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Title: PowerPoint Presentation DuPont ProductPresentation Title

Biotechnology Update
Steve Daugherty Director, Biotechnology Affairs
The World Demands, and We Deliver
Ag Biotechnology TerminologyWhat they mean to me
  • Modern Agricultural Biotechnology Manipulating
    genes from one source to another transgenic
  • Allows farmers to grow plants that are more
    nutritious, resistant to pests and more
  • Genetic Engineering/Modification Changing an
    organisms genes using the methods of modern
    molecular biology (Modern Ag Biotechnology).
  • Living Modified Organism Term used in the
    Cartagena Protocol on Biosafety to reference
    genetically modified organism.
  • Recombinant DNA (rDNA) Transformed DNA.

Ag Biotechnology TerminologyWhat they mean to me
  • Gene a specific sequence of DNA .
  • Protein A molecule composed of amino acids in a
    specific order. Proteins are required for the
    structure, function and regulation of metabolic
    activities in the bodys cells, tissues and
    organs, and each protein has unique function.
    Proteins are expressed by DNA.
  • Event the successful result of inserting genetic
    material into another genome.
  • Trait a distinguishing characteristic.

Example Herculex I
  • Herculex I insect protection for corn
  • Gene Cry1F and pat
  • Protein Cry1F and pat
  • Event 1507 (DAS-01507-1)
  • Traits insect control (pests include European
    corn borer, southwestern corn borer, black
    cutworm, western bean cutworm, lesser corn stalk
    borer, southern corn stalk borer, sugarcane
    borer, corn earworm and fall armyworm) and
    herbicide resistance to glufosinate (Liberty)
  • Herculex I Insect Protection technology by Dow
    AgroSciences and Pioneer Hi-Bred. Herculex and
    the HX logo are registered trademarks of Dow
    AgroSciences LLC.

Ag Biotechnology TerminologyWhat they mean to me
  • Herbicide-Tolerant Crops Crops that are not
    damaged when sprayed with herbicide.
  • Examples Roundup Ready, Liberty Link, Optimum
  • Insect-Tolerant Crops Crops that are not damaged
    by insects.
  • Examples Herculex, YieldGard, Optimum GATTM

Ag Biotechnology TerminologyWhat they mean to me
  • Stewardship Management of a product from its
    inception through to its ultimate end and
  • This is how we keep the genes out of your mill
  • Adventitious Presence (Low Level Presence) The
    unintended presence of genetic material in seed,
    grain, feed or food.
  • Gene Flow Genes moving from one plant to
  • Identity Preservation Segregation of one crop
    from another.

Pioneers Stage-Gate System
Review Decision
Review Decision
Review Decision
Review Decision
Review Decision
StageC OptimizeGeneConstruct
StageD CreateCommercialEvent
StageE Commercial Event toRegulatory
StageF Breedingand Testing
StageG SellProduct
StageA New Ideas
StageB EvaluateGeneticApproaches
Transgene Discovery Event Development
Product Breeding Evaluation
Key Tasks
Key Tasks
Key Tasks
Key Tasks
Key Tasks
US Coordinated Regulatory Framework for
Biotechnology a Matrix of Existing Laws
USDA - Plant Protection Act
EPA (Plants) Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA)
EPA (Microbes) Toxic Substances Control Act
FDA - Federal Food, Drug, and Cosmetic Act (FFDCA)
US Coordinated Regulatory Framework for
Biotechnology Plant Products
Rapid Global Adoption of Biotech Crops
Global Area of Biotech Crops, 1996 to 2007 By
Crop (Million Hectares)
Global Adoption Rates () for Principal Biotech
Crops (Million Hectares) 2007
Source Clive James, 2008
Global Area of Biotech Crops, 1996 to 2007 By
Trait (Million Hectares)
Source Clive James, 2008
CropLife International Industry Priority Issues
  • Low Level Presence
  • Biosafety Protocol
  • Intellectual Property
  • Regulatory Issues
  • Allergenicity, stacks, new technologies/emerging
    issues, data protection, discontinued products,
    detection methods
  • Biotechnology Acceptance

BIO Quality Management ProgramExcellence Through
  • BIO Food Agriculture Section Governing Body
    approved initiative for stewardship and quality
  • BIO member companies pledge to
  • Adopt principles and best practices
  • Implement a program consistent with the QMP
  • Conduct third party audits of QMP
  • Failure to live up to the pledge over time would
    be viewed as conduct detrimental to BIOs best
  • Timeline
  • December 2007 - QMP Guide completed, member
    companies self-certified objectives, principles
    and management practices, audit program defined
  • December 2008 - Third-party audits completed for
    all US operations
  • December 2009 Third-party audits completed for
    global operations

DuPont Bioethics Guiding Principles
  • Commitment to Food/Feed Safety
  • Environmental Focus
  • Conserving Biodiversity
  • Transparency of Information
  • Engaging Stakeholders
  • Advocating Independent Research
  • Contributing to Developing Economies
  • Formalizing Access to Genetic Resources

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Steps to the US Market
  • Laboratory research
  • National Institutes of Health rDNA Guidelines
  • Contained greenhouse evaluation
  • USDA Guidelines for contained research
  • Contained small scale field trials (crop
  • USDA Notifications and Permits for contained
  • EPA Experimental Use Permit (EUP) gt 10 acres
    Plant Incorporated Protectant (PIP) (e.g. Bt)
  • Pre-commercial testing (non-crop destruct)
  • USDA De-regulation
  • FDA Notification and Consultation
  • EUP with Food/Feed Tolerance Exemption
  • Commercial release
  • EPA Registration

U.S. Regulatory System
  • Coordinated Framework for Biotechnology
  • utilizes existing regulations
  • Department of Agriculture
  • Inspects greenhouses for compliance with
  • Issues permits for small scale field trials
  • Reviews petitions for De-regulation of products
  • Environmental Protection Agency (fee for service)
  • Issues Experimental Use Permits for Plant
    Incorporated Protectants (PIPs) (e.g., Bts)
  • Grants Registrations and sets Tolerances for
  • Food and drug Administration
  • Conducts voluntary Early Food Safety Evaluations
    of gene products
  • Conducts voluntary pre-market Consultation on
    food safety

United States
Environmental Protection Agency
United StatesDepartment of Agriculture
Food and DrugAdministration
Submission to the Office of Pesticide
Programs Federal Register (FR) notice Review by
staff Questions EPA Scientific Advisory Panel
(SAP) No Further Questions Final Risk Assessment
Draft FR Notice and 30-day public comment
period Pre-acceptance letter sent Registration
and final tolerance exemption rule decision
Submission to the Biotechnology Regulatory
Services Review by staff Draft environmental
Assessment USDA Federal Register notice
(FR) Draft environmental assessment 60-day
comment period on USDA Deregulation
Submission of EFSE to the Center for Food Safety
and Nutrition Review by staff
EFSE is Optional (takes 4 months)
QuestionsRequest for additional information
No Questions(Deemed Complete)
No Questions
EFSE Consultation Complete
12 18 months
18 24 months
Submission of Biotech Notification to the Center
for Food Safety and Nutrition
Review by staff
12 months
No Questions
FDA Consultation Complete
EPA - Approval
  • Average time to complete all actions is 18 to 24
  • Most submitted studies are conducted under
    EPA/OECD Good Laboratory Practices (GLP) and
    subject to audit
  • Internal review with use of expert Science
    Advisory Panels on case by case basis
  • Notices of proposed Registrations and Tolerances
    published for public comment and final decisions
    published in Federal Register
  • Fee structure for different actions Agency
    commits to timeline for specific action

USDA and FDA Approvals
  • USDA average review time for dossier is 18
  • Internal review Environmental Assessment (EA)
    published for public comment
  • De-regulation notice published in Federal
  • No fees
  • FDA average time for Consultation is 12 months
  • Internal review - Notice of completed
    Consultation and Memorandum to File published on
    FDA web-site
  • No fees

What is Regulated?
  • Transgenic products are regulated by event
  • Each time a piece of rDNA is inserted into a
    plant a new event is created
  • USDA can extend de-regulation decisions to
    include additional similar events
  • Combining two approved events by breeding
    (stacking) does not trigger further USDA action
  • FDA requires notification of new stacks
  • Could request more data (e.g., if two genes
    targeting same pathway produce altered
    nutritional profile)
  • Stacking two or more approved PIPs requires new
    Registration from EPA
  • Data requirements aimed at showing no alteration
    in non-target activity

Basic Information Needs for Risk Assessment
  • Knowledge of the crop and its wild relatives
  • biology, distribution cultivation and uses
  • Knowledge of the modification
  • detailed genetic and molecular characterization
  • Safety of expressed gene products
  • protein characterization and toxic/allergenic
  • Equivalence of the modified crop
  • nutritional equivalence to unmodified crop
  • environmental safety non-target impact

Molecular Analysis
  • Confirm genetic stability of the event
  • Confirm expected segregation of trait over three
  • Analyze the inserted DNA
  • Confirm purity of event
  • Analyze integration pattern of 100 progeny
  • Characterize the integration event
  • Complete high resolution map (Southern)
  • Confirm that unwanted DNA is absent
  • Show absence of unwanted vector sequences
  • Develop event specific diagnostic
  • Use insert/plant DNA borders

Toxicology/Nutritional Assessment
  • Toxicity evaluation
  • Consider any toxic properties of gene donor
  • Screen sequence for homology to known toxins
  • Conduct acute mouse study with purified protein
    (plant purified or microbial equivalent) in a
    single dose (in large excess of dietary exposure)
  • Allergenicity evaluation weight of evidence
    approach considering
  • Determine rate of digestibility in in vitro
    gastric digestion model (pepsin)
  • Screen sequence for homology to known allergens
  • Perform specific IgE serum screen (if gene is
    from commonly allergenic food)
  • Additional studies case by case basis to
    address specific concerns
  • 42 day broiler chicken feeding study with grain
  • 90 day rat feeding study with grain

Composition, Expression and Agronomics (CEA)
  • Grow modified plants at 6 sites for 1 or 2
    seasons to confirm that
  • Composition of modified whole plant (silage) and
    grain is similar to unmodified counterparts and
    within normal range for that crop
  • Modified plants exhibit expected agronomic
    phenotype when grown in regions typical of
    expected cultivation
  • Modified plants expresses novel traits as
    anticipated under variety of field conditions
  • measure gene expression in up to 12 tissue types
    over time, depending on crop

Compositional Analysis
  • Substantial equivalence - starting point for
    safety evaluation - measure more than fifty
    substances including
  • amino acids
  • fatty acids
  • carbohydrates
  • essential vitamins and minerals
  • naturally occurring toxicants, anti-nutrients and
  • secondary metabolites
  • Investigate nutritional significance of any
    changes from non-modified crop or normal range
    for that crop
  • Leads to determination of safety relative to
    equivalent non-modified food with history of safe

Non-target Studies (Tier 1) for Cultivation of
Plant Incorporated Protectants (PIPs)
Test plant tissue (e.g., pollen) or purified
protein against appropriate representative
non-target organisms with focus on beneficial
species (e.g.)
  • Avian
  • quail
  • Aquatic
  • trout/catfish
  • Waterflea
  • Soil
  • springtail
  • earthworm
  • Terrestrial
  • ladybug
  • lacewing
  • parasitic wasp
  • honeybee (adult and larva)
  • butterfly

Effects seen in these Tier 1 studies may require
follow up with field observations (e.g., census
studies of non-target organisms)
Risk Assessment for Cultivation
  • Use hazard information (e.g., toxicity) and
    potential exposure by various routes to determine
  • Measure pollen flow over distance
  • Measure metabolism and fate in soil and water
  • Calculate exposure from pollen and soil
    incorporated material
  • Use information on distribution of non-targets
  • Endangered species
  • Out-crossing to wild and/or weedy species
  • Additional studies as required to address
    specific concerns (e.g., increased fitness)

Post Commercial Activities
  • Post-registration requirements have included
  • Insect Resistance Management resistance
    monitoring and refuge (non-Bt) planting
  • Additional non-target studies (e.g., Monarch
  • Voluntary stewardship activities may be
    undertaken according to the nature of the
    modified crop
  • Rapid detection methods for traceability
  • Livestock performance studies e.g., dairy cows
    and pigs

Commitment to Food/Feed Safety
  • DuPont will develop products derived from
    biotechnology that are at least as safe as their
    conventionally produced counterparts for both
    human food and animal feed using the best
    scientific knowledge.

2. Environmental Focus
  • DuPont will endeavor to apply biotechnology in
    production systems so there is a net gain for the

3. Conserving Biodiversity
  • DuPont will strive to protect and conserve
    natural resource biodiversity.

4. Transparency of Information
  • DuPont believes in the individuals right to
    information regarding product safety. DuPont
    will apply a strict and transparent standard in
    determining what product information is
    proprietary. DuPont will disclose safety
    information on its products in a clear and
    accessible manner.

5. Engaging Stakeholders
  • DuPont will routinely engage stakeholders
    (shareholders, customers, society, and employees)
    and consider their diverse viewpoints in its
    decision-making process for products derived from

6. Advocating Independent Research
  • DuPont will seek opportunities to advocate and/or
    fund biotechnology research important to its
    business at public institutions, research centers
    and non-governmental organizations that follow
    accepted science protocols and peer review

7. Contributing to Developing Economies
  • DuPont will endeavor to be socially and
    culturally responsible as it shares knowledge and
    appropriate technology in developing economies to
    help improve food, nutrition and the quality of
    life. DuPont will seek to utilize its
    intellectual property in ways that help alleviate

8. Formalizing Access to Genetic Resources
  • DuPont will strive to identify the owner(s) of
    natural biological resources and knowledge
    selected for research and product development and
    will develop fair and equitable business
    arrangements that recognize the contributions of
    the involved parties. To the extent possible,
    arrangements will be made public.
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