Enhancing Food Safety The Role of the Food and Drug Administration (2010) / Chapter Skim
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10 Modernizing Legislation to Enhance the U.S. Food Safety System
10 Modernizing Legislation to Enhance the U.S. Food Safety System
Pages 293-304
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From page 293... ...
food safety authority in various significant ways, including (1) a provision defining a food as adulterated "if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health"; (2)
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From page 294... ...
mandating the registration of food facilities,10 (3) giving the FDA access to industry records related to food that "presents a threat of serious adverse health consequences or death to humans or animals,"11 (4)
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From page 295... ...
In these cases, the committee concluded that it would be helpful to provide such authorities to the FDA explicitly. For example, the committee recommends giving the FDA explicit authority to mandate that food facilities establish preventive process controls, maintain records, and provide the agency with access to these records during inspections.
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From page 296... ...
Nonetheless, the FDA should be able to impose preventive controls based on hazard analysis and risk, as defined in Chapter 3, on all food facilities -- and to exercise the other powers enumerated below -- free of any doubt that it has the authority do so. The agency is prone to hesitate before pursuing measures based on broad delegations of authority rather than detailed statutory provisions, and agency actions taken pursuant to such broad delegations are more vulnerable to court challenge.
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From page 297... ...
Every food facility ought to be required to conduct a hazard evaluation, identify potential hazards, implement preventive controls, monitor the controls, establish corrective actions, and maintain comprehensive records of the system's implementation. Each facility should also be required to prepare a food safety plan that sets forth the hazard evaluation results, the identified preventive controls, and the facility's program for monitoring the preventive controls, validating them, taking corrective action, and keeping records.
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From page 298... ...
However, it concluded that the FDA should address this complex issue on a case-by-case basis, pursuant to the overall riskbased food safety management approach proposed in this report. PERFORMANCE STANDARDS The FDCA needs to be amended to require the FDA to periodically issue enforceable, risk- and science-based performance standards for pathogens and other contaminants significant to public health.
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From page 299... ...
The committee believes that Congress needs to give the FDA similarly broad access to records in food facilities. As explained above, the effective enforcement of a food safety system based on preventive controls depends on the FDA's having access to each facility's food safety plan and implementation records.
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From page 300... ...
In communications with the committee, the FDA maintained that it should be given the power to order a company to recall an adulterated food when necessary to protect the public health. The bills currently under consideration in Congress give the FDA the power, subject to specified procedures, to issue a cease distribution order and a subsequent recall order when there is a reasonable probability that a food will cause serious adverse health consequences or death.27 In most instances, the FDA does not need mandatory recall authority to fulfill its food safety mission.
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From page 301... ...
If the party refuses to proceed voluntarily, the FDA should then have the power to order the party to cease distribution immediately, but the party should, except in instances of imminent danger, be given an opportunity for an expeditious informal hearing before the FDA modifies the order to mandate recall. REPORTING OF ADULTERATION In 2007, Congress amended the FDCA to require all registered food facilities to report to the FDA, through an electronic portal into a Reportable Food Registry, any "article of food .
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From page 302... ...
. Pursuant to these statutes and implementing regulations, FSIS permits imports of meat, poultry, and egg products only from countries it has certified as having inspection systems that ensure that exported food products meet American food safety standards.30 FSIS makes the determination that a country's food regulatory system provides food safety protections equivalent to those provided by U.S.
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From page 303... ...
The following are the most critical areas in which Congress should enact amendments: mandatory reregistration of food facilities and FDA authority to suspend registrations for viola tions that threaten the public health, mandatory preventive controls for all food facilities, FDA authority to issue enforceable performance standards, mandatory adoption by the FDA of a risk-based approach to inspection frequency and intensity, expansion of the FDA's access to records, FDA authority to mandate recalls, and FDA authority to identify countries with inadequate food safety systems and to ban all imports from such countries. REFERENCES Degnan, F
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