How are GM foods regulated and what is the government's role in this process?
Governments around the world are hard at work to establish a regulatory process to monitor the effects of and approve new varieties of GM plants. Yet depending on the political, social and economic climate within a region or country, different governments are responding in different ways.
In Japan, the Ministry of Health and Welfare has announced that health testing of GM foods will be mandatory as of April 2001. Currently, testing of GM foods is voluntary. Japanese supermarkets are offering both GM foods and unmodified foods, and customers are beginning to show a strong preference for unmodified fruits and vegetables.
India's government has not yet announced a policy on GM foods because no GM crops are grown in India and no products are commercially available in supermarkets yet. India is, however, very supportive of transgenic plant research. It is highly likely that India will decide that the benefits of GM foods outweigh the risks because Indian agriculture will need to adopt drastic new measures to counteract the country's endemic poverty and feed its exploding population.
Some states in Brazil have banned GM crops entirely, and the Brazilian Institute for the Defense of Consumers, in collaboration with Greenpeace, has filed suit to prevent the importation of GM crops. Brazilian farmers, however, have resorted to smuggling GM soybean seeds into the country because they fear economic harm if they are unable to compete in the global marketplace with other grain-exporting countries.
In Europe, anti-GM food protestors have been especially active. In the last few years Europe has experienced two major foods scares: bovine spongiform encephalopathy (mad cow disease) in Great Britain and dioxin-tainted food originating from Belgium. These food scares have undermined consumer confidence about the European food supply, and citizens are disinclined to trust government information about GM foods.In response to the public outcry, Europe now requires mandatory food labeling of GM foods in stores, and the European Commission (EC) has established a 1% threshold for contamination of unmodified foods with GM food products.
In the United States, the regulatory process is confused because there are three different government agencies that have jurisdiction over GM foods. To put it very simply, the EPA evaluates GM plants for environmental safety, the USDA evaluates whether the plant is safe to grow, and the FDA evaluates whether the plant is safe to eat.
The EPA conducts risk assessment studies on pesticides that could potentially cause harm to human health and the environment, and establishes tolerance and residue levels for pesticides. There are strict limits on the amount of pesticides that may be applied to crops during growth and production, as well as the amount that remains in the food after processing.
Growers using pesticides musthave a license for each pesticide and must follow the directions on the label to accord with the EPA's safety standards. Government inspectors may periodically visit farms and conduct investigations to ensure compliance.
Violation of government regulations may result in steep fines, loss of license and even jail sentences.As an example the EPA regulatory approach, consider B.t. corn. The EPA has not established limits on residue levels in B.t corn because the B.t. in the corn is not sprayed as a chemical pesticide but is a gene that is integrated into the genetic material of the corn itself.
Growers must have a license from the EPA for B.t corn, and the EPA has issued a letter for the 2000 growing season requiring farmers to plant 20% unmodified corn, and up to 50% unmodified corn in regions where cotton is also cultivated. This planting strategy may help prevent insects from developing resistance to the B.t. pesticides as well as provide a refuge for non-target insects such as Monarch butterflies.
The USDA has many internal divisions that share responsibility for assessing GM foods. Among these divisions are APHIS, the Animal Health and Plant Inspection Service, which conducts field tests and issues permits to grow GM crops, the Agricultural Research Service which performs in-house GM food research, and the Cooperative State Research, Education and Extension Service which oversees the USDA risk assessment program.
The USDA is concerned with potential hazards of the plant itself. Does it harbor insect pests? Is it a noxious weed? Will it cause harm to indigenous species if it escapes from farmer's fields? The USDA has the power to impose quarantines on problem regions to prevent movement of suspected plants, restrict import or export of suspected plants, and can even destroy plants cultivated in violation of USDA regulations.
Many GM plants do not require USDA permits from APHIS.
A GM plant does not require a permit if it meets these 6 criteria:
1) the plant is nota noxious weed;
2) the genetic material introduced into the GM plant is stably integrated into the plant's own genome;
3) the function of the introduced gene is known and does not cause plant disease;
4) the GM plant is not toxic to non-target organisms;
5) the introduced gene will not cause the creation of new plant viruses; and
6) the GM plant cannot contain genetic material from animal or human pathogens (see http://www.aphis.usda.gov/bbep/bp/7cfr340.html).
The current FDA policy was developed in 1992 (Federal Register Docket No. 92N-0139) and states that agri-biotech companies may voluntarily ask the FDA for a consultation. Companies working to create new GM foods are not required to consult the FDA, nor are they required to follow the FDA's recommendations after the consultation.
Consumer interest groups wish this process to be mandatory, so that all GM food products, whole foods or otherwise, must be approved by the FDA before being released for commercialization. The FDA counters that the agency currently does not have the time, money, or resources to carry out exhaustive health and safety studies of every proposed GM food product. Moreover, the FDA policy as it exists today does not allow for this type of intervention.
How are GM foods labeled?
Labeling of GM foods and food products is also a contentious issue.
On the whole, agribusiness industries believe that labeling should be voluntary and influenced by the demands of the free market.
If consumers show preference for labeled foods over non-labeled foods, then industry will have the incentive to regulate itself or risk alienating the customer. Consumer interest groups, on the other hand, are demanding mandatory labeling.
People have the right to know what they are eating, argue the interest groups, and historically industry has proven itself to be unreliable at self-compliance with existing safety regulations.
The FDA's current position on food labeling is governed by the Food, Drug and Cosmetic Act which is only concerned with food additives, not whole foods or food products that are considered "GRAS" - generally recognized as safe.
The FDA contends that GM foods are substantially equivalent to non-GM foods, and therefore not subject to more stringent labeling. If all GM foods and food products are to be labeled, Congress must enact sweeping changes in the existing food labeling policy.
There are many questions that must be answered if labeling of GM foods becomes mandatory.
First, are consumers willing to absorb the cost of such an initiative?
If the food production industry is required to label GM foods, factories will need to construct two separate processing streams and monitor the production lines accordingly. Farmers must be able to keep GM crops and non-GM crops from mixing during planting, harvesting and shipping. It is almost assured that industry will pass along these additional costs to consumers in the form of higher prices.
Secondly, what are the acceptable limits of GM contamination in non-GM products?
The EC has determined that 1% is an acceptable limit of cross-contamination, yet many consumer interest groups argue that only 0% is acceptable. Some companies such as Gerber baby foods and Frito-Lay have pledged to avoid use of GM foods in any of their products. But who is going to monitor these companies for compliance and what is the penalty if they fail?
Once again, the FDA does not have the resources to carry out testing to ensure compliance.What is the level of detectability of GM food cross-contamination? Scientists agree that current technology is unable to detect minute quantities of contamination, so ensuring 0% contamination using existing methodologies is not guaranteed. Yet researchers disagree on what level of contamination really is detectable, especially in highly processed food products such as vegetable oils or breakfast cereals where the vegetables used to make these products have been pooled from many different sources.
A 1% threshold may already be below current levels of detectability.
Finally, who is to be responsible for educating the public about GM food labels and how costly will that education be?
Food labels must be designed to clearly convey accurate information about the product in simple language that everyone can understand. This may be the greatest challenge faced be a new food labeling policy: how to educate and inform the public without damaging the public trust and causing alarm or fear of GM food products.
In January 2000, an international trade agreement for labeling GM foods was established. More than 130 countries, including the US, the world's largest producer of GM foods, signed the agreement. The policy states that exporters must be required to label all GM foods and that importing countries have the right to judge for themselves the potential risks and reject GM foods, if they so choose. This new agreement may spur the U.S. government to resolve the domestic food labeling dilemma more rapidly.
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