Biotechnology and Food: Understanding the Issues

1
Biotechnology and Food
Understanding the Issues

• Michael J. Phillips, Ph.D.
• Vice President
• Biotechnology Industry Organization
• National Public Policy Education Conference
• September 22, 2003

2
Areas To Cover

• Adoption Benefits
• Regulatory Policy
• Liability

3
Improvements most often delivered through
biotechnology

• Herbicide tolerance
• Enable improved weed control measures
• Insect resistance
• Enable improved pest management

4
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

5
Global Area of Transgenic Crops, 1996 to 2000
By Crop(million hectares)
Source Clive James, 2000
6
Crops improved through biotechnology that are
grown most frequently

• Soybeans
• Corn
• Cotton
• Canola

7
Global Area of Transgenic Crops, 1996 to 2000
By Trait(million hectares)
Source Clive James, 2000
8
Global Area of Transgenic Crops, 1996 to 2000
Industrial and Developing Countries(million
hectares)
Source Clive James, 2000
9
Global Area Adoption Rates () for Principal
Transgenic Crops (million hectares)
Source Clive James, 2000
10
Biotech Crops-Percent of Plantings - U.S.
80
74
71
70
68
69
61
54
48
47
45
of Total U.S. Acreage
37
37
32
34
26
25
25
13
2
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
11
Biotech Crop Plantings-U.S.
51.3
58.5
45.4
of Acres Planted (Millions)
35
25.3
28.3
19
27
26.9
19.9
20
11.1
10.5
9
9.4
10
7
1
5.8
2003 estimates, USDA, NASS 3/31/03
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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.
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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

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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

15
Science Based Regulatory Systems Advancing
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U.S. Coordinated FrameworkKey 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

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U.S. Coordinated FrameworkKey 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)

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U.S. Coordinated FrameworkKey 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

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U.S. Coordinated FrameworkKey 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

20
Anti-Biotech Myth 1

• Lack of Regulation
• Products rushed to market
• Little or no governmental oversight

21
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

22
Coordinated Framework Case 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)

23
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)

24
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

25
Myth 2

• No Data

26
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

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Myth 3

• No Public Participation

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25-Year Record

• Public Meetings
• Public Comment
• Proposed Rules and Policies
• Web Sites
• Scientific Peer Review
• Published Data

29
Public Participation The Reality

• Extensive Public Participation Opportunities Over
  the Past 25 Years

30
Myth 4

• Harm to Health and the Environment

31
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.

32
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

33
Lets 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.

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Realities

1. Biological systems are inherently imperfect.
2. There is no such thing as 100 percent pure in
   Mother Nature.

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Realities

• 3. Even Ivory Soap is only 99.44/100 Pure
• and that is achieved through production in
  carefully controlled industrial facilities.

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Realities

• Biological systems are dynamic, not static.
• Movement and dissemination of seeds and pollen is
  natural and inevitable.
• Wind
• Water
• Birds
• Insects

37
Realities

• The movement of genetic material (gene flow) is
  as normal and natural as agriculture itself.
• Pollen
• Seeds
• Volunteers

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Realities

• Some plants are sexually promiscuous.
• Crops and their weedy relatives have exchanged
  genes for centuries.

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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

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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.

41
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.

42
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)

43
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)

44
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)

45
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)

46
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)

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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.

48
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.

49
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.

50
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.

51
Reasons Why We Should Care

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.

52
Reasons Why We Should Care

• 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.

53
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

54
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

55
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

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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.

57
Lets 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.

58
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)

59
Plant-Made Pharmaceuticals and Industrials

• USDAs principal focus is protecting health and
  environmental safety and agriculture
• PMPs also regulated by FDA
• More concerned about maintaining PMPs 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

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Plant-Made Pharmaceuticals and Industrials

• 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

61
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

62
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

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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?

64
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

65
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

66
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 Organic
• White corn Non-GMO
• Canola

67
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?

68
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?

69
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

70
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 biotechnology-derived
  crop is not in violation
• Organic growers who contract for zero presence of
  biotechnology-derived material are assuming a
  contractual risk

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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

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For More Information

• www.bio.org