.

Sonny Perdue
Secretary of Agriculture George E. “Sonny” Perdue

“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 Secretary of Agriculture George E. “Sonny” Perdue. “To ensure we effectively balance the two, we need to take a fresh look, explore policy alternatives and continue the dialogue with all interested stakeholders, both domestic and international.”

The withdrawal of the proposed rule was published in the Nov. 7 issue of the Federal Register, which may be found here.

APHIS administers regulations in 7 CFR Part 340, which deals with the introduction of organisms and products altered or produced through genetic engineering. APHIS proposed to revise the regulations in the Jan. 19 issue of the Federal Register, which may be found here. It would have marked the first comprehensive revision of the regulations since they were established in 1987.

APHIS received 203 comments on the proposed rule. APHIS said some commenters thought the criteria for designating genetically engineered organisms as regulated organisms were too expansive, potentially resulting in APHIS regulating a wider range of genetically engineered organisms than necessary and increasing the regulatory burden for the biotechnology industry. APHIS said other commenters thought certain exemptions and exclusions in the proposed rule would narrow the scope of APHIS’ regulatory authority and increase the risk of the unintended presence of genetically engineered crops in organic and other non-G.M.O. crops.

Based on the scope of comments received, APHIS decided to withdraw the rule and begin a new stakeholder engagement.

Mr. Perdue talked about how biotechnology potentially could help in feeding the world in years to come.

“Today, we need to feed some 7 billion people,” he said. “By the year 2050, that population will swell to 9.5 billion, over half of which will be living in under-developed conditions. To put the demand for food into perspective, we are going to have to double our production between now and 2050.

“We will have to produce more food in the next 30 years than has been produced in the last 8,000 years. Innovations in biotechnology have been helping American farmers produce food more efficiently for more than 20 years, and that framework has been essential to that productivity. We know that this technology is evolving every day, and we need regulations and policies that are flexible and adaptable to these innovations to ensure food security for the growing population.”