On January 4, 2013, the U.S. Food and Drug Administration (FDA) released two new proposed rules. These new rules will impact most companies that manufacture, process, pack or hold human food for sale in the United States. Registrar Corp reviews FDA’s New Preventive Controls Rules.
FDA’s proposed Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food rule has two major features. First, it contains new provisions requiring hazard analysis and risk-based preventive controls. Second, it would revise the existing Current Good Manufacturing Practice (CGMP) requirements found in 21 CFR part 110. FDA’s new preventive control requirements and the modified CGMPs would be placed in a new Part 117, “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food.”
Hazard Analysis and Risk-Based Preventive Controls
FDA’s proposed new rule calls for each food facility required to register with the FDA under FSMA to prepare and implement a written food safety plan with science- and risk-based preventive controls. FDA is not proposing to require submission of food safety plans; however, the written plan and other documentation would be required to be made promptly available to FDA upon oral or written request.
FDA would require operators of a facility to understand the hazards that are reasonably likely to occur in their operation and to put in place preventive controls to minimize or prevent the hazards. These hazards include biological, chemical, physical, and radiological hazards. Although FDA’s proposed rule aligns well with HACCP, it differs in part in that preventive controls may be required at points other than at critical control points and critical limits would not be required for all preventive controls. Of note, FDA’s rulemaking is not intended to address hazards that may be intentionally introduced, including by acts of terrorism, as part of the preventive controls proposed rule. FDA plans to implement section 103 of FSMA regarding such hazards in a separate rulemaking in the future.
FDA’s proposed rule would require that in conducting the hazard evaluation specific factors be considered, including:
• Formulation of the food
• Condition, function, and design of facility and equipment
• Raw materials and ingredients
• Transportation practices
• Manufacturing/Processing procedures
• Packaging activities and labeling activities
• Storage and distribution
• Intended or reasonably foreseeable use
• Sanitation, including employee hygiene
• Any other factor that might potentially affect the safety of the finished food for the intended consumer
It is worth mentioning that FDA’s proposed rule would require that the hazard analysis include an evaluation of the whether environmental pathogens are reasonably likely to occur wherever a ready-to-eat (RTE) food is exposed to the environment prior to packaging.
For reasonably likely food hazards, FDA’s proposed rule would require that the owner, operator, or agent in charge of a facility establish a written recall plan. Time is critical during a recall. A written plan is essential to minimize the time needed to accomplish a recall.
Under FDA’s proposed rule, a “qualified individual” would be required to prepare the food safety plan, develop the hazard analysis, validate the preventive controls, review records and conduct a reanalysis of the food safety plan (or oversee these activities). The reanalysis of the food safety plan should take place at least once every 3 years, or whenever there is a significant change that warrants reanalysis (the proposed rule gives other excellent examples of when a reanalysis is required). To be qualified, an individual would be required to successfully complete training in accordance with a standardized curriculum or be otherwise qualified through job experience to develop and apply a food safety system.
Each covered facility would be required to prepare and implement a written food safety plan, which would include the following: a hazard analysis; preventive controls; monitoring procedures; corrective actions; verification; and, record keeping.
Registrar Corp will be providing additional information on different aspects of the proposed Hazard Analysis and Risk-Based Preventive Controls for Human Food and Current Good Manufacturing Practice rule throughout January and February 2013. Please feel free to tweet Registrar Corp (@RegistrarCorp) if you have specific questions. Or, for any questions related to U.S. FDA Regulations, please contact Registrar Corp 24/7 at https://www.registrarcorp.com/livehelp or call us at +1-757-224-0177.