AIB Answers

A. The clock is ticking for compliance with FSMA’s Hazard Analysis and Risk Based Preventive Controls (HARPC) requirements. There are exceptions for small businesses, but most companies will have to be compliant by September 17, 2016. This includes successfully completing documented hazard analysis and implementing preventive controls (PCs) for known or foreseeable hazards associated with recalls for your product type as cited in the FDA’s 4th Annual Reportable Food Registry.

What are you planning to show the state or FDA inspectors who will be asking to see your HARPC food safety plan? If you expect to show them your HACCP plan, you may want to reevaluate. Although these are based on similar concepts, they are not the same.

Your HARPC implementation must be completed or overseen by your preventive control qualified individual (PCQI), who can attend an FDA-recognized curriculum or be otherwise qualified by education, background, and/or experience. Your hazard analysis must be documented regardless of the outcome; even if you didn’t recognize any preventive controls that need to be monitored similar to a CCP.

The table [at right] compares HACCP and HARPC. Additional details about HARPC are necessary to understand the regulation’s intent to prevent food safety recalls. The most important aspects of HARPC are the requirements for documenting risk-based preventive controls and the applicability of the supply chain control program to the raw materials and products shipped. You must conduct hazard analysis to identify and evaluate known or foreseeable hazards for each type of food manufactured, processed, packed, or held at your facility to determine hazards that require a preventive control.

Your hazard analysis will be based on experience (site-specific), illness data, scientific reports and guidance documents from industry, regulators, universities, etc. The hazard analysis must consider the likelihood (probability) that these hazards could or would occur in the absence of a preventive control and resulting severity.

The hazard evaluation must consider the effect of the following on the safety of the finished food for the intended customer:

1. Formulation of the food.
2. Condition, function, and design of the facility and equipment (site evaluation).
3. Raw materials and other ingredients.
4. Transportation practices.
5. Manufacturing procedures.
6. Packaging and labeling activities.
7. Storage and distribution.
8. Intended or foreseeable use.
9. Sanitation, including employee hygiene.
10. Any other relevant factors, seasonal or weather variation affecting conditions that allow for or increase the potential for hazards, e.g. levels of a natural toxin.

This evaluation will need to be documented, particularly the site evaluation, to identify any site-specific PCs that must be applied to produce safe product. Modified requirements contained in Subpart D pertain to the storage of fully packaged refrigerated products that need temperature to control pathogens and the expectation for documented temperature control records. The supply-chain program can be complicated and FDA has said it will be issuing more guidance to further define the expectations. But if your company is relying on a supplier or customer to control an identified hazard, the following will be applicable:

• If your supplier is controlling the hazard, you will need to have a supplier verification program in place to review the adequacy of their controls including their regulatory history.
If you are relying on your customer to control the identified hazard, you will need to have documented assurances and description of those controls that must be updated on an annual basis.

• Regulators have the right to review your HARPC hazard analysis, food safety procedures, training, and records for your preventive controls. It is always in your best interest to have food safety records that accurately reflect the sanitary conditions at your plant and have documented evidence for any improvements that you make while implementing your food safety plan(s).

Len Steed is Manager, Global Innovation, AIB International.