Industry prepares for new food safety requirements

by Jay Sjerven
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WASHINGTON — With President Barack Obama poised to sign the Food Safety Modernization Act (F.S.M.A.) into law, the nation’s food manufacturers considered what changes they may have to make in their operations and prepared to provide comment and advice to the Food and Drug Administration as the agency begins rulemaking to implement key provisions of the new law.

Margaret Hamburg, commissioner of the F.D.A., said of the Food Safety Modernization Act, “This law makes everyone responsible and accountable for each step in today’s global food supply chain. Under this new law, F.D.A. will now have new prevention-focused tools, as well as a clear regulatory framework, to help make substantial improvements in our approach to food safety.”

Both the F.D.A. and many food manufacturers and industry associations began planning for the new regulatory regime well ahead of the passage of the F.S.M.A. In an interview with Food Business News last summer, Michael R. Taylor, the first deputy commissioner for food at the F.D.A., said of the food safety bill then being considered in the Senate, “The legislation basically codifies the modern approach to preventive controls that many in the food industry have been pursuing for a long time and that we all agree would contribute to reducing food-borne illnesses.”

At the same time, many small and medium-size food manufacturers may not be well prepared for the many changes and obligations their businesses will face in the new order, said Peter Barton Hutt, a senior counsel with the law firm of Covington Burling L.L.P., Washington. Mr. Hutt said while large food manufacturers may have teams of professionals working on preventive controls and other mandates contained in the new food safety act, the same was not true for many if not most smaller businesses. These companies may encounter challenges in complying with the act that may require flexibility, outreach and education by the F.D.A. and by associations representing the food industry.

A to-do list for food companies under the new law certainly might begin with drafting a hazard analysis and critical control points plan, and reviewing and perhaps upgrading recordkeeping capabilities.

Under the act, each food facility must have a plan that spells out the possible problems that may occur during manufacturing that may affect the safety of food products. The plan also must outline steps the facility will take to prevent or significantly minimize the likelihood of those problems occurring.

As Mr. Taylor indicated, many food companies over the years have established such plans and procedures, but as Mr. Hutt cautioned, many medium-size and smaller businesses have not. Those without plans may turn to the F.D.A., the U.S. Department of Agriculture or food industry associations for helpful templates that may serve as a framework for a plan. Provisions requiring each food facility to have such a plan and implement it take effect 18 months after enactment.

The act requires the F.D.A. during those 18 months to promulgate regulations establishing minimum standards for such plans and their implementation. All companies will have to pay attention to this process as their food safety plans may have to be adjusted or modified, perhaps on short notice, to comply with the minimum standards.

The safety plans and records of their implementation must be written as the F.D.A., after giving oral or written notice, may review them. Such records about preventive controls and corrective actions must be kept for at least two years.

Related to the food safety plans aimed at preventing or significantly minimizing the possibility of accidental food adulteration at critical points in the manufacturing process, a “sleeper” section in the act, Section 106, may require food companies to implement additional mitigation strategies or measures intended to protect against intentional adulteration of food, said David Acheson of the Washington office of the firm of Leavitt Partners, Salt Lake City. The act requires the Department of Health and Human Services and the Department of Homeland Security in consultation with the U.S.D.A. to promulgate regulations to protect against the intentional adulteration of food subject to the act no later than 18 months after the law takes effect.

Access to records

Food companies might also consider whether their recordkeeping procedures in general may need to be improved, upgraded or otherwise changed to comply with the act’s several provisions, including those providing the F.D.A. much greater access to records.

Under current law, the F.D.A. may have access to records relating to food products the agency reasonably believes are adulterated and present a risk of serious adverse health consequences or death. Under the F.S.M.A., the F.D.A. also may have access to records concerning other food products it believes might be affected in a similar manner.

The change effectively lowers the bar the F.D.A. must clear to demand access to company records, Mr. Acheson said.

Food companies must pay close attention to the process of developing a more efficient food tracing system as is required under the act. This also will affect recordkeeping procedures and capabilities. Under Section 204 of the act, the F.D.A. within 270 days of enactment is required to establish pilot projects to evaluate different systems for tracing packaged foods and fruits and vegetables. Within two years of enactment, based on the results of the studies, the agency must issue proposed regulations requiring the maintenance of records by facilities that will allow the F.D.A. to quickly trace high-risk foods during a food-borne illness outbreak. Before issuing final standards, the F.D.A. must hold public meetings and solicit and consider public comment.

Unlike the far more stringent House version of the food safety bill, the act as passed by both houses of Congress does not require a “full pedigree” of each food or food ingredient and does not require a company to adopt a particular recordkeeping technology uniform to all food companies. But certainly, records at the least must be comprehensive and kept in a form accessible to the F.D.A. and continue to identify the immediate supplier of ingredient and immediate recipient of the food product manufactured by a facility.

Facility inspection frequency

Food companies also must be prepared to accommodate a more robust inspection program that may include a review of safety plans and relevant records. Under the act, the frequency of a facility’s inspection will be tied to whether it manufactures foods that are considered at high risk or low risk of adulteration. High-risk food facilities must be inspected once during the first five years after enactment and every three years thereafter. Low-risk facilities must be inspected once during the first seven years after enactment and every five years thereafter.

Each food company must be registered with the F.D.A. and renew its registration on a biennial basis. Unlike the House

version of the food safety legislation, the act as passed by Congress does not require a registration fee. The F.D.A. may suspend a facility’s registration if the facility was responsible for an adulteration that created a reasonable probability of causing serious adverse health consequences or death, or if the registration holder knew or should have known a food product it held, packed or received posed a risk of serious health consequences or death.

Certainly mandatory recall authority as provided the F.D.A. under the act was at the center of attention of the nation’s new media. The F.D.A. said it envisioned exercising mandatory recall authority rarely as most companies comply with the agency’s request to voluntarily recall products.

It should be noted several mandates contained in the act, such as increased inspections, are not funded and will require appropriations by future Congresses.

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