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2.1.1 Program Description, Context and Summary of Performance

The FDA's Foods Program is responsible for ensuring a safe, nutritious, wholesome, 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 safety 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.

Current 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; and,
• The dietary supplements industry has grown dramatically, as has consumption of dietary supplements.

However, 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, 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, providing information for sound nutrition choices, and correcting problems that are identified.

By striving toward these two goals, FDA will assure the safety and 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.

2.2.2 Strategic Goal Components

Strategic Goal Component 1:
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 FDA has proposed a mandatory premarket notification program for these foods.

The Food Program's key challenge in the premarket area is to expeditiously review 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 premarket notifications for food contact substances within the statutory time frame (Performance Goal 4-11034)
• 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
• 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

Performance Goals	Targets	Actual Performance	Reference
1. Complete review and action on the safety evaluation of 75% of food and color additive petitions within 360 days of receipt. (11001)	FY 04: 75% FY 03: 65% FY 02: 60% FY 01: 50% FY 00: 40% FY 99: 30%	FY 04: FY 03: FY 02: 10/03 FY 01: 70% of 10 FY 00: 91% of 99 FY 99: 77% of 50	4
2. Respond to 95% of notifications for dietary supplements containing "new dietary ingredients" within 75 days. (11025)	FY 04: 95% FY 03: 95% FY 02: 95% FY 01: 90% FY 00: 90% FY 99: NA	FY 04: FY 03: FY 02: 99% of 44 FY 01: 100% of 22 FY 00: 100% of 25 FY 99: 100% of 23	4
3. Complete processing of 80% of GRAS notifications within 180 days. (11003)	FY 04: NA FY 03: NA FY 02: NA FY 01: 80% FY 00: Finalize GRAS Rule late in year or early 01 FY 99: Finalize the rulemaking creating a premarket notification process for independent GRAS determinations.	FY 04: FY 03: FY 02: NA FY 01: roughly 80% of 27 FY 00: made progress toward finalizing GRAS rule FY 99: rule not completed, no measurement	4
4. Review 95% of premarket notifications for food contact substances within the statutory time limit (120 days). (11034)	FY 04: 95% FY 03: 95% FY 02: 95% FY 01: NA FY 00: NA	FY 04: FY 03: FY 02: 100% of 70 FY 01: 100% of 82 FY 00: 99% of 83	4
TOTAL FUNDING: ($ 000)	FY 04: 40,296 FY 03: 42,474 FY 02: 43,260 FY 01: 39,850 FY 00: 39,661	Numbers in the Reference column corresponds to the relevant strategic goal in the HHS Strategic Plan

C. Goal-By-Goal Presentation of Performance

1. Complete review and action on the safety evaluation of 75% of food and color additive petitions within 360 days of receipt. (11001)

Context of Goal: In this goal, performance is defined in terms of a review of all parts of a petition. This review would be followed by issuance of a "not approvable" letter, or by publication of a response in the Federal Register, if appropriate.
This goal refers to completion of the safety evaluation of food and color additive petitions. This includes a review of the information in a filed petition, and one of two conclusions reached: either the petition does not support the requested action and a letter to that effect is transmitted to the petitioner with an explanation of why we reached the conclusion; or based on the review, we are prepared to recommend to the agency officials authorized to sign an order, that the use of the additive be approved (or denied), and communication of this information to the petitioner. It does not include the time to get the order and accompanying rationale for our decision reviewed, signed, and published in the Federal Register.
Almost uniquely among products FDA regulates, food and color additives are not permitted to be marketed by means of correspondence from the agency to the petitioner (except in the case of food additives that are food contact substances, see below). Rather, the statute provides that the agency must, using formal rulemaking, publish in the Federal Register an order laying out the conditions by which anyone (not just the petitioner) may use a food or color additive, or an order denying the request to use a food or color additive, with an explanation in each case of how we came to our conclusions. (Alternatively, a petitioner may choose to withdraw a petition. In that case, the Agency publishes a notice of the withdrawal in the Federal Register). The law also provides a variety of administrative remedies to those who object to FDA's order to permit, or deny, use of a food or color additive, these include stays and administrative hearings. (For example, in the case of a color additive order, any objection automatically stays the regulation). Although objections are not routine, when they occur, they necessitate further "action" on the part of the agency. However, we, and our stakeholders, have considered publication of an order in the Federal Register as "final action".
We have used the time to complete the evaluation of a petition as the goal because it is relatively unambiguous and measurable. It is also the part of the entire process that is most within the control of the organizations responsible for administering the food and color additive petition review process, and thus most amenable to improvement by those organizations. Publishing an order in the Federal Register is subject to factors outside the agency's control. (For example, the statute requires public notice of filing of food and color additive petitions; comments to such filing, which must be reviewed and possibly responded to, may be submitted at any time prior to publication.) Completion of the safety evaluation is also the step that is most analogous to final action in the case of the dietary supplement and food contact substance premarket review processes. Because stakeholders are most interested in publication of a final order, we recognize the need to make all involved parties accountable for reducing the total time to publication as much as possible.
The 360-day time frame used in this goal is not the same as 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 a report from a June 1995 House hearing and FDA recommended a change from the statutory time frame to '360 days of receipt' in a testimony before the House Committee on Government Reform and Oversight in 1996.
Subsequently, the Food and Drug Administration Modernization Act (FDAMA) established a notification process for food contact substances. The premarket notification program began to operate fully on January 18, 2000. With the full implementation of the premarket notification program, many of the simpler food additive petitions that could have been completed within 360 days are being filed under the notification program, thus decreasing the workload for this goal. However, since the remaining petitions are likely to be more complex and take more time to review, the Agency anticipated that performance on this goal could decline initially. Once the notification and the recent improvements to the petition review process are well established, FDA expects performance on this goal to increase substantially toward full performance in succeeding years.
Performance: In FY 2000, FDA exceeded its goal of completing the review of 40%, respectively, of food and color additive petitions with 360 days. The high performance figures in 1999 and 2000 do not presage similar numbers in later years. This is primarily because Congress passed, under the FDA Modernization Act of 1997, and implemented in FY 2000, the Food Contact Substance Premarket Notification Program. As a result, we are now receiving far fewer petitions than in previous years. Those that we do receive are for direct food additive uses of greater potential public health significance, which generally take more time and effort per petition to complete. In addition, as the new PMN program was being implemented, many pending petitions for food contact materials were withdrawn, leading to "completed actions" on many petitions. This artifact led to the increased performance figures for the receipt cohorts of FY 1999 and FY 2000. This is, however, a one-time phenomenon. We have conducted a careful analysis of these trends in recent years. Based on all available data, including receipt of far fewer (but generally far more labor intensive) petitions than in previous years, we project that completing review of 65% of food and color additive petitions in 360 days for the 2003 receipt cohort is a fair and challenging level of performance. For the petition receipt cohort of FY 2001, completed the safety evaluation in less than 360 days for 7 out of 10 (70%) food and color additive petitions that do not qualify for expedited review. This meets our goal to complete 60% of these petitions within 360 days.
Data Sources: CFSAN's electronic workflow system

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

Context of Goal: FDA reviews premarket notifications for new dietary ingredients (NDI) of dietary supplements. Once the notification is received it is reviewed for completeness and justification of safety. A letter is issued to the submitter acknowledging receipt of the notification and raising safety concerns if identified. This represents final action. This letter and notification are filed in Dockets Management Branch 90 days after receipt of the notification. This is the end of the process. The number of notifications the Agency has received in FY 2002 to date has more than tripled compared to what it received in FY 2001 (i.e., receipt of approximately 50 notifications for FY 2002 as of August 2002 versus receipt of 16 notifications in FY 2001). The complexity of the notifications also has increased in recent years. Nevertheless, the Agency will retain its review goal target of 95% for FY 2003 and FY 2004. Since the Agency does not know precisely what the workload will be in any given year, the 95% target is considered full performance the next two fiscal years. Additionally, in response to the additional regulatory responsibilities placed on FDA by the Dietary Supplement Health and Education Act of 1994 (DSHEA), FDA has also developed a Strategic Plan for implementing those responsibilities both in the premarket and postmarket areas. FDA's goal is to have a science-based regulatory program that will provide the Agency with the ability to successfully implement and carry out the regulatory responsibilities imposed by DSHEA within ten years, thereby providing consumers with a high level of confidence in the safety, composition, and labeling of dietary supplement products. The success of this strategy will, however, not only depend on adequate funding levels, but also on FDA's new and continued partnerships with other government agencies, academia, health professionals, industry, and consumers. FDA's FY 2004 OMB Budget Submission includes $2 million for implementation of the Agency's Dietary Supplement Strategic Plan.
Performance: FDA has completed 100% of its reviews of NDI notifications within the 75-day deadline from FY 1998 - FY 2001. Due to the overlapping nature of a 75-day period, a notification review may be completed during the same or following fiscal year in which it was received. In addition, a notification may be received prior to the fiscal year in which the review was completed. Based upon this scenario, the following data represents the actual number of NDI notification reviews completed within the stated fiscal year: 20 in FY 1998; 23 in FY 1999; 25 in FY 2000; and 22 in FY 2001. In FY 2002, the Agency reviewed 44 notifications for new dietary ingredients. All except one were reviewed within the 75-day statutory timeframe. Of the 44 notifications reviewed, 10 were filed without comment; 3 were filed with comments; and 31 were filed with objection (3 of the 31 were not dietary supplements and the remaining 28 notifications had one or more of the following deficiencies: did not meet minimum requirements of 21 CFR 190.6; did not provide an adequate basis that the new dietary ingredient was reasonably expected to be safe; or made disease claims for the new dietary ingredient, thereby representing if as a drug).
Data Sources: CFSAN's Correspondence Tracking System and manual tracking

3. Complete processing of 80% of GRAS notifications within 180 days. (11003)

Context of Goal: (Goal Dropped for FY 2002, 2003 and 2004). GRAS notification is a new program and the final rule creating a premarket notification process for independent GRAS determinations is planned for publication (The final rule on the GRAS Notification Program has been completed and is currently awaiting review and clearance from the Office of Chief Counsel (OCC). 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.
Performance: CFSAN responded to 59% of GRAS notices received in FY 2000 within 180 days. In FY 2000, 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. In FY 2001, 21 of 27 (roughly 80%) GRAS notices received were completed in less than 180 days. The final rule on the GRAS Notice Program has been completed and is currently awaiting review and clearance from the Office of Chief Counsel (OCC).
Data Sources: CFSAN's electronic workflow system; Internal Office of Pre-Market Approval database.

4. Review 95% of premarket notifications for food contact substances within the statutory time limit (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. "Final action" is used in the case of food contact substances because nothing more needs to be done before the substance can be legally marketed, unless we object, which is also a final action.
Performance: In FY 2000, the Agency completed review of 82 of 83 notifications for food contact substances within 120 days. In FY 2001, the Agency received 80 notifications and completed review of 82 notifications, all within 120 days of receipt. The number reviewed includes those that became effective or were withdrawn or placed in abeyance because of deficiency during the previous fiscal year. In FY 2002, the Agency completed review of all (70) premarket notifications for food contact substances in the receipt cohort of FY 2001 within 120 days.
Data Sources: CFSAN's electronic workflow system; Internal Office of Pre-Market Approval database.

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 the need to:

• Work 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;
• Encourage 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;
• Work with foreign countries exporting food and cosmetic products to the U.S. to ensure the implementation of comparable safety standards; and,
• Conduct consumer education and industry education aimed at disease prevention.
• Be prepared to develop new prevention control systems rapidly in response to the emergence of new public health concerns.

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 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.

FDA has requested increased funding in FY 2004 to initiate a grants program with the states under provisions of the recently passed Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Grants to states are intended to prepare that part of the Nation's Food Safety System to better defend the food supply from terrorist threats and other challenges to public health and safety. The performance goal proposed to focus this initiative is outlined below.

Proposed Performance Goal: Enhance states' ability to protect the U.S. food supply from terrorist threats and other health and safety challenges by:

• Increasing surge capacity and sample testing capability in 8 state laboratories; and,
• Increasing the number of risk-based inspections conducted by states by 1,200 state inspections in FY 2004 for a total of 10,500.

Laboratory Analysis
Grants will be awarded to states to enhance their laboratory analysis capacity in order to respond to both terrorist threats and traditional food safety hazards. These labs would join the larger food laboratory response network and be coordinated with the overall public health laboratory information effort. The state labs would address all foods for biological, chemical and radiological issues. Each lab will be capable of doing all three, which makes this different from the long tem goal.

Grants would be targeted to an initial pool of labs in the following areas:

• Training - This would include overview of BT issues, sampling and shipment techniques, specific analytical methods and techniques, safety/environmental issues, etc;
• Proficiency samples - These samples would have to be designed, manufactured, and implemented to test the laboratories' ability to analyze food samples for these agents. They would be sent out quarterly to each of the Grant Labs;
• Reagents, expendables and equipment - As new methods are developed for these agents the labs will need the tools to run the samples;
• Facility maintenance - Due to the exotic nature of these agents considerable care must be taken to assure that the analysts are protected and the community around the test site is protected. This requires sound well-maintained facilities. This is particularly true for the BL-3 facilities, which may be required for some of the agents.
• Method extension - While there are plans to develop the actual methods at research organizations, considerable work will be done on both validation on a limited number of commodities and continual testing to expand the method to other commodities. This work can and should be performed by the labs who are responsible for the testing; and
• Laboratory accreditation and proficiency testing.

Inspections
Grants will also be used for examinations, inspections, investigations and related activities in several food areas. The number of agreements and funding will be increased each year beginning with FY04 to the maximum level in FY06. The grants, in the form of cooperative agreements will supplement the existing state contract program. This new initiative will allow the Agency to achieve a level of 10,500 state food manufacturing, processing, and wholesale inspections annually by 2004 and expand the number of states participating from 37 to the maximum number of states that would be interested in participating. The grants would also improve the equivalence of state programs with federal inspection programs, develop a consistent level of trained staff and achieve program uniformity through audits and oversight by FDA.

Adverse Event Reporting

Once food and cosmetic products are available to consumers, it is important to monitor and evaluate adverse events associated with the 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. 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 first received in FY 2001, 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; and,
• 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

5. Perform 48,000 physical exams and conduct sample analyses on products with suspect histories. (11036 - this goal is repeated as number 19014 in the Agency Wide section)

Context of Goal: In FY 2004 FDA will focus much of its resources on examination and follow-up on import shipments that pose the highest potential risks. Increases in the number of physical examinations will not continue to grow at the rate expected in FY 2002 and 2003. Given the continuing explosion in number of import shipments to this Country, it is not realistic to expect that FDA can keep up with the volume by simply expanding the number of physical examinations. Rather, a significant effort will be launched to develop the appropriate knowledge-based approaches that will give the Agency assurance that it is, in fact, addressing the most serious risks. Finding these risks is a great challenge considering that FDA-regulated imports have grown at 10 to 12% annual rate for several years, and may originate in any of more than 100 countries, many of which have regulatory systems in place which are much more primitive than that found in the U.S. The risk has now been exacerbated in light of security concerns raised by terrorism and counterfeiting incidents.
During FY 2003 FDA will develop a more robust physical examination approach that merges the assessment of information integrity with the safety and security of the product. By FY 2004 FDA will have in place a new version of the import field exam. The new exam will routinely include: verification that the imported product is the same as that which was declared; assessment of security concerns related to labeling and source country; and traditional safety concerns. More importantly, these new exams will be conducted on import entries selected using a more rigorous risk assessment and management rubric. FDA will be developing during FY 2003 the criteria and, to the extend possible, the computer systems to be able to better identify, obtain, process, assimilate, and deliver data relating to an imported product's safety and security. This data will be delivered in a more meaninful and timely fashion to the primary decision makers in FDA's import process located at the borders and throughout the country monitoring imports electronically through OASIS. During FY 2003 FDA will pilot various features to develop a feasible implementation process, and to develop better time estimates so that appropriate resources can be matched with the revised approach. FDA will use a risk-based system to target suspect problem areas. Such areas may include:

• Filer Evaluation Field Audits;
• Pilot with filer evaluation, importer/trader inspections;
• Warehouse blitz programs;
• Transshipment-targeted field examinations;
• Sample collection and analysis for Counterterrorism;
• Implementation of program with Canada and Mexico to enhance advanced identification of transshipped cargo; and
• Expand in-bond entry evaluation including performing examinations of in-bond entries at port of arrival and port of entry or export.

During FY 2003 FDA will gather information about the number and characteristics of these potential targets so that by FY 2004 pilot programs can be identified with enough examination of each type so that practices can be revised again in subsequent years to reflect lessons learned. FDA anticipates that the measures that it uses to assess its success in monitoring the safety and security of imported products will continuously evolve as trade practices and information about risks change. During FY 2003 FDA will also decide on the appropriate methods including summary categories, if appropriate, that are best suited to track various components of this goal. Additional risk based candidates may be identified that will require further pilot studies in FY05 and later.
Performance: This goal was new for FY 2002 and FY 2003. The FY 2002 performance was 800 new investigators and analysts hired and 34,447 physical exams conducted. The FY 2001 baseline was 12,169 physical exams. The FY 2002 goal targets 24,000 exams that target doubles to 48,000 in FY 2003. The FY 2004 goal remains at 48,000 because resources will be devoted to targeting and following through on suspect import entries rather than significantly expanding import coverage.
Data Sources: Field Data Systems

6. Achieve adoption of the Food Code by at least one state agency in 43 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.
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.
The Food Code is a component of an even larger effort aimed at decreasing foodborne illness, the National Retail Food Regulatory Program Standards program. In FY 2004, FDA will assist state programs and provide oversight in implementing the Standards program, and complete the data compilation of the national baseline data collected by CDC during FY 2003. Additionally, FDA plans to enroll 60 new jurisdictions in the Standards and baseline program in each year FY 2004 through FY 2009, while continuing to provide support and guidance to those 120 jurisdictions already enrolled. FDA will conduct audits of those enrolled in the Standards program in accordance with the Standards protocol.
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 1999, 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 2000, agencies in 20 states have adopted the Food Code. In FY 2001, at least one state agency in 28 states adopted the Food Code. In FY 2002, at least one state agency in 40 states adopted the Food Code.
Data Sources: Field Data Systems

7. Inspect 95% of estimated 7000 high-risk domestic food establishments once every year. (11020)

Context of Goal: 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. High-risk establishments are manufactures, packers/repackers, and warehouses processing products that include: modified atmosphere packaged products; acidified and low acid canned foods; seafood; custard filled bakery products; soft, semi-soft, soft-ripened cheese and cheese products; un-pasteurized juices; sprouts or processed leafy vegetables; fresh vegetables shredded for salads and processed root and tuber vegetables; sandwiches; prepared salads; infant formula; and medical foods.
During the course of FY 2002 additional high-risk products were identified that had not previously been included in the base FY 2002 high-risk inventory. These include establishments that manufacture a product that may contain a commonly allergenic substance (milk, eggs, fish, crustaceans, tree nuts, peanuts or soybeans), and dietary supplements that may contain bovine derived ingredients from BSE countries identified in the USDA regulation (9 CFR 94.18). Although the official FY 2003 establishment inventory will still be 7000 when we start, we expect that the inventory will increase as firms manufacturing products that contain allergenic substances and firms that manufacture dietary supplements that may contain bovine ingredients for BSE countries are confirmed.
A history of repeated incidence of a pathogen or a high level of a contaminant in a food product that results in acute or life threatening illness warrants consideration for high-risk designation. Until recently, risk assessments that characterize the hazard and associated foods have been based on historical information. More recently, formal risk assessments have been used. For example FDA conducted a formal risk assessment on the pathogen Listeria that resulted in a risk ranking of 21 food categories.
To date, no foods that have been identified as high-risk have been removed from the high-risk designation. However, in the future, foods may lose their designation as high-risk if it has been demonstrated that industry practices or technologies have eliminated or minimized the prior risk through a history of safe production. Industry practices can include the application of new technologies. Advances in science can also revise previous risk assumptions about the nature of the hazard in certain food types and may influence a food's risk characterization. Additionally, FoodNet, an active surveillance system administered by CDC, provides an annual update of foodborne illness in the U.S. This information affords a measurement of trends in foodborne illness due to exposure to pathogenic microorganisms and aids in food risk characterization.
As an added effort in the area of high-risk foods, FDA will determine the occurrence of the 5 CDC-identified foodborne illness risk factors and environmental risk factors in the inventory of the regulated Interstate Travel Conveyance facilities, in order to establish a reduction in foodborne illnesses over time. Interstate Travel Conveyance facilities serve 900 million meals and snacks annually. FDA's efforts will include the inspection of food and environmental facilities, such as water, wastewater and solid wastes in airline, train, bus and cruise ship airports, hubs, stations and port facilities. In FY 2004, FDA will develop a baseline data collection project, that will include developing forms, a statistical validity assessment, development of a sampling plan, conduct training, provide technical support, establish a pilot study and revise the baseline project as needed. Additionally, FDA will inspect 95 percent of the official establishment inventory (OEI) of the regulated Interstate Travel Conveyance facilities to collect the baseline data. These data collection activities would include the inspection of these high-risk facilities.
Performance: In FY 2000, the number of high-risk food inspections was approximately 5700 or 91% of the identified possible inventory of high-risk product/process domestic firms. In FY 2001, the Agency accomplished 78% of the identified possible 6800 inventory of high-risk product/process domestic firms. The reason FDA fell short of achieving this goal was because the Agency had to concentrate its resources and focus on an even greater threat of BSE that was breaking out in Europe at the time. In FY 2002, FDA conducted 6,784 domestic inspections of firms that produce "high risk" foods (through ORA and the states, under FDA auspices). This exceeded FDA's goal to annually inspect 95% (6,650) of the "high risk" domestic food establishments.
Data Sources: Field Data Systems

8. 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 acquires data on particular commodity/pesticide combinations and carries out its market basket survey, called the Total Diet Study (TDS). In conducting the Total Diet Study, FDA personnel purchase foods from retail outlets 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 residues and environmental contaminants. The levels of pesticides found will be used in conjunction with USDA food consumption data to estimate the dietary intake of the pesticide residues.
Under the regulatory monitoring program, 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.
Performance: FY 1998 - 8,500 samples (3,600 domestic and 4,900 imports); FY 1999 - 9,400 samples (3,400 domestic and 6,000 imports); FY 2000 - 7,400 samples (2,500 domestic and 4,900 imports).
In FY 2001, actual performances for pesticide residues and chemical contaminants monitoring was 8,250 (7,600 for pesticide residues including 1,100 TDS and 650 dioxin including 250 TDS). This figure is slightly higher than the figure the Center previously reported as it contains a more accurate accounting of the total number of samples monitored under our regulatory monitoring program and our Total Diet Study program. Thus, FDA analyzed 7,600 samples for pesticide residues which includes 1,100 samples collected for the Total Diet Study. TDS analyzed for pesticide residues and other chemical contaminants in foods consumed by infants and children. The Total Diet Study is a major element of FDA's pesticide residue monitoring program. Some of the samples collected under the Total Diet Study have also been monitored for dioxins in the past couple of years and, possibly, for other chemical contaminants as well. Therefore, the samples collected for the TDS analyzed for pesticide residues and other chemical contaminants should be counted as "actual performances" under the "pesticides and environmental contaminants". The total number of samples analyzed for dioxins was 650 for a total actual performance of 8,250. FDA must maintain resource levels devoted to the sampling and analyses of pesticide and environmental contaminants, specifically dioxin, not only to ensure that the U.S. food supply is safe, but also to reduce dietary exposure. In FY 2002, FDA collected and analyzed 10,700 food samples to monitor for pesticides and environmental contaminants. This exceeded FDA's goal to collect and analyze 8,000 samples.
Data Sources: FACTS, CFSAN website

Contact Information:
Planning Staff, Office of Planning, FDA
Phone: 301-827-5210

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