FDA's field workforce, comprises about 32 percent of FDA's total staffing and performs inspections, sample collections and analyses of both domestic and imported products, and initiates enforcement actions. In addition to conducting regular surveillance over regulated products, this workforce also serves a critical response function when the Agency must respond to emergencies by immediately mobilizing to investigate reports of product problems including tampering incidents and those due to natural disasters such as hurricanes, floods and earthquakes. The field workforce is also involved in informing businesses and consumers about FDA-related topics, and in working with state and local agencies to develop programs that make the best use of Federal, state, and local resources in protecting the public health.

FDA's field force conducts investigational and laboratory functions for all of FDA's major product areas -- Foods, Human Drugs, Biologics, Animal Drugs and Feeds, and Medical Devices and Radiological Products. With a highly-trained staff versed in all of FDA's product responsibilities, the Agency can respond rapidly to various types of emergencies, and can also redirect field efforts from time to time during the year among FDA's different programs as inspection and product testing needs change.

To complement the regular field force, the Office of Criminal Investigations (OCI) was established during FY 1992 as part of FDAs efforts to more effectively investigate instances of criminal activity in the regulated industries. Agents are given intensive training at the Federal Law Enforcement Training Center in Glenco, Georgia and are assigned to offices throughout the country.

Field facilities include Regional Offices, District Offices, laboratories, OCI field offices, and resident posts. The five Regional Offices are staff offices which coordinate FDA activities and also coordinate with state authorities. The 21 District Offices serve as offices for investigators and compliance action staff, and are the main control point for day-to-day operations in their assigned areas. The 16 laboratories provide FDA's basic field product testing capability. A number of these laboratories serve as specialized facilities for certain types of testing and new regulatory methods development.

In addition to these facilities, FDA maintains over 120 resident posts distributed widely across the country. These are smaller offices which serve primarily as a base for investigators so that FDA can have investigative staff widely dispersed to respond to emergencies whenever they occur, as quickly as possible to minimize any potential harm.

With all of these Field facilities combined, FDA maintains offices and staff in 49 of the States, and in the District of Columbia and Puerto Rico. (A list of FDA facilities follows.)

Field Operations Facilities:

Other Specialized Facilities

The Food and Drug Administration (FDA) is the principal consumer protection agency of the Federal Government. In 1997, for the first time in history, Congress codified FDA's mission statement into the Food and Drug Administration Modernization Act of 1997 (FDAMA), Public Law 105-115. FDAMA has presented FDA with an opportunity to bridge the gap between what FDA is required to do by statute and what it is able to accomplish with current resources. The FDA Plan for Statutory compliance outlines bold and innovative approaches to meet the increasingly complex public health challenges of the 21st century. The successful implementation of this Plan depends on the commitment of resources by both FDA and its stakeholders.

FDA must address several key challenges now and in the future for the Agency to successfully meet its statutory requirements and to fulfill its health promotion and protection mission. These include: research and development-fueled pressures on regulatory responsibilities; greater product complexity driven by breakthroughs in technology; growth in recognized adverse effects associated with product use; unpredictable new health and safety threats; awareness of citizen-stakeholders and their more targeted needs; emerging regulatory challenges in the international arena; and increased volume an diversity of imports. The ability to formulate successful solutions to these challenges depends on innovative approaches used by FDA, creative collaboration with stakeholders, prioritization of FDA activities, and am adequate investment of resources to implement these approaches.

To meet these challenges, FDA has set forth the following objectives:

• Establish risk-based priorities -- focus resources on those health and safety risks that most directly threaten the well-being of U.S. consumers.
• Strengthen the scientific and analytical basis for regulatory decisions -- a strong science base must underpin each of the Agency's regulatory decisions.
• Work more closely with external stakeholders -- collaboration with stakeholders will result in more effective solutions to public health problems.
• Continue to re-engineer FDA processes -- re-engineering will result in regulatory simplification and more cost-effective ways to run FDA's internal processes.
• Adopt a systems approach ro Agency regulation -- regulatory approaches in the future will look for total problem solutions rather than piecemeal review and enforcement decisions.
• Capitalize on information technology -- information technology will help to improve both internal efficiency and communication with stakeholders.

These six strategic directions will guide FDA's efforts to meet its objectives. Many factors over the next several years will have an impact on FDA's ability to meet these objectives including the outcome of a risk-based priority system the success of thirds parties in the regulatory process, improvements in technology and systems engineering, and the synergies created by greater collaboration with other federal agencies, as well as FDA's external stakeholders, new statutory mandates, and emerging public health responsibilities. Reinvention will enable FDA to make up some of the difference between current performance and objectives.

Foods

The Foods Program has the primary responsibility for assuring that the U.S. 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 direct implications for the health of individual consumers as well as the health and well-being of the entire nation.

Over the past several years, FDA has continued to ensure 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. During this period, 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. FDA believes this budget request will provide consumers with a high level of assurance regarding the safety of food products and is working diligently to continue that level of service to the American public. This program plays a major role in keeping the United States food supply among the safest in the world.

RATIONALE FOR BUDGET REQUEST

INCREASES:

PUBLIC HEALTH INFRASTRUCTURE -- + $ 13.9 MILLION, + 57 FTE

The FDA has conducted a comprehensive assessment to identify the gap between current performance and what would be required to meet statutory mandates and public expectations of effective product safety systems. Consistent with principles underlying the FDAMA, the Agency listened carefully to its stakeholders to determine priority needs and to develop collaborative, cost effective solutions to public health problems. Based on this assessment, the FDA has developed strategic initiatives to narrow the gap between stakeholder expectations and reality as follows.

Injury Reporting -- ($ 2.5 million, 6 FTE)

FDA's Foods Program has a critical need for the timely and complete reporting of adverse events associated with food and cosmetic products. To meet this need, the Agency must continue to develop and maintain a modern and responsive system to receive, store, analyze, and report on adverse events.

Recent experiences with serious adverse events -- including death associated with the use of dietary supplement products like ephedra, digitalis-contaminated plantain, and others -- underscores this need. Dietary supplements are not subject to a premarket safety review or approval by FDA. This means that post-market surveillance, including monitoring of adverse events associated with marketed products, is the cornerstone of FDA's ability to meet its public health responsibilities for the safety of these products.

When adverse event reports are received, the Agency must collect additional information on the products being used (e.g., ingredients, claims, manufacturer name and address) in order to evaluate it since there is no publicly available listing or description of marketed dietary supplement products. Follow-up information from health professionals and the injured consumer also must be collected and integrated with the initial adverse event report to provide meaningful information. An enhanced system for monitoring and evaluating the adverse events associated with the use of dietary supplements would provide a faster, more efficient way to evaluate adverse reports, thus shortening the time needed for any responsive actions, potentially saving lives and improving public safety.

The $ 2.5 million requested will provide this enhanced system through:

• implementation of an integrated adverse event reporting system, compliant with Agency standards and designed as a potential module of a larger FDA system;
• improved records management procedures to meet the increasing volume of electronic and other Freedom of Information (FOI) requests for adverse events reported for dietary supplements; and
• increased emphasis on the activities that provide information essential to the evaluation and proper interpretation of adverse events, such as follow-up, coding, and classifying adverse events.

Goal: Establish an integrated adverse event reporting system for food and cosmetics products with emphasis on increasing efforts to design and implement modules needed to record dietary supplement adverse event information.

Premarket Application Review ($ 11.4 million, 51FTE)

Premarket review of food and color additive petitions is one particular area where FDA recognizes the need to improve performance. The FY 2000 budget proposes a two-pronged approach: 1) appropriated funding of $1.4 million and 7 FTE to increase assistance to potential petitioners during the petition development process and during the post-filing review process; and 2) proposed legislation of $10 million and 44 FTE for additive user fees paid by industry which would provide the Agency with the resources necessary to significantly improve our current level of performance.

Appropriated funding of $1.4 million will provide the following:

• Increase assistance to potential petitioners during the petition development process and during the post-filing review process improves the quality of submissions, and hence, the time needed for review.
• Develop and publish comprehensive guidelines for petition preparation.
• Design and develop an education program explaining the types of studies and safety data required to support petitions.
• Create multi-disciplinary teams to help rapidly resolve new and ongoing safety issues related to petition reviews.
• Enhance infrastructure and document workflow system. This coupled with the internal improvements already made in the premarket application review program, along with full funding of the request for the premarket notification program will allow a 10 percent increase in performance over the FY 1999 level.

Goal: Complete first action (i.e., review all parts of the petition and issue a "not approvable" letter, or publish a response in the Federal Register, if appropriate) on 40 percent of food and color additive petitions within 360 days of receipt.

In FY 2000, the Agency is also requesting authorization to collect additive user fees to provide a stable source of resources that will enhance the efficiency of the review processes for food additives. The proposed user fees would be divided into two categories: $ 4.0 million for direct food additive petitions and $6.0 million indirect food additive (food contact substances) notifications.

Direct petitions are the traditional submissions to the Agency. These range in terms of complexity, and hence, time needed to review. Petitions would be grouped into "Tiers" based on complexity. For example, a Tier I petition -- the least complicated -- could be a chemical used to change the color of sugar from its natural brown to white. A Tier III petition -- the most complicated -- would be something that raises questions requiring specialized scientific data because of its wide exposure into the food supply, such as aspertame or olestra. The $4.0 million in additive user fees assessed for the review of direct food additive petitions would allow the Agency to:

• substantially increase the speed of the review process;
• more consistently meet established timeframes for these reviews; and
• provide the type and level of assistance required to help petitioners significantly improve the quality of their submissions.

The FDAMA includes provisions which establish a new premarket notification program (PMN) for food contact substances (indirect petitions). This program requires the FDA to object to a notification within 120 days or the food contact substance may be legally marketed. However, this program has not been implemented because certain funding provisions also included in the FDAMA have not been met. Authorization of these user fees ($6.0 million) would enable the program to begin. The FDA estimates that many of the direct petitions currently in the inventory or expected to come in will be switched to the new, less burdensome PMN program. Congress provided $500,000 in FY 1999 to begin development of the system. The FDA will:

• purchase quality hardware, software, and services needed for development and implementation of a workflow-based tracking system;
• develop a capability for using predictive toxicology in prioritizing reviews;
• hire three FTE to provide scientific expertise and support which are required in advance of full implementation;
• provide education and seek the input from their stakeholders through workshops with industry.

Using the PDUFA as a model, user fee performance goals will be developed commensurate with the user fee collections authorized for a given fiscal year.

PRESIDENTIAL INITIATIVES

Food Safety Initiative -- ($25.9 million, 141 FTE)

With funding provided in FYs 1998 and 1999, a solid infrastructure is being developed to improve food safety and reduce the risk of foodborne illness, for both domestic and imported foods. The FDA must continue expansion of foodborne outbreak response and traceback activities, based on the anticipated increase in outbreaks reported by expanded surveillance with funding in FYs 1998 and 1999. Use of consistent, uniform food safety oversight practices across the country by federal and local officials will greatly expand food safety capability because efforts will be complementary rather than redundant. Thus, the next steps for continuing this improvement is responding quickly and effectively to identified outbreaks, and a vertically integrated system, particularly in inspections.

In FY 2000, to improve the food safety system, the FDA, along with its sister federal agencies, is embarking on an effort to strengthen and enhance federal, state and local food safety systems through the application of uniform minimum standards and practices for inspections and evaluations, consistent enforcement, active surveillance and outbreak response and resources to measure, test products for conformance or identify source of contamination. This effort recognizes the need to harmonize existing systems, fill gaps where they exist, add and share resources, develop capacity for timely coverage of industry and train, educate and inform food producers, handlers and consumers in proper food safety techniques.

Goal: Increase the frequency of high-risk domestic food establishment inspections to once every one to two years, and annually beginning in FY 2001.

Goal: Achieve adoption of the Food Code by at least 35 percent of the states.

Goal: Initiate HACCP in the juice industry.

Goal: Continue to develop and implement voluntary guidance and other efforts to improve the safety of fresh fruits and vegetables, and work with USDA to conduct a 1999-2001 National Agricultural Statistics Survey (NASS) of microbial contamination of fresh produce to collect the data required to evaluate program effectiveness.

Goal: Increase the number of inspections/evaluations of foreign food establishments from 100 to 250.

Surveillance -- ($5.0 million, 34 FTE). In FY 2000, the FDA will increase its outbreak response work, tracing back through the food distribution and production chain to find the source of contamination that caused an outbreak. These activities stop foodborne outbreaks earlier, prevent future outbreaks, and provide information for the establishment of preventive controls. To the improve the swiftness of outbreak response and traceback activities, planned FY 2000 activities will include:

• Expanding the PulseNet system to provide access by more district labs;
• Increasing the FDA and state outbreak response and associated traceback activities based on FoodNet data and other sources; and
• Enhancing the Agency electronic interface with the states to access domestic and import product information.

Food production preventive controls systems work will increase, including development of additional industry guidance and HACCP where appropriate.

Inspections/Evaluations and Compliance -- ($16.9 million, 90 FTE). This funding will support enhanced coverage of both domestic and imported foods. As a complement to the focus on imported foods in FY 1999, food safety resources in FY 2000 will build a more cohesive domestic food safety system, from the federal to the state and local levels. The FDA's strategy to ensuring safer domestic foods will be executed through a two-pronged approach.

Increase domestic coverage through inspections. Inspections are the primary mechanism for ensuring compliance with federal and state laws, regulations, and standards relating to the safe and sanitary processing, storage, transportation and sale of food. The FDA will:

• Increase inspections of high risk foods by the FDA.
• Increase laboratory analysis in support of increased inspections.
• To achieve uniformity in the approach to an integrated food safety system, the FDA will provide, through partnerships, training, tools, resources, and guidance for policy development, regulations or enforcement to the states.
• Begin an integrated national food safety network to achieve uniform and consistent food safety standards and applications of standards at the federal and state levels.
• The FDA and the USDA will work together to achieve adoption of the Food Code by an increased number of states and retail food service establishments.
• Work with states and industry to develop and implement food production preventive control systems, such as voluntary guidance, Hazard Analysis and Critical Control Points (HACCP) processes, or other food safety assurance systems. Preventive control systems permit food establishments to identify and properly control points in processes where hazards, such as sanitation or microbial contamination, may occur and represents a more proactive and efficient approach.
• Provide states with training, training funds, and equipment to aid the retail food service industry in implementing HACCP. The Agency's firsthand experience with the implementation of the seafood HACCP system began in December, 1997.
• Initiate HACCP regulations for the juice industry and other preventive control measures as research and risk assessment provide technology and interventions in FY 2000.

Expand coverage of imported food products. For imports, the FDA will:

• More than double the number of inspections of foreign food processors, and begin evaluations of foreign food processing systems. This includes the laboratory analyses necessary to support this increase.
• Focus on various preventive measures to ensure the safety of imported food products.
• Work with food safety officials abroad and provide technical assistance on Good Agricultural Practices and Good Manufacturing Practices for fruits and vegetables.
• Expand coverage of imports through additional Mutual Recognition Agreements (MRAs) and other types of equivalency agreements for international trade.

Education -- ($1.0 million, 6 FTE). Available data indicates that foods prepared by retail food service are the source of a large number of outbreaks. The Agency deems the education of retail food preparers in the appropriate food safety procedures to be of utmost importance in reducing foodborne illness. The FDA will:

• Work with other Federal agencies and the states to that ensure greater safety in retail food preparation practices using concepts set forth in the Food Code.
• Expand and support partnerships and alliances with other food safety organizations that allow the Agency to leverage resources while spreading food safety messages to a greater number of people.
• Educate industry on proper storage, handling, and transportation practices.
• Coordinate education activities with the USDA and the CDC, with many activities conducted under contracts and partnerships with states, industry, and others.
• Conduct market research to identify barriers for safe food preparation practices by the retail food service industry. This type of research activity produces a knowledge base for educators and helps guide the design of more effective training programs and materials.
• Focus will be on the message and the way it is delivered, such as through multi-lingual education programs for food service workers. Preliminary data indicates that these types of educational messages are having a positive effect on food-related behaviors.

Research and Risk Assessment -- ($3.0 million, 11 FTE). The FDA will continue implementation of the FSI and produce research plans focused on the development of methods to detect and identify pathogens more rapidly, and preventive interventions. The FDA will apply the tools developed in modeling, predictive microbiology, and dose-response research to target resources towards points of contamination. Work in FYs 1998 and 1999 centered around building the interagency forum known as the Risk Assessment Consortium. Through this group, the participating agencies have come to a common understanding of risk assessment and its scientific underpinnings, eliminated unnecessary duplication, and leveraged available resources. For FY 2000, the FDA will:

• Establish expedited review process for food additives which significantly decrease pathogens in foods.
• Transfer of new technologies to state public health and regulatory agencies and to industry for use in ensuring the safety of their products. This transfer will require equipment and training.
• In coordination with other Federal agencies, fund extramural contracts to further expand method development and prevention technology research.
• Improve its capability to estimate risks associated with foodborne contaminants, especially microbial pathogens, to allow faster and more accurate regulatory decisions.
• Conduct risk assessments on pathogens which pose a significant risk. Risk assessment and foodborne illness evaluation models are needed to characterize the nature and size of the risk to human health associated with microbial hazards in food.
• Upgrade scientific equipment.
• Expand data collection on contaminated foods associated with foodborne outbreaks and characteristics of people who did not become ill after exposure to the same foods.
• Applying models developed to better target sampling and testing of food products to where contamination is most likely to occur.
• Expand development of modeling techniques for assessing human exposure to a variety of foodborne contaminants especially emerging pathogens.
• Expand development of appropriate animal models for determining whether threshold or non-threshold models for infectivity are more appropriate for describing low dose infectivity rates for infectious and toxicoinfectious microorganisms.

OTHER -- + $ 4.6 MILLION

Relocation to College Park -- ($ 4.6 million). The FDA's Center for Food Safety and Applied Nutrition is scheduled to move to a new facility in FY 2001. The current GSA project schedule calls for dedication of the building in December 2000 and occupancy in early 2001. We have reviewed the anticipated costs associated with this move and are including items in the FY 2000 request that must be purchased. These are one-time costs of $4.64 million to cover a network and computer room, security, telephone service, some furniture, and equipment.

Physicians' Pay - - $ 0.065 million

The FY 2000 request includes a physician compensation growth guideline to limit the escalation of HHS physicians' payroll (base salaries and special pays). The Foods portion of this reduction is $0.065 million.

JUSTIFICATION OF BASE:

Within base resources, the Agency will continue efforts to ensure the overall safety of food and cosmetic products -- through both the President's Food Safety Initiative (FSI), and other food safety and cosmetics activities that do not fall under the FSI umbrella, but that are equally important.

Product Safety Assurance. Product safety assurance includes periodic inspections of domestic establishments, field examinations of imported products, collection and analyses of product samples, and field surveys to address specific safety/sanitation concerns. The FDA strives to ensure that inspections (excluding seafood HACCP inspections) of domestic food establishments, in conjunction with the timely correction of serious deficiencies identified in these inspections, result in at least an 90 percent rate of conformance with the FDA requirements.

Premarket Application Reviews. Efforts continue to improve the efficiency of the premarket review process for food and color additives. The process continues to be streamlined through more effective use of advanced computer and telecommunications technologies. Significant gains have been made recently, and the Agency is committed to continuing to improve its performance in this area as much as possible.

Nutrition Labeling. The Agency will continue research studies and analysis of scientific and epidemiological data, to better understand the relationships between diet and disease. The FDA expects the proportion of adults who report changing their decisions to buy or use food products because they read the food label to increase to at least 55 percent. The food label serves as a primary tool for producers to provide consumer information regarding that food's nutritive value and its ingredients as part of a healthy diet. The FDA's authority over the content of the food label extends to over 260,000 classes of food products with about 10,000 new products appearing on grocery shelves each year.

International Harmonization. The FDA will increase the safety of imported foods through full participation in international standard-setting organizations and will ensure that FDA's ability to protect the U.S. public health is upheld through participation in activities in implementing or negotiating binding trade agreements dealing with food safety. Mutual Recognition Agreements (MRA) is one type of trade agreement utilized by FDA.

Cosmetics. The FDA will ensure that cosmetics are safe and properly labeled. The Agency primary focus is to protect consumers against potentially hazardous cosmetic ingredients or products with prompt and effective action when necessary. Regulatory activity focuses on unsafe products that pose the greatest risk to consumers. The FDA's cosmetics program develops science-based product standards and guidance for industry and communicates these standards through various information technology means like the Internet.

Food Safety Initiative (FSI). Foodborne illness outbreaks continue to be a problem that affects the health of millions of Americans every year. Based on data from CDC, in 1997, this surveillance showed that 50 cases of these infections were diagnosed per 100,000 population, a rate that translates to 130,000 culture-confirmed cases in the entire U.S. population. Additional FoodNet surveys showed that these cases represent a fraction of the burden of foodborne illness. Based on these surveys, at least 60 more of these infections may have occurred for each one that was diagnosed, suggesting that there may have been about eight million cases of these bacterial infections in 1997 in the U.S.

The President's FSI report, issued in May 1997, laid out a multi-year plan of work for reducing the incidence of microbial foodborne illness in the U.S. The plan called for a multi-faceted approach that would establish the foundation of a national food safety system at the federal level, strengthening the foundation in the second year and expanding it to the state and local level. Funding provided in FYs 1998 and 1999 will allow The FDA to continue the highly coordinated interdepartmental efforts underway to reduce foodborne illness to the greatest extent possible.

Surveillance. The FDA must respond quickly and traceback through the food distribution chain to the source of the outbreak in order to initiate intervention measures and limit the extent of the outbreak. The FDA provides support to FoodNet, and works with CDC, other federal agencies, and states to develop comprehensive and accurate baseline surveillance data on foodborne illnesses to facilitate evaluation of the FSI's effectiveness, priorities, and appropriate outcomes.

The FDA will build on a number of significant accomplishments under surveillance including: adding a new site to the FoodNet foodborne illness surveillance system, thereby expanding the demographic diversity and size of the population represented and the capacity of the system to detect foodborne illness; and enhancing PulseNet -- an interagency DNA fingerprinting system to monitor the prevalence and diversity of such pathogens as E. coli O157:H7 and Salmonella typhimiurium DT104. PulseNet has already yielded benefits: in two instances, apparently independent outbreaks were linked to common sources of contamination by use of PulseNet data. Outbreaks associated with alfalfa sprouts in Michigan and Virginia were linked to a common source, and outbreaks in Connecticut and Illinois associated with mesclun lettuce mix.

Coordination. The FDA enhances the level of public health protection by continuing to respond to interstate outbreaks of foodborne illness and enhancing coordination of federal, state and local agencies responsible for responding to foodborne disease outbreaks. The FDA will continue to work with other agencies at all levels to develop more effective communication tools, such as standard procedures and practices, and to quickly identify additional needs and develop procedures.

Inspections/Evaluations and Compliance. The FDA will continue to promote the use of HACCP systems in the production of foods to more effectively address the rapidly growing health threats posed by microbial pathogens, chemical contaminants, and other food safety hazards. Efforts include working in partnership with other Federal agencies, state and local governments, the food industry, and private sector participants.

In addition, The FDA has worked to significantly enhance the safety of fresh produce through the development of Good Agricultural Practices (GAPs) and Good Manufacturing Practices (GMPs), targeted sampling and analysis of these products; and implementing technical assistance and education programs for foreign and domestic producers.

Through cooperative relationships with state and local governments on milk, shellfish, and retail food safety, The FDA can expand its coverage of the nation's food supply. These relationships provide coverage for approximately 98,000 Grade "A" milk farms and 590 milk pasteurization plants, approximately 2,200 shellfish processor and shipper establishments, 850 shellfish growing areas, more than 785,000 commercial and institutional establishments, 128,000 grocery and convenience stores, and more than 1.5 million vending sites.

The FDA also works through these jointly sponsored programs to set national safety standards and provide the training and technical assistance to ensure uniformity among milk, shellfish, and retail foods programs throughout the nation. The FDA will implement a new system to monitor state and federal inspections and testing required for Grade "A" milk; and provide training, technical assistance and other support, including HACCP principles, required to improve the uniformity of safety and sanitation standards in the Retail Food, Shellfish Safety, and Interstate Travel programs.

Education. Using the concepts set forth in the Food Code, the FDA will work with other Federal agencies and states to implement a national education program to ensure greater safety in food handling practices by consumers and all segments of the retail food industry. Education activities will continue to be coordinated with the USDA and the CDC.

The FDA plans to reach about 40 percent of the nation's consumers with messages on safe food handling practices through Fight Bac!^TM and other education campaigns, and work with the USDA and the CDC in evaluating the effectiveness of the messages developed within the Food Safety Education Partnership. Activities are made easier by formation of the Food Safety Education Partnership, which coordinates the efforts of the FDA, the CDC, the EPA, the USDA, the Department of Education, industry, consumer groups, and associations of state public health officials in a public/private coalition to promote use of safe food handling practices by all segments of the food community from food producers to consumers.

Research. The FDA will emphasize the expanded food science research and related activities required to help maintain a regulatory program that more effectively addresses existing and emerging food safety issues. A key component of the strategy for achieving this objective will be efforts to develop and implement collaborative research programs that involve other Federal agencies, academia, and industry. Such ventures include research programs at the Joint Institute for Food Safety and Applied Nutrition (JIFSAN) operated under a cooperative agreement with the University of Maryland, the National Center for Food Safety and Technology at the Illinois Institute of Technology's Moffet Center in Chicago.

Risk Assessment. Risk assessment techniques for foodborne pathogens are relatively new. These efforts will help increase the effectiveness and efficiency of regulatory programs by providing the information needed to improve surveillance strategies, develop better prevention strategies, and establish stronger inspection models.

Foods

Program Activity Data

1/ FDA is committed to decreasing its petition inventory and to measuring performance based on timeliness rather than counted outputs in compliance with GPRA. The Food and Color Additive Petitions Completed figure is based upon 360 day timeframe.

2/ If the premarket notification program for food contract substances created by FDAMA is fully funded, threshold of regulation exemptions and a portion of the food additive petitions may be converted to notifications.

3/ Seafood HACCP inspections do not include those conducted through partnerships with the states. In FY 1998, 983 inspections were conducted by the states through partnerships or 263 inspections conducted through state contracts (counted in the 'Federal/State Contract Inspections' number of 4,279.

4/ Includes analysis of an additional 1,000 fresh produce samples in FY 1999.

5/ In FY 1998, cosmetic monitoring was phased out. However, the Agency did respond when warranted. In FY 1999, monitoring activities will be restored.

EXPLANATION OF PROGRAM

The Seafood Inspection Program under the National Marine Fisheries Service (NMFS)/National Oceanic Atmospheric Administration (NOAA)/U.S. 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 voluntary program is encompassed by a product quality plan, usage of Federal quality inspections marks and advertising, and the pre-approval of HACCP plans and labels. Activities vary from continuous in-plant inspection to individual lot inspections which may be requested by, among others, importers, exporters, or retail supermarkets. Seafood receiving these inspections may be authorized to carry various official marks such as "U.S. Grade A", "Processed under Federal Inspection", or "Accepted per [contractually define] Specification".

The Seafood Inspection Program inspected/certified over 928 million pounds of seafood during 1997 -- more than 21 percent of the seafood consumed in the United States during that year. Participants in the program paid $ 12.7 million in fees in 1997 to finance the salaries and benefits of an average of 176 employees and the other expenses incidental to carrying out the program.

RATIONALE FOR BUDGET REQUEST

INCREASES - + $ 15.7 million, + 172 FTE

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 National Performance Review (NPR, currently termed the National Partnership for Reinventing Government) was instituted to identify opportunities to "reinvent" the Government. The NPR recognized that necessary Governmental functions could be performed in a more business-like manner if unnecessary bureaucratic constraints were removed. This observation was particularly germane to reimbursable programs. The term Performance Based Organization (PBO) was coined to identify an entity that provides necessary Governmental services on a reimbursable basis and whose activities could be enhanced by allowing it to function in a business-like manner while retaining policy direction from the Executive Branch. Several candidates for conversion to PBOs have been identified by the Administration, including the Seafood Inspection Program of the USDC.

Legislation has been drafted to establish the Seafood Inspection Program as a PBO within the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services. This legislation will, among other things, transfer the employees of the SIP and the authorities of the Agricultural Marketing Act of 1946 to continue the services that are now being provided by the SIP under NMFS/NOAA/USDC.

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. Locating the program and its resources within the FDA will provide further benefits to the Government, industry, and consumers by:

• Providing "One-stop shopping" for all matters regarding seafood inspection;
• Eliminating confusion among foreign governments and others regarding who is responsible for seafood (both FDA and SIP are now authorized);
• Facilitating greater quality control and uniformity of inspections;
• Enhancing cooperation and harmonization among U.S. Government seafood inspectors;
• Providing the potential to eliminate redundant and/or overlapping inspections by permitting FDA to count voluntary program's work as official regulatory inspections once the SIP inspectors are trained to FDA standards; and
• Providing FDA with access to additional resources to strengthen Federal seafood safety assurance efforts.

Using its current authorities and the anticipated additional authorities, the program will provide, on a fee-for-service basis, consultative, inspection, and certification services to individuals that harvest, process, distribute, or market fishery products in the U.S. or foreign countries. These activities may include assisting industry in complying with domestic and foreign requirements at both trade and governmental levels. The program will be authorized to educate its customers regarding the benefits of its services. Like any business, the PBO will be able to solicit the opinions of industry and consumers regarding the functions of the program and any new or modified services that are necessary to address their needs.

Basic services provided by the program may include providing information and/or provide certifications attesting to: 1) the capability of an individual in a specific subject area (e.g. demonstrated understanding of the concept of Hazard Analysis Critical Control Points (HACCP)); 2) the sanitary conditions of a harvesting, processing, or retailing facility; 3) the findings relative to compliance with domestic and foreign (e.g. European Union) processing requirements; and 4) the acceptability of product relative to purchase specifications, domestic and foreign requirements, including safety, wholesomeness, proper labeling, and quality attributes.

Specifically, the services that are currently provided include the following:

The guiding principles of the program will be: Continued customer recognition of the integrity of the PBO's services as its fundamental asset; a stable, well-trained workforce of inspectors to ensure this integrity; and fees established at the minimum level needed to support the technical and financial integrity of the Program.

Program Assets (that transfer to FDA)

The budget request includes a total of $ 15.7 million and 172 FTE for this program. Resources are divided as follows:

• $ 3.0 million in budget authority that will be used to train the SIP inspectors to conduct FDA/HACCP standard inspections ($ 1.5 million); educate the industry as to the transfer and subsequent transfer to a PBO ($ 0.3 million); other administrative costs such as changing letterhead and other transitional costs ($ 0.2 million); and up to $ 1.0 million as a reserve fund to be used in the event that revenues do not cover the costs of the program.
• $ 12.7 million in user fees derived from the seafood industry for services provided. These user fees are to cover the entire costs of the program.
• The 172 FTE represent personnel located as follows:
  • Headquarters: Silver Spring, Maryland (8 FTE)
  • Northeast Inspection Branch: Gloucester, Massachusetts (45 FTE)
  • Southeast Inspection Branch: St. Petersburg, Florida (57 FTE)
  • Western Inspection Branch: Bell, California (50 FTE)
  • Technical Services Branch: Gloucester, Massachusetts (12 FTE)

• Facilities/Property:
  • One fully equipped state-of-the-art sensory laboratory/training facility in Gloucester, Massachusetts.
  • Two operational training facilities in Seattle, Washington, and Gloucester.
  • Six fully equipped special purpose lot inspection facilities in Gloucester and Fairhaven, Massachusetts; Tampa and Miami, Florida; Bell, California; and Seattle, Washington.
  • Other equipment: 81 computers, 25 fax machines, 16 copiers, 3 vehicles, and 6 freezers/refrigerators.