Explore this issueAugust/September 2012
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Food companies and government regulators ARE coming to grips with the immense challenges that await them as they begin to implement FSMA requirements.
For U.S. companies, these challenges will involve verifying ingredients across the global supply chain and adhering to international standards such as GFSI and ISO 22000. Missteps along the way are likely to result in ingredients or finished products being detained and placed on FDA’s Import Alert List. The end result, some experts predict, will be the demise of many small- and mid-sized U.S. food companies that find themselves unable to implement the new law’s many requirements.
“There are challenges for regulators and challenges for the private sector from FSMA,” said David Acheson, MD, director of the food and import safety practice at Leavitt Partners and a former FDA associate commissioner of foods. “Companies are becoming increasingly nervous about their supply chain and the reliance they place on the certificates of analysis on meeting the specs,” Dr. Acheson told Food Quality magazine. “This is especially so if they are relying on a core piece of paper or two to give them assurances that their upstream has the necessary controls or HACCP in place.”
For the FDA, the challenges involve creating new and effective third-party certification and audit regimes and overseeing a vastly more complex import review system. While FSMA imposes scores of new requirements on the FDA, including tight timelines to draft and implement new regulations, it does not provide the funding to hire the hundreds of new employees necessary to implement the law—a substantial drawback, especially during the current budget deficit crisis. The FDA needs $1.4 billion from 2011-2015 to fulfill FSMA requirements, according to the Congressional Budget Office, but the agency’s food safety budget is likely to remain flat or increase only slightly in 2013.
Even if it were provided adequate funding, the FDA acknowledged it will need time to create the necessary process and management infrastructure. “A new management structure, supporting processes, and permanent staff positions must be created to launch a systems approach to risk-based decision making,” the agency said in its five-year strategic plan, released in April.
An additional challenge facing regulators will be audit execution oversight. “That will involve a whole new parallel track for accreditation of auditors,” said Dr. Acheson. “Who will police the auditors? The FDA could do so, but it lacks the resources and skills necessary. So the FDA will probably appoint yet another private third-party organization to audit the auditors and police the system,” he predicted.
FDA’s Broad Responsibilities
Enacted in January 2011, FSMA gives the FDA responsibility for mitigating food safety problems using science- and risk-based approaches to oversee roughly 80% of the nation’s domestic and imported food supplies. In addition to establishing minimum produce safety standards and requiring food growers and facilities to implement hazard prevention control plans, the FDA has the authority to order mandatory recalls of suspected food products, conduct a broad range of food facility inspections, and establish a comprehensive product tracing system.
FSMA requires imported foods to be held to the same standards as domestic foods, and importers and foreign suppliers must have preventive controls in place to ensure product safety. Qualified third parties will be authorized to certify that foreign food facilities comply with all U.S. food safety standards, a step that will help facilitate the entry of their products into the country. The FDA can also expedite review and entry of foods from importers that participate in a voluntary qualified importer program, and refuse entry if the agency is denied access by a facility or by the country in which the facility is located.