Enhancing Food Safety The Role of the Food and Drug Administration (2010) / Chapter Skim
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Appendix B: Past Recommendations About the U.S. Food and Drug Administration's Food Safety Program
Appendix B: Past Recommendations About the U.S. Food and Drug Administration's Food Safety Program
Pages 325-370
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From page 325... ...
Recommendations The Commissioner of FDA should develop a GAO, 2005a sound methodology for district staff to verify that companies have quickly and effectively carried out recalls. To ensure that USDA and FDA have information GAO, 2005a 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.
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From page 326... ...
To ensure that companies promptly and effectively GAO, 2005a 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. To ensure that companies promptly and effectively GAO, 2005a 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.
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From page 327... ...
Union, 2008a Authority to To ensure that companies promptly and effectively GAO, 2005a Require Company recall foods that may cause serious illness or Records and death, the Secretary of Agriculture and the to Develop Commissioner of FDA should revise agency Traceability guidance to recalling companies to include Methods 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. To enhance FDA's oversight of fresh produce GAO, 2008a safety, the Commissioner of FDA should seek authority from the Congress to provide FDA enhanced access to firm records during food related emergencies.
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From page 328... ...
We recommend that FDA seek statutory authority OIG, 2009 to conduct activities to ensure that facilities are complying with its records requirements. Congress, with input from experts, should Taylor and establish traceability requirements that permit David, 2009 federal, state, and local officials to rapidly obtain from food companies reliable information on the source of commodities, ingredients, and finished products.
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Research is needed to develop and evaluate more IOM, 2007 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. continued
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From page 330... ...
Establish a Single CU has also called for consolidation of the 15 Consumers Food Safety agencies that oversee our food safety system. Union, 2008a Agency To implement a science-based system, Congress IOM/NRC, should establish, by statute, a unified and central 1998 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.
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From page 331... ...
We recommended that the Congress consider GAO, 2005b 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. We have recommended that the Congress consider GAO, 2005b 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.
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Congress and the administration should require IOM/NRC, development of a comprehensive national food 1998 safety plan. Funds appropriated for food safety programs (including research and education programs)
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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.
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. the agency to develop Consumers operating plans for food processing facilities that Union, 2008a 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.
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Chronic illness resulting from seafood IOM, 1991 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. With currently available data, it is possible to IOM, 1991 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.
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From page 336... ...
Congress should direct the Secretary of HHS Taylor and to create, in consultation with the Food Safety David, 2009 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)
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Based on the evidence of important foundational FDA, 2007 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 IT must develop the intramural capability FDA, 2007 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.
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Priority areas of this new national policy should include: • improving collection of and accessibility to public information, including CDC outbreak data, Foodborne Disease Outbreak Surveillance Network (FoodNet) data, electronic Laboratory Exchange Network (eLEXNET)
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Increase access to information and publications resulting from publicly funded food safety research • researchers, publishers, and funders should develop and utilize online data repositories, • "open access" to publicly funded research and move to free-and-open model of publication, and • increase back-catalog of online journals. Increase access to industry-generated food safety information • identify specific problem-areas or information needs that industry data could address, and • develop guidelines or "business rules" to govern information collection and sharing Center for Food Safety and Applied Nutrition CRC/SB, 1999 (CFSAN)
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0 ENHANCING FOOD SAFETY TABLE B-1 Continued Topic Recommendations Source To help ensure the success of FDA's modernization GAO, 2009 efforts, we recommend that the Commissioner of FDA require the Chief Information Officer to take expeditious actions to: • set milestones and a completion date for developing a comprehensive IT strategic plan, including results-oriented goals, strategies, milestones, performance measures, and an analysis of interdependencies among projects and activities, and use this plan to guide and coordinate its modernization projects and activities; • develop a documented enterprise architecture program management plan that includes a detailed work breakdown of the tasks, activities, and time frames associated with developing the architecture, as well as the funding and staff resources needed; • complete the criteria for setting priorities for the segment architecture and prioritize the segments; • accelerate development of the segment and enterprise architecture, including "as is," "to be," and transition plans, and in the meantime develop plans to manage the increased risk to modernization projects of proceeding without an architecture to guide and constrain their development; and • develop a skills inventory, needs assessment, and gap analysis, and develop initiatives to address skills gaps as part of a strategic approach to IT human capital planning. Organization We recommend that FDA reform legislation Consumers [to]
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From page 341... ...
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)
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We also recommend that USDA and FDA examine the feasibility and cost effectiveness of establishing a joint training program for their food inspectors. To better use FDA's limited inspection resources GAO, 2005c 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.
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From page 343... ...
To better use FDA's limited inspection resources GAO, 2005c 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.
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From page 344... ...
We recommend that the federal government create Taylor and Batz, two mechanisms to implement this new national 2008 policy: • FSII Council -- Intergovernmental body composed of heads of federal food safety agencies and representatives of state and local food safety agencies -- Coordinate and implement actions needed to fulfill FSII policy responsibilities • FSII Stakeholder Forum -- Administrated by FSII Council, but led by third party, such as the National Academy of Sciences -- No fixed membership, but a tool for convening the food safety community -- Principle vehicle for dialogue and collaboration to enact improvements to FSII
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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 continued core competency.
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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. The ORA review, like the larger FDA Science FDA, 2008 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.
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APPENDIX B TABLE B-1 Continued Topic Recommendations Source Congress should direct HHS to unify the Taylor and management of FDA's food safety functions under David, 2009 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. Prioritize To enhance FDA's oversight of fresh produce GAO, 2008a Research safety, the Commissioner of FDA should see that the agency develop a plan for identifying research priorities and facilitating research related to fresh produce.
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We recommend that the Secretaries of Agriculture, GAO, 1992 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.
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From page 349... ...
The Commissioner of FDA should revise guidance GAO, 2005a to agency staff to include risk-based time frames for completing verification checks promptly. To better use FDA's limited inspection resources GAO, 2005c 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.
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Federal agencies should develop a set of IOM, 1991 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.
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• The FDA should develop requirements for low risk food safety inspections, and certify which States meet these requirements. • Certified States should conduct inspections of low-risk food firms.
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HHS/FDA, working in collaboration with state Taylor and and local agencies, should develop and implement David, 2009 a plan for integrating and modernizing federal and state food manufacturing regulatory programs for facilities under FDA's jurisdiction. HHS/FDA should make the full implementation Taylor and of the Retail Food Regulatory Program Standards David, 2009 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.
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. the agency to develop Consumers operating plans for food processing facilities that Union, 2008a 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.
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To strengthen FDA's current imported seafood GAO, 2004b 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. To strengthen FDA's current imported seafood GAO, 2004b 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.
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We urge the FDA to CSPI, 2003 1) reconsider the advance notice time periods in the interim final rule to assure that the agency obtains information sooner about food imports so that suspect food imports can be adequately inspected, 2)
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ENHANCING FOOD SAFETY TABLE B-1 Continued Topic Recommendations Source We recommended that USDA and FDA, among GAO, 2003 other things, develop a coordinated strategy to identify resources needed to increase inspections of imported goods. Safety of Imports The ever-expanding recall of pet food containing CSPI, 2007b -- Pet Food contaminated ingredients from China demonstrates the immediate need for greater controls on imported foods, especially grain products originating from China.
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Increasing the number of support personnel per CRC/SB, 1999 scientist should be a high priority objective of management. The present number of support staff is woefully inadequate and not cost effective.
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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. CFSAN should strive to move from its current CRC/SB, 1999 full-time equivalent-based budgeting practice to one that is program based.
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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.
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Science at More complete data are needed on the distribution IOM, 2007 the FDA of contaminant levels among types of fish. -- Contaminants 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.
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Develop predictive modeling tools and apply NRC, 2003 them in studies to assess the effects of potential interventions on reducing DLCs in the food supply. CFSAN should carefully monitor the activities of CRC/SB, 1999 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.
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, 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. The committee recommends that CVM base NRC, 1999 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.
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Sufficiently large analytic samples of the most IOM, 2007 common seafood types need to be obtained and examined. Additional data is needed to assess benefits and IOM, 2007 risks associated with seafood consumption within the same population or population subgroup.
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To more efficiently and effectively monitor the GAO, 2004b 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.
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To enhance FDA's oversight of fresh produce IOM, 1991 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. The development of an interagency structure with IOM, 1991 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.
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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.
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State and local governments should better integrate Taylor and their own surveillance, outbreak response, and David, 2009 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. 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.
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HHS, in consultation with the Food Safety Taylor and Leadership Council and working with states and David, 2009 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. Training The Secretary of Agriculture and the GAO, 2005c Commissioner of FDA should work together to examine the feasibility of establishing a joint training program for food inspectors.
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2008a. Increased Inspections Needed for Produce, Processing Plants to Protect Consumers from Unsafe Food.
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1992. Food Safety and Quality: Uniform, Riskbased Inspection System Needed to Ensure Safe Food Supply.
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