This document discusses genetically modified foods (GM foods) and their regulation in the United States and European Union. It describes how GM foods are created through genetic engineering techniques that modify the DNA of crops. The document outlines some benefits of GM foods, existing GM crops, and the US agencies that regulate them. It provides a history of US regulation starting in the 1970s and describes the FDA's substantial equivalence process for assessing the safety of GM foods. The document also discusses labeling requirements and compares the process-based regulatory approach of the EU to the product-based system used in the US.
2. Objectives
Describe GM Foods
History of regulation
Labeling
Processes to assess safety
Discuss US regulations and compare to
those of the EU
3. 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).
5. Existing GM Foods
Available for human consumption
Soybeans
Corn
Potatoes
Not for humans
Fish- not on market yet
Starlink corn- animal feed (EPA)
6. US Regulation of GM Foods
FDA- Safe for consumption. CFSAN
EPA- Pesticides, Environmental Safety
USDA- Several agencies involved
7. 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
8. 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.
9. 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
10. 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
12. 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
13. Allergenicity of GM Foods
Assessment decision tree (Metcalfe et al., 1996) Adapted from FAO/WHO 2001
14. 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
15. 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