Process Authority Letters

Per federal canned food regulations 21 CFR Part 113, 21 CFR Part 114, and 9CFR Part 431, all hermetically-sealed acidified foods (added acid resulting in a pH below 4.6 and water activity below 0.85) and low acid canned foods (pH above 4.6 and water activity above 0.86), are required to have a thermal (cooking) process established by a recognized Process Authority, usually in the form of a Process Authority Letter. Shelf-stable products using novel or emerging non-thermal preservation technologies will also usually need to show a Process Authority letter.

This is a letter provided to a product using a novel or emerging preservation technology stating specifically that a Process Authority has reviewed the data and found it to be exempt from the requirement to file a Scheduled Process as well as from associated obligations, such as attending Better Process Control School.  

If a canned food has a pH below 4.6 and has no significant proportion of any low-acid ingredient, or if a canned food has a water activity less than 0.85 (too dry to support pathogenic bacteria), then by regulation no Process Authority letter is required.

It is common for co-packers to make this a requirement even for foods not required to file a scheduled process by the FDA, because it reduced their legal liability.  

It is hard to determine the regulatory status for certain products, and a process authority letter provides expert, independent documentation for the appropriate regulatory category which is helpful for inspectors and auditors to know which records to examine. It also helps the producer be sure they have the correct logs and records on file. This can avoid mistakes that lead to recalls, non-compliance, or liability concerns. Also, all producers who are not exempt from the Food Safety Modernization Act (FSMA) and who use thermal processes to control potential food safety hazards are required to have validation documents for those thermal processes per the Preventive Controls for Human Foods rule. Having the product and process validated by a Process Authority is one way to obtain this validation.  

No. Safety testing must be carried out by a third-party lab using calibrated equipment and standardized testing methods. If we don’t test your product ourselves, then results must be submitted to us in the form of a report from another lab, on that lab’s official letterhead.  

Please send three (3) separately prepared and separately packaged 4 oz (minimum) samples of each SKU you want tested. The samples must be prepared in the environment and using the equipment where the product is normally prepared and must be maintained at adequate storage conditions (including maintaining cold chain, if necessary) until it arrives to us for testing.

The samples must be sent in their final packaging.

This is the same packaging in which the product will be stored and sold to consumers. Fresh products (such as fresh pastries) may be delivered in labeled food-safe containers or bags. If sending multiple SKUs, please ensure each SKU is clearly labeled. If you need both pH and water activity testing, we can use the same samples for both tests; you only need to send one set of samples.

Samples may be mailed or dropped off to:

• Care of Caitlin Clark
  4780 National Western Dr.
  Denver CO 80216

We can accept deliveries M-F from 9am to 5pm. Fresh samples (those that are not shelf-stable) should be hand-delivered or shipped overnight for arrival at a pre-arranged time, since they must be tested immediately. Please do not send or drop off samples without arranging it with us first.

Once services are agreed upon, and all materials are submitted on behalf of the client and work can begin, the client will receive an invoice that must be paid prior to service completion. All invoices are due upon receipt, and past due invoices are subject to late fees. All materials such as reports, test results, etc. will not be distributed until the invoice is paid. Invoices can be paid via this website on the Pay your Invoice tab on the left pane, or on the home page.