Genetically Modified Foods

Beth RobersonNovember 19, 2004

FST 490

Objectives

Describe GM Foods

History of regulation

Labeling

Processes to assess safety

Discuss US regulations and compare to those of the EU

Genetic Engineering

Genetically engineered (GE) foods are developed by modifying DNA in some way

GE foods are also referred to as transgenic foods and genetically modified organisms (GMOs).

Benefits

Reduce pesticide and herbicide useIncrease crop yieldsImprove nutritional qualityReduce wasteDisease resistanceReduce ecological impactReduce cost

Existing GM Foods

Available for human consumption Soybeans Corn Potatoes

Not for humans Fish- not on market yet Starlink corn- animal feed (EPA)

US Regulation of GM Foods

FDA- Safe for consumption. CFSAN

EPA- Pesticides, Environmental Safety

USDA- Several agencies involved

History of US Regulation

1974- NIH sets up the Recombinant DNA Advisory Committee (RAC)

1976- RAC guidelines for GE research

1980- US Supreme Court in Diamond v. Chakrabarty rules that genetically altered life forms can be patented

1986- Coordinated framework for regulation of biotechnology. Proposed in 1984

1990- FDA approved first GE food ingredient, chymosin

History of US Regulation

May 29,1992 Federal Register vol. 57 Foods derived from new plant varieties

produced by genetic engineering essentially will be regulated no differently than foods created by conventional means, unless special circumstances apply.

Created a voluntary process under which producers could consult with the agency about safety and regulatory issues prior to marketing GE foods.

History of US Regulation

1992- FlavrSavr, the first commercially grown GM food crop submitted to FDA. Released into market 1994

1996- FDA gave additional guidance to industry on procedures for consultations

2001-FDA proposed regulations on two subjects: A mandatory pre-market notification process for GM

foods Voluntary labeling GM foods

Labeling of GM Foods

FDCA- Product described by its common name and all important facts associated with claims made or suggested are shown on the label

Not all GE food products are required to be labeled as such solely because they involved genetic engineering

Certain situations require labeling

FDA Safety Requirements

GRAS

Toxicity standards

Allergy testing

“Substantially equivalent”

Toxicity Standards for GM Foods

Established tests for potential toxins Ames, cell cultures Feeding studies

EPA responsible for pesticides

Compare to database of known toxins

Allergenicity of GM Foods

Assessment decision tree (Metcalfe et al., 1996) Adapted from FAO/WHO 2001

Substantial Equivalence (SE)

Compare GM food to GRAS food

Consider chemical composition, macro and micro nutrients, toxins, and antinutrients. Look for protein and/or metabolite differences

Feeding studies

GM crop “as safe as” its counterpart

Process-based assessment

Separate regulations

SE used to limit toxicology testing

All GE proteins tested for toxicity, carcinogenicity, and teratogenicity

90-day feeding studies on ‘whole plant’

Allergen assessment tree

Labeling required for all products

Product-based assessment

Existing food regulations

Established SE is sufficient for approval

Novel proteins are assessed for adverse effects

Feeding studies required for non-SE products

Allergen assessment tree

Labeling required for potential allergens

US RegulationsEU Regulations VS

QUESTIONS??