"Achieve effective and efficient compliance of regulated products through high quality, science-based work that results in maximizing consumer protection." That is the mission statement of FDA's Office of Regulatory Affairs (ORA), headed by Dennis Baker, associate commissioner for regulatory affairs. Specifically, that means that Baker is responsible for ensuring that FDA-regulated products (food, drugs, medical devices, cosmetics, radiation-emitting products such as microwave ovens, and feed and drugs for pets and farm animals) comply with the consumer protection laws and regulations the agency enforces. Approximately 900 investigators and 100 compliance officers in FDA offices around the U.S. are assigned to ORA.

Where food is concerned, FDA's presence is felt far and wide. "FDA inspects all food (except meat and poultry products) of domestic and foreign origin either directly or through contracts with state agencies. We want to make sure the food is wholesome and not misbranded. That responsibility includes food production, processing, distribution and sale at the retail level. We also investigate issues related to drug residues and pesticides in the food supply. We provide training to state health and agriculture officials and work for passage of the Food Code," said Baker.

Baker said that ORA's approach to food safety is risk-based. "We are targeting inspections to identify those products that have the highest level of contaminants and the highest level of food safety concern, such as low-acid canned foods or sanitation in the seafood industry," he said.

The following articles in this section illustrate ORA's accomplishments in the area of food safety.

For the seafood industry, HACCP is paramount. HACCP, which stands for Hazard Analysis and Critical Control Points, is the science-based food safety system that the seafood industry is required to use to prevent the contamination of product.

FDA conducted the second year of rigorous seafood HACCP inspections, giving priority to processors with implementation problems. FDA inspectors evaluated the adequacy of HACCP plans for 11 types of hazards, ranging from pathogens and histamines to use of unlawful pesticides and food additives. Based on data available at the end of calendar year 1999, FDA found clear progress being made by most seafood processors; approximately 5 percent of seafood firms received warning letters for failure to comply.

Also, in FY 99, FDA worked with the Seafood HACCP Alliance to produce a training course for seafood processors on how to solve problems with the design and implementation of their HACCP plans. Phil Spiller, director of FDA's Office of Seafood, said that over 30 classes were taught around the country.

The New York Sea Grant Extension Program undertook an evaluation of the seafood HACCP program in FY 99. A survey taken of the seafood industry in seven New England and mid-Atlantic states found:

• Significant upgrades in facilities and equipment, primarily to enhance the ability to maintain proper temperatures. Time and temperature control is one of the keys to seafood safety for many products;

• Major changes in daily plant operations, relating to better temperature control, closer evaluation of the incoming products that arrive at the plant door, the use of test kits, sample analysis and other activities;

• Significant re-evaluation of cleaning and sanitizing practices in order to improve overall conditions in plants; and

• Overall, a better understanding of food safety hazards and how to control them.

The Sea Grant study observed that behavioral changes are being reported by the industry, along with the investment in tools needed to carry them out. This is likely to result in a significant improvement in the safety and quality of seafood products available in the marketplace. FDA is working with the Seafood HACCP Alliance, a consortium of government agencies, academia and trade associations to have the Sea Grant study replicated during FY 2000. "We look forward to learning whether the rest of the nation is responding to HACCP as positively as processors in the northeast," Spiller said.

Vibrio parahaemolyticus Control Plan Adopted At the 1999 Interstate Shellfish Sanitation Conference (ISSC), a plan to control V. parahaemolyticus in shellfish was adopted as interim guidance. Under the FDA plan, states are required to monitor shellfish for virulent strains of V. parahaemolyticus using state-of-the-art gene probe methodology, and to close shellfish harvest areas when virulent V. parahaemolyticus strains are detected. FDA is assisting states in implementing the control plan. V. parahaemolyticus is a marine bacterium, not related to pollution, which caused four separate outbreaks of shellfish-related illness in the U.S. in 1997-1998. Prior to the summer of 1997, V. parahaemolyticus cases transmitted by shellfish occurred only sporadically. The V. parahaemolyticus control plan will be voted on for permanent adoption into the Nation Shellfish Sanitation Program (NSSP) at the 2001 ISSC annual meeting. The NSSP, a federal-state cooperative program, was established in 1925 as a national program to address the safety of molluscan shellfish. Under this program, state regulatory agencies are responsible for classifying waters as suitable or unsuitable for the growing and harvesting of shellfish that may be consumed raw. The states are also responsible for monitoring shellfish growing areas, and inspecting processors of shellfish for sanitation and safe handling practices. In 1982, the ISSC was established to provide a forum for state regulatory officials to establish uniform national guidelines for assuring the safety of molluscan shellfish.

Six jurisdictions began testing FDA's newly developed Voluntary National Retail Program Standards in FY 99. Richard Barnes, director of Federal-State Relations in FDA's Office of Regulatory Affairs, explained that the standards serve as a guide to regulatory retail food program managers in the design and management of a retail food program and provide a means of recognition for those programs that meet these standards.

The standards were developed with input from the retail foods regulatory community, industry and consumers. These standards reinforce sanitation, operational and environmental prerequisite programs; provide direction and focus to regulatory agencies and industry on the causes and contributing factors that lead to foodborne illness; and improve and build upon existing mechanisms and programs.

The six jurisdictions will be conducting self-assessments on their ability to meet the standards. The nine standards are: 1) regulatory foundation; 2) trained regulatory staff; 3) inspection program based on HACCP principles; 4) uniform inspection program; 5) foodborne illness response; 6) compliance and enforcement; 7) industry recognition; 8) program resources; and 9) program assessment.

The results of the tests will be discussed at the Conference for Food Protection's meeting in the year 2000.

Digital cameras and laptop computers are now tools of the trade for FDA staff conducting inspections and assessments on farms, processing plants and at the retail level.

Marion Allen, FSI inspections coordinator, explained that the digital cameras allow inspectors to document where problems may exist on a farm, or in the infrastructure of a plant, or with the labeling of a product. "The pictures taken by a digital camera can be downloaded directly into the lap-top computer and become a permanent part of the record. This provides FDA with a better record to support regulatory action," she said.

Access to laptop computers provides inspectors with resources such as the Code of Federal Regulations and the Food, Drug and Cosmetic Act, references they need on a daily basis.

Although scientists have yet to discover which came first—the chicken or the egg—they have recently discovered that harmful bacteria can enter an egg through transovarian contamination before it is laid.

This discovery is a starting point in understanding how to reduce foodborne illness caused by Salmonella Enteritidis (SE) in eggs. It is estimated that 310,000 SE infections occurred in 1997. While more recent statistics from the Foodborne Diseases Active Surveillance Network (FoodNet) indicate a 44 percent decrease in the number of illnesses caused by SE from 1996 to 1998, the remaining public health burden requires additional action.

How FDA is proceeding in this matter illustrates what is meant by the term "science-based food safety system."

In FY 99, FDA issued a proposed regulation that would require safe handling statements on labels of shell eggs that have not been treated, such as with heat, to destroy Salmonella microorganisms. The agency also proposed to require that, when held by retail establishments, shell eggs be stored and displayed under refrigeration at a temperature 45 degrees F or less. FDA took those actions based on the number of outbreaks of foodborne illnesses and deaths caused by SE that are associated with the consumption of shell eggs that have not been treated to destroy this pathogen.

To come to this proposed regulatory decision, however, required looking at the scientific evidence. This evidence included a risk assessment on SE completed by the U.S. Department of Agriculture in 1998, in conjunction with FDA and CDC. Richard Whiting, Ph.D., senior scientist on the FSI staff, explained that the purpose of risk assessment is to identify steps in the processing and handling of eggs from farm to consumer that increase the risk of illness from this pathogen and to identify and evaluate potential risk reduction strategies. The SE risk assessment estimated that of the 47 billion shell eggs consumed annually as shell eggs, 2.3 million are SE-positive, exposing a large number of people to the risk of illness. The risk assessment also determined an 8 percent reduction in illnesses would occur when all eggs are maintained at an air temperature of 45 degrees F throughout shell egg processing and distribution system. Whiting said the risk assessment also concluded that to achieve a 25 percent reduction in human illnesses a broadly-based policy may be more effective than a policy directed solely at one area of the egg production-to-consumption chain. Consumer behavior research regarding the consumption of raw eggs also guided policy makers in developing the proposed safe handling labeling for shell egg packages. (See Education, for more information on FDA's FY 99 activities to educate consumers and the food service industry on safe handling and preparation of eggs.)

"The issuance of the proposed regulations is not the end of the story," according to Lou Carson, deputy director of FSI. "It is a step in the process of assuring consumers a safer egg supply." A following step was the announcement in August by the President's Council on Food Safety—Strategic Planning Task Force—that an action plan on egg safety would be developed. Carson, who coordinated development of the egg safety action plan, said the plan examines the occurrence of SE in shell eggs and egg products using a farm-to-table approach, and steps which can be taken to reduce SE, including increased use of effective quality assurance programs at the producer level or on the farm. The Egg Safety Action Plan set goals of a 50 percent reduction in egg-associated SE illnesses by 2005, leading to the eventual elimination of SE in eggs as an important source of human illness by 2010 through science-based and coordinated regulation, inspection, enforcement, research, and education programs. The action plan also identifies new and existing technologies to control and prevent the presence of pathogens, particularly SE, and steps to enhance their use in the egg industry.

A public meeting was held Aug. 26 to obtain input on the plan's objectives and action items.

The egg safety plan was completed in December 1999 and announced by President Clinton in a weekly radio address.

At the port of Baltimore, in Maryland, huge cranes stand ready to unload cargo ships laden with food from around the world for American consumers. Spices from India, fish from Japan, baked goods from Europe—all destined for U.S. grocery stores or restaurants.

Spices from around the world await FDA approval before being released for further processing into jars and cans for grocery store shelves.

All imported products are required to meet the same food safety standards as domestic goods. Imported foods must be pure, wholesome, safe to eat, and produced under sanitary conditions. All products must contain informative and truthful labeling in English. The Food, Drug and Cosmetic Act, Section 801, directs FDA to refuse admission of any article that appears to be in violation of the Act.

To ensure that FDA is notified of all regulated products imported into the U.S., the importer, or his or her representative, must file an entry notice and an entry bond with the U.S. Customs Service pending a decision regarding admissibility of the product. FDA inspection and enforcement procedures for imports rely on coordination with Customs Service. For more information on coordination with the Customs Service, see page 24.

Dean Cook is an import investigator in FDA's Baltimore District office. He is one of 130 import investigators nationwide. Cook says he sees his job as the first line of defense in keeping unsafe imported products from American consumers.

As Cook describes it, import investigations is a two-step process with an immediate timeframe. Products cannot sit on the docks or in warehouses waiting for FDA to act. "The first step in an import investigation is the analysis of computerized data provided by OASIS (Operational and Administrative System for Import Support). The second step is product sampling," he said.

Each morning and then throughout the day, Investigator Cook and his colleagues Matthew Henciak and Nora Skerry review the OASIS database. This is how the Customs Service notifies FDA of an entry. Based on a review of documents provided by the importer, product description, and a review of various databases, FDA makes a decision as to the product's admissibility. If FDA does not wish to examine the entry, the product is allowed to proceed into U.S. commerce. Cook says that it is important to determine if a product is on the Imports Alert listing. There are approximately 700 import alerts at any given time, which indicate products, firms, or countries that have exhibited past violations. A product that arrives in the United States that is on this list is detained without physical examination until private lab testing is performed. "The importer will have to prove the product is safe before it will be allowed into commerce," said Cook.

Nora Skerry, an FDA import investigator, reviews the OASIS database to determine if an imported product is admissible for entry into the United States.

"If we decide to examine an entry, an import investigator will collect a sample from the shipment for laboratory evaluation. When we sample we look at products that may pose the highest health risk, those that contain harmful bacteria or acidified and low acid foods that may have been underprocessed. The samples are then sent to a laboratory for evaluation. During that time, the product must remain intact until the lab results are known. If the analysis indicates the product is in compliance, the shipment will be released into commerce. If there is a violation, the product will be refused admission," he said.

If there is a violation, the product will be detained. The importer of record then has the right to provide oral or written testimony to the FDA regarding the admissibility of the product or the manner in which the product may be brought into compliance. The product could ultimately be released if brought into compliance. If the product is not brought into compliance, it may be re-exported or destroyed under U.S. Customs supervision.

With four times the number of imported products entering the U.S. as in 1994, FDA has to be sure its import resources are targeted well.

In March 1999, FDA initiated a 1,000 sample survey focused on high volume imported fresh produce: loose-leaf lettuce, cantaloupe, celery, strawberries, scallions/green onions, parsley, cilantro and broccoli. In ranking commodities selected for the produce survey, five risk factors were used: epidemiological outbreak data; structural characteristics; growing conditions; processing; and consumption.

These commodities were analyzed for Salmonella, Shigella, E. coli O157:H7, Aerobic Plate Count, and coliforms. Produce imported from Mexico, Canada, Costa Rica, Guatemala, The Netherlands, Honduras, Israel, Belgium, Chile, Italy, Nicaragua, Trinidad and Tobago, France, Korea, Columbia, Peru and the Dominican Republic was sampled.

Original plans called for 125 samples of each of the eight products. The quota of loose-leaf lettuce was completed by August 1999 and sampling of those products was discontinued. Because most broccoli is cooked prior to consumption, sampling of broccoli was discontinued after 36 negative samples. Collection of the remaining products was continuing into 2000.

Upon completion of the survey in early 2000, results of the entire survey will be released.

While most imported foods are safe, and most importers comply with U.S. food safety requirements, a few importers try to sidestep U.S laws to bring unsafe or contaminated food into the country. In December 1999, FDA and the U.S. Customs Service announced six steps that will be taken to better assure the safety of imported foods:

• Prevent distribution of imported unsafe food by means such as requiring food to be held until reviewed by FDA.

• Destroy imported food that poses a serious health hazard.

• Prohibit the re-importation of food that has been previously refused admission and has not been brought into compliance with U.S. laws and regulations, and require the marking of shipping containers and/or papers of imported food that is refused admission for safety reasons.

• Set standards for private laboratories for the collection and analysis of imported food for the purpose of gaining entry into the U.S.

• Increase the amount of the bond posted for imported foods when necessary to deter premature and illegal entry into the U.S.

• Enhance enforcement against violations of U.S. laws related to the importation of foods, including through the imposition of civil monetary penalties.

FDA planned a series of public meetings in February 2000 to receive public input on these action items. Final implementation on all actions will not take place until the fall of 2000.

On May 14, the FDA/Association of American Feed Control Officials (AAFCO) Bovine Spongiform Encephalopathy (BSE) Feed Regulation Team was honored with Vice President Al Gore's Hammer Award. The Hammer Award honors Federal employees and their partners who have joined forces to streamline procedures, put consumers first, and help build a better and more costeffective government. The award citation reads "For making a significant contribution to reducing the possibility of bovine spongiform encephalopahty (BSE/Mad Cow Disease) becoming established and spread in the U.S." The BSE Feed Regulation Team used an innovative education-oriented partnership program to enforce an FDA regulation designed to control BSE.

The BSE regulation, now in effect for two years, restricts the use of mammalian protein in feeds for cattle and other ruminants. The regulation requires protein renderers, protein blenders, feed manufacturers and distributors to label feeds that contain prohibited material with the following warning statement: "Do not feed to cattle or other ruminants."

Gloria Dunnavan, director of FDA's Center for Veterinary Medicine, Division of Compliance, reports "the data shows that compliance rates for the first inspections of all but one industry segment equaled or exceeded 75 percent. Independent research has shown that major industry adjustments have been made to facilitate compliance with the regulations. FDA and state inspectors have conducted an unprecedented number of educationoriented inspections; a reinvented approach to doing inspections that has resulted in 70 percent savings in the cost of inspections."

"Thanks to the development of the BSE regulation, we can continue to say that there has not been a single case of BSE reported in the United States. Educational efforts with our regulatory partners will help assure that we can continue to make that claim," said Stephen F. Sundlof, D.V.M., Ph.D., director, Center for Veterinary Medicine.