Food Safety

Even before recent bioterrorism, public health experts were concerned about the safety of the food supply and the large amount of food poisoning cases that occur each year. Many cases go unreported, but the Centers for Disease Control and Prevention (CDC) estimates that as many as 76 million cases of food poisoning and 325,000 hospitalizations occur each year.

One part of the problem, as the General Accounting Office pointed out, is the "fragmented structure" of the food safety system, with 12 federal agencies administering 35 different food safety laws. The USDA's Food Safety and Inspection Service (FSIS) has oversight over dairy, poultry, fruit, and meat products, except for shell eggs over which the FDA and USDA share jurisdiction.

According to the FDA's Office of International Programs, 80% of seafood and 20% of produce alone is imported from abroad.

In addition to FSIS and FDA, other important agencies include USDA's Animal and Plant Health Inspection Service, which conducts research on plant and animal diseases; the Environmental Protection Agency, which establishes limits for pesticide residues in food; the USDA's Agricultural Marketing Service establishes grades for meat and poultry products; and the Centers for Disease Control and Prevention conducts surveillance for foodborne diseases and research on food pathogens. State and local agencies inspect and regulate foods as well.

• The FDA may inspect food manufacturers but generally relies on state and local governments to police food retail establishments, such as restaurants and supermarkets. The FDA issues a model food code to encourage consistency in regulations and works with the CDC and state and local governments to conduct disease surveillance.
  
  
• As the GAO notes, the current food safety regulation arrangement can lead to somewhat odd results. Roughly 20% of the foods regulated by the federal government fall under USDA jurisdiction, according to the GAO. These foods account for about 15% of the foodborne illnesses reported in the United States, the report states. The USDA inspects roughly 6,000 meat, poultry, and egg facilities and 130 import facilities. The USDA inspects most facilities daily and in 1999 spent roughly $700 million. By contrast, the FDA regulates about 80% of regulated foods, accounting for 85% of reported foodborne illnesses. The FDA is responsible for inspecting about 57,000 food facilities and 3.7 million imported food items. But the FDA budget in 1999 was only $283 million and, as the report notes, the FDA can inspect only about 1% of imported foods under its jurisdiction and inspects most facilities only once every 5 years.
  
  
• The GAO cites examples of somewhat strange results that can occur under the current system, in which "food products with similar risks that have different inspection frequencies because they are regulated by different agencies." A company manufacturing pizza with meat would be inspected daily by the FSIS, but a company manufacturing pizza without meat would be inspected only once every 5 years by the FDA. Corn dog manufacturers are inspected once daily by FSIS, but bagel dog manufacturers once every 5 years on average by the FDA. Manufacturers of packaged open-faced sandwiches (one bread slice) with meat or poultry would be inspected daily by FSIS, but manufacturers of packaged meat and poultry sandwiches with 2 slices of bread would be inspected only about once every 5 years by FDA.
  
  
• In 1997, then President Bill Clinton ordered the Centers for Disease Control, Environmental Protection Agency, FDA, and U.S. Department of Agriculture to work with each other and the states. President Clinton also established the President's Council on Food Safety, which includes representatives from the Departments of Agriculture, Commerce, and Health and Human Services as well as the Environmental Protection Agency. The Council submitted a Food Safety Strategic Plan in January 2001, laying out steps that could improve food safety.
  
  
• In addition, as part of the Food Safety Initiative, CFSAN has devised a 3-year research plan (National Food Safety Initiative, Three Year Research Plan, 2001).
  
  
• In response to concerns about possible attacks on the food supply, the Center has issued draft guidance to food importers as well as to food processors and retailers. The guidance advises companies to implement security procedures, screen employees, and know their suppliers.
  
  
• In-depth information about the government's food safety efforts is available at foodsafety.gov and the USDA's Food Safety Information Service.

Foods Derived from Biotechnology

• For thousands of years, farmers and scientists have tried to breed plants that could grow larger, grow under certain conditions, or be resistant to certain plant diseases by pollinating one plant with another plant of the same species to produce hybrids that express certain genes. But through the techniques of biotechnology, plants now can be modified to express genes from other species of plants or even from animals, with which, under natural conditions, they would not exchange genetic material.
  
  
• According to the International Service for the Acquisition of Agri-Biotech Applications (ISAAA), 46% of the world's soybeans, 20% of its cotton, 11% of its canola, and 7% of its maize (corn) is derived from genetically modified crops. In 2001, genetically modified crops covered more than 130 million acres worldwide. About 70% of the world's modified crops are grown in the United States, followed by Argentina (22%) Canada (6%) and China (3%).
  
  
• In the United States, genetically modified crops are grown on roughly 75 million acres of land. According to the U.S. Department of Agriculture's National Agricultural Statistical Service Crop production-acreage report, in 2002, 34% of corn, 71% of cotton, 75% of soybeans were derived from genetically modified plants.
  
  
• Responsibility for regulating genetically-modified foods is shared among 3 agencies: the FDA, which ensures these foods are safe for human and animal consumption, the U.S. Department of Agriculture, which ensures modified plants do not adversely affect crops, and the Environmental Protection Agency, which evaluates the safety of plants genetically modified to express pesticides and sets tolerances for these pesticides.
  
  
• Under a 1992 FDA rule, genetically-modified organisms used to produce foods are not considered food additives, and manufacturers need not submit a petition for approval before marketing the food nor are companies required to indicate on the label that the food is derived from genetically modified organisms unless the safety and nutrition of these foods is not "substantially equivalent" to that of conventional foods.
  
  
• The FDA believes that this approach is appropriate because, as the 1992 policy states, there is "no basis for concluding that bioengineered foods differ from other foods in any meaningful or uniform way, or that, as a class, foods developed by the new techniques present any different or greater safety concern than foods developed by traditional plant breeding." Although premarket review by the FDA is not mandatory, manufacturers thus far have voluntarily consulted with the FDA before marketing these foods.
  
  
• Like conventional foods, genetically modified foods may contain allergens, toxins, or antinutrients that can interfere with digestion of nutrients. However, the 1992 policy contains several steps that manufacturers should follow to ensure no allergens are inadvertently introduced into foods and that the modified food is no less nutritious than the conventional food.
  
  
• To date, the FDA has evaluated 50 plants that have been genetically modified so that the plant is more tolerant to herbicides or pesticides, can resist certain insects or plant viruses, produces more nutritious oils or take longer to ripen allowing more product to reach stores and consumers.
  
  
• Foods are evaluated by the FDA and manufacturers to ensure that the new proteins expressed will not cause allergies or pose safety hazards to consumers and that the level of key nutrients, the "nutrition profile," or harmful substances in the modified food, is equivalent to that in the unmodified food. Both companies and Biotechnology Evaluation Teams composed of experts from various disciplines in the Center for Food Safety and Applied Nutrition and Center for Veterinary Medicine (for products intended as animal feed) evaluate a number of factors to ascertain if a gene may present hazards. These factors include the source of the gene, the sequences of amino acids and whether these sequences resemble allergens or toxins, whether the source of the transferred gene has a history of causing allergic reactions, how the proteins are affected in laboratory tests using simulated digestive fluids, serum screening tests to see if the product causes allergies, and the levels of nutrients in the final product compared to the conventional food.
  
  
• The FDA has proposed requiring premarket notification of plant-derived biotechnology foods. This rule is scheduled to be finalized by 2003. The FDA has indicated that the proposed premarket notice rule would allow it to "make data submitted by [genetically modified] food developers available to the public" and "consider" auditing data submitted by manufacturers.
  
  
• A US District Court rejected one consumer group's challenge to the FDA's 1992 policy as scientifically unsound. However, the organizations involved in this suit have indicated that they intend to appeal this decision.
  
  
• A recent case occurred when a major American company was forced to recall its products when a genetically modified crop, StarLink corn, approved for use in animal feed but not intended for human consumption was found in taco shells and other products. The corn contained a gene that expressed an insecticidal protein. Although not believed to pose a hazard to humans, some experts expressed concern that the protein could prove allergenic to some people who consumed the corn. Another concern is that once these genes are in the food supply, they may be difficult to trace and recall should problems be discovered.
  
  
• Critics of biotechnology also were concerned in November 2002, when the FDA announced that a "small amount of corn [biotechnology company] ProdiGene engineered to produce pharmaceutical material for a clinical study had been harvested in a field of soybeans" intended for human and animal food.
  
  
• The Biotechnology Industry Organization emphasized in a Nov. 15, 2002, press release that the incident shows that "the regulatory framework governing plant-made pharmaceutical crops works" because the problem was detected and the soybeans did not enter the food supply (BIO “BIO statement on ProdiGene, Inc. Nov. 15, 2002, press release). U.S. Department of Agriculture officials agreed that the destruction of the contaminated soybeans before their entry into the food supply showed “how biotechnology safeguarding regulations are working to ensure the integrity of the system,” and both the FDA and USDA said they would collaborate to “enforce current safeguards covering research in bioengineered foods” (USDA, USDA Announces Actions, 2002).
  
  
• BIO also has urged member companies not to plant certain biotech crops, such as genetically altered corn, in such "major areas of crop production intended for animal or human consumption" as the Midwest, and ProdiGene told the Washington Post that it “will carefully study the possibility of growing [genetically engineered] corn only in parts of the country where it could not contaminate the food supply” (BIO, 2002; Gillis, Biotech Industry Adopts Precaution, 2002; Gillis, Corn for Growing Far Afield? 2002; Gillis, Farmers Grow a Field of Dilemma, 2002).
  
  
• The FDA announced recently that the agency is investigating an incident in which 386 pigs, the offspring of pigs bioengineered to produce certain proteins in their milk, were inadvertently provided by the University of Illinois-Urbana/Champaign to a livestock dealer. The animals “may have entered the food supply,” but the agency does not believe there is a public health risk because the pigs were not old enough to produce the protein. The FDA issued a list of inspectional observations (Form FDA 483) to the investigators for improperly disposing of these animas (FDA, FDA Investigates Improper Disposal, 2003).
  
  
• The FDA and USDA recently published draft guidance for companies producing therapeutic products such as human and animal drugs from genetically modified plants (67 FR 57828). The draft guidance makes suggestions about steps manufacturers should take to ensure the quality of the final product, address environmental concerns, and reduce the possibility of the modified plant entering the food supply.
  
  
• In comments about this guidance, the Grocery Manufacturers of America, Food Marketing Institute, National Restaurant Association, and National Soft Drink Association and other food industry trade associations have asked on the FDA and USDA to issue “more stringent regulations” to ensure that plants genetically modified to produce therapeutic or industrial components do not inadvertently contaminate major food crops (Grocery Manufacturers of America, 2003).
  
  
• In their comments to the FDA, the food trade organizations said that companies using modified crops to produce therapeutic proteins and other pharmaceutical components should ensure that farmers growing these crops are properly trained, avoid using major food crops if it is possible to use other plants for these purposes and keep food crops isolated from plants that are being used to produce pharmaceutical components by making efforts to make the modified plants sterile or different in appearance from standard food crops, labeling the plants to prevent mix-ups between the plants used to produce pharmaceutical components and food crops, keeping the modified plants isolated from standard crops by using greenhouses, and separate land and farming equipment. The food associations praised BIO’s agreement to grow crops modified to produce drugs and biologics away from major food crops but said more details about BIO’s efforts are needed.
  
  
• The Center for Science in the Public Interest (CSPI) issued a recent report suggesting that the FDA establish a mandatory premarket review system for genetically modified foods rather than relying upon voluntary consultations by manufacturers. According to the CSPI report, under the current voluntary system manufacturers are not responding adequately to FDA concerns that pertain to product safety and the FDA is unable to detect flaws in the data submitted by manufacturers (Gurian-Sherman, 2003; CSPI, Plugging the Holes, 2003; Gillis, FDA policies for gene-altered foods, 2003).
  
  
• Some food biotechnology critics maintain that genetically modified foods should be labeled so that consumers who have concerns about the safety of these foods or the ethics of genetically modifying crop plants can seek alternatives.
  
  
• The FDA has issued draft guidance regarding voluntary labeling of genetically-modified foods. Manufacturers may indicate that foods have been bioengineered or contain ingredients from genetically-modified organisms (GMOs), or they may indicate that foods have not been genetically-engineered or do not contain ingredients from genetically modified organisms. However, manufacturers must label the foods in such a way that they do not suggest foods without genetically modified organisms are superior to foods that do contain these ingredients. For instance, according to the draft guidance the claim "GMO-free" would be "misleading" because "most foods do not contain organisms" but a manufacturer could say that "this oil is made from soybeans that were not genetically engineered." Some members of Congress have proposed bills that would require labeling of GMOs.
  
  
• The issue also has been debated on the state level. Oregon voters rejected a proposal to require labeling of genetically-modified foods. The proposal—Measure 27—was strongly opposed by food manufacturers concerned about the expense and effort that would be required to label their foods for Oregon consumers. Opponents also believed it would be costly for the state that would have to test foods and enforce the law and “hurt Oregon farmers and food processors by slapping an ominous-sounding label” on food products sent to other states or nations (Oregon Bid for GM Labeling Rejected, 2002; Measure 27, 2002). FDA Deputy Commissioner Lester Crawford, at the time the acting leader of the FDA (Mark McClellan, the current commissioner, had not yet been confirmed) sent a letter to Oregon’s governor, reasserting the FDA’s view that genetically modified foods are substantially equivalent to conventional foods and expressing that mandatory labeling “would require different labels for different states impeding the free flow of commerce between the states." But proponents of the measure said that costs have not increased for consumers in Australia, the European Union, or Japan, which require GE labeling and cited health and environmental reasons to require labeling (See the Campaign to Label Genetically Engineered Foods).
  
  
• The FDA also is studying the sale of food from cloned animals. The science behind cloning differs from the techniques used to genetically modify plants or animals; cloning “involves copying adult animals without altering their genes,” rather than the insertion or deletion of genes designed to alter the animal’s growth or some other characteristic, according to a Washington Post article (Gillis, Cloned Food Products Near Reality, 2002; National Academy of Sciences, 2002). For instance, a farmer could clone a pig or cow that was particularly large or had a high volume of milk production. A recent report from the National Academy of Sciences, requested by the FDA’s Center for Veterinary Medicine (CVM), suggested that food from animals cloned using 3 current cloning techniques poses little risk to consumers, although the report does point out that “analytical data comparing the composition of meat and milk products” of cloned animals to “conventionally bred” animals remains lacking.
  
  
• Currently, the Washington Post reports that most companies are adhering to an “informal moratorium” from the FDA that discourages the sale of food products derived from cloned animals while the CVM ponders the issue. While cloning could potentially increase food production, the NAS panel and some animal-rights groups have raised concern about the welfare of cloned animals.