From HACCP to HARPC - how the US Food Safety Modernization Act will affect exporters

Up to 109,000 companies exporting food to the US will be affected by the FDA’s Food Safety Modernization Act (FSMA). The intention behind the act is to prevent problems that can cause foodborne illness from happening rather than trying to fix a problem once it has occurred.

The proposed rule on preventive controls for human food is aimed at reducing the public health burden of foodborne illness. FDA estimates that 1 million cases of foodborne illnesses are attributable each year to the pathogens this rule is designed to eliminate or reduce. The economic cost of illnesses avoided is estimated to be $2 billion a year.

FSMA will apply to around 97,000 US firms and 109,000 foreign firms that manufacture, process, pack or hold human food. Facilities that are required to register include manufacturers, processors, warehouses, storage tanks and grain elevators. Many Australian and New Zealand companies will be affected.

Section 103 of FSMA, Hazard analysis and risk-based preventive controls, requires all of these firms will have to have written plans that identify hazards, specify the steps that will be put in place to minimise or prevent those hazards, identify monitoring procedures and record monitoring results and specify what actions will be taken to correct problems that arise.

FDA will evaluate the plans and continue to inspect facilities to make sure the plans are being implemented properly.

The proposed rule on preventive controls for human food 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

Hazard analysis and risk-based 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 minimise 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 minimise 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 minimised 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 minimise 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 minimise 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 recognises 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 standardised curriculum or be otherwise qualified through job experience to develop and apply a food safety system.

The proposed rule was published in January 2013 and comments are due by 15 November 2013.

Source