What FSMA means for R&D and product development teams
Snack foods are one of the most-innovative food categories, with countless new stock-keeping units (SKUs) introduced each year. As food manufacturers face stricter controls related to the Food Safety Modernization Act (FSMA), questions loom as to whether their innovation will be diminished.
Early in my career, I had a product development role with a food manufacturing company. My aim with each project was to make the final product as easy to manufacture as possible. This meant I focused on using only the company’s most-prevalent ingredients, which were easy to obtain, had good stock rotation and were procured with volume discounts. Needless to say, I never quite created the “wow” factor that brought in key accounts. I now think about how FSMA may create additional hurdles to creativity.
Incorporating food safety into the R&D process is not new. However, the raised bar set by FSMA will require some enhancements, starting at the R&D level. The three FSMA components that will have the greatest impact on R&D are Foreign Supplier Verification Program (FSVP), Hazard Analysis and Risk-Based Preventive Controls (HARPC) and Mitigation Strategies to Protect Against Intentional Adulteration (IA). Let’s look at each individually.
FSVP. Adding a new supplier is often precipitated by R&D introducing new product. While FSVP does not apply when small quantities of ingredients are imported for research purposes, when the product is commercialized, the supplier must be verified. The supplier must be registered with the FDA, and the importing company must provide assurance that the foreign supplier is in compliance with FSMA.
If the supplier has never exported to the U.S., implementing FSMA-compliant programs may be a significant investment in resources to the company. Even if the supplier was verified previously, there are some unique assessments related to receiving a new ingredient from the company. For example, the new ingredient may have hazards that must be controlled by the supplier, such as toxin potentials. If there are hazards that must be controlled by the supplier, the importing firm must verify that the supplier has appropriate controls in place at its operation or upstream.
HARPC. Each site must have a Preventive Controls Qualified Individual (PCQI). Many organizations may find it useful to have PCQIs as part of their R&D teams. Some of the key steps that need to be included at the product development stage are identification of hazards; identification of which part of the supply chain has responsibility for hazard control (supplier, importer, downstream processing); identification of preventive controls; and validation of preventive controls.
Validation of the preventive control may be a manufacturer’s biggest hurdle. Slight changes to product characteristics, such as density, water activity and fat content, can require an entirely new set of validation studies.
IA. Under FSMA, registered facilities must conduct an assessment to identify actionable process steps and to ensure that mitigation strategies have been implemented for those identified steps. If a new or modified process step is being introduced through a new product launch, the assessment needs to be updated to account for this process step.
The FDA has identified four activities that are the most vulnerable: bulk liquid receiving and loading, liquid storage and handling, secondary ingredient handling and mixing. If a new product involves these activities, mitigation strategies must be in place.
Innovation may also involve packaging. Changes in package type may change the product’s vulnerability to tampering. For example, years ago, retorted products required packaging into cans. With new technologies, many retorted products are now being produced in pouches, which may be more susceptible to tampering than cans.
By adding the steps related to FSMA—FSVP, HARPC and IA—to R&D procedures at the appropriate stages, manufacturers can continue to see creativity flourish from their R&D and product development teams. The “wow” factor need not be curtailed in the face of FSMA.