The Critical Role of a Process Authority in Food Safety and Product Development

When it comes to launching safe, shelf-stable food products, having the right technical support isn’t just helpful—it’s essential. One of the most important partners in this process is a Process Authority. But what exactly does a Process Authority do, and why is their role so important?

What Is a Process Authority?

A Process Authority is a qualified expert (usually with advanced knowledge in food microbiology, thermal processing, and regulatory science) who is recognized for their ability to evaluate food processing methods and validate that they produce safe food.

The FDA and USDA require certain types of food products—especially acidified and low-acid canned foods—to be reviewed by a recognized Process Authority. This ensures that the manufacturing process will prevent the growth of harmful pathogens like Clostridium botulinum.

What Does a Process Authority Do?

A Process Authority is involved in several key activities:

• Reviewing product formulations to assess microbial risks based on pH, water activity, and other parameters.

• Evaluating or developing thermal processes to ensure the product receives adequate heat treatment (e.g., retort, hot fill, pasteurization).

• Conducting or overseeing challenge studies to validate safety claims (especially for refrigerated or novel products).

• Providing scheduled processes (also called process filings or process letters) required by FDA/USDA for acidified and low-acid canned foods.

• Guiding HACCP, FSMA compliance, and facility readiness during scale-up and commercialization.

• Collaborating with co-packers and labs to streamline testing and documentation.

Why Is This So Important?

The short answer: public safety and regulatory compliance.

• Foodborne illness prevention: Pathogens like Listeria monocytogenes, Salmonella, and C. botulinum can be deadly if not controlled.

• Legal and financial risk reduction: Incorrect processing puts your company at risk of recalls, lawsuits, or plant shutdowns.

• Regulatory compliance: The FDA or USDA will not approve certain products without proper validation from a Process Authority.

• Brand reputation: Safe, high-quality products keep customers loyal and build trust in your brand.

Do You Need a Process Authority?

If you're producing:

• A shelf-stable product that isn’t clearly high or low acid,

• An acidified food (e.g., pickled products, salsas),

• A novel formulation using new ingredients or preservation methods,

• Or scaling up from a commercial kitchen to a co-packer,

…you absolutely need a Process Authority to guide the safety evaluation and documentation.

How Johnson Consulting Company Can Help

At Johnson Consulting Company, we partner with food businesses of all sizes to:

• Evaluate product safety

• Provide scientifically validated scheduled processes

• Support formulation and shelf-stability challenges

• Assist in navigating the FDA filing process

Whether you're a growing startup or an established brand launching a new product, we’re here to ensure your success—and your compliance.

Interested in working with a Process Authority?

Contact us today to discuss your product and how we can support your journey from concept to compliant commercialization.

brynn@johnsonconsultingcompany.org