Foods

1/ Includes Salaries & Expenses, Rent and PDUFA, where applicable.

2/ For FY 2001, the proposed Export Certification User Fee is included in the Foods Program. Should appropriate user fee legislation be enacted, the FY 2002 budget will reflect this user fee in the Export Certification line of the budget, not the Foods Program line.

EXPLANATION OF PROGRAM

The Foods Program has the primary responsibility for assuring that the US food supply is safe, sanitary, wholesome, and honestly labeled, and that cosmetic products are safe and properly labeled. Since foods are susceptible to a wide variety of potentially hazardous substances including microbial pathogens, chemical residues, natural toxins, and illegal food additives, the Foods Program has an enormous responsibility that has a direct impact on the health of individual consumers as well as the entire nation.

FDA ensures the quality and safety of foods while dealing with the increased responsibilities of additional statutory authorities and implementation of government reinvention initiatives to improve efficiency and effectiveness. The variety and complexity of the food supply has grown dramatically while new and more complex safety issues, such as emerging microbial pathogens, natural toxins, and technological innovations in production and processing, have developed. This program plays a major role in keeping the United States food supply among the safest in the world.

FY 2001 BUDGET REQUEST

ASSURING SAFETY/STRENGTHENING SCIENCE INITIATIVES

PREMARKET INITIATIVES + $1.2 MILLION, 5 FTE

Bringing Products of New Technology to Market + $1.2 million, 5 FTE

FDA will focus on two critical program areas - biotechnology and dietary supplements. Improved scientific knowledge in these areas will lead to safer products by helping the Agency better understand the complexities of the products it is regulating.

• Analyze risks associated with emerging technologies, specifically biotech foods. This information allows FDA to make well-informed regulatory decisions.
• Develop sound scientific data and expertise to support standards and guidance in evaluating the safety of dietary supplements. Use analytical techniques and sampling methodologies for ingredients, contaminants, pre-clinical testing, and models for assessing human risk.

Provide consumers quicker access to new food ingredients and dietary supplements, while assuring their safety and effectiveness. ³ (Foods Strategic Goal # 1)

Respond to 90 percent of notifications for dietary supplements containing "new ingredients" within 75 days. (Foods Performance Goal # 3)

POSTMARKET INITIATIVES + $9.2 MILLION, 17 FTE

Adverse Event Reporting System (AERS) + $2.5 million, 2 FTE

Dietary supplements are not subject to a premarket safety review or approval by FDA. Post-market surveillance activities, including monitoring of adverse events associated with marketed products, are critical for FDA to monitor the safety of these products. There are an increasing number of adverse event reports involving drug interactions in individuals using dietary supplements. To counter this trend, FDA will:

³ We have attempted to align the budget request and performance plan goals. All italicized items represent performance goals in the Agency's performance plan, with the specific reference following. More information on these goals and past performance can be found in the performance plan.

• Enhance the AERS for dietary supplements and develop a system component to collect data on drug-dietary supplement interactions to provide a faster, more efficient way to evaluate adverse event reports, thus shortening the time needed for any responsible actions, potentially saving lives and improving public safety.

Reduce the health risks associated with food and cosmetic products by preventing human exposure to hazards, monitoring product quality and correcting problems that are identified. (Foods Strategic Goal # 2)

Inspectional Activities + $1.7 million, 15 FTE

Complementary to inspectional coverage under the Food Safety Initiative, FDA is requesting additional resources to improve the monitoring of dietary supplements, pesticides, and chemical contaminants. FDA will:

• Expand dietary supplement compliance inspections and sample analyses to better protect consumers.
• Expand monitoring for pesticides and environmental contaminants in foods, including a focus on imports, to meet the requirements of the Food Quality Protection Act (FQPA).

Continue to expand monitoring for pesticides and environmental contaminants in foods through the collection and analysis of a targeted cohort of 11,000 samples. (Foods Performance Goal # 16)

• Revise and expand the FDA Total Diet Program to obtain data on levels of pesticides, industrial chemicals, toxic elements, and vitamins and minerals in foods that is more representative of today's consumer eating habits. This will enable FDA to estimate the risks of pesticides and chemical contaminants, and the level of food nutrients in the American diet.
• Replace outdated field laboratory equipment to improve the accuracy and timeliness of food product analyses to determine compliance with safety requirements.
• Expand the ability of Federal, State and local partnerships to improve food safety by expanding the ability of FDA's partners to share data through the field data systems.
• Establish Quality Management System procedures as a normal part of all field food program activities to increase consistency and quality of field activities nationwide. This is an internal quality system based on ISO 9000 internationally accepted quality standard. It involves a quality information base for system-wide evaluation and assessment. This Quality Management System integrates all field work products and processes: investigative, scientific and enforcement. This unified management system will improve dissemination of scientific and management policy and preserve institutional knowledge.

College Park Relocation + $5.0 million

In 2001, the Center for Food Safety and Applied Nutrition (CFSAN) will be moving to a newly constructed facility in College Park, Maryland. Funds are needed to pay for one-time costs associated with equipping and occupying this facility. The FY 2001 funding will support: telecommunications equipment and necessary network connections; and files consolidation and moving costs.

USER FEES

Proposed New User Fees + $13.7 million, 78 FTE

PREMARKET

Direct Food Additive Petition User Fees + $8.4 million, 55 FTE

Industry support is evident for additive user fees for food additive petitions. The food industry has indicated that their objective is to have a food additive approval process that can regularly deliver high quality and timely scientific reviews and decisions on food additive petitions so that food safety is protected and innovation in food technology is not deterred by the regulatory process.

FDA is proposing fees to supplement rather than replace funding from general revenues for review of direct food additive petitions. Additional resources would enable the Agency to take a number of steps to improve its review of products. This would include enhanced training to support the scientific expertise of reviewers that need to keep pace with increasingly complex products, and prefiling consultations with petitioners.

Complete first action on 50 percent of food and color additive petitions within 360 days of receipt. (Foods Performance Goal # 1)

POSTMARKET

Food Export Certificate User Fees + $5.3 million, 23 FTE

Food exporters are required to comply with an increasing number of European Union (EU) requirements for certificates attesting to the safety of animal-derived foods. Such certificates attest to product compliance with EU directives and standards, not FDA regulations. In order to provide such certificates to US food exporters, the Agency may need to conduct more frequent inspections or analyze products for the presence of substances that may not be considered significant public health risks in the US. FDA must recoup the costs incurred as a result of such inspections or laboratory analyses, and administrative costs associated with issuance of export certificates. Authority currently exists for such a recoupment for Human Drugs, etc. This would merely extend the same authority to the Foods program. A legislative proposal is being forwarded by the Administration.

FDA expects to issue approximately 30,000 export certificates per year at a cost of $175 per export certificate under this provision. This would yield $5.25 million per year in revenue.

Proposed Transfer of User Fees

POSTMARKET

Seafood Inspection Transfer + $12.7 million, 139 FTE

The Seafood Inspection Program under the National Marine Fisheries Service (NMFS)/National Oceanic Atmospheric Administration (NOAA)/US Department of Commerce (USDC) provides voluntary inspections and certification services for fish and fishery products on a fee-for-service basis under the authority of the Agricultural Marketing Act of 1946, and also addresses issues of wholesomeness, economic integrity and quality.

The budget proposes: 1) a transfer of this program from the Commerce Department to the Department of Health and Human Services, under the purview of the Food and Drug Administration, through appropriations language; and 2) the transmittal of legislation to make this program into a Performance Based Organization, still under the auspices of FDA, but to run more like a business. The transfer and subsequent conversion to a PBO will remove unnecessary bureaucratic constraints and allow the program to respond more promptly to the needs of its customers; thereby, actively pursuing the goals of the Agricultural Marketing Act for the benefit of industry and consumers.

SPECIAL PROGRAM INITIATIVES

Food Safety Initiative + $21.6 million and 122 FTE

FY 2001 will mark the fourth year of a highly successful multi-agency initiative to control and reduce foodborne pathogens in the American food supply. The benefits of this investment are evidenced by the fact that the time it takes to respond to numerous outbreaks have been shortened, resulting in fewer potential deaths and illnesses to American consumers.

In FY 2001, FDA will further strengthen and enhance Federal, State and local food safety systems through the use of uniform minimum standards and practices for inspections and consistent enforcement. In collaboration with its sister agencies, the FDA will conduct the following activities to improve inspectional coverage and related research efforts.

Inspections + $17.0 million, 116 FTE

• Expand domestic inspections to ensure annual inspections of all high-risk food establishments and enhance laboratory capabilities for the analytical support associated with this level of inspectional activity. Examples of high risk establishments include: processors of infant formula; establishments that process ready to eat foods, or produce heat and serve products; establishments that process seafood products, all low- acid canned food processing plants, and processors of juice.

Increase the percentage of high-risk domestic food establishments inspected once every year to 100 percent. (Foods Performance Goal # 10)

• Implement State audit programs to ensure consistent application of regulations, e.g., Seafood HACCP.
• Expand the application of HACCP systems with the implementation of the HACCP for fruit and vegetable juices.

Develop the HACCP final rule for fruit and vegetable juices. (Foods Performance Goal # 22)

Research and Risk Assessment + $4.6 million, 6 FTE

• Develop a Risk Strategic Plan to expand the understanding of science-based inspection programs, risk assessment models, data and assessments and to provide information and predict the risk associated with specific pathogens.
• Develop consistent nationwide standards for on-farm preventive controls for egg producers and food handling practices at retail.
• Develop and evaluate on-farm intervention strategies and/or technologies to improve testing methodologies for Salmonella Enteriditis (SE) on the farm and in eggs, and to understand the ecology and epidemiology of SE in the hen and farm environment.

Countering Bioterrorism + $1.2 million and 3 FTE

FDA will conduct the following activities as part of an overall strategy to safeguard the food supply from potentially harmful and lethal biological agents.

• Conduct research to develop rapid methods of detection of biological agents, such as anthrax, that could be used by terrorists. Techniques will be developed to confirm the results of less specific detection methods. These detection methods will provide necessary surveillance tools needed for monitoring programs.
• Work with other governmental agencies (domestic and international) and private sector organizations to develop cooperative programs to exchange information regarding surveillance activities and develop improved crisis management procedures for bioterrorism incidents.
• Participate in the planning and coordination of public health responses to bioterrorist attacks.
• Prepare field staff to safely seize, remove, and dispose of contaminated products by developing procedures and providing appropriate facilities and equipment.
• Develop inspection methods and procedures to assure the safety of regulated products at manufacturing sites and other establishments.

JUSTIFICATION OF BASE

FDA's Foods program will continue to ensure the safety of foods and cosmetics through its activities of premarket review and postmarket surveillance and the National Food Safety Initiative. The Agency develops standards and/or regulations, conducts related research to provide the necessary scientific basis for its regulatory decisions, monitors the marketplace, inspects, works extensively with all stakeholders, uses market research to develop effective strategies, tracks and analyzes adverse event reports, and participates in international standard-setting activities. FDA's Foods program will continue to carry out activities in the following areas:

• Premarket Review of food ingredients, using chemical, toxicological, and environmental analysis. Ingredients that relate to significant reductions in microbial pathogens in foods will receive an expedited review process.
• Health and safety labeling issues ranging from health or nutrient content claims to warnings for special populations, including infant formula and medical food product labeling.
• Dietary supplements, including effective regulation under the Dietary Supplement Health and Education Act (DSHEA).
• Pesticide and industrial chemical contamination, including developing procedures for the safe and sanitary processing of foods, such as the HACCP preventative control system model used for processing seafood and juice.
• Cosmetics, including the Voluntary Cosmetic Registration Program (VCRP), a program designed to collect ingredient and manufacturing data from manufacturers and provide feedback to all stakeholders (industry, consumers, etc.).

The President's Food Safety Initiative has successfully put into place a strong foundation for a science-based, integrated food safety system that has resulted in reductions in the incidence of death and illness attributable to foodborne pathogens. Some of the key activities include:

• Surveillance, to identify, contain, and respond to foodborne outbreaks, as well as assess antimicrobial resistance. Three systems are now in place and nearing full operation. FoodNet is a foodborne disease tracking system that provides information to estimate the frequency and demographic distribution of foodborne illnesses in the United States. PulseNet is a computerized database of bacterial DNA subtypes that can be used to quickly determine whether illness occurring in different geographic locations during the same time frame are linked to a common food source. The National Antimicrobial Resistance Monitoring System (NARMS) allows for identification of disease trends, such as antibiotic resistance among foodborne pathogens, in human and animal medicine, and monitors the transfer of antibiotic resistant bacteria to humans.
•  Inspections in the industry promote and verify the use of techniques that prevent microbiological contamination of both domestic and imported foods. FDA is pursuing similar strategies for domestic and imported foods by using existing expertise and information generated from surveillance, research, and risk assessments to target inspections and preventive measures toward the greatest risk, and to ensure that good manufacturing practices are followed. FDA is developing science-based solutions to the Nation's food safety problems. The Hazard Analysis and Critical Control Point (HACCP) concept, which is currently implemented by the seafood industry, is a scientific program where manufacturers and food preparers identify points in a process where safety problems can occur and establish measures to effectively prevent the problems.
• Educational messages targeted along the farm-to-table continuum, particularly to those in the most vulnerable groups have been very successful. These messages provide information to improve awareness and knowledge of safe food practices. Survey results show increased incidence of safer food handling practices by consumers since the campaign began.
• Microbiological research and the development of risk assessment techniques provide the scientific basis for the integrated food safety system. Inspection and surveillance activities in particular require the development of science-based tools through research. Most contamination is no longer detectable by simple visual review, but rather is microbial in nature and requires sophisticated, state-of-the-art technologies to detect and control. These activities are critical in providing information about pathogens, how they enter and interact with the human body, and the best methods for attacking them.

Foods

Selected FY 1999 Accomplishments

Food Safety Initiative

• Increased surveillance of imported food overseas and at the border. Also, enhanced follow-up and containment of foodborne disease outbreaks associated with imported food.
• Developed a farm investigation questionnaire for use on farms implicated in produce tracebacks has also been developed to provide standardized detailed information.
• Conducted 19 traceback investigations involving FDA regulated products, and visited 10 farms as the result of outbreak tracebacks or positive samples in the Imported Produce Sampling Program.
• Disseminated and promoted the use of the Good Agricultural Practices/Good Manufacturing Practices guidance document to both domestic and foreign agriculture communities, in conjunction with USDA.
• Initiated education/outreach and technical assistance to foreign countries on the use of Good Agricultural Practices (GAP)/Good Manufacturing Practices (GMP) guidance for produce. A six-minute video, "Assuring Safer Produce: A Global Issue," was completed. This new tool provides an overview of the good agricultural and good manufacturing practices, helps explain the Produce Safety Initiative, and is available in four languages. This will improve the safety of foods imported into this country.
• Assessed the food safety systems in Nicaragua, Costa Rica, El Salvador, Guatemala and Honduras, which export a significant amount of food to this country.
• Developed a specialized egg safety campaign to reduce the incidence of foodborne illnesses caused by Salmonella Enteritidis. Two fact sheets were developed: "Playing it Safe with Eggs" for consumers and "Assuring the Safety of Eggs" for food service personnel.
• Proclaimed September 1999, as National Food Safety Education Month. This was an opportunity to promote food safety to consumers and the food industry. This year's theme was "Cook It Safely". FDA, in conjunction with USDA, developed and mailed consumer education guides to public health departments, FDA public affairs specialists and USDA extension agents throughout the country. The guide contained activities and publicity ideas for food safety education during September.

Food Safety: Premarket Review of Food Ingredients

• Implemented new procedures to expedite the review of food additives to decrease the incidence of foodborne illness through its antimicrobial action against human pathogens that might be present in food. The first petitions to meet the criteria for expedited review included antimicrobial agents in the processing of poultry, seafood, fruits, and vegetables, and irradiation of fresh shell eggs.
• Published "Antimicrobial Food Additives - Guidance," designed to clarify FDA's jurisdiction over antimicrobials that are used in food or that may become a component of food. This document provides guidance that is important in delineating the jurisdiction of FDA and EPA over antimicrobial substances, and the regulatory authority over inert ingredients of certain pesticide formulations.
• Completed "first action", defined as a review of all parts of a petition, followed by issuance of a "not approvable" letter, or publication of a response in the Federal Register, on 54 percent of food and color additive petitions within 360 days of receipt, a 12 percent improvement over the FY 1999 goal.
• Reduced the percentage of overdue food and color additive petitions to 30 percent from 38 percent of petitions in process for more than 360 days.
• Developed a new notification program for Generally Recognized as Safe (GRAS) food additive petitions to replace the current lengthy rule-making process. Manufacturers will simply notify FDA of their GRAS determination and provide evidence that supports their decision. After which FDA has 90 days to respond.
• Published a final rule for dietary supplement labeling. Consumers will now see more complete information on dietary supplement products, including an information panel titled "Supplement Facts", a clear identity statement and a complete list of ingredients.
• Published the proposed rule for requiring the amount of trans fatty acids in a food to be included on the Nutrition Facts label. Included in this proposal is a new nutrient claim defining "trans fat free". Consumption of trans fatty acids has been shown to increase blood LDL-cholesterol ("bad" cholesterol) levels and increase the risk of coronary heart disease. Prepared and distributed outreach materials to prepare industry, consumers, and health professionals for the proposed trans fatty acids labeling requirement.
• Published the proposed rule and prepared the final rule allowing the Health Claim for soy proteins reducing the risk of coronary heart disease, and for whole grain foods reducing the risk of coronary heart disease and certain cancers. Received and responded to both nutrient content claims/health claim petitions within 100 days with a decision to the petitioner.
• Published a final rule to amend the ingredient labeling regulation for surimi and surimi-containing foods in response to a petition submitted by the National Fisheries Institute (NFI) requesting more flexible ingredient labeling.

Food Safety: Postmarket Surveillance

• Advanced the Hazard Analysis and Critical Control Point (HACCP) Programs designed to prevent potential hazards. Kept the Seafood HACCP Program on track with the full expectation that 50 percent of the domestic seafood industry will be using preventative controls for safety as evidenced by operating HACCP systems. Programs to educate seafood processors in the design and operation of HACCP systems have been on-going and we have updated and upgraded our guidance materials.
• Targeted foreign inspections toward developing countries with large volumes of seafood exports to the United States, to ensure international compliance with HACCP. We are also pursuing equivalence agreements with our more advanced seafood training partners. We have upgraded the education provided to our own inspectors, offering certification programs and the same training offered to the industry.
• Published the proposed rule for Juice HACCP to require processors of packaged fruit and vegetable juices to implement HACCP to prevent contamination of their products.
• Sponsored a voluntary HACCP Pilot Program for Grade 'A' dairy products in partnership with the National Conference on Interstate Milk Shipments, designed to determine if HACCP can be accepted as an alternative to the traditional inspection system in the Pasteurized Milk Ordinance.
• Emergency Operations: Responded to possible public health emergencies resulting from natural disasters, such as the floods in the Southeast caused by hurricane Floyd, and reports of illnesses or injury that are associated with a regulated product and must be investigated. Below are examples of emergencies that required extensive investigation and follow-up:

• Implemented a plan with the US Customs Service to prevent unsafe imported food from crossing our borders which:
  • requires shipments of unsafe food to be held in a secure storage facility at the importer's expense until released by FDA and Customs;
  • permits the destruction of foods that are refused entry due to a serious public health and/or safety violation;
  • requires refused food shipments not meeting US Standard to be marked "Refused" to indicate that the product was denied entry into the US;
  • establishes standards for importer, contractors, and private laboratories that collect and analyze samples of import food for the purpose of gaining entry into the US;
  • increases the amount of bond posted for imported foods to the full market value of the product to deter illegal entry into the US; and uses civil money penalties against importers who attempt to enter food into the US by means of false statement, act, or admission.
• USDA FSIS/FDA Memorandum of Understanding (MOU): FDA and the USDA Food Safety and Inspection Service (FSIS) signed a MOU to share information and cooperate in the regulation of dual jurisdiction establishments that produce products regulated by both agencies, making joint inspections and joint enforcement actions possible.
• Import Produce Analyzed for Pathogens: Analyzed over 550 samples of fresh imported produce for microbiological pathogens. This first systematic look at this dietary significant group of foods for pathogens found approximately 5 percent of the samples contained pathogens. Pathogens detected were Shigella and Salmonella spp. Commodities found positive included: cantaloupe, celery, cilantro, green onions, lettuce, and parsley.

Cosmetics

With the $2.5 million provided by Congress for the Cosmetics program, FDA:

• Reinstated the Cosmetic Voluntary Reporting Program, to provide quantitative and descriptive data which protects consumers against potentially hazardous cosmetic ingredients and products.
• Completed a clinical study on the effects of Alpha Hydroxy Acids (AHAs), used in some skin preparations, on human skin that will help to support Agency decisions concerning possible public health risks.
• Worked collaboratively with the National Toxicological Program (NTP) in the development of a state-of-the-art phototoxicity testing facility and photocarcinogenicity testing protocol for studying the long-term effects of AHAs on the adverse effects of sunlight.

Foods
Program Activity Data

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1/ The percentage of Food and Color Additive Petitions Completed is based upon 360 days. The goals for first action for petitions (FYs 2000 and 2001) are lower than those achieved in FY 1999 due to the conversion of petitions to notifications in FY 2000. FDA expects there will be a dramatic change in both the number of petitions under review and those overdue. FDA will establish new baseline numbers for these goals at the end of FY 2000.

²An inspection is any visit to an establishment during which all or part of one or more phases of that establishment's operation is evaluated against appropriate FDA requirements.

³Field Exams are the on-site examination of a product that is sufficient in itself to determine that the product is in compliance with FDA requirements.

⁴Laboratory Samples Analyzed are product samples physically analyzed by the laboratory to determine whether or not the product is in compliance with FDA requirements.

Edited 3/1/2000