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Enhancing Food Safety: The Role of the Food and Drug Administration 8 Enhancing the Efficiency of Inspections The word “inspection” is used by Congress, the U.S. Government Accountability Office (GAO), industry groups, individual scientists, and consumers as though it is a standard term. According to the Business Dictionary, the term denotes “critical appraisal involving examination, measurement, testing, gauging, and comparison of materials or items. An inspection determines if the material or item is in proper quantity and condition, and if it conforms to the applicable or specified requirements” (Business Dictionary, 2010). In reality, however, notions of just what the term means vary widely, and few understand what a U.S. Food and Drug Administration (FDA) inspection entails or what procedures are followed. As elaborated below, the FDA states that inspections are conducted with the purpose of enforcing regulations or collecting information in a processing or production setting. Instructions to investigators for how to conduct establishment inspections are contained in the Investigations Operations Manual1 (FDA, 2009a). According to the FDA website, “The Investigations Manual is the primary guidance document on FDA inspection policy and procedures for field investigators and inspectors,” last updated in June 2009 (FDA, 2009a), with numerous specific issuances from the Office of Regulatory Affairs (ORA). As described in Chapter 2, ORA is the broad compliance and enforcement arm for all FDA-regulated products. It is the lead office for all FDA field activities, including inspections, sample analysis, enforcement, and development of policy on compliance and enforcement. In addition to 1 See http://www.fda.gov/ICECI/Inspections/IOM/default.htm (accessed March 2, 2010).
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Enhancing Food Safety: The Role of the Food and Drug Administration staff located at headquarters, more than 85 percent of ORA staff work in 5 regional offices, 20 district offices, 13 laboratories, and more than 150 resident posts and border stations. In a presentation to the committee, the FDA clarified that ORA’s work to foster compliance is often done in partnership not only with the FDA centers but also with industry. During an outbreak, for example, ORA field investigators work closely with the affected center, conduct investigations, and decide on courses of action (Kraemer, 2009; Wagner, 2009). In addition to its inspectional and enforcement activities, ORA hosts an online university that offers required basic courses and specialized training, such as seafood certification for federal investigators. Numerous courses, both web- and classroom-based, are also available to state investigators; however, the FDA has no requirement for state investigators to take them. The training covers such areas as retail establishments, food protection, milk, shellfish, manufactured foods, feed and veterinary medicine, investigation response, incident command systems, rapid response teams, and on-farm investigations (Solomon, 2009). Prior reports have evaluated the adequacy and efficiency of U.S. food inspections and determined that inspections are insufficient, the basis for determining which facilities to inspect is poor (GAO, 2004; HHS, 2010), and there is a critical need to leverage resources to provide for a more efficient system (GAO, 2005a,b). Testimony offered to the U.S. Congress on numerous occasions has also spoken to this concern. An inefficient inspection process results in public health risks that could be avoided with appropriate inspection (for example, inspection of peanut facilities should have prevented the recent outbreak associated with contaminated peanuts). This chapter presents an analysis of the inspection process and explains the committee’s conclusion that the process is inefficient for reasons that range from the cultural to the organizational. It should be noted that a full evaluation of the efficiency of the food safety inspection process cannot be conducted in isolation from similar processes performed by other government agencies, such as the U.S. Department of Agriculture and the National Oceanic and Atmospheric Administration (see Table 2-1 in Chapter 2). In accordance with its statement of task, however (see Chapter 1), the committee evaluated only the FDA’s inspectional activities and refers to the inspectional activities of others only to the extent that they could contribute to improving the efficiency of inspections performed by the FDA. In this chapter, then, the committee offers recommendations for enhancing oversight of the food production system by improving the efficiency of the FDA’s inspections and leveraging its inspectional resources. The committee comments as well on the FDA’s potential use of third-party inspections (also discussed in Chapter 4).
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Enhancing Food Safety: The Role of the Food and Drug Administration BACKGROUND As noted above, the FDA uses establishment inspections for either enforcement or information-gathering (surveillance) purposes. Inspections may be used “to obtain evidence to support legal action when violations [of the law] are found,” or “they may be directed to obtaining specific information on new technologies, good commercial practices, or data for establishing food standards or other regulations” (FDA, 2009a, Subchapter 5.1, p. 213). Although this chapter focuses on the use of inspections as an enforcement tool, the collection of food safety data is essential to the implementation of the risk-based approach to food safety management recommended in Chapter 3. The typical inspection begins when an inspector issues a Notice of Inspection (FDA form 482) to the management of a company to be inspected and presents his/her credentials. Inspections may be carried out by a single inspector or, if specialized techniques (e.g., microscopy, x-ray) are required, by a team. Inspectors begin by becoming familiar with the establishment’s operations and products, its compliance history, pertinent safety factors, and the reporting requirements for the type of inspection to be undertaken. Other preinspectional activities are described in the Investigations Operations Manual (FDA, 2009a, Subchapters 5.4–5.9). General inspectional activities include observation, discussion with establishment management, label review, note taking, audio/video recording, sample collection (when appropriate), and reporting. Management of the establishment being inspected may invite outside observers as long as they do not impede the investigation. The sources of general inspectional procedures and techniques are given in the following quotation from the Investigations Operations Manual: The procedures and techniques applicable to specific inspections and investigations for foods, drugs, devices, cosmetics, radiological health, or other FDA operations are found in part in the Investigations Operations Manual (inspectional and investigational policy/procedure), various Guides to Inspections of … (a “how to” guidance series), and the Compliance Program Guidance Manual (program specific instructions). (FDA, 2009a, Subchapter 5.1, p. 216) The Investigations Operations Manual describes the inspectional approach in general terms as follows: An establishment inspection is a careful, critical, official examination of a facility to determine its compliance with laws administered by FDA. Inspections may be used to obtain evidence to support legal action when violations are found, or they may be directed to obtaining specific informa-
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Enhancing Food Safety: The Role of the Food and Drug Administration tion on new technologies, good commercial practices, or data for establishing food standards or other regulations. In order to facilitate on-the-job training, multiple points of view, and perspectives of firms being inspected whenever practical, those with assignment authority should consider assigning different Investigator/s or different Lead Investigators at different times. This is recommended particularly when there have been multiple sequential NAI (no action indicated) inspections or when the firm’s management has been uncooperative. (FDA, 2009a, Subchapter 5.1, p. 213) The investigation of an establishment ends with the issuance of FDA form 483, Inspectional Observations. That form is … intended for use in notifying the inspected establishment’s top management in writing of significant objectionable conditions, relating to products and/or processes, or other violations of the Federal Food, Drug, and Cosmetic Act and related Acts … which were observed during the inspection. These observations are made when, in the Investigator’s “judgment,” conditions or practices observed, indicate that any food, drug, device, or cosmetic have [sic] been adulterated or are [sic] being prepared, packed, or held under conditions whereby they [sic] may become adulterated or rendered injurious to health. The issuance of written inspectional observations is mandated by law and ORA policy. (FDA, 2009a, Subchapter 5.2, p. 224) The FDA defines two types of inspections—a comprehensive inspection and a directed inspection. Comprehensive inspections “direct coverage to everything in the firm subject to FDA jurisdiction to determine the firm’s compliance status.” Directed inspections “direct coverage to specific areas to the depth described in the program (compliance program), assignment (field assignment), or as instructed by [the] supervisor” (FDA, 2009a, Subchapter 5.2, p. 213). It is unclear what proportion of inspections is typically comprehensive and what proportion is directed. There are also two types of functionally distinct inspections: those based on Good Manufacturing Practices (GMPs) regulations and those based on Hazard Analysis and Critical Control Points (HACCP) regulations. EFFICIENCY OF INSPECTIONS Based on past authoritative reports alluding to this problem, the committee questioned the efficiency of the FDA’s food safety oversight system. Further analysis of FDA-led inspectional activities revealed various reasons for this deficiency. Some of these reasons relate to the division of responsibilities between the FDA centers and ORA, which results in the centers’ lack of authority over inspectors and inspectional priorities and procedures.
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Enhancing Food Safety: The Role of the Food and Drug Administration Also, inspectors are trained as generalists and do not specialize in, for example, food facilities. As a result, they cannot keep up with technological changes in all areas of FDA jurisdiction. Others reasons are related to the inspection procedures, which have not changed over time other than to become more burdensome with regard to paperwork and have not been adapted to the complexities of modern manufacturing establishments. The Investigations Operations Manual has not been reviewed externally to determine, for example, whether it is up to date, overly prescriptive, or otherwise less than ideal. Likewise, the time required for an establishment inspection either has not changed or has increased over time; thus, the number of inspections conducted annually has declined even though more inspectional full-time equivalents (FTEs) have been hired. Finally, the FDA’s organizational structure, whereby ORA and the centers have various responsibilities from enforcing the law to writing risk-based regulations, is not conducive to the efficient implementation of regulations. This issue is of particular concern when roles and processes for collaborating are not completely clear and depend on maintaining good relationships between individuals. The Role of the Inspector as an Investigator One could argue that the inspector is the key to any required preventive food safety procedure (Gombas, 2009). As described by Givens (2009), the inspection process is part of a larger system that promotes compliance within the industry and sensitizes the industry to its responsibilities for ensuring that its products are safe. Inspectors are told which facility to inspect and are instructed that, in addition to following regulations and a compliance program, they are investigators. Thus, they must be observant, noting anything that appears irregular and following up on it while they are in the facility (Givens, 2009). Clearly, then, the instincts, judgment, and training of an inspector are valuable components of the inspection process. The committee concluded, therefore, that the FDA’s food inspectors need the best available, up-to-date training in food safety. For example, although the agency has not proceeded rapidly with modernizing the GMPs, inspectors should receive training that is up to date with regard to the latest epidemiological intelligence, the latest information on pathogens, and any new technologies or techniques salient to the inspection process. Likewise, the FDA should have procedures in place to ensure that its auditors have the necessary experience, competencies, education, and continued training to perform their tasks. In addition, inspectors have an educational function that is linked to the FDA’s role in training the food industry in food safety and the interpretation of rules (see Chapter 9). This function includes directing food industry
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Enhancing Food Safety: The Role of the Food and Drug Administration managers to relevant FDA sources (websites or other information repositories). As recommended in Chapter 9, the FDA should develop a centralized repository for food safety educational materials for industry personnel, promote the accessibility of these materials, and provide technical support for the interpretation of rules and regulations. Inspectors should be trained in improving their communication skills so the transfer of their knowledge and communication with food managers will be effective. Inspectors should also be trained in communicating effectively with industry managers when they are requesting nonregulatory data. The purpose and terms for collecting the data, as well as whether regulatory action will be taken if a contaminant is found, need to be clearly stated (see Chapter 5). Currently, inspectors are trained to inspect establishments that represent the breadth of FDA-regulated products (i.e., drugs, devices, foods, and sometimes animal feed), and specialization is lacking. For example, an inspector who is trained and certified to inspect food processing and storage facilities may be cross-trained to inspect feed facilities. In the past, regulations and manufacturing processes were simpler, and this approach may have had benefits (i.e., a flexible inspectional force capable of being deployed to address any emergency related to any FDA-regulated products). In today’s more complex world, however, those benefits pale in comparison with the benefits of a more specialized inspectional force. Manufacturing operations have become more complex, automated, and computerized over time, and new hazards have been identified. To continue training inspectors in all FDA-regulated products results in inspectors who are generalists and lack the specialized training and knowledge to deal with this context. FDA inspectors are not unlike criminal investigators in this regard. Police departments are divided into specialty areas, allowing investigators to focus their talents and knowledge in one area (e.g., homicide, auto theft). FDA inspectors, like criminal investigators, must be trained to look for clues to violations, some of which may not be readily apparent given the technical complexities of manufacturing. The committee believes that, to have adequately trained inspectors now and in the future, the FDA must begin training inspectors within a single major commodity area (i.e., food or feed) of FDA responsibility. The FDA should review and update curricula specific to general food inspections as well as to particular types of inspections (e.g., seafood HACCP). This specific training is essential so that inspectors will be readily available and prepared to conduct an inspection in any food facility. The committee supports the partnership of the FDA with others, such as the International Food Protection Training Institute, established in 2009, to deliver career-spanning food protection training for state and local food protection professionals. Federal employees with auditing responsibilities should also be provided with specific training.
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Enhancing Food Safety: The Role of the Food and Drug Administration Risk-Based Inspections Since its inception, the FDA has lacked the manpower to place an inspector in every food manufacturing facility under its jurisdiction, let alone all facilities that pack, store, and sell such products. Therefore, the agency has used its inspection authority as a deterrent (Kusserow, 1991; Busta, 2009) since an inspection could occur unannounced at any time. The FDA has suggested prioritizing inspections based on such criteria as history of compliance (Chapter 3). At a more basic level, however, the attributes of a risk-based approach as outlined in Chapter 3 are not clearly incorporated in FDA’s approach to inspection of food facilities. The Investigations Operations Manual defines the “depth of inspection” (FDA, 2009a, Subchapter 5.1, p. 213), noting that the attention given to various operations in a firm depends on information desired or on violations suspected or likely to be encountered. The FDA suggests that inspectors consider the following: (1) current company compliance with regulations, (2) nature of the specific assignment (inspection or investigation), (3) general knowledge of the industry and its problems, (4) firm history, and (5) conditions found as inspection progresses. A walk through is suggested early in the process so the inspector can “become familiar with the operation and plan the investigation strategy” and determine the depth of inspection necessary (FDA, 2009a, Subchapter 5.1, p. 213). Thus in theory, an inspection could be limited to a walk through and expanded as needed for further investigation depending on findings. Giving inspectors flexibility with respect to the length and depth of inspections would make it possible to conduct shorter inspections of compliant establishments while maintaining an adequate presence in all firms, thus preserving the deterrent function of the inspection process. While it appears that the FDA has the statutory authority to allow shorter inspections, there are other barriers to doing so, related to resistance to changing conventional procedures. In a way, risk-based inspections have always existed. However, such approaches need to be adapted to new knowledge in food safety. Before microbiological, chemical, and physical analyses became more or less routine, FDA inspectors used personal observations to detect possible problems with the basic hygienic conditions in an establishment and relied primarily on two of the adulteration provisions of the Federal Food, Drug, and Cosmetic Act for authority to take action on any findings of unhygienic conditions.2 The GMPs for foods,3 which include special provisions for infant formulas, were finalized in the 1980s. GMPs form the basis for many international standard procedures and principles (for example, the Gen- 2 Federal Food, Drug, and Cosmetic Act of 1938, 342(a)(3) and 342(a)(4). 3 Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food, 21 CFR Part § 110.
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Enhancing Food Safety: The Role of the Food and Drug Administration eral Principles of Food Hygiene of the Codex Alimentarius Commission) and provide the foundation for establishment inspection based on sound hygienic principles, facility design, and product handling and processing. GMP inspections may generate adverse findings that are documented by the inspector and presented to a responsible individual in the establishment. Such adverse findings are expected to be corrected, and a follow-up inspection may be conducted to determine what actions were taken to that end. A criticism of GMP-based inspections, however, is that they constitute a “snapshot in time,” and do not necessarily reflect the day-to-day operations of a facility (Givens, 2009). In 2002, the FDA formed the Current Good Manufacturing Practices Working Group to determine whether the GMPs needed updating. The FDA solicited public comment, and the working group issued a report detailing areas in which modernization might be needed, such as training for supervisors and workers, food allergen control, environmental pathogen control, and written sanitation procedures. A major question was whether the food GMP regulations should be extended to facilities (such as farms) involved solely in harvesting, storing, or distributing raw agricultural commodities. To date, no apparent progress has been made on modernizing the GMPs (CFSAN/FDA, 2005), despite the fact that industry has asked the FDA to “revise its GMPs to include requirements for written sanitation plans, allergen controls, environmental monitoring programs for certain production facilities, and supervisor, manager, and employee training in hygiene and food safety measures” (Scott, 2009). The FDA itself has acknowledged the need to revise the GMPs for feed. Fourth Draft: Framework of the FDA Animal Feed Safety System (FDA, 2010) describes the need to update the GMPs for medicated feed. The committee recognizes that there is currently not enough information to justify separate GMPs for nonmedicated feed. As part of a risk-based system, if data indicate that the safety of nonmedicated feed is a concern, GMPs for this category of feed should be considered. Since the promulgation of HACCP rules in the 1990s, in addition to a GMP inspection, a HACCP inspection is required for establishments that make HACCP-regulated products (seafood and juice). GMPs are one prerequisite for HACCP, since basic hygiene underlies specific preventive procedures (Scott, 2009). Because an establishment’s HACCP plan, along with mandatory record keeping, is intended to reflect its daily preventive activities, inspection is viewed as more than the GMP-based inspection’s snapshot in time. However, HACCP inspections are based on “snapshots” provided by the establishment’s management; an inspector sees what management claims to be standard procedure within the facility. For establishments that make HACCP-regulated products, a HACCP inspection is required in addition to a GMP inspection. HACCP inspections
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Enhancing Food Safety: The Role of the Food and Drug Administration are lengthier than GMP inspections because of the required analysis of the establishment’s HACCP plan and its implementation and review of records for each day of operation (Kraemer, 2009). Some in industry believe that “while conducting a hazard analysis and implementing preventive controls should be required of industry, these activities may or may not be in the form of a HACCP plan” (Mavity, 2009). Others believe that for those processes without a kill step (critical control point), such as for preparing fresh-cut produce, a HACCP plan may be unnecessary. While it is true that not all industry processes will have critical control points, control points and limits in the form of performance standards might be possible, thus preserving the essence of HACCP. In Chapter 10, the committee recommends that the FDA be granted the authority to request preventive controls for all food facilities, mindful of the many forms such controls can take and the fact that their adequacy depends on the type of product and process. As noted in Chapter 3, the FDA presented the committee with information on its efforts to develop models for a risk-based inspection system. The committee did not evaluate these models, but it noted the lack of stakeholder involvement in the process. The Inspection Process The committee deliberated about the criticism the FDA has received for the paucity of inspections it conducts on food establishments annually (GAO, 2004, 2005a,b; Halloran, 2009; HHS, 2010). This number appears to be decreasing even as both the number of establishments in the agency’s inventory and the number of food program FTEs steadily increase (GAO, 2008). This paucity of inspections is also seen with animal feed. As noted in Chapter 7, feed mills making nonmedicated feeds are generally regulated only by the states, except in the case of the FDA’s bovine spongiform encephalopathy regulations. These mills are relatively small in number and produce organic feed or are species specific (e.g., horse feeds). Currently, only feed mills that produce feed with specific concentrations of medication in the premix need a license and are inspected routinely by the FDA or contract state inspectors. The committee believes any feed mill that manufactures medicated feed should be subject to the same inspectional processes regardless of the concentration of medication in the premix. One way to increase the number of inspections without new resources is to improve the efficiency of inspections. As stated in testimony to the committee, “inspection time can certainly vary on a number of factors—the type of operation, the complexity of the process and the product, the risk of the product, and the controls that the firm may have in place.” Furthermore, with regard to a firm with a poor history of compliance, an inspector “might want to spend some time, because that firm is not getting it—that
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Enhancing Food Safety: The Role of the Food and Drug Administration may require some more time and attention to that facility” (Givens, 2009). Thus, as suggested earlier, the individual inspector’s training, judgment, and intuition may also play a role in the length of an inspection. An applicable analogy might be a police officer making a traffic stop for a missing tail light. The officer sees the driver is nervous and asks more questions. During that extra time, the officer sees something in the car that prods him or her to ask the driver for access to the trunk, where drugs are found, making the stop a regulatory/legal activity that will take more time than usual. The Investigations Operations Manual, developed mainly by ORA, is the primary guidance document on FDA inspection policy and procedures for field inspectors. There is no specific mechanism for obtaining input on inspection procedures from the centers, states, or other agencies. The committee is not aware of reviews of (or congressional requests to review) the Investigations Operations Manual and the efficiency of inspections, even in the face of the above-noted decrease in annual inspections despite increasing numbers of personnel (Plunkett, 2009). It is possible that, as new requirements have been added to the manual to prevent a specific new problem from recurring, the manual has become unnecessarily lengthy and the inspections costly. A single establishment inspection can take one or more inspectors many days to complete, even if the establishment has a history of compliance or appears to be in compliance when the inspector enters the facility. Likewise, an inspection of a facility that may be in violation because of the presence of insect fragments in food, for example, could be far more abbreviated than one for an establishment in which salmonella is thought to reside. Inspections have become more complex and more onerous over time (Givens, 2009; Kraemer, 2009). Guidelines for inspectors have accumulated to reflect legal amendments, making the paperwork burden on the investigator increasingly time-consuming (Halloran, 2009). There has been no external study of inspection procedures in the United States, and there is no evidence of any innovative thinking applied to those procedures (Plunkett, 2009). By contrast, in 2005 the UK Treasury published a report reviewing the financial burden of government inspections and enforcement on businesses and offering recommendations for improving the efficiency of the country’s inspection system (Hampton, 2005). These recommendations include devoting more resources to riskier businesses, streamlining data-sharing methods, and communicating clearly with businesses about how to comply with regulations. In the absence of such a study in the United States, questions arise as to whether it would be reasonable and more efficient to categorize inspections based on criteria that would take into consideration an inspector’s experience and intuition. ORA appears to have thought about the latitude an inspector may have with regard to its high-risk product–hazard combination list (which was
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Enhancing Food Safety: The Role of the Food and Drug Administration developed to prioritize inspectional resources), asking what the inspector should do with this information—perform an inspection, collect samples, or conduct a field exam. ORA also appears to have thought about “regulatory testing” versus “screening” with regard to sample testing. Solomon (2009) stated to the committee that “FDA is a regulatory agency and needs to have regulatory tests—but that’s not a reason that we don’t have rapid screening tests that we can use to quickly … focus on issues and then follow up with more regulatory tests.” For example, the burden of some inspections could be alleviated by making a distinction between inspections conducted to oversee a facility’s compliance with all food-related regulations and those conducted to screen a facility’s food safety status more rapidly by determining adherence to GMPs. Although the committee did not conduct a review of inspectional procedures, it concluded that such a review is warranted to identify approaches, including risk-based approaches, that could increase the efficiency of the inspection process. Such a review should include examining procedures and techniques employed by other federal, state, and local government agencies, both regulatory and law enforcement, as well as those used in other countries, to determine whether they might be of value to FDA inspectors. Organizational and Cultural Barriers to Efficient Inspections As mentioned in Chapter 2, policy setting for FDA food regulation resides in the Center for Food Safety and Applied Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM), which are both headed by directors, while enforcement of policies and regulations is carried out by ORA, which is headed by an associate commissioner. The district offices and resident posts are staffed primarily by inspectors charged with conducting inspections of establishments’ producing, packing, or holding products regulated by the FDA, including foods, cosmetics, medical devices, and drugs. ORA works with CFSAN and CVM to develop an annual work plan that provides overall guidance to the field on the types and levels of inspections and surveillance activities to be conducted. There are also five field committees, one for each product category regulated by the FDA, composed of field managers and field program experts. The Food Field Committee and the Veterinary Field Committee are expected to work with CFSAN and CVM, respectively, in preparing the annual work plan, and they continue to collaborate during the year as issues arise. In practice, however, the committee questions whether this arrangement results in decisions that meet the regulatory responsibilities of CFSAN and CVM. The committee reviewed testimony and reports suggesting that this organizational structure creates barriers to improving inspection procedures.
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Enhancing Food Safety: The Role of the Food and Drug Administration In a report on revitalizing ORA, Glavin (2008, p. 23) states that “ORA is perceived as being too rigid, resistant to change, … unresponsive to new or different ideas, and too concerned with losing its span of control or turf.” If this observation is true, it does not bode well for effecting meaningful efficiencies in inspection procedures or establishing a system of science-based, policy-driven enforcement. One expert, familiar with the FDA’s component organizations through extensive dealings with both CFSAN and ORA, expressed the opinion that it is extremely difficult to work with those organizations during emergency situations, such as outbreaks, as communication and coordination between the two appear obscure (Osterholm, 2009). Industry-associated groups in particular have alluded to perceived friction between CFSAN and ORA. Interorganizational problems occurring during emergency situations such as disease outbreaks may be somewhat understandable; however, CFSAN and ORA have had decades to develop procedures to prevent or mitigate misunderstandings. The lack of clarity and procedures for their roles constitutes a barrier to efficient management, especially during times of crisis. It is quite likely that the split in administration of the FDA’s food programs between CFSAN and ORA, or between enforcement and policy, fuels such internal miscommunication and misunderstanding (Osterholm, 2009). In conversations with former FDA employees, including counsels, it became clear to the committee that the relationship between ORA and the centers depends largely on the personalities of the individuals who occupy leadership positions in those organizations as well as interpersonal relationships among many individuals at lower echelons of each organization. Natural competitive relationships have evolved as a result of perceptions of the value of field versus scientific experience; in addition, different missions, such as enforcement versus policy development and management, limit the sustainability of good relationships (Osterholm, 2009). Misunderstandings and inconsistencies with regard to an enforcement matter are known to occur not only between district offices within ORA itself but also between district offices and CFSAN. These occurrences are of concern, especially in cases when delaying a decision could jeopardize public health. CAPITALIZING ON FOOD INSPECTIONS: USE OF STATE INSPECTORS AS PRIMARY FOOD INSPECTORS In addition to the use of a risk-based approach, gains in inspection efficiency would be realized if food safety inspection activities at the federal, state, and local levels were coordinated (see Chapter 7). With regard to coordination at the federal level, the committee supports the GAO recommendations (GAO, 2004, 2005a,b) calling for concerted efforts in coordination of the inspectional activities of the various responsible fed-
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Enhancing Food Safety: The Role of the Food and Drug Administration eral agencies (see Appendix B). This section is focused on the utilization of inspectional resources at the state and local government levels. The role of the states in the inspection of food establishments is discussed in detail in Chapter 7. Considered here is whether a system could or should be envisaged in which federally trained state inspectors would assume the role of primary food inspectors, with the FDA serving as auditor of state-conducted inspections. If such a governance model is explored, some functions in addition to auditing should remain in the FDA, such as maintaining experience in inspection methods, providing instructional materials and specialty expertise to state inspectors, developing and evaluating new inspection techniques and training, and serving as a backup corps in times of special need. Preliminary data for 2008 indicate that states performed approximately 2,520,000 inspections (AFDO, 2009), including more than 50,000 in processing/repackaging facilities; the FDA performed only about 16,000, about 60 percent of which were conducted under contract with the states (FDA, 2009b). The committee concluded that recognition of the states as full partners in food safety assurance would be an effective way of greatly increasing the frequency of establishment inspections. Under current law, state inspectors can be commissioned as federal agents, a step that is usually taken for special assignments and is limited in time and scope. With appropriate training and oversight, state inspectors could assume a full-time role as federal deputies. The number of FDA inspectors would be limited to those required for training and auditing, and perhaps for playing an expanded role in import and export (foreign) food establishment inspections or certifying the equivalency of systems between the United States and exporting countries. The FDA would provide training to state inspectors, review inspectional procedures, and ensure that state inspections were equivalent to FDA inspections. The FDA could also defer to the states for inspection of animal feed mills. In most cases, feed mill inspectors are already from the states’ departments of agriculture and are specifically trained and contracted to perform federally required GMP inspections. They also conduct state feed mill audits for label compliance, weights and measures, and sanitation. FDA regional and district offices are spread across the U.S. mainland, but as the food industry shifts over time, they are not necessarily located in the same places as the industry (Fraser, 2009; Givens, 2009). Thus, the number of inspectors in each district office may not align with the number of establishments that need to be inspected. An individual state is in a better position to know what food establishments are within its borders (Osterholm, 2009). Therefore, a system whereby each state receives a pro rata share of inspectional resources based on the number of establishments requiring inspection might ensure more homogeneity with regard to num-
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Enhancing Food Safety: The Role of the Food and Drug Administration bers and quality of inspections. The FDA currently funds state inspections by contract; this pool of funds could be adjusted based on the inspection burden within the states and in lieu of changing the number of federal inspector positions. The agency should include in its budget a line item to fund these state contracts and partnerships to ensure their sustainability. USE OF THIRD-PARTY AUDITS AS A SUBSTITUTE FOR INSPECTIONS There has been a proliferation of both auditing and certifying bodies in the United States and elsewhere, and the data gathered by these third parties could be useful for enhancing the science behind the FDA’s risk-based approach to food safety management. Third-party auditing evolved in the European Union when large retailers demanded certain characteristics from their suppliers, such as quality, safety, limited environmental impact, and animal welfare (see Chapter 4). In Europe, an association of retail chains, EuroGAP, was formed in 1999, changing its name in 2007 to GlobalGAP (GAP = Good Agricultural Practice) (Yudin and Schneider, 2008). Many European buyers will buy only from suppliers that can provide a certificate demonstrating compliance with rules such as those of GlobalGAP. Inspection of the suppliers is carried out by a certification body, a group of third-party auditors who are accredited by an accreditation body. Usually the accreditation body is a technical committee comprised of experts from the retail and supplier sectors (Albersmeier et al., 2009). Further discussion of the potential value of third-party auditing as a governing model for managing food safety can be found in Chapter 4. Third-party auditing was not developed originally to supersede government oversight of food production and manufacture. In Europe, the producer of food must conform to both legal and third-party audit requirements. Private certification is characteristic of the European food industry, whereas public certification schemes still predominate in the United States, Canada, and Japan (Albersmeier et al., 2009). However, private certification is catching up in the United States. For example, the Global Food Safety Initiative (GFSI) was created in 2000 to set common benchmarks for different national and industry food safety programs, and GFSI standards are now used widely around the world, including in the United States. Likewise, the California Leafy Greens Marketing Agreement, operating with oversight from the California Department of Food and Agriculture, provides a mechanism for verifying that the U.S. produce industry (farmers, shippers, and processors) follows appropriate food safety practices in producing leafy greens. In response to a new challenge, private standards can be implemented more quickly than public standards, which are enacted by a government or
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Enhancing Food Safety: The Role of the Food and Drug Administration an organization such as Codex (DeWaal and Plunkett, 2007; Henson and Humphrey, 2009). However, private standards may result in unnecessarily higher food prices. DeWaal and Plunkett (2007) conclude that a government accreditation requirement might be a better solution. The FDA is taking some steps to assess the value of third-party auditing. In 2009, for example, the FDA released its Guidance for Industry on Voluntary Third-Party Certification Programs for Foods and Feeds,4 describing the general attributes the agency believes third-party certification programs should possess whether they are administered by private entities or by federal, state, local, or foreign regulatory bodies (FDA, 2009c). However, the FDA goes further to state that it will recognize a certification program only if it has sufficient confidence in the certification body. Although this stance appears to be directed toward ensuring the safety of imported foods, it could also apply to domestic certification bodies in the future. The committee deliberated about the legitimate role of information from third-party audits as a tool for the FDA to use in overseeing food safety. This question is also being examined at an international level, and an easy answer is unlikely (Henson and Humphrey, 2009). Although third-party certification may drive the industry to a higher standard that benefits everyone, the public acceptance of third-party auditors that are paid for by the industry needs to be evaluated. With appropriate standards in place, these audits could be of value for a risk-based approach. Therefore, before accepting third-party food safety audits, the FDA should develop standards and oversight procedures as necessary to ensure the credibility of the audit results. In particular, the FDA should set minimum standards for auditors and audits with a view to eventually having oversight by an accreditation and standards body. Further, if the type of information gathered during these audits could be of value for a risk-based approach, the FDA should seek ways to determine whether it can legally be mined from third-party audits/auditors. KEY CONCLUSIONS AND RECOMMENDATIONS Irrespective of the potential gains from allocating more funds to the FDA’s inspection capacity, the committee concluded that a more basic and valuable exercise would be for the agency’s inspection procedures to be reviewed for efficiency. The committee believes that, especially in light of resource limitations, the efficiency of the FDA’s inspectional activities could be improved. The committee deliberated on ways to improve inspections with this perspective in mind. 4 See http://www.fda.gov/RegulatoryInformation/Guidances/ucm125431.htm (accessed March 2, 2010).
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Enhancing Food Safety: The Role of the Food and Drug Administration The committee identified the following barriers to improved efficiency of FDA inspections: (1) the FDA’s food programs do not have direct authority over the work of inspectors and inspectional procedures, resulting in substantial delays in policy implementation in the field; (2) inspectional procedures themselves may be inefficient; and (3) the FDA underutilizes other sources of information, such as state inspections. These barriers may result in the duplication of inspections, unnecessary targeting of resources, gaps in model coverage, and misunderstandings about priorities and highest risks, all with the potential to affect public health. (Recommendations for overcoming cultural and organizational barriers to the increased efficiency of inspections are presented in Chapter 11 in the context of other organizational changes.) Gains in efficiency would be realized if food safety inspection activities at the federal level were coordinated, and the committee supports the GAO recommendations to this end (GAO, 2004, 2005a,b; see Appendix B). In keeping with its statement of task, however, the committee did not analyze the inspectional activities of other federal agencies; it focused on formulating recommendations for overcoming the above barriers. In addition to the need for a risk-based approach, the recommendations in this chapter reflect the conclusions presented in Chapter 7 with regard to the need to integrate all food safety activities at the federal, state, and local levels: (1) all food safety programs need to be standardized and harmonized; (2) state and local agencies are conducting many inspections, some of them under contract with the FDA, that need to be standardized and follow a risk-based approach; (3) once inspections (and other aspects of food safety programs) become standardized, the FDA will be able to capitalize on the work the states are already doing in many food safety areas, including inspection, to drive their risk-based models and make policy decisions; and (4) once food safety programs in states meet standards for food safety governance, the role of the FDA in standards setting, education, evaluation, oversight, and audit can be augmented. Finally, the recommendations below apply to feed inspections with a caveat. Although GMPs should be extended for all medicated feed, there is currently insufficient information to justify separate GMPs for non-medicated feed. Recommendation 8-1: The FDA should work toward an inspection system in which the frequency and intensity of inspection of each facility are based on risk, with minimum standards for the frequency and intensity of inspection of all facilities. To support the establishment of such a system, an outside panel should review the potential legal and cultural roadblocks to streamlining inspections and revise the Investigations Operations Manual so as to enhance efficiency and protection of
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Enhancing Food Safety: The Role of the Food and Drug Administration the public health. As a prerequisite for a risk-based inspection system, the FDA should update its GMPs, including those for medicated animal feed, now and hereafter as necessary. Based on the number of food safety inspections already conducted at the state and local levels and on the need for national integration of food safety activities, the committee makes the following recommendation. Recommendation 8-2: As alternative regulatory models emerge, the FDA should evolve toward conducting fewer inspections, instead delegating inspections to the states and localities (including territories and tribes). The FDA should maintain a cadre of inspectors for several critical tasks, such as auditing inspections, providing specialty expertise, developing training and instructional materials for inspectors, identifying and evaluating new inspection techniques, and serving as a backup corps in situations of special need. In preparation for this move, the FDA should review and update curricula specific to general food inspections as well as to particular types of inspections (e.g., seafood HACCP). Agency employees with responsibility for auditing inspections by others should also be provided with specific training. An FDA-sponsored food safety certification program should be established whereby inspectors become certified as they meet agency standards. The agency should include in its budget a line item to fund state contracts and partnerships to help the states move toward and maintain full certification. Plans for implementation of the suggested changes should proceed in an evolutionary fashion, with intermediate goals and associated performance measures. The committee also recommends that the FDA continue to consider the use of third-party certifications. Recommendation 8-3: The FDA should fully consider the implications of accepting inspection data from an auditing program in which third-party auditors would inspect facilities for compliance with food safety regulatory requirements. If this approach is utilized, the FDA should set minimum standards for such auditors and audits, with oversight and implementation being assigned to an accreditation and standards body. REFERENCES AFDO (Association of Food and Drug Officials). 2009. Draft State Resource Survey. York, PA: AFDO.
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Enhancing Food Safety: The Role of the Food and Drug Administration Albersmeier, F., H. Schulze, G. Jahn, and A. Spiller. 2009. The reliability of third-party certification in the food chain: From checklists to risk-oriented auditing. Food Control 20:927–935. Business Dictionary. 2010. Definition: “Inspection.” http://www.businessdictionary.com/definition/inspection.html (accessed March 31, 2010). Busta, F. F. 2009. IFT submitted comments to the Perspectives on FDA’s Role in Ensuring Safe Food Meeting, Washington, DC, March 24, 2009. CFSAN/FDA (Center for Food Safety and Applied Nutrition/U.S. Food and Drug Administration). 2005. Food CGMP Modernization—A Focus on Food Safety. Rockville, MD: FDA. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/CurrentGoodManufacturingPracticesCGMPs/ucm207458.htm (accessed May 14, 2010). DeWaal, C. S., and D. Plunkett. 2007. Building a Modern Food Safety System: For FDA Regulated Foods. CSPI White Paper. Washington, DC: Center for Science in the Public Interest. FDA (U.S. Food and Drug Administration). 2009a. Investigations Operations Manual 2009. Rockville, MD: FDA. http://www.fda.gov/ICECI/Inspections/IOM/default.htm (accessed March 2, 2010). FDA. 2009b. Establishing a Fully Integrated National Food Safety System with Strengthened Inspection, Laboratory and Response Capacity. http://www.fda.gov/downloads/ForFederalStateandLocalOfficials/UCM183650.pdf (accessed March 2, 2010). FDA. 2009c. Guidance for Industry: Voluntary Third-Party Certification Programs for Foods and Feeds. http://www.fda.gov/RegulatoryInformation/Guidances/ucm125431.htm (accessed March 2, 2010). FDA. 2010. Framework of the FDA Animal Feed Safety System (Fourth Draft). Washington, DC: FDA. Fraser, L. M. 2009. FDA’s Regulatory Authority and Division of Responsibility for Food Safety. Paper presented at Institute of Medicine/National Research Council Committee on Review of the FDA’s Role in Ensuring Safe Food Meeting, Washington, DC, March 24, 2009. GAO (U.S. Government Accountability Office). 2004. Food Safety: FDA’s Imported Seafood Safety Program Shows Some Progress, but Further Improvements Are Needed. Washington, DC: GAO. GAO. 2005a. Overseeing the U.S. Food Supply: Steps Should Be Taken to Reduce Overlapping Inspections and Related Activities. Washington, DC: GAO. GAO. 2005b. Oversight of Food Safety Activities: Federal Agencies Should Pursue Opportunities to Reduce Overlap and Better Leverage Resources. Washington, DC: GAO. GAO. 2008. FDA Has Provided Few Details on the Resources and Strategies Needed to Implement Its Food Protection Plan. Washington, DC: GAO. Givens, J. M. 2009. Review of FDA’s Role in Ensuring Safe Food (FDA’s Approach to Risk Based Inspections—A Field Perspective). Paper presented at Institute of Medicine/National Research Council Committee on Review of the FDA’s Role in Ensuring Safe Food Meeting, Washington, DC, March 24, 2009. Glavin, M. 2008. Revitalizing ORA: Protecting the Public Health Together in a Changing World: A Report to the Commissioner. Washington, DC: FDA. Gombas, D. E. 2009. FDA’s Role in Food Safety A Produce Industry Perspective. Paper presented at Institute of Medicine/National Research Council Committee on Review of the FDA’s Role in Ensuring Safe Food Meeting, Washington, DC, March 24, 2009. Halloran, J. 2009. Consumer Perspectives from the Consumers Union. Paper presented at Institute of Medicine/National Research Council Committee on Review of the FDA’s Role in Ensuring Safe Food Meeting, Washington, DC, March 24, 2009.
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Enhancing Food Safety: The Role of the Food and Drug Administration Hampton, P. 2005. Reducing Administrative Burdens: Effective Inspection and Enforcement. London, UK: Her Majesty’s Treasury. Henson, S., and J. Humphrey. 2009. The Impacts of Private Food Safety Standards on Food Chain and on Public Standard-Setting Processes. Paper presented at Report to the Codex Alimentarius Commission, 32nd Session, Rome, Italy, June 29–July 4, 2009 HHS (U.S. Department of Health and Human Services). 2010. FDA Inspections of Domestic Food Facilities. http://www.oig.hhs.gov/oei/reports/oei-02-08-00080.pdf (accessed on May 17, 2010). Kraemer, D. W. 2009. FDA’s Risk Based Prevention. Paper presented at Institute of Medicine/National Research Council Committee on Review of the FDA’s Role in Ensuring Safe Food Meeting, Washington, DC, March 24, 2009. Kusserow, R. P. 1991. FDA Food Safety Inspection. Edited by U.S. Department of Health and Human Services. Washington, DC: Office of the Inspector General. Mavity, S. 2009. Safety of Imported Foods: A Perspective from a Company in the Seafood Industry. Paper presented at Institute of Medicine/National Research Council Committee on Review of the FDA’s Role in Ensuring Safe Food Meeting, Washington, DC, May 28, 2009. Osterholm, M. T. 2009. Role of Foodborne Disease Surveillance and Food Attribution in Food Safety. Paper presented at Institute of Medicine/National Research Council Committee on Review of the FDA’s Role in Ensuring Safe Food Meeting, Washington, DC, March 24, 2009. Plunkett, D. 2009. Perspectives on FDA’s Role in Ensuring Safe Food. Paper presented at Institute of Medicine/National Research Council Committee on Review of the FDA’s Role in Ensuring Safe Food Meeting, Washington, DC, March 24, 2009. Scott, J. 2009. GMA Perspective on FDA’s Role in Ensuring Safe Food. Paper presented at Institute of Medicine/National Research Council Committee on Review of the FDA’s Role in Ensuring Safe Food Meeting, Washington, DC, March 24, 2009. Solomon, S. 2009. Regulating in the Global Environment. Paper presented at Institute of Medicine/National Research Council Committee on Review of the FDA’s Role in Ensuring Safe Food Meeting,Washington, DC, March 24, 2009. Wagner, R. 2009. FDA’S Current Approach to Risk Based Domestic Inspection Planning. Paper presented at Institute of Medicine/National Research Council Committee on Review of the FDA’s Role in Ensuring Safe Food Meeting, Washington, DC, March 24, 2009. Yudin, R. C., and K. R. Schneider. 2008. European Food Safety Certification—The “GlobalGAP” Standard and its Accredited Certification Program. Gainesville: University of Florida Extension.
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