Food Safety Comes to Fore with New FDA Rules for GMP

More than 48 million people (1 in 6 Americans) get food poisoning every year because of contaminated or poor quality food. Foodborne diseases are responsible for about 128,000 hospitalizations and 3000 deaths, many of them infants and children. In Jan 2011, the US Congress FDA passed the Food Safety Modernization Act (FSMA), which gave FDA mandate to create strict GMP requirements for food manufacturers. Under the FSMA, FDA announced it will implement four new rules and three Guidance documents to create mandatory preventive controls at food facilities and mandatory standards for all food manufacturers. This week FDA announced 2 of these rules; one each for the GMP for human food and animal food. FDA treated both human and animal food similarly in requiring that food manufacturing facilities identify and prevent biological, chemical, and physical factors that could contaminate or negatively alter the quality of manufactured food. Reasonable controls such as monitoring, verification and CAPA practices must be implemented to address the risk factors. These rules apply to both the locations of primary manufacture such as farms, and to the harvesting, packaging, and storage/holding facilities. It is now required that all employees be trained in GMP rules, and that the manufacturer assure a combination of education, training, and/or experience of all its employees for the tasks they are assigned to perform. These rules are applicable to all manufacturers from very small businesses with less than a million dollars per year in sales to large corporations. The rules in effect immediately, however, very small businesses are given three years to be compliant, while businesses with up to 500 employees are given 2 years and large businesses are given a year to be complaint from the date of publication of the rules (10 Sep 2015). FDA promises to enforce these rules aggressively including audit of facilities for compliance. FDA also promises to publish guidance documents to explain these rules, and, provide technical assistance and training to food manufacturers to help them understand the rules. These rules signify one of the biggest expansions of FDA oversight of food quality issues. Although Food GMP has been in the books for a long time, for the first time, FDA has created specific mandatory rules that would affect every food manufacturer in the US and every importer of food to the US. Food GMP is arguably more important that even that of drugs since we consume a lot more food than drugs and more often contaminated or poor quality food leads to more adverse effects than any given drug. So, it is about time concrete measures are implemented to prevent it.