FDA is scheduled to release the final new preventive control regulations for the food industry this month. For too many in the food manufacturing industry, the rules will be a culture shock. But the food industry will not be alone, since the animal feed industry also faces new regulatory requirements.
The new regulations will be onerous for many to implement from a technical, operational and facility standpoint, as well as from a managerial standpoint. Some businesses will have to invest in substantial facility improvements to achieve compliance under the new Food Safety Modernization Act (FSMA) Preventive Controls for Human Food. They should keep in mind, however, that this new policy is the result of numerous foodborne illness outbreaks over the last several years, and its purpose is to make America’s food supply safer. FDA is trying to empower manufacturers to take a proactive stance, rather than a reactive one.
The new FDA preventive control regulations are expected to become effective 60 days after the August publication date. Furthermore, food manufacturers are expected to be in full compliance one year later, which would be late 2016. Very small and small businesses—as defined by FDA—will have a longer period in which to become compliant. Although compliance dates seem to be a ways off, companies will need this time to implement operational changes to comply with the new regulations.
Based on the earlier proposal that was published, companies can expect to conduct extensive background research on the hazards that could be associated with each ingredient used in a formula and process related to a finished product. Each process must be documented in a way that provides scientific evidence that the process adequately controls all hazards identified in the hazard control evaluation. This course of action also includes the preventive controls that have been determined to control all identified hazards.
In addition, companies must develop and maintain essential records documenting compliance once the new regulations are in effect. These records and documents will be subject to review by FDA compliance officers for adequacy and accuracy.
Not only will the food industry experience culture shock, so will regulators. Some are already attempting to enforce the proposed preventive control regulations prior to publication of the final rule this month. The enforcement of the FSMA preventive controls will bring a new food-safety landscape for inspectors to focus on while in a plant. They will also have access to FDA subject matter experts if they have any doubts about what they are seeing while in a plant. This is new to FDA inspectors and also to the food industry, and could result in increased time spent in plants and in violations written. I expect there will be an increase in food recalls during the implementation period, as well.
Although an entire plant attitude may change when the new regulations are introduced and fully implemented, a good manager will hopefully set the tone for a smooth transition that overall will positively affect the company’s food-safety program.