2008/SOM1/HLPDAB/008 Agenda Item: 2

Transcription

1 2008/SOM1/HLPDAB/008 Agenda Item: 2 United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS): Implications of Transparent Policies and Regulations in Agricultural Biotechnology Purpose: Information Submitted by: USA High Level Policy Dialogue on Agriculture Biotechnology Lima, Peru February 2008

2 USDA APHIS: Implications of transparent policies and regulations in agricultural biotechnology John B. Pitchford Acting Associate Deputy Administrator Biotechnology Regulatory Services Animal and Plant Health Inspection Service United States Department of Agriculture Seventh Meeting of APEC High Level Policy Dialogue on Agricultural Biotechnology February 27, 2008 Transparency of the Regulatory System Increases compliance with APHIS regulations Helps domestic and international audiences understand how decisions are made Builds public confidence in the regulatory system Reduces costs to APHIS and the regulated community Increases ability to coordinate domestically and internationally 1

3 Fundamental Policies APHIS does not: Promote specific varieties of GE crops Promote biotechnology in general APHIS evaluates new products on case by case basis APHIS Regulations 7 CFR 340 APHIS regulations apply if organism: has been altered/produced through genetic engineering AND could possibly be a plant pest 2

4 APHIS Regulatory System Goals Flexibility, adapting to changing trends and new scientific knowledge Rigorous, science-based, and easily understood To the extent possible, encompass interests of all stakeholders Meet both domestic and international needs Oversight proportionate to risks Transparency and stakeholder input Non-regulated Status APHIS has issued determinations of nonregulated status in response to 71 petitions. The deregulated plants represent 14 crop species. Deregulated products can be used in food, feed, breeding programs in the same way as their conventional counterparts. Commercialization of new, deregulated, biotech products is determined by market. 3

5 Regulatory Changes USDA-APHIS is in the process of revising its regulations for GE organisms Driven by new technological trends Need to reflect extensive experience in regulation since the 1980s Need to address broad authority under the Plant Protection Act of 2000 (including Noxious Weed Act) Regulatory Changes Public comment period on Notice of Intent: 2004 Stakeholder meetings with industry, crop associations, academia, and NGOs Draft EIS publication: Summer 2007 Three public meetings Public comment period Proposed rule target publication date in mid 2008 Public meetings and public comment Final rule target publication date in late

6 Other Steps Towards Transparency Biotechnology Quality Management System Public Communication Users Guide Stakeholder Updates Federal Register notices Public meetings Consultations with other Governments Biotechnology Quality Management System BQMS to improve compliance, increase transparency, and focus on proactive measures Multi-level verification program will recognize Hazard Analysis and Critical Control Point (HACCP) or ISO standards approach used by applicants for field trials USDA audits and inspections of applicant procedures to augment current compliance system Pilot project: involving one company and several universities. Early

7 Public Communication BRS Website: Central link to Coordinated Framework agencies: Public Communication Updated BRS Users Guide Database of Field Releases in U.S. Federal Register notice and comment Publicly announce significant actions Invite public to comment Public Meetings (creeping bentgrass EIS, programmatic EIS) BRS Stakeholder Updates (quarterly via ) 6

8 Public Communication (continued) Policies communicated to and discussed with our trading partners Bilaterally, multilaterally, and in international forums For example, low-level presence, new regulations, BQMS Thank you For more information on USDA APHIS BRS activities, please visit: 7