Getting Started in a Food Business in North Carolina

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Please let us direct you according to your needs by answering these questions:

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Are you just getting started and have you already done some leg work?

A.  YES, I have a recipe my family and friends like and I’m just checking to find out what it would take to produce and sell it.  Please proceed to the Frequently Asked Questions section of our website.

B. YES,  I plan to produce my product in my home and will market it myself.

1.  Initial steps

2.  Frequently asked questions

C. YES, I plan to have someone else produce my product and I will direct the marketing and selling.  Take a look at our Fact sheet “choosing a copacker” or  the PDF file for printing.

D.  YES, I plan to make a product in my restaurant and sell it packaged directly to customers or use a broker.

1.  Frequently asked questions

2.  Initial steps

E.YES, I would like to get into the catering business.  Go to Catering.

1.  Before you invest time and resources in your product or seek technical advice, we suggest you start working on a business plan .  For further assistance please see State resources for small businesses.

2.  Regulation requirements vary according to the category of the product and how it is preserved.  For further assistance take a look at the following publications.
1.   “Who Will Regulate My Food Business?” or  the PDF file for printing.
2.    General Regulatory  Requirements

Is your product to be sold

a.  Ready to eat?  Ready to eat foods.
b.  As a packaged food? Regulation of Packaged Foods

Which category best fits your food product?

1.  Fluid milk product.

Milk Sanitation Branch - http://www.deh.enr.state.nc.us/ehs/mlk.htm

2.  Fresh shellfish product.

Shellfish Sanitation Branch - http://www.deh.enr.state.nc.us/shellfish/new/index.htm

3.  Raw or minimally processed fruit or vegetable.

http://vm.cfsan.fda.gov/~dms/guidance.html#prod

4.  Raw or processed meat or poultry – containing product.

Meat and Poultry Inspection Division - http://www.agr.state.nc.us/vet/mp.htm

5.  Other processed foods.

Other processed foods.

Which category best fits your food product?

a.  A dried product, a baked product such as a cookie, a syrup or chocolate sauce. Low water activity foods

b.  A canned vegetable product or soup other than tomato products. Low Acid Canned Foods

c.  Shelf-stable sauce, marinade, beverage, pickle, fruit or similar product.  Acid or Acidified Foods

d.  A refrigerated or frozen product.  Please take a look at our Fact Sheet “Refrigerated Foods: Some Rules for Handling"  or  the PDF file for printing.

Many foods are preserved by their Aw.  Water activity is a measure of the availability of water for growth of foodborne illness organisms.  It is not a measure of the total amount of water in the food.  The critical control point for these foods is a final water activity (Aw) of  0.85 or below.  For control, the  Aw should  be monitored using an Aw meter.  All products and processes exhibit normal variation, so it is necessary to develop procedures to monitor and ensure adequate processing.  As an alternative to Aw control  you may protect the product with refrigeration below 41 degrees F at all times.

 To determine the Aw in a food, we measure the equilibrium relative humidity (ERH) of the headspace in the food.  The ratio of the ERH of the food to the 100% ERH of pure water gives us the  Aw. If the ERH of the food is 85%, then the Aw (85/100) equals 0.85.  Water activity measurements range from 0 to 1.00.  To protect the food from the growth of dangerous bacteria, foods using  Aw for preservation must test below 0.85.

 In order to use  Aw as your method of preservation, you need equipment to measure  Aw and must demonstrate that adequate controls are in place to prevent product from exceeding 0.85.  Water activity meters are available from scientific supply houses.  They typically are rather expensive.  With a dry product such as a cookie, you only need to satisfy yourself with measured data that the  Aw is very low.

 Since you do not want to destroy all your products produced through testing, you will want to design an adequate testing schedule based on statistical principles to show control of the process.  You must be able to show that adequate safeguards are in place to prevent product with  Aw greater than 0.85 from reaching the consumer.

 Packaging should be chosen to protect the product from taking up moisture. The packaging material supplier can advise you on choosing and sealing a material which will keep the product from absorbing water.  Usually, preservatives such as potassium sorbate and sodium benzoate are added to inhibit the growth of yeasts and molds once the product is opened, especially at  Aw above 0.60.  Preservatives will not take the place of proper water activity.  Products should receive a final heat treatment to destroy dangerous organisms.  Any product not receiving a terminal heat treatment could transmit dangerous foodborne illness organisms to the consumer.

The critical control point for these foods is a final pH of 4.6 or below.  For control, the pH must be monitored using a pH meter.  All products and processes exhibit normal variation, so it is necessary to develop procedures to monitor and ensure adequate processing.

Foods preserved with acid must have a pH of 4.6 or below to be considered safe.  The pH value is a measure of the acidity.  Lower pH values indicate higher levels of acidity.  Foods which have a pH above 4.6 are potentially dangerous and must be kept refrigerated.

Foods, such as tomatoes, which have a natural pH of 4.6 or below are considered to be acid foods.  Some foods which contain small amounts of low-acid foods in a predominantly acid food, such as herbal vinegars, are also in this category.  If the finished equilibrium pH does not vary significantly from the pH of the predominant acid food, and other acids or acid foods are not added, the food is considered to be an acid food.

Acidified foods are low-acid foods to which acids or acid foods have been added to produce a pH of 4.6 or below.  In the absence of information to the contrary, foods preserved with acid are considered by FDA to be acidified foods.  The distinction between these two categories of foods is important.  Acidified foods have additional requirements that the manufacturer file a scheduled process established by a competent process authority and an establishment registration form with FDA.  In addition, the operation must be under the operating supervision of a certified supervisor.

When oil is used in the formulation, low-acid foods must be properly acidified to a pH of 4.6 or below prior to the addition of oil.  This will prevent the oil from coating the food and producing a barrier to acidification.

The proper acidity (finished  equilibrium) pH of 4.6 or below will prevent the growth of spores of deadly botulism bacteria.   Vegetative bacteria, yeasts and molds must be destroyed by heating to 180oF and filling and capping at that temperature.  Inverting the hot jars will destroy microorganisms on the lid.   Foods which are not heated in processing, such as some salad dressings, may transmit organisms such as E. coli 0157:H7 as did unpasteurized apple cider recently.
 Usually, preservatives such as potassium sorbate and sodium benzoate are added to inhibit the growth of yeasts and molds once the product is opened.  Preservatives will not take the place of proper acidification.  Products which do not receive a final heat treatment, such as salad dressings, require preservatives to prevent mold growth, or gas production from yeast growth.  Any product not receiving a terminal heat treatment could transmit dangerous foodborne illness organisms to the consumer.
 

Low acid canned foods must:

1.  Be produced in a registered establishment for retorting products.  Home canning is not possible under the regulations

2.  Have the process determined by a “process authority” who is qualified by training and experience.

3.  File a scheduled process with FDA and adhere to it during processing.

4. Processing operations and seam inspections must be conducted under the operating supervision of a certified supervisor.

Catered foods are regulated by county health departments under statewide rules   adopted by the Food and Lodging Sanitation Branch of the NC Department of the Environmental Health.  An exception to this rule is the preparation of bakery items.  Bakery items are regulated by the  Food and Drug Protection Division.  For a summary of the regulatory agencies see our fact sheet “Who Will Regulate My Food Business?” or  the PDF file for printing.

Prepared and ready-to-eat foods are regulated by  county health departments under statewide rules  adopted by the Food and Lodging Sanitation Branch of the NC Department of the Environmental Health.