- The U.S. Food and Drug Administration (FDA) has released draft guidance for currently nonbinding regulations of documentation requirements for hazard controls to accompany food and beverage products.
- The documentation requirements are part of four of the Food Safety Modernization Act's (FSMA) seven foundational rules: preventive controls for human food and animal food, the produce safety rule and foreign supplier verification programs.
- Part of the rule requires companies to identify any hazards that could necessitate a new preventive control to keep contamination from happening. They must identify types of controls that could be put into place, such as new rules governing process, food allergens, sanitation and the supply chain.
Another key element from part 117's guidance is what the FDA refers to as "customer provisions," which refers to commercial customers, such as retailers and distributors. Under this section of the rule, manufacturers would be able to identify hazards that might require a preventive control but that are out of the manufacturer's hands. These problems could come later down the supply chain at the fault of another manufacturer, distributor or retailer.
If a manufacturer abides by all specific regulations for customer provisions, it won't have to implement a preventive control for every hazard that may be out of its hands. This removes some of the pressure and workload from manufacturers so they don't have to account for everything that could happen after the product leaves their factories.
The FDA is opening the door for comments on this draft guidance, so the finalized regulations could look different depending on how the industry reacts. The agency is closing the comment period for the draft guidance on May 1, 2017, so final guidance likely won't surface until the latter half of next year or later. What could cause confusion is that this guidance impacts the preventive controls for human and pet food rules, even though manufacturers needed to have already been in compliance as of September.