Foods Performance Goals
|Long Term Goal: Increase access to safe and effective veterinary products, and to safe and nutritious food products, including products for unmet animal and human health needs.|
1. Provide premarket reviews within statutory time frames to assure the safety of food ingredients, bioengineered foods and dietary supplements. (11001) (output)
New Measure for FY 2007: Complete review and action on the safety evaluation of 50% of direct and indirect food and color additive petitions, including petitions for food contact substances, within 360 days of receipt.
Old Measure from FY 2002 to FY 2006: Percentage of food and color additive petitions reviewed and acted on within 360 days of receipt. [Starting in FY 2007, the measure will include indirect food additives which includes food contact substances which were, prior to FY 2007, processed under FDA's Food Contact Substances Notification Program. The Food Contact Substance Notification Program will be discontinued in FY 2007 and will result in the statutorily mandated safety review for food contact substances having to be submitted through the rulemaking process for food and color additives.]
|2004||75%||89% of 9|
|2003||65%||80% of 5|
|2002||60%||75% of 8|
|Data Source: CFSAN's electronic workflow system|
|Data Validation: The Food Additives Regulatory Management (FARM) Project's electronic information management system is designed to support electronic processing, review, maintenance, and reporting for food ingredient submissions. This includes management of food and color additive petitions, Food Contact Notifications (FCNs) (until FY 2007), Generally Recognized as Safe Notices (GRNs) and Biotechnology Consultations, by providing modern electronic information management tools necessary for the food ingredient reviewers and managers to maximize their productivity. FARM allows reviewers to spend more time reviewing submissions, since they spend less time searching for, processing, and sharing information. FARM is currently able to support industry electronic submission of food ingredient submissions and correspondence in a consistent/standard electronic format further improving efficiencies for industry and FDA. Freedom of Information (FOI) requests and other communications disclosing information to industry and consumers are done electronically through the FARM System. CFSAN's electronic workflow system within FARM provides real-time tracking information on the progress, status, and timeliness of premarket submissions as well as the capability to generate ad-hoc reports including information and statistics on all significant events during the review process.|
|Cross Reference: This performance measures support HHS Strategic Goal 2.|
|Long Term Goal: Increase ability of consumers to make food choices and to use food handling practices associated with health benefits and reduced risk of food-borne and chronic disease.|
2. New Measure for FY 07: Percentage of the approximately 3,000 eligible state, local, and tribal regulatory agencies in the U.S. and its Territories enrolled in the draft Voluntary National Retail Food Regulatory Program Standards by October 1, 2007 and the percentage of the enrolled jurisdictions which meet 2 or more of the Standards by October 1, 2007. (11010) (outcome)
Old Measure from FY 02 to FY 06: Increase risk management strategies and communication to government, industry and consumers in order to ensure the safety of the nation's food supply by increasing the percentage of the U.S. population that will live in states or territories that have adopted the Food Code.
|2007||9% (270)/ 26%||1/08|
|2006||49 out of 56 states & territories / 84%||1/07|
|2005||49 States/ 84%||48 of out 56 states & territories (45 states & 3 territories)/79%|
|2004||43 states / 83%||44 states/75%|
3. Increase consumer understanding of diet-disease relationships (dietary fats and CHD)
Long Term Measure: Increase by 40 percent the percentage of American consumers who correctly identify that trans fat increases the risk of heart disease.
|Long Term Measure: Increase by 10 percent the percentage of American consumers who correctly identify that saturated fat increases the risk of heart disease.||2007||81%||1/08|
|Long Term Measure: Improve by 10 percent the percentage of American consumers who correctly identify that omega-3 fat is a possible factor in reducing the risk of heart disease.||2007||36%||1/08|
|Data Source: Listing of Jurisdictions Enrolled in the draft Voluntary National Retail Food Regulatory Program Standards: http://www.cfsan.fda.gov/~dms/ret-jur.html. This listing identifies regulatory agencies that have enrolled in the draft Voluntary National Retail Food Regulatory Program Standards and have agreed to publish their status as they perform their self assessments; and develop and implement strategic plans to meet all the Standards. Information is self-reported by the jurisdictions to FDA staff who compile the information and maintain the listing.|
|Data Validation: Food Code adoption is tracked through the contract with the Association of Food and Drug Officials (AFDO) and measured as a percent of the U.S. Population. A listing of jurisdictions enrolled in the draft voluntary national retail food regulatory program standards can be found on the CFSAN web page at http://www.cfsan.fda.gov/~dms/ret-jur.html. This listing identifies regulatory agencies that have enrolled in the draft Voluntary National Retail Food Regulatory Program Standards and have agreed to publish their status as they perform their self assessments; and develop and implement strategic plans to meet all the Standards. Information is self-reported by the jurisdictions to FDA staff who compile the information and maintain the listing.|
|Cross Reference: This performance measures support HHS Strategic Goal 2. This goal supports Healthy People 2010 Objectives.|
|Long Term Goal: Prevent harm from regulated products by increasing the likelihood of detection and interception of substandard manufacturing processes and products, through efficient and effective risk targeting, external partnering and collaboration.|
|4. Perform prior notice import security reviews on food and animal feed line entries considered to be at risk for bioterrorism and/or to present the potential of a significant health risk. (11040) (output)||2007||60,000||01/08|
|5. Perform import food field exams on products with suspect histories. (11036) (output)||2007||71,000||01/08|
|6. Perform Filer Evaluations of import filers. (19015) (output)||2007||1,000||01/08|
|7. Conduct examinations of FDA refused entries as they are delivered for exportation to ensure that the articles refused by FDA are being exported. (19016) (output)||2007||3,000||01/08|
|8. Conduct postmarket monitoring, food surveillance, inspection, and enforcement activities to reduce health risks associated with food, cosmetics and dietary supplements products. (11020) (output)||2007||5,700||01/08|
9. Expand federal/ state/ local involvement in FDA's eLEXNET system by having laboratories submit data in the system; and, beginning in FY 2007,expand the capability of the system to provide automated notification of potential events. (19013) (outcome)
FY 2007 Measure: The number of analytes and select agents routinely tested and evaluated by eLEXNET pattern-detection algorithms such that departures from normal trends of detection trigger notifications to FDA food safety and security officials.
|2007||5 analytes and 5 select agents||01/08|
|10. Establish and maintain a quality system in the ORA Field laboratories which meets the requirements of ISSO 17025 (American Society for Crime Laboratory Directors for the Forensic Chemistry Center) and obtain accreditation by an internationally recognized accrediting body (American Association for Laboratory Accreditation.) (11041) (outcome)||2007||Maintain accreditation for 13 labs||01/08|
|2006||Achieve and maintain accreditation for 13 labs||01/07|
|2005||Achieve and maintain accreditation for 6 labs||Achieved accreditation for 5 labs; maintained accreditation for 1 lab|
|11. Increase laboratory surge capacity in the event of terrorist attack on the food supply.||
Baseline and target under development. Expected completion - Sept 06
|Data Source: Field Data Systems.|
|Data Validation: ORA uses two main information technology systems to track and verify field performance goal activities: the Field Accomplishments and Compliance Tracking System (FACTS) and the Operational and Administrative System Import Support (OASIS). FACTS includes data on the number of inspections; field exams; sample collections; laboratory analyses; and, the time spent on each. OASIS, which is coordinated with U.S. Customs and Border Protection, provides data on what FDA regulated products are being imported as well as where they are arriving. It also provides information on compliance actions related to imports. FDA is currently developing the Mission Accomplishment and Regulatory Compliance Services (MARCS) system. MARCS will incorporate the capabilities of these two field legacy systems and include additional functionality.|
|Cross Reference: These performance measures support HHS Strategic Goal 2. Performance measure 7 supports Healthy People 2010 Objectives.|
1. Provide premarket reviews within statutory time frames to assure the safety of food ingredients, bioengineered foods and dietary supplements. (Measure: Percentage of food and color additive petitions that were reviewed and acted on 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, including those for food contact substances - starting in FY 2007. 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 . 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, including 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 process. 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. This was acknowledged in a report from a June 1995 House hearing. Additionally 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 were completed within 360 days were filed under the notification program, thus decreasing the workload for this goal. While the remaining petitions were in general more complex and took more time to review, once the notification and the recent improvements to the petition review process were well established, FDA's performance on this goal increased substantially toward full performance. The FY 2007 strategic redeployment offsets to fund higher FDA priorities will affect our premarket program by increasing the review time of incoming petitions. The food contact substances notification program will be discontinued in FY 2007. Statutorily mandated safety review for food contact substances will be submitted through the process for food and color additives, which can be a lengthier process.
Performance: As noted, 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 have received fewer petitions than in previous years. Those that we do receive, however, are for direct food additive uses of greater potential public health significance, which generally take more time and effort per petition to complete. Nevertheless, improvements in the petition review process have resulted in the foods program meeting or exceeding our review goals in recent years.
Due to program changes in FY 2007, our performance targets for the petition receipt cohort of 2006 (which will be under review in 2007) and for the petition receipt cohort of 2007 have been adjusted
2. Percentage of the approximately 3,000 eligible state, local, and tribal regulatory agencies in the U.S. and its Territories enrolled in the draft Voluntary National Retail Food Regulatory Program Standards by October 1, 2007 and the percentage of the enrolled jurisdictions which meet 2 or more of the Standards by October 1, 2007. (11010)
Context of Goal: FDA is the lead federal agency in a cooperative effort between federal, state, local and tribal regulatory agencies to prevent foodborne illness associated with foods prepared and sold in retail food establishments. State and local governments provide the largest portion of the program's resources and exercise primary regulatory control over the retail segment of the food industry. FDA's ability to leverage its resources and to influence and guide the much larger investment of state, local and tribal programs represents an effective public health partnership.
For this cooperative endeavor to remain effective in preventing foodborne illness, many aspects of the retail food program must evolve to meet the realities of international trade, new technologies, emerging pathogens, and changing consumer demographics. Budget cuts and competition for funding are forcing state and local governments to re-evaluate their retail food protection programs. In fact, some have even suggested discontinuing these programs.
It is imperative that FDA find new ways to ensure that the resources expended for retail food safety are directed toward activities that produce the greatest degree of consumer protection. There are approximately 3,000 federal, state, local and tribal regulatory agencies with the direct responsibility for monitoring the one million plus retail establishments in the country
It is virtually impossible to achieve the goal of reducing the factors that cause foodborne illness without a mechanism that promotes uniformity and continuous improvement among retail food programs nationwide. Adoption of the Food Code represents a successful federal/state/local/tribal partnership in improving food safety. However, adoption without instituting meaningful foodborne illness interventions and a strong regulatory program infrastructure is not effective. With the current initiative to reduce the occurrence of risk factors known to contribute to foodborne illness, the primary focus is appropriately shifting to measures of success beyond Food Code adoption. These include tracking risk factor occurrences over time by comparing baseline improvements in inspection data and follow-up inspection findings; use of risk-based inspections; applying HACCP principles; and uniformly implementing Food Code provisions.
FDA Regional Specialists are the front line Agency contacts for the Program Standards and work with jurisdictions to make them aware of the standards and to provide technical assistance. FDA promotes the Program Standards by including it in National and regional presentations about the retail program.
Performance: The FDA Food Code is the foundational document of the FDA National Retail Food Program and represents the Agency's policies and best science-based advice for a uniform system of provisions that address the safety and protection of food offered at retail and in food service. The Food Code has long served as the model upon which most state, local and tribal agencies have based their regulations and ordinances for retail food safety and sanitation. Having a regulatory foundation in place such as the Food Code is a key component of an even larger FDA National Retail Team effort aimed at decreasing foodborne illness, the Voluntary National Retail Food Regulatory Program Standards. In FY 2004 - 2005, FDA assisted state programs and provided oversight in implementing the Program Standards. FDA continues to encourage jurisdictions to enroll in the Program Standards while continuing to provide support and guidance to those jurisdictions already enrolled. FDA auditing of those enrolled in the Program Standards will be in accordance with the Standards protocol. For FY 2005 - 2006, work with the Program Standards includes technical assistance and consultation to State and local jurisdictions performing self-assessments and developing strategic work plans using the Program Standards as the foundation for enhancing the effectiveness of their retail food program.
The draft Voluntary National Retail Food Regulatory Program Standards provides a roadmap for the regulatory agencies to focus resources on the reduction of the risk factors most commonly associated with foodborne illness at the retail level. The Program Standards define nine essential elements of an effective regulatory program for retail food establishments, establish basic quality control criteria for each element, and provide a means of recognition for those state, local, and tribal regulatory programs that meet the Standards. The nine program elements addressed by the Program Standards are:
- Regulatory Foundation (substantially equivalent to the FDA Food Code)
- Trained Regulatory Staff
- Inspection Program Based on HACCP Principles
- Uniform Inspection Program
- Foodborne Illness Investigation and Response
- Compliance and Enforcement
- Industry and Community Relations
- Program Support and Resources
- Program Assessment
Enrollment of regulatory agencies in the draft Voluntary National Retail Food Regulatory Program Standards will be used as a performance measure. Enrollment is voluntary and constitutes a commitment by a jurisdiction to embark on a continuous improvement process for program management that focuses on the reduction of risk factors known to cause or contribute to foodborne illness and on the promotion of active managerial control of all factors that may cause foodborne illness.
Jurisdictions participating in the Program Standards also commit to completing the FDA National Registry Report. Data contained in this report will be used to update the FDA National Registry of Retail Food Protection Programs, a listing of retail food safety programs that have voluntarily enrolled as participants in the Program Standards. Participating jurisdictions also complete a Release and agreement with Permission to Publish in the National Registry form that states their agreement to have the Self-Assessment and/or Verification Audit findings published in the National Registry.
Concurrently, FDA continues to encourage adoption of the Food Code by State and territorial agencies. Beginning in FY 2004, the FDA tracked the percentage of the U.S. population that resides in States and territories that have adopted the Food Code, either by reference or by incorporating equivalent provisions into their relevant statutes and regulations. Prior to FY 2003, the FDA tracked the number of States and territories in which a primary retail food regulatory agency had adopted the Food Code. We recognize the importance of adoption of the Food Code by all food safety agencies at the federal, state, local and tribal levels as a means to establish a sound regulatory foundation and legal framework for uniformity in achieving the prevention and reduction of foodborne illness and death from food produced at the retail level. As of December 2005, the current enrollment in the Program Standards was 185 jurisdictions. Food Code adoption levels as of August 2005 are at 45 states and 3 territories for a total of 48 of 56 states and territories (86%) that have adopted codes patterned after the 1993, '95, '97, '99, or 2001 versions of the Food Code. It should be noted that 56 states and territories cover a total of 50 states and 6 territories. Those 48 states and territories represent 79% of the US population. We missed our goal of having 49 states/territories adopt the Food Code by one because changes in the state legislation did not take place in time for a change within fiscal year 2005.
3. Increase consumer understanding of diet-disease relationships, and in particular, the relationships between dietary fats and the risk of coronary heart disease (CHD), the leading cause of death in the U.S. and one that disproportionately affects African-Americans and Hispanics.
Context of Goal: Coronary Heart Disease (CHD) is the leading cause of death among Americans, accounting for more than 1 in 5 deaths annually. CHD is also the leading cause of premature, permanent disability in the labor force. Dietary factors, especially consumption of some fats, play a significant role in CHD risk.
One modifiable factor that is important for reducing mortality and morbidity associated with heart disease is consumer understanding of the consequences of dietary choices with respect to CHD. Increased understanding will strengthen motivation to adopt and maintain recommended healthy dietary behavior and to make informed dietary choices.
The target is directly in line with several of the Department's priorities and strategic goals. First, improving the American diet through informed choice about fats that increase or reduce the risk of heart disease is one of several important steps toward reducing the enormous morbidity and mortality burden of CHD. This burden is borne disproportionately by minority populations, including African-Americans, Hispanics, and Native Americans. As the leading cause of death and a significant cause of illness and disability, CHD also imposes substantial costs on the U.S. health care system.
- Performance: Baseline data for FY 2005 developed. Target year for accomplishment FY 2007.
4. Perform prior notice import security reviews on food and animal feed line entries considered to be at high risk for bioterrorism and/or to present the potential of a significant health risk. (11040)
Context of Goal: FDA's Prior Notice Center (PNC) was established in response to regulations promulgated in conjunction with the Public Health Security and Bioterrorism Preparedness Act of 2002 (BTA). Its mission is to identify imported food and feed products that may be intentionally contaminated with biological, chemical, or radiological agents, or which may pose significant health risks to the American public, from entering into the U.S. FDA will continue to focus much of its resources on Intensive Prior Notice Import Security Reviews of products that pose the highest potential bioterrorism risks to the U.S. consumer. By FY 2007, FDA expects that the PNC will have hired a permanent staff of Reviewers and Watch Commanders that will have achieved the training and gained the experience necessary to expand its scope of targeting to include additional threat parameters.
The PNC targets food and animal feed commodities that have been identified as high-risk based on either threat assessments that have been conducted or the receipt of specific intelligence indicating the items may cause death, illness, or serious injury due to terrorism or other food related emergencies. The PNC also utilizes the import field exams and filer evaluations by receiving feedback from the Investigators who conduct them and subsequently assessing those individuals or firms that continuously violate the prior notice regulations and the provisions set forth in the Bioterrorism Act, and further targeting those that instigate bioterrorism concerns. Strategies used to ensure effective targeting include:
- Intelligence regarding countries at risk for terrorism;
- Intelligence regarding commodities susceptible to, or exploited by, terrorism;
- Intelligence specific to shipment or shipping entities;
- Information gleaned from Foreign and Domestic Establishment Inspection Reports that identify security breaches;
- Sample collection and analysis for counterterrorism;
- Prior Notice discrepancies reported during import field exams; and,
- Filer evaluation field audits.
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.
- Performance: In FY 2005, FDA exceeded this goal of 38,000 by conducting 86,187 import security reviews. FDA collaborated with Customs and Border Protection to direct field personnel to hold and examine five suspect shipments of imported food; refused 141 lines of food for prior notice violations; responded to 49,649 phone and e-mail inquiries; and conducted 86,187 intensive security reviews of Prior Notice submissions out of 8,705,847 in order to intercept contaminated products before they entered the food supply.
5. Perform import food field exams on products with suspect histories. (19014)
Context of Goal: The events of September 11, 2001 heightened the nation's awareness of security and placed a renewed emphasis on ensuring the safety of the nation's food supply. Import food field exams, along with laboratory analyses, were FDA's major tool to physically monitor import entries prior to the enactment of the Bioterrorism Act of 2002. The role of the import food field exam and the number conducted continues to evolve as trade practices and information about risks change.
A field examination is a visual examination of the product to determine whether the product is in compliance with FDA requirements and involves actual physical examination of the product for admissibility factors such as storage or in-transit damage, inadequate refrigeration, rodent or insect activity, and lead in dinnerware, odor and label compliance. A field exam cannot be used to test for microbiological or chemical contamination and must be supplemented with other activities.
The volume of imported food shipments has been rising steadily in recent years, and this trend is likely to continue. FDA-regulated imports have been growing at a 19 percent annual rate. FDA anticipates approximately 12 million line entries of imported food in FY 2007 within a total of over 19 million lines of FDA regulated entries. To manage this ever-increasing volume, FDA uses risk management strategies to achieve the greatest food protection with available resources.
FDA applies strategies that combine visual inspection for apparent labeling and other visual defects, with risk-based targeting, and selective laboratory analysis to detect chemical and microbiological hazards. FDA cannot rely solely on physical examination to reduce the potential risks from imported foods. Currently, a significant effort is underway to develop appropriate knowledge-based approaches that will give the Agency assurance that it is addressing the most serious risks.
It is important to recognize that FDA is transforming how it regulates imports by using risk-based information technology to target physical exams and identify the need to collect samples for laboratory analysis. By focusing on risk, FDA works more efficiently to target products. An additional information technology system currently under development is an artificial intelligence tool. This new data mining tool is a risk-based automated system for screening import entries. This system will conduct continuous data mining of FDA's analytical and inspectional data and use existing business rules, multiple data sources, and artificial intelligence to identify products posing the greatest security and safety risk. The prototype will produce two risk scores for every food entry line, one for security and one for safety concerns, which will be used to immediately identify shipments that may be of high risk.
FDA intends to expand the import data mining prototype to apply risk-based targeting of all types of regulated imports. These risk scores will help FDA target imported products for Agency action. The prototype will greatly enhance the electronic review process already in place at FDA. Entry review decisions made by FDA at border locations will be greatly enhanced by targeting products that present safety risks based on historical information and current events. While the percentage of imports physically examined may decline as imports continue their explosive growth, the exams that we conduct are more targeted and more effective than ever before. ORA continues to think that the best approach to improve the safety and security of food import lines is to devote resources to expand targeting and follow through on potentially high-risk import entries rather than simply increasing the percentage of food import lines given a field exam.
- Performance: In FY 2005, FDA exceeded this goal of 60,000 by completing 84,997 field examinations of imported food lines.
6. Perform Filer Evaluations of import filers. (19015)
Context of Goal: The Food and Drug Administration (FDA) receives electronic import entry data for assessing the admissibility of regulated imported articles. The accuracy of these data directly relates to the level of confidence that American consumers can expect in the quality, safety and compliance of imported articles subject to FDA's jurisdiction. Entry data affects FDA's determination of the labeling, quality, safety, approval status, and efficacy of FDA-regulated import articles.
FDA maintains an electronic interface with the Department of Homeland Security's Bureau of Customs and Border Protection (CBP), the Automated Commercial System (ACS). After successfully completing an initial evaluation for participation in OASIS, filers may submit import data electronically to FDA through the Automated Broker Interface (ABI) and ACS. FDA uses an electronic entry screening system, Operational and Administrative System for Import Support (OASIS), to screen entry data transmitted by filers to perform various regulatory and service functions. Such screening may assess whether FDA import personnel should review an entry further. The FDA uses OASIS to determine whether an entry should be reviewed "on screen," further supported by entry documentation; physically inspected; sampled; or permitted to proceed into domestic commerce without further evaluation. FDA can use the data in the entry system to track an imported item that negatively affected the public health.
At a minimum, this procedure requires filers who fail an evaluation to implement an FDA-approved Corrective Action Plan (CAP) and to pass a tightened evaluation (more stringent criteria) before obtaining, maintaining or regaining the privilege of paperless filing. This protects public health by ensuring quality improvement and reporting compliance for imported articles that FDA regulates. It also ensures FDA is notified when articles appear to be violative that have previously been offered for entry.
ORA continues to develop the policies and practices that govern monitoring filers. Expanded import activities supporting security assignments increase FDA's understanding of the problems associated with appropriate monitoring of Filer activities. FDA will continue to develop and apply methods to evaluate filer accuracy that are consistent with evolving security and import regulation practices.
- Performance: In FY 2005, FDA exceeded this goal of 1,000 by performing 1,407 filer evaluations. This goal is an agency-wide goal and performance data will include activities from all five program areas; however, the majority of the performance activities and resources are from the Foods program. This goal is shown in the Foods section for illustrative purposes.
7. Conduct examinations of FDA refused entries as they are delivered for exportation to ensure that the articles refused by FDA are being exported. (19016)
Context of Goal: Because of safety and security concerns it is important for FDA to be sure that these goods do not slip into domestic commerce but are in fact sent out of the country. FDA monitors this activity in conjunction with Customs in a category of action described as "follow up to refusals."
If a product is refused admission, it must be destroyed or exported under Customs' supervision within 90 days of receiving the Notice of Refusal. FDA is responsible for the protection of the U.S. public regarding foods, drugs, devices, electronic products and cosmetics, and that responsibility exists until the violative article is either destroyed or exported. Although primary responsibility for supervising destruction or exportation rests with the Bureau of Customs and Border Protection (CBP), FDA monitors the disposition of refused shipments and maintains an open file until the product is exported or destroyed. In cooperation with CBP, FDA will, at times, supervise destruction or examine products prior to export in order to ensure that the refused product is actually exported. This performance goal only counts FDA supervised destruction or exportation of refused entries. In other cases FDA relies on notification from CBP that the refused product has been destroyed or exported.
- Performance: In FY 2005, FDA exceeded this goal of 2,000 by performing 5,655 examinations of FDA refused entries as they were delivered for exportation to ensure that the articles refused by FDA were exported. This goal is an agency wide goal and performance data will include activities from all five program areas; however, the majority of the performance activities and resources are from the Foods program. This goal is shown in the Foods section for illustrative purposes.
8. Conduct postmarket monitoring, food surveillance, inspection, and enforcement activities with the objective of reducing the health risks associated with food, cosmetics and dietary supplements products. (11020)
Context of Goal: Important features of the risk-based strategy for this goal will be reducing the occurrence of illness and death by focusing resources on manufacturing establishments and other industry components that have the greatest potential for highest risk. This will result in different inspection frequencies as establishment processes come under control and present lower risk, or as new risks are identified. We note that these goals were reported in previous years as inspection of a fixed percentage of the inventory of establishments. However, given the fluctuation in the inventory, the inspection resources available, and the risk-based prioritization approach that FDA is developing, we believe that it is more appropriate to state the goal in terms of the number of inspections of the highest-risk establishments. We have reformulated the goals accordingly, including prior years for comparability. This strategy will also allow FDA to better communicate to our stakeholders about food safety risks.
FDA applies a risk-based strategy to the inspection of the food establishments in its inventory. High-risk foods refer to those that may contain hazards that have a high potential for causing serious adverse health consequences that would result in FDA Class I recalls. These include foods that may contain bacterial or viral pathogens, biological toxins, allergenic substances, bovine spongiform encephalopathy (BSE) infective materials, as well as foods such as infant formula and medical foods due to a potential hazard from the omission or improper fortification of the nutritive ingredients.
High-risk establishments are manufacturers, packers and repackers of foods 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; unpasteurized juices; sprouts ready-to-eat; fresh fruits and vegetables and processed fruits and vegetables; shell eggs; sandwiches; prepared salads; infant formula; and medical foods. Additional high-risk products identified in recent years include products whose formulations do not include an allergenic ingredient but, because the product is made in a firm that also makes allergen-containing foods, may inadvertently contain an allergen which is not declared on the label. Common allergenic substances include milk, eggs, fish, crustaceans, tree nuts, peanuts or soybeans. Another class of high risk products is dietary supplements that may contain prohibited cattle-derived ingredients.
As part of FDA's risk-based strategy, FDA recently completed a risk assessment of 23 types of ready-to-eat foods for listeriosis from the pathogen Listeria monocytogenes. This assessment ranked risk into categories from very high to low dependant on estimated risk per serving and on an annual basis. There are also foods such as shell eggs and certain produce items that are not ready-to-eat and that have caused outbreaks and are under evaluation.
The approximate annual inspection inventory for this goal is 7,000 firms. The FDA inventory of high-risk establishments is dynamic and subject to change. For example, firms go out of business, firms start or stop making high-risk foods, and new high-risk food firms enter the market. High-risk establishment inspection frequencies vary depending on the products produced and the nature of the establishment. Inspection priorities may be based on a firm's compliance history. As an example, establishments will be subject to differing inspection intervals within this inspection strategy just as Low Acid Canned Food (LACF) establishments have a varying inspection cycle based on risk within the current strategy. Because domestic LACF manufacturers have a long history of exemplary compliance with FDA's good manufacturing practices and individual establishments effectively monitor their individual processing procedures, FDA believes that these establishments need to be inspected only once every three years.
The current risk-based strategy considers food hazard information from various sources such as outbreaks, recalls, and consumer complaints as well as food analysis, epidemiological data, inspectional data and formal risk assessments. This information will be used to update currently listed commodities and establishments as well as the overall high-risk inventory of firms. The strategy includes greater inspection intervals for establishments such as cheese and LACF firms which have achieved a high level of compliance.
- Performance: In FY 2005, FDA exceeded this goal of 6,490 by performing 7,568 inspections of high-risk domestic food establishments.
9. Expand federal/state/local involvement in FDA's eLEXNET system by having laboratories submit data into the system; and, the FY 2007 goal is updated to reflect the addition of a new and changing focus: Provide FDA food safety and security officials with notification of significant departures from normal trends of detection for 5 routinely tested analytes and 5 select agents in foods by incorporating pattern-detection algorithms into the eLEXNET system. (19013)
Context of Goal: The electronic Laboratory Exchange Network (eLEXNET) is a seamless, integrated, secure network that allows multiple agencies (Federal, state and local health laboratories on a voluntary basis) engaged in food safety activities to compare, communicate, and coordinate findings of laboratory analyses. eLEXNET enables health officials to assess risks, analyze trends and provides the necessary infrastructure for an early-warning system that identifies potentially hazardous foods. eLEXNET plays a crucial role in the Nation's food testing laboratory system and is an integral component of the Nation's overall public health laboratory information system.
eLEXNET activities include:
- Increased security-the eLEXNET program is the primary communication tool for the Food Emergency Response Network (FERN), a network of federal, state, and local food testing laboratories that will respond in the event of a terrorist incident involving the Nation's food supply. eLEXNET also handles information on methods of sample analyses and reporting of analytical results.
- Quality-as the number of labs contributing to eLEXNET increases; it becomes increasingly difficult to ensure the quality of the data being entered. In view of the importance that DHS and the National Security Council are placing on this program, ensuring data quality and integrity is vital.
- Outreach-eLEXNET is a storehouse of useful and timely data that enables health officials to make assessments regarding trends and risks, and provides the infrastructure for an early-warning system that identifies hazardous foods.
- International collaboration-expansion into international partnerships and strengthening of those that are already being formed, such as the Trilateral Agreement among the U.S., Canada, and Mexico, which will result in a continent-wide food security network.
The eLEXNET program has successfully met its laboratory expansion efforts to populate its database with valuable data for use in threat detection, risk assessment, inspection planning, and traceback analysis. To date, eLEXNET has obtained the commitment for participation from over 113 laboratories representing multiple government agencies and all 50 states. Of the 113 laboratories, 95 have contributed an extensive amount of food testing data in eLEXNET that is ready for use. By the end of FY 2006, 105 laboratories are expected to provide data into the system continuously.
For FY 2007, the performance goal reflects the next stage in a continuum of activities that strengthen our nation's capability to proactively detect hazards in the food supply. The system will focus its efforts to package and deliver the valuable data that it has collected over the years to better assist food safety and security officials in their decision making processes. eLEXNET will incorporate algorithms and/or functionality that automatically notifies FDA and other officials when detected analytes or agents are in excess of normal trends for a range of commodities. eLEXNET anticipates that the incorporation of these features will enhance the utility of the data, improve data quality, and increase the effectiveness of the nation's food security efforts.
- Performance: FDA met the FY 2005 goal when the system reached 95 laboratories submitting data.
10. Establish and maintain a quality system in the ORA Field Labs which meets the requirements of ISO 17025 (ASCLD for FCC) and obtain accreditation by an internationally recognized accrediting body. (11041)
Context of Goal: FDA is a science-based agency that depends on its regulatory laboratories for timely, accurate, and defensible analytical results in meeting its consumer protection mandate. Our laboratories have enjoyed a long history of excellence in science upon which the agency has built its reputation as a leading regulatory authority in the world health community. Accreditation of laboratory quality management systems will provide a mechanism for harmonizing and strengthening processes and procedures, thereby improving the quality of operations and the reliability of FDA's science.
An FDA quality management system that is accredited to international standards will enable our managers to better maintain high-quality laboratory operations, to more easily control resources, and to act with more confidence in meeting the needs of their customers and stakeholders. More effective operations will result in greater regulatory impact and better consumer protection. Uniform laboratory procedures will enhance data reliability and resource sharing with our domestic and international partners.
FDA's quality management systems include risk management principles. Since laboratories receive accreditation for specific test technologies or methods, we will use risk assessment tools to determine which test technologies and/or methods will be accredited. The quality management system incorporates risk management in targeting resources and controlling processes on an ongoing basis. Targeted resources result in laboratories equipped to respond to national emergencies, food-borne outbreaks, and emerging analytical problems. Controlled processes result in documented procedures and activities that withstand domestic and international scrutiny.
Through laboratory accreditation, FDA will maintain its reputation as a source of scientifically sound information and guidance. Other known benefits of quality systems include preservation of institutional knowledge (through process documentation and records) and increased employee satisfaction and retention. Over the long term, the quality management system implemented in FDA laboratories may serve as a model for managing other FDA regulatory and business processes. The 13 ORA Field Laboratories are currently implementing a new quality system in accordance with the updated Laboratory Manual that was issued in August 2003.
Laboratory accreditation is an important commitment by FDA. It recognizes the need for our laboratories to have international recognition and parity; to share data and other information with other accredited labs around the world; to share a common set of policies and procedures in improving operations and harmonization; and, to provide excellent work products that are defensible and consistent. With accredited laboratories, the credibility of FDA's analytical results will be greatly enhanced, both nationally and internationally; and, the reliability of data is critical in facilitating the sharing of data and in FDA and our partners being willing and able to take regulatory actions without duplicating the analyses.
- Performance: In FY 2005, FDA maintained accreditation for Denver District Laboratory and achieved accreditation for 5 additional laboratories: Forensic Chemistry Center; Arkansas Regional Lab; Pacific Regional Lab Northwest; San Francisco District Lab; and, Philadelphia District Lab.
11. Increase laboratory surge capacity in the event of terrorist attack on the food supply.
- Context of Goal: A critical component of controlling threats from deliberate food-borne contamination is the ability to rapidly test large numbers of samples of potentially contaminated foods for the presence of contaminants. Once the contaminant and food vehicle have been identified through food surveillance or outbreak investigation, FDA has primary responsibility for distinguishing contaminated food products from safe food products as quickly as possible to protect public health and mitigate disruption in distribution of important foods.
- Performance: Baseline and target under development. Expected completion - Sept 06.
 The National Restaurant Association 2005 Restaurant Industry Fact Sheet: http://www.restaurant.org/research/ind_glance.cfm and the Food Marketing Institute 2004 Retail Food Store (grocery) information at http://www.fmi.org/facts_figs/keyfacts/stores.htm