2.1 FOODS

2.1.1 Program Description, Context, and Summary of Performance

The FDA's Foods Program is responsible for ensuring a safe, nutritious, wholesome, and honestly labeled food supply and safe and properly labeled cosmetics for the American public. FDA regulates all food except meat, poultry, and frozen and dried eggs, which are regulated by the U.S. Department of Agriculture. The Foods Program accomplishes its mission by: setting standards and developing regulations for the food industry; taking timely and appropriate action on new food ingredients and dietary supplements before they go on the market to ensure their safety and effectiveness; conducting research to provide the necessary basis for its regulatory decisions; assuring the quality of foods, food ingredients, dietary supplements and cosmetics that are available on the market; identifying food-related health hazards; taking corrective action to reduce human exposure to these hazards and the possibility of food-related illnesses and injuries; and expanding food safety education and training for consumers and industry.

As we enter the 21st Century, trends in the food industry promise better nutrition, greater economies and wider choices for the U.S. consumer than ever before. To illustrate:

• The biotechnology explosion has opened new frontiers in product development, thus providing us the ability to genetically alter foods to make produce more resistant to disease, add desirable consumption characteristics to the foods, and to prolong shelf life.
• The volume and diversity of imported foods has risen dramatically over the last few decades, and foods once considered exotic are now found throughout the U.S.
• The globalization of the food supply means that foods we consume are being produced by a much larger number of source countries.
• The dietary supplements industry has grown dramatically, as has consumption of dietary supplements.

Each of these developments also presents regulatory challenges for FDA. The Agency's job is to give consumers the confidence to enjoy the benefits of these expanded food choices.

Two strategic goals define the Foods Program's approaches for meeting the challenges of the 21st century:

• Provide consumers quicker access to new food ingredients and dietary supplements, while assuring their safety and effectiveness.
• Reduce the health risks associated with food and cosmetic products by preventing human exposure to hazards, monitoring product quality and correcting problems that are identified.

By striving toward these two goals, FDA will assure the quality of food ingredients, dietary supplements and cosmetic products both before and after they go on the market. Since only a limited category of food products is subject to FDA premarket approval, FDA relies heavily on its postmarket surveillance and compliance activities to assure the safety and quality of the products it regulates.

FY 99 Program Accomplishments

Review of Food and Color Additive Petitions -In 1997, FDA changed its procedures and redefined first actions as a review of all parts of a petition before notifying a petitioner. As a result of these changes, the agency succeeded in meeting and surpassing its by completing 54% of food and color additive petitions within a year of receipt. In addition to expediting the review of petitions, the Agency has been able to provide sponsors more timely feedback and information on the status of petitions. We expect our performance in this user fee dependent area to improve continuously toward full performance in succeeding years.

Integrated National Food Safety System- As part of the Presidential Food Safety Initiative, FDA collaborated with states, the food industry and other Federal food safety agencies to establish an integrated national food safety system. Key accomplishments included the following:

• Adoption of the Food Code-Keeping food from becoming contaminated is the intervention that offers the greatest promise for preventing foodborne illness. As of the end of FY 99, the Food Code had been adopted by 15 states. The Food Code is a reference document for regulatory agencies that oversee food safety in restaurants, grocery stores, and institutions such as nursing homes and childcare centers. Adoption by all jurisdictions of the Food Code would result in uniform national food standards and provide the foundation for a more uniform, efficient, and effective, national food safety system.
• Training for Prevention of Microbial Contamination of Foods-The Center for Food Safety and Applied Nutrition (CFSAN), working with FDA's Office of Regulatory Affairs (ORA) and partner Federal agencies, has engaged in training the industry and publishing guidance on safe food handling for food producers and consumers. Targeted education programs were developed and provided to segments of the population that are at high risk of food-related illness and injury. FDA conducted these activities in both the national and international arenas by working with states, industry, and foreign governments to ensure a safe food supply.
• Surveillance of Foodborne Illnesses-FoodNet is a sentinel network that provides accurate national estimates of the burden and source of specific foodborne diseases in the United States. FoodNet is a critical component of the national integrated food safety system because it provides data to measure the occurrence of foodborne illnesses and to study trends over time in the prevalence and incidence of foodborne illnesses. In FY 99, the geographic coverage of FoodNet was expanded to 32.2 million people, which represents 12% of the American population.

Monitoring the Food Supply-FDA inspects establishments, examines or analyzes food samples, and conducts investigations to determine whether product safety and quality standards are met at each stage of commercial food production and distribution. FDA also uses these inspection activities as opportunities to provide technical assistance to the industry to correct problems and improve safety. In FY 99, FDA inspections of domestic food establishments resulted in a 98% rate of conformance with FDA requirements.

Surveillance of Imported Foods Overseas and at the Border -FDA completed 82 foreign inspections in FY 99 of food plants (78) and farms (4) that produce food products at high risk of microbial contamination. Of these inspections, 26 Establishment Inspection Reports (EIRs) have been reviewed; 8 establishments were placed on Detention Without Physical Examination (DWPE) because of unsanitary conditions; and 4 establishments were issued warning letters. Fourteen establishments were in compliance with FDA regulations. FDA conducted assessments of the food safety systems in Nicaragua, Costa Rica, El Salvador, Guatemala and Honduras to evaluate food regulatory systems in these countries.

The Agency's approach to achieving the strategic goals identified above, as well as key performance goals that will advance the Program in these directions, are outlined in the next sections.

2.1.2 Strategic Goals

Strategic Goal 1:

The Foods premarket review program focuses on food and color additive petitions, dietary supplements and substances that are generally recognized as safe (GRAS). Under the FD&C Act, FDA must review and approve food and color additive petitions before food manufacturers and distributors can market them. To initiate this review, sponsors are required to submit a petition that includes appropriate test data to demonstrate the safety of the intended use of the substance. Under the Dietary Supplement Health Education Act (DSHEA), industry is required to notify the Agency of any "new ingredient" for a dietary supplement. DSHEA requires that companies make certain submissions to FDA when health claims are made for dietary supplements and that companies provide a scientific basis for the safety of new dietary ingredients. The Agency must respond to the sponsor's notification with a decision within 75 days. The Agency also has notification programs for substances that GRAS.

The Food Program's key challenge in the premarket area is to expedite review of new food products without jeopardizing public safety. To provide the U.S. public quicker access to new food ingredients and dietary supplements, FDA will:

• Work closely with petitioners, before and after they file premarket approval applications, to avoid or quickly resolve problems
• Simplify and expedite the food and color additive petition review process
• Make timely decisions on new food and color additive petitions (Performance Goal 1-11001)
• Implement review fee programs for food and color additive petition review
• Respond to dietary supplement notifications within 75 days (Performance Goal 2-11025)
• Give priority to those additives that are intended to decrease the incidence of foodborne illness
• Exempt certain substances that are GRAS from the premarket review process and thus make food products containing these substances available on the market more quickly (Performance Goal 3-11003)
• Improve management systems
• Use multi-disciplinary review teams to rapidly resolve new and ongoing safety issues related to petition reviews
• Recruit and hire reviewer-scientists (including professionals with the special skills to evaluate dietary supplements such as medical doctor, consumer safety officers, chemists, botanists, herbalists and toxicologists)
• Use contract personnel for some petition review

Meeting FDA's statutory goals depends on the implementation of review fee programs. These review fee programs, which have the support of industry, would provide a stable source of resources that will permit the Agency to significantly enhance the efficiency of the review processes of food and color additives. The fees would be used to review applications more quickly and meet established review time frames; to provide the consultation required to help petitioners significantly improve the quality of their submission; and to establish the premarket notification program for food contact substances as outlined in FDAMA.

Research and Standard-Setting Contributions to Premarket Review

Several statutes require FDA to ensure that food ingredients, dietary supplements and infant formulas are safe and that health claims appearing on food product labels are based on sound science. A strong connection exists between research and review decisions. Since many new products use new food technologies, it is critical that FDA reviewers have state-of-the-art scientific knowledge when they evaluate the safety and effectiveness of new food technologies and render review decisions. FDA's Foods Program will use several strategies to strengthen its science base. First, the Agency will provide scientific training to reviewers. Second, the Agency will attract highly skilled medical researchers and health professionals to the FDA. Third, multidisciplinary teams will be used to resolve safety issues related to review decisions.

A strong FDA science base will help FDA to develop regulations and guidance for the safety of special nutritionals to implement the 1994 DSHEA. It will also be used to address potential dietary supplement safety issues such as deaths and injuries associated with use of ephedrine alkaloids, and to establish industry guidelines for complying with good manufacturing practices (GMPs). It is critical that FDA develops sound scientific data and expertise to support standards and guidance for dietary supplements. The Agency also needs to undertake research to close the existing gap in scientific knowledge on dietary supplements. This research will involve analytical techniques and sampling methodologies for ingredients, contaminants, pre-clinical and clinical testing, and models for assessing human risk.

Leveraging/Communication

FDA's ability to provide timely and expeditious review of new food ingredients and dietary supplements depends on enhanced communication, collaboration, and cooperation with the food industry, academia, consumers, professional organizations, and health care organizations. Several approaches to leveraging FDA's review efforts have been noted in previous sections. First, one process improvement initiative involves extensive consultation with prospective petitioners before they file, and working closely with petitioners after they have filed, to quickly resolve problems encountered during review. Investing time early in the petition development process will provide valuable feedback to prospective petitioners and save FDA and the petitioner time during the review process. Second, the FDA's use of contract personnel for some petition reviews will permit FDA reviewers to focus their efforts on the more complex applications. Multidisciplinary review teams will continue to help rapidly resolve new and ongoing safety issues related to petition reviews.

Reinvention

The Agency is reinventing its Food Premarket Review program in two important ways. First, FDA is establishing a notification program for food contact substances under the new section 409(h) of the FD&C Act which was added by the Food and Drug Administration Modernization Act (FDAMA). This premarket notification process will become the primary method by which FDA regulates food additives that are food contact substances. This notification process will be used to authorize the marketing of a food contact substance except when the FDA determines that the submission of a food additive petition is needed to provide adequate assurance of safety. The notification process is intended to expedite the marketing of safe food contact substances. Second, during FY 98, FDA implemented a proposed notification procedure for independent GRAS determinations. The Agency solicited and received comments on the proposed notification procedure and is finalizing the regulation for its implementation. Once the regulation is finalized, this procedure will largely replace the resource-intensive GRAS affirmation petition process with a less resource-intensive process.

B. Summary of Performance Goals

C. Goal-by-Goal Presentation of Performance

1. Complete first action on 50% of food and color additive petitions within 360 days of receipt. (11001)

• Context of Goal: In mid-FY 97, FDA changed its procedures and a first action was redefined as a review of all parts of a petition, followed by issuance of a "not approvable" letter, or publication of a response in the Federal Register, if appropriate. The procedure change was made to expedite the review process as well as provide sponsors with more timely, strategic feedback and information about the overall status of a petition. Prior to FY 97, a food and color additive petition was reviewed and if a deficiency in any single area was found, the petitioner was notified and asked for information, and review of the remainder of the petition was suspended. Previously, this notice was defined as a first action.

In this goal, "time to first action" is not the same as meeting the statutory time frame (i.e., 90 days, extendable to 180 days). It is widely recognized that meeting the current statutory time frame is an unrealistic goal for all food and color additive petitions, especially the more complex ones. The impracticability of the current time frame was acknowledged in the report from the June 1995 House hearing, and a recommendation to change the time frame to '360 days of receipt' was included in the Agency's testimony before the House Committee on Government Reform and Oversight in 1996. The target is a projection of FDA performance given additional resources, including those already provided, and those requested for FY 01; and anticipated workload. 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.

Since the 1995 and 1996 hearings, the FDAMA established the notification process for food contact substances. The premarket notification program began to operate on January 18, 2000. Several factors will influence future performance on the goal of completing first action on 50% of food and color additive petitions within 360 days. The most important of these factors is the implementation of the new premarket notification process. Although in the past FDA has been able to predict our annual workload for this goal, with the advent of the premarket notification system, it is extremely difficult to predict what the future workload will be. Second, in FY 01, the year after implementation of the notification program, we expect that many of the simpler food additive petitions that can be completed within 360 days will be filed under the notification program and thus decrease the workload for this goal. However, since the remaining petitions are likely to be more complex and take more time to review, the Agency performance on this goal may decline initially. Third, the premarket notification program may also increase the backlog of overdue petitions (see Performance Goal 2-11002). Once the notification and the petition review processes are well established, FDA expects performance on this goal to increase substantially toward full performance in succeeding years.

• Data Sources: CFSAN's electronic workflow system
• Performance: In FY 99, FDA met and surpassed this goal of 30% by completing "first action" on 54% of food color and additive petitions within 360 days of receipt. The denominator for this measure includes not only the more complex food and color additive petitions, but also petitions of the type that in FY 00 and beyond will be filed under the new premarket notification programs. These less complex petitions contributed substantially to the FY 99 performance level of 54%. In the next few years, we expect that performance on this goal will decline below the actual performance for FY 99 as product sponsors avail themselves of the more rapid review times offered by the premarket notification program. Achievement of this goal also depends on the authorization and collection of review fees in FY 01. This increase in resources is necessary for the Agency to continuously improve performance in the review of food and color additive petitions. These additional resources will be used to hire and train highly qualified personnel to review safety data. In addition, FDA will complete testing and initiate the operation of a document tracking system that will track progress toward the goal and will provide detailed information on the status of petitions and FDA tasks to be completed.

2. Reduce the percentage of overdue food and color additive petitions to 30% of petitions under review. (11002)

• Context of Goal: This is the FY 99 goal. It is included here only for FY 99 reporting. There is no similar goal in FY 00 or FY 01. FDA is committed to reviewing food and color additive petitions within 360 days of receipt. The Agency will not be able to meet full performance level on food and color additive petition review until the overdue petitions have been reduced to a level that permits FDA to devote sufficient resources to reviewing currently incoming petitions within the 360-day timeframe. In this goal, FDA defines "overdue petitions" as petitions under review by FDA for more than 360 days. The denominator for this measure consists of all food and color additive petitions under review. In FY 98, 38% of the petitions under active review were overdue. In FY 99, FDA planned to reduce the percentage of overdue petitions under active review to 30%.

Several factors will influence future performance on this goal. The most important of these factors is the implementation of the new premarket notification process. In the past FDA has been able to predict our annual workload for the goal of completing first actions within 360 days (Performance Goal 1-11001). With the advent of the premarket notification system, it is extremely difficult to predict what the future workload will be. Several product sponsors have already asked the Agency to convert petitions in our current food additive petition inventory into notifications. Since we do not know how many current or overdue petitions in the inventory will be converted or how many new petitions will be submitted in the future, we can not accurately predict our workload for petition reviews. It is also difficult to predict the workload for premarket notifications because under the premarket notification system, each manufacturer or distributor of a food contact substance must submit a notification, whereas approval of a food additive petition allowed any one to manufacture or distribute the additive. The unpredictability of the workload for new petitions and, in turn, for overdue petitions prevents us from setting meaningful targets for FY 00 and FY 01. Second, in FY 01, the year after implementation of the notification program, we expect that many of the simpler food additive petitions that can be completed within 360 days will be filed under the notification program and thus decrease the workload for this goal. However, since the remaining petitions are likely to be more complex and take more time to review, the Agency performance on this goal may decline initially. Third, the premarket notification program may also increase the backlog of overdue petitions (see Performance Goal 2-11002). Once the notification and the petition review processes are well established, FDA expects performance on this goal to increase substantially toward full performance in succeeding years.

In the future, FDA will develop performance baselines for eliminating the backlog of food and color additive petitions and for the notification program. In addition, as discussed in the performance section below, a more appropriate performance metric for assessing FDA's progress toward eliminating the backlog of food and color additive petitions will be developed.

• Data Sources: CFSAN's electronic workflow system
• Performance: In FY 98, 38% of the petitions under active review were overdue. In FY 99, 42% of the petitions under review were overdue. FDA's Foods Program received an unprecedented increase in the number of food and color additive petitions in FY 99. The Agency postulates that streamlining efforts and timely review of petitions have led industry to submit more petitions than ever before. This increase in FDA's workload led the Agency to focus its efforts on timely response to newly submitted petitions and prevented the Agency from reducing the backlog as quickly and significantly as planned. The success in meeting the goal of completing a first action on food and color active petitions within 360 days (Performance Goal 1-11001) also artificially inflates the performance measure for this goal even if the absolute number of overdue petitions does not change. This is because the denominator for the FY 99 goal includes both current and overdue petitions. As performance improved on Goal 1, the overdue petitions became a larger proportion of all the petitions under review.

In the future, FDA will develop a more appropriate measure to track its progress toward eliminating the backlog. The Agency will also develop performance baselines for eliminating the backlog of food and color additive petitions.

3. Respond to 90% of notifications for dietary supplements containing "new ingredients" within 75 days. (11025)

• Context of Goal: FDA must respond within 75 days to the petitioner with a decision on any new ingredient that will be part of a dietary supplement. The Agency anticipates that notifications for dietary supplements containing "new ingredients" will become more complex and that the volume of such notifications submitted to the FDA will increase. For this reason, the Agency's goal target of 90% for FY 01 is the same as for FY 00. Since the Agency does not know precisely what the workload will be in any given year, the 90% target is considered full performance.
• Data Sources: CFSAN's Correspondence Tracking System and manual tracking
• Performance: In FY 98, FDA received and responded to 18 (100%) notifications for dietary supplements containing "new ingredients". Data on FY 99 performance will be available in March 2000.

4. Complete processing of 80% of GRAS notifications within the time frame established by the final rule. (11003)

• Context of Goal: GRAS notification is a new program and the final rule creating a premarket notification process for independent GRAS determinations is planned for publication in FY 00. Through the GRAS notification process, the FDA seeks to exempt certain substances that are generally recognized as safe from the premarket review process and make food products containing these substances available on the market more quickly. Under the proposed notification procedure, FDA intends to evaluate whether the submitted notice provides sufficient basis for a GRAS determination and whether information in the notice or otherwise available to FDA raises issues that lead the Agency to questions whether use of the substance is GRAS. The proposed notification procedure would allow FDA to direct its resources to questions about GRAS status that are a priority with respect to public health protection. FDA performance will be measured based on the timeframe established by the final rule. Completion of this goal represents movement from a time and resource intensive review of GRAS affirmation petitions to a streamlined and expeditious review process. The rule replaces the existing process used by sponsors to notify FDA of their independent GRAS determinations.
• Data Sources: CFSAN's electronic workflow system; Internal Office of Pre-Market Approval database.
• Performance: In FY 99, FDA made substantial progress toward this goal, however due to resource restraints and competing priorities the rule will not be finalized until early 2000. The Agency is accepting new GRAS notifications under the proposed rule.

Strategic Goal 2:

Reduce the health risks associated with food and cosmetic products by preventing human exposure to hazards, monitoring product quality and correcting problems that are identified.

A. Strategic Goal Explanation

Approach

This strategic goal emphasizes three areas of effort-Preventative Control Systems, Compliance Monitoring, and Adverse Event Reporting (AER)-that FDA uses to assure the safety of food and cosmetic products from the point of production through consumption or use by consumers.

Preventative Control Systems

Given the increasing complexity of food safety issues, the most effective strategy for reducing foodborne illness and mortality is to prevent the pathogenic contamination of food through the implementation of food safety standards at all points along the food production chain both in the United States and in foreign countries. FDA's prevention strategies for achieving its objective of reducing health risks associated with food and cosmetic products emphasize:

• Working with states and the food industry to develop and implement food production and preventive control systems that are appropriate to specific product hazard combinations and to establish regulatory processes and systems to more effectively and efficiently monitor the food supply
• Getting more states to adopt the model Food Code, which provides standards and guidance on food safety, sanitation, and fair dealing that may be uniformly adopted by the retail food industry
• Working with foreign countries exporting food and cosmetic products to the U.S. to ensure the implementation of comparable safety standards
• Conducting consumer education and industry education aimed at disease prevention

Compliance Monitoring

Compliance monitoring is a critical component of food safety assurance during and after production and through the commercial distribution stage. FDA has the statutory authority to inspect establishments, examine or analyze samples, and conduct investigations to determine whether product safety and quality standards are met at each stage of commercial food and cosmetic production and distribution. The Agency accomplishes its safety assurance for domestic foods and cosmetics through compliance programs that guide surveillance and enforcement activities.

The greatest challenge the Foods Program faces is how to cope with the growth of the regulated industry and the growth and changes in health risks at a time when resources are decreasing. To improve the coverage for the entire food supply, FDA will:

• Target products with the highest risk of violating food safety and sanitation standards
• Increase the number of domestic establishment inspections,
• Significantly reduce the interval between inspections in domestic food establishments, with an emphasis on dietary supplement establishments and expand import coverage for foods
• Leverage its resources by working with USDA, CDC, other federal agencies and states to establish an integrated food safety system for the nation, including outbreak response coordination and investigation; information sharing and data collection; minimum uniform standards; and laboratory operation and coordination
• Increase the coverage of imports and ensure the existence of an effective international food safety net through three substrategies:
  1. Applying preventive measures at the source of production and thereby reducing the probability that products that violate United States standards will be exported to the United States.
  2. Making rapid and reliable decisions at the border about whether products should be allowed to enter the United States by conducting additional foreign inspections/ evaluations and expanding the reviews of electronic filers.
  3. Targeting products that violate United States standards at the border and preventing their entry, especially those products with a higher risk for violations and those products by firms with historical violations.

The first import substrategy merits further explanation. It is accomplished through several substrategies. First, FDA negotiates bilateral and multinational agreements on specified products and in forums that result in development of acceptable international product standards (for example, the United Nations Food and Agricultural Organization's Codex Alimentarius). These standards can be extended to a large percentage of imports through agreements in which source countries confirm product conformance to these standards. Second, FDA provides educational and technical assistance to foreign governments. Third, the agency evaluates food safety systems in foreign nations. Finally, FDA enters into international agreements that permit the Agency to establish safety and sanitation standards that food products must meet before they are exported to the United States.

Adverse Event Reporting

Once food and cosmetic products are commercially available to consumers, it is also important to monitor and evaluate adverse events associated with the consumer use of these products. The development of more effective surveillance techniques for detecting, preventing, and controlling potential hazards associated with food and cosmetic products is a top priority for the Agency. The Agency needs better ways of identifying problems with dietary supplements. In view of the rapidly increasing use of, and safety hazards associated with some dietary supplements (e.g., ephedra) and other special nutritional products, improving databases/ surveillance systems for these food products is also a top priority for FDA.

With resources requested in FY 00, FDA will continue to work diligently to enhance the Agency's capacity for collecting, monitoring and evaluating adverse events by:

• Improving the infrastructure with hardware/ software upgrades
• Increasing epidemiological staff
• Creating a series of links with existing database and surveillance systems external to the Agency

Research and Standard-Setting Contributions to Surveillance/Compliance

Research

A strong science-base is vital for effective achievement of the Foods Program's product assurance goals. The Agency's research activities for its food and cosmetics program are directed toward understanding the nature and severity of hazards to the consumer and the means to control these hazards. The Foods Program will strengthen its science base through the following strategies:

• Providing scientific training to field investigators and reviewers
• Attracting highly skilled medical researchers and health professionals to the FDA
• Expanding existing collaborations with industry and academia to build upon other research activities
• Expanding research efforts to fill critical gaps in the Agency food science base

The National Center for Food Safety and Technology (Moffett Center) and the Joint Institute for Food Safety and Applied Nutrition (JIFSAN) are key components of FDA's efforts to achieve established food safety objectives, especially those under the FSI and Produce and Imports Food Safety Initiative (PIFSI). These partnerships with academia and industry allow for more efficient use of research resources and enhance the quality of food safety and nutrition research and public health policy. The additional resources requested for FY 01 will permit FDA to expand risk assessment efforts in JIFSAN and the Moffett Center to fill critical gaps in its ability to assess exposure to foodborne hazards. This expanded risk assessment research effort 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, as well as the effects of intervention. More rapid and accurate risk assessment techniques are critical to Agency efforts to provide consumers with greater protection against potential hazards posed by foodborne pathogens and other contaminants.

To fill critical gaps in the FDA food science base, the Agency will develop an intensive research program on dietary supplements that will result in the development of sound scientific data and understanding from which standards and guidance on the safety of these products will be established. The research program will include development of analytical methods for active ingredients and contaminants, pre-clinical tests, clinical trials, epidemiological and other specialized studies, and development of models for assessing human risks. This research program will be a collaborative effort with a major university with an established research program on dietary supplements.

Microbiological research and the development of risk assessment techniques provide the scientific basis for the integrated food safety system. Inspection and surveillance activities in particular require the development of science-based tools through research. Most contamination is no longer detectable by simple visual review, but rather is microbial in nature and requires sophisticated state-of-the-art technologies to detect and control. These activities are critical in providing information about pathogens, how they enter and interact with the human body, and the best methods for attacking them.

Research to improve analytical methods and sampling techniques, two essential tools in postmarket surveillance and other monitoring and compliance activities, will be funded with additional resources in FY 01. Areas of particular emphasis in the research program will be:

• Biotechnology
• Dietary supplements
• Bioterrorism agents

Research is also needed to develop data and scientific understanding from which standards, guidance, and regulations will be revised or established to ensure the safety of foods and cosmetics. The research program will include development of detection methodologies, studies of sources and modifiers of allergic response(s), elucidation of the toxicology of photosensitizers, and market research.

Standard Setting

Regulations are the principal means by which law and policy are translated into standards for compliance. Innovations in technology, manufacturing processes and new products change is constant in the industries the Agency regulates. The Agency endeavors to stay abreast of the changes to develop new regulations and amend or revoke old regulations, when necessary to protect consumers against potentially hazardous products. In FY 01, activities on standard development will focus on special nutritionals, especially dietary supplements. The following are examples of public health issues to be addressed with additional resources in FY 01.

• The FDA will face a more pronounced "tug-of-war" between consumer demand for protection from hazards and consumer desire for earlier and free access to regulated products such as dietary supplements to improve their health. There is a need for a single, well-defined overall strategy for dietary supplements and special nutritionals that demand objective, measurable standards of safety.
• The dietary supplements industry sells products on which millions of Americans rely. Consumers spend approximately $12 billion a year on dietary supplements according to the 1998 "Nutrition Business Journal" annual report. These products are now readily available in supermarkets, retail stores and the Internet, making them easily accessible to children and adolescents, as well as to adults. A Good Manufacturing Practice (GMP) regulation for dietary supplements will be a useful tool for both the industry and the Agency in preventing significant or unreasonable harm to the consumer. CFSAN will publish a final rule on GMP regulations assisting industry in producing dietary supplements that are not adulterated and that comply with the safety provisions of the FD&C Act.
• Develop regulations and guidance for the safety of special nutritionals to implement the 1994 Dietary Supplement Health and Education Act (DSHEA). Address potential dietary supplement safety issues such as deaths and injuries associated with use of ephedrine alkaloids, and establish industry guidelines for complying with good manufacturing practices (GMPs).
• An effective and efficient system of controls to enhance food safety must be developed for the food industry and for commodities with known histories of illness outbreaks including fresh cut produce, sprouts, and eggs. HACCP regulations are being developed in various sectors of the food industry to reduce food safety risks and increase regulatory efficiency.

Leveraging/Communication

FDA's ability to fulfill its mission to assure the safety of food and cosmetic products depends upon enhanced communication, collaboration, and cooperation with the food industry, states, academia, consumers, professional organizations, domestic and international health care organizations, foreign governments, and international standard setting organizations. To accomplish this, FDA does the following:

• Provides assistance to a variety of agencies and organizations in both the public and private sectors to promote a safe food supply and safe and properly labeled cosmetics.
• Fosters cooperation with trade and professional associations, and others on the implementation of preventative control systems in the food and cosmetic industries through outreach efforts.
• Participates in planning and conducting seminars and workshops, which include the international foods and cosmetics community.
• Engages stakeholders in the decision-making process on program priorities, as required by FDAMA.

In FY 01, the Agency will focus on enhancing information exchange with industry, academia, and trade associations. The following are examples of the public health benefits of the Agency's outreach and communication initiatives.

• Greater stakeholder understanding of food and cosmetic safety issues and risks associated with foods and cosmetics beyond the current emphasis of microbial pathogens.
• Increased technical assistance to state and local governmental jurisdictions will encourage and facilitate compliance with FDA regulatory requirements.
• As the competent U.S. authority for regulating the safety of all foods, except meat and poultry, FDA must either issue export certificates for U.S. food products that are exported, or oversee issuance by other federal and state agencies or third parties.
• Disseminate information via fact sheets and industry assistance materials; respond to increased inquiries via telephone or e-mail; translate videos explaining our basic science-based control programs; conduct consumer studies to develop effective education strategies and approaches; develop partnerships to conduct education campaigns; and target education messages to those especially vulnerable populations.
• Expand research efforts in dietary supplements, applied nutrition, food labeling, and cosmetics through collaborative programs and partnerships to further develop the program for training of professional staff; to increase technical assistance to state and local government jurisdictions; and to encourage and facilitate compliance with FDA regulatory requirements.
• FDA, as the lead federal public health agency involved in food safety, promotes uniform implementation of national food regulatory policy among several thousand federal, state, and local agencies and tribes that have primary responsibility for the regulation of retail food establishments. Experience has shown that industry conformance with acceptable procedures and practices is more likely when regulatory officials speak with one voice about what is required to protect public health, why it is important, and which alternatives for compliance may be acceptable. The model Food Code provides guidance on food safety, sanitation, and fair dealing that may be uniformly adopted by the retail food industry. This document is a result of the efforts and contributions of many individuals, agencies, and organizations. With additional resources, the Agency will increase efforts to get more states to adopt the Food Code. FDA will also expand its work with other federal agencies and states to implement a national education program that ensures greater safety in retail food preparation practices using concepts set forth in the Food Code.
• Partnership agreements with states and equivalence agreements with foreign countries are necessary to help FDA promptly assure that seafood products available to consumers are produced under effective HACCP-based systems. FDA has developed a national seafood HACCP inspection database to record industry compliance. The Agency will implement the HACCP regulation for the fresh juice industry. In FY 01, the Agency will begin implementing appropriate preventative systems for the egg industry.

To improve the coverage for the entire food supply, FDA will work with USDA, CDC, other federal agencies and states to establish an integrated food safety system for the nation. These federal and state partners collaborated extensively during 1998 and continue to collaborate in 1999 on issues related to the development of an integrated food safety system, including roles and responsibilities, outbreak response coordination and investigation, information sharing and data collection, minimum uniform standards and laboratory operation and coordination. In FY 01, FDA will continue to work with federal and state agencies to increase efforts toward making an integrated food safety system a reality. Effective coordination between all the collaborating food safety agencies involved in ensuring the safety of foods offers the best opportunity to significantly improve protection for consumers and achieve substantial reductions in the annual number of food-borne illnesses.

Other FDA leveraging activities include:

• Signing an agreement with the University of Maryland to form the Joint Institute for Food Safety and Applied Nutrition, is paving the way for both organizations to pool specialized knowledge, equipment and facilities.
• Working with CDC and state health departments to resolve food safety concerns and economic fraud cases.
• Working with international organizations, such as Codex Alimentarius Commission-an international food standard setting organization of the Food and Agricultural Organization and World Health Organization - and foreign governments, to help establish internationally recognized safety standards, rules and regulations for imported foods
• Working with states and the food industry to develop and implement food production and preventive control systems (e.g., HACCP) and establish regulatory processes and systems to more efficiently and effectively monitor the food supply.

The Agency will continue existing collaborations with industry and academia to build upon research activities. The Moffett Center and JIFSAN are key components of FDA's efforts to achieve established food safety objectives, especially those under the FSI and PIFSI. These partnerships with academia and industry allow for more efficient use of research resources and enhance the quality of food safety and nutrition research and public health policy. The additional resources requested for FY 01 will permit FDA to expand risk assessment efforts in JIFSAN and the Moffett Center to fill critical gaps in its ability to assess exposure to foodborne hazards. This expanded risk assessment research effort 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, as well as the effects of intervention. More rapid and accurate risk assessment techniques are critical to Agency efforts to provide consumers greater protection against potential hazards posed by foodborne pathogens and other contaminants.

B. Summary of Performance Goals

C. Goal-by-Goal Presentation of Performance

5. Achieve adoption of the Food Code by at least 25 states in the USA. (11010)

• Context of Goal: The Food Code is a reference document for regulatory agencies responsible for overseeing food safety in retail outlets, such as restaurants and grocery stores, and institutions, such as nursing homes and child care centers. It is neither federal law nor federal regulation, but may be adopted voluntarily and used by agencies at all levels of government that have responsibility for managing food safety risks at retail.

  To achieve the public health goal of reducing foodborne illness to the fullest extent possible, steps must be taken at each point in the farm-to-table chain where hazards can occur. Adoption by all jurisdictions of the Food Code would result in uniform national standards and provide the foundation for a more uniform, efficient, and effective, national food safety system. FDA endorses the Food Code because the Code provides public health and regulatory agencies with practical science-based advice and manageable, enforceable provisions for mitigating risk factors known to contribute to foodborne disease.

  In June 1998, the Secretary of Health and Human Services, Donna Shalala, and the Secretary of Agriculture, Dan Glickman, wrote to U.S. Governors asking them to support adoption of the Food Code by agencies in their states that have responsibility for regulating retail establishments that sell or serve food should use the Food Code as a model to help develop or update their own food safety rules and provide consistency among jurisdictions.

• Data Sources: Field Data Systems
• Performance: The Food Code was revised and a notice of its availability was published in the Federal Register on February 22, 1999 (64 FR 8576). In FY 99, agencies in 15 States have adopted the Food Code. State agencies achieving adoption of the Food Code are: Minnesota, Rhode Island, New Hampshire, Missouri, North Dakota, South Dakota, Nebraska, Mississippi, Texas, Florida, Kansas, Florida, Utah, Arizona and Iowa.

6. Increase to at least 70% the proportion of adults who report changing their decision to buy or use a food product because they read the food label. (11007)

• Context of Goal: Food labels provide consumers information about the composition and nutritional content of foods that they need to make healthy food choices. To help consumers get the most from food labels, FDA and USDA are continuing their multi-year food labeling education campaign. The campaign involves participation by consumer, trade and health groups, as well as by other government agencies. Its purpose is to increase consumers' knowledge and effective use of the food label and assist them in making accurate and sound dietary choices in accordance with the Dietary Guidelines for Americans.

• The Health and Diet Surveys that are conducted every five years are the most effective means of measuring the effectiveness of educational interventions in promoting the use of food labels. In FY 90, the Health and Diet Survey (pre-NLEA) found that 30% of adults used the food labels to make a decision on the purchase or use of food products. Data from the 1995 survey disclosed that 48% of people age 18 and older reported changing their decision to buy or use a food product because they read the food label. The FY 99 goal focused on measuring the number of people that currently just look at the label but do not make a decision on the purchase or use of food products. In FY 01 the indicator and target for the goal change. The denominator for the FY 01 goal consists of adults who read food labels. Among those adult, FDA wants to measure the percentage who report changing their decision to buy or use a food product because they read the food label. The next national Health and Diet Survey, scheduled for 2001, will provide data on the percentage of adults who use the food label to make decisions on buying food products. Out of those people, our goal in FY 01 is for 55% of them to read labels and make a decision on the purchase or use of food products based on the label.

• Data Sources: FDA National Health and Diet Surveys.
• Performance: In FY 99, no survey was conducted to measure this goal. However, FDA collaborated with several Federal agencies to develop education tools for educators and consumers that are designed to teach consumers how to use of food labels. Collaborating agencies included the Interagency Coordinating Committee on School Health, the Interagency Task Group on 'Child Health; USDA's Dietary Guidelines Working Group, the Human Nutrition Coordinating Committee; and CDC, SAMHSA, ODPHP, NIH, FTC, FNS CNPP, and USDA. FDA also engaged in non-governmental liaison activities that contributed to increasing the number of consumers who use the food label to make purchasing decisions. These activities included: networking with the Dietary Guidelines Alliance; working with Shape Up American on a Web program; participation in the Partnership for Health Weight Management; completion of phase I of focus group research in four areas of the country, and shared findings with the 'Girl Power and You!' Coalition.

7. 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 document the occurrence of food service behaviors, actions, and conditions that fall in to the CDC-identified risk factor categories classified as "contributing factors to foodborne illness outbreaks." (11016)

• Context of Goal: This is the FY 99 goal. It is included here only for FY 99 reporting. There is no similar goal in FY 00 or FY 01. The Agency's Food Safety Education efforts are aimed at designing and implementing innovative methods to more effectively deliver food safety messages to retail food operations (especially institutional service operations such as hospitals, nursing homes and day care centers where a large percentage of food-related infections occur), and directly to vulnerable subpopulations.
• Data Sources:Consumer Surveys and Reports
• Performance:In FY 98, the Agency offered 30 training courses for state and local retail food regulatory staff. Additionally, the Agency initiated collaborative programs for school-based education and consumer education tailored for vulnerable subpopulations.

8. Increase the percentage of domestic produce produced consistent with GAPs/GMP broadscope guidance to reduce contamination.(11005)

• Context of Goal: This is the FY 99 goal. It is included here only for FY 99 reporting. There is no similar goal in FY 00 or FY01. American consumers enjoy one of the safest food supplies in the world. However, over the past several years the number of reported foodborne illness outbreaks associated with both domestic and imported fresh fruits and vegetables has increased compared to other foods. In October 1998, FDA published a guidance document for industry called Guide to Minimize Microbial Food Safety Hazards for Fresh Fruit and Vegetables. In FY 99, FDA also conducted grassroots meetings GAPs and GMPs with domestic fresh and foreign fresh produce growers, producers, processors, and manufacturers. The Guide is intended to assist the U.S. and foreign produce industry in enhancing the safety of domestic and imported produce by addressing common areas of concern in growing, harvesting, sorting, packing, and distributing fresh produce. The Guide identifies the broad microbial hazards associated with each area of concern, the scientific basis for that concern, and good agricultural and management practices for reducing the risk of microbial contamination in fresh produce.

FDA wants to assess the effectiveness of this guidance in promoting the adoption of agricultural and manufacturing practices that are intended to minimize the risk of microbial contamination of fresh produce. A key objective is to establish baseline data on the adherence by domestic producers to GAPs and GMPs. FDA is collecting, reviewing, and evaluating data collected from surveys and other sources to establish a baseline of agricultural practices to assess the risk of contamination in the U.S. food supply and to focus efforts toward prevention, including the development of guidance and prevention systems, and removal of contaminated product from the marketplace. Based on survey findings, FDA will develop and implement a training curriculum in collaboration with USDA/CREES and in consultation with industry on GAPs and GMPs for domestic fresh produce growers, packers and shippers. This training will ensure that best practices in industry are being used to minimize food safety hazards associated with fresh produce and to encourage industry to adopt the use of safe practices. Plans are also underway to adapt the domestic survey to the international arena. In FY 00, USDA will conduct the National Agricultural Statistics Survey (NASS), which will provide the baseline data regarding current agricultural practices and a means to measure change in these practices as guidance and other efforts to improve the safety of fresh fruits and vegetables are developed and implemented. In FY 00 a pilot survey will be conducted in Costa Rica.

• Data Sources: National Agricultural Statistical Survey (NASS) to be conducted in FY 00
• Performance: In October 1998, FDA published a guidance document for industry called Guide to Minimize Microbial Food Safety Hazards for Fresh Fruit and Vegetables. This guide is commonly referred to as the GAPs/GMPs. In FY 99, FDA also conducted grassroots meetings on GAPs and GMPs with domestic fresh and foreign fresh produce growers, producers, processors, and manufacturers. In FY 99, FDA also worked with USDA to (1) develop survey questions for the NASS that could be used in surveys for produce operations and (2) complete a pretest of the survey instrument among growers and packers in California and New York. The revised NASS survey will integrate data collection activities for chemical use an for food safety activities. Data collection for the national survey is expected to begin in 2000, and data will be available in 2001. In addition, survey questions are being designed so they can be used in surveys or produce operations in foreign countries.

9. 50% of the domestic seafood industry will be operating preventive controls for safety as evidenced by functioning HACCP systems. (11004)

• Context of Goal:This is the FY 99 goal. It is included here only for FY 99 reporting. There is no similar goal in FY 00 or FY01. An automated computer data collection system was established to receive and record inspection findings sent from remote locations by fax machines. To ensure uniformity in determining compliance with the seafood HACCP regulation, only inspection results from HACCP trained and certified inspectors using the standardized inspection forms are accepted. Findings are given a quality control review before entry into the National Seafood HACCP Compliance Database.
• Data Sources: FDA's Field Data System; National Seafood HACCP Compliance Database
• Performance: In the first round of inspections of approximately 4,100 domestic seafood processors, approximately 1,200 firms achieved full compliance with the regulation. In FY 99, although fewer than 50% of these processors met all the criteria for operating a functioning HACCP system, only 4% of the firms inspected warranted regulatory action due to problems that raise significant public health concerns. FDA's implementation of HACCP in the domestic seafood industry has resulted in increased awareness, compliance and application of food safety principles by the industry. In addition, HACCP implementation enabled FDA to ascertain that the vast majority of the domestic seafood industry uses HACCP principles in a way that minimizes serious public health threats. In evaluating the public health outcome of HACCP implementation in this industry, we feel that the Agency has met the intent of using HACCP as a strategy for to prevent microbial contamination of seafood produced in the United States. As a consequence, beginning in FY 00, this goal was combined with the performance goal for that relates to conformance rates resulting from the inspection of domestic food establishments (Performance Goal 11).

10. Increase the percentage of high-risk domestic food establishment inspections to once every year. (11020)

• Context of Goal: The existing Field Data Systems currently do not differentiate between low-, medium-, and high-risk domestic food establishments. The Agency has established a definition for high risk establishments that includes those involved in the manufacture of low acid canned food (LACF) products, infant formula products, heat and serve products, ready to eat products and other products that do not require heating to a temperature sufficient to kill bacteria prior to consumption. Based on this definition, the Agency estimates that there are approximately 6,250 such establishments in its establishment inventory. It is also estimated that these establishments are currently inspected on an average of once every three to four years or more. In FY 01, the number of high-risk establishment inspections conducted annually will be increased to include coverage of the entire inventory (approximately 6,250 establishments). FDA, in conjunction with the States, will focus on those establishments that produce foods most susceptible to contamination of foodborne pathogens. The percentage range provided for the inspection frequency allows for unanticipated redirection of resources for emergencies or related incidents, such as foodborne illness outbreaks.
• Data Sources: Field Data Systems
• Performance: This goal is a new commitment in FY 00.

11. Assure that FDA inspections of domestic food establishments (including domestic seafood 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. (11011)

• Context of Goal: Conformance rates estimate the post-inspection status of the establishments inspected in the given year. They are based on the number of establishments inspected, the incidence of serious deficiencies detected (Official Action Indicated), and statistical data of deficiency corrections. Since firms inspected are not randomly selected from the entire population, the rates should not be applied across that population. However, as coverage of the inventory of firms is improved, the rates will better represent the overall status of the industry sector. Before FY 00, the Agency had measured conformance of the domestic seafood industry and conformance of all other domestic food establishments separately. In FY 99, in evaluating the public health outcome of HACCP implementation in this industry, the Agency concluded that it had met its intent of using HACCP as a strategy for to prevent microbial contamination of seafood produced in the United States. As a consequence, beginning in FY 00, the performance goal relating to conformance of the domestic seafood industry with HACCP (Performance Goal 9) was combined with the performance goal for that relates to conformance rates resulting from the inspection of domestic food establishments (Performance Goal 11)
• Data Sources: Field Data Systems; National Seafood HACCP Compliance Database
• Performance: In FY 97, 98 and 99, FDA inspections of domestic food establishments (excluding the domestic seafood industry) resulted in a 98% rate of conformance with FDA requirements.

12. During FY 99, enhance the safety of imported products through surveillance of imported food products at the border, increase foreign inspections (from 40 to 75-100), provide education, outreach and evaluate food production systems in foreign countries. (11021.01)

• Context of Goal: This is the FY 99 goal. It is included here only for FY 99 reporting. There is no similar goal in FY 00 or FY01. FDA data show that the number of imported food entries has doubled over the past 7 years and that, based on recent trends, imports are expected to increase by an additional 30% by 2002. The reality of the "global marketplace" means that substantive changes in philosophy and approach are now required to ensure the safety of the U.S. food supply. The agency recognizes that reliance on a limited number of border inspections and foreign establishment inspections as the primary means of ensuring food safety is no longer effective or sufficiently resource efficient to enable the FDA to ensure that imported foods are safe. The Agency has developed a strategy that includes conducting inspections of selected high-risk foreign food establishments to determine their compliance with applicable FDA regulations and inspection of firms that consistently have compliance violations. Inspections provide FDA an opportunity to assess controls that prevent or minimize hazards. FDA uses the results of inspections to promote the use of more effective controls, and thereby prevent outbreaks, reduce or eliminate hazard controls, and reduce the burden of end products sampling. Due to FDA's lack of authority in inspecting foreign food establishments, the Agency is working with foreign countries and foreign establishments in order to seek the necessary permission to inspect / evaluate these firms. These inspections will lead to safer imports and expedited processing of foreign food products.
• Data Sources: Field Data Systems
• Performance: FDA completed 82 foreign inspections in FY 99 of food plants (78) and farms (4) that produce food products at high risk of microbial contamination. Off these inspections, 26 Establishment Inspection Reports (EIRs) have been reviewed; 8 establishments were placed on Detention without Physical Examination (DWPE) because of unsanitary conditions; and 4 establishments were issued warning letters. Fourteen establishments were in compliance with FDA regulations.

13. Increase the number of import exams of high-risk food products. (11021.02)

• Context of Goal: Traditionally, FDA has been viewed as a domestic public health agency, charged primarily with protecting the health and economic interests of American consumers. This traditional, domestically oriented regulatory approach, complemented by selective enforcement programs for imports, was quite effective until the emergence over the last twenty years of the "global marketplace", where foods available to U.S. consumers may originate in any of more than one hundred countries. Imported foods now constitute more than 10% of the U.S. food supply, and for some commodities, such as many fresh fruits and vegetables, 40% or more are imported. The volume of imports is increasing at a rate that far exceeds the level of resources that FDA can devote to inspections, even with recent resource increases received under the Food Safety Initiative. FDA data show that the number of imported food entries has doubled over the past 7 years and that, based on recent trends, imports are expected to increase by an additional 30% by FY 02. FDA is using three main strategies to target its efforts and to better utilize existing resources earmarked for ensuring the safety of imported foods. These strategies include reducing the probability that violative products will be exported to the United States; making rapid and reliable decisions on product entry at the U.S. borders; and targeting violative products at the border and preventing their entry.

This goal supports the third strategy of targeting suspect products at the border. Import examinations include sample analyses, detentions without physical exams, and import field exams. A small percentage of import entries are directly assessed, through field examinations, and less than 1 percent of imports, through laboratory analyses. The need to directly examine a small percentage of imports is based on empirical evidence that selected product categories from certain source countries or shippers have shown significant violation rates. In addition, surveillance examination of imported products is necessary to identify new problem firms or emerging health concerns. Certain violative firms and products with poor histories of compliance are subject to detention without physical examination at the border until the importer can prove the product complies with FDA standards. FDA uses the Operational and Administrative System for Import Support (OASIS), in coordination with the U.S. Customs Service, to provide data on what products are being imported and at what U.S. port they arrive. It also provides information on compliance actions related to imports. FDA will continue to refine and standardize its risk-based criteria for screening imports as more comprehensive information concerning the product and country of origin are entered into the automated review system.

• Data Sources: Field Data Systems
• Performance: This goal is a new commitment for FY 00.

14. Increase the number of audits and assessments of foreign food safety systems, with an emphasis on high volume exporters to the U.S. to ensure a level of food safety protection comparable to domestically produced foods. (11028)

• Context of Goal: Traditionally, FDA has been viewed as a domestic public health agency, charged primarily with protecting the health and economic interests of American consumers. This traditional, domestically oriented regulatory approach, complemented by selective enforcement programs for imports, was quite effective until the emergence over the last twenty years of the "global marketplace", where foods available to U.S. consumers may originate in any of more than one hundred countries. Imported foods now constitute more than 10% of the U.S. food supply, and for some commodities, such as many fresh fruits and vegetables, 40% or more are imported. The volume of imports is increasing at a rate that far exceeds the level of resources that FDA can devote to inspections, even with recent resource increases received under the Food Safety Initiative. FDA data show that the number of imported food entries has doubled over the past 7 years and that, based on recent trends, imports are expected to increase by an additional 30% by FY 02. FDA is using three main strategies to target its efforts and to better utilize existing resources earmarked for ensuring the safety of imported foods. These strategies include reducing the probability that violative products will be exported to the United States; making rapid and reliable decisions on product entry at the U.S. borders; and targeting violative products at the border and preventing their entry.

This goal supports the first strategy of reducing the probability that violative products will be exported to the U.S. FDA conducts a thorough assessment of foreign food safety systems to maintain an assurance that a country's exports comply with the standards established by the FD&C Act. The assessment of foreign food safety systems includes food production, storage, transportation and delivery. This is important for determining the equivalence of foreign country standards, for assuring that foreign nations have the regulatory sitemaps in place to meet those standards and for developing international mutual recognition agreements. In addition, the results of these assessments are useful in determining training, education, and infrastructure development needs. Foreign countries must request an audit or assessment of their food safety system from FDA. FDA prompts these requests by contacting foreign officials. The Agency is concentrating on nations with a high volume of exports to the U.S., particularly seafood and produce exporters. Once a food safety system is audited, the Agency plans to re-evaluate the system annually. In FY 98, FDA completed food safety system assessments in two countries: Honduras and Trinidad & Tobago. In FY 99, FDA conducted audits/assessments of foreign food safety systems in four countries: Costa Rica, Nicaragua, Guatemala and El Salvador.

• Data Sources: Field Data Systems
• Performance: This is a new commitment in FY 01.

15. Work with CDC 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. (11008)

• Context of Goal: This is the FY 99 goal. It is included here only for FY 99 reporting. There is no similar goal in FY 00 or FY01. This goal relates to FDA's role as a leader in developing an "integrated food safety system." As stated in the National Food Safety Report to the President in 1997, "...prevention of all diseases might not be possible, stopping outbreaks of foodborne illness before they affect large numbers of people is a major goal." Reducing foodborne outbreaks can only be achieved by coordinating efforts of the state and federal agencies involved in food safety assurance. FDA is and will continue to be actively involved in numerous activities to accomplish this goal. This is one of the many process goals necessary to develop the "integrated food safety system." FoodNet, a sentinel network that is producing more stable and accurate national estimates of the burden and source of specific foodborne diseases in the United States through active surveillance and additional studies, has been expanded to eight Emerging Infection Program (EIP) sites. These eight sites provide sufficient geographical coverage and population coverage to allow the frequency and severity of foodborne disease, the proportion of common foodborne diseases that results from eating specific foods and the epidemiology of new and emerging bacterial, parasitic, and viral foodborne pathogens to be determined. FoodNet will also document the effectiveness of new food safety initiatives in decreasing the rate of foodborne diseases in the United States each year.

PulseNet, an early warning system for outbreaks of foodborne diseases, has been established. PulseNet is a national network of public health laboratories that performs DNA "fingerprinting" on bacteria that may be foodborne. The network identifies and labels each "fingerprint" pattern and permits rapid comparison of these patterns through an electronic database at the Centers for Disease Control and Prevention to identify related strains.

PulseNet will play a vital role in surveillance for and investigation of foodborne illness outbreaks that were previously difficult to detect. Finding similar patterns through PulseNet, scientists can determine whether an outbreak is occurring, even if the affected persons are geographically far apart. Outbreaks and their causes can be identified in a matter of hours rather than days.

• Data Sources: The FoodNet Surveillance System and PulseNet System
• Performance: In FY 99, the Agency published "Food-Related Illness and Death in the United States" Emerging Infectious Diseases (in September 1999). This was the first set of estimates for the United States based on active surveillance. The number of illnesses was estimated at 76 million and the deaths at 5,000. In FY 99, FDA also completed three major goals towards developing an integrated food safety system: (1) creation of a coordinating body to focus on a vision and next steps; (2) establishment of work groups to draft proposed plans and projects; and (3) solicitation of input from stakeholders (consumers; federal state, and local officials; industry; and academia.). In addition, the geographic area covered by FoodNet was expanded to include approximately 32.2 million persons or 12% of the American population. Based on data collected at the eight FoodNet sites existing in 1999, FDA and CDC concluded the following: the rate of Campylobacter, Salmonella and Cryptosporidium infection has declined; the rate of salmonella enteriditis (SE) infections declined in all states except Oregon; and Cyclosporiasis declined substantially. In addition, a sustained increase in Vibrio rates was observed, and the rate of E. coli 01:57 infections increased slightly.

16. Expand monitoring for pesticides and environmental contaminants in foods through the collection and analysis of a targeted cohort of 11,000 samples. (11027)

• Context of Goal: Three federal government agencies share responsibility for the regulation of pesticides. The Environmental Protection Agency (EPA) registers and approves the use of pesticides and sets tolerances (the maximum amount of residue that is permitted in or on a food) if use of that particular pesticide may result in residues in or on food. The USDA's Food Safety and Inspection Service (FSIS) is responsible for enforcing tolerances in meat, poultry, and certain egg products. FDA is charged with enforcing tolerances in imported foods and in domestically produced foods shipped in interstate commerce. FDA also collects acquires data on particular commodity/pesticide combinations and carries out its market basket survey, called the Total Diet Study. In conducting the Total Diet Survey, FDA personnel purchase foods from supermarkets or grocery stores four times a year, once from each of four geographic regions of the country. The foods are prepared table-ready and then analyzed for pesticide residue and chemical contaminants. The levels of pesticides found are used in conjunction with USDA food consumption data to estimate the dietary intake of the pesticide residues.

FDA samples individual lots of domestically produced and imported foods and analyzes them for pesticide residues to enforce the tolerances set by EPA. Domestic samples are collected as close as possible to the point of production in the distribution system; Import samples are collected at the point of entry into U.S. commerce. FDA's pesticide program focuses its efforts on raw agricultural products which are analyzed as the unwashed, whole (unpeeled), raw commodity. Processed foods are also included. If illegal residues (those that are above EPA tolerances) are found in domestic samples, FDA can invoke various sanctions, such as a seizure or injunction. For imports, shipments may be stopped at the port of entry when illegal residues are found. "Detention without physical examination" may be invoked for imports based on the finding of one violative shipment if there is reason to believe that the same situation will exist in future lots during the same shipping season for a specific shipper, grower, geographic areas, or country.

Personnel in FDA Field offices interact with their counterparts in many states to increase FDA's effectiveness in pesticide residue monitoring. In many cases, Memoranda of Understanding or more formal Partnership Agreements have been established between FDA and various state agencies. These agreements provide for more efficient monitoring by broadening coverage and eliminating duplication of effort, thereby maximizing Federal and state resources allocated for pesticide activities.

In planning the types and numbers of samples to collect, FDA considers several factors. These factors include: recently generated state and FDA residue data, regional intelligence on pesticide use, dietary importance of the food, information on the amount of domestic food that enters interstate commerce and of imported food, chemical characteristics and toxicity of the pesticide, and production volume/pesticide usage patterns. In FY 98, the Agency analyzed a total of 7,650 pesticide and contaminant samples. These samples included 3,600 domestic and 4,050 imports. FDA expects to analyze approximately 7,800 samples in FY 99. The actual number of samples analyzed in FY 99 will not be available until March 2000. In FY 01, FDA expects to analyze 11,000 samples. Recent reductions in non-FSI programs may limit the Agency's capacity to reach this level. FDA must maintain resource levels devoted to the sampling and analyses of pesticide and other chemical contaminant levels in foods.

• Data Sources: FDA's Pesticide Residue Monitoring Program and Chemical Contaminant Analyses.
• Performance: This is a new commitment in FY 01.

17. Improve public access to timely information on adverse events related to dietary supplement products, infant formulas, and medical foods by increasing the frequency of releases of information in the SN/AEMS from 2 to 4 per year. (11009)

• Context of Goal: This is the FY 99 goal. It is included here only for FY 99 reporting. There is no similar goal in FY 00 or FY01. The FD&C Act requires FDA to monitor and report adverse events associated with food and cosmetics. Adverse event monitoring is particularly important for assuring the safety of dietary supplements because they are not subject to premarket review or approval by FDA. Recent experience with serious adverse events, including death associated with the use of dietary supplements like ephedra, digitalis-containing plantain, and other products, underscores this need. An enhanced system for monitoring and evaluating adverse events associated with the use of dietary supplements would provide a faster more efficient way to evaluate adverse event reports., thus shortening the time FDA needs to take any responsible action, saving lives, and improving public safety. In the past, each component of the Foods program maintained its own adverse event reporting system. The four reporting systems comprising the Foods program's adverse event reporting systems are not linked and lack the technological capacity to provide the data on information. The Foods program has the multi-year goal of developing a single integrated adverse event reporting system that can be used to examine trends in adverse events, identify safety problems early, and respond more quickly to Freedom of Information Act requests regarding adverse events.
• Data Sources:
.
• Performance: In October 1998, one summary of adverse events information from the Special Nutritionals Adverse Events Monitoring System was released to the public. Thereafter, an Internet WEB page was created and is now being used to provide public access to information on adverse events.

18. Implement a multi-year research plan to develop and improve methods for detection, control and prevention of microbial contamination on fresh produce and evaluate the effectiveness of technologies for eliminating this contamination. (11012)

• Context of Goal: This is the FY 99 goal. It is included here only for FY 99 reporting. There is no similar goal in FY 00 or FY01. An essential component of a comprehensive strategy to enhance food safety is the development of an arsenal of rapid and sensitive test methods for detecting pathogens. Real-time detection methods developed will be useful for verification of critical control points to minimize microbial contamination from the 'farm to table'.
• Data Sources: Periodic management and peer reviews
• Performance: In August 1999, FDA finalized and distributed the Three-Year Plan for Research in Support of the National Food Safety Initiative and Produce and Imported Foods Safety Initiative - 1999-2000 Update.

19. 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. (11013)

• Context of Goal: This is the FY 99 goal. It is included here only for FY 99 reporting. There is no similar goal in FY 00 or FY01. An important element in controlling foodborne illness is to improve risk assessment methods for foodborne pathogens that would help regulators better characterize the nature and magnitude of risk to humans and make decisions on how best to allocate resources to control those hazards. In FY 99, FDA's risk assessment was conducted to determine how frequently Listeria monocytogenes occurs and in what amounts they occur in certain foods, particularly ready-to-eat foods, and what populations were susceptible to illness as a result of their exposure, the severity of illness, and how much of the pathogen a person had to consume before becoming ill. A similar risk assessment was undertaken for Vibrio parahaemolyticus. The risk assessment for and Vibrio parahaemolyticus in raw molluscan shellfish will provide the scientific framework for developing food safety guidance and policies to reduce the risk of diseases from this seafood borne pathogen. The risk assessment for Listeria monocytogenes will provide the scientific information needed to develop policies to create effective programs designed to minimize the public impact of this pathogen.
• Data Sources: Periodic management and peer reviews
• Performance: In FY 99, FDA completed the draft risk assessments for Listeria monocytogenes and Vibrio parahaemolyticus and sent them to the Risk Assessment Consortium.

20. Work with industry and academia to develop new techniques for eliminating pathogens on sprouts and in citrus juice and apple cider. (11014)

• Context of Goal: This is the FY 99 goal. It is included here only for FY 99 reporting. There is no similar goal in FY 00 or FY01. The processing of commercial produce is a rapidly expanding industry that offers convenient products with fresh-like qualities. Preservation and extension of shelf life for produce is frequently achieved through refrigeration, bactericidal rinses, modified atmosphere packaging and other technologies. To assure the safety of minimally processed produce, FDA is accumulating information on the effect of environmental and food formulation factors on the growth and survival of pathogenic bacteria that may be present. For example, the resident microflora on produce, which can vary by product, can alter the growth rates of pathogens on produce. In addition, the growth of pathogenic bacteria during germination of sprouted seeds may greatly increase the risk of foodborne illness. The results of these research efforts will serve as a basis for developing guidelines for produce handling and intervention technologies for minimizing bacterial contamination. As part of the FSI research program, the Agency has developed effective collaborations with industry and academia to achieve specific research goals and objectives.
• Data Sources: Periodic management and peer reviews
• Performance: In FY 99, FDA generated data on the presence of S. aureus on three types of domestic sprouted seeds, including alfalfa, mung beans and mustard. The Agency also began testing imported sprouted seeds from the Import Compliance Program. Finally, the Agency awarded several research grants to major universities to develop critical data on pathogens.

21. 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. (11015)