PLANT BIOTECHNOLOGY REGULATIONS

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PLANT BIOTECHNOLOGY REGULATIONS
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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
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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

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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
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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
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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

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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
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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
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Argentina Roundup Ready Soybeans
70
65
60
50
50
40
of Planted Acres
30
23
20
10
2
0
1996
1997
1998
1999
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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

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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

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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).

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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
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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.

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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.

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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

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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

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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)

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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.

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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

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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.

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Tests for USDA clearance

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

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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.

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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

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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).

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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.

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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

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Tests for EPA clearance

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

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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

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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

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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.

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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.

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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.

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Tests for FDA clearance

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

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Changes in FDA Policy

• Transparency
• Mandatory Notification
• Labeling

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Transparency

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

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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

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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

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Food Biotech Public Issues

• Food Safety
• Labeling
• Intellectual property
• Environment

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Food Biotech Public Issues

• North/South
• Global Food Security
• Research
• International Trade

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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?

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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

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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

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• 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

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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
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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 -

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• "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

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• 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