By Jennifer Allen
Are you wondering what a HACCP or HARPC plan is and whether you need one? You probably aren’t alone. Recent changes in the regulations governing food products have many food manufacturers asking those very questions.
First things first, what is a HACCP plan? HACCP stands for Hazard Analysis Critical Control Point. FDA and USDA have long required producers of juice, seafood, meat, and poultry, as well as manufacturers of low-acid, hermetically sealed foods, to have a HACCP plan. Recently, a proposed rule was pending that would also subject egg products to similar regulations. Other types of food, however, didn’t need a HACCP plan. But then along came the Food Modernization Act’s Preventive Controls Rule (21 CFR 117) and the advent of the HARPC plan.
HARPC stands for Hazard Analysis and Risk-Based Preventive Controls. In a nutshell, a HARPC plan is a written plan that
- Identifies known or reasonably foreseeable hazards that may occur during a food’s manufacturing process and that are serious enough to require some kind of preventive control
- Develops those preventive controls.
HARPC plans are broader than HACCP plans because they must address radiological, as well as biological, chemical, and physical hazards. And they must identify hazards in general, not just critical control points.
HARPC plans go hand in hand with current good manufacturing practices; they do not replace them. And these plans require the manufacturer to develop and document verification and validation processes. Verification involves making sure that the risk reduction processes are actually happening. Validation involves making sure that those processes actually reduce the risk.
As an example, say the risk-reduction process is mandatory handwashing after bathroom breaks. Verification of that process would involve making sure that all workers did, in fact, wash their hands; validation of that process would involve making sure that handwashing actually led to the desired effect – reduced risk of contamination. Depending on the food, the number of manufacturing steps, and the number and types of ingredients, a HARPC plan could be a short and simple document, or it could be voluminous. FDA has provided detailed and helpful draft guidance on how to create and follow a HARPC plan.
So, who needs a HARPC plan? With the exception of producers who already had to have a HACCP plan, all food manufacturers now need a HARPC plan unless they meet one of the Preventive Control Rules exemptions. The primary exemption is the qualified-facility exemption. This exemption shields smaller food producers from having to implement a HARPC plan. A qualified facility is one that meets the rule’s definition of a very small business, or one that averages less than $500,000 in sales annually and also sells more food directly to consumers or to nearby restaurants and retail food establishments than to any other purchaser. Manufacturers should check the detailed definitions of these terms (see part 117.3) to see if their facility qualifies.
Be aware that even if a facility qualifies, manufacturers still have certain obligations. Part 117.201 of the rule requires them to submit a written attestation each year that they have met the criteria for the exemption. In addition, manufacturers must attest either that they either have identified potential hazards, are implementing preventing controls for those hazards, and are monitoring the performance of those controls for effectiveness or that they are in compliance with all applicable food laws and regulations.
If a facility does not qualify, then manufacturers will need a HARPC plan unless the food produced is subject to one of the rule’s other exemptions (found at part 117.5). Following is a summary of those exemptions:
- Food products already required to have a HACCP plan.
- Dietary supplements, so long as the manufacturer is following the regulations at 21 CFR 111 and FDCA 761.
- Farms growing produce subject to the standards for produce safety.
- Low-risk activities conducted at certain kinds of farms involving low-risk foods (e.g., packing or sorting breads and cereals or cocoa products; coating vegetables with wax).
- Alcoholic beverages if certain other conditions are met.
- Storage of raw agricultural commodities, other than fruits and vegetables, intended for further distribution or processing.
- Storage of unexposed packaged foods.
If a facility does not qualify and none of these exemptions are met, the manufacturer needs a HARPC plan. For more information, the regulations referred to here are available at the U.S. eCFR. Browse Title 9 for regulations dealing with meat, poultry, and egg products, and Title 21 for regulations dealing with other foods.
The author is an attorney at Stinson LLP with experience in and knowledge of USDA and FDA regulations pertaining to the food industry. For more information, visit www.stinson.com.
