New FSMA requirements require further FDA work
Language including 'qualified individuals' needed under new rules does not yet specify what qualifications are
Under the proposed Food Safety Modernization Act rules governing animal feed and petfood, each covered facility must prepare and enforce a hazard analysis and risk-based preventative controls process (a written food safety plan). Among the items that must be included in such a plan is the requirement that a "qualified individual" prepare and oversee the entire process. Unfortunately, what makes someone qualified has not yet been fleshed out.
The definition of a "qualified individual" is someone who has successfully completed training in the development and application of risk-based preventive controls under a standardized curriculum recognized as adequate by the US Food and Drug Administration (FDA), under a program that is at least equivalent to that standardized FDA-approved curriculum, or be otherwise qualified through job experience. But, as of yet, there is no FDA-approved curriculum to either attend or compare job experience to.
The Food Safety Preventative Controls Alliance (FSPCA), a private alliance of leaders in the industry, academia and state and local food protection agencies, will be responsible for creating the standardized curriculum, with FDA offering input. The ultimate goals are that the FSCPA will:
- Develop standardized hazard analysis and preventive controls training and distance education modules for food industry and regulatory personnel. The first individuals who will receive the training are those individuals who will then train others. The second to receive the training will be federal and state regulatory inspectors. Finally, training will be made available to industry members.
- Design and deliver a state-of-the-art distance learning training portal at the IIT IFSH Moffett Campus in Bedford Park, Illinois. In addition to in-person training, it is anticipated that training will be offered online.
- Create a technical assistance network, such as a website community, where small- and medium-size food companies can go to for help with their preventative control or food safety plans.
- Develop commodity/industry sector-specific guidelines for preventive controls.
- Over time and as technology develops, assess knowledge gaps and research needs for further enhancement of preventive control measures.
- Identify and prioritize the need for, and compile, critical limits for widely used preventive controls.
Once the curriculum is completed and approved, the "qualified individual" will have much more solid measurements to meet.