Here They Come

In December 2010, Congress passed the Food Safety Modernization Act (FSMA), which FDA said at the time represented the “most sweeping reform” of U.S. food safety laws in more than 70 years. Essentially, the FSMA “transforms FDA’s approach to food safety from a system that far too often responds to outbreaks rather than prevents them” to a system that requires food facilities to evaluate operational hazards, implement and monitor measures to prevent contamination, and put a plan into place to take any necessary corrective actions.

Some major FSMA provisions, however, are late in being finalized. In August 2012, the Center for Food Safety said it filed a lawsuit in federal court against FDA and the Office of Management and Budget for their failure to implement several of the FSMA’s critical food safety regulations. In February 2014, the Center for Food Safety and FDA reached an agreement whereby FDA would follow a court-ordered schedule for issuing specific final FSMA regulations between late 2015 and mid-2016, according to the Congressional Research Service.

The delays are not necessarily a bad thing, suggests Tom Chestnut, senior vice president of the Global Food Division of Ann Arbor, Mich.-based NSF International.

“Building a prevention-based food safety system is a long-term process,” he notes. “This massive regulatory overhaul is a large undertaking and delays can be expected, especially given the thousands of public comments already provided on the proposed rules. If FDA is taking extra time to ensure that the regulations achieve the end goal to make the food safer for consumers in the USA, it shows they want to do it right.”

Time to prepare

With the final rules looming, private label suppliers (including retailers that manufacture some of their own products) and retailers offering store brand items should take steps to ensure they will be in compliance within the timeframe set out in the final rules. On the food processing front, companies might want to ensure they are implementing the main components of FDA’s proposed rules; the final rules are not expected to differ greatly from the proposed rules, Chestnut explains.

“The basic elements of a prevention-based food safety operation will not change in any meaningful way because they will still require compliance with sanitation, GMPs (good manufacturing processes), training, documentation, traceability, etc.,” he says. “These organizations would also benefit by using this time to test their systems over and over to ensure complete compliance with the proposed rules.”

For food processors that are less advanced when it comes to food safety systems, Chestnut suggests that they use this extra time to assess the actions they need to take to become FSMA-compliant and work toward implementing those actions. He notes that they could take advantage of a variety of tools and resources here, including NSF International’s FSMA Readiness Assessment Tool (http://info.nsf.org/extranet/fsma/), an online program.

Gerald Kelly, senior technical consultant for UL Verification Services Inc., Fremont, Calif., notes that traceability should be a focus area right now for many private brand manufacturers. And traceability begins with the ingredients being used.

“The one thing I think manufacturers can do in light of the FSMA is, in my opinion, look at their raw receipt program,” he says. “A lot of companies rely solely on certificates of analysis for their ingredients, and I think 90 percent of the problems, if they occur, occur at the receiving dock. So they need to ensure their own verification, which means maybe periodic testing of raw materials and maybe a periodic inspection/review of their suppliers to show that the ingredients they are bringing in are safe and wholesome.”

From there, traceability must continue through processing and product transport, Kelly says. The party that owns the product once it leaves the plant, for example, has to have a system in place to ensure the product is shipped in a manner that will keep it safe — and maintain all of the records involved with doing so.

Time for scrutiny

Because the FSMA is designed to emphasize prevention when it comes to food safety issues, it should ultimately enhance the safety of retailers’ own-brand foods and beverages — and, therefore, boost consumer trust in those products. But the FSMA should not require any significant efforts from retailers that do not manufacture any of their own products, Chestnut says, unless they are classified as the importer of record.

Retailers still will want to perform periodic audits of their private label suppliers to ensure compliance, but Kelly notes that the SQF and BRC auditing schemes that came out of the Global Food Safety Initiative (GFSI) that was launched in 2000 actually have eased the audit process somewhat within many plants.

“When I go into a plant for one of my clients, we’ll take that SQF or that BRC [audit] … as a basis for the fact that the sanitation and the pest control and all that kind of baseline stuff that a good plant needs to be involved with — that they have reached a level of competency in that so we don’t have to spend the time going over that,” he says. “And in the meantime, what I can do for the client is check on the traceability, check on maybe HACCP issues and kind of drill down more things specifically to that manufacturer rather than having to go through all of the regular GMP stuff.”

Many retailers now require their private label food suppliers to be SQF-certified, a reality that has already resulted in significant food safety improvements. But participants among the entire store brand food supply chain still will need to be prepared for the release and implementation of the final FSMA rules.

“FSMA will mandate high levels of control and compliance in terms of food safety record-keeping, documentation of food safety practices and putting robust supply chain traceability and recall programs in place,” Chestnut stresses. “For the retail industry, this is the time to examine and re-examine food safety processes, procedures and systems to identify any gaps within the provisions of the new FSMA regulations and put corrective actions in place immediately.”

NSF also offers consulting and training services to help organizations here, he adds.

And Kelly notes that UL is able to perform product testing for safety, components and contaminants, and can also assist in helping companies develop quality assurance and HACCP plans.