Monday, June 15, 2009

APHIS seeks comments on Genetically-Engineered Draft Standard

USDA-Animal and Plant Health Inspection Service (APHIS) is seeking comments until August 3, 2009 on its draft audit standard for the pilot Biotechnology Quality Management System (BQMS).

BQMS is a voluntary program that aims to enhance compliance with regulations for field trials and transportation of certain GE organisms, by compiling draft standards that utilize current regulations on environmental releases, importations and interstate movements. APHIS selected five participants in September, 73 Fed. Reg. 51266, for the BQMS pilot program that have applied the draft audit standard to their organization's regulated biotechnology program to plan, implement, document, and examine the efficacy of quality assurance and quality control measures related to introductions of regulated articles.

APHIS is seeking comments on the draft audit standard that is currently in use in the pilot program as a whole, and specifically Requirement 7 regarding critical control points for the introduction of regulated articles by developing containment procedures for regulated articles; developing measures for the identification of regulated articles in storage, being moved, imported, or transferred, and in field locations; developing procedures for planning and monitoring environmental releases of regulated articles; developing methods for post-harvest handling activities and methods to maintain the identity of regulated material; developing procedures for the devitalization and disposition of regulated articles; as well as developing procedures for the submission of regulatory compliance incidents to the appropriate regulatory authorities.

The specific questions to submit comments are:

1.) Does Requirement 7 cover all areas required to comply with 7 CFR Part 340?
2.) Is the draft audit standard consistent with current best practices for the regulated commodity?
3.) Are there identifiable incentives to encourage participation in the BQMS?
4.) Is the flexibility to apply to any organization apparent in the draft audit standard?

The notice can be found in the June 4, 2009 Federal Register at 74 Fed. Reg. 26831. A copy of the draft audit standard can be downloaded as a PDF from here!