PROCEDURE FOR STARTUP PRODUCTION OF ACIDIFIED FOODS

This procedure is for use by people who want to produce and sell food products that are shelf stable (not requiring refrigeration). These items are either acid or acidified foods such as pickled items, salsa, BBQ sauce etc. Here is the procedure.

1) Send me a sample of your product so I can determine the pH (degree of acidity). To be classified as an acid or acidified food, the food must have a pH of 4.6 or less, usually accomplished with the use of an acid like citric acid or vinegar. You may be able to get a pH locally if you have access to a middle or high school science lab.

2) Now you must consider where you will make this product. Home kitchens are totally unacceptable. Most restaurants are not approved for producing food for sell outside the front door. You can go to your county sanitarian officed in the County Health Department for information on requirements for manufacturing for sale.

3) In order to manufacture acidified food products, at least one person on each shift has to have attended the Better Process Control School. A list of Better Process Control Schools is listed in the Workshops section of this website. This is a federal requirement that at least person per shift must have attended a Better Process Control School.

4) You have to register your facility and process with the FDA ( Food & Drug Administration). This can be accomplished by filling out forms 2541 ( Facilities Registration) and 2541a ( Process Registration) This forms and directions for filling them out can be obtained on-line at; Click Here;

1. Fill out FDA forms 2541 and 2541a. These forms must then be signed by a process authority in the middle of the front page of 2541a in the area referred to as “Establishment Source”. Excellent help in filling out the forms is at; Click Here.
2. If I am to approve your process, I will need a letter from you delivered by email in the format shown as below. (Sample Process authority letter)
3. There are several Process Authorities that can approve your 2541a. William McGlynn at OSU (405 /744-6071; ) Technicale in LA ( http://www.tcal.com/thermal-process-authority-services) and myself

5) You will have to develop a label with the five required items (Principle display panel - Name of product and net weight) and on the back or side -information panel - nutritional label, list of ingrdients and allergen list, responsible party). These components are described at the following URL; Click Here.Finished products must also have some sort of coding system such as "use by" date or coding system that will permit a recall if the need should ever arise.

6) If your goal is to make money, I suggest that you spend your time and effort on sales and marketing your food product idea and leave the manufacturing up to a copacker. A copacker is a person who will manufacture the food product for you at a price most times cheaper than you can do it yourself. You can skip steps 2-5 above by contacting a copacker and letting him manufacture it for you.

 

ADDITIONAL INFORMATION

 

1) REGULATIONS FOR ACIDIFIED FOODS

a) CFR title 21; Part 113; Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers.

b) CFR Title 21; Part 114; Acidified Foods.

c) CFR Title 21; Part 108; Emergency Permit Control

d) Newest FDA Guidance Document on Acidified Foods. Click here.

e) Food must be manufactured in a Commercial Kitchen. The rules regarding the food processing plants can be found by clicking here.

f) If you are planning on building a food processing facility, you should first get your plans approved. Plans must be submitted and approved by the Arkansas Department of Health prior to construction or remodeling of the proposed establishment.  There is a plan review fee based on 1% of the total estimated cost of the project with a minimum $50 fee and a maximum $500 fee.  After plans have been approved, the kitchen must be inspected by the county Environmental Health Specialist prior to opening.  When the establishment has been approved to open, the Arkansas Department of Health bills the owner for a $35 annual food establishment permit.  The Arkansas Department of Health website is www.healthy.arkansas.gov.  Go to the left hand bottom of the main page and click on “Current Rules and Regulations” directly under “Rules and Regulations.”  Scroll down to and click on the two documents “Food Establishment Project Cost Estimate Worksheet” and “Food Establishment Plan Review Guidelines.”  For assistance with the plan review process, please contact ADH Phillips County Environmental Health Specialist Nathaniel Wright at 870-572-9028.

2) FORMS TO FILL OUT

a) 2541 – Canning Establishment Registration . 

1. Instructions at;http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/AcidifiedLow-AcidCannedFoods/EstablishmentRegistrationThermalProcessFiling/Instructions/ucm125590.htm
2.   Form is at. http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM076778.pdf

b) 2541a – Process Filing

1. Instructions at;http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/AcidifiedLow-AcidCannedFoods/EstablishmentRegistrationThermalProcessFiling/Instructions/ucm125755.htm
2. 2) Help in filling out 2541a; http://www.foodsafety.wisc.edu/assets/acidified_foods/Completing%20Form%20FDA%202541a_2.pdf
3. Form is at; http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM076784.pdf

1. Name of company and address
2. Name of product
3. Type of product – tell me what the product is.
4. Ingredients, - (list all ingredients and the percentage of each item). I need to use this information to determine if product is an acid food, an acidified food or a low acid food.
5. Procedure\ - step by step procedure on how you make your product. I need to know if you have large chunks, proteins that buffer pH etc. I would like to see lots of details.
6. pH – must be below 4.6. How often will you measure this during a production batch.
7. Heat treatment – describe how you heat treat your product – times and temperatures. This is also on page 2 of the process filing form. Use one of the LSVs above.
8. Attach copies of 2541 and 2541a

John Rushing and H.P. Fleming at North Carolina State University wrote a very good description of the acidification and process description. Click here to read.

Institute of Food Science & Engineering
2650 North Young Ave
Fayetteville AR, 72704