FDA had previously extended compliance dates on some provisions of FSMA, which is the most sweeping change in food safety regulation shince the passing of the Food Safety and Cosmetic Act in 1938. But FDA went further when it announced on Jan. 4 that it will exercise enforcement discretion for the time being for specific provisions of four of the seven rules that make up the implementation of the act. Those are: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (PC Human Food), Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals rule (PC Animal Food), Foreign Supplier Verification Programs rule (FSVP), and Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule (Produce Safety).
The announcement is a welcome one, but doesn’t mean that all FSMA bets are off, said Larisa Pavlick, vice president of regulatory and compliance for the United Natural Products Alliance.
“It’s important that people understand that this doesn’t mean ‘FSMA is on hold for this year.’ Only four of the seven rules have been delayed,” she told NutraIngredients-USA.
Problems with written assurances
One of the most vexing issues mentioned by a number of stakeholders who submitted comments concerned the ‘written assurances’ specified in FSMA. This has to do with identifying hazards in the food supply chain and specifying who in that chain has taken responsibility for controlling for that hazard. It appears that when the rule was written, FDA did not have a sufficiently clear and detailed picture of just how complex the global supply chain has become, Pavlick said.
“It had been suggested in comments that this could be very difficult for industry to accomplish,” Pavlick said. “Even in our most recent training we had a lot of distressed attendees saying, ‘Oh my gosh, how am I ever going to be able to make that happen?’ I had one attendee tell me, ‘I am going to go to jail. I won’t be able to comply.’”
The original rule stated that if a hazard was identified at one point in the chain, say for example a microbial risk from a botanical that was dried in a field setting such as on a tarp on the group or in an open shed, then a plan must be put into place with written documentation to show that that particular hazard was controlled. If the initial processor is not taking that responsibility, then that firm must send along a written statement with the shipment that the hazard exists and still must be controlled for at some point further along the chain.
“What this provision is saying is that you have to notify the person downstream that a certain hazard has not been controlled for. Most people don’t want to use these kinds of statements, having to admit they haven’t done something,” Pavlick said.
“I think once the whole industry has adjusted to this requirement, we’ll be better off for it. Every person in the supply chain will understand exactly what they are receiving and what they are distributing. The enforcement discretion will give industry more time to get these assurances. I was gratified to see that FDA understands these concerns and complexities in the supply chain relationship,” she said.
Defining a ‘farm’
Another problem identified within the FSMA language had to do with the definition of what exactly a ‘farm’ is. And further, making it more clear what kinds of operations performed at a farm might transform it into a food processing facility under FSMA.
“Here at UNPA we have been to define when the produce rule might apply to the ingredients supplied by our members. The rule mostly applies to things you might understand as produce—fruits and vegetables—but can also include some botanicals that we would use within our industry as ingredients,” she said.
“So there was confusion among our members, who were wondering, am I a farm? Or am I a processor?” Pavlick said.
Pavlick said that in the announcement last week, FDA indicated that it will initiate a rule-making procedure that better define this divide. It is assumed the rule will more precisely define what kind of packaging and shipping steps cross over the line from a farming operation to a food processing one. Does the size of the package matter, such as a big tote versus a smaller container? While the distinctions might seem arcane, they can be of critical importance to individual operations. As an example, Pavlick mentioned a farm she once inspected while working for FDA in which chili peppers were being boxed for shipment to super markets to be sold as a fresh seasonal item. Did putting the peppers into boxes transform that farm into a food processor? Pavlick said that most botanicals that go into the dietary supplement supply chain have at least some initial processing take place at the point of harvest, such as drying and cutting.
“If a person doesn’t understand where they fall [on the farm/processor divide], they don’t know what is expected of them,” she said.