| Total Program Resources (FY 2000): | $000 | FTEs | |
| Center | 126,011 | 895 | |
| Field | 149,944 | 1,583 | |
| Total | 275,955 | 2,478 |
A safe, nutritious and wholesome food supply is important to the health and well being of each citizen and the nation as a whole. Although the U.S. food supply is reputed to be one of the safest in the world, much can be done to improve the protection provided to consumers. This fact is clearly illustrated by the high yearly cost in human illness, medical expense, and lost wages caused by food-related infections. The United States Department of Agriculture's (USDA) Economic Research Service (ERS) has estimated that every year up to 81 million illnesses and as many as 9,000 deaths can be attributed to foods. ERS also estimated that the cost of medical treatment and lost wages associated with these illnesses ranges between $6.6 and $37.1 billion.
In its recent report on imported foods, the Government Accounting Office (GAO) indicated that "ensuring the safety of domestically produced foods is a daunting task, but the challenge of ensuring the safety of the entire food supply is even more difficult as Americans consume more imported foods." This is part of the reality FDA faces in its mission to develop and maintain the regulatory, research, and other capabilities required to protect consumers from harmful domestically produced or imported food products. FDA is responding to a rapidly growing number of complex and challenging food safety issues. These include emerging pathogens, natural toxic constituents in foods, macro food ingredients, hazardous dietary supplements, pesticides and industrial chemical contaminants, biotechnology products, new processing systems, and the rapidly increasing numbers of foods imported from foreign nations. Strategies to address these important food safety issues must be innovative, based on sound science, and effectively coordinated with the Agency's federal partners and the states.
Since FY 1996, FDA has worked more cooperatively with its federal partners to enhance the safety of the nation's food supply. The goals and objectives of these government-wide efforts were established through two Presidential Initiatives on food safety. The first focused on enhancing surveillance of foodborne disease outbreaks, improving inspection and compliance, targeting important new research and risk assessment initiatives to fill critical gaps in food science, and expanding food safety education and training, especially for those who handle food at critical points from the retail setting to the home. A second Presidential Directive, issued on October 2, 1997, focused on actions to improve the safety of domestic and imported fresh fruits and vegetables. These initiatives respond to the increasing number of foodborne illness outbreaks, especially those caused by the sudden appearance of newly recognized pathogens, and the public's increasing concern for the safety of foods available in the marketplace.
Although the first phases of the Food Safety Initiative (FSI), funded in FY 1998, provide much-needed resources to deal with critical food safety issues, namely those related to bacterial contamination and mycotoxins, a number of other foodborne contaminants threaten the health and well being of consumers. These include a wide range of pesticides and industrial chemical contaminants and natural toxins. The safety of dietary supplements and other nutrition supplements is another concern. Also, while food labeling is most critical for those who are subject to allergic reactions to food ingredients, it provides information that helps consumers make more healthful dietary choices and avoid the effects of diet-related diseases such as heart disease, stroke, and certain cancers.
Over the past several years, another major focus of the Food Safety Program has been streamlining the process for premarket reviews of food and color additive petitions. Significant steps have been taken to make this process more efficient and reduce the number of overdue food and color additive petitions. These steps include management improvements, modernization of the electronic information infrastructure to increase efficiency, reallocation of resources from other program activities to petition review, and extramural contracts to provide for third-party reviews of scientific data supporting petitions. In FY 2000, the Agency is requesting authorization to establish user fee programs for food additive petition reviews and reviews of premarket notifications for food contact substances (indirect food additives). If Congress grants this authorization, the Agency will have a stable source of resources to increase significantly the speed of petition and premarket notification reviews and improve its ability to meet statutory time frames for completing these reviews.
In this plan, FDA's food safety activities are organized into four strategic goal areas: Product Safety Assurance; Injury Reporting; Premarket Application Reviews; and Food Labeling, Cosmetics and Economics. Product Safety Assurance, the largest goal area, includes compliance monitoring, program coordination, food safety education, and the bulk of the Program's food safety research and risk assessment activities. Activities in the Injury Reporting strategic goal include injury surveillance, adverse event reporting, epidemiology, consumer studies and other activities that provide information on the numbers, trends and types of foodborne illnesses. The Premarket Application Review goal includes activities to ensure that food and color additives are safe, infant formulas are safe, and health claims are scientifically valid. Activities in the Food Labeling, Cosmetics and Economics strategic goal include nutrition policy and other activities related to food labeling, cosmetics safety, and activities related to protecting consumers from economic fraud. The activities in each goal area make important contributions to efforts to protect the public health.
| Resources: | $31,294,000 | 244 FTEs |
Performance Goals:
Rationale:
Under several statutes, including the Federal Food, Drug, and Cosmetic Act (FD&C Act) and Nutrition Labeling and Education Act (NLEA), FDA has authority to ensure that food ingredients and infant formulas are safe and that health claims are based on sound science. The Agency also has premarket notification programs for GRAS substances and biotechnology products and is required under the Food and Drug Administration Modernization Act (FDAMA) to establish similar procedures for food contact substances.
Under the FD&C Act, food and color additives are required to undergo premarket review before entering commerce. To initiate this premarket review, sponsors are required to submit a petition including appropriate test data to demonstrate the safety of the intended use of the substance. Once the review is complete, the Agency is required in many cases to publish its decision in the Federal Register. Under the premarket notification program for food contact substances established by FDAMA, industry will submit a notification to FDA 120 days prior to marketing a food contact substance. If FDA does not object during the 120-day review period, the notifier may legally market the substance for the use described in the notification.
This strategic goal includes all premarket review and consultation activities within the Foods program that are associated with food additives, color additives, GRAS food ingredients, and foods derived from new varieties of crop plants using biotechnology. These premarket activities must implicitly or explicitly address the question of whether a substance or product is safe for human use.
Under NLEA, FDA must ensure that nutrient content claims and health claims that appear on food product labels comply with its regulations or are based upon an authoritative statement of a scientific body of the U.S. Government. NLEA and FDA regulations specify the time frames within which FDA must act on submissions for approval of these claims. FDA's timely response to these submissions enables industry to plan more efficiently its introduction of products to the marketplace.
The Infant Formula Act of 1980 and later amendments protect infants and young children by requiring that infant formula companies notify the FDA before offering a new formula for sale, when changing processing methods or formulations, and when the company has reason to believe a formula does not meet the requirements of the Act or is otherwise adulterated or misbranded. Infant formula submissions are to be reviewed and a response issued to the company within the prescribed time limit of 90 days in those cases where FDA determines that there is a potential problem.
Since the objective of premarket reviews is to prevent exposure to hazardous substances and to prohibit scientifically unsupported health claims, their contribution to disease prevention and health is undeniable. However, performance outcomes cannot be clearly identified or measured without data systems that can directly link these activities to incidence of disease. The Agency is exploring ways to assemble the types and amounts of data required to establish realistic performance baselines for its food-related premarket review activities.
Approaches, Skills, Technology, and External Factors:
Food and Color Additives
In keeping with FDAMA and stakeholder requests for an FDA that is more open and transparent about its processes and procedures, a major objective for FY 2000 will be to improve the quality of incoming petitions. This will be accomplished with the appropriated increase by offering more assistance to potential petitioners during the petition development process and during the post-filing review process. To achieve this, FDA plans to develop and publish comprehensive guidelines for petition preparation, and to design and develop an education program explaining the types of studies and safety data required to support petitions. The Agency also plans to consult extensively with potential petitioners before they file, and will work closely with petitioners after they have filed to resolve quickly any problems encountered during review. Multidisciplinary review teams will be created to help rapidly resolve new and ongoing safety issues related to petition reviews. Moreover, additional resources will be devoted to administrative record keeping to enhance internal processing of petition review information.
In mid-FY 1997, FDA changed its procedures, and first actions were redefined as a review of all parts of a petition, followed by issuance of a "not approvable" letter, or publication of a response in the Federal Register, if appropriate. Previously, as a petition was reviewed, whenever a deficiency in any one area was found, the petitioner was notified and asked for the information, and review of the remainder of the petition was suspended. This notification was counted as a "first action." The effect of this policy was to increase the percentage of first actions completed in a given time frame, compared to what would have been the case if FDA initially examined the entire petition.
If Congress authorizes user fees for food additives, FDA will establish user fee programs for direct food additive petitions and indirect food additive (food contact substances) notifications. These user fee programs, which are supported by industry, would provide a stable source of resources that will permit the Agency to significantly enhance the efficiency of the review processes for food additives. Fees assessed for the review of direct food additive petitions would provide the resources needed to substantially increase the speed of the review process, permit the Agency to meet established time frames for these reviews more consistently, and provide the type and level of assistance required to help petitioners significantly improve the quality of their submissions. User fees would also permit FDA to establish the premarket notification (PMN) procedure for food contact substances as outlined in FDAMA. The notification procedure for food contact substances has not been implemented due to a provision in the FDAMA legislation that stipulates that the program can only commence when certain funding requirements are met. Although FDA received an increase in appropriated funds in FY 1999 for this effort, the resources appropriated are not adequate to establish the systems and regulations that are necessary to implement the program.
Health Claims and Infant Formula Notifications
FDA maintains a cadre of scientists and other specialists to review and act on nutrient content claim and health claim petitions and notifications without delay. FDA also consults with other agencies in DHHS and USDA on the appropriateness of claims and their justification.
The review of Infant Formula Notifications requires a staff of highly trained people, including Medical Officers, Consumer Safety Officers and Nutritionists with knowledge of the nutrient requirements of infants. Review material consists of company formulations, rationale for formula change, clinical studies of the new or changed formula, and other relevant material. FDA must review these submissions within the 90-day time limit and report results of the review to the company. In addition, FDA must review other changes or issues that arise during the year and provide comments to the company within narrow time limits.
Assumptions: The FY 2000 performance goals of this strategic goal area assume that FDA will receive the resources requested in the budget to enhance the premarket application review process and that the petition/notification workload will not increase significantly. If the statute is amended to authorize the collection of user fees to support food and color additive petition reviews, performance goals will be negotiated with the affected industry and will be commensurate with the additional resources made available through the collection of these fees. This would have a direct impact on the performance goals established in this Plan for food additive petition reviews and could also indirectly impact the goals established for premarket notifications.
Performance Goals, Data Sources, and Baselines:
Goal Statement: Complete first action (i.e., review all parts of the petition and issue a "not approvable" letter, or publish a response in the Federal Register, if appropriate) on 40 percent of food and color additive petitions within 360 days of receipt. (1)
Data Sources: CFSAN's electronic workflow system
Baseline Data:
FDA does not yet have quantitative baseline data comparable to this goal (see Note about Baseline Data). Baseline data based on the new definition of first actions will be available for FY 1999 by October 2000.
FY 1997:
For petitions received in FY 1996, using the previous
petition review procedure, 24% of petitions received
"first action" within 180 days.
FY 1998:
Developed and tested an electronic workflow system
that will facilitate tracking and assignment of petition
reviews. Additional work required to make the system
fully operational by the end of FY 1999 was not funded
in FY 1998.
FY 1999:
Complete "first action" on 30% of food and color
additive petitions within 360 days of receipt. The
workflow system will be operational (target).
Milestones:
FY 2002:FY 2004:
Complete "first action" on 80% of the food and color
additive petitions within 360 days of receipt (target).
Note about Baseline Data: In this goal, "time to first action" is not the same as meeting the statutory time frame (i.e., 90 days, extendable to 180 days). It is widely recognized that meeting the current statutory time frame is an unrealistic goal for all food and color additive petitions, especially the more complex ones. Indeed, the impracticability of current time frame was acknowledged in the report from the June 1995 hearing before Congress, and a recommendation to change the time frame was included in the Agency's testimony before the House Committee on Government Reform and Oversight in 1996.
Goal Statement: Reduce the percentage of overdue food and color additive petitions (i.e., under review for more than 360 days) to 20 percent of petitions under review.
Data Sources: CFSAN's electronic workflow system
Baseline Data:
FY 1997: FY 1998:
38%. Develop electronic workflow system to facilitate
tracking and assignment of petition reviews (target).
FY 1999:
30% (target).
Goal Statement: Complete initial processing of 80 percent of biotechnology consultations within established time frames.
Data Sources: CFSAN's Correspondence Tracking System and other internal CFSAN Office of Premarket Approval (OPA) databases; CFSAN's electronic workflow system
Baseline Data:
Under development. Baseline data are expected for FY 1999. The projected goal is based on the Agency's analysis of its limited tracking data and to a larger degree on FDA experience thus far with these submissions. Finally, based on the Agency's inability to control the number of submissions, we believe that the goal in this area represents full performance.Goal Statement: Complete processing of 80 percent of Generally Recognized as Safe (GRAS) notifications within the time frame established by the final rule.
Data Sources: Internal OPA database; CFSAN's electronic workflow system
Baseline Data:
Under development. FDA currently does not have quantitative data
to establish a baseline for this goal (see Note about Baseline Data.)
Baseline data are expected for FY 1999. The projected goal is based
on the FDA's analysis of its experience thus far implementing this
process on an interim basis.
Note about Baseline Data: GRAS notification is a new program, and the final rule establishing the GRAS notification process has not yet been published. Thus, the final time frame upon which this goal will be measured has not been established. Nevertheless, the Agency believes, based on limited experience in the review of interim notice submissions that the above performance goal can be reached. We also believe that this represents a full performance level for this program.
Goal Statement: Finalize guidance and regulations necessary to support operations of the premarket notification program for food contact substances established by the FDA Modernization Act and as set out in Sec. 409(h) of the Federal Food, Drug, and Cosmetic Act.
Data Source: Federal Register
Baseline Data:
Systems to collect data to establish baselines are under development
and will be implemented when the program for food contact
substances is developed and becomes operational.
Goal Statement: Respond to 95 percent of nutrient content claim and health claim petitions/notifications within the statutory and regulatory time frames.
Data Sources: Internal data systems.
Baseline Data:
FY 1996:
All four health claims received were processed in
statutory time frames.
FY 1997:
Received and processed one health claim.
FY 1998:
Received and processed three health claims.
FY 1999:
Receive and process three health claims (target).
| Resources: | $223,835,000 | 2,047 FTEs |
Performance Goals:
Rationale:
FDA regulates approximately 70 percent of the food supply. The products regulated are susceptible to a wide range of serious potential health hazards, including microbial pathogens, natural toxic substances, man-made chemical contaminants, and toxic elements. Hazardous nutrition supplements are also a concern. Activities in this goal area are meant to minimize the possibility that foods in the marketplace contain these or other human health hazards.
FDA's Food Safety Program must address issues that are more numerous and more complex than those faced in the past. Moreover, the scope of its regulatory responsibilities, which is already enormous, is continually growing. The Agency is responsible for regulating over 50,000 establishments that process, distribute or store food products. While the number of establishments remains relatively constant from year to year, the volume of food produced is increasing as industry produces products to meet the needs of a growing population. FDA is also responsible for ensuring the safety of a growing volume of imported foods. The number of food lots entering the country increased by 100 percent between 1991 and 1997, from 1.1 million to 2.2 million. The Agency's primary mechanisms to ensure that food products conform to applicable safety and sanitation laws and regulations include compliance monitoring activities, inspections, equivalency evaluations, foreign country, wharf examinations and sample collections and analyses. In addition, the Agency provides technical assistance and training, including inspector training, to help foreign nations improve their ability to ensure the safety and sanitation of imported foods.
The Agency also works with and through states to expand inspection coverage of the food supply. Under the Cooperative Programs, FDA works jointly with states to ensure the safety of milk products, shellfish, and retail foods. States conduct inspections of establishments engaged in interstate commerce under contractual agreements with FDA. In recent years, partnership arrangements have been established with states in which they agree to conduct food safety inspections that meet the Agency's regulatory specifications. Additionally, the Agency has begun working with state and local agencies and other Federal agencies, including USDA and CDC, to develop an integrated food safety system for the Nation. This system will ensure greater coverage of the food supply, more efficient use of available resources, and greater uniformity and consistency in safety standards.
Ensuring the safety of nutrition supplements is another important area of activity under this strategic goal. Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, FDA is required to regulate dietary supplements as foods and to respond to companies on certain questions of labeling and other requirements. In view of the rapidly increasing use of and safety hazards associated with some of these products (e.g., ephedra), dietary supplements are a major health concern.
FDA is developing and using new and innovative approaches to respond to the increasing number and complexity of food safety issues, the rapidly increasing size of the food supply, and consumer demands for greater protection from foodborne hazards. One of these approaches is the expanded use of quality control systems (such as HACCP) that emphasize preventing food contamination. The main advantage of HACCP systems is that they permit food establishments to identify and properly control points in the process where safety or sanitation problems could occur.
FDA also uses food safety education and technical assistance as another strategy to protect consumers from foodborne hazards. These activities, which are often sponsored in conjunction with other federal agencies, states and professional associations, provide the most cost-effective means to prevent processing, preparation, handling and storage practices that could cause food to become contaminated with microorganisms or other substances that could cause illnesses. Research-based food safety education campaigns can reach large numbers of food preparers, including those in the retail sector and consumers, with information on safe food handling practices that can prevent food contamination and reduce pathogen growth. Also, through its education activities, the Agency efficiently and effectively delivers food safety messages to special populations (e.g., pregnant mothers, the elderly, and immune-compromised individuals) who are especially vulnerable to certain foodborne hazards such as microbial pathogens.
Research and risk assessment are critical and interdependent components of FDA's strategies for prevention and control of microbial pathogens and their toxic metabolites and for responding efficiently to foodborne disease outbreaks. Food safety practices and programs must be based on sound scientific research. Research must be conducted in a manner that supports the Agency's ability to perform risk assessments. Conversely, risk assessment provides a framework for assessing the relative impact of foodborne hazards and setting program priorities. Increased coordination between the risk assessment and research programs will enhance the responsiveness and cost-effectiveness of the Agency's food safety research program and thus enhance the Agency's capability to achieve its regulatory mission. Research provides the detailed information needed about each pathogen. Risk assessment uses analytic approaches that allow FDA to evaluate these pathogens and their toxins from initial production, through processing, to consumption. Critical elements are identified that focus research and lead to developing cost-effective means for lowering the risk of illness.
The international harmonization activities included under this strategic goal promote the development of science-based international standards for foods. The Agency takes a leadership role in the development of the Codex Alimentarius General Standard for Food Additives and the North American Free Trade Agreement Technical Working Group (NAFTA TWG), and promotes the development of science-based international standards for foods. Also, the technical support provided in trade disputes involving the safety of food additives promotes the use of science-based international safety standards. These and other international efforts will help ensure that imported foods meet safety and sanitation standards that are comparable to those in this country.
All of the activities in this strategic goal directly benefit consumers. Compliance monitoring activities permit the Agency to reduce the risk of foodborne illness by preventing contaminated foods from entering the marketplace or quickly removing them once they are identified. Through its education and technical assistance activities, the Agency is able to provide industry and consumers information on how to prevent food safety hazards. International harmonization activities help ensure that consumers are protected from hazardous imported food products. Moreover, research and risk assessment activities of this cluster provide the information, knowledge and expertise that establish the foundation upon which the Agency must base policies, standards and regulatory initiatives to help reduce the incidence of food-related illnesses. However, public health data systems currently do not provide the data required to accurately and realistically establish ultimate outcome goals for these activities. In the next few years, it is expected that the FoodNet systems, which are active surveillance programs, will provide data adequate to establish baselines for foodborne illnesses. These baselines will permit the Agency to objectively assess the impact of its activities on the public health. (For further information, see the Verification and Validation section at the end of the Foods Program section.)
Approaches, Skills, Technology, and External Factors:
Preventive Control Systems
Partnership agreements with states and equivalence agreements with foreign countries are necessary to help FDA promptly assure that seafood products available to consumers are produced under effective HACCP-based systems. FDA has developed a national seafood HACCP inspection database to record industry compliance. Efforts are also being undertaken to explore ways to evaluate the effectiveness and benefits of the new system. In addition, the Agency will implement the HACCP regulation for the fresh juice industry.
Compliance Monitoring
Resources requested for FY 2000 for compliance monitoring will permit FDA to increase domestic establishment inspections and to expand import coverage for foods. This funding request will provide the resources needed to significantly reduce the interval between inspections in domestic food establishments that produce high risk products. High-risk products include low acid canned foods (LACF), infant formulas, heat and serve products, ready-to-eat products and other foods that do not require heating to a temperature sufficient to kill bacteria prior to consumption. The current interval between inspections of most of these establishments is between three and four years. With the additional resources requested in FY 2000 for this strategic goal, the Agency will begin implementing a strategy that will permit it to cover the entire inventory of approximately 6,250 domestic high-risk food establishments on an average of once every one to two years. As the Agency works with states on an integrated food safety system, including additional state partnerships, it expects to reduce the inspection interval for these establishments to once every year.
To increase the effectiveness of the seafood HACCP program, the Agency will seek to transfer from the National Oceanic and Atmospheric Administration to FDA the personnel and functions of the National Seafood Inspection Program of the National Marine Fisheries Service (NMFS). NMFS' voluntary inspection program is essentially trade-oriented, but also works to obtain industry compliance with FDA's safety standards. If the Voluntary Seafood Inspection Performance-Based Organization Act is passed, it will establish the Seafood Inspection Program as a Performance-Based Organization within FDA. A Performance-Based Organization is an entity that provides necessary Governmental services for a fee, and whose activities could be enhanced by allowing it to function in a business-like manner while retaining policy direction from the Agency. The location of the PBO within FDA will help promote the efficiency and effectiveness of seafood safety activities at the federal level. This arrangement will permit closer coordination of inspectional activities, enhance uniformity in regulatory approaches and safety standards, and assure the most efficient use of resources. Under the PBO, the cost for services will be recovered through user fees paid by those who benefit from these services.
To improve the coverage for the entire food supply, FDA will use resources provided at the increased funding level to work with state and local agencies as well as USDA, CDC, and other federal agencies to establish an integrated food safety system for the Nation. On September 14 - 17, 1998, a meeting attended by 170 participants, including representatives from federal agencies and all 50 states, was held in Kansas City to explore how regulators at the federal and state levels can work together to improve the safety of foods. Such a system would ensure greater uniformity and consistency in food safety standards and may include federal oversight. A subsequent meeting on the integrated food safety system was held in December in Baltimore where work groups composed of federal and state officials were created to identify and discuss issues related to the development of an integrated food safety system. These issues included roles and responsibilities, outbreak response coordination and investigation, information sharing and data collection, minimum uniform standards and laboratory operation and coordination. In FY 2000, FDA will work with federal and state agencies to plan the implementation of an integrated food safety system. Effective coordination between all the partnering agencies and organizations involved in ensuring the safety of foods offers the best opportunity to significantly improve protection for consumers and achieve substantial reductions in foodborne illness.
Additional resources requested for this strategic goal for FY 2000 will permit the Agency to achieve a much-needed increase in the coverage of imports. With the rapid growth in imported food products over the past decade, the level of coverage declined from 7 percent in FY 1991 to around 2 percent in FY 1997. The increase in coverage will be achieved primarily by conducting additional foreign inspections/evaluations and expanding the reviews of electronic filers. Filer reviews help the Agency detect deliberate or inadvertent miscoding of filed information on imports. For example, canned mushrooms, which are automatically detained, may be miscoded as dried mushrooms that are not automatically detained. Similarly, mixed entries may be coded as one type of food product. In other cases, firms whose products are flagged for automatic detention may use the code for another firm whose products are not detained. One goal is to increase the accuracy of import entry data electronically submitted to the FDA so that no more than 10 percent of entry lines contain an error. Since the tariff codes assigned by U.S. Customs do not identify and differentiate FDA-regulated products, FDA regroups products, forming Customs' tariff codes into "entry lines." Entry lines are individual lots of imported products, such as a truckload of canned peas, a single x-ray machine, or a boatload of bananas. In addition, resources will be available to increase the number of partnerships and MRAs with foreign nations. These international agreements permit the Agency to establish safety and sanitation standards that food products must meet before they are exported to the United States. The development of these agreements must be supported by evaluations conducted of food safety systems in foreign nations.
Education and Technical Assistance
With the additional resources provided for this strategic goal, FDA will work with states and the food industry to develop and implement food production and preventive control systems (e.g., HACCP) and establish regulatory processes and systems to more efficiently and effectively monitor the food supply. The Agency will also encourage more states to adopt the Food Code. FDA will also expand its work with other federal agencies and states to implement a national education program that ensures greater safety in retail food preparation practices using concepts set forth in the Food Code.
Research and Risk Assessment
Resources requested for this goal in the FY 2000 budget will permit FDA to expand its research efforts to fill critical gaps in its food science base. This includes developing more rapid and accurate analytical methods for detecting bacterial agents in foods, especially those that are difficult to detect, and more effective techniques to prevent and control microbial pathogens on foods. The resources provided will also allow FDA's scientists to provide more technical guidance and assistance to industry, consumers, and other constituencies. Moreover, FDA scientists will be better equipped to serve as national and international experts who provide technical expertise for the development and harmonization of international food safety specifications and standards.
The National Center for Food Safety and Technology (Moffett Center) and the Joint Institute for Food Safety and Applied Nutrition (JIFSAN) are key components of FDA's efforts to achieve established food safety objectives, especially those under the Food Safety Initiative (FSI) and Produce and Imports Food Safety Initiative (PIFSI). These partnerships with academia and industry allow for more efficient use of research resources and enhance the quality of food safety and nutrition research and public health policy. The additional resources requested for FY 2000 will permit FDA to expand risk assessment efforts in JIFSAN and the Moffett Center to fill critical gaps in its ability to assess exposure to foodborne hazards. This expanded risk assessment research effort will enhance FDA's ability to more rapidly and accurately characterize the nature and size of the risk to human health associated with foodborne hazards, as well as the effects of intervention. More rapid and accurate risk assessment techniques are critical to Agency efforts to provide consumers greater protection against potential hazards posed by foodborne pathogens and other contaminants.
Dietary Supplements
The Dietary Supplement Health and Education Act (DSHEA) requires that companies make certain submissions to FDA when health claims are made for dietary supplements and provide a scientific basis for the safety of new dietary ingredients. Review of these submissions requires a varied collection of skills such as those of Medical Officers, Consumer Safety Officers, Chemists, Botanists, Herbalists, Toxicologists and other scientists. Notifications that are reviewed by FDA must be done within the specified time frames.
Performance Goals, Data Sources, and Baselines:
Goal Statement: Eighty percent of the domestic seafood industry will be operating
preventive controls for safety as evidenced by functioning Hazard Analysis Critical
Control Point (HACCP) systems.
**This goal supports the accomplishment of the NPR High Impact Agency goal, Stronger Food
Quality Assurance**
Data Sources: FDA's Field Data System; National Seafood HACCP Compliance Database System
Baseline Data:
Under development. The requisite software programs are being
designed and tested to analyze the results of inspection findings.
FY 1998:
Conducted 3,876 initial HACCP verification inspections.
FY 1999:
50% of the seafood industry will be operating preventive
controls for safety as evidenced by functioning HACCP
systems (target).
Note about Baseline Data: Data on seafood HACCP verification inspections that are needed to establish realistic baselines for this goal will not be available until March 31, 1999. An automated computer data collection system was established to receive and record inspection findings sent from remote locations by fax machines. To assure uniformity in determining compliance with the seafood HACCP regulation, only inspection results from HACCP trained and certified inspectors using the standardized inspection forms are accepted. Findings are given a quality control review before entry into the National Seafood HACCP Compliance Database. Once the compliance baseline is established (by 3/31/99), the performance goals for industry compliance in FY 1999-2002 will be reassessed.
Goal Statement: Increase the frequency of high-risk domestic food establishment inspections to once every one to two years, and annually beginning in FY 2001.
Data Source: Field Data Systems.
Baseline Data:
FY 1998:
Through a combination of FDA and state contract
inspections, cover 25% to 33% of the 6,250 high risk
food establishments
FY 1999:
Same as FY 1998 (target).
Note about Baseline Data: The existing Field Data Systems currently do not differentiate between low-, medium-, and high-risk domestic food establishments. The Agency has established a definition for high-risk establishments, which include those involved in the manufacture of low acid canned foods (LACF) products, infant formula products, heat and serve products, ready to eat products and other foods that do not require heating to a temperature sufficient to kill bacteria prior to consumption. Based on this definition, the Agency estimates that there are approximately 6,250 such establishments in its establishment inventory. It also estimates that these establishments are currently inspected on average once every three to four years. Beginning in FY 2000, the number of high-risk establishment inspections conducted annually will be increased to at least half of the inventory (approximately 3,125 establishments). As work progresses on this goal, better distinctions will be made between high-risk and the medium and low-risk inspections, and more accurate information will be obtained regarding the actual number of high-risk establishments. This information, along with annual inspection accomplishments, will provide the basis for establishing an accurate baseline for high-risk inspections.
Goal Statement: Assure that FDA inspections of domestic food establishments,(2) in conjunction with the timely correction of serious deficiencies identified in these inspections, result in a high rate of conformance (at least 90 percent) with FDA requirements.
Data Source: Field Data Systems
Baseline Data:
FY 1997:
98%
FY 1998:
98%
FY 1999:
at least 90% (target)
Note about Goal: Conformance rates estimate the post-inspection status of the establishments inspected in the given year. They are based on the number of establishments inspected, the incidence of serious deficiencies detected (Official Action Indicated), and statistical data of deficiency corrections. Since firms inspected are not randomly selected from the entire population, the rates should not be applied across that population. However, as coverage of the inventory of firms is improved, the rates will better represent the overall status of the industry sector.
Goal Statement: Initiate Hazard Analysis Critical Control Point (HACCP) systems in the juice industry.
Data Source: Field Data Systems.
Baseline Data: Baselines for juice HACCP will be established based on the inspection data collected and analyzed during the first year of implementation.
FY 1998:
Publish a proposed regulation for juice HACCP and
evaluate comments.
FY 1999:
Publish a final rule and prepare to implement the juice
HACCP regulation by providing training, technical
assistance, guidance and other assistance to industry
and states.
Note about Baseline Data: A target for this goal describing the percentage of the industry to be covered will depend on the final rule and the date on which the verification process is initiated. Based on experience in implementing HACCP in the seafood industry, the sequence of milestones to be reached in the implementation of HACCP in the juice industry will include reviewing public comments on the proposed rule; finalizing the rule; meeting with industry to explain the new rule, how they can implement it, and what the elements of a good HACCP plan are; publishing a document similar to the seafood "Bad Bug" book; developing guidance for state partnerships to conduct juice HACCP inspections; and providing technical assistance to industry before and after verification inspections.
Goal Statement: Continue to develop and implement voluntary guidance and other efforts to improve the safety of fresh fruits and vegetables, and work with USDA to conduct a 1999-2001 National Agricultural Statistics Survey (NASS) of microbial contamination of fresh produce to collect the data required to evaluate program effectiveness.
Data Source: NASS survey for 1999-2001 for fresh fruits and vegetables.
Baseline Data:
FY 1998:
Conduct grassroots meetings on GAP and GMP
guidance with domestic and foreign fresh produce
growers, producers, processors and manufacturers.
Issue broad-scope guidance on GAPs/GMPs for
growers and producers of fruits and processors of fresh
produce.
FY 1999:
Complete a pretest of the survey instrument by early
FY 1999. Assuming OMB approval under the
Paperwork Reduction Act, surveys will be conducted in
New York State and California covering 20 of the most-consumed fruit and vegetables.
Note about Baseline Data: The raw data for establishing baselines for these products are expected to be available in FY 2000. Current plans include the ongoing development and implementation of surveys to cover produce from other states. In addition, survey questions are being designed so they can be used in surveys of produce operation in foreign countries.
Goal Statement: Increase the number of inspections/evaluations of foreign food establishments from 100 to 250.
Data Sources: Field Data Systems and surveys.
Baseline Data:
FY 1998:
Conducted 43 foreign inspections/evaluations.
FY 1999:
Conduct approximately 75-100 foreign inspections/
evaluations (target).
Goal Statement: Achieve adoption of the Food Code by at least 35 percent of the states.
Data Source: Field Data Systems
Baseline Data:
FY 1997:
Three states (6%) adopted the Food Code.
FY 1998:
Ten states/jurisdictions (20%) reported adopting the
Food Code.
FY 1999:
Achieve adoption of the Food Code by 13 (25%) of the
states (target).
Goal Statement: Develop modeling techniques to assess human exposure and dose-response to certain foodborne pathogens, the potential risk for those pathogens causing human illness, and the setting of safety performance standards to regulate microbial content of food towards reducing incidence of foodborne disease.
Data Source: Periodic modeling techniques and peer reviews.
Baseline Data:
FY 1999:
There are no generally agreed-upon modeling
techniques to assess human exposure and dose
response to foodborne pathogens and the potential risk
of human illness. The development of modeling
techniques will result in more rapid and accurate
evaluation of risks associated with bacterial pathogens
and will help FDA establish research and regulatory
priorities.
FY 2000:
Conduct a quantitative microbial risk assessment of a
pathogen/food pair that represents a current food safety
issue such as Vibrio parahaemolyticus in molluscan
shellfish and Listeria monocytogenes in raw or ready-to-eat foods.
Goal Statement: Develop and make available an improved method for the detection of hepatitis A virus, Cyclospora cayetanensis and Escherichia coli O157:H7 on additional fruits and vegetables, and provide knowledge and technologies needed to develop guidance and methods for the control and elimination of pathogens on particular fruits and vegetables such as Escherichia coli O157:H7 and Salmonella spp. from juices, leafy vegetables and sprouted seeds and Cyclospora from soft fruit (e.g., berries).
Data Sources: Periodic management and peer reviews.
Baseline Data:
FY 1998:
Developed and began implementing an interagency
research plan that more effectively coordinates the food
safety research activities in FDA and USDA.
FY 1999:
Continue efforts to implement research projects in the
interagency research plan that are designed to develop
more rapid and accurate methods for detecting bacterial
contaminants on fresh produce. Traditional analytical
techniques often do not work well in fresh produce
because of interference from natural constituents in
these products. Therefore, these activities are essential
to Agency efforts to provide consumers a greater level
of protection against these potential food safety
hazards.
Goal Statement: Develop more rapid and accurate analytical methods for foodborne chemical contaminants (including bacterial toxins).
Data Sources: Periodic management and peer reviews and progress on the interagency research plan developed with USDA.
Baseline Data:
Baseline data do not currently exist for these research activities. This
research supports the program's compliance monitoring, regulatory,
education and other activities to improve the safety of the food supply.
Using the results of these research efforts, FDA will be able to
respond more effectively to hazards posed by foodborne
contaminants, including bacterial toxins and newly identified food
safety hazards such as naturally occurring toxin constituents.
| Resources: | $11,026,000 | 90 FTEs |
Performance Goals:
Rationale:
Accurate and comprehensive intelligence on foodborne illnesses and their causes is essential to the development and implementation of effective strategies to protect consumers. While a number of systems provide information on narrow aspects of food safety, no public health data systems provide the amount and types of accurate and comprehensive data required to better understand foodborne illnesses and the substances that cause them. FDA is working internally and in conjunction with other agencies and states to develop better foodborne illness data.
In FY 1995, FDA and USDA began working with CDC to improve foodborne illness surveillance activities. FoodNet is a major product of this cooperative venture. FoodNet attempts to estimate the incidence of foodborne illness that is not revealed in obvious outbreaks. Most foodborne illness occurs in ways that appear sporadic and unrelated to each other. FoodNet, which has the ability to provide more comprehensive information through sources such as case-control studies and surveys of laboratories and physicians, can help FDA and its federal partners link illnesses that have a common cause, no matter where they occur. In a related project, FDA is working in concert with CDC and the Conference of State and Territorial Epidemiologists (CSTE) to improve the forms used by state and local authorities to report on foodborne outbreaks of illness and injury.
FDA, USDA, and CDC are also cooperating in PulseNet, a computer-supported network that will compare deoxyribonucleic acid (DNA) fingerprints of microbial isolates from patients and from food products anywhere in the farm-to-table continuum. Although still in the start-up stage, this system has already proved valuable in linking and speeding trace-backs of illnesses caused by E. coli O157:H7 contamination in sprouts, lettuce, and cheese curds. When fully implemented, PulseNet will permit illness investigations to more accurately pinpoint specific products and even sources of raw materials for the products that are implicated in illness outbreaks. This capability will permit FDA and USDA to save time and resources in conducting trace backs to determine the source of foodborne contaminants.
A Foodborne Outbreak Coordination Response Group (FORCG) was established to evaluate the effectiveness of current response procedures in large outbreaks that involve several agencies, and to assure better federal-state-local coordination of the evaluation and response to foodborne illness. FORCG is composed of representatives from FDA, CDC, USDA, Environmental Protection Agency (EPA), Association of Food and Drug Officials, CSTE, and several other organizations. This group is currently working with state health organizations to help them understand its foodborne illness information needs.
FDA has a number of other systems that provide information on food and cosmetics-related injuries. These include the Adverse Reaction Monitoring System that contains consumer complaints of illness and injury from food products regulated by FDA. The Cosmetic Adverse Reaction Monitoring program is the principal way that the Agency obtains information about harmful cosmetic products. The National Health and Nutrition Examination Survey, which is funded by FDA, CDC, and the National Center for Health Statistics, is another system that provides valuable information on the nutrient status of the American public that may be used in assessing the effectiveness of nutrition activities, initiatives and programs.
The Agency has a critical need at this point to improve the timeliness and accuracy of the reporting of adverse events associated with food and cosmetic products. In order to meet this need, FDA must expand efforts to develop and maintain a modern and responsive system to receive, store, manipulate and report out information on adverse events, especially those associated with dietary supplements. Recent experiences with ephedra and cases of serious injury including deaths associated with other dietary supplements underscore this need. Dietary supplements, including vitamins/minerals, botanicals, amino acids, glandulars, and other naturally occurring compounds, are not subject to premarket review and approval by FDA before they are marketed. Therefore, information on patterns of usage, target populations of those most vulnerable to adverse reactions and other relevant data are critical to efforts to improve the protection provided consumers against potentially hazardous dietary supplement products.
Systems that provide better intelligence on food and cosmetic safety hazards, the types of contaminants that cause them, and information on changes in food consumption behaviors and attitudes ultimately benefit consumers in several ways. First, they provide the information required to more rapidly and accurately identify and respond to products that pose a potential risk to consumers. Each day saved in responding to an illness outbreak can prevent thousands of illnesses and save many lives. Second, better foodborne illness data permit the Agency to develop and focus regulatory strategies to prevent foods from becoming contaminated. Third, with better information about illnesses associated with food and cosmetic products, the Agency can focus research, education campaigns and other activities where the greatest food safety problems exist. Finally, these data systems will provide the information needed to establish realistic outcome measures that will permit FDA to evaluate the effectiveness of its programs to promote and protect the public health more objectively and become more accountable to Congress and consumers.
Approaches, Skills, Technology, and External Factors:
The FDA must maintain and increase its human resources and skills in epidemiology, statistics, molecular microbiology, federal/state cooperation, and international cooperation. In each of these areas, the skills will be leveraged through cooperation with other agencies and state officials. Many FDA officials will also invest time to learn to use the new, more complex and more informative injury reporting results. Additionally, more FDA laboratory experts will be trained in and equipped with the newest methods of molecular subtyping of pathogenic microbes.
The additional resources requested for this strategic goal will permit FDA to work with USDA, CDC and states to expand foodborne outbreak response and traceback activities. These resources will be used to increase involvement of state public health officials in the process and establish an electronic system to promote more efficient communications among the states and other involved agencies. Also, the Agency will develop more effective practices and procedures for illness outbreak coordination and work to build a strong, cooperative approach to ensure more rapid response to outbreaks of foodborne illness.
FDA will also use the additional resources requested for FY 2000 to develop the capability to deal more effectively with the ever-increasing number of reported adverse events associated with food and cosmetics products. Emphasis will be placed on improving adverse events reporting for dietary supplements. Specifically, the increased resources will be devoted to the following:
Performance Goals, Data Sources, and Baselines:
Goal Statement: Establish an integrated adverse event reporting system for food and cosmetic products, with emphasis on increasing efforts to design and implement modules needed to record dietary supplement adverse event information.
Data Sources: Integrated Agency Science-Based Reporting, Monitoring, and Evaluating Adverse Events System.
Baseline Data:
The requisite hardware and software systems need to be purchased
for integration of current Center-based systems with limited capacity.
Goal Statement: Work with the Centers for Disease Control and Prevention (CDC), the U.S. Department of Agriculture (USDA), and states to increase food safety surveillance and to improve responses to foodborne illness outbreaks.
Data Sources: The FoodNet Surveillance System and PulseNet System
Baseline Data:
FY 1998:
Expand the demographic diversity and size of the
population covered by FoodNet by increasing the
number of active surveillance sites from 7 to 8. Begin
implementation of PulseNet which provides data
required to do more rapid and accurate tracebacks to
determine the causes of foodborne illness outbreaks.
FY 1999:
Continue FoodNet and add more states to PulseNet.
| Resources: | $9,800,000 | 97 FTEs |
Performance Goals:
Rationale:
This goal includes food labeling, cosmetic and economics activities. The food label and associated labeling is the food producer's primary tool to provide information to the consumer concerning nutritive value, ingredients and information on safe handling and use. FDA's authority over the content of the food label extends to over 260,000 classes of food products with about 10,000 new products appearing on grocery shelves each year. Cosmetic activities include compliance monitoring and follow up to cosmetic injury reports. These activities are critical to Agency efforts to ensure the safety of cosmetics since there is no premarket approval requirement for either cosmetic products or their ingredients, except colors. The Agency's food economics activities protect consumers from products that are fraudulent.
Major food labeling objectives are: 1) improve the nutritional quality of the American diet and 2) provide information for the safe consumption of food. Recent information has demonstrated the significance of a healthy diet for the overall health of the consumer. Additionally, the label can serve as an important medium for providing the consumer with information on ingredients of food, including allergens and other substances that cause adverse reactions, as well as cautionary information on food handling, such as the need to promptly refrigerate foods.
Because unsafe cosmetics pose a risk to public health, it is critically important that FDA take prompt and effective steps to find unsafe products and remove them from distribution. The burden is on the Agency to find harmful products and develop the data necessary to support legal action. Under these circumstances, consumers may be exposed to a public health hazard that is difficult to detect, especially when the effect is subtle and/or not easily associated with use of the product. FDA protects public health mainly through monitoring the marketplace and through enforcement of cosmetic regulations. These activities ensure that appropriate actions are taken to find and remove unsafe products from the marketplace and to prevent problems before they occur.
FDA's role in preventing economic deception is essential in maintaining consumer confidence in marketed food products. The primary objective is to reduce the potential for economic adulteration through the use of cheaper ingredients and to ensure that consumer expectations are consistently met on subsequent purchases of the same commodity food item. Industry stakeholders have requested that FDA revise food standards to make them more flexible in accommodating newer technologies and more healthy ingredients. In addition, agencies such as the Food and Nutrition Program of USDA rely on FDA Standards of Identity to set specifications for its School Lunch and Special Supplemental Food for Women, Infants and Children (WIC) programs.
The activities in this goal benefit consumers by ensuring that food labeling is useful and accurate, that cosmetics are safe, and that foods represent the value they purport to deliver. Food labeling provides consumers the nutritional information needed to make healthy food choices that help prevent diet-related diseases such as heart conditions, strokes and certain cancers. Also, ingredient labeling provides valuable information for those who need to avoid certain food components, especially foods that may cause an allergic reaction. FDA's cosmetic program is the consumer's primary regulatory protection against hazardous cosmetic products or ingredients. While the economic issues do not present a public health hazard, they do help consumers assure that the foods they buy represent a fair value. As is the case with the other goal areas for food safety, these benefits cannot be quantified in outcome performance measures. This is primarily because data systems do not currently exist to provide the types and amounts of data required to establish and verify baselines.
Approaches, Skills, Technology, and External Factors:
Food Labeling
Currently, there are no collaboratively studied methods for measuring nutrition components, such as total trans fatty acids or conjugated linoleic acids, in food products. Also, current methods for measuring total dietary fiber in foods exclude a number of fiber components that appear to have beneficial effects. Research related to food labeling activities focus primarily on assuring the availability of accurate and efficient analytical methods for measuring the nutrients present in food products.
Clear labeling policies and provisions need to be implemented to better protect the consumer from adverse reactions , including serious reactions that could be a threat to life. These policies should ensure that food labels adequately inform consumers of the presence of allergens and other substances that may cause adverse reactions. In addition, consumers have asked the Agency to develop a strategy that can be used for disseminating such information to consumers in restaurants and food service establishments. It is also critically important that FDA take measures to assure that the public understands how to use the label as a dietary tool to a much greater extent than presently exists. Understanding how to use the food label effectively represents a major opportunity for the government to empower consumers with the ability to make choices that will help prevent chronic and acute diseases caused or exacerbated by poor nutrition.
Cosmetics
Cosmetic enforcement and regulation require a thorough knowledge of cosmetic law, regulations, past precedent actions and known product safety issues. It also requires a thorough knowledge of procedures and effective interaction with responsible field offices, other FDA centers, FDA general counsel, laboratory support, outside experts, states, and individual companies to pursue Agency actions against violative products.
Cosmetic enforcement and regulation activities are critical to implementing program initiatives through the field offices and preparation of guidance documents. For example, this project is responsible for preparation and coordination of the field work plan for monitoring cosmetic manufacturers for their use of bovine ingredients and ensuring that U.S. consumers are protected from exposure to the bovine spongiform encephalopathy (BSE) infectious agent.
Performance Goals, Data Sources, and Baselines:
Goal Statement: Increase to at least 55 percent the proportion of adults who report changing their decision to buy or use a food product because they read the food label.
Data Sources: FDA Health and Diet Surveys.
Baseline Data:
FY 1990:
In FY 1990, the Health and Diet Survey (pre-NLEA)
found that 30% of adults used the food labels to make
a decision on the purchase or use of food products.
FY 1995:
Data from the 1995 survey disclosed that 48% of
people age 18 and older reported changing their
decision to buy or use a food product because they
read the food label.
FY 2000:
The next Health and Diet Survey will include FDA's
tracking questions related to food labeling.
Goal Statement: Maintain the restored level of activity for cosmetic voluntary reporting to protect consumers against potentially hazardous cosmetic ingredients or products.
Data Sources: Voluntary reporting information for cosmetic establishments and product formulations submitted to FDA by cosmetic product manufacturers, packers and distributors
Baseline Data: FDA suspended operation of the cosmetic voluntary reporting program in March 1998 due to budget shortfalls. The database has been maintained since it was suspended but has not been updated with any new submissions. In FY 1999, the Agency will work with the regulated industry to update the database for voluntary reporting. The updated database will provide the information required to establish an accurate baseline for this activity.
Public health data systems currently are not adequate to provide accurate and comprehensive baseline data needed to draw direct relationships between FDA's regulatory activities and changes in the number and types of foodborne illnesses that occur annually in this country. Because of the need to have better data on food related illnesses, FDA and USDA began working with CDC in 1995 to improve food safety surveillance. FoodNet, an active surveillance program, was created through this joint effort. Currently, there are seven FoodNet sites and another one will be added this year.
These sites, which operate in areas that are representative of the geographic and demographic population distributions in this country, provide much better data on the number of foodborne illnesses and trends in terms of the types of contaminants that are causing these illnesses. This type of information can be critical to efforts by food safety agencies to redirect their regulatory and research resources to those food safety problems that pose the greatest threat to the health of consumers. Moreover, in 2002 when the data will be sufficient in volume and quality to establish baselines against which to measure changes in foodborne illnesses, FDA will be in a better position to establish broad scope outcome goals that are essential to effective performance planning.
Food Safety regulation development and research activities are planned and tracked through internal management systems. Progress on the development of regulations is tracked mainly through CFSAN's document tracking system and the Federal Register document tracking system. These systems permit the Agency to track the processing of regulations from the time they are filed to the point at which action is complete--usually the publication of a final regulation in the Federal Register.
CFSAN uses a number of internal data systems to track premarket review progress. These include the Management Assignment Tracking System (MATS) to track progress of petition reviews, Correspondence Tracking System (CTS) to track progress on biotechnology consultations, and internal databases to track biotechnology consultations, and reviews of GRAS notifications, nutrient content claims, and health claims petitions/notifications. Outcome-oriented performance information can be extracted from MATS only by a labor-intensive manual process. CFSAN's internal data systems are limited to tracking time to a completed review and do not have the capability to track distinct phases of the review process. In FY 1998, the internal OPA database will be modified to permit more detailed tracking of CFSAN's action on biotechnology consultations. In FY 1999, CFSAN will implement an electronic workflow system that will replace MATS and CTS and permit real-time monitoring of review progress. The electronic workflow system is expected to be in full use in FY 2000. This new system will automatically track actions related to the processing of food and color additive petitions, GRAS petitions and biotechnology consultations.
FDA uses a variety of data systems to develop and verify performance goals for its safety activities. Among these are several field data systems. The most important of the field data systems are the Program Oriented Data System (PODS) and the Operational Administrative System for Imports (OASIS) . PODS tracks field activities conducted by FDA's field force and the firms over which FDA has legal responsibility. Information provided by this system includes data on the number of inspections, wharf examinations, and sample collections and analyses as well as the time spent on each. OASIS, which is coordinated with the U.S. Customs Service , provides data on what products are being imported as well as where they are arriving. It also provides information on compliance actions related to imports. By FY 2000, the Field Accomplishments Tracking System (FACTS) will replace PODS as the primary mechanism for tracking compliance activities for the domestic food industry. The National Seafood HACCP Compliance Database System maintains information on seafood HACCP inspections conducted by FDA and States under partnership with FDA. Standardized forms (Cardiff forms) are used to assure comparability of HACCP compliance data whether the inspections are conducted by FDA or the states. Another field data collection instrument is the field survey. Field surveys are special assignments that are developed and implemented specifically to collect information needed to more thoroughly evaluate the nature and extent of particular postmarket food safety problems.
Data are also gathered through a number of other surveys designed for specific purposes. These include the Health and Diet Survey that provides information required to evaluate the impact of the Agency's food labeling activities. These surveys include questions that are designed to query consumers on how they use food labeling information to make decisions to use or purchase food products. Another survey is the NASS survey currently being developed jointly by FDA and USDA to evaluate the impact of GAPs and GMPs for improving the safety of fresh fruits and vegetables. The survey questions will be designed to provide data on practices employed in the production and processing of fresh fruits and vegetables. The results of the NASS surveys will be used to establish baselines for industry practices as well as evaluate the impact of voluntary GAPs and GMPs on improving production and processing practices for fresh produce.
Comprehensive data on illness caused by food and cosmetic products are critical to efforts to protect the health of consumers. Some of the illness data are provided by databases that contain information on adverse events, reported by consumers and industry on food and cosmetics products. In FY 2000, the Agency will improve the quality of data on adverse events through the development and implementation of an integrated adverse event reporting system.
Proposed research projects are subjected to management reviews prior to implementation and periodic management reviews after the projects have been initiated. The primary planning and management system for food safety research is the Center Program Resources (CPR) plan system which provides quarterly resource use reports and semi-annual reports on accomplishments versus planned milestones. In addition, research projects are subjected to periodic external peer reviews. Peer reviews by recognized scientific experts in various disciplines related to food safety provide objective feedback that helps FDA evaluate the progress, quality and relevance of its research activities. In addition, risk assessment models are verified periodically using statistical models that assess their ability to make rapid and accurate estimates of risks associated with a particular food safety hazard.
PulseNet is another data system that will be critical to federal and state efforts to provide greater protection for consumers. PulseNet is being developed and implemented jointly by CDC, FDA, USDA, and states. Using this new system, participating public health laboratories anywhere in the Nation can share information on the distinctive fingerprinting patterns of a pathogen that is causing illness. This will permit public health officials to determine quickly whether a widespread food borne illness outbreak is underway. If the information indicates that there is a widespread food safety problem, action can be taken to remove quickly potentially hazardous products from the marketplace and conduct tracebacks that can rapidly and effectively identify the source of the contamination.
1. Achievement of this performance goal target level is dependent upon passage of User Fee legislation and establishment of management systems to implement user fees by the beginning of FY 2000.
2. Excludes domestic seafood establishments.
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