STRATEGIC FUTURE
(FY 1999-2004)

FDA's activities to ensure the safety of food products are important to every consumer. This is largely because these products, which are used daily, are susceptible to contamination by a wide variety of substances including microbial pathogens, chemicals and illegal food additives, which can have a serious adverse impact on human health. Recent estimates on infectious diseases indicate that foodborne contaminants, particularly microbial pathogens, are significant contributors to illnesses and deaths that occur annually in the U.S.

Major food safety issues currently confronting FDA include emerging pathogens, new and novel food ingredients, hazardous dietary supplements, naturally occurring foodborne toxins, and international trade. In addition, concerns for safety and nutrient quality are raised by some of the new processing systems and the rapidly expanding array of ready-to-eat convenience foods that require little or no further cooking or preparation prior to eating.

In order to deal effectively with these and other major food safety issues, FDA has decided to focus on two major goals over the next five years. Specifically, these are to complete efforts to reform the premarket approval process for food and color additives and to implement the Presidential Food Safety Initiatives, which incorporate innovative strategies for significantly improving the safety of the nation's food supply.

Efforts to reform the premarket approval process for food and color additives began several years ago, and a number of efforts to streamline the petition review process have already been initiated. Additional reforms are required to further reduce the petition inventory and ensure that a streamlined process is established that assures the timely completion of petition reviews. Also, the new FDA Reform legislation requires that FDA implement a notification procedure for indirect food additives in FY 1999.

In May 1997, the President announced a multi-agency Presidential Food Safety Initiative (FSI), in which Federal and state agencies were asked to work together to develop a comprehensive plan to enhance the safety of the nation's food supply. The primary objective of the FSI is to reduce foodborne illness. It is estimated that, when totally implemented by all participating organizations, the FSI could ultimately "prevent 2 to 9 million illnesses, head-off up to 3,000 deaths and save society billions of dollars in preventable health care costs each year."

On October 2, 1997, the President expanded the FSI to include an initiative directed at developing a more coordinated and effective multi-agency effort on improving the safety of fresh fruits and vegetables. This initiative responds to the rapidly increasing number of illness outbreaks in recent years that have been attributed to microbial contamination (e.g. Cyclospora, Hepatitis A, and E. coli 0157: H7) in domestic and imported and minimally processed fresh produce. This Initiative directs FDA and other Federal agencies, including the United States Department of Agriculture (USDA), Environmental Protection Agency (EPA), Centers for Disease Control and Prevention (CDC), and Department of Labor (DoL), to develop guidance and work with domestic and foreign growers, processors and manufacturers to prevent hazardous contamination of fresh produce.

FDA's participation in the development of the Food Safety and Fresh Produce Initiatives provides two important opportunities for enhancing its food safety activities. First, these initiatives re-emphasize FDA's commitment to using preventive quality control systems and to working with other Federal agencies to expand the use of these systems throughout the food industry. Second, they allow the Agency to significantly improve the efficiency and effectiveness of its regulatory programs by working cooperatively and collaboratively with other Federal agencies, states, professional associations, academia and industry.

In addition, the FSI will permit FDA to continue efforts to work with other Federal agencies to develop more comprehensive and accurate baseline data on foodborne illnesses in the U.S. This effort began in FY 1995, when FDA and USDA worked with CDC and funded the establishment of a pilot (Sentinel Site) project. The Sentinel Sites are an active surveillance program that will provide better baseline data on foodborne illness in this country. Since the initial pilot, Sentinel Sites have expanded to provide greater coverage of representative areas in the nation. With the FY 1998 FSI funds, Sentinel Sites will be operating in areas that are representative of the geographic and demographic distribution in the U.S. By the year 2002, these Sites will be able to produce the volume and quality of baseline data against which we can more accurately measure decline in foodborne illnesses. Moreover, these data will be critical to efforts by FDA and other Federal agencies to establish more realistic and measurable performance goals and targets for their food safety programs.

STRATEGIC GOAL AREA: PREMARKET REVIEW

FY 1999 Performance Goal Highlights Review 30% of food and color additive petitions within 360 days. Reduce the number of overdue food and color additive petitions to 30% of those petitions under review. Finalize rulemaking creating a premarket notification process for independent GRAS determinations.

Cluster Rationale: Under the Food, Drug, and Cosmetic Act (FD&C Act), food and color additives must receive premarket approval before entering commerce. To receive approval, sponsors must submit a petition containing appropriate test data to demonstrate the safety of the intended use of the additive. Upon completing the review, the Agency publishes its decision regarding the petition in the Federal Register.

This performance goal cluster includes all premarket review and consultation activities within the Foods Program that are associated with food additives, color additives, Generally Recognized As Safe (GRAS) food ingredients, and foods derived from new varieties of crop plants using biotechnology. This is a natural cluster because all of these premarket activities must address the question of whether a petitioned (or notified) food ingredient (direct or indirect) or color additive is safe.

The goals within this cluster focus on streamlining the review process through the allocation of resources to petitions in proportion to the potential risk of the substance to the public health. This results in the most timely review of all submissions while maintaining the integrity and credibility of the review process. Laboratory research programs support premarket review efforts by providing the necessary input to develop science-based standards for use in the premarket review process. These and other reinvention initiatives are consistent with the principles and intent of the new Food and Drug Administration Modernization Act of 1997.

Outcomes from realizing these performance goals include the availability of more high-quality, safe food products from which consumers can choose, and the reduction in development time and costs for the regulated industry.

Resources, Approaches, Processes, Skills, And Technology: Resources are primarily devoted to petition review, but also include other activities supporting the review process. Food and color additive and GRAS petitions are submitted to FDA by industry, and the data in these petitions must be evaluated to determine if the data supports the safety of the proposed use of the substance. After completing the review, the Agency must either publish a regulation in the Federal Register permitting the proposed use of the additive or publish a notice denying the petition and specifying the grounds for denial or withdrawal. Intermediate steps include communication with the industry sponsor regarding deficiencies that may prevent the petition from being approved if not corrected.

STRATEGIC GOAL AREA: POSTMARKET ASSURANCE

FY 1999 Performance Goal Highlights Assure that 50% of the seafood industry is operating under appropriate HACCP systems. Increase the percentage of domestic produce produced using GAP and GMP guidance for minimizing microbial contamination. Begin implementing HACCP regulation in the juice industry. Increase the proportion of adults who use food labels to make nutritious food selections to at least 77%. Work with CDC and other Federal agencies to develop improved baseline surveillance data on foodborne illnesses. Release information on Special Nutritionals Adverse Events to the public more frequently. Achieve adoption of the Food Code by 25% of the states. Assure that the domestic food manufacturing establishments inspected by FDA achieve a 90% rate of conformance with FDA requirements.

Cluster Rationale: The primary goal of the Food Safety Assurance cluster is to provide consumers the greatest assurance possible that food products in the marketplace are safe and in full compliance with laws and regulations governing food processing, distribution and storage, and proper labeling. This is the largest and most varied aggregation of activities within the Foods Program. This cluster includes food safety activities related to the President's Food Safety Initiatives (FSI) and non-FSI food safety activities. In view of the wide variety of potentially hazardous substances which may contaminate these products, this is a major responsibility which has important implications for the health and well-being of consumers, as well as for the Nation.

The goals of this cluster are accomplished through a variety of mechanisms including food safety compliance monitoring, nutrition and other product labeling activities, and activities related to regulating dietary supplements (including the implementation of the Dietary Supplement Health and Education Act (DSHEA)), infant formulas and medical foods.

Compliance monitoring activities provide coverage for approximately 53,000 domestic establishments involved in the production, storage and distribution of food products and over 2.2 million lots of imported products offered at U.S. ports of entry. These activities cover a wide variety of food-related safety concerns such as microbial pathogens, chemical contaminants, sanitation problems and food defects. Safety and sanitation problems identified through monitoring activities are dealt with through a variety of enforcement activities, such as warning letters, seizures, injunctions, and import detentions as well as industry-initiated product recalls.

Food labeling has become increasingly important in recent years as scientific and epidemiological data have more clearly demonstrated that diets play a critical role in the development of certain human diseases. Scientifically established relationships between diet and disease, including heart disease, cancer, diabetes, and osteoporosis, have significant implications for the health and well-being of consumers. Using information provided on current labeling formats, consumers are better able to make dietary choices that are best suited to their particular nutritional needs and that help maintain their health.

This cluster also includes a number of other activities such as those directed at establishing regulations, policies, and standards for dietary supplements and other special nutritional products, such as infant formulas and medical foods. During the past several years, dietary supplements have become a major regulatory concern due to the rapidly expanding use and misuse of products.

An important objective for this cluster in FY 1999 will be to increase efforts in the priority areas identified in the Presidential Food Safety and Fresh Produce Initiatives. Activities which have the most direct impact on this cluster include those related to expanding industry's use of quality control systems, including hazard assessment and critical control point (HACCP) systems, which prevent food safety hazards; using Federal/state partnerships and state contract inspections to increase the frequency of compliance monitoring in food establishments; developing and implementing guidelines to prevent microbial contamination of fresh fruits and vegetables; and increasing efforts to integrate FDA's inspection activities and share monitoring data with states and other Federal agencies.

Ultimate outcome-oriented goals and performance measures are difficult to establish and track due to the inability to relate specific regulatory initiatives to health quality and disease statistics. This problem is exacerbated by the fact that foodborne illness outbreaks do not follow a linear pattern but tend to vary significantly from year to year depending on a variety of circumstances. Moreover, there are a number of other players in the food safety game, and isolating a particular result to any specific Federal or state agency is problematic. Because of these and other complications and variables, ultimate outcomes are difficult to establish and track even with the most comprehensive databases.

Resources, Approaches, Processes, Skills, and Technology:

HACCP
The resources provided under the Food Safety Initiative in FY 1998 and FY 1999 will permit FDA to promptly verify that domestic seafood establishments have adequate HACCP systems. In addition, FDA will increase effort to work with industry to expand HACCP to fresh juices and other appropriate non-seafood segments of the food industry. A major initiative for FY 1998 and FY 1999 will be preparation for the implementation of the HACCP regulation for the juice industry. The Agency will also continue to develop pilot HACCP programs for other segments of the food industry. Based on the results of the pilot programs, FDA will develop strategies for expanding HACCP to other appropriate food industries.

Guidance (GAPs/GMPs) for the Domestic and Foreign Fresh Produce Industries
The additional resources for the Fresh Produce Initiative will permit FDA to increase efforts to work cooperatively and collaboratively with other Federal agencies, state governments, foreign governments and industry to develop and implement voluntary good agricultural practice and good manufacturing practice (GAP/GMP) guidance for fresh fruits and vegetables. In the U.S., FDA will work with USDA and states in this effort. In foreign countries, FDA expects to engage in similar cooperative arrangements with foreign governments, international organizations (e.g., United Nation's Food and Agricultural Organization (FAO) and World Health Organization (WHO) and exporter associations. In addition, FDA will work through USDA's Foreign Agriculture Service (FAS) and the State Department to facilitate the development of education programs for foreign producers. By working with and through these other organizations FDA hopes to achieve maximum efficiency and effectiveness in this effort to significantly reduce potentially harmful microbial contamination on fresh produce.

Coverage of the Nation's Food Supply
Several strategies will be used to improve the monitoring of the nation's food supply. One strategy will focus on increasing Federal/state partnerships to help achieve this objective. Another strategy will focus on increasing imports coverage through the expanded use of equivalency, MOU and MRA agreements with foreign governments. Equivalency agreements are possible with other nations when FDA has determined by its own investigations that their food safety systems are at least comparable to those in the U.S. Under MOUs and MRAs, producer nations are responsible for ensuring the safety and sanitation of foods before they are exported to the U.S. In addition, efforts will be made to improve the efficiency of domestic and import monitoring activities through more extensive uses of automated systems for reporting and analyzing inspection results.

Early Warning System
FDA will increase efforts to work with other Federal and state agencies to enhance the monitoring and surveillance of foodborne disease, to upgrade the national surveillance system for foodborne infections, to enhance monitoring under HACCP and to develop better techniques for characterizing foodborne pathogen isolates.

Assumptions:

Seafood HACCP
Effective implementation of the Seafood HACCP regulation is based on following assumptions:

1. The Agency must be able to hire up to 80 investigators/microbiologists to work on the HACCP verification effort.

2. Some HACCP inspections will be conducted under state partnerships and state contracts.

Guidance (GAPs/GMPs) for the Domestic and Foreign Fresh Produce Industries
Many of the goals for this activity are based on the assumption that Congress will appropriate the increases requested in the FY 1999 budget for the Fresh Produce Initiative. Without the additional resources, FDA will not be able to achieve goals that are critical to its efforts to increase the safety of fresh produce.

STRATEGIC GOAL AREA: INTERNAL CAPACITY

FY 1999 Performance Goal Highlights Implement a multi-year research plan to develop scientific methods for detecting, controlling and preventing microbial contamination on fresh produce. Develop and improve risk assessment techniques for microbial pathogens. Develop new alternatives to thermal processing systems for processed fresh produce. Conduct studies of factors that cause foodborne pathogens to develop multiple antibiotic resistance and resistance to traditional food preservation techniques.

Cluster Rationale: The Internal Capacity Building cluster focuses on conducting the scientific research and related activities that are needed to develop and maintain the regulatory program required to address twenty-first century food safety issues effectively. This activity groups both laboratory and non-laboratory research investigations that address questions of immediate applicability to regulatory problems, and fundamental studies that can affect FDA review and regulatory responsibilities over the longer term. As defined within this cluster, research includes the development of new analytical approaches and methodologies, but excludes routine laboratory or non-laboratory testing and analysis using established methodologies. This cluster includes research related to the President's Food Safety Initiatives (FSI).

One important goal of this cluster is the implementation of innovative strategies in the Presidential Food Safety and Fresh Produce Initiatives that are designed to facilitate the development and maintenance of a state-of-the-art food science capability. Risk assessment and research strategies contained in the Presidential Initiatives emphasize the development of collaborative research programs with academia, industry and other Federal agencies. This approach is needed because no single segment of the food industry, in the broadest terms (i.e., industry, government, academia, other representatives of the food safety, nutrition, and public health communities), can conduct the research needed to generate the knowledge bases and develop the expertise to ensure the continued safety and wholesomeness of the food supply.

Collaborative Research Initiatives
The Joint Institute for Food Safety and Applied Nutrition (JIFSAN) is a key component of FDA efforts to achieve objectives established in the Presidential Food Safety and Fresh Produce Initiatives. JIFSAN's collaborative research program will be conducted under the direction of a cooperative agreement between the University of Maryland at College Park (UMCP) and the FDA. This institute is patterned after the National Center for Food Safety and Technology (Moffett Center) in Chicago, Illinois. These programs bring together the resources of industry, academia and FDA to address food safety issues.

The activities of this cluster will benefit consumers by permitting FDA to ensure a safer food supply and, thereby, help reduce the impact of food-related illnesses. This will be accomplished primarily by developing and maintaining the capability to respond more rapidly to health emergencies; taking regulatory actions based on the latest scientific information; and targeting compliance monitoring and research resources where the greatest needs exist. Another important benefit of the enhanced collaboration with other agencies will be more comprehensive and coordinated regulatory activities without significant additional costs.

Resources, Approaches, Processes, Skills, and Technology: The Joint Institute for Food Safety and Applied Nutrition (JIFSAN) was established between FDA and the University of Maryland College Park (UMCP) in April 1996 to create a partnership that will allow for more efficient use of research resources and enhance the quality of food safety and nutrition research and public health policy. As the role of FDA research scientists in regulatory activities increases, it is vital that these scientists have ready access to the very specialized research facilities and expertise (e.g., Center of Bimolecular Structure and Organization) in close proximity to FDA administrative offices to expedite regulatory policy and decisions (e.g., petition review).

The resources provided for the Food Safety Initiative and Fresh Produce Initiative in the FY 1999 budget will permit FDA to expand research efforts in JIFSAN and the Moffett Center that are required to fill critical gaps in its food science capability. This includes more rapid and accurate analytical methods for bacterial agents in foods, especially those that are difficult to detect (e.g., Cyclospora) as well as techniques to more effectively prevent and control microbial pathogens on foods. There will also be an expansion of research efforts to improve risk assessments and risk management techniques, particularly for microbial contamination on fresh produce. The results of this research will enhance FDA's ability to more rapidly and accurately characterize the nature and size of the risk to human health associated with foodborne hazards, and make clear the degree of scientific certainty of the data and the assumptions used to develop safety estimates. More rapid and accurate risk assessment techniques are critical to Agency efforts to provide consumers greater protection against potential hazards posed by foodborne pathogens. Other resources to support research in these areas will be obtained through public-private research partnerships using the cooperative research and development agreement (CRADA) process.

These and other expanded research efforts made possible through fully funded Food Safety and Fresh Produce Initiatives will significantly increase the capability of FDA's scientists to provide technical guidance and assistance to industry, consumers, and other constituencies on improving the safety of foods. In addition, these scientists will be better equipped to serve as national and international experts who provide technical expertise for the development and harmonization of international food safety specifications and standards.

Assumptions: The goals established under this cluster assume the following:

1. Requested amounts will be appropriated for the FSI and Fresh Produce Initiative.

2. Funding for Cooperative Agreement with UMCP will continue.

3. Post-doctoral and graduate students will be available through UMCP.

STRATEGIC GOAL AREA: EXTERNAL LEVERAGING

FY 1999 Performance Goal Highlights Reduce the prevalence of reported risky food consumption behavior and risky food preparation/handling practices, and increase the use of thermometers during cooking. Participate in international organizations that set food safety standards.

Cluster Rationale: The Coordination cluster includes goals related to the Cooperative Programs, the Presidential Food Safety Initiatives, international harmonization and standards setting activities, consumer and industry education activities, and coordinated regulatory initiatives with other Federal and state agencies. Consumer and industry education and enhanced coordination between Federal and state agencies on food safety are key components of the Food Safety Initiative. Performance goals within the cluster permit FDA to use external relationships and education/technical assistance activities to expand the impact of its regulatory programs, provide information that can help prevent contamination and reduce the chances of foodborne illness, and leverage the resources of other organizations to enhance the safety of food. Moreover, many of the activities within this cluster are cross-cutting and, therefore, provide support critical to achieving the regulatory objectives of the other clusters, especially Food and Color Additive Review and Food Safety Assurance.

Cooperative programs with states and Federal agencies, which constitute a major component of this cluster, permit FDA to expand coverage of the food supply significantly. These activities include Memoranda of Understanding (MOUs) with states and Federal agencies on the regulation of milk products, shellfish and retail food operations. Through these cooperative activities with states, the Agency is able to assure that safety and sanitation standards applied to milk, shellfish and retail food operations are adequate and uniform across the Nation.

Education and technical assistance activities, another key component of this cluster, permit FDA to develop and implement cost-effective strategies for providing information to consumers and industry that will help to reduce the risk of illness from foodborne infections. These activities are crucial to accomplish the goals of the FSI and Fresh Produce Initiatives. Under the FSI, the Agency will continue efforts to design and implement innovative methods to more effectively deliver food safety messages to consumers and retail food operations (especially institutional food service operations such as hospitals, nursing homes and day care centers), where large percentages of food-related infections occur.

Under the Fresh Produce Initiative, FDA will work to ensure that training and technical assistance is provided to foreign and domestic growers, processors and manufacturers of fresh fruits and vegetables to ensure adoption of safety principles contained in GAPs. This effort will be undertaken jointly with other organizations, including Federal agencies, state governments, foreign governments, international organizations and the foreign and domestic industries. In this country, FDA will work primarily with USDA and states to provide training and technical assistance on GAPs and other safety guidance. In exporting countries, FDA expects to develop cooperative arrangements with foreign governments, international organizations (e.g., FAO/WHO), and exporter associations to ensure the adoption of the voluntary safety guidance. Moreover, FDA will work through FAS and the State Department to facilitate the development of education programs for foreign producers. Through these joint efforts, FDA will achieve maximum efficiency and effectiveness in this effort to significantly increase the safety of fresh produce.

Full participation in efforts of international standard setting organizations including those dealing with the General Agreement on Tariffs and Trade (GATT), the North America Free Trade Agreement (NAFTA), and Codex Alimentarius, is required if FDA is to promote the development and adoption of science-based international safety standards and control systems for foods. Acceptance and utilization of international standards that satisfy U.S. consumer protection goals will improve product safety and public health, reduce FDA's import inspection burden, and facilitate the import and export of foods.

Data are currently not adequate to establish baselines for many of the activities that support the goals of this cluster as well as the other clusters in the Foods Program. In FY 1999, FDA will continue its efforts to improve the amount and quality of data needed to more thoroughly assess the impact of its efforts to assure the safety of the nation's food supply and establish appropriate intermediate outcome measures for some of these activities. One effort will attempt to supplement information from FY 1998 consumer research activities with information from the Behavioral Risk Factors Survey (BRFS) and Food Safety Surveys to track the effectiveness of educational campaigns and programs. Efforts to measure the impact of the Public Affairs Specialist (PAS) activities related to foods using informal surveys and PAS feedback on services and needs will continue. In addition, FDA will work with USDA to conduct surveys required to obtain data to evaluate the effectiveness of, and the extent to which the fresh produce industry has adopted guidance for improving the safety of fresh produce.

Resources, Approaches, Processes, Skills, and Technology: With resources in FY 1999, FDA will expand effort to significantly reduce the potential for foodborne illnesses through new and innovative education and information sharing programs; more effective coordination with Federal agencies and states on foodborne disease surveillance as well as responses to foodborne illness outbreaks; and efforts to harmonize international standards for food safety and sanitation. These represent some of the most cost-effective strategies available for preventing foodborne infections.

FDA will expand efforts to work with Federal and state agencies to develop and implement innovative food safety education programs to reduce the potential for foodborne illness by changing unsafe food handling behaviors in the home and in retail food establishments. In one of the major efforts to be undertaken in this area, FDA and its partners will use concepts set forth in the Food Code to develop and implement a national education program directed at improving food handling practices of consumers and the retail food industry. The Food Code is designed to help state and local regulatory agencies develop or update their own food safety rules and to assure consistency between jurisdictions on the regulation of grocery stores, restaurants, and institutions that sell or serve food across the United States.

FDA will increase its efforts to play a major leadership role in influencing worldwide food safety standards so that it can ensure a safer food supply for U.S. consumers. This will mean that FDA will actively participate in a wide variety of international organizations that address food safety issues. Those who represent the Agency in these organizations must thoroughly understand Federal food regulations and standards and the science that supports them. As indicated in the Internal Capacity cluster, FDA scientists must be well equipped with knowledge and experience to provide expert scientific advice on safety standards. Such knowledge and expertise is critical to evaluate proposals for international safety standards and control systems that assure comparability with the nation's domestic standards.

In addition, FDA will increase its efforts to work with other Federal agencies to develop and implement an "early warning" system that will ensure more coordinated and rapid responses to foodborne illness outbreaks. This will include working with other Federal and state agencies to enhance the monitoring and surveillance of foodborne disease, to upgrade the national surveillance system for foodborne infections in humans, and develop better techniques for characterizing foodborne pathogen isolates. Reducing the response time to illness outbreaks is vital to Agency and Departmental efforts to significantly reduce the adverse health and economic impacts of food-related health emergencies.

Assumptions: The goals for this cluster are based on the assumptions that:

1. The requested increases for the FSI and Fresh Produce Initiative will be fully funded.

2. Resources for activities not covered under the two Presidential Initiatives will be at or near the current level.

Strategic Goal Area:	PREMARKET REVIEW
Cluster:	Food and Color Additive Review
1. By the end of FY 1999, complete reviews of 30% of food and color additive petitions within 360 days.
Agency Strategies:	Streamline reviews.
Data Sources:	An electronic document management and workflow system is being developed to facilitate tracking and assignment of petition reviews.
Baseline Data:	Under development. FDA does not have quantitative baseline data comparable to this goal (See note).
	FY 1997:	The information technology infrastructure required to support this system has been upgraded; and a prototype document management and workflow system has been designed and was tested.
	FY 1998:	Document management and workflow system is being tested.
Note about Baseline Data: In the past, actions included issuance of a "reject" letter based on partial reviews of petitions. FDA is now committed to timely review of a complete petition package within time frames in performance goals. Previously, performance measures were reported for the year in which an action was taken on a petition rather than the year in which the petition was filed with the FDA (the reference which will be used to measure this goal). This and other changes in the FDA review process, including those required by the FDA Modernization Act, are expected to change the spectrum of submissions received by the FDA.
2. By the end of FY 1999, reduce the number of overdue food and color additive petitions to 30% of those petitions under review.
Agency Strategies:	Streamline reviews.
Data Sources:	An internal tracking database will be improved and incorporated in the electronic workflow system mentioned in Goal #1 above.
Baseline Data:	FY 1997:	As of the end of FY 97, 44% of petition under active review were "overdue" (defined as under review for more than 180 days, the statutory time frame).
3. During FY 1999, finalize the rulemaking creating a premarket notification process for independent generally recognized as safe (GRAS) determinations.
Agency Strategies:	Focus on high priority applications.
Data Sources:	Finalized rulemaking will be published in the Federal Register.
Baseline Data:	Currently, the review of FDA's GRAS affirmation petitions is time- consuming and resource-intensive. The proposed rule will replace the existing process used by sponsors to notify FDA of their independent GRAS determinations and, in response to the reinvention government initiative (REGO), will streamline and expedite the review process.

Strategic Goal Area:	POSTMARKET ASSURANCE
Cluster:	Food Safety Assurance
1. By 12/30/99, 50% of the seafood industry will be operating preventive controls for safety as evidenced by functioning, appropriate HACCP systems [1].
Agency Strategies:	Develop science-based products and process standards and guidance; Inform and assist firms to achieve conformance; Foster industry quality assurance programs, e.g., HACCP; Maintain inspection visibility.
Data Sources:	FDA's Field Data System; National Seafood HACCP Compliance Database System.
Baseline Data:	FY 1997:	FY 1996 compliance data based on establishment inspections indicate that a minority of establishments in the seafood industry will operate under the Seafood HACCP regulation as published.
	FY 1998:	Conduct verification inspections of the domestic seafood industry to ensure that adequate seafood HACCP systems are in place. Provide technical assistance as required to help firms correct deficiencies.
	FY 1999:	Complete verification inspections of the Seafood industry to ensure that HACCP has been adequately implemented.
2. Increase the percentage of domestic produce produced consistent with voluntary good agricultural practices (GAP)/good manufacturing practices (GMP) broadscope guidance to reduce microbial contamination [1].
Agency Strategies:	Inform and assist firms to achieve compliance; Maintain inspection visibility; Develop science-based products and process standards and guidance.
Data Sources:	FDA's Field Data System; USDA's 1998 and 2000 National Agricultural Statistics Survey (NASS) Vegetable Chemical Use Surveys, 1997, 1999 and 2001 NASS Fruit Chemical Use Surveys; USDA compliance data systems.
Baseline Data:	FY 1998:	Conduct grassroots meeting on good agricultural practices (GAPs) and good manufacturing practices (GMPs) guidance with domestic and foreign fresh produce growers, producers, processors and manufacturers. Issue broadscope guidance on GAPs/GMPs for growers and producers of fruit and processors of fresh produce in July 1998. USDA conducts 1998 NASS Vegetable Chemical Use Survey. Obtain baseline data from USDA's compliance data systems and USDA's 1997 NASS Fruit Chemical Use Survey. Obtain baseline data from USDA's 1998 NASS Vegetable Chemical Use Survey and USDA compliance data systems.
	FY 1999:	USDA conducts 1999 NASS Fruit Chemical Use Survey. Obtain data from USDA's 1999 NASS Fruit Chemical Use Survey and USDA compliance data systems.
	FY 2000:	USDA conducts 2000 NASS Vegetable Chemical Use Survey.
	FY 2001:	USDA conducts 2001 NASS Fruit Chemical Use Survey. Compare baselines with USDA's 2000 NASS Vegetable Chemical Use Survey and 2001 NASS Fruit Chemical Use Survey to evaluate the adoption and compliance with the voluntary GAPs and GMPs guidance.
3. During FY 1999, take steps to implement the HACCP regulation for the juice industry, including providing training, technical assistance and guidance to industry and states [1].
Agency Strategies:	Develop science-based product and process standards and guidance; Foster industry quality assurance programs, e.g., HACCP; Collaborate with Federal and state regulators to reduce health risks.
Data Sources:	FDA Field data systems.
Baseline Data:	FY 1997:	1997 E. coli O157:H7 contamination in apple juice resulted in one death and 66 illnesses (including 14 with hemolytic uremic syndrome).
	FY 1998:	At present, there are no established juice HACCP regulations or guidelines.
4. By the end of FY 1999, increase to at least 77% the proportion of people aged 18 and over who use food labels to make nutritious food selections.
Agency Strategies:	Inform and assist firms to achieve compliance; Empower consumer choice through product labeling and education.
Data Sources:	Tracked by FDA's Diet and Health Survey.
Baseline Data:	FY 1995:	74%
	FY 1996:	75%
5. During FY 1999, work with the Centers for Disease Control and Prevention (CDC) and other Federal agencies to develop baseline surveillance data on foodborne illnesses required to evaluate the effectiveness of, set better priorities for, and determine appropriate outcomes for the Food Safety Initiative [1].
Agency Strategies:	Improve surveillance and follow-up on adverse events.
Data Sources:	FoodNet Sentinel Site surveillance system. CDC, state and local health department passive surveillance systems.
Baseline Data:	FY 1995:	FDA and USDA worked with CDC and funded the establishment of a pilot (Sentinel Site) project. This is an active surveillance program that will provide baseline data on foodborne illness in the U.S.
	FY 1996 & 1997:	Sentinel Sites expanded to provide better coverage of the representative areas of the U.S.
	FY 1998:	Using FSI funds, eight Sentinel Sites will be operating in areas that are representative of the geographic and demographic distribution in the U.S.
	FY 2002:	Sentinel Sites will be able to produce baseline data against which change in foodborne illnesses can be measured.
6. By the end of FY 1999, improve public access to timely information on adverse events related to dietary supplement products, infant formulas, and medical foods by increasing the frequency of public releases of information in the Special Nutritional Adverse Events Monitoring System (SN/AEMS) from 2 per year to 4 per year.
Agency Strategies:	Improve surveillance and follow-up on adverse events. Empower consumer choice through product labeling and education.
Data Sources:	Special Nutritional Adverse Events Monitoring System (SN/AEMS).
Baseline Data:	FY 1997:	two releases.
7. By the end of FY 1999, enhance the safety of the nation's food supply by achieving adoption of the Food Code by 25% of the states [1].
Agency Strategies:	Inform and assist firms to achieve compliance.
Data Sources:	FDA's Field Data System.
Baseline Data:	FY 1997:	Three states have adopted the Food Code: Utah, Rhode Island and Mississippi.
8. Assure that FDA inspections of domestic food manufacturing establishments, in conjunction with the timely correction of serious deficiencies identified in these inspections, result in a high rate of conformance (at least 90%) with FDA requirements by the end of the fiscal year.
Agency Strategies:	Inform and assist firms to achieve compliance.
Data Sources:	Field Data Systems.
Baseline Data:	FY 1996:	98% (see note)
Note about Baseline Data: Prior compliance performance measures have been essentially counts of activities at various points along the enforcement continuumói.e., number of inspections, violative inspections, warning letters, prosecutions, etc. This new measure strives to integrate the results of these activities into an end-of-the-year statement about the compliance status of this specific industry sector. A prototype of the new measure will be generated in FY 1998.

Strategic Goal Area:	INTERNAL CAPACITY BUILDING
Cluster:	Internal Capacity
1. Implement a multi-year research plan to develop and improve methods for the detection, control and prevention of microbial contamination on fresh produce and evaluate the effectiveness of technologies for eliminating this contamination [1].
Agency Strategies:	Develop science-based product and process standards and guidance; Consolidate and prioritize research activities; Collaborate with Federal and state regulators to reduce health risks; Pursue public private partnerships to expand resources.
Data Sources:	Progress will be monitored by technology transfers, CRADAs, reduced costs, etc. and periodic management and peer review.
Baseline Data:	FY 1997:	The limited number of scientific methods are either not effective for fruit and vegetables because the natural constituents of these products frequently interfere with the methods or the method must be modified for the specific commodity.
	FY 1998:	Establish an interagency research committee to determine research needs and to plan and coordinate food safety research for FY 1998. Develop long-range research plan that has four major areas of focus (i.e., improved detection methods, antibiotic resistance, resistance to traditional preservation technologies, and intervention strategies).
2. During FY 1999, develop modeling techniques for assessing human exposure to a variety of foodborne pathogens and for describing low dose infectivity rates for infectious and toxicoinfectious microorganisms [1].
Agency Strategies:	Develop science-based product and process standards and guidance; Collaborate with Federal and state regulators to reduce health risks.
Data Sources:	Progress will be monitored by periodic management and peer reviews.
Baseline Data:	There are no generally agreed upon modeling techniques to assess human exposure to foodborne pathogens and the potential risk of these causing human illness.
3. During FY 1999, work with industry and academia to develop new techniques for eliminating pathogens on fresh produce where traditional thermal processing systems used for processed foods cause fresh produce to deteriorate and become inedible [1].
Agency Strategies:	Develop science-based product and process standards and guidance; Collaborate with Federal and state regulators to reduce health risks.
Data Sources:	Progress will be monitored by periodic management and peer reviews.
Baseline Data:	Traditional thermal processing systems used for processed foods cause fresh produce to deteriorate and become inedible.
4. During FY 1999, conduct studies on factors that cause foodborne pathogens to develop multiple antibiotic resistance and resistance to traditional food preservation techniques and factors that prevent the development of such resistance [1].
Agency Strategies:	Develop science-based product and process standards and guidance; Collaborate with Federal and state regulators to reduce health risks review standards.
Data Sources:	Progress will be monitored by periodic management and peer reviews.
Baseline Data:	These phenomena are recent developments and very little research has been conducted to date. The FY 1999 studies will help fill this gap.

Strategic Goal Area:	EXTERNAL LEVERAGING
Cluster:	Coordination
1. Use educational campaigns and activities to reduce the prevalence of reported risky food consumption behavior, reduce the prevalence of reported risky food preparation/handling practices, and increase the percentage of people who report using thermometers to assure the safety of foods during cooking [1].
Agency Strategies:	Empower consumer choice through product labeling and education; Inform and assist firms to achieve compliance.
Data Sources:	FDA's FY 1993, 1998, and 2000 Consumer Survey; and FDA's January 1998 Retail Food Establishment Survey.
Baseline Data:	FY 1993:	FDA conducted a national survey of the public's knowledge, attitudes and practices related to food safety. Risky food consumption: Among consumers 18 years or older, 57% reported consuming raw eggs and 25% reported eating undercooked hamburger. Risky food preparation/ handling: 54% reported leaving raw meat at room temperature for more than 2 hours. 33% did not always wash knives or cutting boards with soap after using them to prepare raw meat and before continuing to prepare a meat. 4% used thermometers to check cooking temperatures.
	FY 1997:	Develop data collection instrument for FDA's FY 1998 Consumer Survey.
	FY 1998:	Continue developing data collection instrument for FDA's FY 1998 Consumer Survey; Collect data for FDA's FY 1998 Consumer Survey; Develop and launch educational campaigns and activities on risky food consumption behavior targeting special populations for key safety messages, promoting the use of the Food Code and science-based safety standards, and overcoming barriers to communicating proper food safety behaviors to food service workers.
	FY 1999:	Continue educational campaigns and activities.
	FY 2000:	Continue educational campaigns and activities.
2. During FY 1999, increase the safety of imported foods through participation in international standard setting organizations (such as Codex Alimentarius of the United Nations World Health Organization (WHO) and the Food and Agricultural Organization (FAO), the North American Free Trade Agreement's (NAFTA) Standard Phytosanitary Committee, and the World Trade Organization (WTO)) that consider or establish international standards for food safety and sanitation [1].
Agency Strategies:	Support U.S. interests in global standard setting; Increase coordination of international harmonization activities.
Data Sources:	Food safety and sanitation standards of standard setting organizations.
Baseline Data:	FY 1998:	Participate in: all meetings of Codex Alimentarius Committees that elaborate food safety standards including limits for contaminants in foods, codes of practice (e.g., GMPs) and guidelines (e.g., HACCP and decisions on equivalence); all WTO and NAFTA SPS matters involving food safety; discussion of all trade disputes involving legal interpretation of provisions of trade agreements that have implications in upholding U.S. food safety requirements.

1. Achievement of goal assumes that additional personnel can be acquired via contract or other means.