SUMMARY

The Centers for Disease Control and Prevention (CDC) released in September new estimates showing that each year in the United States 76 million people get sick, 325,000 are hospitalized, and 5,000 die from food-related illnesses. Food-borne illness is a serious public health problem. Often, people do not seek medical help and their illness is not officially reported. Yet, consumers have become aware of the serious consequences of illnesses linked to a growing variety of foods, produced domestically or imported. Consumers want the government to regulate the food supply, and industry is interested in producing foods that are safe at a reasonable price. As a result there is congressional interest in oversight and legislation in this area.

Several federal agencies, along with cooperating agencies in the states, are responsible for assuring the safety, wholesomeness, and proper labeling of all foods for human consumption in the United States. The Federal Food, Drug, and Cosmetic Act (FFDCA) gives the Food and Drug Administration (FDA) in the Department of Health and Human Services (DHHS) authority to set and enforce standards for safety of all domestic and imported foods, except for meat and poultry. FDA also ensures that all animal drugs and feeds are safe, labeled properly, and produce no human health hazard when used in food-producing animals. Also under the FFDCA, the Environmental Protection Agency (EPA) sets legal limits (tolerances) on the amounts of pesticide residues that can be found in or on food. The Federal Meat Inspection Act and the Poultry Products Inspection Act authorize the U.S. Department of Agriculture (USDA) to set and enforce standards for the safety of red meats and poultry.

The food safety activities of these agencies consist of inspecting, testing, researching, and monitoring the food supply. In response to limited federal funding, FDA and USDA recently adopted a new approach to food safety and inspection. Known as the Hazard Analysis and Critical Control Point (HACCP) system, it identifies where hazards could enter food during its preparation for market and steps that can be taken to prevent hazards.

In addition to HACCP, the federal agencies are implementing several presidential food safety initiatives. The first is a six-step strategic plan to minimize the risk of food-borne pathogens in the U.S. food supply. The second initiative aims to upgrade the safety of domestic and imported produce. A third deals with egg safety and imports. On August 1998, the President also established a Council on Food Safety to create a strategic plan, to coordinate all federal agencies' budgets for food safety activities and to respond to a National Academy of Sciences report.

The 106^th Congress debated a number of food safety proposals. Several bills would have established a national food safety program to ensure the safety of food consumed in the United States. One would increase the federal government's authority to recall unsafe meat and poultry products. Others would ensure the safety of produce and of imports. Bills also were introduced to consolidate into a single agency all food safety inspection and labeling activities. Other bills would require mandatory labeling of genetically modified foods (GM foods), or would require all GM foods be reviewed by FDA either separately or under the "food additive" category, or establish an information program about GM foods.

MOST RECENT DEVELOPMENTS

StarLink corn, a variety developed through biotechnology only as an animal feed, has been found mixed with other corn throughout the U.S. food supply. It is not to be consumed by humans because EPA did not receive data from Aventis, the company which developed StarLink, on whether humans had trouble digesting the modified corn nor whether the corn had characteristics that might cause allergenic reactions in humans. Consequently, EPA granted conditional approval to plant the corn subject to strict handling and end use rules (the company was to require that growers keep the corn out of the human food supply). On October 25, 2000, Aventis supplied EPA for the first time with test data on the human health effects, and on November 28, 2000, an EPA scientific advisory group will hold a public meeting to discuss this data. Meanwhile, StarLink corn has been found in many parts of the U.S. food supply chain, i.e., in grain elevators as well as in processed foods such as taco shells, necessitating recalls of many products and lost sales. Mission Foods, Inc. claims that their food product recalls will cost their company over $10 million. In addition, Japan has found StarLink in some U.S. corn shipments threatening a major export market. Opponents of genetically engineered foods (GE foods) have used this event to gain support for a stronger federal regulatory, testing, and labeling GE foods policy. Proponents of the current system argue that a more stringent federal testing or labeling system would not have prevented this incident for StarLink corn was never supposed to be in human food.

BACKGROUND AND ANALYSIS

Introduction

While most experts agree that the U.S. food supply is among the safest in the world, every year food-borne pathogens in the food supply make many people ill. Consumers have expressed increasing concerns about microbial contaminants in their foods and are asking whether the federal regulatory system adequately deals with those problems. The nation's food safety system consists of activities carried out by several federal, state, and local government agencies that inspect, test, research, and monitor the food supply. For the most part, these agencies monitor whether food manufacturers are adhering to their legal responsibility of assuring the production of safe food. However, reported occurrences of outbreaks of food-borne illnesses have been increasing, and current safety efforts are not providing the confidence in the food supply that U.S. consumers demand.

In response, in 1997, the Administration launched several efforts to correct and augment the safeguards in the food safety system with a "farm-to-table" initiative. In 1998, the Administration finalized guidance to the industry on the production, handling, and processing of fresh fruits and vegetables. In 2000, the President's Council on Food Safety has been coordinating research on food-borne pathogens, and working on a long-term strategic plan. The 106^th Congress faced a number of proposals that would have strengthened the federal government's food safety authority. Some claimed that reorganizing the regulatory structure for food safety would better protect the public health. The food industry, on the other hand, resisted these proposed changes claiming that the agencies need to enforce better the current rules governing food and that agencies need no new authority to enforce food safety requirements.

This issue brief characterizes the public health problems caused by food-borne pathogens and describes activities of federal agencies charged with ensuring that consumers can purchase "safe" food from appropriately regulated food companies. It briefly discusses the President's several food safety initiatives, and describes requested resources for federal funding and for cooperation among federal agencies involved in food safety activities.

Public Health Problems

CDC estimates that food-borne diseases cause approximately 76 million illnesses, 325,000 hospitalizations, and 5,000 deaths each year in the United States. These estimates are based on data from a variety of sources including new surveillance systems, death certificates, and academic studies. Experts claim that rather than any changes in disease frequencies, better surveillance data have contributed to the new numbers. Often, victims mistake food poisoning for some other illness and do not report them to a doctor. Other experts estimate that over 40 million cases of food-borne illness go unreported each year. Different population groups, such as the elderly, very young, pregnant women, and people with HIV/AIDS and cancer, are particularly vulnerable to diseases caused by food-borne pathogens. While many food-borne illnesses are mild and non-life-threatening, 1-3% of those afflicted develop secondary complications such as reactive arthritis, kidney failure, and Guillain Barré Syndrome -- a form of acute paralysis.

Officials of the Department of Health and Human Services (DHHS) project that the reported incidence of food-borne disease may increase by 10-15% during the next decade. Some postulate that changes in production practices, centralized product distribution, environmental conditions, and food consumption patterns could be contributing to the emergence of new microbial threats to health.

Several other factors are contributing to the concern of public health officials about the increased risk of getting ill from food. The highly mechanized, efficient production and distribution practices of the food industry make it possible for a contaminated product to be quickly distributed nationally or even internationally. Long-distance distribution channels also give more opportunity for time and temperature abuse. With people eating out frequently and more retail establishments processing foods on-site, there is more opportunity for a contaminated food to cause illness in many people. In addition, more cases of illness from pathogenic organisms on fresh fruits and vegetables have been reported as consumers eat more produce for its nutritional benefits.

Food-borne diseases are caused primarily by bacteria, viruses, parasites, and fungi that produce toxic substances. There also may be long-term health effects from chemical residues or drug residues found in food. Nonpathogenic microorganisms may become pathogenic when they mutate or adapt to changing environments. For instance, one strain of Escherichia coli, a common, harmless bacteria found in intestines of all birds and mammals, has mutated into a deadly form known as E. coli O157:H7. A more virulent type of Salmonella Enteritidis (SE) called phage type 4, has been found in chickens and dairy cows. Both pathogens have contributed to the growing number of food borne outbreaks.

USDA's estimated costs associated with medical expenses and losses in productivity from seven major types of food-borne illnesses are between $5.6 and $9.4 billion annually (in 1993 dollars). These major food-borne illnesses include illnesses caused by Campylobacter jejuni, Clostridium perfringens, E. coli O157:H7, Listeria, Salmonella, Staphylococcus, and Toxoplasma gondii. One of these, Campylobacter jejuni has been associated with Guillain-Barré syndrome (GBS), is an autoimmune reaction that can cause acute neuromuscular paralysis. Campylobacteriosis, the disease caused by this pathogen, is a major cause of human bacterial food-borne illness with an estimated 2.1 million cases occurring annually at an estimated cost of $1 billion.

Federal Regulatory Framework for Food Safety

The U.S. food industry makes available to U.S. consumers a wide variety of food that is produced domestically or imported. The federal government attempts to ensure that the food supply is safe from the farm and ports to consumer tables under statutory mandates and regulatory policies. Federal regulatory jurisdiction depends on the type of food, the way the food is processed, or the type of adulterant to be found in a particular food. Critics charge that the agencies' overlapping jurisdictions and duplication of effort are wasting taxpayers' money. Overlapping jurisdictional responsibilities inhibit efforts to focus where the risk of adulteration and contamination is the greatest, they claim. Administration officials, however, argue that by recently working cooperatively and through formal understandings among the agencies, federal agencies now avoid duplicating efforts, for the most part.

Agency Regulatory Responsibilities

Federal regulatory responsibilities for food safety vary. For example, the U.S. Department of Agriculture (USDA) regulates red meat, poultry, and certain egg products while the Food and Drug Administration (FDA) is responsible for the safety of all other foods. Preventing and detecting food-borne contamination is currently the job of three federal agencies: the Food Safety Inspection Service (FSIS) of USDA; two centers within FDA (an agency of DHHS) -- the Center for Food Safety and Applied Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM); and the Office of Pesticide Programs (OPP) of the Environmental Protection Agency (EPA). In addition, the Centers for Disease Control and Prevention (CDC), also part of DHHS, tracks food-borne illness incidents and outbreaks, and provides data and information to the other food safety agencies.

Even with all these federal agencies playing a role in ensuring the safety of foods, manufacturers, producers, and distributors of food have the primary responsibility of ensuring that the food, when marketed in interstate commerce, is not harmful or unfit and does not contain unacceptable chemical residues. To assist in this effort, federal agencies set standards for producers, processors, and manufacturers that minimize food hazards. Federal agencies then enforce these standards through inspections.

Federal laws mandate how each federal agency approaches its role in food safety, and these laws dictate very different approaches. The Federal Food, Drug, and Cosmetic Act (FFDCA) prohibits the entry into interstate commerce of adulterated or misbranded foods. Section 402 of the FFDCA defines food as "adulterated" if it "contains any poisonous or deleterious substance which may render it injurious to health." FDA is responsible for establishing guidance and regulatory requirements for assuring that food is safe and not adulterated. FDA monitors through inspections whether food manufacturers adhere to their legal responsibility of producing foods that are not found to be defective, unsafe, filthy, or produced under unsanitary conditions. However, as noted below, these inspections occur infrequently. FDA also is authorized to seize contaminated food and review petitions for approval of food and color additives, among other things.

The meat and poultry acts mandate different inspection requirements. The Federal Meat Inspection Act of 1906, as amended by the Wholesome Meat Act of 1967, requires that USDA continuously inspect all cattle, sheep, swine, goats, and horses brought into any plant to be slaughtered. It also requires that a federal inspector be present at least for part of every shift while a firm is processing meat products for human or animal consumption. Congress instituted similar requirements for poultry in the 1957 Poultry Products Inspection Act, amended by the 1968 Wholesome Poultry Products Act. Under these acts, USDA is responsible for inspecting most meat, poultry, and processed egg products for safety, wholesomeness, and proper labeling. USDA also has established a mandatory program called Hazard Analysis and Critical Control Point (HACCP) for meat and poultry plants.

Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA regulates pesticide products sale and use and weighs the products costs and benefits. Under the "safety-only" clause, Section 408 of the FFDCA, EPA sets limits for pesticide residues (called tolerances) in or on foods and animal feed. Foods with a residue of a pesticide for which there is no tolerance established, or with a residue level exceeding an established tolerance limit, are declared "unsafe" and "adulterated;" such foods cannot be sold in interstate commerce in the United States. EPA has set over 9,000 pesticide residue tolerances. FDA and USDA enforce those tolerances on their portions of the food supply. The Food Quality Protection Act of 1996 [P.L. 104-170] changed the so-called "zero-risk" standard of Section 409 of the FFDCA (the Delaney Clause) so that all food, both raw and processed, have tolerances set under a standard that requires all residues be "safe," and ensures that there is a "reasonable certainty of no harm" from the pesticide residues.

State, local, and county public health and agriculture departments with the CDC play a major role in helping FDA and USDA carry out their responsibilities. Even though federal law mandates the safety of all food, more than 3,000 state and local regulatory agencies monitor most retail food establishments to ensure that consumers are protected from unsafe food. U.S. retail establishments include approximately 785,000 commercial and institutional food establishments, 128,000 grocery and convenience stores, and 1.5 million vending operations. CDC's primarily assists state and local health departments in investigating outbreaks of illness and in identifying the cause of the outbreak. State health departments send CDC reports of confirmed food-borne illnesses for a national surveillance database.

Agencies carry out five activities to ensure that food is safe: 1) provide guidance to industry about what is expected, and develop policies and regulations; 2) enforce compliance by inspections and programs; 3) give pre-market approval to additives that will be added to food and to labeling; 4) track food-borne illnesses in the United States and overseas; and 5) conduct research on all phases of food science including detection methods for contaminants.

Establishing Guidance and Regulatory Requirements. FDA promulgates regulations and issues guidance and advisories, known as "good manufacturing practices" (GMPs), to food manufacturers and both FDA and USDA publish regulatory requirements which food processors must meet. Standards and requirements are developed through a public rule-making process. In developing GMPs, for example, FDA considers a variety of sources, including advice from international organizations. GMPs for food production represent generally recognized practices for food processing and handling to avoid contamination with poisonous or deleterious substances, filth, or potentially harmful microorganisms. GMPs address layout and maintenance of facilities, personnel qualifications, equipment and utensils, processes and controls, and other measures required to ensure basic sanitation and cleanliness. GMPs reflect FDA's interest in establishing a general standard of quality in the U.S. food supply, and serve as guidance rather than as regulatory requirements.

FDA and USDA have adopted a preventive approach called the "Hazard Analysis and Critical Control Point" (HACCP) program to ensure the safety of food. FDA used a similar preventive program in its low-acid canned foods regulations for more than 30 years. FDA instituted HACCP in December 1997 for seafood products and has published a rule proposing HACCP for fruit and vegetable juices. USDA is phasing in HACCP for red meat and poultry. The HACCP program for food safety gained support in 1993, when President Clinton and Vice President Gore issued a report under the National Performance Review initiative (known as the Reinventing Government report or ReGo). The ReGo report on foods called for a uniform science-based approach to food safety, and favored giving more responsibility for assuring the safety of the food supply to the food industry. A HACCP program typically involves seven principles, based on scientific and technical knowledge. The seven principles are (1) analyze hazards; (2) identify critical control points to control identified hazards; (3) establish the point at which a preventive action must be taken; (4) establish procedures to monitor the control points; (5) establish corrective actions to be taken when monitoring shows that a critical limit has not been met; (6) establish procedures to verify that the system is working consistently; and (7) establish effective record keeping to document the HACCP system. Once the system is in place, FDA and USDA review the records of monitoring the critical points to ensure compliance and evaluate the products and facility. Both agencies require some regulated industries to have HACCP plans in place at all processing plants by certain dates.

The most important and controversial step is the choice of the critical control points or CCPs. CCPs are where control must be exercised because loss of control at a CCP is likely to result in contamination of a food. An example of a CCP would be a heat treatment step where a specific combination of time and temperature is maintained to eliminate all pathogens. Under HACCP, food companies are responsible for setting the limits of this critical step and putting in place control measures that are activated when the limits are breached. The federal government role is to give guidance, oversee safety programs, and monitor records of those CCPs and to determine that the company corrected problems. FDA is currently collecting information, through a voluntary pilot program, on how HACCP might be implemented for food service, food retail stores and other retail food establishments.

HACCP for Meat and Poultry. USDA's final regulations for Pathogen Reduction/ HACCP in meat and poultry processing have four elements: (1) each plant had to develop sanitation standard operating procedures (SSOPs); (2) all plants must meet performance standards and keep records that ensure the Salmonella enterica incidence rate is below the national baseline level established by USDA; (3) every plant must test for the bacterium E. coli (all strains, not specifically O157:H7) to verify that the process is controlling fecal contamination; and (4) every meat and poultry plant must develop a HACCP plan to identify where hazards occur and how to prevent them.

On September 20, 2000, at a hearing of the Senate Agriculture Committee on how the current food safety system addressed microbial contamination and the role of HACCP, Secretary of Agriculture Dan Glickman said that HACCP is working and that USDA testing data shows Salmonella prevalence as declining on all meat and poultry products. For example, the prevalence of Salmonella on raw chicken has declined by 50% since 1997, he claimed. Supporters claim that the Salmonella performance standards are based on science and are a legitimate regulatory tool for verifying good HACCP process controls. Critics question whether Salmonella testing should be used, as it is now, as a pass/fail regulatory tool for meat and poultry plants.

Enforcing Compliance with Inspections and Sanctions. The FFDCA and other statutes give FDA the responsibility to prohibit entry of adulterated or misbranded foods and other products into interstate commerce. FDA officials (fewer than 700 and some state officials under contract with FDA) are authorized to enter and inspect, at reasonable times, any factory, warehouse, or establishment in which foods are manufactured, processed, packed, or held prior to introduction into interstate commerce or in a vehicle transporting food. Inspections occur on average once every 7 years. If violations are found, FDA can request that the Justice Department initiate an injunction, seizure, or prosecution. FDA also uses a number of administrative enforcement tools. It can send warning letters and other regulatory correspondence, request voluntary recalls, create import alert lists, detain imported foods, and prosecute misdemeanors and felonies through the Department of Justice. It does not have the power to mandate recalls or look at all records kept by the plant. If further action is necessary, FDA requests the Department of Justice to impound the contaminated foods.

FSIS inspectors, under the authority of the Federal Meat Inspection Act and the Poultry Products Inspection Act, must be continuously present at all the 6,000 meat and poultry plants while processing. FSIS inspectors (more than 7,500), who examine each meat and poultry carcass slaughtered and are present in all meat and poultry processing plants daily, have summary powers to withdraw their inspection services, which stops processing operations, condemn foods, and obtain plant records. FSIS compliance staff investigate any alleged violations of the meat and poultry inspection acts. FSIS can detain the product in the plant or institute a seizure action requesting a federal district court to direct a U.S. Marshall to take custody of the product. It also does not have mandatory recall authority. The Safe and Fair Enforcement and Recall for Meat and Poultry Act (SAFER Meat and Poultry Act), S. 18/H.R. 983, would provide FSIS with authority to require a recall of unsafe meat and poultry products. FDA and FSIS have the power, if a company refuses to conduct a voluntary recall, to issue a public warning, and may then proceed to seize the products.

Approving Food Additives and Labeling. The FFDCA, Section 409 defines food additives to include not only directly and indirectly added substances to foods but also certain substances used in "producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, and including any source of radiation intended for any such use." An industry or sponsor with a proposed food additive must file a petition for pre-market approval with FDA that includes test data showing that the food additive meets the FFDCA standard of "safe." "Safe" means that there is a "reasonable certainty that no harm would result from the substance under its intended conditions of use." In its petition review process, FDA determines the types of food in which an additive can be used, the maximum quantity of the additive that can be used, and the information that must appear on the label. During the review, the agency assesses the risks associated with the additives. If the petition establishes an adequate basis for finding that the use of a substance is safe, the agency publishes in the Federal Register a regulation prescribing safe conditions for use. In addition, the statute permits use, without prior agency approval, of a substance with a long history of use, if it is considered "generally-recognized-as-safe" (GRAS).

Food Contact Substances. If FDA concludes that a substance used in manufacturing, packing, packaging, transporting, or holding food might reasonably be expected to migrate into the food, the substance is regulated as a "food contact substance." Formerly, petitions for approval of those substances followed the same procedures as direct food additives. The Food and Drug Administration Modernization Act of 1997 (FDAMA, P.L. 105-115) created an alternative approval mechanism for them; the sponsor or manufacturer may now notify the agency of the identity, and its intended use, and submit all necessary information to show that the substance is safe. Unless FDA specifically objects, the manufacturer can begin using the food contact substance. This Premarket Notification Program (PMN) diminished the time the agency spent reviewing "food contact substance" petitions for approval.

Meat, Poultry, and Egg Irradiation. As shown above, the FFDCA definition of a food additive includes the phrase "any source of radiation intended for any such use." On December 2, 1997, FDA approved the use of irradiation of red meats. Approval came after FDA examined the impact on the nutrient content of irradiated products, potential toxicity concerns, and the death of microorganisms in or on irradiated products. In December 1999, USDA finalized its rule governing the use of irradiation in raw meats and meat by-products to control disease-causing microorganisms and to extend shelf life (64 FR 9089-9105). It extended the same rules to poultry products. On July 20, 2000, FDA approved irradiation on eggs in shell to reduce the level of pathogens, particularly Salmonella. According to a recent GAO report, Food Irradiation: Available Research Indicates That Benefits Outweigh Risks,

the process benefits consumers by eliminating pathogens which cause illness.

Critics of meat and egg irradiation are concerned that some producers, processors, and consumers will have unrealistic assumptions about the safety of the products and, believing that the meat, poultry, and eggs to be safe, will not be careful with sanitary food-handling practices. Critics also say that the treatment kills helpful bacteria that aid digestion and may alter the nutritional value of a food. Supporters, however, see this rule as giving the industry another "safety" tool to control food-borne pathogens. Irradiation may become a primary tool in ensuring the safety of fresh produce such as alfalfa sprouts.

Tracking Food-borne Illnesses. In 1998, the Administration initiated PulseNet, a system for linking electronically investigators at CDC, FDA, and USDA to public health laboratories in 17 states. This network of more than 35 laboratories is designed to rapidly identify strains of all food-borne pathogens by matching DNA "fingerprints" of pathogens found both in food and in people stricken with gastro-intestinal illness. These data are collected in addition to data under FoodNet, a cooperative active surveillance project for food-borne disease in eight targeted locations in the United States. FoodNet, also supported by CDC, USDA, and FDA, began in 1995 because public health officials, who rely on epidemiology to identify and track the source of outbreaks of food-borne illness, did not have an accurate accounting of outbreaks. Many times, when people are diagnosed with a food-borne illness, their doctor or the laboratory that detects a pathogenic organism in a fecal sample may or may not report the incident to the local county health department. That department only reports periodically cases that it knows about to the state department of health. States collect local data and send reports to CDC which updates a national surveillance database. Preliminary data from FoodNet for 1999 indicate a decline in several of the major bacterial and parasitic causes of food-borne illness.

Research. Discovery of food-borne microorganisms that have acquired pathogenic characteristics raises concerns over whether the current food safety system is adequate to detect and identify new pathogens and their sources before they reach consumers. In July 1998, the National Research Council released a report entitled The Use of Drugs in Food Animals: Benefits and Risks. According to the report, bacteria that resist antibiotics can be passed from food animals to humans, but it does not appear to constitute an immediate public health concern. The report recommends increased research and monitoring of drug resistance, usage, and residues in farm animals.

Administrative Initiatives

Food-borne disease outbreaks have recently received much media attention and have shaken public confidence in food safety. In 1993, E. coli O157:H7 in hamburgers killed 4 children. Between 1995 and 1999, over 10 food borne illness outbreaks were associated with sprouted seeds. In 1996 alone, there were 29 outbreaks of illness caused by E. coli O157:H7, according to the CDC. Since 1997, there has been a series of highly publicized outbreaks of food-borne illness: Hepatitis A associated with frozen, sliced and sugared strawberries from Mexico in a school lunch program, Cyclospora associated with lettuce, basil, and Guatemalan raspberries, E. coli O157:H7 in frozen beef patties from a packing plant, Salmonella Agona in dry oat cereal in 11 states, and Listeria monocytogenes in hot dogs and deli meats. Upper New York State experienced an outbreak from E. coli O157:H7 last year. In late May 2000, illnesses caused by E. coli O157:H7, found in the city drinking water of Walkerton, Ontario, Canada, caused 7 people to die, most of whom were aged 56 to 92.

The Clinton Administration's "Farm-to-Table" Food Safety Initiative

President Clinton continues his support for a Food Safety Initiative to improve methods to track and prevent microbial food-borne illnesses. An interagency effort produced a report entitled Food Safety From Farm to Table which covers six major areas of activity: an early warning system for food-borne disease surveillance, coordination of response to interstate outbreaks, risk assessment, research, improved inspections and compliance, and education. The report takes a comprehensive view of the problem of food-borne illness and discusses how to further reduce the incidence of food-borne illness to the greatest extent feasible. Each federal agency has often acted separately to deal with problems that arise in products over which each agency has regulatory jurisdiction.

The President's initiative is improving the coordination by all agencies with food safety responsibilities, particularly FDA and USDA, to identify and prevent hazards in foods that present the greatest public health risk. It expanded FoodNet, and the national early warning system. The initiative increased resources for research to develop tests that detect microbes that cause food-borne illness, to expand inspections to improve compliance, and to support educational programs, such as "Fight BAC," to improve food handling at home and at the retail level.

The Second Initiative on the Safety of Fruits and Vegetables. FDA issued voluntary guidelines entitled "Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables" on October 29, 1998. The guide, available on the web at http://www.fda.gov/ohrms/dockets, addresses microbial food safety hazards and good agricultural practices common to the growing, harvesting, packing, and transporting of most unprocessed or minimally processed fruits and vegetables sold to consumers. Industry officials have expressed concern that, although FDA regards the document as guidance without the force or effect of law, it may ultimately have this effect. Produce wholesalers/buyers might insist these standards are followed before they purchase produce.

The fresh produce initiative included two new regulations for juice manufacturers. First, FDA implemented a final rule on September 8, 1998, that requires all packaged fresh juices to bear a statement warning of potential risk of illness if the juice is not pasteurized or otherwise treated to reduce pathogens 5-log cycles (99.999%). Juice manufacturers had to comply with this rule by July 8, 1999. A proposed rule, published on April 24, 1998, would require juice manufacturers to implement a HACCP program for all packaged juices that are not intended for consumption at the point of sale (63 FR 20486). A final rule is expected by the end of the summer of 2000. Critics suggest that large juice processors support mandatory pasteurization to eliminate competition from smaller fresh juice processors.

A Third Initiative on the Safety of Eggs and Imported Foods. On December 11, 1999, the President announced an Egg Safety Action Plan initiative to cut in half by 2005 the number of Salmonella Enterititis (SE) illnesses attributed to eggs. The plan asks that all egg producers practice good sanitation, test eggs for SE and divert infected eggs away from consumers. It also asks that during processing and packing, eggs receive treatments to eliminate SE. (See CRS Report RS20338, Federal Regulatory Structure for Egg Safety: Fact Sheet.) At a public meeting on July 31, 2000, the Administration laid out possible performance standards for the treatment of in-shell, packed, and processed eggs. For imported foods, FDA and the U.S. Customs Service have complied with a Presidential directive and developed a plan to target unscrupulous importers who try to import unsafe food into the United States. The agencies now require that import shipments be stored in secure facilities at the importers expense until released, destroy foods refused entry due to a serious public health or safety violation, and label refused foods and accompanying paperwork to show the product was previously denied entry. Such a requirement may prevent "port shopping."

The President's Council on Food Safety

On August 25, 1998, President Clinton signed Executive Order 13100 establishing the President's Council on Food Safety. The Council is headed by the Secretaries of Agriculture and Health and Human Services and the Assistant to the President for Science and Technology. Its purpose is to develop a strategic plan that contains recommendations on changes needed to reach food safety goals, to coordinate the annual food safety budgets of all the federal agencies, to assist the Joint Institute for Food Safety Research in developing priorities for food safety research, and to review the August 20, 1998, National Academy of Sciences (NAS) report Ensuring Safe Food from Production to Consumption. The Council so far has not issued a coordinated interagency budget request so the current food regulatory system has remained intact. A final national food safety plan is due to the President sometime in October 2000. The report is likely to include recommendations on making statutory changes and an examination of the feasibility of establishing a single food safety agency.

Appropriations for the President's Food Safety Initiative

Table 1 shows the total amount of funding FDA and USDA received under the President's Food Safety Initiative (FSI) for FY1999 through FY2001. Funding between FY1999 and FY2000 increased 21% and funding between FY2000 and FY2001 increased 19%. With these appropriations, Congress supported the President's initiative request. Funding for activities such as federal meat and poultry inspections under the food safety initiative are in addition to other federal food safety programs and activities.

Congressional Oversight Structure for Food Safety

Congressional oversight for food safety is shared among several committees. In the Senate, food safety issues are considered by the Committees on Agriculture, Nutrition, and Forestry; Commerce, Science, and Transportation; Environment and Public Works; Government Affairs; and Health, Education, Labor and Pensions. In the House, food safety is considered by the Committees on Agriculture; Commerce; Government Reform and Oversight; and Science. The Appropriations Committees also serve an oversight role in how the major agencies set and carry out policies affecting the safety of foods.

Issues

Do Federal Food Safety Agencies Need More Regulatory Authority?

The Administration has called for new statutory authority to enforce food safety standards. It supports statutory changes that would give agencies mandatory recall authority and strengthen their ability to halt food imports. The food industry, on the other hand, has been critical of these legislative proposals, saying that additional resources are needed, not more regulatory authority.

Authority To Mandate Recalls. The Safe and Fair Enforcement and Recall for Meat and Poultry Act (SAFER Meat and Poultry Act, S. 18/H.R. 983) would amend the Federal Meat Inspection Act and the Poultry Products Inspection Act to give USDA direct authority to mandate recalls of suspected contaminated products, to ensure that USDA is notified when meat products test positive for certain pathogens, and to levy civil fines (called "civil money penalties") against processors who repeatedly violate safety standards. H.R. 5591, the FDA Food Embargo Act of 2000, would authorize embargo authority for FDA.

Improved Safety of Food Imports. The Imported Perishable Product Safety Improvement Act (S. 2480) and the Imported Products Safety Improvement and Disease Prevention Act of 2000 (S. 2692) would strengthen the existing system to deny entry of any perishable product or food that has been associated directly with outbreaks of food-borne illness. They would also enhance the enforcement and penalties for importing contaminated perishable products and would improve the public health infrastructure to enhance research, surveillance, and training for the detection of food borne pathogens in foods.

Table 1. FY1999, FY2000, and FY2001 Appropriations
(million dollars)

Note: USDA agencies: AMS- Agricultural Marketing Service; ARS-Agricultural Research Service; CSREES-Cooperative State Research, Education and Extension Service; ERS-Economic Research Service; FCS-Food and Consumer Service; FSIS-Food Safety and Inspection Service; NASS-National Agricultural Statistics Service; OCE-Office of the Chief Economist. DHHS agencies: FDA-Food and Drug Administration and CDC-Centers for Disease Control and Prevention. Source: USDA, Office of Budget and Program Analysis; FDA, Office of Financial Management; CDC-Infectious Diseases Budget Office.

Should the Regulatory Structure for Federal Food Safety Be Reorganized?

Over time, Members of Congress have questioned whether the current monitoring and inspection systems of USDA and FDA are capable of safeguarding the nation's food supply. The NAS report Ensuring Safe Food from Production to Consumption recommended changing federal statutes so that inspection, research, and enforcement would be rooted in scientifically supportable assessments of risk to public health. It also recommends coordinating federal food safety agencies by establishing a unified, central framework for managing food safety programs headed by one official with control of resources for all federal food safety activities.

On June 24, 1999, the Safe Food Act of 1999 (S. 1281/H.R. 2345) was introduced. The Act proposes to consolidate into a single independent agency in the executive branch the responsibilities regarding food safety, labeling, and inspection currently divided among several Federal agencies. On January 19, 2000, the Strategic Planning Task Force of the President's Council on Food Safety held a public meeting to hear public feedback on a draft strategic plan aimed at improving cooperation and communication among federal food safety agencies. The draft plan laid out 5 options for a reorganization of food safety responsibilities within the federal government. One option would designate a single chair person to coordinate the current system. Another would consolidate food safety functions in an existing agency. A third option would designate one or two agencies with specific responsibilities, i.e., one agency would conduct all food inspections, another all research and surveillance functions. A fourth option would consolidate food safety regulatory functions within an existing organization but responsible parties would report to a current cabinet secretary or the management of an existing independent agency. A fifth option would be to create a new consolidated "stand alone" agency organized around specific types of food, or types of processing or different kinds of risks.

Supporters claim reorganization will address the problem of several federal agencies performing food safety functions which, they assert, at times overlap and at times leave undone necessary activities to protect the public health from food-borne illness. Supporters say that a single food safety agency can identify the most serious public health risks, to research testing methodologies, conduct risk assessments, and identify the most cost-effective interventions without regard to the type of food or to bureaucratic "turf." Critics of reform believe that the time is not right for major reform because of fear that a new agency would cause dislocation and upheaval. Parent agencies would need to relinquish their current budget authority and control. Other opponents claim that reorganization proposals do not address the flaws in the fundamental regulatory structure for food safety created by the current statutes. What is needed is a new food safety mandate, they argue.

Should Bioengineered Foods Be Labeled and Regulated?

Questions have been raised in the 106^th Congress, as to whether genetically modified or bioengineered foods were safe, and whether they should be labeled. Bioengineered foods, or genetically engineered foods (GE foods), refers to the use of recombinant DNA and related techniques to alter the genetic makeup of living organisms. These techniques allow scientists to identify and isolate genes of interest from any organism and put them into other organisms. All the food safety agencies, FDA, USDA, and EPA, are involved in the regulatory process for GE foods. Currently, GE food crops planted and marketed by U.S. farmers include corn, canola, tomatoes, potatoes, soybeans, and sunflowers. (For more information, see CRS Report RL30198, Food Biotechnology in the United States: Science, Regulation, and Issues).

Supporters claim that GE foods have environmental benefits because there is less need to use pesticides and farmers benefit from lower input costs. They also say these foods have been carefully tested, and that, in fact, genetic engineering is more precise than traditional cross-breeding, a technique that often transfers unwanted genes to the food plant. However, critics raised questions about whether the agencies had scrutinized properly the long-term effects of these products on human and environmental health since the agencies do not require or check test data. In response to the growing public concerns, on May 3, 2000, the Clinton Administration announced an interagency plan to reinforce the basis for its policies regarding GE foods. FDA will publish a rule mandating that developers of GE foods and animal feeds notify the agency 120 days before GE products are marketed. FDA will also require developers to submit data on whether the GE foods pose any potential safety, labeling, or adulteration risks, and is drafting guidance on how to label food being made with or without GE ingredients. USDA's responsibilities will include expanding research, facilitating the design of reliable tests and quality assurance programs for differentiating GE commodities from non-GE commodities, and providing farmers with information on markets to inform their planting decisions with these new crop varieties. FDA, USDA, EPA, and the State Department will enhance outreach and education efforts, both domestically and overseas, and work together to assess federal environmental regulations on GE crops and, if appropriate, recommend improvements.

Farmers have also reacted to the recent negative publicity about GE crops by lessening corn plantings but increasing the percentage of acres planted with GE soybeans and cotton. According to USDA, the percentage of acres planted with GE corn declined from 37% in 1999 to 25% in 2000. GE soybeans plantings increased from 47% to 54%, and GE cotton from 56% to 61% in 2000.

In November 1999, the Genetically Engineered Food Right to Know Act (H.R. 3377) was introduced and on February 22, 2000, the Genetically Engineered Food Right-to-Know Act, (S. 2080), with a similar purpose to the House bill, was introduced to require labeling of foods that contain genetically engineered material. Currently, FDA does not require such labeling. In 1992, FDA determined that GE foods pose scientific and regulatory issues that are not substantially different from those for conventional food. Special labeling is required if the GE food significantly differs from its conventional counterpart such that the common name would no longer apply, or if they contain allergens. The agency had concluded that it was unnecessary to mandate labeling to indicate the method by which a new variety of food was developed (e.g., that it was genetically engineered). (See CRS Report RS20507, Labeling of Genetically Modified Foods.) On September 26, 2000, the Senate Health, Education, Labor, and Pensions Committee held a hearing on the future of food biotechnology and consumer confidence. Questions were raised about labeling and whether voluntary labeling would give consumers confidence in these foods. According to FDA official, Joseph Levitt, labeling of any kind would not have prevented the food recalls.

On April 5, 2000, the National Research Council released a report on "Genetically Modified Pest-Protected Plants: Science and Regulation. In it, the committee emphasized that there is no evidence that genetically engineered (GE) foods are unsafe to eat. However, the committee said that given the current level of public concern over these foods, the federal agencies must make some regulatory changes and conduct more research to reduce the concern about potential harm to human health and the environment. Two similar bills were recently introduced which would have all GE foods considered "food additives." Such a designation would mean that FDA would have to approve the foods for safety prior to marketing. H.R. 3883 and S. 2315, both named the "Genetically Engineered Food Safety Act," would amend the FFDCA to require all data collected supporting the food/seed companies claims of safety be made available publically. Both bills would require all GE food to be analyzed for allergenic substances and toxins, among other factors. Both would impose user fees, similar to those collected for prescription drugs, on industry to pay for the government review.

H.R. 4627 and S. 2838, both named the "Food Biotechnology Information Initiative Act,"would require the development of a program to tell consumers about the scientific basis of the safety of foods produced with biotechnology and provide $10 million for research to address economic and environmental impacts of biotechnology on the food supply. H.R. 5095 would require that USDA, acting through the National Academy of Sciences, study and report what type of tests are needed to assess human health risks, what type of monitoring system is needed to assess long term consumption of GE foods, and what federal structure is needed to ensure these foods are safe. S. 3184, the Genetically Engineered Foods Act, would require developers of the GE food to consult with FDA, increase FDA's authority to review these foods, and monitor more closely imported foods. It also calls for a registry of GE foods that have been approved and what restrictions, if any, are required in their use.

LEGISLATION

H.R. 3266 (Brown)
Preservation of Essential Antibiotics for Human Diseases Act of 1999. Amends FFDCA to direct that essential antibiotic drugs not be used in livestock unless there is a reasonable certainty of no harm to human health. Introduced November 9, 1999; referred to Committee on Commerce.

H.R. 3377 (Kucinich)
Genetically Engineered Food Right to Know Act. Amends FFDCA, Federal Meat Inspection Act, and Poultry Products Inspection Act to require that food that contains a genetically engineered material, or that is produced with a genetically engineered material, be labeled accordingly. Introduced November 16, 1999; referred to Committee on Agriculture and Commerce.

H.R. 3883 (Kucinich)
Genetically Engineered Food Safety Act. Amends FFDCA with respect to safety of genetically engineered foods, and for other purposes. Introduced March 9, 2000; referred to House Committee on Commerce.

H.R. 4627 (Holt)
Food Biotechnology Information Initiative Act. Amends the Food, Agriculture, Conservation, and Trade Act of 1990 to provide for a program to educate the public regarding the use of biotechnology in producing food for human consumption, to support additional scientific research regarding potential economic and environmental risks and benefits of using biotechnology to produce food, and for other purposes. Introduced June 9, 2000; referred to House Agriculture Subcommittee on Risk Management, Research and Specialty Crops, June 22, 2000 and House Commerce Subcommittee on Health and Environment, June 21, 2000.

H.R. 5095 (Tierney)
Requires the Secretary of Agriculture to complete a report regarding the safety and monitoring of genetically engineered foods, and for other purposes. Introduced July 27, 2000; referred to the House Committee on Agriculture.

H.R. 5591 (Kucinich)
FDA Food Embargo Authority Act. Amends the FFDCA to establish the authority of officers and employees of the Department of Health and Human Services to issue detention orders regarding food in any case in which there is a reasonable belief that the food is in violation of such Act, and for other purposes. Introduced October 27, 2000; referred to the House Commerce Committee.

S. 18 (Harkin)/H.R. 983 (Baldacci)
Safe and Fair Enforcement and Recall for Meat and Poultry Act (SAFER Meat and Poultry Act). Amends Federal Meat Inspection Act and Poultry Products Inspection Act to provide for improved public health and food safety through enhanced enforcement. S. 18 introduced January 19, 1999; referred to Committee on Agriculture, Nutrition, and Forestry. H.R. 983 introduced March 4, 1999; referred to Committee on Agriculture.

S. 908 (Dorgan)/H.R. 1612 (Pallone)
Consumer Food Safety Act of 1999. Amends FFDCA to establish national Food Safety Program to require registration and quarterly inspections of food processing and importing facilities. Introduced April 28, 1999. S. 908 referred to Committee on Agriculture, Nutrition, and Forestry; H.R. 1612 referred to House Committee on Commerce.

S. 1126 (Mikulski)/H.R. 2055 (Eshoo)
Imported Food Safety Improvement Act of 1999. Amends FFDCA to improve safety of imported food. S. 1126 introduced in Senate May 26, 1999; referred to Committee on Agriculture, Nutrition, and Forestry. H.R. 2055 introduced June 8, 1999; referred to House Committee on Commerce, and on June 24, 1999, referred to Subcommittee on Health and Environment.

S. 1281(Durbin)/H.R. 2345 (DeLauro)

Safe Food Act of 1999. Consolidates into single independent agency in executive branch responsibilities regarding food safety, labeling, and inspection currently divided among several Federal agencies. S. 1281 introduced June 24, 1999; referred to Committee on Governmental Affairs. H.R. 2345 introduced June 24, 1999; referred to Committees on Agriculture and Commerce.

S. 1868 (Durbin)/H.R. 3526 (Pallone)

Egg Safety Act of 1999. Amends Egg Product Inspection Act to improve safety of shell eggs. S. 1868 introduced November 5, 1999; referred to Senate Committee on Agriculture, Nutrition, and Forestry. H.R. 3526 introduced January 24, 2000; referred to House Committee on Agriculture.

S. 2080 (Boxer)
Genetically Engineered Food Right-to-Know Act. Amends FFDCA to require that food containing genetically engineered material, or that is produced with genetically engineered material, be labeled as such. Introduced February 22, 2000; referred to Senate Committee on Agriculture, Nutrition, and Forestry.

S. 2106 (Ashcroft)
Advancing the Global Opportunities for Biotechnology in Agriculture Act of 2000. A bill to increase internationally the exchange and availability of information regarding biotechnology and to coordinate a federal strategy in order to advance the benefits of biotechnology, particularly in agriculture. Introduced February 24, 2000; referred to Committee on Foreign Relations. Incorporated into S. 2382, a bill to authorize appropriations for technical assistance for FY2001, to promote trade anti-corruption measures, and for other purposes.

S. 2315 (Moynihan)
Genetically Engineered Food Safety Act. Amends the FFDCA with respect to the safety of genetically engineered foods, and for other purposes. Introduced March 29, 2000; referred to Senate Committee on Agriculture, Nutrition, and Forestry.

S. 2480 (Collins)
Imported Perishable Product Safety Improvement Act. Amends FFDCA to improve safety of perishable products whose import is regulated by Commissioner of Food and Drugs, and for other purposes. Introduced April 27, 2000; referred to Committee on Health, Education, Labor, and Pensions.

S. 2692 (Mikulski)
Imported Products Safety Improvement and Disease Prevention Act of 2000. Amends FFDCA to improve the safety of imported products, and for other purposes. Introduced June 7, 2000; referred to Committee on Health, Education, Labor, and Pensions.

S. 2760 (Harkin)
The Microbiological Performance Standards Clarification Act. Amends Federal Meat Inspection Act to clarify authority of Secretary of Agriculture to establish performance standards for reduction of microbiological pathogens in meat and poultry. Introduced June 21, 2000; referred to Committee on Agriculture, Nutrition, and Forestry.

S. 2838 (Hutchinson)
Food Biotechnology Information Initiative Act. Amends Food, Agriculture, Conservation, and Trade Act of 1990 to provide for a program to provide information to the public on use of biotechnology to produce food for human consumption, to support additional research regarding potential economic and environmental risks and benefits of using biotechnology to produce food, and for other purposes. Introduced June 30, 2000; referred to Committee on Agriculture, Nutrition, and Forestry.

S. 3184 (Durbin)
Genetically Engineered Foods Act. Amends the FFDCA to require premarket consultation and approval with respect to genetically engineered foods, and for other purposes.

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