Before FSMA, only a few food companies were required to have a food safety management plan by the FDA. These include manufacturers of juices and seafood, as well as low-acid canned foods (for biological hazards only). Under FSMA, all food processing operations (with some exceptions) will be required to establish a food safety plan. This is especially new for producers of animal food. Control of animal foods make sense since they can be a source of foodborne illness for humans, and humans can pass the illness on to other humans. The rules for human and animal foods are very similar, and so they are dealt with together in this summary. The rules do not apply to: food processing operations that currently require a HACCP plan, alcoholic beverages, dietary supplements, grain elevators and farms. The rule however, does apply to farm-mixed operations where the farm also conduct processing. Food processing companies that make an average of less than 1 million dollars ($2.5 M for animal food) as a combination of sales and value of products in finished product warehouse do not have to have a food safety plan but must follow current good manufacturing practices (cGMP).

Under FSMA, food safety plans must include the following elements:

  1. Hazard analysis
  2. Preventative controls
  3. Supply chain program
  4. Recall plan
  5. Monitoring procedures
  6. Corrective actions procedures
  7. Verification procedures

Hazard Analysis

This is an identification and evaluation of hazards to determine their likely occurrence and severity. Hazards include biological, chemical (including radiological) and physical hazards.

Preventive Controls

Food companies are required to manage food safety by implementing a hazard analysis and risk-based preventive control (HARPC) plan. This is a plan that is similar to HACCP. However, the difference is that strictly speaking, HACCP focuses only on critical control points and not prerequisite programs which is an essential part of what makes HACCP work. With HARPC, CCP control and prerequisite programs are not treated in separate compartments but are seen as one integrated program.

Supply Chain Program

Appropriate protocols must be established to ensure safety of raw material and finished goods that are received and sent to customers respectively. Suppliers must be from an approved source and must be verified following appropriate procedures that may include onsite audits, sampling and testing, and records review. Processors are not required to control a given hazard if the customer will further process the material to control the hazard. Therefore the rule establishes that in such circumstances, the processor include a statement on the product container saying that it is not treated to control the stated hazard and is packaged for further processing. In addition, the costumer must provide assurance in writing of how the hazard will be adequately controlled.

Recall Plan

Food companies must be able to trace finished products in commerce by ingredient lots, and recall them if necessary.

Monitoring Procedures

Appropriate procedures must be followed to ensure that hazards are controlled and that actions taken to control them are recorded. For example, temperatures must be checked at established intervals make sure that critical limits are met.

Corrective Actions Procedures

When monitoring shows that established limits are not met, appropriate corrective actions should be taken. This includes identifying the problem, determining the cause of the problem, isolating the problem, evaluating foods for safety, preventing affected food from reaching commerce, and making steps to prevent recurrence of the problem.

Verification Procedures

These are procedures for checking that the right protocols are being implemented (validation) and that monitoring and corrective actions are being followed according to plan (verification). Verification procedures may include calibration, product and environmental testing, and record keeping. A reanalysis of the plan must be done every three years or if any change in the plan suggest the possible introduction of a new hazard that is not adequately controlled.

Courtney Simons
Courtney Simons is a food science professor. He holds a BS degree in food science and a Ph.D. in cereal science from North Dakota State University.
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