Machinery Lubrication magazine published by Noria Corporation
Issue link: https://www.e-digitaleditions.com/i/875060
46 | September - October 2017 | www.machinerylubrication.com n Januar y 2011, the Food Saf e t y Mode r niz ation A c t (FSMA) became law in the United States. With roughly 15 percent of the U.S. food supply impor ted, this law was intended to strengthen the food safet y system. Previously, the Public Health Security and Bioterrorism Preparedness Response Act had been signed into law following the events of Sept. 11, 2001. It gave the Food and Drug Administration (FDA) the deten- tion authority over food items if there is a credible threat of serious health conse- quences or death. The law also requires any facility engaged in the manufacture, processing, packing or holding of food for consumption in the United States to be registered with the secretary of Health and Human Services, and allows the debarment of importers with a history of repeated or serious food import violations. These two pieces of legislation granted the FDA the power to confiscate adulterated food and potentially close a business. The FDA also has resurrected usage of the Park Doctrine, which is based on a 1975 Supreme Court decision affirming the right to bring criminal charges against corporate executives according to a strict liability theor y. This enables the FDA to charge executives with a criminal misdemeanor for violations of the Federal Food, Drug and Cosmetic Act (FD&C) of 1938. Penalties for these violations are a maximum of one year in prison and/or a $100,000 fine if the violation does not result in a death. In a case involving death, the fine is $250,000. Keep in mind that these penalties are just for the executives. The organization can be fined $250,000 for a case not involving death and $500,000 if a death is involved. If the viola- tion is found to have been committed with the intent to defraud or mislead, or occurs after a prior conviction, the penalties are up to three years of imprisonment and/or a fine of $250,000 and $500,000. Please note that these violations can result in hef ty fines and possible prison sentences for executives regardless of the intent or knowledge of violations occurring within an individual's area of responsi- bility. It is also important to understand that the definition of executives includes plant managers. FSMA Regulations The FSMA has created six new types of criminal violations under the FD&C and brought about the implementation of a seventh. These violations are: I CHANGING FOOD-GRADE LUBRICANTS Understanding the Requirements for F o o d - g r a d e L u b r i c a n t s PERSPECTIVE L oren Green | Nori a Corpor at ioN Plant managers 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.