The proposals would hold companies and their managers to account in ensuring they follow through on implementing tougher food safety requirements throughout their processing and packagingprocedures. It would also result in higher administrative costs.
The report is an outcome of consultation by the Food and Drug Administration (FDA) to revise the country's Good Manufacturing Practices (GMPs) regulation. The code was formed almost 20 years ago.
Since then the food manufacturing industry undergone many changes, including newly recognized pathogens, more sophisticated technologies, and increased automation, the FDA
"While GMPs can control for many food safety problems, it is not clear that current GMPs adequately address these new developments," the FDA stated. "The food safetyliterature reviewed for this study shows that there continue to be food safety problems."
Better training is one of the major changes recommended by the FDA. The regulator calls for new rules requiring companies to make the appropriate training for supervisors and workers to ensure thatthey have the necessary knowledge and expertise in hygiene, protection, employee health and personal hygiene to produce safe food products.
"This training must be delivered in a manner that can be easily understood by the worker," the FDA stated. "Food processors must maintain a record of this training for eachworker."
The FDA also wants to require processors that produce foods containing one or more of the eight major allergens to have a written allergen control plan.
The eight major allergens are milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans. The plan must address the training of processing and supervisory personnel. It mustalso address the segregation of food allergens during storage and handling, validated cleaning procedures for food contact equipment, the prevention of cross-contact during processing, product labelreview and label usage, and a supplier control program for ingredients and labels.
The FDA wants processors to have a written environmental pathogen control program for those making ready-to-eat foods that support the growth of Listeria monocytogenes. The control programwould have to be geared for the risks present in the particular processing and packaging environment and must include microbiological monitoring.
Processors will be required to maintain the records necessary to judge the effectiveness of the program, to identify the root cause of sanitation failures, and to document corrective actions.
The FDA also wants new rules requiring that food processors develop and maintain written sanitation procedures that define the scope, objective, management responsibility, monitoring, correctiveaction, and record keeping associated with a company's procedures.
At a minimum, sanitation procedures would have to be developed for all food contact equipment and food contact surfaces.
Food processors would be required to maintain critical records available for review and evaluation by FDA investigators. Critical records are those records that a processor or the FDA would need toreview in order to confirm that a firm is operating in compliance with the proposed GMP regulation.
"The need to maintain records is consistent with well known quality system principles, namely that control procedures must be defined, documented, reviewed, and appropriate correctiveaction taken," the regulator stated.
Before entering into any rulemaking the FDA wants further consultation on the use of time-temperature controls, in the form of microbial growth models, for incorporation into regulations orguidance for proper refrigerated storage or hot holding.
Further comments are needed on removing the exclusion from GMP compliance in for establishments engaged solely in the harvesting, storage or distribution of raw agricultural commodities, theregulator stated.