The movement of U.S. food safety efforts away from a reactive, punitive measures to a preventive system of safeguards has many food company owners fizzing. The Food Safety Modernization Act — known as FSMA in written materials and pronounced “fizz-ma” by business and regulatory people — is the source of the trepidation along the food supply chain. Among the congressional mandates in FSMA are seven rules developed and published by the U.S. Food and Drug Administration. One of those, commonly known as the Preventive Controls Rule for Human and Animal Food covers everyone from individual farmers market vendors to Walmart and McDonald’s. The preventive controls rule applies to all “facilities engaged in manufacturing, processing, packing, or holding food for consumption in the United States,” requiring that they conduct Hazard Analysis and Risk-Based Preventive Controls (HARPC) reviews and implementations to establish science-based measures to reduce the risk of food contamination. In some industries the HARPC concept is referred to as HACCP — Hazard Analysis and Critical Control Points. Recent real-life examples of a business embarking on a HARPC or HACCP review and implementation project is Chipotle Mexican Grill’s much-publicized internal investigation and operating procedures following a string of six foodborne illness outbreaks in 2015. Many government and non-profit groups, including the Food Safety Preventive Controls Alliance and the Produce Marketing Association (PMA), have educational and training programs and materials to help food businesses complete the HARCP reviews necessary to develop preventive procedures. FDA materials describe two key activities food facilities must implement once a HARCP review and prevention plan is completed:
- Monitoring — These procedures are designed to provide assurance that preventive controls are consistently performed. Monitoring is conducted as appropriate to the preventive control. For example, monitoring of a heat process to kill pathogens would include actual temperature values and be more frequent than monitoring preventive maintenance activities used to minimize metal hazards, which could be a simple record of the date on which the activity took place.
- Verification — These activities are required to ensure that preventive controls are consistently implemented and effective. They include validating with scientific evidence that a preventive control is capable of effectively controlling an identified hazard; calibration (or accuracy checks) of process monitoring and verification instruments such as thermometers, and reviewing records to verify that monitoring and corrective actions (if necessary) are being conducted.
Ponderous piles of paperwork The verification part of the Preventive Controls Rule is particularly loathed by many managers and rank-and-file employees. Keeping hot food hot and cold food cold is one thing. An entirely different skill set is needed, for example, to check temperatures at regular intervals and document the time, date, location, product, etc., for every item checked. Such documentation takes employees away from other job duties and presents many opportunities for human errors in crucial records. Traditionally such safety checks have been done with checklists, clipboards, pencils and food thermometers. Separate forms used at different times by different employees are often used for inventory and ordering. Paper checklists and forms then must be scanned or keyed into various computer systems, providing another opportunity for human error during data entry. Increasingly food facilities are turning to technology to reduce the number of man hours required to verify and document their food safety procedures and controls. One such company is Lund Food Holdings, an upscale supermarket chain in the Twin Cities. Earlier this year officials with Lund Food Holdings announced they would deploy the SureCheck platform from PAR Technology Corp. to collect, store and collate data. “The SureCheck Advantage solution automates our HACCP processes to improve efficiency, digitize our data, and proactively monitor all of our stores’ quality and compliance,” Lund’s Chris Gindor, senior manager of quality assurance and food safety, said recently. The SureCheck enterprise server enables cloud-based storage of safety data, checklists, and HACCP processes. Users log in to view records for compliance, reporting, business intelligence and analytical purposes. Included with such systems from PAR Technology Corp. are handheld mobile devices that are equipped a tethered temperature probe, bar code scanner, RFID sensor, and infrared temperature reader so employees can check and record food temperatures in one step. If corrective action is needed — for example, if a hot food item has become too cold — the employee receives an alert. The employee can then correct the problem, log the action, and have the information saved to the cloud. Compliance dates begin this fall for largest food companies The FDA has a staggered compliance schedule, allowing smaller operations longer to implement changes because of budget constraints they face. The compliance schedule from FDA for the Preventive Controls Rule for Human and Animal Food is:
- Very small businesses averaging less than $1 million per year, adjusted for inflation, in both annual sales of human food plus the market value of human food manufactured, processed, packed, or held without sale: Three years, except for records to support its status as a very small business, which are required beginning Jan. 1, 2016;
- Businesses subject to the Pasteurized Milk Ordinance compliance dates extended to allow time for changes to the PMO safety standards that incorporate the requirements of this preventive controls rule: Three years;
- Small businesses a business with fewer than 500 full-time equivalent employees: Two years; and
- All other businesses: One year.
Compliance dates after publication of the final rule for the requirements of the supply chain program:
- Receiving facility is a small business and its supplier will not be subject to the human preventive controls rule or the produce safety rule: Two years;
- Receiving facility is a small business and its supplier will be subject to the human preventive controls rule or the produce safety rule: Two years or six months after the supplier is required to comply with the applicable rule, whichever is later;
- Receiving facility is not a small or very small business and its supplier will not be subject to the human preventive controls rule or the produce safety rule: 18 months; and
- Receiving facility is not a small or very small business and its supplier will be subject to the human preventive controls rule or the produce safety rule: Six months after the supplier is required to comply with the applicable rule.
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