NC State Extension Publications

 

During the infancy of a new business, it is important to understand what regulatory requirements must be met and what the financial implications are in meeting those regulations. The following steps are needed to legally sell your food product in a retail market and their associated costs (in BOLD). Keep in mind that these steps do not include costs associated with your facility meeting current Good Manufacturing Practices (cGMP’s) and the adherence to those practices during the production of your product.

1. If you are considering making food products in your home begin with: Starting a Home-Based Food Business.

2. Request product testing by submitting a request form on the NC State Food Business website. You may be asked to submit a sample to be tested to define the food per FDA regulations. A testing results letter will be returned to you via e-mail. This testing costs $100. If your product is considered acidified and you are not considering co-packing please continue to Step 3. If your food is defined as acid or exempt skip to step 12. To learn more about these definitions go to: http://www.ncsu.edu/foodscience/extension_progra m/documents/acidified_formulating_dressings.pdf. To learn more about co-packing visit: http://www.ncsu.edu/foodscience/extension_progra m/documents/entrepreneurs_copackers.pdf If you are co-packing, you may stop here as they will handle the remaining steps. Visit the Other Services & Supplies page for a list of copackers.

3. If your product is acidified you will be required by federal law to pass a better process control school “Acidified Foods Manufacturing School.” The school is intended for and directed at the level of operating supervisors of conventionally canned processing and packaging systems in food processing establishments. It will qualify individuals to be commercial operators of plants producing conventionally foods canned to meet the requirements of the umbrella Good Manufacturing Practice (GMP), the specific GMP for acidified foods (21 CFR Part 114). By definition, an "operating supervisor" is a person who is in the plant at the time product is processed and packaged. The operating supervisor is responsible for the use of adequate pH and time and temperature processes as well as closure integrity inspections for rendering the product safe, and for proper record keeping and control programs that will detect deviations from safe operating procedures. The operating supervisor may be the same person. However, each operation during each hour of plant operation must be under the supervision of a person who has been certified as having satisfactorily completed the approved course of instruction. The school is 3-days long and costs $450 (cost includes materials, thermometer, lunches, and certification). The certification is good for a lifetime.

4. If you are producing a product using a water bath you may be asked to process it using a hot fill method that will be provided by NC State after product and process submission (Step 2). If you cannot process your product without a water bath it may also be necessary to validate your procedures and process in order for NC State to provide you with a process authority letter. A process authority letter is required for you to file your process with the FDA as required by law. The water bath validation is done in person at the processing facility while each product is being made. In-state rates are $500 per day, $300 ½ day, or $75/hr. Out-of-state rates are $1,000 per day.

5. You will need to register your facility as a Canned Food Processing facility with the FDA Form 2541. You must print the form, fill it out and then mail it to: Food and Drug Administration LACF Registration Coordinator (HFS-303) Center for Food Safety & Applied Nutrition 5001 Campus Drive, College Park, Maryland 20740-3835. It will be mailed back to you with an FCE #.

6. You will need to send an e-mail to brenda.pinkney@fda.hhs.gov and request that your FCE number be linked to your on-line registration (after you complete Step 12).

7. Register your facility online as a Low Acid Canned Food Facility.

8. You must file your process for each product in each container size with the FDA with the process authority letter we provided to you. If you choose we can file your process for you. The cost is $100 (optional).

9. If your testing letter indicates you must monitor and record temperature to produce a safe product you may need to purchase a non-glass thermometer that can be calibrated or a digital thermometer. The cost is approximately $10. If you are taking the Acidified Foods Manufacturing School mentioned in step 3 one will be provided to you.

10. If your testing letter indicates you must monitor and record pH to produce a safe product you must purchase a pH meter that can be calibrated. Cost varies widely but we recommend you spend approximately $200.

11. Once processing you will be required to perform a closure evaluation and keep a record of it. One of the assessments for proper closure is the determination of vacuum which can be checked with a gauge. The cost for the vacuum gauge is approximately $110 (optional) and among other places, it can be purchased from Dixie Canner Co.

12. You will need to create an account and register your facility to comply with the Bioterrorism act.

13. If you choose, you may also have a nutritional facts panel made for your product. This is optional for most small processors; however, many grocery stores require it for sale in their establishments. The cost is $100. Submit a form to request this service.

Author

Extension Specialist, Associate Professor
Food, Bioprocessing & Nutrition Sciences

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Publication date: Nov. 28, 2011

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