Tag Archives food safety/FSMA

The Food and Drug Administration (FDA) has requested public comments on the information collection provisions of regulations that “require registration for domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States.” According to FDA, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 requires food facilities to provide information via Form FDA 3537 (§1.231) or the electronic Food Facility Registration Module that will support FDA’s enforcement activities and help the agency issue notifications in the event of accidental or deliberate contamination. In 2011, the Food Safety Modernization Act amended these regulations to compel facilities to renew their registrations biennially and to submit additional information, such as “the email address for the contact person of a domestic facility and the email address of the U.S. agent for a foreign facility.” Based on the registrations received in previous years,…

The Food and Drug Administration (FDA) has proposed two new food safety rules addressing foodborne illness prevention and produce safety under the Food Safety Modernization Act. According to FDA, the first rule would require both foreign and domestic food manufacturers “to develop a formal plan for preventing their food products from causing foodborne illness” and to establish plans “for correcting any problems that arise.” The second rule proposes “enforceable safety standards for the production and harvesting of produce on farms,” including “science- and risk-based standards for the safe production and harvesting of fruits and vegetables.” Before drafting the rules, FDA apparently conducted “extensive outreach” involving the produce industry, consumers, other government agencies, and the international community. It will accept comments on both rules until May 16, 2013, and plans to issue further proposals addressing the safety and oversight of imported foods. “We know one-size-fits-all rules won’t work,” said FDA Deputy…

The Government Accountability Office (GAO) has issued a report recommending that the Food and Drug Administration (FDA) revise its approach when comparing foreign food safety systems with the U.S. system to better ensure the safety of imported food. Under the FDA Food Safety Modernization Act, FDA’s enhanced oversight of food imports includes express authority to implement a system for accrediting third parties like foreign governments and private auditing firms to certify foreign food facilities’ compliance with U.S. food safety requirements. The agency has apparently faced some challenges doing so. According to GAO, FDA has already started assessing selected foreign food safety systems to determine if they provide the same level of public health protection as domestic resources. But FDA has also stated “that it needs new approaches to improve its oversight of imported food that take into account the entire food supply chain and that it needs to push prevention…

While foreign and domestic food facilities, including farms, must renew their registrations with the Food and Drug Administration (FDA) beginning October 1, 2012, under the Food Safety Modernization Act, the agency is not accepting registration renewals at this time. Facilities required to be registered under the law are asked to check FDA’s website to learn when the system becomes available,

The Government Accountability Office (GAO) has issued a July 26, 2012, report criticizing the Food and Drug Administration’s (FDA’s) efforts to implement a comprehensive food advisory and recall process. As directed by the FDA Food Safety Modernization Act, GAO reportedly assessed the agency’s ability to order recalls and effectively inform consumers and retailers about food safety issues, concluding that although FDA has established internal procedures “describing the steps it will take to order a food recall ... these procedures are not yet public and the agency has not issued regulations or industry guidance to clarify its ordered food recall process.” In particular, the report faults FDA for failing to fashion “a comprehensive food recall communication policy and related implementation plans.” Noting that recent foodborne illness outbreaks have drawn national attention to food supply safety issues, GAO argues that FDA has not yet drafted measures to better manage its communication challenges or…

The Food and Drug Administration (FDA) has announced a public meeting titled “International Capacity Building with Respect to Food Safety.” Scheduled for June 19, 2012, in Washington, D.C., the meeting will highlight “FDA’s comprehensive plan to expand the technical, scientific, and regulatory capacity of foreign governments and their respective food industries in countries that export foods to the United States.” Under the auspices of the Food Safety Modernization Act, the capacity-building plan seeks input from food industry representatives, federal and foreign government officials, consumer organizations, and other stakeholders. The plan seeks (i) “[r]ecommendations for bilateral and multilateral arrangements and agreements, including providing for responsibilities of exporting countries to ensure food safety”; (ii) “[p]rovisions for secure electronic data sharing”; (iii) “[p]rovisions for mutual recognition of inspection reports”; (iv) “[t]raining of foreign governments and food producers on U.S. requirements for safe food”; (v) “[r]ecommendations on whether and how to harmonize requirements under…

The Food and Drug Administration (FDA) has issued updated industry guidance “pertaining to the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food.” Although this fifth edition is effective immediately, FDA welcomes comments at any time. Requiring records that identify “immediate previous sources and the immediate subsequent recipients of food” along the food-distribution chain, FDA has been given expanded authority by the Food Safety and Modernization Act of 2011 to “access records relating to foods that may cause serious adverse health consequences or death to humans or animals.” Although the guidance incorporates these statutory changes, it has not deviated much from the fourth edition released in September 2006, FDA said. Rather, it provides practical information on such topics as records requirements, retention and availability, and “the consequences of failing to establish and maintain required records or failing to make required records…