FSMA First Steps

As the Food Safety Modernization Act regulatory process grinds it way to completion months into the future, fresh-cut companies are considering what to do now to prepare for the final rule.
Two proposed rules were announced in early January, the produce rule and the preventive controls rule. All fresh-cut companies are affected by the preventive controls rule. If fruit and vegetables are sliced, chopped or peeled, the facility must be registered as a food processor and follow the regulations.
The key word to remember in the preventive controls rule is “preventive.” It would require food processing facilities to have a written food safety plan that anticipates hazards, along with methods to react to hazards.
“It (the plan) will have to identify hazards and implement preventive controls to manage those hazards,” said Bob Whitaker, chief scientific officer of the Produce Marketing Association, during a PMA webinar held in January. Under the proposed rule, the plan would describe ways to prevent microbial, chemical and physical hazards.
This preventive process triggers the need for fresh-cut companies to get familiar with a new acronym: HARPC (hazard analysis and risk-based preventive controls). These guidelines are complementary to, yet different than, the more-familiar HACCP (hazard analysis and critical control points).
The seven principles of HARPC are:
–Conduct a hazard analysis
–Determine critical control points
–Establish critical limits
–Establish monitoring procedures
–Establish corrective actions
–Establish verification procedures
–Establish record-keeping and documentation procedures
“So it’s like HACCP, but a little broader in its focus,” said Whitaker.
The food safety plan would also have to address allergens, cross-contamination and sanitation controls, and include a set of procedures to follow for product recalls. The overall food safety plan would have to be facility-specific and would need to be revised to reflect any significant changes in the physical plant or the product mix.
How aggressive should a fresh-cut business be in adjusting to a proposed rule that is not yet final?
“While there are certainly big changes coming, we don’t know exactly what the end results will be,” said Ray Gilmer, vice president of public policy issues for United Fresh. “It’s not time to make any big investments or changes in operations yet. Comply with any audits or buyer standards agreements you have, and follow best practices.”
That leaves plenty of ways for a company to prepare for full implementation of FSMA.
Study the proposed rules. A list of helpful websites can be found below. Read the rule, participate in industry educational sessions, including webinars, and attend public hearings conducted by FDA and other regulatory agencies. Archives of the webinars are available on the PMA and United FSMA websites.
Comment. Major commodity groups such as United and PMA are poring over the FSMA documents and preparing detailed comments. Individual comments are also encouraged. “You can share your thoughts about how what you’re seeing in the rule might affect your operations, or if you have a better idea,” Gilmer said.
Review current food safety procedures.  Lou Cooperhouse, president of consulting firm Food Spectrum, thinks the time is now to conduct an evaluation along the entire chain of custody, starting with a small list of commodities that present the highest risk.
“Use risk assessment to develop a food safety supplier audit program to identify suppliers that might be at a higher risk based on the type of raw commodity or origin of a commodity,” Cooperhouse said. “Start small and start where the greatest risk is. Look at the known frequency of food safety outbreaks due to the inherent nature of the commodity.”
This process should result in a “gold standard” set of procedures that would serve as a model for addressing food safety throughout the entire supply chain, he added.
Train line workers and top brass.  Line workers need training in food safety because they are the ones closest to both the raw material and finished product. Cooperhouse advocates training for line workers on a quarterly basis at the minimum. The entire senior management team should be trained at a high level also, including becoming HACCP certified, he said.
Ramp up record-keeping and monitoring.  Processors will need to come up with procedures to check the progress of their food safety plans. “Every day you’re in operation, you have an obligation to monitor the effectiveness of the plan,” said Whitaker at the PMA webinar. “You will need to verify that the procedures are ongoing and that you are keeping records. The plan becomes a living document.”
The proposed rule requires the keeping of five different kinds of records: the written food safety plan; how preventive controls are being monitored; any corrective actions taken; validation and verifications of controls in place; and training records for individuals in charge of the plan. These records must include actual values or numbers (“good” or “OK” won’t suffice) and be presented promptly to inspectors on request.
Designate a point person. The proposed regulations call for the identification of a responsible and qualified individual who will be in charge of the food safety plan. That person must have demonstrable skill in developing and applying preventive controls in a food setting.
For Cooperhouse, the issue of enforcing food safety measures comes down to self-empowerment.
“Farmers and processors will truly adopt best practices because that’s the way they do business, not because a government inspector is going to audit their program,” he said. “It really comes down to training, and having information that is adaptable, in a user-friendly form and in some cases better technological solutions to make this as easy to apply as possible.”

Here are websites with a wealth of information about the produce and preventive control rules:

–FDA: http://www.fda.gov/Food/FoodSafety/FSMA/default.htm

–United Fresh: http://www.unitedfresh.org/newsviews/food_safety_resource_center/fda_food_safety_modernization_act

–PMA: http://www.pma.com/fsma

Lee Dean, editorial director

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