What flexibility means
F.S.M.A. provides more leeway than previous regulatory schemes, softening the blow of the new mandatory aspects.
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| Bill Bremer, principal of Kestrel Management |
“The flexibility included the additional time for compliance under rulemaking,” said Bill Bremer, principal of Kestrel Management, a provider of operational risk management services. “Additionally, the compliance deadline will vary depending on the size of the company; however, in all cases, a company’s compliance must meet the requirements of their customers.”
Working through the rulemaking process, the F.D.A. asked for feedback from the public, industry groups and affected companies.
“It incorporated a lot of what it learned about best practices in food processing,” Mr. Payne said.
Among the things the agency learned was that one size does not fit all.
“The food facility operator can choose the preventive control for their process,” Dr. Brackett said. “In some cases, it may be that their ingredient supplier has preventive controls in place. But the key thing is that the facility will need to document why they chose this particular preventive control, how it is being implemented and the results of applying it.”
Mr. Steed observed, “Not all preventive controls will need to be managed with the same level of rigor and frequency.” Considerable freedom is allowed to decide monitoring methods, corrective actions, verification, validation, frequency and documentation.
After undertaking a hazard analysis, it may be that the food safety team determines a particular hazard requires no preventive control. If so, “it has to document why there is no need for control,” Dr. Brackett said. “In other words, [explain] why this facility did what it did regarding this particular hazard.”
Such leniency has its limits, according to Cornelius Hugo, manager of global innovation at AIB International. It works for minor cGMP issues and corrections in documenting them.
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| Cornelius Hugo, manager of global innovation at AIB International |
“However, for preventable recalls such as undeclared allergens and controls for pathogenic bacteria in ready-to-eat food, there will not be flexibility for documenting effective plant programs that prevent these type of recalls,” he said.
There are pros and cons involved, too.
“If I were a baker, I would see this open-ended approach as encouraging,” Mr. Payne said. “There is some risk, however, because how I interpret something and how the F.D.A. inspector interprets the same thing may differ. That’s where a third-party inspector can help.”
