Biotechnology and Food:
Understanding the Issues
Michael J. Phillips, Ph.D.
Vice President
Biotechnology Industry Organization
National Public Policy Education Conference
September 22, 2003
Areas To Cover

Adoption & Benefits
 Regulatory Policy
 Liability
Improvements most often
delivered through biotechnology
 Herbicide

Enable improved weed control
measures
 Insect

tolerance
resistance
Enable improved pest
management
Products in the Market

High-performance cooking oils -- reduce
need for processing, create healthier food
products (sunflower, peanuts, soybeans)
 Delayed-ripening fruits and vegetables -superior flavor, color, texture (tomatoes)
 Food enzymes -- purer, more stable form of
chymosin used in cheese production -- the
first biotechnology food product
Global Area of Transgenic Crops,
1996 to 2000: By Crop
(million hectares)
30
25
20
Soybean
Corn
Cotton
Canola
15
10
5
0
1996
1997
1998
1999
2000
Source: Clive James, 2000
Crops improved through
biotechnology that are grown
most frequently:
Soybeans
 Corn
 Cotton
 Canola

Global Area of Transgenic Crops,
1996 to 2000: By Trait
(million hectares)
35
30
25
Herbicide tolerance
20
Insect resistance
15
Herbicide tolerance /
Insect resistance
10
5
0
1995
1996
1997
1998
1999
2000
Source: Clive James, 2000
Global Area of Transgenic Crops, 1996 to
2000; Industrial and Developing Countries
(million hectares)
40
35
30
25
Industrial
Developing
20
15
10
5
0
1995
1996
1997
1998
1999
2000
Source: Clive James, 2000
Global Area Adoption Rates (%)
for Principal Transgenic Crops
(million hectares)
160
140
120
100
80
60
40
20
0
Nontransgenic
Transgenic
Soybean
Cotton
Canola
Maize
Source: Clive James, 2000
Biotech Crops-Percent of
Plantings - U.S.
80
80
74
68
70
69 71
70
61
60
54
50
48
47
45
40
37
37
32
30
20
25
13
10
2
0
Soybeans
Cotton
Corn
1999 figures are based on a survey of BIO member seed sales.
2000-02 figures are based on USDA/NASS
2003 figures are estimates of USDA, NASS 3/31/03
34
1996
1997
1998
1999
2000
2001
2002
2003
Biotech Crop Plantings-U.S.
60
51.3
50
45.4
40
35
30
58.5
28.3
27
20
20
9
10
1
11.1 10.5
9.4
10
7
5.8
0
Soybeans
Cotton
*2003 estimates, USDA, NASS 3/31/03
Corn
26.9
1996
1997
1998
1999
2000
2001
2002
2003*
Economic Impact
With crops improved through
biotechnology, the key commodity is
information, and this is carried in the
seed itself. Further, its delivery is
scale neutral and not capital
intensive for the farmer.
Through the 8 crop varieties
widely planted in the U.S. to date,
biotechnology has:
Increased yields by 4 billion pounds
 Saved growers $1.2 billion annually
 Reduced pesticide use by 46 million
pounds annually

-Leonard Gianessi
National Center for Food and Agricultural Policy
If an additional 32 crop
varieties were adopted:
Crop yields would increase by an
estimated 10 billion pounds
 Costs to growers would be reduced by
an additional $400 million annually
 Further reduce pesticides by 117 million
pounds

-Leonard Gianessi
National Center for Food and Agricultural Policy
Science Based Regulatory
Systems Advancing
2002 Biotechnology
 Granting Production & Import Approvals
 Granting Import Approvals
 Conducting Pre-Commercial Field Trials
 Commercialization Delayed
U.S. Coordinated Framework
Key Concepts

Federal “Safety Net”
– All crops subject to science-based regulation with
individual products or categories eligible for
exemption over time based on experience and data
– “Precautionary approach” adopted by U.S. in 1986
– Ensure that biotechnology-derived crops are as safe
to grow as conventional crops
– For crops intended for food or feed, ensure they are
as safe to eat as conventional crops
U.S. Coordinated Framework
Key Concepts

Department of Agriculture (USDA)
– Plant Protection Act (PPA)
– Animal Health Protection Act (AHPA)
– Federal Seed Act (FSA)
– Virus-Serum-Toxin Act (VSTA)
 Animal biologics
– National Environmental Policy Act (NEPA)
U.S. Coordinated Framework
Key Concepts

Environmental Protection Agency (EPA)
– Federal Insecticide, Fungicide & Rodenticide
Act (FIFRA)

Health & environmental safety of pesticides
– Federal Food, Drug & Cosmetic Act (FFDCA)
 Dietary safety of pesticide residues
– Toxic Substances Control Act (TSCA)
 Health & environmental safety of other chemicals
U.S. Coordinated Framework
Key Concepts

Food and Drug Administration (FDA) –
Federal Food, Drug & Cosmetic Act (FFDCA)
– Food and feed



Safety of whole food and food ingredients
“As safe as” conventional foods
Significant changes may require food additive regulation
– Human drugs and biologics
– Animal drugs
– Medical devices
Anti-Biotech Myth #1
 Lack
of Regulation
– Products rushed to market
– Little or no governmental oversight
Coordinated Framework
Case Study

Insect-resistant Corn (MON 810)
 Protected Against European Corn Borer and
Other Damaging Insect Pests
 Bt (Bacillus thuringiensis) Insecticidal
Protein
– Derived from naturally-occurring soil microbe
– Used by conventional and organic farmers for 3
decades
Coordinated Framework
Case Study
1.
2.
3.
4.
Large-scale field tests, EPA/FIFRA,
USDA/PPA (1992-96)
Small-scale field tests, USDA/PPA (1991)
Determination not a plant pest,
USDA/PPA & environmental assessment,
USDA/NEPA (1996)
Food safety/nutrition review,
FDA/FFDCA (1996)
Coordinated Framework
Case Study
5. Health and environmental review and
approval as plant-incorporated protectant
(5-year) with tolerance exemption,
EPA/FIFRA/FFDCA (1996-97)
6. Health and environmental reassessment
and renewed approval (7-year),
EPA/FIFRA/FFDCA (1998-2001)
Regulation – The Reality

Unprecedented Regulation of Plants and Plant
Products
– Health, safety and environmental data reviewed by
three federal agencies over 11-year period

7 pre-commercial/4 post-commercial
– No comparable oversight for conventional hybrids

EPA/USDA/FDA
– Jurisdiction uniformly exercised and consistently
recognized and supported by industry
Myth #2
No Data
Data –
The Reality

Data Routinely Submitted to and Reviewed
by USDA, EPA & FDA
– 2000 NAS Report - App. B

www.nap.edu/catalog/9795.html
– Bibliography of health, safety & environmental studies


www.agbios.com
New Data Requested As Needed
– EPA for insect resistance and non-target impacts
– USDA for outcrossing of virus-resistant squash
Myth #3
No Public Participation
25-Year Record

Public Meetings
 Public Comment
 Proposed Rules and Policies
 Web Sites
 Scientific Peer Review
 Published Data
Public Participation –
The Reality
 Extensive
Public Participation
Opportunities Over the Past 25 Years
Myth #4
Harm to Health and the
Environment
Harm –
The Reality

With intensive governmental, academic and
commercial oversight for the past 16 years,
not a single instance of actual harm to
health, safety or the environment has ever
been confirmed for biotechnology derived
crops on the market today.

Key Messages for
Biotechnology
Strong Federal Oversight
– All products initially subject to review with individual
products or categories eligible for exemption over time
– Clear, consistent rules developed with public
participation
– Rigorous, science-based safety assessment by federal
regulatory agencies
– Superior risk management

Conditions placed on approvals tailored to address potential
risks
– Dynamic process – open to improvement based on
experience and new scientific information
Let’s Get Real About Production
of Biotech Food and Feed Crops

Federal agencies that regulate biotechnology crops
must address the potential for the unintended
presence in conventional or organic crops of
material from biotechnology-derived plants
developed for food or feed use.
 Must establish reasonable, science-based standards
and procedures that acknowledge the realities of
growing food, feed and fiber commodity crops in
a biological system.
Realities
1.
Biological systems are inherently
imperfect.
2.
There is no such thing as “100 percent
pure” in Mother Nature.
Realities
3. Even Ivory Soap is “only” 99.44/100%
Pure®
 and that is achieved through production in
carefully controlled industrial facilities.
Realities
4.
5.
Biological systems are dynamic, not static.
Movement and dissemination of seeds and
pollen is natural and inevitable.
 Wind
 Water
 Birds
 Insects
Realities
6.
The movement of genetic material (“gene
flow”) is as normal and natural as
agriculture itself.
 Pollen
 Seeds
 “Volunteers”
Realities
7.
Some plants are sexually promiscuous.
8.
Crops and their weedy relatives have
exchanged genes for centuries.
Realities
9. Unintentional commingling of seed, grain,
and other agricultural products, as well as
processed commodities, occurs routinely
in agricultural and food production.
 Seed in farm equipment
 Grain residues in shipping containers
 Food residues in the processing vat
Realities
10. As analytical techniques continue to
increase in sensitivity (chemical,
biological & genetic), if we look hard
enough, long enough and often enough,
we are likely to find imperfections,
impurities and contaminants just about
everywhere.
Societal Response

Historically, the presence of unintended
impurities in food, feed and seed has been
recognized and accepted in laws,
regulations and standards that establish
allowances for these impurities or
otherwise ensure that their presence is
safe.
Societal Response
•
Examples of existing allowances include:
 “Corn” must consist of at least 50% corn and
no more than 10% of other grains for which
standards have been set (USDA)
 “No. 1 Grade Corn” may include up to 2%
broken corn and “foreign materials” (USDA)
Societal Response
 Seed of a particular hybrid may contain up to
5% of a different hybrid without identification
(USDA)
 “Organic” products may include up to 5% of
listed synthetic substances (including listed
pesticides) and up to 5% of the EPA
“tolerance” or allowable level for prohibited
pesticides under the Organic Rule (USDA)
Societal Response
 “Sugar Free” foods may contain up to 0.5
gram of sugar per serving (FDA)
 “Nonfat Yogurt” may contain up to 0.5%
milkfat (FDA)
 “Decaffeinated” coffee may contain up to 3%
caffeine (FDA)
Societal Response
 Compound food ingredients that make up less
than 5% of a food need not be further
identified (CODEX)
 An agricultural chemical for which a residue
limit has not been set may legally be present in
food up to the default action level of 0.1 ppm
(Canada)
Societal Response
•
Example of an existing safety standard:
 Naturally occurring substances that are not
intentionally added to food may legally be
present in the food if the amount of the
substance “does not ordinarily render it
injurious to health.” (Federal Food, Drug and
Cosmetic Act)
Definitions
•
•
“Adventitious Presence” is a new term for
an old concept.
In its broadest sense, the concept refers to
the unintended, incidental presence of an
impurity in a product.
Definitions

In the context of agricultural
biotechnology, “adventitious presence” is
the unintended, incidental occurrence of
plant material from crops improved
through modern biotechnology in seed,
grain, food or feed products.
Why Do We Care?
•
The presence of biotechnology-derived
material in and of itself is not a health, safety
or environmental concern.
 Historical lack of concern with conventional crops
 Concern arises only if science establishes that the
presence of the biotechnology-derived material is
found to present a risk (i.e., hazard x exposure),
which is not the case.
Why Do We Care?

With intensive governmental, academic
and commercial oversight for the past 16
years, not a single instance of actual harm
to health, safety or the environment has
ever been confirmed for biotechnology
derived crops on the market today.
Reasons Why We Should
Care
1.
2.
3.
Proactive product stewardship requires
assurance of health and environmental
safety.
Without a national policy, the “standard”
becomes zero by default.
Some regulators view detection of DNA as
a surrogate for the protein.
Reasons Why We Should
Care
4.
5.
6.
Potential economic impacts of unintended
presence lead to calls for liability/compensation
Detection and sampling capabilities, not
potential harm, are being used as basis for
regulation and standard setting.
Each country going its own way undermines
benefits of international harmonization.
Reasons Why We Should
Care
All of these trends have the effect of:
 Undermining consumer confidence
 Causing unnecessary commercial/trade
disputes and market disruptions
 Adversely impacting growers and the rest
of the food and commodity industries
 Undermining investor confidence in crop
biotechnology
Key Issues Going Forward
•
Build on the existing U.S. regulatory process for
early (field test stage) safety assessment of
biotechnology-derived crops developed for food
or feed use.
 Easily accommodated at FDA under same science-
based standards used for pre-market food safety
reviews
 Well-established review process for field tests at
USDA and EPA
Key Issues Going Forward
•
White House Office of Science &
Technology Policy took first step to:
•
Update field test requirements
• Establish early food safety assessments
•
Proposed Federal Actions
•
August 2, 2002
• 67 Fed. Reg. 50578
Key Issues Going Forward
•
•
Finalize proposed federal actions
Work with trading partners to harmonize
standards and policies to address the
unintended presence of biotechnologyderived material from food and feed crops
cleared for field testing and/or commercial
introduction.
Let’s Get Real About Production
of Non-Food Biotech Crops

Federal agencies that regulate biotechnology
crops must address the potential for the
unintended presence in conventional or organic
crops of material from biotechnology-derived
plants intended not to be used for food or feed.
 Must enforce reasonable, science-based
standards and procedures to avoid unintended
presence based on the realities of growing
specialty crops in a biological system.
Plant-Made Pharmaceuticals
(PMPs) and Industrials (PMIPs)

Regulated by USDA at all stages of testing and
production
 Not subject to expedited review
–
–
–

Interim Final Rule (Aug. 6, 2003)
Permits always required for field testing
Permits required for commercial production for
foreseeable future
Not grown as commodity crops (e.g., contract
growers only)
Plant-Made Pharmaceuticals and
Industrials
USDA’s principal focus is protecting health and
environmental safety and agriculture
 PMPs also regulated by FDA

–

More concerned about maintaining PMP’s purity
BIO White Paper for Confinement and
Development of PMPs (5-17-02)
–
–
Addresses protection of health and environmental
safety, agriculture and PMP purity
www.bio.org/pmp/PMPConfinementPaper.pdf
Plant-Made Pharmaceuticals and
Industrials
•
USDA and FDA Guidance for Industry for
PMPs:
•
Updated confinement measures
• Addressed manufacturing, process, preclinical and clinical testing considerations
• September 12, 2002
• 67 Fed. Reg. 57828
Plant-Made Pharmaceuticals and
Industrials
•
USDA has tightened 2003 permit
conditions for plants engineered to
produce pharmaceutical and industrial
compounds
•
March 10, 2003
• 68 Fed. Reg. 11337
• Comments by May 9, 2003
Plant-Made Pharmaceuticals and
Industrials
•
•
•
•
•
•
Increased perimeter fallow zone (25’ to 50’)
Restricted next season plantings
Required dedicated equipment and storage
facilities
Required approved training programs
Increased isolation distance for open-pollinated
pharmaceutical corn to 1 mile
Increased field test inspections
Liability for Farming?
•
•
•
•
Are biotechnology-derived crops
regulated?
Is the safety of these crops reviewed?
Do these crops grow differently than
others?
Can these crops co-exist with other types
of crops?
Regulation and Safety
•
•
•
Biotechnology-derived crops are regulated
and reviewed for safety by two and
sometimes three federal agencies
Conditions placed on approvals tailored to
address potential risks
No comparable review or regulation of
conventional or organic crops
Biotech Crops Grow Like All
Other Crops
•
Specific genetic changes made through
molecular biology do not change the basic
nature of the crop
•
Still pollinate exactly like their conventional
counterparts
• Pose no more risk of cross-pollination with
neighboring crops than any other type of crop
Biotech Crops Grow Like All
Other Crops
•
•
Any open pollinating crop has the potential
to cross-pollinate with another neighboring
crop
Growers of specialty crops protect against
this:
•
•
•
Blue corn
White corn
Canola
• Organic
• “Non-GMO”
Liability for Farming?
•
•
•
Should a blue corn grower sue a yellow
corn grower for planting too close?
Should a sweet corn grower sue a field
corn grower for planting too close?
Should an organic grower sue a
conventional grower for planting too
close?
Liability for Farming?
•
•
Should you sue your neighbor whose grass
makes you sneeze?
Should your neighbor have to dig up his
lawn and install a rock garden? “Native”
grasses?
Co-existence With Other Crops
•
Specialty Growers Earn a Premium Price
•
•
•
•
•
•
They contract to meet certain standards
They assume the responsibility to meet those
standards
They take extra effort to meet those standards
They are rewarded with a premium price
They do not share premium with neighbors
Specialty crops include “Identity Preserved,” PMP,
PMIP and organic crops
Organic Crops Are Specialty
Crops
•
•
•
•
“Organic” does not mean zero biotech
National Organic Program is process based
Organic grower who follows the standard but
still has detectable residue of a biotechnologyderived crop is not in violation
Organic growers who contract for zero presence
of biotechnology-derived material are assuming a
contractual risk
Is There a Need for a New
Liability Scheme?
•
•
•
•
•
•
Not based on safety
Not based on lack of regulation
Not based on unique pollen concerns
Not based on inability of growers to segregate
crops
Not based on requirement for new standards for
organic farming
Not based on lack of access to the courts
For More Information
www.bio.org