On January 4, 2013, the FDA issued a proposed rule implementing the hazard analysis and risk-based preventive control (HARPC) provisions of the FDA Food Safety Modernization Act (FSMA). The proposed rule applies to certain unintentional hazards – e.g., microbiological, chemical, physical or radiological hazards – that may occur at a food facility that manufactures, processes, packs or holds human food.
HARPC is similar in concept to hazard analysis and critical control points (HACCP), which is required for foods such as seafood, juices and USDA-regulated meat and poultry. Importantly, HARPC is not applicable to those HACCP facilities or to any USDA-regulated facilities, among others.
For several decades, current Good Manufacturing Practices (CGMPs) have provided the main food safety framework for most foods regulated by FDA. The CGMP regulations cover general practices to be followed to ensure that food is manufactured, processed, packed and held under sanitary conditions, and that such food is safe, clean and wholesome.
Of course, HARPC has the same goals, but the approach is quite different from CGMP, as HARPC ushers in a new preventative framework designed to identify specific potential threats to the food supply and take appropriate steps to counter them before any harm occurs.
FSMA section 103, the statutory basis for HARPC, provides important background regarding the purpose and general framework of preventive controls. Section 103 generally requires the owner, operator, or agent in charge of a food facility to prepare a written plan to:
- Evaluate the hazards that could affect food manufactured, processed, packed, or held by the facility.
- Identify and implement preventive controls.
- Monitor the performance of those controls.
- Develop corrective actions if preventative controls are not effective.
- Verify that preventative controls are effective.
The proposed rule implements each of those aspects of the required written plan, which are discussed in greater detail below.
The first step is to evaluate the hazards that could affect the food. FDA proposes that a written hazard analysis identify "known or reasonably foreseeable" hazards for each type of food subject to the regulation. Accordingly, a facility may need to conduct multiple hazard analyses, even for similar foods.
FDA provides the example of tea beverages packaged in both glass and plastic bottles at the same facility as presenting different hazard profiles due to the risks of the different packaging. In addition, the hazard analysis must also evaluate whether the identified hazards are "reasonably likely to occur" and, if the hazards were to occur, the severity of the potential illness or injury.
Once the known or reasonably foreseeable hazards are identified, FDA proposes that preventive controls are implemented for the hazards that are reasonably likely to occur. The preventative controls should provide assurances that the identified hazards will be "significantly minimized or prevented" and that the food will not be adulterated or misbranded under the Food, Drug and Cosmetic Act. The types of preventive controls will vary, depending on the facility and the food it produces. FDA believes that most hazards would be addressed through process, food allergen and sanitation controls. Some of those controls will require the establishment of critical limits, such as a heat process, which must have controlled parameters of temperature and time.
After the preventative controls are established, FDA proposes that they be monitored to show consistent performance and that records documenting the monitoring procedures be maintained. Examples of monitoring activities include visual observation and measurement of temperature, time, pH, and moisture level. The frequency of monitoring must be sufficient to ensure that the preventive control is consistently performed and effective.
FDA also proposes to require that facilities establish written corrective action procedures to be used if monitoring reveals that the preventive controls are not properly implemented or in the event of an unanticipated problem.
FDA additionally proposes that facilities take steps to verify the proper functioning of the overall written plan, including
- Validation of the preventive controls.
- Verification that monitoring is being conducted.
- Verification that appropriate corrective actions are taken
- Verification that the preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the identified hazards that are reasonably likely to occur.
FDA proposes that the final rule would be effective 60 days after publication in the Federal Register, with compliance required one year after the effective date — except that businesses meeting the definition of "small business" or "very small business" would be expected to comply two or three years, respectively, after the effective date. Comments on HARPC may be submitted to FDA until May 16.
This article originally appeared in the March 2013 issue of Food Processing Magazine.