Under the FDA Food Safety Modernization Act most food and beverage companies are required to implement preventive controls systems by July 3, 2012.
Also under the new law, preventive controls systems are subject to FDA inspection starting on the same date. These new provisions mandate that all facilities have food safety plans and make all related records available to FDA during an inspection, even in the absence of FDA regulations.
Although the agency has publicly stated that they will not “enforce” the new provisions until after final regulations are issued, which will likely take an additional one to two years, it is likely that FDA will want to “keep the pressure” on food and beverage companies by monitoring good faith efforts by each facility to implement the new law.
In preparing for increased scrutiny following July 3, 2012, GMA members are encouraged to take the following five steps developed by Hogan Lovells, and documenting them clearly:
1. Develop and implement a Food Safety Plan that includes a hazard analysis of known or reasonably foreseeable hazards that may be associated with the products produced at the facility and designates appropriate preventive controls to significantly minimize or prevent those hazards. The plan should designate any critical controls points and describe monitoring steps, corrective actions, and verification activities. Be sure you have sufficient support to show that the preventive controls are adequate to control the identified hazards (i.e., validation). A food safety plan is also required for warehouses, but an abbreviated plan may be appropriate.
2. Have your product and environmental testing regimens clearly delineated as verification activities under your Food Safety Plan. Note that product testing may include testing incoming ingredients, in-process testing, or finished product testing. Your plan for environmental testing should include the remedial actions that will be taken if positive test results are found. You should explain in your plan, or be able to explain to the FDA inspector, why you believe your testing regimen as a whole adequately verifies the performance of your Food Safety Plan.
3. Implement corrective actions, when needed, and document these actions. Be sure you take corrective actions whenever there is a deviation from your Food Safety Plan material to food safety and that you document those actions clearly. This documentation should include a root cause analysis and actions taken to reduce the likelihood of recurrence. It should also include an assessment that all affected product has been evaluated for safety and, if appropriate, is prevented from entering into commerce.
4. Develop and implement a program to verify suppliers (including both ingredient and packaging suppliers) to ensure that they provide products that are safe and are produced in accordance with FDA’s regulations. Have your program described in a Supplier Verification Plan that FDA can review, if requested.
5. Develop and implement a food defense plan that identifies and evaluates hazards that may be intentionally introduced, including by acts of terrorism, and implement controls to significantly minimize or prevent these hazards. Be able to show FDA the methodology (i.e., food defense tool) you used to develop this plan.