# Presentation: 300217

## 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 Administration**
**Center 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 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  Modifications**
**Genetic stability**
**Composition — **
**Nutrients **
**Toxicants**

## FDA’s 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

## New or modified fats or oils

- 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**

**No**

**No**

**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

## Introduced Traits

## 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**

## Slide 29

## Slide 30

## 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