Big changes coming
As the food industry struggled in recent months with renewed efforts to address and prevent microbial problems, it also faced imminent changes in the way food safety will be regulated. FDA is under court-ordered deadlines to issue key final FSMA rules in the summer, with the first due out Aug. 30. The rest will emerge during fall 2015 and spring 2016, with implementation dates to kick in during 2016 and 2017.
The supporting law, enacted in the wake of produce contamination episodes, is clear about the need to move food manufacturers from reactive, passive controls to proactive, anticipatory and preventative controls. FDA, too, has been charged with getting out of after-the-fact enforcement and into before-the-fact prevention.
It’s a big assignment. “Overseeing industry compliance with seven new regulations — essentially at the same time — is practically unheard of and has, and will, continue to take a tremendous effort by many in FDA’s foods and feed programs,” said Roberta Wagner, deputy director for regulatory affairs in FDA’s Center for Food Safety and Applied Nutrition, in an interview posted on FDA’s website.
Although a federal mandate, FSMA regulations will have local impact, too. “The states have an important role in FSMA implementation — both in helping educate industry and in conducting inspections on FDA’s behalf,” said Joann Givens, acting regional food and drug director for the Central Region in FDA’s Office of Regulatory Affairs, in the same interview. She and Ms. Wagner are co-leads of the agency’s implementation team steering committee.
Unlike nearly every other regulation written by FDA, FSMA rules take a flexible approach — flexible in how the agency can interpret and enforce them, according Michael R. Taylor, deputy commissioner for foods and veterinary medicine, FDA.
Charles M. Breen, senior regulatory consultant, EAS Consulting Group, Alexandria, VA, explained, “The program will be more flexible — for FDA. FSMA rules are being written so broadly that there will be no one way that every company must comply with the regulation. Rather, there will be many ways. One industry’s means of compliance may likely be different from another industry’s.”
What does that mean, specifically? “For example, a baker making a cream-filled pastry will have different food safety needs than someone making baked chips,” Mr. Breen said. “That’s because the microbiological risks with cream are higher.
“In actual enforcement, we are not sure whether FDA will want to see everyone in a given industry do the same thing,” he added, “however, the flexibility within an industry or industry segment won’t be as broad as the flexibility that FDA has to interpret the regulations.”
“We are hearing concerns that the agency may not have the resources to accomplish the roll-out of FSMA on time,” Mr. Breen said.
Get prepared, stay prepared
News bulletins and targeted communications about webinars, specialized training, inspection services and evaluation programs now bombard food manufacturers as announcement day approaches for FSMA regulations. It’s hard to escape the “be prepared” message.
Every food manufacturer should look at the proposed rules carefully, Mr. Breen advised. “Start with what is different about FSMA. What is a hazard? What is a preventative control? What are the microbiological controls? You have to look at each aspect as it applies to your business and your situation,” he said.
Mr. Breen explained that in baking operations, bake time is an aspect of preventative control of microorganisms. “For some items, the result can be safe foods — processed long enough to be the kill step, the preventative control point — but the food may not be salable. The baked item reaches kill temperature, but that may not be high enough to set the structure,” he said. “You must look at how the rules apply to your situation.”
Validation of kill steps is an essential part of FSMA. “It will be the mantra of FSMA,” Dr. Channaiah predicted. “You have to provide scientific documentary evidence for the kill step, proving it consistenly delivers the desired lethen effect to ensure destruction of pathogeic microorganisms. [In the baking and snack industries], foods pass through a kill step — baking, boiling, roasting, frying — but these stages will need to provide scientific validation of their effectiveness now.”
Data supporting validation — for example, readings of data loggers put through ovens or fryers to record temperature conditions — must be made available to FDA inspectors. “The agency will want to see the actual data,” Mr. Hahn said.
Food processors must keep in mind that food safety and food quality are different. “FDA is concerned about food safety,” Mr. Breen advised, “and food processors are also concerned about food quality.”
FDA has already offered final regulations for two of the seven FSMA priorities. Next up will be Preventative Controls for Human Food.
“Companies need to be prepared,” Dr. Plimpton said. “You will need to have preventative controls in place within the compliance period. Those who have gone through Global Food Safety Initiative programs will be ahead of others who have not.”