1. Inadequacies in the Federal Regulation of Agricultural Biotechnology Gregory Jaffe Director, Biotechnology Project Center for Science in the Public Interest March 14, 2003

2. Center for Science in the Public Interest (CSPI) Food and nutrition consumer organization Nutrition Action Healthletter No industry funding No government funding

3. CSPIs Biotechnology Project Purpose Identifying benefits and risks Establishing strong regulatory systems in US and abroad Educating and informing the public Positions Current crops in US appear safe to eat and environmental risks are manageable Some benefits from current crops Address new products on a case-by-case system Regulatory systems in US and abroad need strengthening to address next generation of products

4. Goal of Regulatory System Ensure that ag biotech products are safe to humans and the environment Products get a thorough evaluation to determine they are safe to eat Products get an environmental assessment to determine potential environmental effects (and approval conditions adequately minimize or eliminate the negative effects)

5. Attributes of Strong Regulatory System Adequate legal authority Mandatory Agency determinations that products are safe Open and transparent Participatory Oversight of industry compliance with regulations and enforcement where needed

6. FDAs Voluntary Review of GE Crops FDA review of GE crops involves voluntary consultation Not food additive but considered GRAS No determination by FDA that crop is safe for human or animal consumption No legal authority to have mandatory, premarket approval process as is found in most other countries

7. CSPIs Report: Holes in Biotech Safety Net (Jan. 2003) FDA could not acquire desired data Obvious errors went undetected by FDA Important toxicants and anti-nutrients were not tested Data submitted contained insufficient detail

8. FDA Approves Transgenic Animals Behind Closed Doors Treated as animal drugs under Section 512 of the FFDCA. Reviewed for human and animal safety Mandatory premarket approval Process is NOT Transparent Process is NOT Participatory Result: No public trust in decision

9. Regulatory System Lacks Adequate Measures to Ensure Environmental Safety FDA lacks authority to address environmental concerns of transgenic animals USDA does not conduct environmental assessments prior to release for many crops Environmental assessments conducted by USDA are inadequate USDA has no authority over commercial products that have obtained nonregulated status

10. Oversight and Adherence to Permits StarLink Violations of EPA permits by Pioneer and Dow for Bt corn rootworm trials in 2002 Prodigene violations U. Of Illinois transgenic pig violations Approximately 60 USDA permit violations between 1995 and 2000 Do the agencies have the will and resources to oversee the industry and punish the bad actors?

11. Possible Solutions to Enhance Regulatory System Legislative Changes Genetically Engineered Foods Act (S. 3095) introduced by Senator Durbin (IL) in October, 2002 Sets up transparent, open approval process for biotech crops Provides explicit environmental authority to FDA for transgenic animals Opens up the review process for transgenic animals Requires a premarket food-safety approval process for any engineered food crop (includes pharming)

12. Possible Solutions to Enhance Regulatory System (Cont.) Administrative Changes End process of deregulating GE crops at USDA Require environmental assessments before USDA issues permits

13. Possible Solutions to Enhance Regulatory System (Cont.) Oversight changes Strong inspection system by federal government Third party independent auditing of compliance with permit conditions Documentation requirements Certification of farmers Strong penalties as a deterence

14. What About Pharming Using Food Crops? Federal food law only covers products intended for use as food or feed Current federal biotech crops policy is voluntary consultation Recent federal policies dont adequately cover those crops OSTP proposals FDA/USDA guidance Recent USDA permit conditions (March 10, 2003)

15. A Regulatory Scheme for Pharming Crops Strict containment procedures Includes physical isolation Segregation procedures Mandatory premarket food safety approval before commercialization Oversight by federal government (inspections, documentation, etc…) Third party independent verification systems

16. Gregory Jaffe Director CSPI Biotechnology Project Website: www.cspinet.org/biotech/index.html www.cspinet.org/biotech/index.html E-mail address: gjaffe@cspinet.org