The U.S. Department of Agriculture recently finalized a major overhaul of biotech regulations that will exempt many genetic modifications from the lengthy regulatory approval process. This is the first significant change to the agency’s rules for GE crops since it was put in place over thirty years ago.

USDA claims the “Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient” (SECURE) rule will help expedite the development of new innovative crops using genetic engineering and gene editing and reduce unnecessary regulatory burdens for developers. GE plants will also not be subject to regulation if they have plant-trait combinations that are the same as other plants that APHIS has conducted a regulatory review on and approved.

Additionally, the agency leaves it up to biotech developers themselves to determine whether a new crop is exempt from regulatory review. USDA’s Animal and Plant Health Inspection Service (APHIS) says the exemptions would “apply to plants containing single targeted modifications” deemed to be low plant-pest risks.

When the USDA first developed the rules back in 1987 it largely focused on genetically modified organisms, where a gene is added from another organism. As AHIS explains, the new exemptions “were formulated to apply to what could otherwise be achieved through conventional plant breeding techniques in any species,” something that gene-editing techniques like CRISPR-Cas9 are able to achieve at a rapid pace today.  

APHIS says farmers will benefit from the new relaxed regulation by gaining access to a wider variety of traits as well as a greater number of new GE crop species. Some of the innovations APHIS expects to see are crops with greater resistance to disease and insect pests; greater tolerance of stress conditions such as drought, high temperature, low temperature, and salt; and more efficient use of fertilizer.

At the same time, APHIS has warned that growers of “identity-preserved crops,” such as “organic, other non-GE and other agricultural commodities segregated for specific purity and quality tolerances” could see negative impacts due to cross-pollination or commingling risks, particularly if there is a wider adoption of GE crops. “Costs incurred by growers of organic and other identity-preserved varieties who seek to prevent such unintended presence may increase,” APHIS said.    

Major industry groups back the rule changes, including American Seed Trade Association, American Farm Bureau Federation, and National Council of Farmers Cooperative. At the same time, some environmental and public health advocacy groups oppose the exemptions, saying the rule will leave consumers in the dark about new biotech products that have entered the marketplace.

EPA Administrator Andrew Wheeler welcomed the new rule, noting that his agency is also working to reduce unnecessary regulations and break down barriers to advancements in biotechnology. “We plan to issue our proposed rule early this summer,” he says in a statement released by the USDA. Click HERE for a larger view of the first graphic below. (Sources: AgriPulse, Chemical & Engineering News, Genetic Literacy Project)

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