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Requirements for Selling Food to Retail in South Dakota

Updated November 09, 2020
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Curtis Braun

SDSU Extension Food Safety Field Specialist

Producer unloading fresh, farm-grown produce from a delivery truck at a super market.

It’s an exciting time to be a food processor in the state of South Dakota. Now more than ever, we are seeing food processors and entrepreneurs bringing products, not only to farmers markets, but also to retail stores as well. With this in mind, it can be difficult to navigate through how to bring food products to retail that are not only in regulatory compliance, but are also safe. This article is meant to provide regulatory guidance and outline the necessary steps required that must be met to allow for the sale of foods to retail stores.

Food Safety and Evaluation of Products

There are a number of hurdle techniques that can be utilized to reduce, eliminate, or control pathogens in food. These techniques can include controlling the amount of water in the product, controlling the pH, adding preservatives, controlling the atmosphere, or using time and temperature to inactivate pathogens. It is important to understand which hurdle is being utilized and whether that hurdle is sufficient to control, eliminate, or reduce pathogens in the product. Below is a brief explanation of these hurdle techniques.

Water Activity

Water activity is the partial vapor pressure of water in a substance divided by the standard state partial vapor pressure of water. This is frequently used as an indicator of pathogen growth in food. Although water activity can help predict things such as bacterial growth in food and spoilage caused by yeast and mold, it cannot be used to as a means to inactivate or destroy pathogens. Below, Table 1 shows how different organisms respond to differing water activity levels.

pH

pH is a scale used to determine the acidity or basicity of a product or solution on a scale of 1 to 14. Acidic solutions will have a higher concentration of H+ ions and will have a lower pH. Basic solutions will have a higher concentration of OH- and will have a higher pH. pH can be a very effective way to control the growth of pathogens in food. In some instances, such a low pH can actually create not only a bacteriostatic environment, or no growth, it can also create a bactericidal environment, or bacterial death. However, pH cannot always be considered a means to kill pathogens. Below, Table 1 shows how different organisms respond to differing pH levels.

Pathogens

The temperature, pH, water activity, atmosphere, presence of preservatives, food matrix, and much more can play a role in how a pathogen can survive and grow in any given food matrix. Table 1 is an illustration of the many factors that go into evaluating the growth and survival of pathogens in food. SDSU Extension and the SD DOH use such information about pathogens to help determine the food safety of products.

Time and Temperature

Time and temperature are also a hurdle technology to control, reduce, or eliminate pathogens to an acceptable level. The time and temperature needed to inactivate an organism can vary from food to food. Other characteristics can affect the time and temperature needed to inactivate an organism. For example, an organism with lower water activity may be more thermal resistance than if that same organism is in a product that has high water activity. Water activity, pH, the starting bio burden (initial micro load) can all impact the time and temperature necessary to inactivate pathogens. For this reason, it is important not to assume a time and temperature for a given product will apply to another product even if it is fairly similar.

Table 1. Factors influencing pathogen growth and survival.

Organism
Temperature °F
(°C)
pH
Water Activity (aw)
Max. %
water phase salt
 
Min.
Optim.
Max.
Min.
Optim.
Max.
Min.
Optim.
Max.
 
Bacillus cereus
39
(4)
86-104
(30-40)
131
(55)
4.3
6.0-7.0
9.3
0.92
-
-
10
Campylobacter
86
(32)
108-109
(42-43)
113
(45)
4.9
6.5-7.5
9.5
>0.987
0.997
-
1.7
Clostridium botulinum
Proteolytic ABF
50
(10)
95-104
(35-40)
-118
(48)
4.6
-
9
0.935
-
-
10
Clostridium botulinum
Non-proteolytic BEF
38
(3.3)
82-86
(28-30)
113
(45)
5.0
-
9
0.970
-
-
5
Clostridium perfringens
50
(10)
109-117
(43-47)
126
(50)
5
7.2
9
0.93
0.95-0.96
>0.99
7
Enterohemorrhagic
Escherichia coli (EHEC)
44
(6.5)
95-104
(35-40)
121
(49.4)
4
6-7
10
0.95
0.995
-
6.5
L. monocytogenes
31
(-0.4)
99
(37)
113
(45)
4.4
7.0
9.4
0.92
-
-
10
Salmonella
41
(5.2)
95-109
(35-43)
115
(46.2)
3.7
7-7.5
9.5
0.94
0.99
>0.99
8
Shigella
43
(6.1)
-
117
(47.1)
4.8
-
9.3
0.96
-
-
5.2
Staph. Aureus
growth (aerobic)
45
(7)
99
(37)
122
(50)
4
6-7
10
0.83
(0.90)
0.98
>0.99
20
Staph. Aureus
toxin (aerobic)
50
(10)
104-113
(40-45)
118
(48)
4
7-8
9.8
0.85
0.98
>0.99
10
Streptococcus group A
50
(10)
99
(37)
<113
(<45)
4.8-5.3
7
>9.3
-
-
-
6.5
Vibrio spp.
41
(5)
99
(37)
114
(45.3)
4.8
7.6-8.6
11
0.94
0.91-0.99
0.998
10
Yersiniz enterocolitica
30
(-1.3)
77-99
(25-37)
108
(42)
4.2
7.2
10
0.945
-
-
7

From FDA 2011. Fish and Fishery Products Hazards and Controls Guidance. 4th Edition and International Commission on Microbiological Specifications for Foods. 1996. Microorganisms in Foods 5: Microbiological Specifications of Food Pathogens. Blackie Academic and Professional, New York.

Regulatory Requirements

a mother and daughter putting labels on home-canned food products. Photo by Stephen Ausmus, USDA

For foods being sold at retail, the DOH regulates and oversees many of the products that are made by small processors in SD that are selling intrastate (i.e. not selling across SD borders). Any business making a food product in South Dakota and selling across South Dakota borders is engaging in interstate commerce and would be subject to complying with FDA regulations. However, for those processors in South Dakota who are selling their products intrastate and not interstate, the following guidelines must be met.

  • Obtain a SD food service license under the “Processor” category.
    • Meet applicable food service establishment guidelines (e.g. hand sink, 3-comp sink, prep sink etc...).
    • Meet applicable food service code regulations.
  • Register with the FDA if selling interstate or online with the intent to ship interstate. No registration required if selling intrastate.
  • Process out of a licensed kitchen.
    • The South Dakota Department of Health’s Search for Inspection Results website shows all approved licensed kitchens in the state of South Dakota that have been approved by the SD DOH.
  • Meet minimum labeling standards addressed in 21 CFR 101 OR state statute 34-18-37 (as applicable).
  • Provide a means to trace product using lot number or date code in event of recall/withdrawal.
  • Maintain all approved recipes/process(es) and any product testing documentation on file and available upon DOH inspection. Approved recipes are not to be altered or adapted in any way.
  • Additional requirements may apply depending on the type of food and process(es) and packaging involved.

However, not every food group is created equally, so the information below has been provided to help give guidance by specific food type and the requirements that must be met.

Product Approval Guidance for Retail

Acidified Canned Foods

  • Examples:
    • Salsa, dill pickles, dilled cauliflower.
  • Guidance:
    • Must be reviewed and approved by a 3rd party processing authority according to law 34-18-36.
    • Obtain a SD food service license under the “Processor” category.
    • Labeled according to labeling law 34-18-37 and/or FDA Guidance.
    • Maintain all approved recipes/process(es) and any product testing documentation on file and available upon DOH inspection. Approved recipes are not to be altered or adapted in any way.
    • Provide a means to trace product using lot number or date code in event of recall/withdrawal.
    • These products must be processed out of a licensed kitchen.

Alcoholic Beverages (0.5% ABV alcohol by volume)

  • Examples:
    • Beer, wine, possibly kombucha drinks.
  • Regulatory Requirements:

Barbeque Sauce and Similar Foods

  • Guidance:
    • Obtain a SD food service license under the “Processor” category.
    • Labeled according to labeling law 34-18-37 and/or FDA Guidance.
    • Maintain all approved recipes/process(es) and any product testing documentation on file and available upon DOH inspection. Approved recipes are not to be altered or adapted in any way.
    • These products must be processed out of a licensed kitchen.
    • Provide a means to trace product using lot number or date code in event of recall/withdrawal.
    • Have the product tested for pH and evaluated for processing by SDSU.

Candies

  • Examples:
    • Lollipops, candy canes, fudge, caramels, cotton candy, truffles, rock candy.
  • Guidance:
    • Labeled according to labeling law 34-18-37 and/or FDA Guidance.
    • Provide a means to trace product using lot number or date code in event of recall/withdrawal.
    • Hard candies such as lollipops, candy canes, fudge, caramels, cotton candy, truffles, and rock candy have a low water activity, so no testing is required.
    • For chocolate covered fruits or other products such as cream-filled chocolates or fudge, the amount of moisture can vary so these foods should be tested for pH and water activity by the SDSU Food Safety Lab.

Canned, Shelf Stable Naturally High Acid Foods

  • Examples:
    • Canned applesauce, canned fruits.
  • Guidance:
    • Must be reviewed and approved by a 3rd party processing authority according to law 34-18-36.
    • Obtain a SD food service license under the “Processor” category.
    • Labeled according to labeling law 34-18-37 and/or FDA Guidance when sold.
    • Maintain all approved recipes/process(es) and any product testing documentation on file and available upon DOH inspection. Approved recipes are not to be altered or adapted in any way.
    • Provide a means to trace product using lot number or date code in event of recall/withdrawal.
    • These products must be processed out of a licensed kitchen.

Certain Cut Produce and Cut Herbs

  • Examples:
    • Leafy greens (e.g. lettuce, cabbage), tomatoes, melons.
  • Regulatory Requirements:
    • Obtain a SD food service license under the “Processor” category.
    • Labeled according to labeling law 34-18-37 and/or FDA Guidance (as applicable).
    • Maintain all approved recipes/process(es) and any product testing documentation on file and available upon DOH inspection. Approved recipes are not to be altered or adapted in any way.
    • Provide a means to trace product using lot number or date code in event of recall/withdrawal
    • These products must be processed out of a licensed kitchen.
    • Must be stored and sold ≤ 41F°.

Dairy Products; Milk

  • Examples:
    • Milk, cheese, yogurt, etc. from cows, goats, other mammals.
  • Regulatory Requirements:
    • Dairy products must be Pasteurized and processed at a manufacturing plant that has been licensed by the state of South Dakota Dept of Ag. Product should be labeled appropriately.

Dough

  • Examples:
    • Refrigerated or frozen cookie dough, pizza dough, pie dough.
  • Regulatory Requirements:
    • Obtain a SD food service license under the “Processor” category.
    • Labeled according to labeling law 34-18-37 and/or FDA Guidance.
    • Maintain all approved recipes/process(es) and any product testing documentation on file and available upon DOH inspection. Approved recipes are not to be altered or adapted in any way.
    • Provide a means to trace product using lot number or date code in event of recall/withdrawal.
    • Doughs must be processed out of a commercial kitchen and held at appropriate refrigeration and freezing temperatures when in storage or at point of sale.

Dry Baking Mixes

  • Examples:
    • Cake mix, cookie mix.
  • Guidance:
    • Labeled according to labeling law 34-18-37 and/or FDA Guidance.
    • Provide a means to trace product using lot number or date code in event of recall/withdrawal.
    • Low water activity product, but should consider including instructions not to eat raw.

Eggs

  • Regulatory Requirements:
    • Labeled according to labeling law 34-18-37 and/or, USDA Guidance.
    • Provide a means to trace product using lot number or date code in event of recall/withdrawal.
    • Egg Dealer License and a Candler/Grader License must be obtained from the SD Dept of Agriculture on an annual basis.
    • Eggs must be labeled properly with producer, grade, and weight of egg, expiration date (which is 30 days from date of packing), and safe handling/preparation instructions: “To prevent illness from bacteria: keep refrigerated, cook eggs until firm, and cook foods containing eggs thoroughly.” Eggs must be sold at ≤45F°.

Fresh/Initial Cut (or Dried) Uncut Fruits, Vegetables, or Herbs (not cut beyond normal harvesting)

  • Examples:
    • Beans, apples, tomatoes, cucumbers, strawberries.
  • Guidance:
    • No Requirements.

Grain Products

  • Examples:
    • Home-ground flour, cornmeal, popcorn, intact grain.
  • Guidance:
    • Labeled according to labeling law 34-18-37 and/or FDA Guidance.
    • Provide a means to trace product using lot number or date code in event of recall/withdrawal.
    • Low water activity product, but should consider including instructions not to eat raw.

Home-Canned Fruit Jams and Jellies

  • Examples:
    • Fruit jams and jellies.
  • Guidance:
    • Must be reviewed and approved by a 3rd party processing authority according to law 34-18-36.
    • Obtain a SD food service license under the “Processor” category.
    • Labeled according to labeling law 34-18-37 and/or FDA Guidance.
    • Maintain all approved recipes/process(es) and any product testing documentation on file and available upon DOH inspection. Approved recipes are not to be altered or adapted in any way.
    • Provide a means to trace product using lot number or date code in event of recall/withdrawal.
    • These products must be processed out of a licensed kitchen.

Homemade Dried Pasta

  • Examples:
    • Dried egg noodles
  • Regulatory Requirements:
    • Obtain a SD food service license under the “Processor” category.
    • Labeled according to labeling law 34-18-37 and/or FDA Guidance.
    • Maintain all approved recipes/process(es) and any product testing documentation on file and available upon DOH inspection. Approved recipes are not to be altered or adapted in any way.
    • Provide a means to trace product using lot number or date code in event of recall/withdrawal
    • Must be processed out of a commercial kitchen.

Honey

  • Regulatory Requirements:
    • Labeled according to labeling law 34-18-37 and/or FDA Guidance.
    • Provide a means to trace product using lot number or date code in event of recall/withdrawal.
    • State law (SDCL) 38-18 requires that all apiaries must be registered with the SD Dept of Ag. The vendor must be in compliance with all Apiary laws set forth by the SD Dept of Ag. The honey must be produced by bees kept by the vendor (Visit the SDDA Apiary Program website for more information).

Intact/Initial Cut Salad Greens (not cut beyond normal harvesting)

  • Examples:
    • Mixed greens with only intact leaves, includes microgreens and shoots (not cut beyond normal harvesting practices).
  • Guidance:
    • No Requirements.

Juice

  • Examples:
    • Orange juice, apple juice
  • Regulatory Requirements:
    • Obtain a SD food service license under the “Processor” category.
    • Labeled according to labeling law 34-18-37 and/or FDA Guidance.
    • Maintain all approved recipes/process(es) and any product testing documentation on file and available upon DOH inspection. Approved recipes are not to be altered or adapted in any way.
    • Provide a means to trace product using lot number or date code in event of recall/withdrawal.
    • Juice would need to be processed out of a commercial kitchen and consult SD DOH. See Selling Juice in South Dakota article.

Meat

  • Examples:
    • Beef, sheep, goats, deer
  • Regulatory Requirements:
    • Labeled according to labeling law 34-18-37 and/or FDA Guidance.
    • Maintain all approved recipes/process(es) and any product testing documentation on file and available upon DOH inspection. Approved recipes are not to be altered or adapted in any way.
    • Provide a means to trace product using lot number or date code in event of recall/withdrawal.
    • Must be processed at a SD State Inspected facility that has been approved by the South Dakota Animal Industry Board or by a federally inspected facility. The meat must be properly labeled and stored at appropriate refrigeration or frozen temperatures. See Regulatory Requirements for Selling Meats at Farmer’s Market.

Naturally Fermented Canned Foods

  • Examples:
    • Sauerkraut, kimchi, Kombucha.
  • Regulatory Requirements:
    • Obtain a SD food service license under the “Processor” category.
    • Labeled according to labeling law 34-18-37 and/or FDA Guidance.
    • Maintain all approved recipes/process(es) and any product testing documentation on file and available upon DOH inspection. Approved recipes are not to be altered or adapted in any way.
    • Provide a means to trace product using lot number or date code in event of recall/withdrawal.
    • Must be reviewed and approved by a 3rd party processing authority according to law 34-18-36.
    • These products must be processed out of a licensed kitchen.

Non-Temperature Controlled Baked Goods

  • Examples:
    • Cookies, breads, cakes, cinnamon rolls, muffins, scones.
  • Guidance:
    • Obtain a SD food service license under the “Processor” category.
    • Labeled according to labeling law 34-18-37 and/or FDA Guidance.
    • Provide a means to trace product using lot number or date code in event of recall/withdrawal.
    • These products must be processed out of a licensed kitchen.

Nut Butters

  • Examples:
    • Almond nut butter, cashew nut butter, pecan nut butter
  • Regulatory Requirements:
    • Obtain a SD food service license under the “Processor” category.
    • Labeled according to labeling law 34-18-37 and/or FDA Guidance.
    • Maintain all approved recipes/process(es) and any product testing documentation on file and available upon DOH inspection. Approved recipes are not to be altered or adapted in any way.
    • Provide a means to trace product using lot number or date code in event of recall/withdrawal.
    • These products must be processed out of a licensed kitchen.
    • Review of whether nuts are pasteurized and all other ingredients are considered Ready to Eat (RTE).
    • If nuts are raw but there is a thermal step, there needs to be a validated kill step either by literature or by a challenge study.
    • Test for water activity.

Peanuts, Nuts

  • Examples:
    • Almonds, pecans, walnuts, cashews.
  • Guidance:
    • Obtain a SD food service license under the “Processor” category.
    • Labeled according to labeling law 34-18-37 and/or FDA Guidance.
    • Maintain all approved recipes/process(es) and any product testing documentation on file and available upon DOH inspection. Approved recipes are not to be altered or adapted in any way.
    • Provide a means to trace product using lot number or date code in event of recall/withdrawal.
    • These products may need to be processed out of a licensed kitchen.
    • Consideration of how the raw commodity has been treated to ensure pathogens likely to occur in the environment are reduced, controlled, or eliminated to an acceptable level.

Poultry <20,000 birds/year

  • Examples:
    • Chicken, duck, goose, turkey, etc.
  • Regulatory Requirements:
    • Labeled according to labeling law 34-18-37 and/or FDA Guidance.
    • Provide a means to trace product using lot number or date code in event of recall/withdrawal.
    • Growers selling <20,000 birds/year must ensure that they meet all the criteria by the Package Labeling of Poultry processed under PPIA. Ensure compliance with FSIS and USDA.
    • The poultry must be processed out of a commercial kitchen and stored at proper refrigerated or freezing temperatures.
    • See the Selling Poultry at a Farmer’s Market in South Dakota article for more information.

Spices (Commercially Available Spices)

  • Examples:
    • Nutmeg, cinnamon, cloves, turmeric, cumin, dry rubs.
  • Guidance:
    • Provide a means to trace product using lot number or date code in event of recall/withdrawal.
    • Labeled according to labeling law 34-18-37 and/or FDA Guidance.

Sprouts

  • Examples:
    • Alfalfa sprouts, bean sprouts
  • Regulatory Requirements:
    • Requires SDDOH approval.

Temperature Controlled Baked goods

  • Examples:
    • Cheesecake, cream filled cupcakes or donuts, cream cheese-based frostings or fillings, cream or meringue pies, custards, pumpkin pie.
  • Regulatory Requirements:
    • Obtain a SD food service license under the “Processor” category.
    • Labeled according to labeling law 34-18-37 and/or FDA Guidance.
    • Maintain all approved recipes/process(es) and any product testing documentation on file and available upon DOH inspection. Approved recipes are not to be altered or adapted in any way.
    • Provide a means to trace product using lot number or date code in event of recall/withdrawal
    • These products must be processed out of a licensed kitchen and stored at appropriate refrigerated temperatures.

Conclusion

Ensuring that food is processed safely and meeting regulatory guidance is of utmost importance. With so much excitement and enthusiasm of processors seeking to sell their foods to retail, it is important that these processors know the regulatory guidelines as well as factors that play a role in making food safe.