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Biotechnology and Food: Understanding the Issues

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Title: AGRICULTURAL BIOTECHNOLOGY Author: rheiner Last modified by: mphillips Created Date: 9/25/2002 12:51:13 PM Document presentation format: On-screen Show – PowerPoint PPT presentation

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Title: 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
12
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.
13
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

14
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
16
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

17
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)

18
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

19
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

27
Myth 3
  • No Public Participation

28
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.

34
Realities
  1. Biological systems are inherently imperfect.
  2. There is no such thing as 100 percent pure in
    Mother Nature.

35
Realities
  • 3. Even Ivory Soap is only 99.44/100 Pure
  • and that is achieved through production in
    carefully controlled industrial facilities.

36
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

38
Realities
  • Some plants are sexually promiscuous.
  • Crops and their weedy relatives have exchanged
    genes for centuries.

39
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

40
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)

47
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

56
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

60
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

63
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

71
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

72
For More Information
  • www.bio.org
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