Starting a Wholesale Food Business in Indiana

In Indiana, food operations are divided between Retail and Wholesale operations. Retail operations include restaurants, grocery stores, local festivals and fairs, and other businesses selling food products directly to the consumer. Wholesale food operations are those that manufacture and/or distribute to another entity for resale or distribution.

Introduction
Business Registration
Rules and Regulations
Short Checklist
Labeling
 

Introduction
When exploring the possibility of starting a wholesale food business, it is important to contact the Wholesale Food Protection Program to discuss your prospective business. Once the scope of your business has been determined an information packet containing the appropriate rules and regulations will be mailed to you, or you may download them from this website.

Starting a wholesale food business requires careful planning, skillful management and knowledge of several local, state and federal regulations. A wholesale food business is any establishment within the state that manufacturers, packages, repackages, stores or transports human food products for distribution to another entity for resale or redistribution. This does NOT include a residential kitchen, bed and breakfast, meat, poultry or dairy processing plants. A wholesale business may be located within a primary retail establishment as long as it complies with Retail Food Establishment Sanitation Requirements (Title 410 IAC 7-20) and the Wholesale Food Code (Title 410 IAC 7-21)
 

Business Registration
A wholesale food establishment that maintains a place of business in Indiana shall file with the department, on forms to be furnished by the department, a written statement of the name and address of the owner, the name of the business, the character of the business and the business address of each place of business in Indiana.

A new wholesale food establishment shall not be established in Indiana until the place of business has been registered. The department shall be notified of intent to operate at least thirty (30) days prior to beginning operations.

If ownership of a registered place of business changes, the new owner shall register the place of business before operating.

If the name of the business or the address of a registered place of business changes, the owner shall register the change.

Prior to beginning a business or for more information, please contact:

Indiana State Department of Health
Wholesale Food Protection Program
2 North Meridian Street, 5C
Indianapolis, Indiana 46204
Telephone: 317-233-7360
Fax: 317-233-7334
Vonda Allen, Coordinator, e-mail vallen@isdh.state.in.us
Shirley Vargas, Supervisor, e-mail svargas@isdh.state.in.us

(Please include your telephone number with your e-mail message)
 

Rules and Regulations
The Wholesale Food Code Title 410 IAC 7-21 was implemented by the Indiana State Department of Health to assure that foods are manufactured, processed and handled in a safe and sanitary manner. The conditions set forth in the Wholesale Food Code Title 410 IAC 7-21 must be met in order to operate and maintain your business.

The Wholesale Food Code Title 410 IAC 7-21 Sections are:

Personnel Health
Personnel Hygienic Practices
Personnel Training
Physical Facilities and Grounds
Sanitary Operations and General Maintenance
Toxic and Poisonous Substances and Pest Control
Plumbing and Sewage Systems
Sanitary Facilities and Controls
Equipment and Utilities
Raw Materials: Production and Process Control
Manufacturing Operations
Reduced Oxygen Packaging
Acidified Foods
Warehousing and Distribution
Accurate Representation of Packaged Food, Honest Presentation, Food Labels
Public Health Protection: Access, Reporting Imminent Health Hazards
Registration of a Wholesale Food Establishment

For detailed information on the specific rules and regulations that apply for your proposed food product, contact the Indiana State Department of Health, Wholesale Food Protection Program, at 317-233-7360 or e-mail food@isdh.state.in.us.
 

A Short Check List
Foods processed, repackaged and/or warehoused are subject to health regulations controlling facility construction, sanitation, product standards and package labeling. “Food processing” means the handling or processing of any food in any manner for the sale for human consumption.

The following is a short checklist to follow when getting ready to start a new food business:

Adequate water and sewage systems
Equipment designed, constructed and installed properly
Facility secure from insects, birds and rodents
Physical Facility
Foods/ingredients obtained from approved sources
Lighting
Processing or repackaging areas separated from other operations
Refrigeration/freezer equipment to meet the needs of the operation
Sinks for handwashing, equipment/utensil washing and floor clean up
Transportation
Ventilation
 

Adequate water and sewage systems
Each facility shall be equipped with effective plumbing and sewage facilities and adequate accommodations including, but not limited to, the following:

• The water supply shall be sufficient for the operations intended and shall be derived from an approved source. Drinking water and water used for food processing operations shall meet bacteriological and chemical quality standards specified in 327 IAC 8-2. Running water at a suitable temperature and under pressure as needed shall be provided in all areas where required for the processing of food, for the cleaning of equipment, utensils, and food-packaging materials, or for employee sanitary facilities.
   
• If a food processing plant obtains water from a water system not subject to 327 IAC 8-2 for its operations the operator shall sample the water at least annually for bacterial analysis by a certified laboratory, maintain records of analysis of sample results for three (3) years, and provide such records to the department upon request.
   
• A plumbing system shall be of sufficient size and shall be designed, constructed, installed and maintained according to the applicable Indiana Plumbing Code, 675 IAC 16.1, to:
  • Carry sufficient quantities of water to required locations throughout the facility.
  • Properly convey sewage and liquid disposable waste from the facility.
  • Avoid becoming a source of contamination to food, water supplies, equipment and utensils or creating an unsanitary condition.
  • Provide sufficient floor drainage in all areas where floors are subject to flooding-type cleaning or where normal operations release or discharge water or other liquid waste on the floor.
  • Prevent backflow or back siphonage from, or cross-connection between, piping systems that discharge wastewater or sewage and piping systems that carry water for food or food manufacturing.
     
• Sewage disposal shall be conveyed into an approved sanitary sewerage system or other system, including the use of sewage transport vehicles, pumps, hoses, and connections that are constructed, maintained and operated according to law.
   

Equipment designed, constructed and installed properly
All processing equipment and utensils shall be so designed and of such material and workmanship as to be effectively cleanable and shall be properly maintained. The design, construction, and use of equipment and utensils shall preclude the adulteration of food with lubricants, fuel, metal fragments, contaminated water, or any other contaminants. All equipment shall be so installed and maintained as to facilitate the cleaning of the equipment and of all adjacent spaces. Food-contact surfaces shall be corrosion-resistant when in contact with food. They shall be made of nontoxic materials and designed to withstand the environment of their intended use and the action of food, and, if applicable, cleaning compounds and sanitizing agents. Food-contact surfaces shall be maintained to protect food from being contaminated by any source, including unlawful indirect food additives by the following means:

• Seams on food-contact surfaces shall be smoothly bonded or maintained so as to minimize accumulation of food particles, dirt, and organic matter and thus minimize the opportunity for growth of microorganisms.
   
• Equipment that is in the manufacturing or food-handling area and that does not come into contact with food shall be so constructed that it can be maintained in a clean condition.
   
• Holding, conveying, and manufacturing systems, including gravimetric, pneumatic, closed, and automated systems, shall be of a design and construction that enables them to be maintained in an appropriate sanitary condition.
   
• Worktables and counters must be in good repair and have surfaces that are easily cleaned and non-corrosive:

 
Facility Secure from insects, birds and rodents
Protect outer openings against the entry of insects, rodents, or other vermin by:

• Filling or closing holes and other gaps along floors, walls and ceilings;
• Closed, tight-fitting windows;
• Solid, self-closing, and tight fitting doors, except emergency exit and dock doors which do not need to be self-closing;
• Using screening, air curtains or other effective means, when appropriate.
• Keeping doors closed when not in operation.
   

Physical Facility
Constructing facility in such a manner that:

• Floors, walls, and ceilings may be adequately cleaned and maintained in good repair,
• Drip or condensate from fixtures, ducts and pipes does not contaminate food, food contact surfaces, or food-packaging materials.
• Aisles or working spaces are provided between equipment and walls and food products and walls are adequately unobstructed and have adequate width to permit employees to perform their duties and to protect against contaminating food or food-contact surfaces with clothing or personal contact.

Floor Materials. The type of flooring material varies with different processing areas and the amount and type of foot traffic. Food processing areas require flooring which can be readily cleaned and maintained in good repair. Materials such as well-sealed hardwood may be suitable for some areas of a bakery where dry clean-up methods are appropriate.

Food processing areas that require flood-type cleaning (such as a cider mill) need well-sealed concrete floors with cove base and adequate drains. Heavy use areas with large, moveable equipment require more durable flooring.

Unfinished wood floors are NOT suitable in any plant areas.
In general, vinyl linoleum or tile floor covering may be satisfactory for very small operations where vacuuming and wet mopping provide sufficient clean up. Larger operations, particularly those processes that are "wet" in nature (e.g., fish, fruit, vegetables, beverages, tofu) require an easily drained, well-sealed concrete or tile floor.

Wall Materials. The kind of wall finish depends on wall location in the plant, the proximity to work counters, sinks, and equipment and the amount of splash and cleaning exposed to the wall. Painted drywall may be suitable in warehouse areas, but it is NOT suitable in fish plants and produce processing operations such as potato or apple processors and other plants where wet clean up is necessary.

In general, wall areas in "wet" operations must be covered with a washable, non-porous, non-corrosive, smooth material that will not deteriorate when it gets wet. Wall areas within three feet of work counters, tables, and equipment must be covered with a similar material. Recommended material includes Stainless steel, fiberglass paneling (called glass board or Chemlite in the trade). Satisfactory material includes Galvanized aluminum and Formica. Vinyl covered fiberboard panels (also called Marlite in the trade), commonly used to panel bathrooms, may be used, but are easily scratched and worn from scouring and cleaning.

Ceiling Materials. The ceiling of a food processing area must be smooth and easily cleanable.

Food Ingredients obtained from Approved Sources
Food should be obtained from sources that comply with applicable state and federal statutes, regulations and local ordinances.

Raw materials and other ingredients shall be inspected and segregated or otherwise handled as necessary to ensure that they are clean and suitable for processing into food.

Food prepared in a private home kitchen may not be used or offered for human consumption.

Lighting
Provide sufficient lighting in all areas where food is examined, processed, or stored and where equipment or utensils are cleaned. Sufficient lighting must also be provided in hand washing areas, dressing and locker rooms and toilet rooms.

• Light bulbs shall be protected in the following manner:
  • Shielded, coated, or otherwise shatter-resistant in areas suspended over exposed food in any step of preparation and over clean equipment, utensils and linens.
  • Shielded, coated, or otherwise shatter-resistant bulbs need NOT be used in areas used only for storing food in unopened packages if:
    • The integrity of the packages cannot be affected by broken glass falling onto them; and
    • The packages are capable of being cleaned of debris from broken bulbs before packages are opened.
       

Processing or Repackaging Areas Separated From Other Operations
Food-contact surfaces of equipment shall be cleaned as frequently as necessary to protect against contamination of food by performing the following:

• Food-contact surfaces of equipment and utensils used for manufacturing, repackaging or holding low moisture food shall be in a dry, clean and sanitary condition at the time of use. When the food-contact surfaces are wet cleaned, they shall be sanitized and thoroughly dried before subsequent use.
• Where equipment and utensils are used in a continuous production operation, food- contact surfaces of the equipment shall be cleaned and sanitized as necessary to prevent contamination.
• Sanitizing agents shall be effective and safe under conditions of use. Any facility, procedure, or machine is acceptable for cleaning and sanitizing equipment and utensils if it is established that the facility, procedure, or machine will routinely render equipment and utensils clean and sanitized.

Equipment and utensils that must be cleaned and sanitized will require the use of a 3-compartment sink or automatic dishwashing machine. For utensils used in the repackaging area, a 3-compartment sink must be in close proximity to the repackaging room.

There must be a separate room for repackaging food items. In addition to meeting all the regulations for food handling, a warehouse that repackages food items must comply with the following:

• Designated repackaging room
• Hand sink
• 3-compartment sink
   

Refrigeration/freezer equipment to meet the needs of the operation
Food that can support the rapid growth of undesirable microorganisms, particularly those of public health significance, shall be held in a manner that prevents the food from becoming adulterated. Compliance with this section shall be accomplished by an effective means, including, but not limited to, the following:

• Maintaining cold, potentially hazardous foods at forty-one (41) degrees Fahrenheit or below. Exceptions to this requirement are when the receiving and storage temperatures are specified in another law, such as laws governing milk, molluscan shellfish, and shell eggs. These foods may be received and stored at the temperature specified by law.
• Maintaining frozen foods in a frozen state at zero (0) degrees Fahrenheit or below.
• The amount of food stored in a refrigerator or frozen food storage unit shall not exceed the designed capacity of that unit. Adequate space should be provided to allow for proper inspection and rotation of products.
• Each freezer and refrigeration unit, including transportation vehicles, used to store, hold or transport food capable of supporting growth of microorganisms shall be fitted with an indicating thermometer, temperature measuring device or temperature recording device so installed as to show the temperature accurately within the compartment. Each freezer and refrigeration unit should be fitted with an automatic control for regulating temperature or with an automatic alarm system to indicate a significant temperature change in manual operation. The operator shall:
  • Record the temperature shown by each measuring device installed in the unit, with the date on which the temperature reading was taken. Temperature shall be monitored and recorded at least weekly.
  • Retain and have available for inspection the temperature records for the last six (6) months.
     

Sinks for Handwashing, Equipment/Utensil Washing and Floor Clean-up
Each facility shall provide handwashing facilities that are adequate, readily accessible, and convenient. Compliance with this requirement shall be accomplished by providing the following:

• Handwashing facilities at each location in the plant where good sanitary practices require employees to wash their hands. Each handwashing facility shall be:
  • Furnished with hot and cold running water tempered by means of a mixing valve or combination faucet.
  • Capable of reaching a minimum water temperature of eighty-five (85) degrees Fahrenheit within sixty (60) seconds.
• Effective hand-cleaning preparations.
• Sanitary towel service, paper towels or suitable drying devices.
• Devices or fixtures, such as water control valves, designed and constructed to protect against recontamination of clean hands.
• Signs directing food employees handling unprotected food, unprotected food- packaging materials, and food-contact surfaces to wash and, where appropriate, sanitize their hands. These signs should be posted in the processing room and in all other areas where employees handle food, food-packaging materials, or food- contact surfaces. If necessary, the signs should be multilingual.

If mops or similar wet floor cleaning tools are used, at least one (1) service sink or one (1) curbed cleaning facility equipped with a floor drain and supplied with hot and cold water under pressure shall be provided and conveniently located.

Food-contact surfaces of equipment shall be cleaned as frequently as necessary to protect against contamination of food by performing the following:

• Food-contact surfaces of equipment and utensils used for manufacturing or repackaging or holding low moisture food shall be in a dry, clean and sanitary condition at the time of use. When the food-contact surfaces are wet cleaned, they shall be sanitized and thoroughly dried before subsequent use.
• In wet processing, when cleaning is performed to protect against the introduction of microorganisms into food, food-contact surfaces shall be cleaned and sanitized before use and after any interruption during which the food-contact surfaces may have become contaminated.
• Where equipment and utensils are used in a continuous production operation, food- contact surfaces of the equipment shall be cleaned and sanitized as necessary to prevent contamination.
• Nonfood-contact surfaces of equipment used in the operation of food plants should be clean as frequently as necessary to protect against contamination of food.
• Single-service articles, such as utensils intended for one-time use, paper cups, and paper towels, should be stored in appropriate containers and shall be handled, dispensed, used, and disposed of in a manner that protects against contamination of food or food-contact surfaces.
• Cleaned and sanitized portable equipment with food-contact surfaces and utensils shall be stored in a location and manner that protects food-contact surfaces from contamination.
• Sanitizing agents shall be effective and safe under conditions of use. Any facility, procedure, or machine is acceptable for cleaning and sanitizing equipment and utensils if it is established that the facility, procedure, or machine will routinely render equipment and utensils clean and sanitized.
• Chemical sanitizers and other chemical antimicrobials applied to food-contact surfaces shall meet the requirements specified in 21 CFR 178.1010.

Equipment and utensils that must be cleaned and sanitized will require the use of a 3-compartment sink or automatic dishwashing machine.
 

Transportation
During transportation frozen foods shall remain frozen and should be at zero (0) degrees Fahrenheit or below.

During transportation refrigerated foods shall be at forty-one (41) degrees Fahrenheit or below unless law governing their distribution applies, such as temperature requirements for shell eggs.

All incoming loads should be checked for adulteration and proper temperature. Any adulterated food products must be discarded or returned to the supplier.

Before shipping any product, the delivery vehicle should be checked for cleanliness. If the truck is not clean or cannot maintain proper temperature for any refrigerated or frozen food items, another delivery vehicle must be used.

All food products should be kept separate from any chemical, toxic, or non-food items. Chemicals should not be stored on top of food or transported in a manner whereby food products may become contaminated.
 

Ventilation
Provide adequate ventilation or control equipment to minimize odors and vapors, including steam and noxious fumes, in areas where they may contaminate food. Locate and operate fans and other air blowing equipment in a manner that minimizes the potential for contaminating food, food-packaging materials, and food-contact surfaces.

Clean intake and exhaust air ducts and change filters so they are not a source of contamination by dust, dirt and other materials.

If vented to the outside, ventilation systems must not create a public health hazard or nuisance or unlawful discharge.
 

Labeling of Products
Foods sold in packaged form must be labeled in accordance with the requirements of the Wholesale Food Code Title 410 IAC 7-21, including the name and address of the manufacturer, an accurate statement of the net quantity or weight of the contents, the common or usual name of the product, and a list of ingredients in order o predominance by weight (Indiana Labeling Statute, IC 16-42-2).

In addition to listing the above information, the label may need to contain nutritional labeling information as required by the Nutrition Labeling and Education Act of 1990. This Act requires nutritional labeling for most foods (except meat and poultry) and authorizes the use of nutrient content claims and appropriate FDA approved health claims. Most small manufacturers are exempt from the nutritional labeling regulation. The exemptions can be found on the following site: www.cfsan.fda.gov/~dms/sbel.html.

It is particularly important to label those ingredients that can cause allergic reactions in certain individuals. The following common food allergens may prompt product recalls if not declared as ingredients: peanuts, tree nuts, eggs, fish, soybeans, milk, shellfish and wheat. Allergen information (link to Allergen Section on ISDH site).