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

35
30
25
20
15
10
5
0
Too much Too Little Right Don't
Amount Know/No
Opinion
Source: http://pewagbiotech.org/research/2003update/2003topline.pdf
 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

40
35
30
25
20
15
10
5
0
Strongly Not Not Strongly Don't
Agree strongly Strongly Disagree Know/No
Agree Disagree Opinion

Source: http://pewagbiotech.org/research/2003update/2003topline.pdf
 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

80
70
60
50
40
30
20
10
0
Strongly Strongly Don't
Agree Disagree Know

Source: http://pewagbiotech.org/research/2003update/2003topline.pdf
 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

50
45
40
35
30
25
20
15
10
5
0
More Willing Less Willing No Difference Don't
Know/Not
Sure
 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: www.cspinet.org
/biotech/
E-mail address:
gjaffe@cspinet.org