DAVID VERSUS GOLIATH - Foodopoly: The Battle Over the Future of Food and Farming in America - page 156

crop only in 2000. 19 The potential cumulative, long-term risks have not been studied. These considerations
should be critical in determining the safety of a product prior to approval, and not left to attempt to assess
once the product is on the market without labeling.
The FDA allows companies to self-regulate when it comes to the safety of genetically engineered foods.
The 1992 FDA guidance that Quayle was so proud of gave the industry responsibility for ensuring that new
GE foods are compliant with the Federal Food, Drug, and Cosmetic Act (FD&C Act). 20 In 2001, because
of public pressure, the FDA proposed a rule requiring companies to submit data and information on new
biotech-derived foods 120 days before commercialization. 21 As of 2012, the decade-old rule still has not
been finalized, and industry data submissions remain voluntary.
The FDA regulates genetically engineered animals as veterinary medicines—one of the more bizarre
industry-friendly rules. In 2009 the agency decided that the FD&C Act definition of veterinary drugs as
substances “intended to affect the structure of any function of the body of man or other animals” includes
genetically altered animals. This process allows the biotech company to keep most of the safety data secret
because it is of a “proprietary nature.” As of spring 2012, only GE salmon and Enviropig™ have been
considered for commercial approval, but no genetically engineered animals have been approved to enter
the food supply.
For whole foods (foods that are largely unprocessed and unrefined), safety responsibility is on the man-
ufacturer and no FDA premarket approval is necessary. 22 However, for substances added to food, such as
biotech traits, the FDA classifies them as “generally recognized as safe” (GRAS) or as food additives. 23
The FDA grants GRAS determinations to GE-derived foods that are considered equivalent to the structure,
function, or composition of food that is currently considered safe. The FDA has awarded “generally recog-
nized as safe” status to almost all—95 percent—of the GRAS applications submitted for food since 1998,
according to the agency's GRAS Notice Inventory. 24
By contrast, the FDA must preapprove food additives before they can be sold. However, the FDA trusts
biotechnology companies to certify that their new GE foods and traits are the same as foods currently on
the market. The company may send information on the source of the genetic traits (i.e., which plants or or-
ganisms are being combined) and on the digestibility and nutritional and compositional profile of the food,
as well as documentation that demonstrates the similarity of the new GE substance to a comparable con-
ventional food. The FDA evaluates company-submitted data and does not do safety testing of its own. 25
The agency can approve the GE substance, establish certain regulatory conditions (such as setting toler-
ance levels), or prohibit or discontinue the use of the additive entirely. 26 The FDA evaluates the safety of
all additives, but it has evaluated only one GE crop trait as an additive: the first commercialized GE crop,
Flavr Savr™ tomatoes. 27
Once a GE food product has been approved and is on the market (either with the GRAS designation or
as a food additive), the FDA is responsible for its safety. The FDA did pressure a company to recall one
GE food product: StarLink corn, which was unapproved for human consumption, when it entered the food
supply. 28 The FDA's lack of postmarket monitoring can expose the public to unapproved GE traits in the
food supply.
GE insect-resistant crops may also contain potential allergens. One “harmless” bean protein that was
spliced onto pea crops to deter pests caused allergic lung damage and skin problems in mice. 29 Yet there
are no definitive methods for assessing the potential allergenicity of bioengineered proteins in humans. 30
This gap in regulation has failed to ensure that potential allergenic GE crops are kept out of the food supply.
The StarLink corn fiasco is a good example of the problems caused by multiple agencies having con-
flicting roles in the approval of GE products. Under the bewildering system of multiple agency jurisdic-
tions, the EPA sets pesticide residue limits for food and feed crops, and the agency is required to meet all
food and feed safety standards enforced by the FDA. It has jurisdiction over the approval (registration) of