U.S. Food and Drug Administration
Performance Plan
2002

2.1 FOODS

2.1.1 Program Description, Context, and Summary of Performance

Total Program Resources:

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; 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.

On January 3, 2000, CFSAN set forth its overall dietary supplement strategy. This strategy is built on the foundation of law and science. This strategy establishes a clear program goal to accomplish, by the year 2010, having a science-based regulatory program that fully implements the Dietary Supplement Health and Education Act of 1994, thereby providing consumers with a high level of confidence in the safety, composition, and labeling of dietary supplement products.

FDA will continue to seek additional resources for initiatives identified in this plan through the established budget process. The success of this strategy will not only depend on adequate funding levels, but also on FDA's new and continued partnerships with other governmental agencies, academia, health professionals, industry, and consumers. FDA will continue its outreach to stakeholders to enhance two-way dialogue, establish stronger working relationships, leverage resources, and communicate dietary supplement information. On July 6, 2000, FDA issued an import alert for bulk or finished dietary supplements and other products that may contain aristolochic acid. Aristolochic acid is a potent carcinogen and nephrotoxin. Products containing aristolochic acid cause renal damage and can cause or contribute to renal failure. Its nephrotoxic potential has been shown in animals and has been demonstrated in humans in both case reports and in at least one human clinical study. Products that contain a large amount of aristolochic acid have been documented to result in the rapid onset of acute toxicity symptoms. Outbreaks of aristolochic acid-associated renal failure have been reported in several countries, including Belgium, France, Spain, Japan, Australia, and the United Kingdom. Recent chemical analysis of currently marketed Chinese herbal medicines and dietary supplements by British and Canadian health authorities identified products that contained aristolochic acid. However, the labels of the products did not indicate that they contained an ingredient known to contain aristolochic acid. This indicates that there is a potential for dietary supplements and some traditional herbal medicines to inadvertently be formulated using aristolochic-acid containing ingredients. FDA is aware that these and similar products are being sold in the United States.

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, bioengineered foods, and dietary supplements, while assuring their safety.
• Reduce the health risks associated with food and cosmetic products by preventing human exposure to hazards, monitoring product quality and correcting problems that are identified.

By striving toward these two goals, FDA will assure the quality of food ingredients, dietary supplements, bioengineered foods, 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.

2.1.2 Strategic Goals

Provide consumers quicker access to new food ingredients, bioengineered foods, and dietary supplements, while assuring their safety.

A. Strategic Goal Explanation

The Foods premarket review program focuses on food and color additive petitions, dietary supplements, substances that are generally recognized as safe (GRAS), and bioengineered foods. Under the FD&C Act, FDA must review the safety of food and color additives before food manufacturers and distributors can market them. To initiate this review, sponsors are required to submit a petition or notification 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 a notification program for substances that are GRAS. Finally, the Agency consults with developers of foods derived from bioengineered plants to ensure that all safety and regulatory questions are resolved prior to marketing, and has proposed a mandatory premarket notification program for these foods.

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)
• Respond to dietary supplement notifications within 75 days (Performance Goal 3-11025) … Give priority to those additives that are intended to decrease the incidence of foodborne illness
• Improve management systems
• Recruit and hire reviewer-scientists (including professionals with the special skills to evaluate dietary supplements and food and color additives, such as medical doctors, consumer safety officers, chemists, botanists, herbalists and toxicologists)
• Conduct specific research to develop science-based policies for effective regulation and effectively communicate any risks associated with bioengineered foods
• Use contract personnel for some petition reviews

B. Summary of Performance Goals

C. Goal-by-Goal Presentation of Performance

1. Complete first action on 65% 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 02; 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 a notification process for food contact substances. The premarket notification program began to fully operate on January 18, 2000. Several factors will influence future performance on the goal of completing first action on 65% of food and color additive petitions within 360 days. The most important of these factors is the implementation of the new premarket notification process. By FY 01, 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. Similarly, the premarket notification program may also initially increase the fraction of pending petitions that are overdue because many recently submitted petitions for food contact substances will have been converted to notifications. 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 beginning in FY 02.

• Data Sources: CFSAN's electronic workflow system
• Performance: The data for FY 00 will be available October 2001. In FY 99, FDA exceeded its goal of completing the review of 30% , respectively, of food and color additive petitions within 360 days. Continued progress to full performance on this goal is dependent on the continued provision of adequate resources to the food and color additive review program. With the continued provision of necessary resources, the Agency can continuously improve performance in the review of food and color additive petitions by gradually hiring and training highly qualified personnel. In addition, FDA will complete testing and initiate the operation of a document tracking and workflow system that will track progress toward full performance and provide detailed information on the status of petitions and FDA tasks to be completed.

2. Reduce the number of remaining overdue food and color additive petitions by 50%. (11002)

• Context of Goal: This goal has been revised since FY 99. 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. In the past, 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%. This goal was not met in part because of the significant gains in timeliness of review of recently submitted petitions (see goal 1), so that action was completed on many petitions that were not overdue. To continue its progress on reducing the percentage of overdue petitions under active review, in FY 00 the Agency focused on those petitions that are most overdue (four years).

  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. More than 50 product sponsors have already converted 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 targets for FY 00 and FY 01 similar to the one set in FY 99; rather, as noted above, we are focussing on clearing the oldest petitions in the inventory. As the notification program is fully implemented, we expect that many of the simpler food additive petitions that were previously often 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 implementation of the premarket notification program may also increase the initially increase the percentage 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: As noted above, in FY 00, the Agency focussed on reducing the number of petitions that were overdue by more than four years. These petitions often present particularly problematic issues for the Agency. In FY 00, we completed action on 11 of 25 such petitions. Also, during FY00, we reduced the total number of food and color additive petitions in the inventory from 147 to 66.

3. Respond to 95% of notifications for dietary supplements containing "new dietary ingredients" within 75 days. (11025)

• Context of Goal: Within 75 days, FDA reviews notifications for new dietary ingredients that will be part of dietary supplements. 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 95% target is considered full performance in FY 02.
• 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". In FY 99 FDA received and responded to 100%. In FY 00, FDA received and responded to 24 notifications for new dietary ingredients.

4. Complete processing of 85% 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 01. 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 00, FDA made substantial progress toward the goal of publishing a final rule for this program. However, due to resource restraints and competing priorities the rule was not finalized.

5. Complete review of 100% of premarket notifications for food contact substances within 120 days. (11034)

• Context of Goal: As provided in the Food and Drug Administration Modernization Act (FDAMA), the Agency was mandated to establish a premarket notification program for food contact substances as a vehicle to re-inventing the premarket review process for food and color additives. The Congress appropriated resources in FY 2000 to fully fund this Program, and the first notifications became effective in March 2000. The statute provides that a food contact substance notification shall become effective (i.e., the food contact substance may be lawfully marketed) 120 days after receipt unless the agency objects that the use of the food contact substance has not been shown to be safe. Thus, to ensure that unsafe food contact substances do not enter the marketplace, the program goal is to review all notifications within 120 days. Doing this will require that adequate resources continue to be provided for this program.
• Data Sources: CFSAN's electronic workflow system; Internal Office of Pre-Market Approval database.
• Performance: In FY 00, the Agency completed review of 82 of 83 notifications for food contact substances within 120 days.

6. Publish a final rule to require premarket notification for bioengineered foods.

• Context of Goal: Currently, FDA has a voluntary process through which companies marketing bioengineered foods consult with the Agency on safety and other regulatory issues. FDA believes no safety problem exists with any genetically engineered food that is currently on the market. However, as part of a government-wide initiative to strengthen science-based regulation and improve public access to information about bioengineered foods, FDA has proposed a regulation that, if finalized, would require developers of bioengineered foods to notify the agency 120 days prior to marketing a new bioengineered food (66 FR 4706; January 18, 2001). As part of the proposed rule, FDA would make available, through an Internet-based electronic reading room, the information provided by the developer to FDA. FDA also would update its food biotechnology Internet site to make more information available to the public, including FDA's memoranda of evaluation and letters to sponsors of bioengineered foods. FDA took this action because it expects that biotechnology methods are likely to be used to an increasingly greater extent by plant breeders, and because it expects that the products of this technology are likely in some cases to present more complex safety and regulatory issues than has been seen to date.
• Data Sources: Federal Register; FDA's Internet site
• Performance: FDA already has issued a proposed rule to require premarket notification for bioengineered foods. The proposed rule, if finalized, will ensure that FDA has the appropriate amount of information about bioengineered foods to help to ensure that all market entry decisions by the industry are made consistently and in full compliance with the law. The proposed action will permit the agency to assess on an ongoing basis whether plant-derived bioengineered foods comply with the standards of the Federal Food, Drug, and Cosmetic Act. FDA also has already updated its Internet site to provide more information about bioengineered foods that the agency has evaluated under the current, voluntary process. At the halfway point in the comment period, FDA had received more than 1000 comments on the proposed rule. In order to complete the goal, FDA must analyze the comments and determine whether the complete administrative record of the rulemaking (including the comments) supports the requirement as proposed. If the complete administrative record supports the issuance of a final rule, FDA intends to issue a final rule by the end of FY 2002.

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

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 01, 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

B. Summary of Performance Goals

C. Goal-by-Goal Presentation of Performance

7. Achieve adoption of the Food Code by at least one state agency in 28 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 adopted the Food Code. State agencies achieving adoption of the Food Code were: Minnesota, Rhode Island, New Hampshire, Missouri, North Dakota, South Dakota, Nebraska, Mississippi, Texas, Florida, Kansas, Florida, Utah, Arizona and Iowa. In FY 00, agencies in 20 states have adopted the Food Code. This exceeds FDA's goal of 18 states adopting the Code.

8. 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: There were approximately 3600 domestic seafood processors in the first round of inspections. In FY 99, 56% of these processors met all the criteria for operating a functioning HACCP system. A recent GAO report indicated that there were fewer than 50% of these processors that had fully developed HACCP plans. The reason for a lower figure for plans than for complete systems is because a significant percentage of processors did not need plans as part of their HACCP systems. 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 or to prevent microbial contamination of seafood produced in the United States. As a consequence, in FY 00, this goal was combined with the performance goal that relates to conformance rates resulting from the inspection of domestic food establishments (Performance Goal 10).

9. 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 defined high-risk establishments as those producing foods with the greatest risk for microbial contamination and those foods requiring specific components for a safe and nutritious product. Foods following under this definition were infant formula, medical foods, scrombotoxic seafood, molluscan shellfish, low acid canned and acidified foods, ready to eat foods such as processed fresh fruits and vegetables, bakery goods (with filling), soft and soft ripened cheeses, cooked pasta dishes, prepared salads and heat and serve products. Based on this definition, the Agency estimates that there are approximately 7,000 such establishments in its establishment inventory. In FY 01, the number of high-risk establishment inspections conducted annually will be increased to include coverage of the entire inventory. 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. In FY 02, the entire high-risk establishment inventory is expected to increase and thus the target for FY02 has been changed from 90 -100% to at least 95%, to anticipate the level of increase in the number of high-risk establishment inspections.
• Data Sources: Field Data Systems
• Performance: In FY 00, the number of high-risk food inspections was approximately 5700.

10. 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 to prevent microbial contamination of seafood produced in the United States. As a consequence, in FY 00, the performance goal relating to conformance of the domestic seafood industry with HACCP (Performance Goal 8) was combined with the performance goal for that relates to conformance rates resulting from the inspection of domestic food establishments (Performance Goal 10)
• 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. FDA inspections of domestic food establishments, in conjunction with the timely correction of serious deficiencies identified in these inspections, resulted in a 97% rate of conformance in FY00.

11. Increase the number of import exams of 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: There were 56,300 import exams of products conducted in FY00.

12. 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.

13. Maintain current level of monitoring for pesticides and environmental contaminants in foods through the collection and analysis of a targeted cohort of 8,000 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 8,500 pesticide and contaminant samples. These samples included 3,600 domestic and 4,900 imports. In FY 99, the Agency analyzed a total of 9,400 pesticide and contaminant samples. These samples included 3,400 domestic and 6,000 imports. In FY 01, FDA expects to analyze 8,000 plus. 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 was a new commitment in FY 01.

2.1.3 Verification and Validation

Public health data systems currently are not adequate to provide accurate and comprehensive baseline data needed to draw direct relationships between FDA's regulatory activities and changes in the number and types of foodborne illnesses that occur annually in this country. Because of the need to have better data on food related illnesses, FDA and USDA began working with CDC in 1995 to improve food safety surveillance. FoodNet, an active surveillance program, was created through this joint effort. Currently there are eight FoodNet sites.

These sites, which operate in areas that are representative of the geographic and demographic population distributions in this country, provide much better data on the number of foodborne illnesses and trends in terms of the types of contaminants that are causing these illnesses. This type of information can be critical to efforts by food safety agencies to redirect their regulatory and research resources to those food safety problems that pose the greatest threat to the health of consumers. Moreover, in 2002 when the data will be sufficient in volume and quality to establish baselines against which to measure changes in foodborne illnesses, FDA will be in a better position to establish broad scope outcome goals that are essential to effective performance planning.

Food Safety regulation development and research activities are planned and tracked through internal management systems. Progress on the development of regulations is tracked mainly through CFSAN's document tracking system and the Federal Register document tracking system. These systems permit the Agency to track the processing of regulations from the time they are filed to the point at which action is complete-usually the publication of a final regulation in the Federal Register.

CFSAN uses a number of internal data systems to track premarket review progress. These include the Management Assignment Tracking System (MATS) to track progress of petition reviews, Correspondence Tracking System (CTS) to track progress on biotechnology consultations, reviews of GRAS notifications, nutrient content claims, and health claims petitions/notifications. Outcome-oriented performance information can be extracted from MATS only by a labor-intensive manual process. CFSAN's internal data systems are limited to tracking time to a completed review and do not have the capability to track distinct phases of the review process. In FY 98, the Office of Premarket Approval's (OPA) internal database was modified to permit more detailed tracking of CFSAN's action on biotechnology consultations. In FY 99, CFSAN implemented an electronic workflow system that will replace MATS and CTS and permit real-time monitoring of review progress. The electronic workflow system is expected to be in full use in FY 01. The new system will track automatically actions related to the processing of food and color additive petitions, GRAS petitions and biotechnology consultations.

FDA uses a variety of data systems to develop and verify performance goals for its food safety activities. Among these are several field data systems. The most important of the field data systems are the Program Oriented Data System (PODS) and the Operational Administrative System for Imports (OASIS). PODS tracks field activities conducted by FDA's field force and the firms over which FDA has legal responsibility. Information provided by this system includes data on the number of inspections, wharf examinations, sample collections and analyses as well as the time spent on each. OASIS, which is coordinated with the U.S. Customs Service, provides data on what products are being imported as well as where they are arriving. It also provides information on compliance actions related to imports. In FY 01, the Field Accomplishments Tracking System (FACTS) will be the primary mechanism for tracking compliance activities for the domestic food industry. The National Seafood HACCP Compliance Database System maintains information on seafood HACCP inspections conducted by FDA and states in partnership with FDA. Standardized forms (Cardiff forms) assure comparability of HACCP compliance data whether FDA or states conduct the inspections. Another field data collection instrument is the field survey. Field surveys are special assignments that are developed and implemented specifically to collect information needed to more thoroughly evaluate the nature and extent of particular postmarket food safety problems.

Data are also gathered through a number of other surveys designed for specific purposes. These include the Health and Diet Survey that provides information required to evaluate the impact of the Agency's food labeling activities. These surveys include questions that are designed to query consumers on how they use food labeling information to make decisions to use or purchase food products. Another survey is the NASS survey currently being developed jointly by FDA and USDA to evaluate the impact of GAPs and GMPs for improving the safety of fresh fruits and vegetables. The survey questions will be designed to provide data on practices employed in the production and processing of fresh fruits and vegetables. The results of the NASS surveys will be used to establish baselines for industry practices as well as evaluate the impact of voluntary GAPs and GMPs on improving production and processing practices for fresh produce.

Comprehensive data on illness caused by food and cosmetic products is critical to efforts to protect the health of consumers. Some of the illness data are provided by databases that contain information on adverse events, reported by consumers and industry on food and cosmetic products. In FY 01, the Agency will begin improving the quality and accessibility of data on adverse events through the development and implementation of a new adverse event reporting system for dietary supplements. In FY 02, the Agency will build upon the system nodule for dietary supplements by developing and implementing an integrated adverse reporting system for all food and cosmetic products.

Proposed research projects are subjected to management reviews prior to implementation and periodic management reviews after the projects have been initiated. The primary planning and management system for food safety research is the Center Program Resources (CPR) plan system that provides quarterly resource use reports and semi-annual reports on accomplishments versus planned milestones. In FY 00, the Center formed a research management task group responsible for evaluating related processes and systems and developing recommendations for improvement. In addition, research projects are subjected to periodic external peer reviews. Peer reviews by recognized scientific experts in various disciplines related to food safety provide objective feedback that helps FDA evaluate the progress, quality and relevance of its research activities. In addition, risk assessment models are verified periodically using statistical models that assess their ability to make rapid and accurate estimates of risks associated with a particular food safety hazard.

In FY 99, the Center began implementation of its Resource Planning, Prioritization, and Allocation Process. The primary purpose of this Process is to provide pertinent data throughout the fiscal year on program activities, including GPRA performance goals, Center program priorities, Congressional directives, statutory responsibilities under FDAMA, and Food Safety Initiative objectives.

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