Released for public comment on 14 January 2013, Docket Number FDA-2011-N-09203, comments due by 16 May 2013 on their proposed rule on preventive controls for human food that focuses on preventing problems that can cause foodborne illness.These rules would apply to both foreign and domestic firms that manufacture, process, pack or hold human food. If you have or operate a facility that is required to register with the FDA under Section 415 of the FD&C Act then you are effected by these proposals.
If your facility is involved in one of the following activities, it does NOT have to register with FDA.
Private residences of individuals, even though food may be manufactured/processed, packed, or held in them.
Non-bottled water drinking water collection and distribution establishments and structures, such as municipal water systems.
Transport vehicles that hold food only in the usual course of their business as carriers.
Farms — i.e., facilities in one general location devoted to growing and harvesting crops (washing, trimming outer leaves, and cooling produce are part of harvesting) and/or raising animals (including seafood). The term “farm” includes facilities that pack or hold food, provided that all food used in those activities is grown, raised, or consumed on that farm or another farm under the same ownership, as well as facilities that manufacture/process food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership.
Restaurants — i.e., facilities that prepare and sell food directly to consumers for immediate consumption, including pet shelters, kennels, and veterinary facilities that provide food directly to animals. Facilities that provide food to interstate conveyances, such as commercial aircraft, or central kitchens that do not prepare and serve food directly to consumers, are not restaurants for purposes of 21 CFR Part 1, Subpart H.
Retail food establishments, such as grocery stores, delis, roadside stands that sell food directly to consumers as their primary function, meaning that annual food sales directly to consumers are of greater dollar value than annual sales to other buyers.
Nonprofit food facilities,which are charitable entities that meet the terms of § 501(c)(3) of the Internal Revenue Code and that prepare or serve food directly to the consumer or otherwise provide food or meals for consumption by humans or animals in the U.S. This includes central food banks, soup kitchens, and nonprofit food delivery services.
Fishing vessels that do not process fish. Such fishing vessels may engage in practices other than processing such as harvesting and transporting fish, and heading, eviscerating, or freezing fish solely to prepare the fish for holding on board the vessel.
Facilities regulated exclusively and throughout the entire facility by the U.S. Department of Agriculture, that is, facilities handling only meat, poultry, or egg products.
The 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. The 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
Under the proposal, each owner, operator or agent in charge of a facility (those required to register with FDA under Section 415 of the FD&C Act), with certain exceptions, would be required to comply with the hazard analysis and risk-based preventive controls. The preventive controls are science and risk based in that the rule would require controls only where necessary to prevent hazards to public health and exempt certain facilities from requirements or modify requirements for certain low-risk activities. Second, they are flexible in that firms could develop preventive controls that fit their products and operations, as long as they are adequate to significantly minimize or prevent all food safety hazards that are reasonably likely to occur.
The proposed hazard analysis and risk-based preventive control requirements are similar to Hazard Analysis and Critical Control Points (HACCP) systems, which were pioneered by the food industry and are required by FDA for juice and seafood. Operators of a facility would be required 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. Although this 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.
Each covered facility would be required to prepare and implement a written food safety plan, which would include the following:
A Hazard analysis that identifies and evaluates known or reasonably foreseeable hazards for each type of food manufactured, processed, packed or held at the facility.
Preventive controls, which would be required to be identified and implemented to provide assurances that hazards that are reasonably likely to occur will be significantly minimized or prevented. Preventive controls would be required to include, as appropriate: (1) process controls, (2) food allergen controls, (3) sanitation controls, and (4) a recall plan. However, the preventive controls required would depend on which, if any, hazards are reasonably likely to occur. It is unlikely that all possible prevention measures and verification procedures would be applied to all foods at all facilities. FDA believes a supplier approval and verification program is a risk-based and appropriate control to significantly minimize or prevent hazards from raw materials and ingredients that is consistent with current scientific understanding of food safety practices and is seeking comment on such a program.
Monitoring procedures to provide assurance that preventive controls are consistently performed and records to document the monitoring.
Corrective actions that would be used if preventive controls are not properly implemented. Facilities would be required to correct problems and minimize the likelihood of reoccurrence, evaluate the food for safety and prevent affected food from entering commerce when necessary. If specific corrective action procedures were not identified for the problem, or if a preventive control were found to be ineffective, the facility would also be required to re-evaluate the food safety plan to determine if modifications are needed.
Verification activities to ensure that preventive controls are consistently implemented and are effective. Verification activities might include validation that the preventive controls are adequate for their purpose and are effective in controlling the hazard, activities to verify that controls are operating as intended and review of monitoring records. In addition, the proposed rule would require reassessment of the food safety plan at least every three years and at other times as appropriate. FDA recognizes that product and environmental testing programs are science-based verification activities that are commonly accepted in many sectors of the food industry and is seeking comment on these programs. FDA also is asking for comments regarding review of customer and other complaints as part of verification.
Recordkeeping. Facilities would be required to keep a written food safety plan, including the hazard analysis. They also would be required to keep records of preventive controls, monitoring, corrective actions, and verification.
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). 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.