FDA

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FDAs Policy for Evaluating Bioengineered Foods

• Jeanette Glover Glew
• Food and Drug Administration
• Center For Food Safety and Applied Nutrition
• September, 2003

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Overview

• Regulatory Framework
• Policies and Procedures
• Public Outreach
• Recent Initiatives

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Regulatory Authority

• Bioengineered foods are regulated by three
  Federal agencies
• United States Department of Agriculture (USDA)
• Environmental Protection Agency (EPA)
• Food and Drug Administration (FDA)

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Roles of Federal Agencies

• USDA oversees safety for cultivation
• addresses plant protection issues
• EPA oversees the safe use of pesticides
• Includes pesticidal substances produced in plants
• Sets tolerances or establishes exemption from
  tolerance

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Food and Drug Administration

• Statutory Authority
• The Federal Food, Drug, and Cosmetic Act (FFDCA)
• Function
• Ensuring the safety and proper labeling of foods
  and food substances
• Oversight
• Cereals, fruits, vegetables, plant by-products,
  milk, seafood, and substances added to foods

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Regulatory Authority Under FFDCA

• Post market adulteration provisions (Section 402)
• Producers have a legal duty to market products
  that are safe and wholesome
• Primary legal tool for whole foods
• FDA has authority to remove food that is a hazard
  to human health
• Ex would give FDA authority to act if there was
  an elevated level of toxicant or introduction of
  allergen that was not obvious to the consumer

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Regulatory Authority Under FFDCA

• Premarket approval of food additives (Section
  409)
• A food additive that is not GRAS has to undergo
  premarket review and approval before it can be
  used in food
• This authority may be used for substances added
  to food that are substantially different (and
  cannot be presumed to be GRAS) from substances
  that have been safely consumed

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• Policies and Procedures

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FDAs 1992 Policy for Foods Derived from New
Plant Varieties

• Published in the Federal Register, May 29, 1992,
  (57 FR22984)
• Applies to all methods of breeding, including
  recombinant DNA
• All foods are regulated under existing paradigm

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Some Basic Principles in the Policy Statement

• The regulation of new plant varieties should be
  based on the objective characteristics or
  components of the food, rather than the fact that
  a new development method was used to produce the
  food.

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Some Basic Principles in the Policy Statement

• Todays food is the standard new varieties are
  evaluated relative to traditional counterparts
• Bioengineered foods must be as safe as foods on
  the market today.

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Some Basic Principles in the Policy Statement

• Provided guidance to industry on scientific and
  regulatory issues
• Recommended voluntary consultation
• w/ FDA
• Purpose of consultation make sure any safety
  questions are resolved before go to market

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Procedures derived from 1996 Consultation
Procedures

• As part of a consultation
• FDA meets with a notifier early in the
  development process to discuss potential safety,
  nutritional or other regulatory issues
• FDA recommends testing as necessary
• Process is iterative
• Prior to commercialization, notifier provides
  data and information about their safety
  assessment
• FDA evaluates data package and responds by letter

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Safety Evaluation under 1992 Policy

• Approach is multidisciplinary
• Agronomic and quality characteristics
• Characteristics of new substances
• Genetic analysis
• Chemical and nutritional analysis

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Elements of Safety Evaluation

• Intended Modification New Substance
• Identity
• Source
• Digestibility
• Dietary Exposure
• Altered Nutrition
• Unintended Modifications
• Genetic stability over multiple generations
• Composition
• Nutrients
• Anti-nutrients
• Toxicants

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Elements of Safety Evaluation

• Host Plant
• Taxonomy
• History of safe use
• Presence of harmful constituents
• Important nutrients

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Elements of Safety Evaluation

• Donor Organism
• Taxonomy
• History of use
• Presence of harmful constituents
• Passage through microbial hosts
• Identity and function of introduced material

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Elements of Safety Evaluation

• Substance(s) Introduced Into Host Plant
• Concentration of expression product
• Potential for allergenicity
• Potential for toxicity
• Similarity to other substances in the food supply
• Alterations in plant metabolism
• Posttranslational modifications
• Presence of antibiotic resistance marker

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Elements of Safety Evaluation

• Inserted Genetic Material
• Method of transformation
• Activity of regulatory sequences
• Presence of extraneous open reading frames
• Number of inserts and insertion sites
• Genetic stability

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• Public Outreach
• Recent Initiatives

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Public Outreach

• In 1999, FDA held 3 public meetings
• To communicate policy
• To solicit opinions on current policy and
  procedures
• FDA received about 50,000 written comments from
  those meetings

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Results of Public Outreach

• No new data to question safety of bioengineered
  foods currently marketed
• Some concern from the public about the
  consultation process - may not be sufficient to
  deal with future scientific developments

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Recent Initiatives

• Enhance FDAs science base
• Establish food biotech subcommittee
• Support research on allergenicity
• Support study by the National Academy of Science
  on unintended effects

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New Bioengineered Varieties
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New Bioengineered Varieties
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Goals

• To ensure that FDA is prepared to meet scientific
  and regulatory responsibilities in the future
• To enhance public confidence in the safety of
  bioengineered foods

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Information

• FDAs foods web page
• http//www.cfsan.fda.gov
• Click on biotechnology program area