Food Safety and Quality:

Uniform, Risk-based Inspection System Needed to Ensure Safe Food Supply

RCED-92-152: Published: Jun 26, 1992. Publicly Released: Jul 29, 1992.

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Pursuant to a congressional request, GAO reviewed the consistency, efficiency, and effectiveness of the federal food safety inspection system, focusing on: (1) the logic and consistency of federal food inspection systems; (2) whether agencies used their inspection resources efficiently; and (3) whether agencies effectively coordinated their food inspection efforts.

GAO found that: (1) federal food inspection agencies, including the Food and Drug Administration (FDA) and the Food Safety and Inspection Service (FSIS), have diverse regulatory approaches to inspecting foods that pose similar health risks; (2) food inspection agencies operate under differing enforcement authorities that in some cases adversely affect their ability to protect public health; (3) food processing firms under FDA jurisdiction are not required to register, making it difficult for FDA to identify all firms under its jurisdiction; (4) some food inspection agencies focus too much attention on low-risk products, while providing insufficient oversight for higher-risk food products; (5) FSIS has the legal authority to implement discretionary, risk-based inspections, but has not done so because of public and industry opposition to its proposed implementing regulations; (6) some food establishments are inspected by more than one agency, resulting in duplication of effort and wasted inspection resources; (7) while the food inspection agencies have entered into over 25 agreements to coordinate their efforts, agencies frequently do not make required referrals or notifications of problems they discover; and (8) those referrals that agencies do make do not always lead to timely investigations by the appropriate agency. GAO also identified three alternative approaches to revamping the food safety inspection system, including creating a single agency to administer a uniform set of food safety laws, creating a uniform set of food safety laws to be administered by the current agencies, and developing a model for a risk-based inspection system.

Matters for Congressional Consideration

  1. Status: Closed - Not Implemented

    Comments: Congress has been considering this issue for many years. Recently, the conference report on the USDA 1999 appropriations directed USDA to submit a report on the merits and effectiveness of a mandatory ratite inspection program. In June 1999, USDA submitted its plan for making such a determination. In November 1999, USDA presented a draft concept paper on extending mandatory inspection to additional species--the first step in the process to amend the meat and poultry acts--and plan to finalize the paper by the end of 2000. However, Congress has not acted on this issue.

    Matter: To provide consistent coverage of foods that pose similar risks, Congress may wish to consider amending the meat and poultry acts to include alternative meat and poultry products whose consumption has been increasing and that pose health risks similar to those products traditionally covered by the acts.

  2. Status: Closed - Implemented

    Comments: As a result of the Jack in the Box food poisoning outbreak, congressional interest in improving the federal food safety inspection system has increased. The House Agriculture Committee held hearings on meat inspection on March 16, 1993. Additional hearings have been held. In response to a request by the House Government Operations Subcommittee, GAO is currently reviewing the adequacy of FDA enforcement authorities. Also, GAO testified on May 25, 1994, before this subcommittee (GAO/T-RCED-94-223). Currently, there is strong congressional interest in food safety and strengthening government programs. In the current congressional climate, the development of additional federal regulations is not expected.

    Matter: To provide the federal regulatory agencies with the authorities they need to ensure a safe, high-quality food supply and to prevent unsafe food products from reaching U.S. consumers, Congress may wish to consider providing FDA with enforcement authority that is consistent with that of other food safety agencies, such as FSIS.

  3. Status: Closed - Implemented

    Comments: In August 1998, the National Academy of Sciences issued a report on food safety which, similar to the intent of GAO's recommendation, called for eliminating mandated meat and poultry inspection requirements, moving toward a science-based inspection system. FSIS is pilot testing an alternative inspection model that, in effect, has industry conduct carcass inspections under its oversight. The Senate Committee on Agriculture, Nutrition, and Forestry, recently requested that GAO assess the effectiveness of such alternative models. If such a model proves effective and is adopted, it could, in effect, accomplish the goal of risk-based inspections and free resources for use on other high-risk activities.

    Matter: To make more efficient use of federal food safety resources, Congress may wish to consider extending FSIS discretionary inspection authority and requiring FSIS to implement a discretionary inspection program for meat and poultry processors.

  4. Status: Closed - Implemented

    Comments: The Farm Security and Rural Investment Act of 2002 established a national Food Safety Commission (blue ribbon panel) charged with making specifid recommendations for drafitng legislative language. The Commission is to submit a report to the President and Congress within one year on how to improve the food safety system.

    Matter: To develop a uniform, risk-based inspection system, Congress should 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.

Recommendations for Executive Action

  1. Status: Closed - Not Implemented

    Comments: HHS did not concur in the recommendation, and USDA, while agreeing it has merit, raised various problems with it. HHS' and USDA's objections to the recommendations involved what they see as differences in the roles and tasks of the agencies' inspectors and graders. GAO disagrees and believes that federal food inspectors and graders, regardless of agency, perform similar functions, and with only minor exceptions, there is no reason why different federal agencies should inspect the same plant. Nevertheless, agency action is not expected.

    Recommendation: The Secretaries of Agriculture, Commerce, and Health and Human Services should 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 follow up on referrals made by other agencies.

    Agency Affected: Department of Agriculture

  2. Status: Closed - Not Implemented

    Comments: Commerce took no position, indicating that it would follow HHS' lead. HHS did not concur in the recommendation and USDA, while agreeing it has merit, raised various problems with it. HHS' and USDA's objections to the recommendations involved what they see as differences in the roles and tasks of the agencies' inspectors and graders. GAO disagrees and believes that federal food inspectors and graders, regardless of agency, perform similar functions, and with only minor exceptions, there is no reason why different federal agencies should inspect the same plant. Nevertheless, agency action is not expected.

    Recommendation: The Secretaries of Agriculture, Commerce, and Health and Human Services should 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 follow up on referrals made by other agencies.

    Agency Affected: Department of Commerce

  3. Status: Closed - Not Implemented

    Comments: HHS did not concur in the recommendation and USDA, while agreeing it has merit, raised various problems with it. HHS' and USDA's objections to the recommendations involved what they see as differences in the roles and tasks of the agencies' inspectors and graders. GAO disagrees and believes that federal food inspectors and graders, regardless of agency, perform similar functions, and with only minor exceptions, there is no reason why different federal agencies should inspect the same plant. Nevertheless, agency action is not expected.

    Recommendation: The Secretaries of Agriculture, Commerce, and Health and Human Services should 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 follow up on referrals made by other agencies.

    Agency Affected: Department of Health and Human Services

  4. Status: Closed - Implemented

    Comments: All departments and agencies have agreed with this recommendation and taken action to revise and update their food safety coordination agreements, including directions on referring food safety problems to the appropriate regulatory agency.

    Recommendation: To help ensure effective coordination between federal agencies with food safety and quality responsibilities, the Secretaries of Agriculture, Commerce, and Health and Human Services should 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.

    Agency Affected: Department of Agriculture

  5. Status: Closed - Implemented

    Comments: All departments and agencies have agreed with this recommendation and taken action to revise and update their food safety coordination agreements, including directions on referring food safety problems to the appropriate regulatory agency.

    Recommendation: To help ensure effective coordination between federal agencies with food safety and quality responsibilities, the Secretaries of Agriculture, Commerce, and Health and Human Services should 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.

    Agency Affected: Department of Commerce

  6. Status: Closed - Implemented

    Comments: All departments and agencies have agreed with this recommendation and taken action to revise and update their food safety coordination agreements, including directions on referring food safety problems to the appropriate regulatory agency.

    Recommendation: To help ensure effective coordination between federal agencies with food safety and quality responsibilities, the Secretaries of Agriculture, Commerce, and Health and Human Services should 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.

    Agency Affected: Department of Health and Human Services

  7. Status: Closed - Implemented

    Comments: All departments and agencies have agreed with this recommendation and taken action to revise and update their food safety coordination agreements, including directions on referring food safety problems to the appropriate regulatory agency.

    Recommendation: The Commissioner, FDA, and the Secretaries of Agriculture and Commerce should incorporate referral procedures into inspector manuals or handbooks to assist agency personnel in making referrals properly and in a timely manner.

    Agency Affected: Department of Agriculture

  8. Status: Closed - Implemented

    Comments: All departments and agencies have agreed with this recommendation and taken action to revise and update their food safety coordination agreements, including directions on referring food safety problems to the appropriate regulatory agency.

    Recommendation: The Commissioner, FDA, and the Secretaries of Agriculture and Commerce should incorporate referral procedures into inspector manuals or handbooks to assist agency personnel in making referrals properly and in a timely manner.

    Agency Affected: Department of Commerce

  9. Status: Closed - Implemented

    Comments: All departments and agencies have agreed with this recommendation and taken action to revise and update their food safety coordination agreements, including directions on referring food safety problems to the appropriate regulatory agency.

    Recommendation: The Commissioner, FDA, and the Secretaries of Agriculture and Commerce should incorporate referral procedures into inspector manuals or handbooks to assist agency personnel in making referrals properly and in a timely manner.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

  10. Status: Closed - Implemented

    Comments: FDA is examining the feasibility of developing a formal tracking system in a cost-effective manner, but action to implement such a system is unlikely because of what HHS believes is a lack of funds due to budget constraints. FDA's San Francisco region has developed a formal tracking system but other regions appear to show little interest. Additional action by the agency is not expected.

    Recommendation: The Commissioner, FDA, should: (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.

    Agency Affected: Department of Health and Human Services: Public Health Service: Food and Drug Administration

  11. Status: Closed - Not Implemented

    Comments: There is no evidence yet that agencies will review coordination agreements at least annually. There is little apparent interest by departments.

    Recommendation: The Secretaries of Agriculture, Commerce, and Health and Human Services should direct the agency heads to periodically, but no less than annually, review their respective coordination agreements and update them when necessary.

    Agency Affected: Department of Agriculture

  12. Status: Closed - Not Implemented

    Comments: There is no evidence yet that agencies will review coordination agreements at least annually. There is little apparent interest by departments.

    Recommendation: The Secretaries of Agriculture, Commerce, and Health and Human Services should direct the agency heads to periodically, but no less than annually, review their respective coordination agreements and update them when necessary.

    Agency Affected: Department of Commerce

  13. Status: Closed - Not Implemented

    Comments: There is no evidence yet that agencies will review coordination agreements at least annually. There is little apparent interest by departments.

    Recommendation: The Secretaries of Agriculture, Commerce, and Health and Human Services should direct the agency heads to periodically, but no less than annually, review their respective coordination agreements and update them when necessary.

    Agency Affected: Department of Health and Human Services

 

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