The FDA Food Safety Modernization Act (FSMA) (P.L. 111-353), enacted on January 4, 2011, implements some of the most significant changes to food safety regulation in 70 years. The FSMA represents a major reform of the food safety provisions of the Federal Food, Drug, and Cosmetic Act of 1938 (FDCA) and expands the powers of the Food and Drug Administration (FDA) with respect to food. The new law generally does not apply to meat, poultry, or egg products regulated by the U.S. Department of Agriculture.
Records and registrations. The FSMA expands the FDA’s authority to address food safety issues preemptively through registration, food standards, and a fee structure. The agency is now authorized to inspect the records of any person or establishment if there is a reasonable assumption that the food passing through the supply chain will cause serious health consequences and to suspend registrations when warranted. Concurrently, HACCP plans must be implemented by food facilities, with very few exceptions. Facilities must register biennially and fees will be collected for facilities subject to reinspections or recall orders.
High-risk foods and recalls. Resources will be allocated to increase the frequency of inspections for domestic high-risk, non-high risk and foreign facilities and articles of food imported into the United States based on safety risk profiles. A pilot project also will be established to research and evaluate methods for rapidly and effectively tracking and tracing processed food or foods to identify the source of an outbreak and the recipients of contaminated food. The FDA can order a responsible party to immediately cease distribution and provide notice to relevant persons if the responsible party does not voluntarily cease distribution or recall an adulterated or misbranded article of food, if exposure will cause serious adverse health consequences or death to humans or animals.
Supplier requirements. Several initiatives under the FSMA focus on the quality, safety, and security of food imported from foreign suppliers. Among other things, the FSMA authorizes the inspection of foreign facilities, a verification program, and an accreditation system for third-party auditors that certify foreign entities in the food chain. Additionally, HHS is required to expand the food safety capacity of foreign governments and establish FDA offices in foreign countries.
Enhancement. The FSMA enhances existing administrative efforts and adds additional provisions to assure food safety and quality. Reports on food safety and the activities of the food and agriculture coordinating councils must be submitted to Congress. Whistleblower protection is extended to employees who object to violations of the FDCA. In addition, HHS must collaborate with different agencies to create a national food defense strategy and also establish a voluntary allergy program for children.
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