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PLANT BIOTECHNOLOGY REGULATIONS

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... influenced by arguments that have no basis in fact or logic. ... Yet it is interesting to note that no EUPs have been required ... Jimmy Carter February ... – PowerPoint PPT presentation

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Title: PLANT BIOTECHNOLOGY REGULATIONS


1
PLANT BIOTECHNOLOGY REGULATIONS
2
We have recently advanced our knowledge of
genetics to the point where we can manipulate
life in a way never intended by nature. We must
proceed with the utmost caution in the
application of this new found knowledge.
LUTHER BURBANK, 1906
3
I believe we are entering an era now where pagan
beliefs and junk science are influencing public
policy. GM foods and forestry are both good
examples where policy is being influenced by
arguments that have no basis in fact or logic.
  • Patrick Moore, Founding Member of Greenpeace,
    New Scientist, December 1999

4
The Crop Agriculture Technology Timeline graph
Cultivation Selective Cross breeding Mutagensis
and selection Cell culture Somaclonal variation
Embryo rescue Polyembryogenesis Anther culture
Recombinant DNA Marker assisted
selection Genomics Bioinformatics
2,000 BC 19thC Early 20th C Mid 20th
C 1930s 1940s 1950s 1970s 1980 1980s 1990s 2
000
5
Insect-Protected Corn - From Idea to Reality 14
Years of Research and Development
Seed companies cross into elite germplasm 11/93
Safety studies completed 5/95
First field tests 6/92
First US sales Insect-protected 4/97
First Bt corn plants 6/90
First transgenic plant
83 84 85 86 87 88 89 90 91 92
93 94 95 96 97 98 99 00 01 02
EPA approval 12/96
FDA Consultation completed 9/96
Lead lines selected
USDA deregulation of Insect-protected 3/96
Commercialization decision 10/95
6
Crop Biotechnology
  • Agronomic Traits
  • Biotic Stress
  • Insect Resistance
  • Disease Resistance
  • Viral, Bacterial, Fungal, Nematode
  • Weed- herbicide tolerance
  • ABiotic Stress
  • Drought, Cold, Heat, Poor soils
  • Yield
  • Nitrogen Assimilation, Starch Biosynthesis, O2
    Assimilation
  • Quality Traits
  • Processing
  • Shelf-life
  • Reproduction sex barriers, male sterility,
    seedlessness
  • Nutrients (Nutraceuticals)
  • Macro Protein, Carbohydrates, Fats
  • Micro vitamins, antioxidants, minerals,
    isoflavonoids, glucosinolates, phytoestrogens,
    lignins, condensed tannins
  • Anti-nutritionals Phytase, Toxin removal
  • Taste

7
(No Transcript)
8
United States Biotech Adoption Rates
70
60
55
53
50
48
40
35
of Planted Acres
30
26
27
23
20
13
16
10
9
7
0
1996
1997
1998
1999
Corn
Cotton
Soybeans
9
Canada Biotech Adoption Rates
70
65
60
50
50
47
40
38
35
of Planted Acres
30
20
20
10
3
5
6
0
1996
1997
1998
1999
Canola
Corn
Soybeans
10
Argentina Roundup Ready Soybeans
70
65
60
50
50
40
of Planted Acres
30
23
20
10
2
0
1996
1997
1998
1999
11
Biotech Crops Worldwide
  • Mexico
  • Bollgard (Bt) cotton 1999 30 of planted acres
  • Australia
  • Bollgard (Bt) cotton 1999 35 of planted acres
  • Brazil
  • Roundup Ready soybeans 2001 season?
  • Significant acreage (10-20) already seed brown
    bagged from Argentina
  • China
  • Various cotton varieties 1999 1 mil hectares
  • Europe
  • Minimal acreage

12
Benefits to farm environment
  • Boost yields
  • Reduce pesticide use
  • Increase fertilizer efficiency
  • Reduce mycotoxin contamination
  • Flexible weed control
  • Promote conservation tillage, water quality
    protection soil
    conservation

13
HISTORICAL CONTEXT
  • 1263 English Parliament decreed, in order to
    protect the safety of the food supply, nothing
    could be added to the staple foods that was not
    wholesome for mans body - over 700 years later
    the statutory standard for the US is that nothing
    can be added to foods if it is a poisonous or
    deleterious substance that may render the food
    injurious to health
  •  
  • NAS Committee on Recombinant DNA Molecules in
    Nature on July 19, 1974 which effectively
    called for a moratorium on genetic engineering
    research (Berg et al. 1975) Paul Berg, Baltimore,
    Boyer and Cohen
  • National Institutes of Health (NIH) Recombinant
    DNA Advisory Committee (RAC) and the development
    of RAC Guidelines in 1976
  •  
  • Institutional Biosafety Committees (IBC) were set
    up to assist the RAC by reviewing projects at
    each institution (NIH, 1978 1986).

14
National Research Council (NRC) "Field Testing
Genetically Modified Organisms A Framework for
Decision Making" (NAS 1989).
  (a) The product not the process of genetic
modification and selection constitutes the
primary basis for decisions about regulator
oversight   (b) Knowledge of the process
provides information about the product which is
useful for risk assessment but is not in itself a
useful criterion to determine the appropriate
level of oversight,   (c) Organisms modified by
modern molecular techniques are subject to the
same laws of nature as are those produced using
classical methods for which there is a wealth of
experiential data
15
National Research Council (NRC) " Genetically
Modified Pest-Protected Plants Science and
Regulation " (NAS 2000).
  • Emphasize that we believe it is the properties
    of a genetically modified plant -- not the
    process by which it was produced -- that should
    be the focus of risk assessments." Committee
    chair Perry Adkisson, chancellor emeritus Texas
    AM
  • Even given the strengths of the U.S. system
    governing transgenic plants, regulatory agencies
    should do a better job of coordinating their work
    and expanding public access to the process as the
    volume and mix of these types of plants on the
    market increase.
  • The committee emphasized it was not aware of any
    evidence suggesting foods on the market today are
    unsafe to eat as a result of genetic
    modification.
  • No strict distinction exists between the health
    and environmental risks posed by plants
    genetically engineered through modern molecular
    techniques and those modified by conventional
    breeding practices.
  • Any new rules should be flexible so they can
    easily be updated to reflect improved scientific
    understanding.

16
National Research Council (NRC) " Genetically
Modified Pest-Protected Plants Science and
Regulation " (NAS 2000).
  • The National Academy of Sciences, joined by six
    other academies from around the world (Royal
    Society of London, Third World Academy of
    Sciences and national academies of Brazil, China,
    India and Mexico) recently issued a report
    declaring that biotechnology
  • should be used to increase the production of main
    food staples,
  • improve the efficiency of production,
  • reduce the environmental impact of agriculture
    and provide access to food for small-scale
    farmers.
  • The Food and Agriculture Organization of the
    United Nations and the World Health Organization
    also issued a joint report approving the method
    we use to assess the safety of biotech crops.

17
Who Minds the Shop? http//gophisb.biochem.vt.edu
/
  • Agency Products Regulated
  • U.S. Department of plant pests, plants,
    veterinary
  • Agriculture biologics, animals, fish
  • Environmental microbial/plant pesticides, new
    Protection uses of existing pesticides,
    novel
  • Agency microorganisms
  • Food and Drug food, feed, food additives,
    veterinary
  • Administration drugs, human drugs and medical
    devices

18
Assuring Safety U.S. Regulatory Framework
  • U.S. Department of Agriculture
  • USDA governs field-testing of crops improved
    through biotechnology
  • Uses pre-existing statutes
  • USDA clearance is required prior to commercial
    growth and sales of such crops

19
United States Dept. Agriculture
http//www.aphis.usda.gov/biotechnology/role.html
  • Scope for coverage is food and fiber products.
    Broad regulatory authority to protect against the
    adulteration of foods products made from
    livestock and poultry, to protect agriculture
    against threats to animal health, and to prevent
    the introduction and dissemination of plant
    pests. Its primary concerns are the safety of
    crop plant and food animals, and the safety and
    wholesomeness of food products.
  • The USDA has 10 divisions that deal with
    biotechnology the Agricultural Research Service
    (ARS), the Food Safety and Inspection Service
    (FSIS), the Animal and Plant Health Inspection
    Service (APHIS), the Agricultural Marketing
    Service (AMS), the Cooperative State Research
    Service (CSRS), Extension Service, the National
    Agricultural Library (NAL) the Forest Service
    (FS), The Economic Research Service (ERS)
    Foreign Agricultural Service (FAS) (GIPSA)

20
United States Dept. Agriculture
  • The Committee on Biotechnology in Agriculture
    (CBA) - administrators of the USDA agencies with
    major activities involving biotechnology.
  • Agricultural Biotechnology Research Advisory
    Committee (ABRAC) (similar to NIH-RAC), to review
    proposals, provide guidance on matters of
    biosafety in the development and use of
    biotechnology in Agriculture. Biotechnology Risk
    Assessment Research Grants Program(BRARGP)
    jointly with CSREES
  • APHIS is the watchdog that guards the licensing
    of veterinary biological material and issues
    permits for transport of biological material and
    field tests and commercialization of genetically
    engineered plants and microorganisms. APHIS
    formed the Biotechnology, Biologics and
    Environmental Protection Division (BBEPD) with
    responsibility for all biotechnology products.
  • FSIS' assure the safety and wholesomeness of food
    products.

21
United States Dept. Agriculture
  • USDA policy on the regulation of biotechnology,
    consistent with the overall federal policy, does
    not view GMOs as fundamentally different from
    those produced using traditional methods.
  • The USDA considered that the products of the new
    techniques of biotechnology were in principle
    covered by regulations that had been implemented
    for existing technologies.
  • They did, however, consider that the assessment
    of the products of the new technologies in some
    instances required specific information that
    necessitated the introduction of some new
    regulations and the updating of some existing
    ones.
  • 1999, Secretary's Advisory Committee on
    Agricultural Biotechnology -- a cross-section of
    25 individuals from government, academia,
    production agriculture, agribusiness, ethicists,
    environmental and consumer groups

22
United States Dept. Agriculture
  • 1993, 1995 Final rule notification in lieu of
    permit process for GEOs that are field tested in
    accordance with specific safety criteria.
  • May 1997 Final Rule. The amendment simplifies
    procedures for the introduction of certain
    genetically engineered organisms, expedites
    review for certain determinations of nonregulated
    status, and adjusts procedures for the reporting
    of field tests conducted under notification to
    the biology of the test organisms. This enables
    APHIS, when appropriate, to extend the existing
    determination of nonregulated status for new
    products that do not raise new risk issues.

23
Tests for USDA clearance
  • Origin of transferred gene
  • Potential for weediness and outcrossing
  • Impact on non-target organisms (e.g. beneficial
    insects, birds)

24
Tests for USDA clearance
  • Over 6,500 field tests have been analyzed by USDA
    involving more than 18,000 sites throughout the
    United States. The agency has assessed the
    biotech plants for their efficacy, performance
    and suitability for release in the environment.
  • Additionally, around the world, some 25,000 field
    trials have been done on more than 60 crops in 45
    countries, including most of the 15 countries of
    the EU.
  • There has not been a single report of any
    unexpected or unusual outcome.

25
Assuring Safety U.S. Regulatory Framework
  • Environmental Protection Agency
  • EPA regulates environmental exposure to
    insect-protected crops to guard against harm to
    the environment, beneficial insects, and other
    living things

26
Environmental Protection Agency
  • 1947, any chemicals used as pesticides were
    reviewed and registered under this law. In 1948,
    the first microbial pesticides, Bacillus
    popilliae and B.lentimorbus were registered by
    the USDA. By 1970, the diverse authorities for
    pesticide registration were transferred to the
    newly formed EPA.
  • In 1982 the agency included GMOs in its policy of
    regulating microbial pest-control agents (MPCA,
    for the control of pests and weeds) as
    distinctive entities from chemicals (Federal
    Register, 1974, 1982).
  • This was followed by the recombinant-DNA testing
    guidelines which were published in 1984 (Federal
    Register, 1984).

27
Environmental Protection Agency
  • 1997 "Microbial Products of Biotechnology Final
    Regulations Under the Toxic Substances Control
    Act".
  • Microbes subject to this rule are "new"
    microorganisms used commercially for such
    purposes as production of industrial enzymes and
    other specialty chemicals agricultural
    practices (e.g., biofertilizers) and break-down
    of chemical pollutants in the environment.
  • The EPA claims to review each application on a
    case-by-case basis based on the product and the
    risk and not the means by which the organism was
    created. Yet it is interesting to note that no
    EUPs have been required for undirected
    mutagenesis, most transconjugants and
    plasmid-cured strains. Yet EUPs were required for
    all live recombinant DNA GEOs irrespective of
    product or risk.

28
Environmental Protection Agency
  • Plant-Pesticides Subject to the FIFRA
  • The EPA wanted to expand its federal regulatory
    powers over the characteristics of plants that
    help plants resist diseases and pests. The
    agency coined a new term for these
    characteristics, calling them "plant-pesticides."
  • All plants are able to prevent, destroy, repel or
    mitigate pests or diseases. That ability occurs
    naturally, and some crops have been bred for
    resistance to specific pests. EPA proposes to
    single out for regulation those pest-resistant
    qualities that were transferred to the plant
    through recombinant DNA technology (genetic
    engineering).
  • Appropriate Oversight for Plants with Inherited
    Traits for Resistance to Pests A Report From 11
    Professional Scientific Societies (July 1996)
  • Evaluation of the safety of substances in plants
    should be based on the toxicological and exposure
    characteristics of the substance and not on
    whether the substance confers protection against
    a plant pest.
  • EPA changed terminology to Plant pesticidal
    proteins

29
Tests for EPA clearance
  • Impact on beneficial insects and non-target
    organisms
  • Toxicity of pesticidal compound
  • Safety for human consumption
  • Ecological hazards
  • Insect resistance

30
Monarch Butterfly Research
  • Concentration of pollen drops off very rapidly a
    short distance from the corn field
  • Concentration of pollen found on milkweed plants
    nearby corn fields not sufficient to harm monarch
    butterflies
  • Beneficial insects fare much better in modified
    corn than in conventional fields where chemical
    insecticides are sprayed
  • --- Research Symposium, Nov. 2, 1999

31
Assuring Safety U.S. Regulatory Framework
  • Food and Drug Administration
  • FDA regulates by same rules it applies to
    safeguard all foods in the marketplace.
  • Nutrition and safety of each product evaluated at
    many stages before reaching the consumer

32
Food and Drug Administration
  • The FDA regulates biotechnology under
  • Food, Drug, and Cosmetic Act (FDCA) and
  • Public Health Services Act (PHSA).
  • The agency has a mandate to insure efficacy and
    safety of food and pharmaceutical products.
  • The agency has a major responsibility in
    biotechnology in that 65 of the current market
    share of biotechnology products passes through
    the agency for review and it has already reviewed
    thousands of biotechnology products.
  • The FDA has very broad authority to regulate the
    introduction of new foods. Every company or
    individual that produces whole foods or any food
    product is legally required to ensure the safety
    and quality of anything they introduce into the
    food supply.

33
Food and Drug Administration
  • FDA relies primarily on two sections of the Act
    to ensure the safety of foods and food
    ingredients. Generally, whole foods, such as
    fruits, vegetables, and grains, are not subject
    to premarket approval. The primary legal tool
    that FDA has successfully used to ensure the
    safety of foods is the adulteration provisions of
    section 402(a)(1).
  • The Act places a legal duty on developers to
    ensure that the foods they present to consumers
    are safe and comply with all legal requirements.
    FDA has authority to remove a food from the
    market if it poses a risk to public health. Foods
    derived from new plant varieties developed
    through genetic engineering are regulated under
    this authority as well.

34
FDA Policy Statement
  • May 1992 FDA issued a policy statement on
    regulating biotechnology Food Products.
  • FDA requires premarket review only for foods
    into which substances are intentionally
    introduced, significantly changing the structure,
    function or amount currently found in the food.
  • If a new food product developed through
    biotechnology does not contain substances that
    are significantly different from those already in
    the diet, it does not require premarket approval.
  • May 2000, FDA will publish a proposed rule
    mandating that developers of bioengineered foods
    and animal feeds notify the agency when they
    intend to market such products. FDA also will
    require that specific information be submitted to
    help determine whether the foods or animal feeds
    pose any potential safety, labeling or
    adulteration issues.

35
Tests for FDA clearance
  • Source of gene
  • History of use
  • Toxicity
  • Nutritional profile
  • Chemical composition
  • Allergenic potential
  • Antibiotic resistance
  • usually
    requires in vivo tests

36
Changes in FDA Policy
  • Transparency
  • Mandatory Notification
  • Labeling

37
Transparency
  • Provide more and better information on website
  • Industry safety data submitted will be posted on
    FDA website (except CBI)

38
Mandatory Notification
  • FDA stated that the consultative process has
    worked well but is perceived as weak
  • FDA will institute a mandatory notification
    process
  • Will issue company a letter describing its
    conclusion on the regulatory status of the food
    or animal feed

39
Labeling
  • FDA will draft labeling guidance to assist
    manufacturers who want to place voluntary claims
    on the label
  • Guidelines will be for foods made with or without
    biotech ingredients
  • Guidelines are to help ensure that labels are
    truthful and not misleading

40
Food Biotech Public Issues
  • Food Safety
  • Labeling
  • Intellectual property
  • Environment

41
Food Biotech Public Issues
  • North/South
  • Global Food Security
  • Research
  • International Trade

42
What Can Labels Say?
  • GMO free - difficult to define
  • No universal tests (can test RR)
  • Tests of commodities costly, time consuming
  • Tests of complex foods still inaccurate
  • 99 GMO free? 95 GMO free?

43
Comment on Labels
  • Many look to labels to end controversy, but that
    is unlikely
  • Stringent labels are difficult to define and
    enforce
  • Mandatory labels likely will be quite bland
  • May contain GMO
  • GMO-free products are risky to offer
  • Who is liable if new tests find GMOs?
  • And, GMO-free products likely will be quite
    expensive
  • GMO-free labels with high tolerances are unlikely
    to satisfy GMO opponents

44
Questions Remain
  • What percent biotech crops allowed in non-biotech
    corn and soybeans?
  • Must meat products be labeled if animals consumed
    biotech feed?
  • What regulations will govern food ingredients in
    processed food?
  • Many complications in defining labeling
    regulations

45
  • EXAMPLES OF INTERAGENCY OVERVIEW
  • New Trait/Organism Regulatory Review Conducted
    byReviewed For
  • Viral Resistance USDA Safe to grow
  • in food crop EPA Safe
    for the environment
  • FDA
    Safe to eat
  • Herbicide Tolerance USDA
    Safe to grow
  • in food crop EPA
    New use of companion
    herbicide FDA Safe to eat
  • Herbicide Tolerance USDA Safe
    to grow
  • in ornamental crop EPA
    New use of companion herbicide
  • Modified Oil content USDA
    Safe to grow
  • in food crop FDA
    Safe to eat
  • Modified flower color USDA Safe to grow
  • ornamental crop
  • Modified soil bacteria USDA Safe for the
    environment
  • degrades pollutants EPA

46
International Harmonization of Regulatory
Approaches
Commission of the European Union established a
Permanent Technical Working Group on
Biotechnology and the Environment. Informal
meetings with representatives of the Commission
of the European Union and key trading partners to
discuss policy developments on the
commercialization of, and trade in, new
agricultural commodities. OECD Environment and
Agriculture Directorates, US lead in a project on
the Commercialization of Agricultural Products
Derived Through Modern Biotechnology. Oversight-
ensure safety, make oversight policies more
transparent, facilitate trade. Regular meetings
continue with Canada and Mexico to address safety
issues relevant to biotechnology-derived
commodities that are under regulatory review or
already approved in one of our three nations, and
to facilitate trade in these products. APHIS
participates in Conference of Parties (COP) to
the Convention on Biological Diversity. The COP,
of which the United States is not a member,
decided to negotiate a binding protocol that may
affect international transfer of certain
biotechnology products, and set up an ad hoc
working group to develop it. APHIS is working
along with other Federal agencies to ensure that
appropriate policies are agreed upon to guarantee
the safe international use and development of new
biotech products. Living modified organisms
(LMOs) Protocol Regulatory framework for
international trade in bioengineered products
adopted by 130 countries -Jan. 29, 2000, must be
ratified by 50 countries
47
The costs of over-regulation
  • The purpose of regulations should be to insure
    safety and efficacy, to limit potential product
    risks while encouraging innovation and economic
    development.
  • By raising the cost of biotechnology RD
    over-regulation drains capital resources and
    slows the pace of research.
  • Overregulation leads to higher operating costs
    and extended development times which raises
    investment risks and exacerbates concerns about
    long term prospects for company success.
  • Over-regulation disproportionately affects the
    academic research community -

48
  • "To forestall a major US-EU trade conflict, both
    sides of the Atlantic must tone down the
    rhetoric, roll up our sleeves and work toward
    conflict resolution based on open trade, sound
    science and consumer involvement. I think this
    can be done if the will is there. However, I
    should warn our friends across the Atlantic that,
    if these issues cannot be resolved in this
    manner, we will vigorously fight for our
    legitimate rights.
  • Sec. Ag. Dan Glickman, July 1999

49
  • Responsible biotechnology is not the enemy
    starvation is. Without adequate food supplies at
    affordable prices, we cannot expect world health,
    or peace
  • President Jimmy Carter February 1999
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