Appendix B
Past Recommendations About the U.S. Food and Drug Administration’s Food Safety Program
TABLE B-1 Past Recommendations about U.S. Food and Drug Administration (FDA) Food Safety Program
Topic |
Recommendations |
Source |
General Authorities |
We recommended that FDA and U.S. Department of Agriculture (USDA) study their agencies’ existing statutes and identify what additional authorities they may need relating to security measures. On the basis of the results of these studies, the agencies should seek additional authority from the Congress. |
GAO, 2003 |
Authority for Mandatory Recalls and Related Recommendations |
Consumers Union (CU) has called … for Congress to grant the agency broad mandatory recall authority in light of the recent outbreak of salmonella in tomatoes. |
Consumers Union, 2008a |
|
The Commissioner of FDA should develop a sound methodology for district staff to verify that companies have quickly and effectively carried out recalls. |
GAO, 2005a |
|
To ensure that USDA and FDA have information and authority so they can act quickly to remove potentially unsafe food from the marketplace and can better protect consumers, Congress may wish to consider legislation that would require a company to notify the responsible agency when it becomes aware that a food it has distributed is unsafe. |
GAO, 2005a |
Topic |
Recommendations |
Source |
|
To ensure that USDA and FDA have information and authority so they can act quickly to remove potentially unsafe food from the marketplace and can better protect consumers, Congress may wish to consider legislation that would give USDA and FDA authority to issue a mandatory recall order and establish recall requirements. |
GAO, 2005a |
|
To ensure that companies promptly and effectively recall foods that may cause serious illness or death, the Secretary of Agriculture and the Commissioner of FDA should revise agency guidance to recalling companies to include specific time frames for notifying their customers, removing recalled food from the marketplace, and providing the agencies with the names and locations of customers that received the food. |
GAO, 2005a |
|
To ensure that companies promptly and effectively recall foods that may cause serious illness or death, the Secretary of Agriculture and the Commissioner of FDA should use agency data systems to routinely generate reports for recall program managers so that they may monitor ongoing recalls and oversee recall timeliness and effectiveness. |
GAO, 2005a |
|
To ensure that companies promptly and effectively recall foods that may cause serious illness or death, the Secretary of Agriculture and the Commissioner of FDA should track in their data systems the dates that the agencies start and finish verification checks. |
GAO, 2005a |
|
To ensure that companies promptly and effectively recall foods that may cause serious illness or death, the Secretary of Agriculture and the Commissioner of FDA should track in their recall data systems the dates that companies (1) start and finish notifying their customers, (2) provide the agency with the lists of customers that received the food, and (3) start and finish recovering the recalled food. |
GAO, 2005a |
Topic |
Recommendations |
Source |
|
To ensure that companies promptly and effectively recall foods that may cause serious illness or death, the Secretary of Agriculture and the Commissioner of FDA should work jointly to determine what, if any, additional approaches are needed for alerting consumers about recalls. |
GAO, 2005a |
Authority to Impose Penalties |
FDA needs the authority to enforce meaningful penalties to deter behavior like the Peanut Corporation of America’s. The maximum penalties for such wrongdoing should be increased from the current cap of $10,000 to $1 million. |
Consumers Union, 2009a |
|
To ensure that USDA and FDA have information and authority so they can act quickly to remove potentially unsafe food from the marketplace and can better protect consumers, Congress may wish to consider legislation that would give USDA and FDA authority to … impose monetary penalties or seek fines or imprisonment for failing to follow food recall requirements. |
GAO, 2005a |
Authority to Inspect |
CU urges Congress to overhaul the nation’s food safety laws and to mandate annual inspections of food processing facilities. |
Consumers Union, 2009b |
|
CU has called for the FDA to increase inspections of food processing plants. |
Consumers Union, 2008a |
Authority to Require Company Records and to Develop Traceability Methods |
To ensure that companies promptly and effectively recall foods that may cause serious illness or death, the Secretary of Agriculture and the Commissioner of FDA should revise agency guidance to recalling companies to include specific time frames for notifying their customers, removing recalled food from the marketplace, and providing the agencies with the names and locations of customers that received the food. |
GAO, 2005a |
|
To enhance FDA’s oversight of fresh produce safety, the Commissioner of FDA should seek authority from the Congress to provide FDA enhanced access to firm records during food-related emergencies. |
GAO, 2008a |
Topic |
Recommendations |
Source |
|
We recommend that FDA seek statutory authority, if necessary, to strengthen existing records requirements regarding lot-specific information. |
OIG, 2009 |
|
We recommend that FDA consider seeking additional statutory authority to improve traceability. |
OIG, 2009 |
|
We recommend that FDA seek statutory authority to conduct activities to ensure that facilities are complying with its records requirements. |
OIG, 2009 |
|
Congress, with input from experts, should establish traceability requirements that permit federal, state, and local officials to rapidly obtain from food companies reliable information on the source of commodities, ingredients, and finished products. |
Taylor and David, 2009 |
Develop Traceability Methods |
We urge FDA to move quickly to improve product traceability, and in particular to focus on the most problematic produce—the produce that has caused the most illnesses—first. |
Consumers Union, 2008b |
|
In addition, trace-back systems that include package identifiers allowing each product to be traced back to the field in which it originated are needed to further protect consumers from contaminated food. |
Consumers Union, 2008a |
|
We recommend that FDA work with the food industry to develop additional guidance to strengthen traceability. |
OIG, 2009 |
Education of Consumers/Communication |
A more consistent and focused effort in determining and communicating public health risks from contaminated seafood should also be developed. |
IOM, 1991 |
|
One-fifth of the fish and shellfish eaten in the United States is derived from recreational or subsistence fishing, and these products are not subject to health-based control; there is need to improve protection for consumers of these products by regulation of harvest and by education concerning risks associated with their consumption. |
IOM, 1991 |
Topic |
Recommendations |
Source |
|
There is a lack of understanding of the nature of seafood hazards in the food service sectors and by the consuming public and health professionals; a vigorous campaign for information dissemination and education in these matters is needed, particularly for high-risk consumers and high-risk products such as raw shellfish. |
IOM, 1991 |
|
The FDA should implement targeted educational programs to inform the public about the risks of consuming raw milk and raw milk products. |
IOM/NRC, 2003 |
|
Consolidated advice is needed that brings together different benefit and risk considerations, and is tailored to individual circumstances, to better inform consumer choices. |
IOM, 2007 |
|
Partnerships should be formed between federal agencies and community organizations. This effort should include targeting and involvement of intermediaries, such as physicians, and use of interactive Internet communications, which have the potential to increase the usefulness and accuracy of seafood consumption communications. |
IOM, 2007 |
|
Dietary advice to the general population from federal agencies should emphasize that seafood is a component of a healthy diet, particularly as it can displace other protein sources higher in saturated fat. |
IOM, 2007 |
|
Although advice from federal agencies should also support inclusion of seafood in the diets of pregnant females or those who may become pregnant, any consumption advice should stay within federal advisories for specific seafood types and state advisories for locally caught fish. |
IOM, 2007 |
|
Consumer messages should be tested to determine if there are spillover effects for segments of the population not targeted by the message. |
IOM, 2007 |
|
Research is needed to develop and evaluate more effective communication tools for use when conveying the health benefits and risks of seafood consumption as well as current and emerging information to the public. |
IOM, 2007 |
Topic |
Recommendations |
Source |
|
Among federal agencies there is a need to design and distribute better consumer advice to understand and acknowledge the context in which the information will be used by consumers. |
IOM, 2007 |
|
Appropriate federal agencies (National Oceanic and Atmospheric Administration [NOAA], U.S. Environmental Protection Agency [EPA], and FDA) should increase monitoring of methylmercury and persistent organic pollutants in seafood and make the resulting information readily available to the general public. Along with this information, these agencies should develop better recommendations to the public about levels of pollutants that may present a risk to specific population subgroups. |
IOM, 2007 |
|
To ensure that companies promptly and effectively recall foods that may cause serious illness or death, the Secretary of Agriculture and the Commissioner of FDA should work jointly to determine what, if any, additional approaches are needed for alerting consumers about recalls. |
GAO, 2005a |
|
We recommend that [FDA] conduct education and outreach activities to inform the food industry about its records requirements. |
OIG, 2009 |
Establish a Single Food Safety Agency |
CU has also called for consolidation of the 15 agencies that oversee our food safety system. |
Consumers Union, 2008a |
|
To implement a science-based system, Congress should establish, by statute, a unified and central framework for managing federal food safety programs, one that is headed by a single official and which has the responsibility and control of resources for all federal food safety activities, including outbreak management, standard-setting, inspection, monitoring, surveillance, risk assessment, enforcement, research, and education. |
IOM/NRC, 1998 |
|
To address the growing threat of foodborne illnesses, Congress should unify the USDA’s Food Safety and Inspection Service and the food safety activities of FDA within U.S. Department of Health and Human Services (HHS) and ensure provision of adequate resources for high-quality inspection, enforcement, and research. |
IOM, 2009 |
Topic |
Recommendations |
Source |
|
To develop a uniform, risk-based inspection system, we recommend that the Congress hold oversight hearings to evaluate options for revamping the federal food safety and quality system, including (1) creating a single food safety agency responsible for administering a uniform set of food safety laws, (2) creating a uniform set of food safety laws that are administered by the current federal food safety agencies, or (3) establishing a blue-ribbon panel to develop a model for inspection and food safety enforcement based on the public health risks posed by the products and processes. |
GAO, 1992 |
|
To provide more efficient, consistent, and effective federal oversight of the nation’s food supply, Congress may wish to consider establishing a single, independent food safety agency at the Cabinet level. |
GAO, 2004a |
|
If the Congress does not opt for an entire reorganization of the food safety system, it may wish to consider modifying existing laws to designate one current agency as the lead agency for all food safety inspection matters. |
GAO, 2004a |
|
We recommended that the Congress consider enacting comprehensive, uniform, and risk-based food safety legislation to streamline inspection and enforcement efforts, and consolidate food safety functions by establishing a single, independent food safety agency or by designating one current agency as the lead agency for all food safety inspection matters. |
GAO, 2005b |
|
We have recommended that the Congress consider statutory and organizational reforms, and we continue to believe that the benefits of establishing a single national system for the regulation of our food supply outweigh the costs. In making these recommendations, we fully recognize the time and effort needed to develop a reorganization plan and to transfer authorities, as necessary, under such a reorganization. |
GAO, 2005b |
Topic |
Recommendations |
Source |
|
Congress should give the Secretary of HHS a legislative mandate to lead the development of an integrated, national food safety system that incorporates and enhances the food safety capacity of state and local agencies. |
Taylor and David, 2009 |
|
HHS and the states should declare as a matter of policy that the establishment and enforcement of nationally uniform food safety standards is a common goal and joint responsibility of federal, state, and local governments, with the federal government bearing primary responsibility for establishing science-based standards for preventing foodborne illness and states and localities preserving full legal power to adopt and directly enforce federal standards and establish their own. |
Taylor and David, 2009 |
Feed |
The committee recommends that the government’s risk management strategy for dioxin-like compounds (DLCs) give high-priority attention to reducing the contamination of animal forage and feed and interrupting the recycling of DLCs that result from the use of animal fat in animal feed. |
NRC, 2003 |
|
We recommended that … FDA strengthen enforcement of the feed ban and its management of inspection data. |
GAO, 2003 |
Funding |
CU has called for more funding for the FDA to perform yearly inspections. |
Consumers Union, 2008a |
|
The assessment and collection of fees from domestic and foreign food plants would also supplement appropriated funds, and the fees could fund routine, up-front inspection work. |
Consumers Union, 2009a |
|
Congress and the administration should require development of a comprehensive national food safety plan. Funds appropriated for food safety programs (including research and education programs) should be allocated in accordance with science-based assessments of risk and potential benefit. |
IOM/NRC, 1998 |
Topic |
Recommendations |
Source |
|
Congress should declare that the federal government has a responsibility to support the capacity building needed to strengthen the performance of state and local agencies in the national food safety system and has a shared responsibility with the states to adequately fund food safety programs and capacity building, in accordance with the integration plan and benchmarks. |
Taylor and David, 2009 |
|
To help carry out the federal responsibility for state and local capacity building, Congress should authorize and establish an appropriation line item for FDA to provide federal funding to the states in the form of a food safety block grant, with a specified share flowing to local agencies. In addition, Congress should establish a matching grant program to foster improvement and innovation beyond base capacity building. |
|
|
State and local governments should maintain stable funding streams sufficient to meet their responsibility for funding of food safety programs, in keeping with agreed criteria and benchmarks for food safety capacity and performance. |
|
Topic |
Recommendations |
Source |
Implement Preventative Approaches |
On behalf of the Center for Science in the Public Interest (CSPI) and our 900,000 members, we are submitting a petition to the FDA urging the agency to issue standards and regulations to help ensure the safe production of fresh fruits and vegetables. These regulations are clearly needed, as demonstrated by recent multi-state outbreaks in produce, including the E. coli O157:H7 outbreak from spinach that sickened over 200 people and killed at least four and the more recent Salmonella outbreak caused by tomatoes that has sickened nearly as many. Many other outbreaks have been traced to produce, and these will continue to occur until FDA adopts enforceable standards for this important sector. CSPI urges the FDA to develop mandatory regulations and auditing programs for produce growers and processors to reduce the likelihood of microbial contamination. These regulations are authorized under the Federal Food, Drug, and Cosmetic Act, section 402(a) and the Public Health Service Act, section 361. |
CSPI, 2006 |
|
We also hope that FDA will expedite development and publication of produce regulations. |
|
|
The best way to minimize or prevent contamination [in produce] is through implementation of hazard identification and process control systems. These systems should be mandated, starting with the highest risk products first—those that have been repeatedly linked to illness outbreaks. To that end, regulations should be developed that require processors and others in the fresh-cut produce supply chain to have written plans that identify hazards associated with their product and the steps, interventions, and programs taken to address those hazards…. [I]t is critical that these mandatory programs be developed and implemented by FDA. |
CSPI, 2007a |
|
CU has called for … the agency to develop operating plans for food processing facilities that insure safety, and for domestic and foreign food producers to be required to be certified as in compliance with these safety plans and with U.S. food safety standards. |
Consumers Union, 2008a |
Topic |
Recommendations |
Source |
|
To enhance FDA’s oversight of fresh produce safety, the Commissioner of FDA should seek authority from the Congress to make explicit FDA’s authority to adopt preventive controls for high-risk foods. |
GAO, 2008a |
|
To enhance FDA’s oversight of fresh produce safety, the Commissioner of FDA should: |
GAO, 2008a |
|
1) see that the agency update its good agricultural practices guidance for fresh produce to incorporate new knowledge about safe growing practices, |
|
|
2) see that the agency update its current good manufacturing practice regulations for food to incorporate new knowledge about the food industry and safe manufacturing, processing, and holding practices. |
|
|
Chronic illness resulting from seafood consumption is associated primarily with environmental contamination; thus, control depends on improved understanding of the occurrence and distribution of the chemical agents involved, the exclusion of contaminated seafood from the market, and increased action to prevent additional pollution of the waters. |
IOM, 1991 |
|
With currently available data, it is possible to identify the source of much of the acute illness associated with seafood consumption, though the dimensions of the problems are not always known; these data, in turn, can form the basis for national control programs. |
IOM, 1991 |
|
The Center needs to carefully devise management procedures for emergency events so that these events will not disrupt other activities. Although emergency events cannot be eliminated, management should attempt to develop systems and regulations that lessen their frequency and seriousness. |
CRC/SB, 1999 |
Topic |
Recommendations |
Source |
Improve Surveillance and Outbreak Response |
Appropriate federal agencies (NOAA, EPA, and FDA) should increase monitoring of methylmercury and persistent organic pollutants in seafood and make the resulting information readily available to the general public. |
IOM, 2007 |
|
An improved national surveillance system should be developed to provide more reliable and comprehensive information on seafoodborne disease incidence. Data will then permit risk identification and risk assessment as a basis for effective regulation of seafoods (current data on disease occurrence in seafood consumption are too fragmentary to allow reliable risk assessment of microbiological and natural toxin hazards). |
IOM, 1991 |
|
We recommend specific initiatives to improve the Food Safety Information Structure (FSII) |
Taylor and Batz, 2008 |
|
1) Create a food safety epidemiology user group, to address: |
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|
|
|
|
Congress should direct the Secretary of HHS to create, in consultation with the Food Safety Leadership Council and in collaboration with the states, a National Foodborne Illness Data Program that builds on existing efforts of the U.S. Centers for Disease Control and Prevention (CDC), states and localities, and Council to Improve Foodborne Outbreak Response (CIFOR), but with the goal of significantly expanding the contribution of food safety epidemiology and other data collection to understanding and preventing foodborne illness. |
Taylor and David, 2009 |
|
HHS, working through CDC and FDA and in collaboration with the Food Safety Leadership Council, should support and build on CIFOR’s continuing efforts to define and foster implementation of best practices for foodborne outbreak response. |
Taylor and David, 2009 |
Topic |
Recommendations |
Source |
Information Technology (IT) at FDA |
The FDA should enhance the program to monitor performance metrics and put the appropriate IT infrastructure in place to track the evolution of those metrics. |
FDA, 2007 |
|
Based on the evidence of important foundational work to date in IT and yet the continued existence of critical IT capability gaps, there should be significant investment in IT at the FDA to accelerate progress toward an information processing and communications capability that can support all regulatory science. |
FDA, 2007 |
|
FDA IT must develop the intramural capability to support all regulatory science activities and should catalyze the development of multi-sectoral shared health information exchanges to support industry innovation and fulfillment of regulatory responsibilities. |
FDA, 2007 |
|
The FDA should identify and implement high-return enhancements of FDA IT infrastructure. |
FDA, 2007 |
|
FDA IT must develop the intramural capability to support all regulatory science activities and should catalyze the development of multi-sectoral shared health information exchanges to support industry innovation and fulfillment of regulatory responsibilities. |
FDA, 2007 |
Topic |
Recommendations |
Source |
|
We recommend that the federal government via legislation (or executive order) enact a national policy that would: |
Taylor and Batz, 2008 |
|
|
|
|
Priority areas of this new national policy should include: |
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|
|
|
Topic |
Recommendations |
Source |
|
We recommend specific initiatives to improve the FSII: |
Taylor and Batz, 2008 |
|
Create a “network of networks” to improve interconnectivity of the food safety web |
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|
|
|
|
Create a database for tracking research and information collection |
|
|
|
|
|
Increase access to information and publications resulting from publicly funded food safety research |
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|
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|
Increase access to industry-generated food safety information |
|
|
|
|
|
Center for Food Safety and Applied Nutrition (CFSAN) should, if they are not already doing so, develop tools to measure the effectiveness of the technology transfer process, and apply these tools on a routine basis. |
CRC/SB, 1999 |
Topic |
Recommendations |
Source |
|
To help ensure the success of FDA’s modernization efforts, we recommend that the Commissioner of FDA require the Chief Information Officer to take expeditious actions to: |
GAO, 2009 |
|
|
|
Organization |
We recommend that FDA reform legislation [to] consolidate and reorganize the food safety functions of the agency into one office—rather than the four FDA offices within which it is currently placed—in order to increase the agency’s accountability both to Congress and to consumers. |
Consumers Union, 2009a |
|
Rebuild CFSAN, Center for Veterinary Medicine (CVM) scientific base and their related inspection and enforcement functions to a level that is commensurate with their regulatory responsibilities. |
FDA, 2007 |
Topic |
Recommendations |
Source |
|
We recommend that the Secretaries of Agriculture, Commerce, and HHS enter into agreements that require the agency most frequently visiting a food-processing plant to act as the lead federal inspection agency. The lead agency would perform the inspection tasks, if any, required by the other agencies and request plants to make changes to comply with all federal food safety laws and regulations. However, when necessary, the lead agency would refer continuing violations to the responsible regulatory agency to pursue corrective action in the courts. In addition, the agency with regulatory responsibility would retain primary responsibility and inspect plants when warranted, such as to respond to consumer complaints or to follow up on referrals made by other agencies. |
GAO, 1992 |
|
To help ensure effective coordination between federal agencies with food safety and quality responsibilities, we recommend that the Secretaries of Agriculture, Commerce, and HHS evaluate and revise as necessary all current coordination agreements related to food safety and quality. Specifically, the Secretaries should direct the agency heads to revise the agreements, as necessary, to (1) define the responsibilities of each agency, (2) require the referral of firms with unsanitary food-processing conditions or unsafe food products to all agencies with regulatory oversight or grading responsibilities, (3) specify how and when referrals should be made, and (4) identify the individual or office to which referrals should be made. In addition, the Secretaries should direct the agency heads to periodically, but no less than annually, review their respective coordination agreements and update them when necessary. |
GAO, 1992 |
Topic |
Recommendations |
Source |
|
To more efficiently and effectively monitor the safety of imported seafood, the Secretary of HHS should direct the Commissioner of FDA to work toward developing a memorandum of understanding with NOAA that leverages NOAA’s Seafood Inspection Program’s resources. The memorandum of understanding should address mutually agreeable protocols and training programs that are necessary to begin using NOAA employees to provide various services. Those services could include inspections of foreign firms, importer inspections, port-of-entry examinations and sample collections, and laboratory analyses. |
GAO, 2004b |
|
GAO recognizes that, short of reorganization, other improvements can be made to help reduce overlap and duplication and to leverage existing resources. For example, the FDA could use existing authority to commission USDA inspections of dual jurisdiction establishments. |
GAO, 2005b |
|
If cost effective, we recommend that FDA, as authorized under the Bioterrorism Act, commission USDA inspectors to carry out inspections of FDA regulated foods at food establishments that are under their joint jurisdiction. We also recommend that USDA and FDA examine the feasibility and cost effectiveness of establishing a joint training program for their food inspectors. |
GAO, 2005b |
|
To better use FDA’s limited inspection resources and leverage USDA’s resources and if appropriate and cost effective, the Commissioner of the FDA, as authorized under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, should enter into an agreement to commission USDA inspectors to carry out FDA’s inspection responsibilities for food establishments that are under the jurisdiction of both agencies. |
GAO, 2005c |
Topic |
Recommendations |
Source |
|
To strengthen management controls and maximize the effectiveness of interagency agreements that are designed to reduce overlap, increase coordination, and leverage resources, the Secretary of Agriculture, the Commissioner of the FDA, the Administrator of the EPA, and the Under Secretary of Commerce for Oceans and Atmosphere should identify and inventory all active interagency food safety-related agreements. |
GAO, 2005c |
|
To strengthen management controls and maximize the effectiveness of interagency agreements that are designed to reduce overlap, increase coordination, and leverage resources, the Secretary of Agriculture, the Commissioner of the FDA, the Administrator of the EPA, and the Under Secretary of Commerce for Oceans and Atmosphere should evaluate the need for these agreements and, where necessary, update the agreements to reflect recent legislative changes, new technological advances, and current needs. |
GAO, 2005c |
|
To better use FDA’s limited inspection resources and leverage National Marine Fisheries Service’s (NMFS’s) resources, the Commissioner of the FDA and the Under Secretary of Commerce for Oceans and Atmosphere should ensure the implementation of the interagency agreement that calls for FDA to recognize the results of NMFS inspections when determining the frequency of its seafood inspections. |
GAO, 2005c |
|
FDA has opportunities to better leverage its resources. |
GAO, 2008b |
|
Tools such as a commission or chief operating officer can help agencies to address management challenges. |
GAO, 2008b |
|
The development of an interagency structure with a single focus on seafood safety could contribute significantly toward increasing communication within the federal regulatory system, but the responsibility for primary control should be with the state. |
IOM, 1991 |
Topic |
Recommendations |
Source |
|
A more pronounced and consistently defined federal role in the risk characterizations leading to seafood health advisories should be developed. |
IOM, 1991 |
|
Effort should be made to improve coordination of federal guidance with that provided through partnerships at the state and local level. |
IOM, 2007 |
|
The FDA is responsible for the safety of most of the nation’s food supply. To accomplish this formidable task, and still have the resources to tackle their other duties we believe that the inspection of low-risk food firms should be restructured. |
OIG, 1991 |
|
This restructuring is necessary because of the vital ongoing need to inspect low-risk food firms coupled with FDA’s need to devote more resources to their higher priorities. |
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|
FDA should enhance its internal capacities to conduct effective oversight. |
OIG, 2000 |
|
We recommend that the federal government create two mechanisms to implement this new national policy: |
Taylor and Batz, 2008 |
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|
Topic |
Recommendations |
Source |
|
The CFSAN Review Committee (CRC) encourages the Center to move with dispatch to develop a strategic plan that provides clarity of mission and goals, and needed measures of accountability. Use of outside expertise to facilitate development and execution of the plan is advised. The plan must be devised so as to assure that: |
CRC/SB, 1999 |
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This strategic plan will benefit the Center in several ways. Most importantly, it will provide clear guidance for organization, management decisions and operational practices. Publicizing such a plan will also enhance the Center’s credibility, particularly if progress in attaining the stated goals is evident. Additionally, this plan will, if developed with participation of the CFSAN staff, serve as the “blueprint” for the culture change the Center must bring about. |
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The subcommittee applauds the Office of Regulatory Affairs (ORA’s) efforts in planning, futuring and visioning. Clearly ORA recognizes its need to change and is trying through a transparent and inclusive process to make and act on strategic choices that have far reaching consequences. We wish to express our full support both for the vision and for the initial outline of implementation plans. However, these choices represent today’s assessment and are based on assumptions about a future that is more and more difficult to predict. This describes a “strategy paradox” that is a reality today as organizations plan forward. The subcommittee encourages ORA to include more external experts to help them continue to assess driving forces and assumptions as they move forward to implement the Revitalization business cases and beyond. The subcommittee also encourages ORA to recognize the need to develop greater flexibility and to recruit skillful people to address future uncertainty and ambiguity, which is both an important strategy in itself and a emerging core competency. |
FDA, 2008 |
Topic |
Recommendations |
Source |
|
To a certain extent, ORA has conducted a self examination and finds itself knowing that it needs to change; creating plans and strategies for change; yet, also caught up in an antiquated system/processes along with an unsympathetic public and congress that breeds a parochialism and stymies innovation, imagination, and change. ORA is taking on a leadership role in their efforts to become more strategic and contemporary but must have the support, internally and externally, to achieve revitalization. |
FDA, 2008 |
|
Furthermore, the ORA Subcommittee believes that the ORA planning must not be fragmented or separate from the larger FDA efforts to change and build critical scientific foundation. |
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The ORA review, like the larger FDA Science Board Review has especially focused on capacity and to some extent it is difficult to judge organizational efficiency in the context of the significant under resourcing which exists. Yet it is clear from discussions with ORA management and staff that even if the resource gap were immediately addressed, ORA would not be performing optimally. ORA must be enabled as well as resourced to develop further the requisite skills, experienced leadership and scientific foundation for success. To achieve these ORA must be allowed to incorporate the best technologies by which to accomplish its mission, and must be culturally receptive to the aggressive change management initiative that is called for in their Revitalization Report. |
FDA, 2008 |
|
In addition, there is a special need to better quantify capacity. The subcommittee recommends that ORA evaluate capacity index systems that can better quantify personnel needs to build their scientific capacity. These systems are based on logic models that define critical outcomes and results, then uses these end points to inform strategic hires. |
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Topic |
Recommendations |
Source |
|
Congress should direct HHS to unify the management of FDA’s food safety functions under a single official with direct access to the Secretary of HHS whose full-time job is food safety and who would have clear authority, responsibility, and accountability for leading HHS food safety activities. |
Taylor and David, 2009 |
Prioritize Research |
To enhance FDA’s oversight of fresh produce safety, the Commissioner of FDA should see that the agency develop a plan for identifying research priorities and facilitating research related to fresh produce. |
GAO, 2008a |
|
We recommend specific initiatives to improve the FSII: |
Taylor and Batz, 2008 |
|
Conduct targeted analyses to identify knowledge and information gaps |
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Initiate dialogue to prioritize information needs |
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CFSAN should carefully review research programs at field laboratories and deactivate those programs that are too feeble to be effective, or are improperly focused. Cost savings that accrue from a paring of these activities should be used to augment research programs in well-established CFSAN laboratories. |
CRC/SB, 1999 |
|
Research on antibiotic resistance of microorganisms is of major importance and should be carefully integrated in a cross-center effort. This subject is also of central importance to CVM and other centers. |
CRC/SB, 1999 |
Topic |
Recommendations |
Source |
|
The FDA should develop an agency-wide plan for method development research. A strategic approach using defined criteria for priority setting should be adopted. This process should involve all relevant governmental centers both within and outside the FDA. All aspects of food safety should be addressed. A strategy should also be developed to prioritize the development of methods for detecting new agents of public health concern. Direct ties to overall program priorities and research plans should be in place. |
CRC/SB, 1999 |
Review Inspection Approaches |
CSPI has petitioned for FDA to adopt written food safety control plans for produce growers and consider the implementation of a third-party certification system for U.S. growers and processors to ensure that these plans and facilities are reviewed at least once per year. |
CSPI, 2008 |
|
We recommend that the Secretaries of Agriculture, Commerce, and HHS enter into agreements that require the agency most frequently visiting a food-processing plant to act as the lead federal inspection agency. The lead agency would perform the inspection tasks, if any, required by the other agencies and request plants to make changes to comply with all federal food safety laws and regulations. However, when necessary, the lead agency would refer continuing violations to the responsible regulatory agency to pursue corrective action in the courts. In addition, the agency with regulatory responsibility would retain primary responsibility and inspect plants when warranted, such as to respond to consumer complaints or to follow up on referrals made by other agencies. |
GAO, 1992 |
Topic |
Recommendations |
Source |
|
To help ensure effective coordination between federal agencies with food safety and quality responsibilities, we recommend that the Secretaries of Agriculture, Commerce, and HHS evaluate and revise as necessary all current coordination agreements related to food safety and quality. Specifically, the Secretaries should direct the agency heads to revise the agreements, as necessary, to (1) define the responsibilities of each agency, (2) require the referral of firms with unsanitary food-processing conditions or unsafe food products to all agencies with regulatory oversight or grading responsibilities, (3) specify how and when referrals should be made, and (4) identify the individual or office to which referrals should be made. In addition, the Secretaries should direct the agency heads to periodically, but no less than annually, review their respective coordination agreements and update them when necessary. |
GAO, 1992 |
|
We also recommend that the FDA Commissioner and the Secretaries of the Departments of Agriculture and Commerce incorporate referral procedures into inspector manuals or handbooks to assist agency personnel in making referrals properly and in a timely manner. |
GAO, 1992 |
|
We recommend that the FDA Commissioner (1) develop a formal system to track referrals received from other agencies, (2) establish minimum times for follow-up action on referrals, and (3) periodically advise the referring agencies of the status of active referrals. |
GAO, 1992 |
|
The Commissioner of FDA should revise guidance to agency staff to include risk-based time frames for completing verification checks promptly. |
GAO, 2005a |
|
To better use FDA’s limited inspection resources and leverage NMFS’s resources, the Commissioner of the FDA and the Under Secretary of Commerce for Oceans and Atmosphere should ensure the implementation of the interagency agreement that calls for FDA to recognize the results of NMFS inspections when determining the frequency of its seafood inspections. |
GAO, 2005c |
Topic |
Recommendations |
Source |
|
We recommend that FDA explore the potential for certifying third-party inspectors; consider accrediting private laboratories to test seafood; and develop a memorandum of understanding with NOAA to use NOAA’s Seafood Inspection Program resources to complete inspections on FDA’s behalf. |
GAO, 2008b |
|
Inspection at the processing level is important to maintain safety of seafoods, but there is little evidence that increased inspection activities at this level would effectively reduce the incidence of seafoodborne disease. |
IOM, 1991 |
|
Federal agencies should develop a set of monitoring and inspection practices focusing more strongly on environmental conditions and on contaminant levels in the edible portion of seafood at the point of capture. |
IOM, 1991 |
Topic |
Recommendations |
Source |
|
The FDA is responsible for the safety of most of the nation’s food supply. To accomplish this formidable task, and still have the resources to tackle their other duties we believe that the inspection of low-risk food firms should be restructured. |
OIG, 1991 |
|
This restructuring is necessary because of the vital ongoing need to inspect low-risk food firms coupled with FDA’ s need to devote more resources to their higher priorities. |
|
|
The FDA, working with the States, should develop and seek legislative authority for a system to inspect low-risk food firms based on the following principles: |
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At a minimum, the system should include the following recommendations. |
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|
|
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FDA should reevaluate its reliance on the partnership agreements as a mechanism for conducting inspections. |
OIG, 2000 |
Topic |
Recommendations |
Source |
|
FDA should work with states to achieve basic equivalency in food safety standards and laws, and in inspection programs and practices. |
OIG, 2000 |
|
FDA should devote high priority to improving its on-site audit mechanism for evaluating the effectiveness of state inspections. |
OIG, 2000 |
|
FDA should require that states routinely provide FDA with standardized information on the inspections they conduct. |
OIG, 2000 |
|
FDA should draw on multiple external sources of information in assessing state inspection performance. |
OIG, 2000 |
|
FDA should provide substantive and timely feedback to states on their inspection performance. |
OIG, 2000 |
|
FDA should increase public disclosure of its oversight of state food firm inspections. |
OIG, 2000 |
|
HHS/FDA, working in collaboration with state and local agencies, should develop and implement a plan for integrating and modernizing federal and state food manufacturing regulatory programs for facilities under FDA’s jurisdiction. |
Taylor and David, 2009 |
|
HHS/FDA should make the full implementation of the Retail Food Regulatory Program Standards and the Manufactured Food Regulatory Program Standards a central component of its plan for building an integrated national food safety system and inspection program and should provide needed resources and incentives for state and local governments to participate. |
Taylor and David, 2009 |
Risk-Based/Science-Based Legislation |
To provide more efficient, consistent, and effective federal oversight of the nation’s food supply, Congress may wish to consider enacting comprehensive, uniform, and risk-based food safety legislation. |
GAO, 2004a |
Topic |
Recommendations |
Source |
|
To achieve a food safety system based on science, current statutes governing food safety regulation and management must be revised. |
IOM/NRC, 1998 |
|
Congress should change federal statutes so that inspection, enforcement, and research efforts can be based on scientifically supportable assessments of risks to public health. |
|
|
Most current health risks associated with seafood safety originate in the environment and should be dealt with by control of harvest or at the point of capture. With minor exceptions, risks cannot be identified by an organoleptic inspection system. |
IOM, 1991 |
Safety of Imports |
CU has called for … the agency to develop operating plans for food processing facilities that insure safety, and for domestic and foreign food producers to be required to be certified as in compliance with these safety plans and with U.S. food safety standards. |
Consumers Union, 2008a |
|
CSPI believes that a mandatory certification program is the best way to ensure the safety of imported food. |
CSPI, 2008 |
|
To strengthen FDA’s current imported seafood program and ensure the safety of seafood consumed in the United States, the Commissioner of FDA should make it a priority to establish equivalence or other similar types of agreements with seafood-exporting countries, starting first with countries that have high-quality food safety systems. |
GAO, 2004b |
|
While we recognize that third-party certification may in fact have a place in a robust food safety system, we urge FDA to remember that certification is not a guarantee of safety or a panacea for the problems that plague the agency. Certification programs may in fact be well-suited to certain commodities, and not all at useful for others. CSPI believes that both produce and imported FDA products may be appropriate for certification programs, provided that those programs are well-regulated and wisely implemented. |
CSPI, 2008 |
Topic |
Recommendations |
Source |
|
To strengthen FDA’s current imported seafood program and ensure the safety of seafood consumed in the United States, the Commissioner of FDA should develop and implement a system to track the time involved in documenting, reviewing, and processing regulatory and enforcement actions, such as issuing warning letters and detaining unsafe products, so that FDA can identify the reasons for the delays and take actions to address them. |
GAO, 2004b |
|
To strengthen FDA’s current imported seafood program and ensure the safety of seafood consumed in the United States, the Commissioner of FDA should give priority to taking enforcement actions when violations that pose the most serious public health risk occur. |
GAO, 2004b |
|
To strengthen FDA’s current imported seafood program and ensure the safety of seafood consumed in the United States, the Commissioner of FDA should consider the costs and benefits of implementing an accreditation program for private laboratories. |
GAO, 2004b |
|
To strengthen FDA’s current imported seafood program and ensure the safety of seafood consumed in the United States, the Commissioner of FDA should explore the potential of implementing a certification program for third-party inspectors, which would involve reviewing FDA’s legal authorities and considering the costs and benefits, including developing and implementing the standards, controls, and oversight necessary to provide FDA with reasonable assurance that third-party inspectors are qualified and independent. |
GAO, 2004b |
|
The Secretary of Agriculture and the Commissioner of the FDA should work together to consider the findings of USDA’s foreign country equivalency evaluations when determining which countries to visit. |
GAO, 2005c |
|
We recommended that FDA make it a priority to establish equivalence agreements with other countries. |
GAO, 2008b |
Topic |
Recommendations |
Source |
|
Because well over half the nation’s seafood supply is imported and environmental contamination is globally pervasive, it is important that the safety of imported seafood be ensured through equivalent control measures in exporting countries. |
IOM, 1991 |
|
Consideration should be given to the development of agreements with foreign authorities and individual producers to ensure that imported products are treated in a manner consistent with and equivalent to domestic products. |
IOM, 1991 |
|
As more countries require the equivalency of domestic and imported products, it is apparent that the time has come for the international community to begin a process that would minimize the differences existing among national regulatory guidelines and approaches. |
IOM, 1991 |
|
The FDA should develop strategies to ensure the safety of imported seafood and produce by focusing on pathogen intervention strategies prior to shipment and on international harmonization of standards. |
IOM/NRC, 2003 |
|
We urge the FDA to |
CSPI, 2003 |
|
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CFSAN should be a world leader in establishing standards and procedures (reliable sampling procedures; rapid, accurate, and economical tests) for assuring the safety of foods crossing international boundaries. Safety when leaving the country of origin should be emphasized. |
CRC/SB, 1999 |
Topic |
Recommendations |
Source |
|
We recommended that USDA and FDA, among other things, develop a coordinated strategy to identify resources needed to increase inspections of imported goods. |
GAO, 2003 |
Safety of Imports—Pet Food |
The ever-expanding recall of pet food containing contaminated ingredients from China demonstrates the immediate need for greater controls on imported foods, especially grain products originating from China. In light of the wheat and rice gluten problems, CSPI calls on the FDA to ban all grain imports from China until they can be certified by U.S. inspectors as free of illegal chemical or microbial contamination, including but not limited to pesticides, rat poison, and melamine. In addition, FDA should evaluate if the ban should extend to other foods or ingredients coming into the U.S. from China or any other country. |
CSPI, 2007b |
Science at the FDA |
The FDA should institute a new scientific organization. |
FDA, 2007 |
|
The FDA must develop a program to manage “new science” that will provide a standardized approach to enable the FDA to address all emerging sciences and technologies. |
FDA, 2007 |
|
The FDA should create a distinctive research culture, take concrete steps to hire more high-quality scientific talent, and create better career ladders. |
FDA, 2007 |
|
FDA should develop and support a strong ongoing professional development program to ensure that staff maintains its scientific competence. |
FDA, 2007 |
|
The FDA must develop the capability to innovate in information science and technology to better support its regulatory mandate and more specifically to support regulatory activities for new science. |
FDA, 2007 |
|
Strengthen and organize the IT workforce to ensure that it can support the rapid evolution of the FDA information science and technology infrastructure. |
FDA, 2007 |
|
The FDA resource gap must be corrected to enable the Agency to fulfill its regulatory mandate. |
FDA, 2007 |
Topic |
Recommendations |
Source |
|
An effective and efficient food safety system must be based on science. |
IOM/NRC, 1998 |
|
The FDA should expand research on risks associated with many specific practices in the fresh produce sector, and on the potential for and significance of internalization of pathogens into fresh produce. |
IOM/NRC, 2003 |
|
The FDA should work with industry to conduct research to assess the pathogen reduction efficacy of cheese manufacturing conditions and to develop science-based performance standards for reduction of targeted pathogens in finished cheese products. |
IOM/NRC, 2003 |
|
Postdoctoral and student intern programs are needed to expose researchers and management to new views and to provide the Center with an effective means for evaluating potential new hires. |
CRC/SB, 1999 |
|
Increasing the number of support personnel per scientist should be a high priority objective of management. The present number of support staff is woefully inadequate and not cost effective. The consequences are inefficient research and decreased employee morale. |
CRC/SB, 1999 |
|
Procedures for reviewing the performance of research personnel need to be carefully evaluated and redesigned. These reviews should occur on a regularly scheduled basis and should focus on matters of research productivity, quality, impact relevance to the CFSAN mission, and ability of the researcher to interact effectively with associates. These reviews, if properly conducted, can be a powerful tool for improving employee morale and effectiveness. This matter should be a high priority consideration by CFSAN management. |
CRC/SB, 1999 |
Topic |
Recommendations |
Source |
|
The program for professional development should be greatly improved and expanded. This includes assuring that scientists regularly attend internal and external short courses in their areas of responsibility, attend at least one national or international scientific conference per year, have access to a sabbatical program, and are encouraged to accept adjunct faculty positions at universities. The successful adoption of these initiatives should strengthen CFSAN’s research programs, improve employee morale, and improve the Center’s ability to develop reasonable, effective regulations and to respond rapidly and effectively to public health emergencies. |
CRC/SB, 1999 |
|
CFSAN should strive to move from its current full-time equivalent-based budgeting practice to one that is program based. Without such a change, true costs, effectiveness and accountability of research programs cannot be meaningfully assessed. |
CRC/SB, 1999 |
|
CFSAN should prioritize its instrument purchases with great care. |
CRC/SB, 1999 |
|
CFSAN’s laboratories should be certified. CRC/SB, 1999 Participation of CFSAN personnel in CODEX programs and other similar international programs is essential and should be continued. |
CRC/SB, 1999 |
|
Management should determine which aspects of research in chemical toxicology should be in CFSAN and which aspects can be provided by other governmental groups. Those aspects that support CFSAN’s unique regulatory responsibilities should be strengthened in-house as well as through partnerships with other organizations. For example, CFSAN should consider partnering with, and in some cases depending on, state-of-the-art toxicology laboratories, such as FDA’s National Center for Toxicological Research. |
CRC/SB, 1999 |
Topic |
Recommendations |
Source |
|
CFSAN’s microbial risk assessment program should be helping to establish improved Hazard Analysis and Critical Control Points protocols. CFSAN’s in-house capability in microbial risk assessment should be enhanced with additional personnel and resources to help propel CFSAN toward a leadership role in this field. Partnering with other world experts, in the United States and other countries, should be considered to facilitate development of common methodologies and enable broader coverage. In addition to developing methodologies, a greater number of risk assessments should be performed annually to facilitate control of microbiological hazards. Methodologies for determining “acceptable” levels of risk for use in regulating microbial contaminants are also needed. Current partnerships with CDC and use of international data bases should continue to be emphasized, as should evaluation of risks from microbial contaminants in actual food matrices. |
CRC/SB, 1999 |
|
To use risk assessment appropriately in regulation, CFSAN should develop a public health-oriented approach to establish regulatory priorities for hazardous chemical and microbial agents. The priorities established should encompass the full food chain from pre-harvest to consumer. Because CFSAN alone does not have the mandate or resources to conduct a comprehensive assessment of public health, it should collaborate with other agencies. |
CRC/SB, 1999 |
|
The CRC endorses CFSAN’s research activities to determine safe practices for new or modified food processes, but recommends that management regularly: (a) evaluate these projects for conformance to CFSAN priorities, progress and impact, and (b) determine for each project how the objectives can be achieved most effectively and efficiently, i.e., should the studies be conducted in-house, in collaboration with other groups, or by contract with other parties? |
CRC/SB, 1999 |
Topic |
Recommendations |
Source |
|
CFSAN laboratory practices should conform to the principles of the Association of Analytical Communities Food Laboratory Accreditation Working Group. Consideration should also be given to achieving full International Organization for Standardization 25 accreditation for CFSAN laboratories. |
CRC/SB, 1999 |
|
A long-term strategic plan for dealing with critical issues related to food and nutrition should be developed. This plan should be based on public health needs as revealed by the National Nutrition Monitoring Programs. |
CRC/SB, 1999 |
|
The subcommittee also encourages ORA along with the entire FDA to further develop the discipline of regulatory science. The subcommittee meetings and discussions reinforced the uniqueness and importance of regulatory science as an intellectual field, and the subcommittee believes that ORA, together with the FDA Centers, must reinforce this regulatory science identity by championing risk based programs, risk assessments, evidence based policy and regulation, and knowledge management among other disciplines in order to successfully work in a world of greater uncertainty. These skills and activities need to be paralleled by the development of stronger analytical skills in decision making. We understand that this discipline is still in a formative stage but encourage ORA to help lead the further maturation and use of regulatory science across FDA. |
FDA, 2008 |
Science at the FDA—Contaminants |
More complete data are needed on the distribution of contaminant levels among types of fish. |
IOM, 2007 |
|
More quantitative characterization is needed of the dose-response relationships between chemical contaminants and adverse health effects, in the ranges of exposure represented in the general U.S. population. |
|
Topic |
Recommendations |
Source |
|
The committee recommends more research on useful biomarkers of contaminant exposures and more precise quantitative characterization of the dose-response relationships between chemical contaminants and adverse health effects, in the ranges of exposure represented in the general U.S. population, in order to reduce uncertainties associated with recommendations for acceptable ranges of intake. |
IOM, 2007 |
|
Develop cost-effective analytical methods and reevaluate the use of toxicity equivalents in assessing DLC exposure. |
NRC, 2003 |
|
To move effectively toward reducing human exposure to DLCs through food, the federal government should begin by pursuing the following strategic courses of action: (1) establish an integrated risk management strategy and action plan, (2) foster collaboration between the government and the private sector to reduce DLCs in the food supply, and (3) invest in the data required for effective risk management. |
NRC, 2003 |
|
Increase research efforts on the effects of dietary DLCs on fetuses and breastfeeding infants. |
NRC, 2003 |
|
Develop predictive modeling tools and apply them in studies to assess the effects of potential interventions on reducing DLCs in the food supply. |
NRC, 2003 |
|
CFSAN should carefully monitor the activities of the private sector, other governmental agencies, and academia in developing rapid methods for specific pathogens, toxins and chemicals and enter into collaborative arrangements when these are feasible and effective. Management should also identify and prioritize the individual microorganism or toxin for which rapid methods are most needed and communicate these priorities to potential developers in the private sector to help avoid duplication of effort. |
CRC/SB, 1999 |
Science at the FDA—Contaminants in Feed |
Increase research efforts aimed at removing DLCs from animal forage and feed. |
NRC, 2003 |
Topic |
Recommendations |
Source |
Science at the FDA—Food Animals |
The committee recommends that CVM continue procedural reform to expedite the drug approval review process and broaden its perspective on efficacy and risk assessment to encompass review of data on products already approved and used elsewhere in the world. |
NRC, 1999 |
|
The committee recommends that, to improve drug availability [for food animals], worldwide harmonization of requirements for drug development and review be considered and further enhanced among the federal agencies that are responsible for ensuring the safety of the food supply. |
NRC, 1999 |
|
The committee recommends that CVM base drug use guidelines on maximal safe dosage regimens for specific food animals, consider greater emphasis on the pharmacokinetics of drug elimination from tissues that are consumed in large quantity, and set drug withdrawal times accordingly. |
NRC, 1999 |
|
The committee recommends establishment of integrated national databases to support a rational, visible, science-driven decision-making process and policy development for regulatory approval and use of antibiotics in food animals, which would ensure the effectiveness of these drugs and the safety of foods of animal origin. |
NRC, 1999 |
|
The committee recommends that further development and use of antibiotics in both human medicine and food-animal practices have oversight by an interdisciplinary panel of experts composed of representatives of the veterinary and animal health industry, the human medicine community, consumer advocacy, the animal production industry, research, epidemiology, and the regulatory agencies. |
NRC, 1999 |
|
The committee recommends increased funding for basic research that explores and discovers new or novel antibiotics and mechanisms of their action, including the development of more rapid and wide-screen diagnostics to improve the tracking of emerging antibiotic resistance and zoonotic disease. |
NRC, 1999 |
Topic |
Recommendations |
Source |
Science at the FDA—Seafood |
New tools apart from traditional safety assessments should be developed, such as consumer-based benefit-risk analyses. A better way is needed to characterize the risks combined with benefit analysis. |
IOM, 2007 |
|
A consumer-directed decision path needs to be properly designed, tested, and evaluated. The resulting product must undergo methodological review and update on a continuing basis. Responsible agencies will need to work with specialists in risk communication and evaluation, and tailor advice to specific groups as appropriate. |
IOM, 2007 |
|
Research is needed on systematic surveillance studies of targeted subpopulations. |
IOM, 2007 |
|
Sufficiently large analytic samples of the most common seafood types need to be obtained and examined. |
IOM, 2007 |
|
Additional data is needed to assess benefits and risks associated with seafood consumption within the same population or population subgroup. |
IOM, 2007 |
|
Future epidemiological studies should assess intake of specific species of seafood and/or biomarkers, in order to differentiate the health effects of eicosapentaenoic acid/docosahexaenoic acid from the health effects of contaminants such as methylmercury. |
IOM, 2007 |
|
More complete data are needed on the distribution of contaminant levels among types of fish. |
IOM, 2007 |
|
More quantitative characterization is needed of the dose-response relationships between chemical contaminants and adverse health effects, in the ranges of exposure represented in the general U.S. population. |
IOM, 2007 |
Topic |
Recommendations |
Source |
|
The committee recommends more research on useful biomarkers of contaminant exposures and more precise quantitative characterization of the dose-response relationships between chemical contaminants and adverse health effects, in the ranges of exposure represented in the general U.S. population, in order to reduce uncertainties associated with recommendations for acceptable ranges of intake. |
IOM, 2007 |
|
Research is needed to develop and evaluate more effective communication tools for use when conveying the health benefits and risks of seafood consumption as well as current and emerging information to the public. |
IOM, 2007 |
|
Among federal agencies there is a need to design and distribute better consumer advice to understand and acknowledge the context in which the information will be used by consumers. |
IOM, 2007 |
Sharing Information/Interagency Collaboration |
The FDA should strengthen its collaboration across Centers and with other government agencies. It should appoint a Director of External Collaborations to administer a competitive external grants program. |
FDA, 2007 |
|
To more efficiently and effectively monitor the safety of imported seafood, the Secretary of HHS should direct the Commissioner of FDA to work toward developing a memorandum of understanding with NOAA that leverages NOAA’s Seafood Inspection Program’s resources. The memorandum of understanding should address mutually agreeable protocols and training programs that are necessary to begin using NOAA employees to provide various services. Those services could include inspections of foreign firms, importer inspections, port-of-entry examinations and sample collections, and laboratory analyses. |
GAO, 2004b |
Topic |
Recommendations |
Source |
|
The Secretary of Agriculture and the Commissioner of FDA should work together to ensure the implementation of the interagency agreement that calls for, among other things, sharing inspection- and enforcement-related information at food-processing facilities that are under the jurisdiction of both agencies. |
GAO, 2005c |
|
To foster transparency and accountability, the Commissioner of FDA should provide specific information to the Congress and to the public on the strategies and resources for implementing the Food Protection Plan. |
GAO, 2008a |
|
To enhance FDA’s oversight of fresh produce safety, the Commissioner of FDA should see that the agency identify approaches for obtaining testing and other information from industry members to inform its research agenda. |
IOM, 1991 |
|
The development of an interagency structure with a single focus on seafood safety could contribute significantly toward increasing communication within the federal regulatory system, but the responsibility for primary control should be with the state. |
IOM, 1991 |
|
A more concise, comprehensive, and generally available single source for all FDA guidelines relating to seafood safety should be developed and updated on a regular basis. This information should be disseminated to industry and integrated into state regulatory processes through more routine and uniform training programs. |
IOM, 1991 |
|
Congress should provide the agency responsible for food safety at the federal level with the tools necessary to integrate and unify the efforts of authorities at the state and local levels to enhance food safety. |
IOM/NRC, 1998 |
Topic |
Recommendations |
Source |
|
Partnerships should be formed between federal agencies and community organizations. This effort should include targeting and involvement of intermediaries, such as physicians, and use of interactive Internet communications, which have the potential to increase the usefulness and accuracy of seafood consumption communications. |
IOM, 2007 |
|
Effort should be made to improve coordination of federal guidance with that provided through partnerships at the state and local level. |
IOM, 2007 |
|
The CRC endorses research collaboration among various groups with interests in food safety practices and regulations, provided these collaborations have been determined to be the most effective and efficient approaches available. Factors that should be considered when contemplating collaboration include availability of appropriate personnel, equipment, and facilities; cost effectiveness of various alternative options, and likely long-term effectiveness of the partnership. |
CRC/SB, 1999 |
|
Research should not duplicate that which is being conducted elsewhere, and partners should be sought whenever appropriate and possible. For example, the CRC noted that research on soy products and their effects is currently underway at Iowa State University, University of Illinois, Loma Linda University and other institutions. Thus, work at these institutions should not be duplicated by CFSAN. |
CRC/SB, 1999 |
|
By the nature of its mission ORA’s work is increasingly more reliant on partners and collaborations, including various stakeholders within and outside of the FDA. The extensive collaboration among federal, state inspection and increasingly foreign regulatory agencies is already impressive. The subcommittee encourages ORA to continue expend the time, energy, and resources necessary to build and secure greater collaboration locally, statewide, across other federal agencies outside FDA and globally. |
FDA, 2008 |
Topic |
Recommendations |
Source |
|
Congress should establish and fund an intergovernmental Food Safety Leadership Council to foster federal-state-local collaboration in the design and implementation of an integrated national food safety system. |
Taylor and David, 2009 |
|
The Secretary, in consultation with the Food Safety Leadership Council and in collaboration with appropriate professional organizations, should conduct a survey of the current food safety capacities of state and local agencies—including staffing and skill levels, laboratory capacities, information systems, legal authorities, and organizational arrangements—and, on the basis of the survey, identify and prioritize capacity building and other state and local needs that must be met to fulfill their roles in the national food safety system. |
Taylor and David, 2009 |
|
Congress should direct HHS to develop, based on the capacity survey and consultations with the Food Safety Leadership Council, a 5-year plan for better integrating federal, state, and local food safety efforts and improving state and local capacity for that purpose. The integration plan should be based on mutually agreed criteria and benchmarks for such matters as timeliness of outbreak investigations, frequency of retail inspection, food safety staffing and skill levels, laboratory capacity, and information systems. |
|
|
State and local governments should better integrate their own surveillance, outbreak response, and food safety regulatory and inspection activities, and each state should establish a focal point for better linking and integrating the state’s food safety activities with the national system. |
Taylor and David, 2009 |
|
State and local governments should collaborate on the development and widespread adoption of a model state and local food safety law that addresses all aspects of state and local roles in food safety, modernizes food safety regulatory laws to adopt a more preventive and risk-based approach, clarifies the roles of state and local agencies in a more integrated system, and legally empowers state and local agencies to work more collaboratively among themselves and with the federal government. |
|
Topic |
Recommendations |
Source |
|
HHS, working through CDC and FDA and in collaboration with states and localities, should establish a network of regional, federally-funded foodborne outbreak response centers to ensure an integrated “systems” approach to outbreak response and follow-up investigations. The centers would be staffed fulltime with a multi-disciplinary team of federal, state, and local epidemiologists, environmental health experts, regulatory officials, and food safety communicators (all federally funded) for purposes of: (1) supporting state and local agencies in their day-to-day foodborne illness surveillance and response activities; (2) improving the thoroughness and timeliness of outbreak detection, response, and follow-up investigation to inform future prevention; and (3) establishing the relationships, expertise, continuity, and surge capacity needed to ensure well-coordinated and effective response to major outbreaks. |
Taylor and David, 2009 |
|
HHS, in consultation with the Food Safety Leadership Council and working with states and localities, should establish protocols for managing multi-state outbreaks, including clear definition of federal, state, and local roles; mechanisms for collaboration; and criteria for triggering federal-level management of outbreaks. |
Taylor and David, 2009 |
Training |
The Secretary of Agriculture and the Commissioner of FDA should work together to examine the feasibility of establishing a joint training program for food inspectors. |
GAO, 2005c |
|
All personnel should be fully cognizant of the goals of their program. Each project should undergo a formal review annually and be evaluated for progress, current priority status, and likelihood that continuation will lead to success. |
CRC/SB, 1999 |
|
We also recommended that both agencies provide training for all field personnel to enhance their awareness and ability to discuss security measures with plant personnel. |
GAO, 2003 |
Topic |
Recommendations |
Source |
|
HHS, in collaboration with the Food Safety Leadership Council, should establish a Food Safety Leadership and Training Institute focused on building among food safety professionals at all levels a common vision for the nation’s food safety system and the leadership skills, network of relationships, and trust needed for an integrated system to succeed. |
Taylor and David, 2009 |
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Consumers Union. 2008a. Increased Inspections Needed for Produce, Processing Plants to Protect Consumers from Unsafe Food. http://www.consumersunion.org/pub/core_food_safety/005732.html (accessed September 9, 2009).
Consumers Union. 2008b. CU Testimony on Product Tracing for Fresh Produce. http://www.consumersunion.org/pub/core_food_safety/006294.html (accessed September 9, 2009).
Consumers Union. 2009a. CU letter to Senator Durbin Regarding FDA Food Safety Modernization Act. http://www.consumersunion.org/pub/core_food_safety/009641.html (accessed September 9, 2009).
Consumers Union. 2009b. Consumers Union: House Hearing on Industry Role in Salmonella Outbreak Underscores Need for Comprehensive, Annual Food Inspections; Companies Cannot Rely on Paid-for Third-Party Safety Reviews. http://www.consumersunion.org/pub/core_food_safety/009779.html (accessed September 9, 2009).
CRC/SB (Center for Food Safety and Applied Nutrition Review Committee/Science Board). 1999. Review of Research Programs. Center for Food Safety and Applied Nutrition. U.S. Food and Drug Administration. April 13–16, 1999. http://fda.gov/ohrms/dockets/AC/06briefing/2006-4211b_02_CFSAN1999Review.pdf (accessed August 9, 2010).
CSPI (Center for Science in the Public Interest). 2003. Comments on Interim Final Rule to Implement Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. http://cspinet.org/new/pdf/fda.biot.priornot.finalrule.pdf (accessed September 9, 2009).
CSPI. 2006. CSPI Petitions FDA to Regulate Manure, Water Sanitation on Farms. http://cspinet.org/new/pdf/fda_produce_petition.pdf (accessed September 9, 2009).
CSPI. 2007a. Comments on Handling Regulations for Leafy Greens Under the Agricultural Marketing Agreement Act of 1937. http://cspinet.org/new/pdf/ams_produce_comments.pdf (accessed September 9, 2009).
CSPI. 2007b. Letter to Commissioner von Eschenbach Regarding the Pet Food Recall and Ban on Chinese Grain Imports. http://cspinet.org/new/pdf/fda_pet_food_letter_final.pdf (accessed September 9, 2009).
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