6 June 2019
Proposal to Modernise U.S. Biotechnology Regulations Under Consideration
The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service is seeking input from interested parties by 5 August on a proposed new rule regarding the regulation of certain genetically engineered organisms. APHIS oversees the importation, interstate movement and/or environmental release of plants to ensure that they do not pose a plant pest risk and may seize, quarantine, treat, destroy or apply other remedial measures to an organism deemed to pose such a risk. The agency issues an emergency action notification to the organism’s owner to specify the remedial measures.
The proposed sustainable, ecological, consistent, uniform, responsible, efficient (SECURE) regulations on GE organisms are intended to modernise U.S. biotechnology regulations in an effort to provide regulatory flexibility for advances in genetic engineering while protecting against plant pest risks. USDA Under Secretary for Marketing and Regulatory Programs Greg Ibach said that the update will enable APHIS to evaluate GE organisms for plant pest risk “with greater precision than the current rule allows, ensuring oversight and risk are based on the best available science.” SECURE is the most significant revision of the USDA’s biotechnology regulations since 1987.
Under SECURE, developers would be able request a regulatory status review of a GE plant. Decisions on regulatory status would be based on APHIS assessment of plant pest risk. If movement of a GE plant is found to not pose a plant pest risk, the plant could be moved without a permit, but if APHIS determines that the GE plant could pose a risk a permit would be required. Plants not subject to APHIS GE regulations could still be subject to other APHIS or USDA regulations while plants developed for pharmaceutical or industrial purposes may be subject to Food and Drug Administration and/or Environmental Protection Agency regulations.
For a GE organism under APHIS permit to be imported into the United States, the outmost container must bear information regarding the nature and quantity of the contents; the country and locality where it was collected, developed, manufactured, reared, cultivated or cultured; the name and address of the shipper; the name, address and telephone number of the consignee; the identifying shipper’s mark and number; and the permit number authorising the importation. For organisms imported under permits by mail, the container must also be addressed to a plant inspection station listed in the USDA Plants for Planting Manual. All imported containers of organisms under permit must be accompanied by an invoice or packing list indicating the shipment contents. Following shipment completion, all packing material, shipping containers and other accompanying material must be treated or disposed to prevent their dissemination in the environment. Import records for an organism under permit must be retained for at least two years, while all other records related to a permit must be retained for five years following the expiration of the permit, or longer if specified in the permit.
Under the proposed rule, APHIS regulatory oversight would not be required for GE organisms that fall into an exempted category or that have been found by a regulatory status review to be unlikely to pose plant pest risks. The USDA does not plan to regulate organisms that could otherwise have been developed through traditional breeding techniques since such products of biotechnology are likely to pose no greater plant pest risk than the traditionally bred varieties. SECURE should reduce regulatory costs for the development of GE plants for which permits are no longer required, based on a reduced need to collect field data and fewer reporting requirements. A developer whose GE plant belongs to an exempted category would have the option to request written confirmation of this self-determination from APHIS; this confirmation letter may be useful to market products by providing verification to a purchaser or importing country that APHIS concurs with the self-determination.