Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter.
Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.
OCR for page 325
Enhancing Food Safety: The Role of the Food and Drug Administration
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
OCR for page 326
Enhancing Food Safety: The Role of the Food and Drug Administration
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
OCR for page 327
Enhancing Food Safety: The Role of the Food and Drug Administration
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
OCR for page 328
Enhancing Food Safety: The Role of the Food and Drug Administration
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
OCR for page 329
Enhancing Food Safety: The Role of the Food and Drug Administration
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
OCR for page 330
Enhancing Food Safety: The Role of the Food and Drug Administration
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
OCR for page 331
Enhancing Food Safety: The Role of the Food and Drug Administration
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
OCR for page 332
Enhancing Food Safety: The Role of the Food and Drug Administration
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
OCR for page 333
Enhancing Food Safety: The Role of the Food and Drug Administration
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.
OCR for page 334
Enhancing Food Safety: The Role of the Food and Drug Administration
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
OCR for page 335
Enhancing Food Safety: The Role of the Food and Drug Administration
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
OCR for page 360
Enhancing Food Safety: The Role of the Food and Drug Administration
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.
OCR for page 361
Enhancing Food Safety: The Role of the Food and Drug Administration
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
OCR for page 362
Enhancing Food Safety: The Role of the Food and Drug Administration
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
OCR for page 363
Enhancing Food Safety: The Role of the Food and Drug Administration
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
OCR for page 364
Enhancing Food Safety: The Role of the Food and Drug Administration
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
OCR for page 365
Enhancing Food Safety: The Role of the Food and Drug Administration
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
OCR for page 366
Enhancing Food Safety: The Role of the Food and Drug Administration
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
OCR for page 367
Enhancing Food Safety: The Role of the Food and Drug Administration
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.
OCR for page 368
Enhancing Food Safety: The Role of the Food and Drug Administration
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
OCR for page 369
Enhancing Food Safety: The Role of the Food and Drug Administration
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
REFERENCES
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).
CSPI. 2008. Comments on Third-Party Certification Programs for Foods and Feeds. http://cspinet.org/new/pdf/fda_3rd_part_cert_comment.pdf (accessed September 9, 2009).
FDA (U.S. Food and Drug Administration). 2007. FDA Science and Mission at Risk. Report of the Subcommittee on Science and Technology. Prepared for FDA Science Board.
FDA. 2008. Review of the FDA Office of Regulatory Affairs (ORA): Report by the ORA Subcommittee to the FDA Science Board. http://www.fda.gov/ohrms/dockets/AC/08/briefing/2008-4365b1_02_02_subcommitteereportonORA.pdf (accessed August 9, 2010).
OCR for page 370
Enhancing Food Safety: The Role of the Food and Drug Administration
GAO (U.S. Government Accountability Office). 1992. Food Safety and Quality: Uniform, Risk-based Inspection System Needed to Ensure Safe Food Supply. Report No. RCED-92-152. Washington, DC: GAO.
GAO. 2003. Bioterrorism. A Threat to Agriculture and the Food Supply. Report No. GAO-04-259T. Washington, DC: GAO.
GAO. 2004a. Federal Food Safety and Security System: Fundamental Restructuring Is Needed to Address Fragmentation and Overlap. Report No. GAO-04-588T. Washington, DC: GAO.
GAO. 2004b. Food Safety: FDA’s Imported Seafood Safety Program Shows Some Progress, but Further Improvements Are Needed. Report No. GAO-04-246. Washington, DC: GAO.
GAO. 2005a. Food Safety: USDA and FDA Need to Better Ensure Prompt and Complete Recalls of Potentially Unsafe Food. Report No. GAO-05-51. Washington, DC: GAO.
GAO. 2005b. Overseeing the U.S. Food Supply: Steps Should Be Taken to Reduce Overlapping Inspections and Related Activities. Report No. GAO-05-549T. Washington, DC: GAO.
GAO. 2005c. Oversight of Food Safety Activities: Federal Agencies Should Pursue Opportunities to Reduce Overlap and Better Leverage Resources. Report No. GAO-05-213. Washington, DC: GAO.
GAO. 2008a. Food Safety: Improvements Needed in FDA Oversight of Fresh Produce. Report No. GAO-08-1047. Washington, DC: GAO.
GAO. 2008b. Federal Oversight Of Food Safety: FDA’s Food Protection Plan Proposes Positive First Steps, but Capacity to Carry Them Out Is Critical. Report No. GAO-08-435T. Washington, DC: GAO.
GAO. 2009. Information Technology. FDA Needs to Establish Key Plans and Processes for Guiding Systems Modernization Efforts. Report No. GAO-09-523. Washington, DC: GAO.
IOM (Institute of Medicine). 1991. Seafood Safety. Washington, DC: National Academy Press.
IOM. 2007. Seafood Choices: Balancing Benefits and Risks. Washington, DC: The National Academies Press.
IOM. 2009. HHS in the 21st Century: Charting a New Course for a Healthier America. Washington, DC: The National Academies Press.
IOM/NRC (National Research Council). 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: National Academy Press.
IOM/NRC. 2003. Scientific Criteria to Ensure Safe Food. Washington, DC: The National Academies Press.
NRC (National Research Council). 1999. The Use of Drugs in Food Animals: Benefits and Risks. Washington, DC: National Academy Press.
NRC. 2003. Dioxins and Dioxin-Like Compounds in the Food Supply: Strategies to Decrease Exposure. Washington, DC: The National Academies Press.
OIG (Office of Inspector General). 1991. FDA Food Safety Inspection. Report No. OEI-05-90-01070. Washington, DC: OIG.
OIG. 2000. FDA Oversight of State Food Firm Inspections A Call for Greater Accountability. Report No. OEI-01-98-00400. Washington, DC: OIG.
OIG. 2009. Traceability in the Food Supply Chain. Report No. OIE-02-06-00210). Washington, DC: OIG.
Taylor, M. R., and M. B. Batz. 2008. Harnessing Knowledge to Ensure Food Safety. Opportunities to Improve the Nation’s Food Safety Information Infrastructure. Gainesville, FL: Food Safety Research Consortium.
Taylor, M. R., and S. D. David. 2009. Stronger Partnerships for Safer Food. An Agenda for Strengthening State and Local Roles in the Nation’s Food Safety System. Final Report. Washington, DC: School of Public Health, The George Washington University.