A Consumer Perspective on Biotech Foods Gregory Jaffe Director, Biotechnology Project Center for Science in the Public Interest October 7, 2004

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

CSPI’s 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 –Future products need to be assessed individually –Regulatory systems in US and abroad need strengthening to address next generation of products

The Road to Consumer Acceptance Providing benefits Addressing risks Ensuring biotech foods are safe to eat Eliminating, minimizing, and/or managing environmental risks Addressing controversial applications (biopharming, transgenic animals)

Current GE Crops Crops: primarily corn, cotton, canola, and soybeans Traits: built-in pesticide or resistance to an herbicide. Countries grown: United States, Argentina, Canada and China 67 million hectares and 7 million farmers In Africa, South Africa grows 400,000 hectares of GE corn and cotton

Beneficial Products? Environmental Benefits –Less insecticide use –Less harm to wildlife –Less soil erosion and water pollution –Less harmful chemicals –Comparison to organic agriculture Farmer Benefits Consumer Benefits? NEED TO EXPLAIN BENEFITS TO PUBLIC

Potential Food-Safety Risks from Biotech Foods Allergenicity Toxicity Unintended Effects –Toxicants and anti-nutrients Compositional Equivalence –Comparison of conventional and biotech food

Potential Environmental Risks Gene Flow –Wild relatives –Native land races (center of origin, biodiversity) –Superweeds Harm to non-targets Insect resistance

Social, Economic and Ethical Concerns International trade Impact on small farmers Reliance on multinational corporations Intellectual property concerns Effect on other farmers (e.g. organic growers)

Safe Biotech Food New foods tested before marketed Independent agency determination that food is safe Mandatory regulatory system Government oversight of companies marketing the new food Equity in treatment of products

Government Regulation of Genetically Modified Foods Source:

FDA Biotech Food Safety Policy -- Plants Food, not process Not food additives Voluntary consultation –everyone has complied –“substantial equivalence”

Problems with Current FDA Policy -- Plants Voluntary Developer-driven scientific data “Not a comprehensive scientific review” (See CSPI Report “Plugging Holes in the Biotech Safety Net”) “No further questions at this time” response Future biotech products will need additional scrutiny Proposed mandatory pre-market notice

Advantages of Mandatory Approval System FDA checks industry and shares responsibility for safety Conforms process to EPA process for pesticidal plants and FDA’s process for GE animals Treats Americans the same as Europeans, Canadians, and South Americans Not more burdensome than FDA proposed process

Companies should be encouraged, but not required, to let the FDA review data regarding the safety of a GM food before that product goes on the market Source:

Companies should be required to submit safety data to the FDA for review, and no genetically modified food should be allowed on the market until the FDA determines it is safe Source:

Willingness to eat GM Foods if the Federal Government made it mandatory for FDA to approve all GM Foods before they enter the market place

CSPI’s Proposal for Approval at FDA Mandatory, transparent process completed before marketing Specific data requirements and testing guidance

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

Possible Legislative Solution to Enhance Regulatory System Genetically Engineered Foods Act (S. 2546) introduced by Senator Durbin (IL) in June, 2004 –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”)

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”

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 Bt corn insect resistance management (See CSPI Report “Planting Trouble: Are Farmers Squandering Bt Corn Technology?”

Enforcement Do the agencies have the will and resources to oversee the industry and punish the “bad actors”?

The Re-emergence of Biopharming CSPI Report: “Sowing Secrecy: The Biotech Industry, USDA, and America’s Secret Pharm Belt.” 16 applications for 2004 (6 in corn, 5 in tobacco) States covered: CA, TX, AZ, WA, IA, MO, NE, KY, SC Both field trials and commercial applications

What About “Pharming” Using Food Crops? USDA regulations are inadquate Federal food law only covers products intended for use as food or feed Current federal biotech crops policy is voluntary consultation Recent federal policies don’t adequately cover those crops –OSTP proposals –FDA/USDA guidance –Recent USDA permit conditions (March 10, 2003)

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

Transgenic Animals Extremely controversial Current confidential nature of regulation will be viewed very negatively by public More than issues of safety – ethical, social, and religious issues Potential to harm crop biotechnology

Education and Information Need education on biotechnology Need education on agriculture Need education on the food we currently eat and how it is produced Need information about the benefits of biotech foods Need to know which specific foods are biotech

Conclusions Agricultural Biotechnology is one tool to move agriculture forward Need strong regulatory system to safeguard human health and the environment Transparency and public participation are essential Must have consumer trust in regulatory process to achieve consumer confidence in the marketed products Risks to eating current biotech foods are extremely small

Gregory Jaffe, Director CSPI Biotechnology Project Website: address: