KANSAS CITY — With less than a month left before very small food businesses — including bakers and snack makers — need to comply to the Food and Drug Administration’s Preventative Controls for Human Food (PCHF) rule, verifying proper action for reducing and eliminating food safety hazards is essential.

By Sept. 17, two requirements should be completed with the PCHF rule: an updated Current Good Manufacturing Practice (CGMP) and a documented food safety plan. 

The updates to the CGMPs make actions such as the education and training of employees binding and creates rules for distributing human food by-products that are used for animal food, according to the F.D.A. website. In addition, the modified rule is explicit that companies should address allergen cross-contact.

Undeclared allergens are the No. 1 cause for recalls in the United States, and labeling is a big part of it, according to Fabiola Negrón, food safety specialist, Registrar Corp., Hampton, Va.

“Companies must have controls in place during the creation of product labels to ensure all ingredients are properly listed, conduct checks at receipt of labels manufactured by a supplier to ensure labels are printed correctly, and they must conduct label checks at the labeling step to verify that the correct label is being used for a particular product,” she said. 

The second part of PCHF requires that bakers and snack producers have a food safety plan that includes these steps of compliance: a hazard analysis, preventive controls, a risk-based supply chain program and a recall plan.

David Lennarz, president of Registrar Corp., has noticed a pattern of companies thinking they’ve complied with the regulation because they have a Hazard Analysis Critical Control Point (HACCP) program in place.

“There is this misconception out there that HACCP and the Preventive Controls are the same thing,” he explained. “While HACCP is a foundation for it and a lot of what they do with it is applicable, there are pieces that are not in HACCP that are required.” 

One of these differences include types of hazards that require controls. Ms. Negrón gave the example of radiological hazards such as chemical hazards and those due to Economically Motivated Adulteration. PCHF also requires a recall plan, which was not implemented with HACCP. 

Foreign companies are making the same mistake, but their misconception can be a more significant issue. US importers must have a Foreign Supplier Verification Program (FSVP) to bring food products into the country, but they typically can’t create an FSVP without the supplier’s food safety plan. 

“Those two pieces really go together,” Mr. Lennarz said. “It’s definitely more of a challenge for foreign companies just because they might not be following the rules as closely and might export to a lot of different markets and often English is not their first language.”

However, the most important requirement under the PCHF rule might the qualified individual.

“Understanding the need for this qualified individual has been a pretty big learning stumbling block for companies,” Mr. Lennarz said.

The F.D.A. deems a qualified individual as “someone who has successfully completed certain training in the development and application of risk-based preventive controls or is otherwise qualified through job experience.” This person develops and implements the food safety plan and can be someone within the company, a consultant or someone else outside the business. 

If companies are not in compliance with PCHF yet, Mr. Lennarz advised that they write a safety plan as soon as possible — even if it’s not perfect. 

“F.D.A. is in an education stage, but they don’t tell you when they’re going to go from education to enforcement,” he explained. “Reading the regulations and taking a qualified individual course to become certified, those are all excellent ways to get your food safety team up to speed.”