NC State Extension

Frequently Asked Questions

ENTREPRENEURIAL PROGRAM SERVICES

ACIDIFIED FOODS MANUFACTURING SCHOOL / OPERATING SUPERVISOR

ACIDIFIED FOODS

REGULATIONS


ENTREPRENEURIAL PROGRAM SERVICES

What services are provided by the Entrepreneurial Program?

The Entrepreneurial Program offers two primary services:

SERVICE A: Product Testing & Processing Recommendations

We will analyze a shelf-stable product sample, classify it (as acid, acidified, water activity controlled or other) according to Federal and State regulations and provide processing recommendations.

SERVICE B: Nutritional Information

We use a Nutrition Database to input a product formulation and provide a Nutrition Facts Panel and Ingredient Statement for food products. We are currently only providing the Nutrition Labeling and Education Act 1990 Nutrition Facts Panel format.

Is my product information kept confidential? And, do you sign Confidentiality Forms or Non-disclosure Agreement Statements?

    1. The information collected on our form is for the purpose of classification and nutritional labeling only. We will maintain your product information on the computer, under password protection, for a short time in case you request changes or modifications.

The University makes no warranties or guarantees, either expressed or implied, as to the outcome of any services provided, although all reasonable efforts, consistent with the standards of a research university, will be made to provide the appropriate recommendations and achieve a successful outcome. Once the services are provided, no refunds are available.

As a public institution, and instrumentality of the State of North Carolina, NC State University is subject to the NC Public Records laws. This means that records provided to the university may be subject to public disclosure, unless an exception applies. Records that would not be subject to public record disclosure include research data, records or information of a proprietary nature, as well as information that may be deemed trade secrets and have been marked “confidential” when the information was disclosed to NC State. For more information regarding public records, please visit the Office of General Counsel webpage on public records, accessible here.

How do I submit a product to the Entrepreneurial Program for Product Testing & Processing Recommendations and/or Nutritional Information?

    1. Go to our website
    2. Fill out & Submit the Online Request Form – click on “Online Sample Submission Form”. The form will ask for your basic contact information, formulation for a batch of product, and current product processing information. Do not send any samples until you have been contacted by us.
    3. Once you submit the Online Request Form, we will review your Online Request Form & reply with information on next steps including how to send a sample, quantity needed, and pricing information.

Confidentiality Note:
The information collected on our form is for the purpose of classification and nutritional labeling only. We will maintain your product information on the computer, under password protection, for a short time in case you request changes or modifications.

What is the cost of receiving Product Testing & Processing Recommendations and/or Nutritional Information from the Entrepreneurial Program?

Each service costs $150. For example, for a product receiving both Product Testing & Processing Recommendations and Nutritional Information, the cost will be $300.

I have reformulated my food product since I received my submission results, do I have to pay for the resubmission of this reformulated product?

You can send us the reformulation via our Online Request Form. For reformulated products, each service costs $75. For example, for a reformulated product receiving both Product Testing & Processing Recommendations and Nutritional Information, the cost will be $150.

How is Nutritional Information calculated by the Entrepreneurial Program?

The “Nutrition Facts” panel for a food label can use data from two sources: nutritional analysis or a nutrient database.
Nutritional analysis is when several lots of food are sampled and analyzed in a laboratory. For certain products, this is the only appropriate method. Another way is to calculate the nutritional content using a nutrient database where nutrient analyses on a variety of ingredients is stored in a computer database. Only the second method is available from the Entrepreneurial Program.

Does the Nutritional Information database used by the Entrepreneurial Program work for all types of food products?

No, your label may be wrong if the ingredients and amounts submitted in the ingredient report are not correct. If you have not actually weighed the ingredients, there may also be mistakes.
Unless otherwise noted, the assumption is used that all the ingredients in the formula are present in the product and that there was no cooking loss, breading loss or added ingredients, such as added frying oil. In some cases an ingredient does not appear in the database, it then is up to you to furnish that information.
Database calculations, while useful, are not analyses. We recommend laboratory analysis of your product by one of the many consulting labs which perform nutrient analyses. The database may not have the exact nutritional information for your ingredient, (i.e. one brand of catsup may not have the same nutrients as another brand). Database calculation gives a reasonable approximation of the nutrient value of the submitted formulation, but because there are so many factors to consider, it cannot be assumed to be a substitute for laboratory analysis. The choice to use this information on a label is solely yours.

Should I have my product analyzed or should I use a database calculation?

Calculation of nutritional data from a database is usually the easiest and least expensive. The information you provide to the department is entered into the computer to combine these analyses and produce a Nutrition Facts panel for your product.
Laboratory analysis of products for nutritional data is more expensive and time consuming. It requires that the product be properly sampled according to FDA protocol and analyzed by chemical methods. In some products such as fried, salted or coated products, the amounts of ingredients are difficult to determine and a laboratory analysis would be necessary.

What if my ingredient does not appear in the database?

Sometimes, an ingredient may not appear in our database. In this case, you will need to contact the supplier of the ingredient for a “nutrient analysis per 100 grams.” This data will then be entered into the computer. The Nutrition Facts panel from your ingredient will not suffice for this purpose.


ACIDIFIED FOODS MANUFACTURING SCHOOL / OPERATING SUPERVISOR

What is the Acidified Foods Manufacturing School?

The Acidified Foods Manufacturing School provides instruction primarily for operating supervisors for acidified foods, the individual who is in the plant or kitchen at the time an acidified preserved food product is processed and packed. The school is particularly intended for operators or operating supervisors involved in production of thermally processed acidified foods.

What is an Operating Supervisor of Acidified Foods?

Under the acidified foods regulation (21 CFR 114.10) an operating supervisor is defined as a person who has attended a school approved by the Commissioner for giving instruction in food-handling techniques, food-protection principles, personal hygiene and plant sanitation practices, pH controls and critical factors in acidification, and who has been identified by that school as having satisfactorily completed the prescribed course of instruction. The supervisor must be on duty during processing, packing operations, and container closure of acidified product.

Does the Acidified Foods Manufacturing School provide the same Certificate of Completion as the Better Process Control School?

Yes, the Acidified Foods Manufacturing School is equivalent to the training received by attending a standard in-person Acidified Foods Only Better Process Control School course.

What is the Acidified Foods Manufacturing School course structure?

The Acidified Foods Manufacturing School is 100% online. Those who complete the Internet course will receive a Certificate of Course Completion to demonstrate they meet the training requirement of the FDA Acidified regulation. This training sequence is equivalent to the training received by attending a standard in-person Better Process Control School course.

Do you offer a 100% online Acidified Foods Manufacturing School?

Yes, the Acidified Foods Manufacturing School is 100% online.

My acidified food operation is extremely small. Do I still need an Operating Supervisor Certificate of Completion?

Yes, based on the acidified foods regulation any food company producing acidified food products must comply with the regulations. Even if someone only sells 10 cans of acidified product in a year, they must comply with the regulations.

How long is my Certificate of Completion effective? Will it ever expire?

No, your Certificate of Completion will never expire. Your Certificate of Completion for the course is good indefinitely.

Can I share my Acidified Foods Manufacturing School Segment One online course Moodle ID with someone else?

You cannot share your Moodle ID account information with other people. Each person will have their own Moodle ID. Each participant must pay for and complete the 100% online course prior to receiving their Operating Supervisor Certificate of Completion.

Do you offer the Acidified Foods Manufacturing School in Spanish?

No, we do not offer the Acidified Foods Manufacturing School in Spanish. But you can look at GMA’s national Better Process Control School course listing for offerings in Spanish and other languages.


ACIDIFIED FOODS

Is my product an acidified food?

It may be. An acidified food (AF) is a low-acid food to which acid(s) or acid food(s) are added and which has a finished equilibrium pH of 4.6 or below and a water activity (aw) greater than 0.85 (see 21 CFR 114.3). If your product is formulated with low-acid food to which acid(s) or acid food(s) are added AND has a finished equilibrium pH of 4.6 or below & a water activity (aw) greater than 0.85 AND is stored, distributed, and sold shelf-stable (unrefrigerated), it is most likely an acidified food. The determination between a product being classified as an ACID PRODUCT or an ACIDIFIED PRODUCT all depends on the product formulation — a product with a higher percentage of low acid ingredients may fall into the acidified classification. To receive product classification, testing, and processing recommendations, please submit to the Food Entrepreneurial Lab by filling out the Online Sample Submission Form.

I am not sure if I am producing an acidified product. How do I find out if my product is classified as an acidified product?

If you want to find out the classification of your product(s), you need to contact a process authority. You can submit your product(s) to our process authority by filling out our Online Request Form.
This will help classify your product based on regulations and help you determine the safety parameters for your product(s). If your product is classified as acidified, you will need to take the Acidified Foods Manufacturing School to get your Operating Supervisor Certificate of Completion to legally produce your product(s) OR you will need to work with a co-packer who has already received the Operating Supervisor Certificate of Completion.

Is fermented food such as Kimchi, Kombucha and Sauerkraut an acidified food?

No, it is a fermented food and therefore is exempt from the acidified food regulations.


REGULATIONS

Who regulates the food I plan to sell?
Food products in North Carolina are mainly regulated by two agencies.

Prepared and ready-to-eat foods are regulated by county health departments under statewide rules adopted by the Dairy and Food Protection Branch of the NC Department of Agriculture and Consumer Services.

Packaged foods
 are regulated under the NC Department of Agriculture and Consumer Services (NCDA&CS). Meat and meat-containing products are regulated by the Meat and Poultry Inspection Division. Packaged foods other than meats are regulated by the Food and Drug Protection Division. Certain seafood and milk products have separate rules.

Who should I call if I have a question about North Carolina regulations on processing my product or inspections?

You should contact the North Carolina Department of Agriculture. You can go to their website or call one of their Food Compliance Officers at 919-733-7366

Can I sell food made in my home kitchen?
The short answer is, “probably not.”

Most products cannot be manufactured in a home kitchen. However, some food products regulated by the NCDA&CS Food and Drug Protection division can be manufactured from a home kitchen. More information is available at www.nchomeprocessing.com.
Food regulatory agencies are established to protect the safety and wholesomeness of foods offered for sale in the marketplace. These agencies are required to make unannounced inspections of the manufacturing facility to ensure the food is produced under Good Manufacturing Practices (GMP). This would obviously conflict with privacy guaranteed for the home. However, some manufacturers have built a separate home processing area to process food which can meet the standards in the GMP.

I am making a baked good product, does this need Product Testing & Processing Recommendations?

Baked goods are typically low-risk food products and do not typically require Product Testing & Processing Recommendations through our lab but North Carolina Department of Agriculture may require you to submit your product for food safety testing so check with them.

When is a product required to have a Nutrition Facts Panel on the label?

Nutritional labeling is required on food products but with the following exemptions:
– Retailers with annual gross sales of not more than $500,000. For these exemptions, a notice does not need to be filed with the Food and Drug Administration (FDA).
– Person claiming the exemption employs fewer than an average of 100 full-time equivalent employees and fewer than 100,000 units of that product are sold in the United States in a 12-month period. For these exemptions, a notice must be filed annually with FDA.
Although, even if you fall into one of these exemptions, your consumers, retailers, and/or distributors may still want to view the nutritional labeling on your product.

Can I produce foods in my home and cater them to other homes or events?

No, catered foods are regulated by local County Health Departments under statewide rules adopted by the Food Protection Program of the NC Health and Human Services.
An exception to this rule is the preparation of bakery items. Bakery items are regulated by the Food and Drug Protection Division. For further information on catering baked items, visit the NCDA&CS web site on Starting a Home-Based Food Business.

Who can help me determine whether I can use a home kitchen or have a copacker produce my product?

Our food scientists would be glad to provide assistance in making this decision, however, this is a business decision you should make in accordance with your business plan.

Can I have someone else produce my food for me to sell?

Yes, many manufacturers both large and small, will “copack” food items for others to sell.

Do you have a list of copackers who can help with the production of my product?

Bobbees Bottling, Inc.
3959 Highway 39 South, Louisburg, NC 27549, (919) 496-4286
www.bobbeesbottling.com

Creative Foods, Inc.

5912 Campbell St., Hanahan, SC 29406, (843) 747-5102
www.creativefoodinc.com

Golding Farms

6061 Gun Club Rd., Winston-Salem, NC 27103, (336) 766-6161
www.goldingfarmsfoods.com

I am trying to come up with a new product. Would you or anyone else in the department be able to help me?

No, we do not help with creation of new products or product development. But, Roger Townley is a product development consultant who may be able to help. His contact information is:

Roger Townley, M.S.

Townley Associates
252 904 6057 mobile
3409 Merrifield RD
Rocky Mount, NC 27804
www.townleyassociates.com
email: roger@townleyassociates.com