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U.S. FDA’s Approach to the Safety Assessment of Bioengineered Plants Used as Food
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Transcript of U.S. FDA’s Approach to the Safety Assessment of Bioengineered Plants Used as Food
U.S. FDA’s Approach to the Safety Assessment of
Bioengineered Plants Used as Food
Mary Ditto, Ph.D.October 21, 2002
Food and Drug AdministrationCenter For Food Safety and Applied Nutrition
U.S. Federal Oversight for Bioengineered Foods
Coordinated Framework for the regulation of foods
Involves three federal agencies
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)
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
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
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
FDA Food Biotechnology Policy
• Federal Food, Drug, & Cosmetic Act• Science based regulation• Ensure safe and wholesome food
supply• ‘92 policy; scientific guidance
FDA’s 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
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)
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
General Safety Assessment ApproachGeneral Safety Assessment Approach
Today’s 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
Food Safety Assessment
Intended Modification New Substance(s) —
– Identity; structure/function– Source (allergenicity)– digestibility– Dietary exposure– Nutrition
Food Safety Assessment
Unintended ModificationsUnintended Modifications• Genetic stability• Composition —
– Nutrients – Toxicants
FDA’s 1992 Policy Statement “Standard of Care”
Policy statement addresses food safety assessment
allergenicity of newly introduced proteinsnutrient composition and anti-nutrientsknown toxins and new toxinsantibiotic resistance markersunintended effects
Has there been an intentional alteration in the identity,
structure, or composition of fats or oils in the new variety?
No concerns
Have the intentional alterations been in a fat or oil that will be a
macroconstituent in the diet?
Are any unusual or toxic fatty acids produced in the new
variety?
Consult
FDA
Consult
FDA
Yes
Yes
Yes
NoNo
No
New or modified fats or oils
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.
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 FDA’s Internet site.
New Bioengineered Varieties
Beet (2) Canola (8) CantaloupeCorn (16) Cotton (5) FlaxPapaya Potato (4) RadicchioRice Soybean (3) Squash (2)Tomato (6)
Introduced Traits
Herbicide Tolerance
Insect Resistance
Insect Resist./Herb. Tolerance
Pollen Modified/Herb. Tolerance
Virus Resistance
Insect & Virus Resistance
Delayed Ripening
Other
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
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
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
New Initiatives: Proposed Rule Premarket Notice Concerning Bioengineered Foods
Published in the Federal Register, January 18, 2001 (66 FR4706)
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 FDA’s ability to assess whether new bioengineered plant varieties comply with FFDCA on an on-going basis.
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”
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
Current Status FDA received over
- 100,000 comments to the proposed rule for premarket notification
FDA is reviewing comments
Working towards a final regulation
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
Draft Guidance for Labeling
Issued January 18, 2001
Agency is considering comments received
On web at – http://www.cfsan.fda.gov/~dms/biolabgu.html
FDA’s Labeling Authority
Federal Food, Drug and Cosmetic Act (FFDCA)-Sections 403(a) and 201(n)
Fair Packaging and Labeling Act (FPLA)
Draft Guidance for Labeling
Restates agency’s 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
FDA’s 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
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
International Activities
International activities - promote harmonization– Codex– OECD
Interact with foreign governments to provide information and expertise
Information about FDA
FDA Main Web site: www.fda.gov FDA Biotechnology Web site
www.cfsan.fda.gov/~lrd/biotechm.html