Ask the Expert: FSMA Preventive Controls
With the second Preventive Controls for Human Food deadline approaching next month, one of the most common questions we hear from food manufacturers is: “What do I have to do and when?”
Question 1: Is a HACCP (Hazard Analysis and Critical Control Points) Plan the same as a HARPC (Hazard Analysis and Risk-based Preventive Controls) Plan?
Although a well-designed HACCP Plan may cover many of the same areas of a HARPC Plan, the two types of plans are distinct, as indicated by the FDA. HACCP Plans are required for seafood and juice products, whereas HARPC Plans are required for all other types of food except certain products such as alcoholic beverages.
The primary difference between the two plans is the use of “preventive controls” in a HARPC Plan during processing beyond those used at Critical Control Points (CCPs). For instance, sanitation and food allergen controls may be necessary in a HARPC Plan and not addressed in a traditional HACCP Plan. HARPC Plans also require the inclusion of radiological hazards and hazards intentionally introduced for purposes of economic gains in the hazard analysis. Lastly, food facilities must also develop supply chain programs with supply-chain controls and a written recall plan for their foods under the HARPC requirements.
Question 2: When exactly are the compliance dates for Preventive Controls for Human Food?
FDA anticipated that smaller enterprises would need more time complying with the new regulation, so the Administration staggered the compliance dates based on the number of employees and sales numbers of the business. For businesses with less than $1 million in global sales and inventory per year, they must submit a “Qualified Facility Attestation” to FDA in late 2018 if they wish to claim exemption status from the HARPC Plan requirement. Otherwise, they will be required to have a HARPC Plan implemented at their facility.
- For businesses (including all subsidiaries and affiliates) with global sales and inventory of $1 million or more annually and 500 full-time equivalent employees or more: September 19th, 2016
- For businesses (including all subsidiaries and affiliates) with global sales and inventory of $1 million or more annually and fewer than 500 full-time equivalent employees: September 18th, 2017
- For businesses (including all subsidiaries and affiliates) with global sales and inventory of less than $1 million annually: September 17th, 2018