U.S. FDA

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U.S. FDAs Approach to the Safety Assessment of
Bioengineered Plants Used as Food

• Mary Ditto, Ph.D.
• October 21, 2002
• Food and Drug Administration
• Center For Food Safety and Applied Nutrition

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U.S. Federal Oversight for Bioengineered Foods

• Coordinated Framework for the regulation of foods
  
• Involves three federal agencies

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U.S. Regulatory System for the Evaluation of
Bioengineered Food Products

• United States Department of Agriculture (USDA)
• Environmental Protection Agency (EPA)
• Food and Drug Administration (FDA)

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U.S. Federal Statutory Authority

• USDA/APHIS - Federal Plant Protection Act (FPPA)
  and Plant Quarantine Act (PQA)
• regulation of the introduction (importation,
  interstate movement, or release into the
  environment) of genetically engineered organisms

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U.S. Federal Statutory Authority

• EPA Federal Insecticide, Fungicide and
  Rodenticide Act (FIFRA) and FFDCA
• - regulation of pesticidal substances including
  those produced in plants
• - sets tolerances (or establishes exemptions
  from tolerance) for pesticides in or on food

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U.S. Federal Statutory Authority

• FDA - Federal Food, Drug and Cosmetic Act (FFDCA)
• regulation of foods, feeds, food additives, and
  labeling of foods
• Ensuring the safety and proper labeling of foods
  and food substances

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FDA Food Biotechnology Policy

• Federal Food, Drug, Cosmetic Act
• Science based regulation
• Ensure safe and wholesome food supply
• 92 policy scientific guidance

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FDAs 1992 Policy Statement

• Published in the Federal Register, May 29, 1992,
  (57 FR 22984)
• Applies to all methods of breeding, including
  recombinant DNA
• New foods must be as safe as foods on the market
  today
• All foods regulated under existing paradigm,
  FFDCA

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Two provisions of FFDCA gives FDA authority to
regulate foods

• Post market adulteration provisions
• --(Section 402(a)(1))
• Premarket approval of food additives
• --(Section 409)

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Objectives of 1992 Policy

• Develop guidance for industry on food safety
  assessment
• Establish procedures for consultations with FDA
  on scientific and regulatory issues
• Ensure a safe and wholesome food supply

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General Safety Assessment Approach

• Todays food is the standard
• New varieties are evaluated relative to
  traditional counterparts
• Multi-disciplinary approach Agronomic and
  quality characteristics genetic, chemical,
  nutritional analyses
• If questions remain toxicological tests

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Food Safety Assessment

• Intended Modification
• New Substance(s)
• Identity structure/function
• Source (allergenicity)
• digestibility
• Dietary exposure
• Nutrition

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Food Safety Assessment

• Unintended Modifications
• Genetic stability
• Composition
• Nutrients
• Toxicants

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FDAs 1992 Policy Statement

• Standard of Care
• Policy statement addresses food safety assessment
• allergenicity of newly introduced proteins
• nutrient composition and anti-nutrients
• known toxins and new toxins
• antibiotic resistance markers
• unintended effects

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Has there been an intentional alteration in the
identity, structure, or composition of fats or
oils in the new variety?
New or modified fats or oils
Yes
Have the intentional alterations been in a fat or
oil that will be a macroconstituent in the diet?
Consult FDA
Yes
No
No
Are any unusual or toxic fatty acids produced in
the new variety?
Consult FDA
Yes
No
No concerns
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Consultation Procedure

• FDA established a consultation procedure to
  ensure that new products are safe and lawful.
• FDA believes that all developers of commercially
  marketed bioengineered foods sold in the U.S.
  have consulted with FDA prior to marketing their
  products.

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Consultation procedure

• Firms submit a summary of safety and nutritional
  data of the product.
• When all safety and regulatory issues have been
  resolved firms receive a letter stating that FDA
  has no questions at this time.
• Completed consultations are listed on the FDAs
  Internet site.

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New Bioengineered Varieties
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Introduced Traits
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International Approach

• 90 FAO/WHO Expert consultation
• 93 OECD report
• 96 FAO/WHO Expert consultation
• 00 OECD report to G-8
• 02 FAO/WHO Expert consultation
• 02 Codex Task Force Draft Guidelines

21
Biotech 2000 and Beyond

• FDA held three public meetings in 1999
• Communicate policy and solicit opinions on
  current policy and procedures
• Requested comments
• Received over 50,000 comments

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Public Comments

• No new data to question safety of bioengineered
  foods currently marketed
• Divergent views on labeling
• Consultation process is voluntary
• Lacked transparency
• Concern that current procedures may not be
  sufficient to deal with future developments

23
New Initiatives Proposed Rule Premarket Notice
Concerning Bioengineered Foods

• Published in the Federal Register, January 18,
  2001 (66 FR4706)

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Proposed Requirement for Premarket Notice (PMN)

• Requirement for premarket notification for
  bioengineered plant derived foods
• If finalized, would require developers of
  bioengineered foods to notify FDA 120 d before
  commercial distribution.
• Would enhance FDAs ability to assess whether new
  bioengineered plant varieties comply with FFDCA
  on an on-going basis.

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Proposed Requirement for Premarket Notice (PMN)

• Plant-derived bioengineered foods consumed by
  humans and animals
• If a pesticidal substance- EPA evaluates
  pesticide FDA evaluates other issues
• Timing 120 days before market
• Recommend Presubmission Consultation
• Safety Standard As safe as comparable foods

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Proposed Requirement for Premarket Notice (PMN)

• Recommended testing in accordance with the 1992
  policy
• Proposed codified requires a specific format and
  content for a submission
• Notifier attests that the food is as safe as
  comparable food and is otherwise lawful
• FDA will post notices on the internet when first
  filed

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Current Status

• FDA received over
• 100,000 comments to the proposed rule for
  premarket notification
• FDA is reviewing comments
• Working towards a final regulation

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New Initiatives

• Increased transparency
• Issued draft guidance for voluntary labeling
• Guidance on allergenicity and antibiotic
  resistance marker genes
• Supplement FACs with scientists with agricultural
  biotechnology expertise
• Enhance research

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Draft Guidance for Labeling

• Issued January 18, 2001
• Agency is considering comments received
• On web at
• http//www.cfsan.fda.gov/dms/biolabgu.html

32
FDAs Labeling Authority

• Federal Food, Drug and Cosmetic Act (FFDCA)
• -Sections 403(a) and 201(n)
• Fair Packaging and Labeling Act (FPLA)

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Draft Guidance for Labeling

• Restates agencys policy regarding when special
  labeling is required for bioengineered foods.
• Truthful and not misleading
• Misleading if fails to reveal facts that are
  material in light of representations made

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FDAs position on labeling of bioengineered foods

• Food must be labeled when there is a significant
  change in the food, i.e.,
• nutritional
• compositional
• change in conditions of use
• or when an allergenic component has been
  introduced in a food where it does not naturally
  occur

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Status of Initiatives

• Finalize the proposed rule for mandatory
  premarket notification
• Finalize guidance on labeling
• Finalize guidance on the use of antibiotic
  resistance marker genes
• Developing guidance for the assessment of
  allergenicity
• Recent meeting of Biotech subcommittee of FAC

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International Activities

• International activities - promote harmonization
• Codex
• OECD
• Interact with foreign governments to provide
  information and expertise

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Information about FDA

• FDA Main Web site www.fda.gov
• FDA Biotechnology Web site www.cfsan.fda.gov/lrd
  /biotechm.html