The U.S. Department of Agriculture's Animal and Plant Health Inspection Service (APHIS) is requesting comments by Aug. 23 on the draft audit standard being used to evaluate quality-management systems to be used by biotechnology providers to protect against the inadvertent release of unauthorized biotech-enhanced events.
In particular, APHIS is seeking comments on a requirement – designated as requirement 7 within the draft audit standard – that specifies that participants address critical control points in their containment procedures to prevent the unauthorized introduction of regulated biotech commodities. Regulated biotech products are those biotechnology-enhanced events that still are under USDA regulatory oversight, such as those involved in pilot tests. Under the U.S. biotech regulatory framework, APHIS regulates the importation, interstate movement and environmental release of biotech-enhanced organisms that are, or may be, plant pests.
Requirement 7 also stipulates that providers develop procedures or methods for: 1) identifying regulated articles while they are in field locations, in storage, or when being transported, imported or transferred; 2) planning and monitoring the environmental release of regulated articles; 3) post-harvest handling activities and methods to maintain the identity of regulated products; 4) devitalizing and disposing of regulated products; and 5) submitting regulatory compliance incidents to the appropriate regulatory authority.
APHIS seeks comments on whether the critical control points in requirement 7 of the draft audit standard identify all areas and elements on which biotech providers should focus to meet the agency's regulatory requirements. The agency also seeks information on whether the draft audit standard is consistent with current best practices used by the biotech industry; whether there are incentives USDA could use to encourage participation in the voluntary audit program; and whether there is sufficient flexibility in the draft audit standard.
Submitting Comments: Comments may be submitted through the U.S. government's electronic portal by clicking here. Contact NGFA Director of Legislative Affairs Chris Holdgreve at choldgreve@ngfa.org or at 202-289-0873, ext. 13 if you would like more information on this issue.