This preview shows page 1. Sign up to view the full content.
Unformatted text preview: FOOD SAFETY ----------------------how might India assess the safety of your GM tomato product, and what does that mean for your business plan? NOTE: most developing countries do not have food safety regulations or means of enforcing them --- which can be a particular problem for industry. Regulatory compliance can provide some legal and public cover in case of a problem, but in its absence a firm is an easy target of criticism. CONSIDER: General regulatory approaches for food safety Regulatory agencies Standards Allowable exclusions FOOD SAFETY can include a number of aspects: Contamination Residues Additives Processing standards Traditionally bred foods GM foods Production traits Nutritional traits Consider how traditionally bred foods are generally regulated --Based on a long history of safety, most food releases are exempt as being: Generally Recognized As Safe (GRAS) Of course, many naturally occurring foods are toxic, or contain toxic components which can be enhanced in some varieties. General food safety concerns: Toxicity very few proteins are toxic to vertebrates, and those toxins are well characterized. Toxicity of whole foods difficult to test. Nutritiousness (whole food value) difficult to test for individual foods Allegernicity about 2% adults and 5% children (perceptions far higher) Immune system response 90% caused by few foods: Fish Peanuts Soybeans Milk Eggs Crustacea Wheat Tree nuts BUT virtually any food can cause an allergic response in some few people, and at very low dosages. Digestibility gluten-containing foods Wheat Rye Barley Oats Hence, often rely on known changes from safe products to determine if GRAS. That is, base tests on expectations/predictions of problems, not on routine testing. Note, these are all short term safety factors. Little is known of the long term safety of most foods. For GM foods --------------------Extend treatment of traditionally bred foods through concept of substantial equivalence: If GM food (or food component) is found to be substantially equivalent to an existing food, then it can be concluded to be safe Three `degrees' of substantial equivalency:
1- SE to a conventional counterpart already available in the food supply
- Show equivalence to the same characteristics as the traditional food 2- SE except for specific defined differences
- Generally, the `new' proteins are well characterized, and safety analysis focused on their traits 3- not possible to demonstrate substantial equivalence
- focus on composition and properties, based in part on the role of the food in the diet. No fully satisfactory test methods exist ADDITIONAL CONSIDERATIONS: Unintended Consequences Gene transfer, especially of antibiotic markers Rare, but risk exists Discontinuing use of antibiotic markers Unintended alterations change of one component can affect others evaluate nutritional profile the rats refused to eat the tomato. Farmers, students, reporters and scientists from across America, reported that when given a choice, a large variety of animals avoid eating GM foods. These include cows, pigs, geese, squirrels, elk, deer, raccoons, mice and rats. They force fed rats the FlavrSavr tomato for 28 days. 7 of 20 rats developed stomach lesions. Another 7 of 40 died within 2 weeks. In the documents made public, scientists said that the study doesn't show "a reasonable certainty of no harm." The company had created two lines of the GM tomato, both with the same gene inserted. One was associated with these high rates of lesions and deaths, the other was not. The company voluntarily decided to market the one that was not associated with the rat problems. intestinal wall of a rat
Left is the intestinal wall of a rat who was fed non-GMO potato. Picture on right is from a rat who was fed GMpotato. Dr. Arpad Pusztai was interviewed on national TV and expressed concerns about GM food safety Then, two phone calls were allegedly placed from the UK Prime Minister's office The next day, Dr. Pusztai was fired from his job after 35 years and silenced with threats of a lawsuit. same process used to create Dr. Pusztai's potatoes were used to create the GM crops on the market. IN PRACTICE -------Peoples worldwide respond similarly to food so that results from one country may be applied elsewhere the same event is used Testing is generally done during the biosafety trials, which can be used as a source of materials Codex Alimentarius Commission - the FAO/WHO body responsible for compiling the standards, codes of practice, guidelines and recommendations that constitute the Codex Alimentarius. Recommended basis of national standards and international harmonization. ad hoc Intergovernmental Task Force on Foods Derived from Biotechnology would develop standards, guidelines or recommendations, as appropriate, for foods derived from biotechnology or traits introduced into foods by biotechnology. WTO ---------------------Agreement on Sanitary and Phytosanitary Measures Can restrict trade "only to the extent necessary to protect human, animal or plant life or health" and if "based on scientific principals". May use higher standards only if there is a "scientific justification" When scientific evidence is insufficient, standards must be based on "available pertinent information". Example: Cloned Animals
12/28/06: US FDA in a preliminary decision said meat and milk from cloned animals is safe to eat Products not required to be labeled FDA does not require pre-approval Scientific Conclusions Genetic twin no difference from traditional livestock Not a GMO product no manipulation of genes (replace nuclei of donor egg) `Assisted reproduction' Since cannot verify source cannot label ATTITUDES 64% respondents uncomfortable eating products (Pew Initiative) 42% unlikely to buy food from cloned animals 57% likely or somewhat likely (IFIC) ...
View Full Document
- Spring '08