biotechnology and food: understanding the issues michael j. phillips, ph.d. vice president...
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Biotechnology and Food: Biotechnology and Food: Understanding the IssuesUnderstanding the Issues
Michael J. Phillips, Ph.D.Vice President
Biotechnology Industry Organization
National Public Policy Education ConferenceSeptember 22, 2003
Improvements most often Improvements most often delivered through biotechnologydelivered through biotechnology
Herbicide toleranceEnable improved weed control
measures
Insect resistanceEnable improved pest
management
Products in the MarketProducts 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, Global Area of Transgenic Crops, 1996 to 2000: 1996 to 2000: By CropBy Crop
(million hectares)(million hectares)
0
5
10
15
20
25
30
1996 1997 1998 1999 2000
Soybean
Corn
Cotton
Canola
Source: Clive James, 2000
Crops improved through Crops improved through biotechnology that are grown biotechnology that are grown
most frequently:most frequently:
SoybeansCornCottonCanola
Global Area of Transgenic Crops, Global Area of Transgenic Crops, 1996 to 2000: 1996 to 2000: By TraitBy Trait
(million hectares)(million hectares)
0
5
10
15
20
25
30
35
1995 1996 1997 1998 1999 2000
Herbicide tolerance
Insect resistance
Herbicide tolerance /Insect resistance
Source: Clive James, 2000
Global Area of Transgenic Crops, 1996 to Global Area of Transgenic Crops, 1996 to 2000; Industrial and Developing Countries2000; Industrial and Developing Countries
(million hectares)(million hectares)
0
5
10
15
20
25
30
35
40
1995 1996 1997 1998 1999 2000
Industrial
Developing
Source: Clive James, 2000
Global Area Adoption Rates (%) Global Area Adoption Rates (%) for Principal Transgenic Crops for Principal Transgenic Crops
(million hectares)(million hectares)
020406080
100120140160
Soybean Cotton Canola Maize
Nontransgenic
Transgenic
Source: Clive James, 2000
Biotech Crops-Percent of Biotech Crops-Percent of Plantings - U.S.Plantings - U.S.
0
10
20
30
40
50
60
70
80
Soybeans Cotton Corn
19961997199819992000200120022003
% o
f T
otal
U. S
. Acr
eage
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
2
13
37
47
54
6874
80
45
48
61
6971 70
25
37
252632 34
Biotech Crop Plantings-U.S.Biotech Crop Plantings-U.S.
0
10
20
30
40
50
60
Soybeans Cotton Corn
19961997199819992000200120022003*
# of
Acr
es P
l ant
ed (
Mil
l ion
s)
1
9
27
35
45.4
51.3 58.5
5.87
9.4 11.1 10.5
10
20
28.3
19.9
1925.3
26.9
*2003 estimates, USDA, NASS 3/31/03
Economic ImpactEconomic 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 Through the 8 crop varieties widely planted in the U.S. to date, widely planted in the U.S. to date,
biotechnology has:biotechnology has:
Increased yields by 4 billion poundsSaved growers $1.2 billion annuallyReduced pesticide use by 46 million
pounds annually
-Leonard Gianessi National Center for Food and Agricultural Policy
If an additional 32 crop If an additional 32 crop varieties were adopted: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
Granting Production & Import Approvals Granting Import Approvals Conducting Pre-Commercial Field Trials Commercialization Delayed
2002 Biotechnology
Science Based Regulatory Science Based Regulatory Systems AdvancingSystems Advancing
U.S. Coordinated FrameworkU.S. Coordinated FrameworkKey ConceptsKey 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 FrameworkU.S. Coordinated FrameworkKey ConceptsKey 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 FrameworkU.S. Coordinated FrameworkKey ConceptsKey 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 FrameworkU.S. Coordinated FrameworkKey ConceptsKey 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 #1Anti-Biotech Myth #1
Lack of Regulation– Products rushed to market– Little or no governmental oversight
Coordinated Framework Coordinated Framework Case StudyCase Study
Insect-resistant Corn (MON 810)Protected Against European Corn Borer and
Other Damaging Insect PestsBt (Bacillus thuringiensis) Insecticidal
Protein– Derived from naturally-occurring soil microbe– Used by conventional and organic farmers for 3
decades
Coordinated Framework Coordinated Framework Case StudyCase Study
1. Large-scale field tests, EPA/FIFRA, USDA/PPA (1992-96)
2. Small-scale field tests, USDA/PPA (1991)3. Determination not a plant pest,
USDA/PPA & environmental assessment, USDA/NEPA (1996)
4. Food safety/nutrition review, FDA/FFDCA (1996)
Coordinated Framework Coordinated Framework Case StudyCase 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 RealityRegulation – 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
Data – Data – The Reality 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
25-Year Record25-Year Record
Public MeetingsPublic CommentProposed Rules and PoliciesWeb SitesScientific Peer ReviewPublished Data
Public Participation – Public Participation – The Reality The Reality
Extensive Public Participation Opportunities Over the Past 25 Years
Harm – Harm – The RealityThe 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 Key Messages for BiotechnologyBiotechnology
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 Let’s Get Real About Production of Biotech Food and Feed Crops 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.
RealitiesRealities
1. Biological systems are inherently imperfect.
2. There is no such thing as “100 percent pure” in Mother Nature.
RealitiesRealities
3. Even Ivory Soap is “only” 99.44/100% Pure® and that is achieved through production in
carefully controlled industrial facilities.
RealitiesRealities
4. Biological systems are dynamic, not static.
5. Movement and dissemination of seeds and pollen is natural and inevitable. Wind Water Birds Insects
RealitiesRealities
6. The movement of genetic material (“gene flow”) is as normal and natural as agriculture itself. Pollen Seeds “Volunteers”
RealitiesRealities
7. Some plants are sexually promiscuous.
8. Crops and their weedy relatives have exchanged genes for centuries.
RealitiesRealities
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
RealitiesRealities
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 ResponseSocietal 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 ResponseSocietal 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 ResponseSocietal 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 ResponseSocietal 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 ResponseSocietal 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 ResponseSocietal 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)
DefinitionsDefinitions
• “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.
DefinitionsDefinitions
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?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?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 Reasons Why We Should CareCare
1. Proactive product stewardship requires assurance of health and environmental safety.
2. Without a national policy, the “standard” becomes zero by default.
3. Some regulators view detection of DNA as a surrogate for the protein.
Reasons Why We Should Reasons Why We Should CareCare
4. Potential economic impacts of unintended presence lead to calls for liability/compensation
5. Detection and sampling capabilities, not potential harm, are being used as basis for regulation and standard setting.
6. Each country going its own way undermines benefits of international harmonization.
Reasons Why We Should Reasons Why We Should CareCare
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 ForwardKey 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 ForwardKey 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 Key Issues Going Forward
• Finalize proposed federal actions• Work with trading partners to harmonize
standards and policies to address the unintended presence of biotechnology-derived material from food and feed crops cleared for field testing and/or commercial introduction.
Let’s Get Real About Production Let’s Get Real About Production of Non-Food Biotech Cropsof 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 Plant-Made Pharmaceuticals (PMPs) and Industrials (PMIPs)(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 Plant-Made Pharmaceuticals and IndustrialsIndustrials
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 Plant-Made Pharmaceuticals and IndustrialsIndustrials
• USDA and FDA Guidance for Industry for PMPs:• Updated confinement measures• Addressed manufacturing, process, pre-
clinical and clinical testing considerations• September 12, 2002• 67 Fed. Reg. 57828
Plant-Made Pharmaceuticals and Plant-Made Pharmaceuticals and IndustrialsIndustrials
• 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 Plant-Made Pharmaceuticals and IndustrialsIndustrials
• 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? 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 SafetyRegulation 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 Biotech Crops Grow Like All Other Crops 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 Biotech Crops Grow Like All Other CropsOther Crops
• Any open pollinating crop has the potential to cross-pollinate with another neighboring crop
• Growers of specialty crops protect against this:• Blue corn • Organic• White corn • “Non-GMO”• Canola
Liability for Farming? 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? 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 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 Organic Crops Are Specialty Crops 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 biotechnology-derived 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 Is There a Need for a New Liability Scheme? 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