BIOTECHNOLOGY REGULATIONS

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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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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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PUBLIC CONCERNS ABOUT BIOTECHNOLOGY

• Ethics of genetic modification (interfering with
  nature)
• Safety of food and of introducing genetically
  engineered organisms into the environment
• The alleged radical novelty, unpredictability, or
  irreversibility of biotechnology
• Possible negative impacts on employment or small
  farms
• Trust or lack of trust of government regulatory
  agencies
• Enhancement of corporate power and ownership of
  intellectual property
• Possible exploitation of developing countries
• Possible mistreatment of animals

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Food Biotech Public Issues

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

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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) issued a report in 2000
  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
• Plant-Incorporated Protectant -Rules issued
  Jan17, 2001

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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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Tests for FDA clearance
FDA requires labeling in two instances if the
characteristics significantly differ from what is
normally expected or if safety issues arise.

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

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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.
• October 2000, FDA published 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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FDA Labeling Requirements

• The FDA's approach to the labeling of foods,
  including those genetically engineered or
  otherwise novel, is that the label must be
  accurate and "material." There are only two
  situations in which the FDA can require that a
  transgenic origin or ingredient be disclosed on
  the food label
• (i) The FDA may mandate the disclosure of facts
  on a product label that relate to material
  consequences that can follow the consumption of a
  food (for example, kidney beans that must be
  soaked and cooked before eating).
• (ii) The FDA can require that a label reveal
  facts necessary to correct or balance other
  representations made by the manufacturer or
  seller. Accordingly, labeling is required "if a
  food derived from a new plant variety differs
  from its traditional counterpart such that the
  common or usual name no longer applies, or if a
  safety or usage issue exists to which consumers
  must be alerted".

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FDA Labeling Requirements

• Under their oversight structure, the FDA does
  not routinely subject foods from new plant
  varieties to pre-market review or to extensive
  scientific safety tests, although there are
  exceptions.
• The agency has judged that the usual safety and
  quality control practices used by plant breeders,
  such as chemical and visual analyses and taste
  testing, are generally adequate for ensuring food
  safety.
• Additional tests are performed, however, when
  suggested by the product's history of use,
  composition, or characteristics.

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FDA Labeling Requirements

• The FDA's approach is consistent with the
  scientific consensus that
• the risks associated with recombinant organisms,
  and with products derived from them, are
  fundamentally the same as for nonrecombinant
  products.
• Dozens of new plant varieties modified with
  traditional genetic techniques (such as
  hybridization and mutagenesis) enter the
  marketplace every year without premarket
  regulatory review or special labeling. Many are
  from "wide crosses" in which genes have been
  moved across natural breeding barriers, that is,
  from one species or genus to another. None of
  these plants exist in nature. Nonetheless, they
  have become an integral, familiar, and safe part
  of our diet they include bread and durum wheat,
  maize, rice, oats, black currants, pumpkins,
  tomatoes, and potatoes.

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FDA Labeling Requirements

• If present, certain safety-related
  characteristics of new foods require greater
  scrutiny by the agency. These include
• The presence of a substance that is completely
  new to the food supply (and that therefore lacks
  a history of safe use)
• An allergen presented in an unusual or unexpected
  way (for example, a peanut protein transferred to
  a potato).
• New carbohydrates with unusual structural or
  functional groups, or oils that contain new or
  unusual fatty acids, may require premarket
  approval as food additives.
• Other characteristics of potential concern are
  changes in amounts of major dietary nutrients or
  increased concentrations of toxins normally found
  in foods. For example, potatoes are generally
  tested for the glycoalkaloid solanine.

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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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The Labeling Issue

• Where the government has earned just criticism is
  in failing to generate public confidence in GM
  food. Consumers, independent scientists and even
  farmers have been excluded from the process of
  government testing and approval. To its credit,
  the FDA has made amends by holding hearings
  across the country, and the Department of
  Agriculture is bringing the public to its
  "arm's-length regulatory process."
• But unless it is found that GM food is any
  different in quality or safety from conventional
  food, adding a label would be misleading.
• LA Times Feb 1, 2000

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The Labeling Issue

• There is no evidence that recombinant DNA
  techniques or rDNA-modified organisms pose any
  unique or unforeseen environmental or health
  hazards.
• In fact, a National Research Council study found
  that
• "as the molecular methods are more specific,
  users of these methods will be more certain about
  the traits they introduce into plants."
• Greater certainty means greater precision and
  safety. The subtly altered products on our plates
  have been put through more thorough testing than
  any conventional food ever has been subjected to.

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Labeling Economics

• Special-interest groups have called for stringent
  labeling requirements, but these may not be in
  the best interest of consumers.
• Labeling can add significantly to production
  costs of foods, particularly those that are
  produced from pooled fresh fruits and vegetables.
  
• To maintain the accuracy of such labels,
  recombinant DNA-modified fruits and vegetables
  would have to be segregated through all phases of
  production (planting, harvesting, processing, and
  distribution), which would add costs and
  compromise economies of scale.
• These added production costs constitute, in
  effect, a special tax levied on producers who use
  a new technology.
• They reduce profits to plant breeders, farmers,
  food processors, grocers, et al. in the
  distribution pathway, while also decreasing
  competition and increasing prices.

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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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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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Labeling Psychology

• Regulatory stringency is also an unmistakable
  signal to the public that there is something
  fundamentally different and worrisome about
  biotech foods
• The psychological aspect of this general strategy
  was conveyed to the National Biotechnology Board
  by the head of a national consumer advocacy
  group "The consumer views the technologies that
  are most regulated to be the least safe ones.
  Heavy involvement by government, no matter how
  well intended, inevitably sends the wrong
  signals".
• On another level entirely, demanding proof that
  genetically modified foods are safe is all very
  well, but without a rational system for testing
  conventional foods, we may never get it.

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This product contains potentially toxic genes
from deadly nightshade
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Would you buy this Product?
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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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Voluntary Labeling

• Voluntary labeling by companies to show goodwill
  might be a good consumer relations strategy and
  perhaps give a level of reassurance about, and
  greater transparency to the regulatory process.
  However, this is a highly complex issue.
• It is recommended that when any voluntary
  statements are used, such as "GMO-free" or
  "Contains GMO ingredients", three criteria need
  to be met
• First, a detection or threshold limit
• Second, substantiation, including identity
  preservation (traceback to the seed)
• Third, disclosures or accompanying statements.
• Well-defined criteria are very important to the
  integrity of this growing market

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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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And What of Animals?
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APHIS - Veterinary Biologics

• Virus-Serum-Toxin Act (VSTA) This act covers all
  production, movement and use of such products
  within the US. The term biological products is
  very broad and covers all viruses, sera, toxins
  and analogous products of a natural or synthetic
  origin, such as diagnostics, antitoxins,
  vaccines, live microorganisms and antigenic or
  immunizing components of microorganisms intended
  for use in the diagnosis, treatment or prevention
  of diseases in animals.
• APHIS issues licenses and permits for production,
  importation, sale and experimental use of various
  types of animal biological products. Requests to
  use unlicensed products for experimental field
  studies must include information to demonstrate
  that the experimental conditions will be adequate
  to prevent the spread of the disease. Specific
  information that must be submitted for GMOs and
  products includes detailed information on
  stability, genetic constructs and vectors, and
  the effects of any insertions and deletions on
  the organism.

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APHIS - Veterinary Biologics

• GEOs for the purposes of VSTA are classified into
  three groups,
• (1) Inactivated products such as recombinant
  DNA-derived vaccines, bacterial-toxins, viral and
  bacterial subunits, and monoclonal antibodies
• (2) Live products, such as those containing live
  or infective organisms modified by insertion or
  deletion of one or more genes
• (3) Live vectored products, such as products
  using live vectors to carry recombinant-derived
  foreign genes that code for immunizing antigens
  or other immune stimulants.
• Under consideration interagency/industry/public
  dialogue on plant-derived vaccines, therapeutics
  and diagnostics.
• Risk analysis model - multifactorial approach to
  risk assessment risks to animals, public health
  and the environment.

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APHIS - Animal Quarantine Statutes
Where the introduction and field testing of GMOs
is concerned, the AQS also apply. Permits are
required for GMOs that, in their construction,
use material from infectious, contagious,
pathogenic, or oncogenic organisms. The
submission requirements are similar to those
described above for biologics. The safety
characteristics of the GMO must be evaluated
within the context of the target environment.
Thus, the release assessment consists of a
comprehensive evaluation of the proposed release
so as to determine 1) the location and
characteristics of the release site 2) the
test dose and total amount of the experimental
biologic to be used in the proposed study 3)
the frequency and duration of exposure to the
test material 4) potential escapes into
occupational, residential, or outdoor
environments 5) the individuals,
populations, or ecosystems that will be, or may
be, exposed to the experimental biologic.
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Food Safety Inspection Service
FSIS function is to assure the safety and
wholesomeness of food products. FSIS is
regulating the slaughter of animals derived from
biotechnology experiments under the experimental
animal regulations. 1989 decided that they
needed to develop regulatory oversight to ensure
the food derived from these animals was safe for
human consumption December, 1991 - Decision
criteria for the evaluation of nontransgenic
animals from transgenic research. January 1993,
FSIS petitioned ABRAC to address the scientific
questions associated with the human food safety
of products prepared from transgenic animals. In
response, ABRAC formed a transgenic animal
working group comprised of specialists in the
field of animal biotechnology from industry,
academia and government, which held a public
meeting to address these questions.
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FDA - Center for Veterinary Medicine Transgenic
Animals

• There are three groupings that FDA have
  identified that they expect to differ in
  approach
• (1) transgenic germ line animal strains with
  heritable modifications focused on animal health,
  productivity or economic characteristics
• (2) somatic cell therapies for the treatment or
  modification of individual animals, i.e.,
  nonheritable modifications and,
• (3) animals of either type used to produce drugs,
  biologics, medical foods, food additives, or
  other regulated products in milk, blood or other
  tissues, i.e., biopharm animals.

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FDA - Center for Veterinary Medicine Transgenic
Animals

• Other Considerations
• What are the public health issues that FDA should
  be concerned about with transgenic animals?
• What labeling issues arise?
• Can animals under investigational applications
  enter the food supply and under what conditions?
  
• How will the environmental impact potential of
  transgenic fish and shellfish be assessed, who
  will assess this, and who must be informed?
• Should laboratory and non-food animal species be
  subject to pre-market review?
• Should we be concerned about uncontrolled
  introgression of transgenes, individually and in
  combination, into domesticated and feral animal
  species?

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TRANSGENIC ANIMAL AG PRODUCTS EXPECTED WITHIN SIX
YEARS

• AquaAdvantage Salmon, Tilapia, Trout, Flounder
  (A/F Protein) These fish grow from egg to market
  size (8 to 10 lb.) in less than 1.5 years.
  Conventional breeding techniques require 3 years
  to bring a fish to market. This could make fish
  more plentiful, decrease overfishing and lower
  consumer costs.
• Concerns Escape
• Solution Biological Containment - Triploidy
  resulting in sterile females

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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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Safety First

• The most that we can ask is that all foods
  produced by whatever method receive the same
  level of evaluation both with regard to impact on
  the environment, and safety to the consumer.
• Millions of people have already eaten the
  products of genetic engineering and no adverse
  effects have been demonstrated.
• Scientists are confident in the scientific
  validity of the systems that regulate and oversee
  the food supply.
• They are equally confident that if we abandon the
  scientific process in judging the safety of the
  food supply, we will slow or destroy the advances
  that will reduce the use of unsafe chemicals and
  agricultural practices in this country and
• We will limit the wonderful potential of improved
  nutrition and quality that promise to strengthen
  agriculture economies around the world.

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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

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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