Federal Lawsuit Filed to Force U.S. FDA to Implement Provisions of Food Safety Modernization Act
August 29, 2012
The Center for Food Safety and the Center for Environmental Health have recently filed a lawsuit in federal court arguing that the U.S. Food and Drug Administration has not met its implementation schedule regarding the regulations implementing various provisions of the FDA Food Safety Modernization Act, which was signed into law in January 2011. The two plantiffs want to force the FDA to implement the provisions of the Food SDafety Modernization Act.
The FDA has not complied with “hundreds” of deadlines for completing certain tasks, including the release of rules concerning FSMA provisions on the following issues which the final rule deadline has come and gone:
- Mandating each importer to perform risk-based foreign supplier verification activities for the purpose of verifying that the food imported by the importer or its agent is in compliance with provisions on hazard analysis and risk-based preventive controls and standards for produce safety and is not adulterated or misbranded
- Mandating (I) that third-party audits be performed unannounced. (ii) a structure to decrease the potential for conflicts of interest, including timing and public disclosure, for fees paid by eligible entities to accredited third-party auditors, and (iii) appropriate limits on financial affiliations between an accredited third-party auditor or audit agents of such auditor and any person that owns or operates an eligible entity to be certified by such auditor.
- Mandating shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food to use sanitary transportation practices to ensure that food is not transported under conditions that may render it adulterated
- Protecting against the intentional adulteration of food subject to FSMA by (i) specifying how a person shall assess whether the person is required to implement mitigation strategies or measures intended to protect against the intentional adulteration of food and (ii) specifying appropriate science-based mitigation strategies or measures to prepare and protect the food supply chain at specific vulnerable
- Establishing science-based minimum standards for conducting hazard analysis, documenting hazards, implementing preventive controls and documenting such implementation.
- Clarifying activities that constitute on-farm packing, holding, manufacturing or processing of food that is not grown, raised or consumed on such farm or another farm under the same ownership.
- Establishing science-based minimum standards for the safe production and harvesting of certain types of fruits and vegetables, including specific mixes or categories of fruits and vegetables that are raw agricultural commodities for which the FDA has determined that such standards minimize the risk of serious adverse health consequences or death.
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