Summary of Food Safety Modernization Act

Congress has passed the Food Safety Modernization Act of 2010 (FSMA) and President Obama has indicated he will sign the bill into law before the end of the year. In a surprise development, the Senate passed SA 4890, a manager's amendment to S. 510, on December 19, and the House passed the Senate bill two days later. This document provides a summary of the final version of this landmark legislation.

The new legislation represents a major reform of the food safety provisions of the Federal Food, Drug, and Cosmetic Act (FDCA) and significantly expands the powers of the Food and Drug Administration (FDA) with respect to food.Provisions were made in the original House bill which exempts most farms from regulatory requirements.Ginners, cottonseed crushers and handlers will see no additional burden above what is required under the Bioterrorism Act.

EXECUTIVE SUMMARY

The FDA Food Safety Modernization Act represents the most significant expansion of food safety requirements and FDA food safety authorities since the original enactment of the FDCA in 1938. It grants FDA a number of new powers, including mandatory recall authority, which the agency has sought for many years. The FSMA requires FDA to undertake more than a dozen rulemakings and issue at least 10 guidance documents, as well as a host of reports, plans, strategies, standards, notices, and other tasks. Therefore, implementation of the legislation is likely to take several years.

The FSMA is divided into four titles: prevention of food safety hazards, detection of and response to food safety problems, improving the safety of imported foods, and miscellaneous provisions.

The following are key provisions of the new law:

New regulatory requirements

• Food facilities are required to register with FDA biennially. Food from an unregistered facility may not be imported into the United States or introduced into interstate or intrastate commerce.
• Registered food facilities are required to conduct hazard analyses and to develop and implement written preventive controls plans.
• Registered food facilities must maintain additional records, including copies of their hazard analyses and preventive controls plans, related records, and additional records to assist FDA in tracking and tracing high-risk foods.
• Food importers are required to implement foreign supplier verification programs and to take steps to verify that the food they import is safe.
• Food facilities and food importers are subject to new fees, including a fee to be paid by each domestic food facility or importer that undergoes a re-inspection because of a material non-compliance identified during an initial inspection.
• Laboratory tests to be used for regulatory purposes must be performed by either a Federal laboratory or an accredited non-Federal laboratory, and lab test results must be sent directly to FDA.
• Food facilities will be inspected with greater frequency and not less often than once every 5 years.

New FDA powers

• FDA has the authority to order a recall of food.
• FDA has the authority to administratively detain food based only on a "reason to believe" the food is adulterated or misbranded.
• FDA has the power to suspend the registration, and thereby suspend the operations, of any food facility if FDA determines that food manufactured, processed, packed, or held by the facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals.
• FDA is authorized to require that an article of food offered for import be accompanied by a safety certification from an accredited third-party auditor as an additional condition of granting admission.
• FDA is required to review relevant health data every two years and to issue guidance documents or regulations setting contaminant-specific performance standards for the most significant foodborne contaminants.
• Registered food facilities are required to conduct hazard analyses and to develop and implement written preventive controls plans.
• Registered food facilities must maintain additional records, including copies of their hazard analyses and preventive controls plans, related records, and additional records to assist FDA in tracking and tracing high-risk foods.
• Food importers are required to implement foreign supplier verification programs and to take steps to verify that the food they import is safe.
• Food facilities and food importers are subject to new fees, including a fee to be paid by each domestic food facility or importer that undergoes a re-inspection because of a material non-compliance identified during an initial inspection.
• Laboratory tests to be used for regulatory purposes must be performed by either a Federal laboratory or an accredited non-Federal laboratory, and lab test results must be sent directly to FDA.
• Food facilities will be inspected with greater frequency and not less often than once every 5 years.
• FDA is required to establish a product tracing system within FDA to improve the agency's capacity to effectively and rapidly track and trace food.

A number of provisions of the House bill, and earlier versions of the Senate bill, did not survive the legislative process. These include provisions giving FDA authority to levy civil fines for any prohibited act, giving FDA authority to quarantine food, establishing annual registration fees for registered food facilities and food importers, and establishing a new country-of-origin labeling requirement under the FDCA.

The FSMA can be said to move FDA regulation of food closer to the USDA regulatory model in significant ways. For example, FDA now has the power to suspend a food facility's registration, and thereby suspend its operations, similar to USDA's power to suspend inspection. FDA has the authority to set performance standards for contaminants as USDA has done for pathogens in meat and poultry. Food facilities registered with FDA will have to perform hazard analyses and implement preventive controls plans similar to the HACCP (Hazard Analysis and Critical Control Points) plans required of meat and poultry establishments.