Are we exempt from HARPC and the need of a PCQI?
I am so confused!!
We are a 're-packing' warehouse - all product we re-pack is fully enclosed, and does not require temperature controls. (ex: taking two different flavors of oatmeal packets, and combining them into a variety pack - with packaging and product supplied by customer) All in all, we just supply our labor.
One reading makes me think we do need to comply, and the next, that we don't.
At the time of our 3rd party audit, I asked our auditor, and even he was unsure.
Thanks so much for your help and advice - it is much appreciated, and I am still learning.
From HARPC.Com
There are 6 major categories of food facilities that are exempt from HARPC.
The first major exemption relates to food companies under the exclusive jurisdiction of the U.S. Department of Agriculture (those handling, processing, shipping meat, poultry, pork, eggs, etc.).
The second major exemption is for companies that are subject to FDA’s new Standards for Produce Safety authorities, which were also created by FSMA. This exemption applies to farms, cooperatives, growers, harvesters and other companies handling raw fresh fruits and vegetables.
The third major exemption applies to facilities that are subject to and comply with FDA’s seafood and juice HACCP regulations.
The fourth, more limited exemption, involves low acid and acidifed canned food processors, but only as the regulatory controls govern and control certain aspects of microbiological contamination (e.g., botulism).
The fifth group of exempt companies includes those defined as “small” or “very small” businesses. FDA is required to define these terms by regulation.
Sixth and last, and very similar to the immediately previous exemption, is the group of companies with a previous 3-year average product value of less than $500,000. FDA may also, by future regulations, exempt facilities that solely produce food for animals, store raw agricultural commodities (other than fruits and vegetables) intended for further processing or that store packaged foods that are not exposed to the environment.
My company is considered a "small business" and I was sure that we were required to institute HARPC. After reading above I was also utterly confused, but I have referenced the FDA rules and this fact sheet provided by the FDA and am once again confident that we are required to practice HARPC.
@s.sirek - I found this fact sheet helpful and if you scroll down, you will see compliance information for business and supply chain entities. Also here is the full text of the law. Section 103 also identifies what exemptions include.
Good luck!
Yes, you are. We are a repacking facility and we fall under the new FSMA rulings. To understand the exemptions, you will need to go the PCQI class. I have uploaded a copy of the FSMA Class Manual on the Forum for reference and it is also available @http://www.iit.edu/ifsh/alliance/ . If you are handling food, you are subject to implement Preventive Controls. Some businesses are given more time to implement this new programs due to the size or income.
I hope this helps :smile:
Even though you are a repacker you are handling food. If you already have a HACCP plan it's not much harder to change it to HARPC.
If you really don't want to do it you can get guidance from FDA. They have helpful customer service. The deadline is September to have a HARPC plan.
Even though you are a repacker you are handling food. If you already have a HACCP plan it's not much harder to change it to HARPC.
Hi Cal,
I appreciate the "much" . For some people i suspect it's going to be diabolical.
Hi Cal,
I appreciate the "much" . For some people i suspect it's going to be diabolical.
You're right :oops2:
I meant that if you already invested the hard work towards the HACCP plan adding the preventative requirements to comply with HARPC is not "much" more work.
We all have the guts of the plan already established. HACCP plans take a lot of work for sure.