Machinery Lubrication magazine published by Noria Corporation
Issue link: https://www.e-digitaleditions.com/i/875060
www.machinerylubrication.com | September - October 2017 | 47 • Operating a facility not in compliance with the FSMA Preventive Controls Regulations (for both human and animal food) • Failure to comply with the FSMA Produce Safety Regulation • Failure to comply with the FSMA Food Defense Regulation • Refusal or failure to comply with an FDA recall order • Knowing and willful failure to comply with consumer recall notification requirements • The importing or offering for importation of a food if the importer does not have a foreign supplier verification program in compliance with the FSMA Foreign Supplier Verification Program Regulation • Failure to comply with the Sanitar y Food Transpor tation Act Regulation In September 2013, two melon farmers in Colorado were arrested for violations of the FD&C Act following a deadly listeria outbreak that was traced back to their produce. They pled guilty to the charges and were sentenced to five years of probation, with the first six months under house arrest, 100 hours of community service and $150,000 to the victims of the outbreak. In September of the following year, the former owner, president and CEO of the Peanut Corporation of America was found guilty on 67 federal felony counts associated with a salmonella outbreak. His brother, who was the vice president of the company, was found guilty on 30 charges. While these are extreme examples, it is apparent the FDA is not taking violations of the law lightly. It is also easy to see how plant managers and others could be held criminally liable for food being "adulterated" or contaminated with oils and greases used in manu- facturing and other related processes of food production. Other changes outlined in the FSMA include fees associated with reassessments conducted by the FDA. The rate for these fees is $221 per hour for domestic travel and $285 per hour for international travel, which can add up quickly. These fees are to be paid by the "responsible party" within 90 days of receiving the invoice. A Focus on Prevention One of the cornerstones of the FSMA is the realization that the FDA likely would not be staffed sufficiently to oversee all the changes mandated by the law. Much of the burden falls on a company's CEO and board of directors to ensure that the food they produce is safe. The primary guiding principle is the application of the Hazard Anal- ysis and Critical Control Points (HACCP) to the roughly 80 percent of the food supply regulated by the FDA. This represents a major shift in ideology. Previously, the focus had been on responding to contam- ination in the U.S. food supply. Now the focus is on prevention. Section 103 of the Food Safety Modernization Act deals specif- ically with prevention. It requires the owner, operator or agent in charge of a human or animal food facility which manufactures, processes, packs or holds food to evaluate hazards that could affect food safety, identify and implement preventive controls to prevent those hazards, monitor those controls and maintain monitoring records, and conduct verification and reverification activities. In addition, the responsible parties are to identify and evaluate hazards that may be intentionally introduced, including acts of sabotage or terrorism, as well as develop a written analysis of the hazards. A major piece of the required documentation is a "food safety plan." This plan addresses, among many other things, lubricants and lubrication. It should also include written hazard analysis, preventive controls, a supply chain program, procedures for monitoring preven- tive controls, corrective action procedures, verification procedures and a recall plan. HACCP Principles The HACCP system provides a logical, scientific approach for controlling safety issues in food production. The seven principles that make up an HACCP plan are: to conduct a hazard analysis, identify critical control points, set critical limits for each critical control point, create monitoring procedures, determine corrective actions, develop record-keeping procedures, and establish verification procedures. Hazard Analysis According to the HACCP principle, conducting a hazard analysis involves preparing a list of steps in the process where significant hazards occur and describing preventive measures. A food safety hazard is defined as "any biological, chemical or physical property that may cause a food to be unsafe for human consumption." The focus of this article is on the chemical properties. ML