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Get a Documented Food Safety Plan
Food safety bill will mean more FDA on-site reviews
by Joel R. Pecoraro
Get ready to meet your new Food and Drug Administration (FDA) inspector. On Jan. 4, 2010, President Obama signed into law the FDA Food Safety Modernization Act (PL 111-353). The bill essentially takes provisions from the House-passed H.R. 2749 and combines it with S. 510 (Senate) to make one bill. The new bill will impose stiff penalties for known violations. To ensure enforcement, the House bill includes a minimum $1,000/year registration fee to be assessed to all food facilities to help pay for mandatory FDA on-site inspections.1 While the Senate bill does not make clear how much the fee will be, both bills include mandatory FDA inspections.
Although the particulars of the bill have not yet been worked out, it is clear that the new legislation will impact any firm that “manufactures, processes, packs, transports, distributes, holds or imports an article of food in the United States.”2 The wording is so vague that the phrase could be read to mean every firm with a vending machine. Although clarity is needed on which groups will be affected, those of us who are clearly impacted must be prepared.
The new legislation includes multiple regulations, but a major component is the requirement to maintain a documented food safety plan and to demonstrate conformance to the plan with clearly documented records.
The new legislation includes multiple regulations, but a major component is the requirement to maintain a documented food safety plan and to demonstrate conformance to the plan with clearly documented records. Regardless of the size and complexity of your operation, there are some basic components that must be addressed in your food safety plan, including the following.
You will need to define the specific activities and responsibilities relating to recalling potentially harmful product. At a minimum, you must consider:
- Criteria to issue a recall: Small issues arise regularly, but what type and severity of an issue will prompt a recall?
- Who is involved: Identify the key personnel and outside experts (i.e., lawyers, insurance) who are involved in the process and who will ultimately make the final decision.
- Communication: How will you communicate any recall information to affected parties? Affected parties usually involve the customers, distributors, regulatory bodies, and your own staff.
What is your system for tracing product back to any relevant inspection, certification, and operating specifications that were used to process the product? New country of origin labeling requirements are being applied in this area. Keep in mind that if your product is sold through a distribution channel or you use subcontractors in the process, you must ensure that the traceability system is maintained.
The Role of HACCP
Hazard Analysis and Critical Control Point (HACCP) programs have been around since the early space program when the National Aeronautics and Space Administration was analyzing potential problems with food contamination in outer space. HACCP forces the identification of potential problems before they occur and encourages the development of an action plan designed to both prevent problems and react in the event of an occurrence.
A major concern with many HACCP plans is trying to identify potential problems realistically. The legislation defines a potential problem as a “hazard for which a prudent person who, as applicable, manufactures, processes, packs, transports or holds food would establish controls because experience, illness data, scientific reports or other information provide a basis to conclude that there is a reasonable possibility that in the absence of those controls the hazards will occur in the type of food being manufactured, processed, packed, transported or held.” So while it is possible for a pack of wild dogs to attack your facility, it is not a likely occurrence.
Under the new regulations, all affected firms would have to make food safety records available to FDA inspectors. Your company must identify not only the records that are maintained, but also their storage duration, their storage location, and how the records are protected (hard copy and electronic). Keep in mind that the bill would grant the FDA authority to compel the production of documents.
Specifications and requirements must be developed with some scientific rationale. The FDA websites and trade journals can provide valuable scientific data relating to contamination controls. If no scientific data is available, consider creating your own studies based on accepted practices.
Each company should detail the basic steps employed to prevent food hazards and should put those requirements into an auditable format so that compliance can be verified internally.
Your system needs to address the initial and ongoing evaluation of your supply chain. This will be particularly important for those companies importing product from foreign countries. Try to address any certification programs or quality expectations a new supplier must meet before purchase. In addition, identify how any raw materials or processes will be verified. Every company that intends to stay in business has a system for dealing with upset customers. A necessary component of any effective food safety plan covers the proactive steps taken to prevent food contamination. Many of these steps can be addressed in the HACCP plan.
My guess is you wouldn’t be in business if you didn’t already employ basic good manufacturing practices, which can range from pest control to facility security. The difficulty for some companies is providing a written plan that defines these processes. Each company should detail the basic steps employed to prevent food hazards and put those requirements into an auditable format so that compliance can be verified internally.
There’s no question about it; the new food safety bill is going to include more FDA on-site review. Good food safety plans can take time to develop, document, and implement, so it is probably not in your best interest to wait until you get that “we can’t wait to visit your facility” notice in the mail.
- Food Safety Enhancement Act of 2009. H.R. 2749, section 743˚Facility registration fee. Available at: www.gpo.gov/fdsys/pkg/BILLS-111hr2749rfs/pdf/BILLS-111hr2749rfs.pdf. Accessed January 23, 2011.
- Food Safety Modernization Act. S. 510, section 101—Inspections of records. Available at: www.gpo.gov/fdsys/pkg/BILLS-111s510es/pdf/BILLS-111s510es.pdf. Accessed January 23, 2011.