We American's put a lot of trust in our government agencies. We believe that the agencies are doing their job in protecting the health and best interests of the public. However, if we think about the not so distant past, we have plenty of examples of our government's failings in protecting us. For instance, the horrors of DDT, initially hailed with great fervor in the early 1940's only to find out it's deadly and long-term effects by the late 1940's, or  Dexatrim (phenylpropanolamine, PPA for short,) very popular  over-the-counter weight loss pill in the 1970's and 1980's raised a red flag with British researchers as early as 1980. PPA was given to healthy medical students. Alarming side effects were noted such as high blood pressure elevation, dizziness, heart palpitations, restlessness, and anxiety.  In 1990, 142 negative reactions to PPA were reported by U.S. doctors which included strokes and seizures and even death. Still, it took the FDA another TEN years to announce that PPA must be removed from weight loss products.

Who Regulates Agriculture Biotechnology?

Genfood is regulated by three government agencies, the Food and Drug Administration (FDA), the Environmental Protection Agency (EPA) and the US Department of Agriculture (USDA). These three agencies currently regulate genetically engineered products under a handful of statutes. These statutes were originally designed to regulate other products and were put in place before genetically engineered products had even been imagined. Thus they have been adapted to a purpose for which they were not intended. The result is a patchwork of regulations and programs with different requirements and underlying philosophies. The safety standards they stand behind do not adequately address important concerns regarding long term consequences, allergens, and toxicity.

In general, the products of genetic engineering are regulated for their health and environmental risks, and those risks are balanced against benefits. The major statutes applied to non pharmaceutical and non therapeutic uses of genetic engineering are implemented by three agencies: the Environmental Protection Agency, the Food and Drug Administration, and the United States Department of Agriculture.

The EPA oversees genetically engineered microbial pesticides and certain genetically engineered crops under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and non pesticidal, nonfood microbial products under the Toxic Substances Control Act (TSCA). Organisms regulated under FIFRA are subject to stringent permit standards under which the EPA can require new studies on possible harm to health and the environment. By contrast, the legal provisions of TSCA require only 90 days notice to the EPA before the commencement of manufacture and provide less straightforward mechanisms for persuading companies to conduct studies of risks. Currently, the EPA regulates Bt crops and microbial pesticides under FIFRA and microorganisms intended for pollution cleanup under TSCA.

FDA has the authority to regulate all genetically engineered foods under the Food, Drug and Cosmetic Act. Its only specific policy for genetically engineered foods applies to crops and only the end product, not the process in which it becomes transgenic.  Under the current FDA food policy, most genetically engineered crops are not subject to regulation.   Though released Jan 18, 2001 the FDA issued a new Biotech proposal, as follows:

1)  Mandatory notification: Food developers would be required to notify the FDA at least 120 days in advance of their intent to market a food or animal feed developed through biotechnology.
2) Scientific data: In their notification (called a "Pre market Biotechnology Notice," or PBN), food developers would be required to provide information and data that demonstrate their new product is as safe as its conventional counterpart.
3) Increased transparency: the FDA would increase the transparency of the agency's review process for biotech foods by posting information submitted by food developers as well as the FDA's responses to that information on the FDA's Web site. -

Though this is a step in the right direction, there is still concerns that, if finalized, the proposed rule would only slightly modify the FDA's existing regulatory guidance, which was laid out in 1992. That policy ("Statement of Policy: Foods Derived from New Plant Varieties," 57 FR 22984) stipulates voluntaryŚnot mandatoryŚnotification to the FDA by biotech food developers. In addition, the agency is not required to make public its correspondence with biotech firms.

The USDA regulates genetically engineered products under several statutes: genetically engineered crops under the Plant Pest Act and related authorities; animal vaccines under the Virus, Serum and Toxin Act; and engineered poultry and livestock under various meat inspection statutes. Within USDA, the Animal and Plant Health Inspection Service (APHIS) is responsible for protecting US agriculture from pests and diseases. Under the authority of the Federal Plant Pest Act, APHIS regulations provide procedures for obtaining a permit or for providing notification, prior to "introducing" a regulated article in the United States. Under the Plant Pest Act, the USDA issues de facto commercial permits in the somewhat confusing form of determinations that the products are not pests and do not need further regulation. These determinations are accompanied by environmental assessments done under the National Environmental Policy Act (NEPA). The USDA Plant Pest Act program has overseen thousands of field tests of genetically engineered crops and issued about twenty de facto commercial permits. Crops approved for commercial use include engineered versions of most major commodity crops such as corn, cotton, and soybeans, as well as several fruits and vegetables.

The framework of regulations applied to genetic engineered organisms is weak because it leaves important categories of genetically engineered organisms uncovered and because it often lacks strong authority to require pre market review of genetically engineered products.

The current programs differ widely in the degree to which they allow the public to participate in decisions about engineered products. Most of the statutes grant companies broad privileges to withhold data and information, including health and safety information, from the public.

Labeling is a sore spot with consumers and the FDA. The FDA decided against labeling genfood because the FDA judged that genfood does not differ significantly from their conventional counterparts solely due to the process from which they were developed. Which strikes one as strange, for when you read through FDA regulations, they have the same concerns that I do regarding long-term health and environmental impacts.

In the FDA labeling guidelines, they do suggest that the consumer contact the food manufacturer to request labeling identification of genfood ingredients if they so desire. However, when I personally made phone calls to several large name food manufacturers and asked that their food products be labeled, I was politely read the company's policy about their concern for food safety and that they will comply with FDA rulings; which says labeling is voluntary.

Personally, I think the consumer has a right to know if there are genetically altered ingredients in the food they are buying. If you think so too, you can check out my resource page that has several links to organizations that are campaigning for the labeling of genfood.



EPA Plant Pesticide Regulatory Decisions
FDA Focus Group Study on Biotechnology
FDA Regulations/Guidance on Safety Assessments
USDA Plant Pest Law and Regulations
Petitions of Nonregulated Status Granted by APHIS as of 2-8-2002.
APHIS Daily Status of Recent Applications
Agroecology/Sustainable Agriculture Program
Environment News Service

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