reglab/statecodes huggingface dataset:
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 21 - Wholesale Food Establishment Sanitation Requirements › Section 21-19 - "Lot" defined

Current through July 10, 2024
Authority: IC
				  16-42-5-5
Affected: IC 16-42-5
Sec. 19.
"Lot" means the food produced during a period of time
				  indicated by a specific code.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 21 - Wholesale Food Establishment Sanitation Requirements › Section 21-20 - "Low-acid food" defined

Current through July 10, 2024
Authority: IC
				  16-42-5-5
Affected: IC 16-42-5
Sec. 20.
"Low-acid food" means any food, other than alcoholic
				  beverages, with a finished equilibrium pH greater than 4.6 and a water activity
				  (aw) greater than eighty-five hundredths (0.85).
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 21 - Wholesale Food Establishment Sanitation Requirements › Section 21-21 - "Micro-organisms" defined

Current through July 10, 2024
Authority: IC
				  16-42-5-5
Affected: IC 16-42-5
Sec. 21.
"Micro-organisms" means yeasts, molds, bacteria, protozoa,
				  and viruses and includes, but is not limited to, species having public health
				  significance. The term "undesirable micro-organisms" includes those
				  micro-organisms that are of public health significance and those of nonpublic
				  health significance that result in food spoilage or that indicate that food is
				  contaminated with filth, or that otherwise may cause food to be adulterated.
				  "Microbial" is used in some instances instead of using an adjectival phrase
				  containing the word micro-organism.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 21 - Wholesale Food Establishment Sanitation Requirements › Section 21-22 - "Pest" defined

Current through July 10, 2024
Authority: IC
				  16-42-5-5
Affected: IC 16-42-5
Sec. 22.
"Pest" refers to any objectionable animals or insects,
				  including, but not limited to, the following:
(1) Birds.
(2) Rodents.
(3) Flies.
(4) Larvae.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 21 - Wholesale Food Establishment Sanitation Requirements › Section 21-23 - "pH" defined

Current through July 10, 2024
Authority: IC
				  16-42-5-5
Affected: IC 16-42-5
Sec. 23.
"pH" means the symbol for the negative logarithm of the
				  hydrogen ion concentration, which is a measure of the degree of acidity or
				  alkalinity of a solution. Values between zero (0) and seven (7) indicate
				  acidity, and values between seven (7) and fourteen (14) indicate alkalinity.
				  The value for pure distilled water is seven (7), which is considered neutral.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 21 - Wholesale Food Establishment Sanitation Requirements › Section 21-24 - "Plant" defined

Current through July 10, 2024
Authority: IC
				  16-42-5-5
Affected: IC 16-42-5
Sec. 24.
"Plant" means the building or facility or parts thereof,
				  used for or in connection with the manufacturing, packaging, labeling, holding,
				  or storing of human food.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 21 - Wholesale Food Establishment Sanitation Requirements › Section 21-25 - "Potentially hazardous food" defined

Current through July 10, 2024
Authority: IC
				  16-42-5-5
Affected: IC 16-42-5
Sec. 25.
(a)
				"Potentially hazardous food" means a natural or synthetic food and requires
				temperature control because it is in a form capable of supporting any of the
				following:
(1) The rapid and progressive
				growth of infectious or toxigenic micro-organisms.
(2) The growth and toxin production of
				Clostridium botulinum.
(3) In raw
				shell eggs, the growth of Salmonella enteritidis.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 21 - Wholesale Food Establishment Sanitation Requirements › Section 21-26 - "Public health significance" defined

Current through July 10, 2024
Authority: IC 16-42-5-5
Affected: IC 16-42-5
Sec. 26.
"Public health significance" means:
(1) the potential for causing diseases with
				symptoms, such as, but not limited to:
(A)
				diarrhea;
(B) fever;
(C) jaundice;
(D) vomiting or sore throat with fever;
				or
(E) boils; or
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 21 - Wholesale Food Establishment Sanitation Requirements › Section 21-27 - "Quality control operation" defined

Current through July 10, 2024
Authority: IC
				  16-42-5-5
Affected: IC
				  16-42-2-2; IC
				  16-42-5
Sec. 27.
"Quality control operation" means a planned and systematic
				  procedure for taking all actions necessary to prevent food from being
				  adulterated as defined under IC
				  16-42-2-2.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 21 - Wholesale Food Establishment Sanitation Requirements › Section 21-28 - "Reduced oxygen packaging" defined

Current through July 10, 2024
Authority: IC
				  16-42-5-5
Affected: IC 16-42-5
Sec. 28.
(a)
				"Reduced oxygen packaging" means the following:
(1) The reduction of the amount of oxygen in
				a package by:
(A) removing oxygen;
(B) displacing oxygen and replacing it with
				another gas or combination of gases; or
(C) otherwise controlling the oxygen content
				to a level below that normally found in the surrounding twenty-one percent
				(21%) oxygen atmosphere.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 21 - Wholesale Food Establishment Sanitation Requirements › Section 21-29 - "Restricted use pesticide" defined

Current through July 10, 2024
Authority: IC
				  16-42-5-5
Affected: IC
				  15-16-4-37;
				  IC 16-42-5
Sec. 29.
"Restricted use pesticide" has the same meaning as defined
				  in IC 15-3-3.5-2(27)
[IC 15-3 was repealed by P.L. 2-2008,
				  SECTION
				  83, effective July 1, 2008. See IC
				  15-16-4-37.]
.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 21 - Wholesale Food Establishment Sanitation Requirements › Section 21-30 - "Rework" defined

Current through July 10, 2024
Authority: IC
				  16-42-5-5
Affected: IC 16-42-5
Sec. 30.
"Rework" means clean, unadulterated food that has been
				  removed from processing for reasons other than insanitary conditions or that
				  has been successfully reconditioned by reprocessing and that is suitable for
				  use as food.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 21 - Wholesale Food Establishment Sanitation Requirements › Section 21-31 - "Sanitization" defined

Current through July 10, 2024
Authority: IC
				  16-42-5-5
Affected: IC 16-42-5
Sec. 31.
"Sanitization" means the application of cumulative heat or
				  chemicals on cleaned food-contact surfaces that, when evaluated for efficacy,
				  is sufficient to yield a reduction of five (5) logs, which is equal to a
				  ninety-nine and nine hundred ninety-nine thousandths percent (99.999%)
				  reduction of representative disease-causing micro-organisms of public health
				  significance.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 21 - Wholesale Food Establishment Sanitation Requirements › Section 21-32 - "Scheduled process" defined

Current through July 10, 2024
Authority: IC
				  16-42-5-5
Affected: IC 16-42-5
Sec. 32.
"Scheduled process" means the process selected by a
				  processor as adequate for use under food manufacturing conditions to achieve
				  and maintain a food that will not permit the growth of micro-organisms having a
				  public health significance. The term includes control of pH and other critical
				  factors equivalent to the process established by a competent processing
				  authority.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 21 - Wholesale Food Establishment Sanitation Requirements › Section 21-33 - "Water activity" defined

Current through July 10, 2024
Authority: IC
				  16-42-5-5
Affected: IC 16-42-5
Sec. 33.
"Water activity" indicated by the symbol
				  aw means water activity that is a measure of the free
				  moisture in a food and the quotient of the water vapor pressure of the
				  substance divided by the vapor pressure of pure water at the same temperature.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 21 - Wholesale Food Establishment Sanitation Requirements › Section 21-34 - "Wholesale food establishment" defined

Current through July 10, 2024
Authority: IC 16-42-5-5
Affected: IC 15-17-5; IC 15-18-1; IC 16-42-11
Sec. 34.
(a)
				"Wholesale food establishment" means any establishment within Indiana that
				manufactures, packages, stores, repackages, or transports human food products
				for distribution to another entity for resale or redistribution.
(b) The term does not include the following:
(1) A residential kitchen in a private
				home.
(2) Bed and breakfast
				establishments subject to
				410 IAC
				7-15.5.
(3) An establishment engaged solely in the
				harvesting, storage, or distribution of one (1) or more raw agricultural
				commodities, that is not ordinarily cleaned, prepared, treated, or otherwise
				processed before being marketed to the consuming public.
(4) Meat and poultry processing plants
				subject to IC 15-2.1-24
[IC 15-2.1 was repealed by P.L. 2-2008,
				SECTION
				83, effective July 1, 2008. See IC
				15-17-5.]
; dairy processing plants subject to IC 15-2.1-23
[IC
				15-2.1 was repealed by P.L. 2-2008,
				SECTION
				83, effective July 1, 2008. See IC 15-18-1.]
and 345 IAC 8; or shell egg plants subject to
				370 IAC 1-10-1
				and IC 16-42-11.
(5) Any
				establishments as defined in
				410 IAC
				7-24-79, except when engaged in activities under
				subsection (a) or when producing acidified foods in hermetically sealed
				containers.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 21 - Wholesale Food Establishment Sanitation Requirements › Section 21-35 - Personnel health

Current through July 10, 2024
Authority: IC
				  16-42-5-5
Affected: IC 16-42-5
Sec. 35.
(a) The
				plant management shall take all reasonable measures and precautions to ensure
				compliance with the following:
(1) Any person
				who, by medical examination or supervisory observation, is shown to have, or
				appears to have:
(A) an illness;
(B) an open lesion, including:
(i) boils;
(ii) sores; or
(iii) infected wounds; or
(C) any other abnormal source of
				microbial contamination;
by which there is a reasonable possibility of food,
				  food-contact surfaces, or food-packaging materials becoming contaminated shall
				  be excluded or restricted from any operations, which may result in
				  contamination until the condition is corrected. Personnel shall be instructed
				  to report such health conditions to supervisory personnel.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 21 - Wholesale Food Establishment Sanitation Requirements › Section 21-36 - Personnel hygienic practices

Current through July 10, 2024
Authority: IC
				  16-42-5-5
Affected: IC 16-42-5
Sec. 36.
All persons working in direct contact with food,
				  food-contact surfaces, and food-packaging materials shall conform to good
				  hygienic practices while on duty. The methods for maintaining good hygiene
				  include, but are not limited to, the following:
(1) Wearing clean outer garments suitable to
				the operation in a manner that protects against the contamination of food,
				food-contact surfaces, or food-packaging materials.
(2) Maintaining adequate personal
				cleanliness, including:
(A) keeping
				fingernails clean and neatly trimmed; and
(B) not wearing fingernail polish or
				artificial fingernails;
while working with exposed food.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 21 - Wholesale Food Establishment Sanitation Requirements › Section 21-37 - Personnel training

Current through July 10, 2024
Authority: IC
				  16-42-5-5
Affected: IC 16-42-5
Sec. 37.
(a)
				Personnel responsible for identifying sanitation failures or food contamination
				shall have an educational background or experience, or a combination thereof,
				to provide a level of competency necessary for production of unadulterated,
				honestly presented, safe food. Food employees and supervisory personnel
				involved in food processing shall receive appropriate training in proper
				food-handling techniques, foodborne illness prevention, and food protection
				principles and be informed of the danger of poor personal hygiene and
				insanitary practices.
(b) Competent
				supervisory personnel shall be clearly assigned responsibility for assuring
				compliance by all food employees engaged in food processing with all
				requirements. Supervisory personnel shall hold a certification or be trained at
				a minimum on the following areas of knowledge as are applicable to the
				operations conducted at the wholesale food establishment:
(1) The relationship between the prevention
				of foodborne disease and the personal hygiene of a food employee.
(2) Responsibility of supervisory personnel
				for preventing the transmission of foodborne disease by a food employee who has
				an illness or medical condition that may cause foodborne disease.
(3) Symptoms associated with the diseases
				that are transmissible through food.
(4) Required food temperatures and times for
				safe cooking, cooling and reheating of potentially hazardous foods, and
				refrigerated storage temperatures include those for meat, poultry, eggs, and
				fish.
(5) The relationship between
				the prevention of foodborne illness and the management and control of the
				following:
(A) Cross-contamination.
(B) Hand contact with ready-to-eat
				foods.
(C) Hand washing.
(D) Maintaining the wholesale food
				establishment in a clean condition and in good repair.
(6) The correct procedures for cleaning and
				sanitizing utensils and food-contact surfaces of equipment.
(7) Poisonous or toxic materials
				identification and the procedures necessary to ensure that they are safely
				stored, dispensed, used, and disposed of according to law.
(8) Knowledge of important processing points
				in the operation from purchasing through sale or service.
(9) The principles and details of a HACCP
				plan, if used, or if required by federal or state law, or if an agreement
				between the department and the establishment exists.
(10) Water sources identification and
				measures taken to ensure that it remains protected from contamination, such as
				providing protection from backflow and precluding the creation of
				cross-connections.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 21 - Wholesale Food Establishment Sanitation Requirements › Section 21-38 - Physical facilities and grounds

Current through July 10, 2024
Authority: IC
				  16-42-5-5
Affected: IC 16-42-5
Sec. 38.
(a) The
				grounds surrounding a food plant under the control of the operator shall be
				kept in a condition that will protect against the contamination of food. The
				methods for adequate maintenance of grounds include, but are not limited to,
				the following:
(1) Properly storing or
				removing unnecessary equipment, removing litter and waste, and cutting weeds or
				grass within the immediate vicinity of the physical facility that may
				constitute an attractant, breeding place, or harborage for pests.
(2) Maintaining roads and parking lots so
				that they do not constitute a source of contamination in areas where food is
				exposed.
(3) Adequately draining
				areas that may contribute contamination to food by seepage, footborne filth, or
				providing a breeding place for pests.
(4) Operating systems for waste treatment and
				removal of liquid and solid waste at such a frequency that the waste does not
				constitute a source of contamination in areas where food is exposed.
(5) Constructing, if needed, an outdoor
				storage surface of nonabsorbent material, such as concrete or asphalt that
				shall be smooth, durable, and sloped to drain for refuse, recyclables, and
				returnables. Refuse, recyclables, and returnables shall be handled by:
(A) storing them in receptacles or waste
				handling units so that they are inaccessible to insects and rodents;
(B) keeping receptacles and waste handling
				units for refuse, recyclables, and returnables covered with tight-fitting lids
				or doors; and
(C) locating
				receptacles and waste handling equipment at a distance from the building that
				minimizes the entrance of pests and other vermin.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 21 - Wholesale Food Establishment Sanitation Requirements › Section 21-39 - Sanitary operations; general maintenance

Current through July 10, 2024
Authority: IC 16-42-5-5
Affected: IC 16-42-5
Sec. 39.
(a) The
				plant shall be:
(1) maintained in a sanitary
				condition; and
(2) kept in repair
				sufficient to prevent food from becoming adulterated.
Cleaning and sanitizing of utensils and equipment shall be
				  conducted in a manner that protects against contamination of food, food-contact
				  surfaces, or food-packaging materials.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 21 - Wholesale Food Establishment Sanitation Requirements › Section 21-40 - Toxic and poisonous substances; pest control

Current through July 10, 2024
Authority: IC 16-42-5-5
Affected: IC 15-16-5; IC 16-42-5
Sec. 40.
(a)
				Cleaning compounds and sanitizing agents used in cleaning and sanitizing
				procedures shall be free from undesirable micro-organisms and shall be safe and
				adequate under the conditions of use. Compliance with this requirement may be
				verified by an effective means, including, but not limited to, purchase of
				substances under a supplier's guarantee or certification, or examination of the
				substances for contamination.
(b)
				Only the following toxic materials may be used or stored in a plant where food
				is processed or exposed:
(1) Chemicals
				required for maintaining clean and sanitary conditions.
(2) Chemicals necessary for use in laboratory
				testing procedures.
(3) Chemicals
				necessary for plant and equipment maintenance and operation.
(4) Chemicals necessary for use in the
				plant's operations.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 21 - Wholesale Food Establishment Sanitation Requirements › Section 21-41 - Plumbing and sewage systems

Current through July 10, 2024
Authority: IC 16-42-5-5
Affected: IC 16-42-5
Sec. 41.
Each facility shall be equipped with effective plumbing and
				  sewage facilities and adequate accommodations, including, but not limited to,
				  the following:
(1) 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.
(2) 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 analyses of sample results for three (3) years, and provide
				such records to the department upon request.
(3) 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
				16-1.3, to do the following:
(A) Carry sufficient quantities of water to
				required locations throughout the facility.
(B) Properly convey sewage and liquid
				disposable waste from the facility.
(C) Avoid constituting a source of
				contamination to food, water supplies, equipment, and utensils or creating an
				unsanitary condition.
(D) 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.
(E) Prevent backflow or backsiphonage from,
				or cross-connection between, piping systems that discharge wastewater or sewage
				and piping systems that carry water for food or food manufacturing. This shall
				be accomplished by the following:
(i)
				Installing a backflow or backsiphonage prevention device on a water supply
				system which meets the standards in
				675 IAC
				16-1.3 for construction, installation, maintenance,
				inspection, and testing for that specific application and type of approved
				device.
(ii) Using an air gap, if
				necessary, between the water supply inlet and the flood level rim of the
				plumbing fixture, equipment, or nonfood equipment. It shall be at least twice
				the diameter of the water supply inlet and may not be less than one (1) inch.
				It shall be a minimum of two (2) pipe diameters of the pipe or six (6) inches,
				whichever is the lesser.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 21 - Wholesale Food Establishment Sanitation Requirements › Section 21-42 - Sanitary facilities and controls

Current through July 10, 2024
Authority: IC
				  16-42-5-5
Affected: IC 16-42-5
Sec. 42.
(a) Each
				facility shall provide its employees with adequate, readily accessible toilet
				facilities. Compliance with this requirement shall be accomplished by, but not
				limited to, the following:
(1) Maintaining the
				facilities in a sanitary condition.
(2) Keeping the facilities in good repair at
				all times.
(3) Providing
				self-closing doors.
(4) Providing
				doors that do not open into areas where food is exposed to airborne
				contamination, except where alternate means have been taken to protect against
				contamination, such as double doors or positive airflow systems.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 21 - Wholesale Food Establishment Sanitation Requirements › Section 21-43 - Equipment and utensils

Current through July 10, 2024
Authority: IC
				  16-42-5-5
Affected: IC 16-42-5
Sec. 43.
(a) 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:
(1) 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
				micro-organisms.
(2) 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.
(3) 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.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 21 - Wholesale Food Establishment Sanitation Requirements › Section 21-44 - Raw materials; production and process controls

Current through July 10, 2024
Authority: IC 16-42-5-5
Affected: IC 16-42-5
Sec. 44.
(a) All
				operations in the receiving, inspecting, transporting, segregating, preparing,
				manufacturing, packaging, and storing of food shall be conducted in accordance
				with current sanitation principles as follows:
(1) Appropriate quality control operations
				shall be employed to ensure that food is suitable for human consumption and
				that food-packaging materials are safe and suitable.
(2) Overall sanitation of the plant shall be
				under the supervision of one (1) or more competent individuals assigned
				responsibility for this function.
(3) All reasonable precautions shall be taken
				to ensure that production procedures do not contribute contamination from any
				source by adhering to the following:
(A)
				Chemical, microbial, or extraneous material testing procedures shall be used
				where necessary to identify sanitation failures or possible food
				contamination.
(B) All food that
				has become contaminated to the extent that it is adulterated shall be rejected
				or, if permissible, treated or processed to eliminate the
				contamination.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 21 - Wholesale Food Establishment Sanitation Requirements › Section 21-45 - Manufacturing operations

Current through July 10, 2024
Authority: IC 16-42-5-5
Affected: IC 16-42-5
Sec. 45.
(a)
				Equipment and utensils and finished food containers shall be maintained in an
				acceptable condition through appropriate cleaning and sanitizing and when
				necessary the following:
(1) Equipment shall
				be taken apart for thorough cleaning and sanitizing.
(2) A CIP system may be used when the design
				of the equipment requires the circulation or flowing by mechanical means
				through a piping system of a detergent solution, water rinse, and sanitizing
				solution.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 21 - Wholesale Food Establishment Sanitation Requirements › Section 21-46 - Reduced oxygen packaging

Current through July 10, 2024
Authority: IC
				  16-42-5-5
Affected: IC 16-42-5
Sec. 46.
(a) A
				wholesale food establishment that packages food using a reduced oxygen
				packaging method, with Clostridium botulinum identified as a microbiological
				hazard in the final packaged form, shall ensure that there are at least two (2)
				barriers in place to control the growth and toxin formation of Clostridium
				botulinum. These controls may include refrigeration, pH, and water
				activity.
(b) An establishment that
				packages food using a reduced oxygen packaging method, with Clostridium
				botulinum identified as a microbiological hazard in the final packaged form,
				shall have a HACCP plan that does the following:
(1) Contains a flow diagram by specific food
				or category type identifying critical control points and providing information
				on the following:
(A) Ingredients, materials,
				and equipment used in the preparation of that food.
(B) Formulations or recipes that delineate
				methods and procedural control measures that address the food safety concerns
				involved.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 21 - Wholesale Food Establishment Sanitation Requirements › Section 21-47 - Acidified foods

Current through July 10, 2024
Authority: IC
				  16-42-5-5
Affected: IC 16-42-5
Sec. 47.
A wholesale food establishment that processes acidified
				  foods shall employ appropriate quality control procedures to ensure that
				  finished foods do not present a health hazard as follows:
(1) All operators of processing and packaging
				systems shall be under the operating supervision of a person who has:
(A) attended a school giving instruction in
				food-handling techniques, food-protection principles, personal hygiene and
				plant sanitation practices, pH controls, and critical factors in acidification;
				and
(B) been identified by that
				school as having satisfactorily completed the prescribed course of instruction.
A United States Food and Drug Administration (FDA) sponsored
				  Better Processing Control School is an approved school. Other equivalent
				  schools approved by the department may be attended. The department shall
				  consider students who have satisfactorily completed required portions of the
				  school to be in compliance with the requirement of this subdivision.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 21 - Wholesale Food Establishment Sanitation Requirements › Section 21-48 - Warehousing and distribution

Current through July 10, 2024
Authority: IC
				  16-42-5-5
Affected: IC 16-42-5
Sec. 48.
Storage and transportation of finished food shall be under
				  conditions that will protect food against physical, chemical, and microbial
				  contamination as well as against deterioration of the food and the container.
				  Potentially hazardous foods shall be transported at the temperatures as
				  specified in section 45(c)(1) of this rule and sections 45(d) through 45(e) of
				  this rule
[section 45(c)(1) and 45(d) through 45(e) of this
				  rule]
.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 21 - Wholesale Food Establishment Sanitation Requirements › Section 21-49 - Accurate representation of packaged food using standards of identity, honest presentation of food, and food labels

Current through July 10, 2024
Authority: IC 16-42-5-5
Affected: IC 16-42-1; IC 16-42-2
Sec. 49.
(a)
				Packaged food shall comply with standard of identity requirements in 21 CFR 130
				through 21 CFR 169.
(b) Food shall
				be offered for human consumption in a way that does not mislead or misinform
				the consumer.
(c) Food or color
				additives, colored overwraps, or lights may not be used to misrepresent the
				true appearance, color, or quality of the food.
(d) Food packaged or stored in a wholesale
				food establishment shall be labeled as specified in law, including the
				following:
(1) IC 16-42-1.
(2) IC 16-42-2.
(3)
										410 IAC
				7-5.
(4)21
				CFR 101.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 21 - Wholesale Food Establishment Sanitation Requirements › Section 21-50 - Public health protection; access; reporting imminent health hazards

Current through July 10, 2024
Authority: IC
				  16-42-5-5
Affected: IC 16-42-5
Sec. 50.
(a) The
				department shall uniformly apply this rule to all wholesale food establishments
				in a reasonable manner that promotes its underlying purpose of safeguarding
				public health and ensuring that food is safe, not misbranded, unadulterated,
				and honestly presented when offered to the consumer.
(b) Facilities and equipment that were
				installed prior to the effective date of this rule, that do not fully meet all
				of the design and fabrication requirements, shall be deemed acceptable in that
				wholesale food establishment if it is in good repair, capable of being
				maintained in a sanitary condition, and the food-contact surfaces are
				nontoxic.
(c) After the department
				presents official credentials and expresses an intent to inspect, investigate,
				or collect food samples, the supervisory personnel shall allow the department
				access to the establishment during the establishment's hours of operation and
				other reasonable times. Information and records to which the department is
				entitled according to law and are specified in this rule shall be provided upon
				request.
(d) A wholesale food
				establishment shall immediately discontinue operations and notify the
				regulatory authority if an imminent health hazard may exist because of an
				emergency, such as:
(1) a fire;
(2) a flood;
(3) an extended interruption of electrical or
				water service;
(4) a sewage
				backup;
(5) a misuse of poisonous
				or toxic materials;
(6) an onset of
				an apparent foodborne illness outbreak;
(7) a gross unsanitary occurrence or
				condition; or
(8) other
				circumstance that may endanger public health.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 21 - Wholesale Food Establishment Sanitation Requirements › Section 21-51 - Registration of a wholesale food establishment

Current through July 10, 2024
Authority: IC
				  16-42-5-5
Affected: IC 16-42-5
Sec. 51.
(a) 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.
(b) A new
				wholesale food establishment shall not be established in Indiana until the
				place of business has been registered as provided in this subsection. The
				department shall be notified of intent to operate at least thirty (30) days
				prior to beginning operations.
(c)
				If ownership of a registered place of business changes, the new owner shall
				register the place of business before operating the same.
(d) If the name of the business or the
				address of a registered place of business changes, the owner shall register the
				change.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 21 - Wholesale Food Establishment Sanitation Requirements › Section 21-52 - Incorporation by reference

Current through July 10, 2024
Authority: IC 16-42-5-5
Affected: IC 16-42-5
Sec. 52.
(a) The
				following are hereby incorporated by reference:
(1)21 CFR 11 (April 1, 2001
				Edition).
(2)
										21
				CFR 110.110 (April 1, 2001
				Edition).
(3)21 CFR 101 (April 1,
				2001 Edition).
(4)21 CFR 113 (April
				1, 2001 Edition).
(5)21 CFR 129
				(April 1, 2001 Edition).
(6)21 CFR
				130 through 21 CFR 169 (April 1, 2001 Edition).
(7)21 CFR 170 through 21 CFR 180 (April 1,
				2001 Edition).
(8)21 CFR 181
				through 21 CFR 182, 21 CFR 184, and 21 CFR 186 (April 1, 2001
				Edition).
(9)
										21 CFR
				173.310 (April 1, 2001 Edition).
(10)
										21
				CFR 173.315 (April 1, 2001
				Edition).
(11)
										21 CFR
				178.1010 (April 1, 2001 Edition).
(12)
										21 CFR
				178.3570 (April 1, 2001 Edition).
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 22 - Certification of Food Handlers › Section 22-1 - Applicability

Current through July 10, 2024
Authority: IC
				  16-42-5.2-13
Affected: IC 16-42-5.2
Sec. 1.
The definitions in this rule apply throughout this rule.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 22 - Certification of Food Handlers › Section 22-2 - "Accreditation" defined

Current through July 10, 2024
Authority: IC
				  16-42-5.2-13
Affected: IC 16-42-5.2
Sec. 2.
"Accreditation" means that an accrediting organization has
				  verified a food safety certification examination meets the standards
				  established by the Conference for Food Protection. The food safety
				  certification examination shall be reviewed by an independent accrediting
				  organization to verify compliance with standards established by the Conference
				  for Food Protection.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 22 - Certification of Food Handlers › Section 22-3 - "Accredited certification examination" defined

Current through July 10, 2024
Authority: IC
				  16-42-5.2-13
Affected: IC 16-42-5.2
Sec. 3.
"Accredited certification examination" means a food
				  protection certification examination that meets the criteria established by the
				  Conference for Food Protection and has met the Conference for Food Protection
				  standards, such as the American National Standards Institute standards for such
				  programs.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 22 - Certification of Food Handlers › Section 22-4 - "Accrediting organization" defined

Current through July 10, 2024
Authority: IC
				  16-42-5.2-13
Affected: IC 16-42-5.2
Sec. 4.
"Accrediting organization" means an independent organization,
				  such as the American National Standards Institute, that determines whether a
				  food protection certification examination meets the standards established by
				  the Conference for Food Protection.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 22 - Certification of Food Handlers › Section 22-5 - "Accredited testing service" defined

Current through July 10, 2024
Authority: IC
				  16-42-5.2-13
Affected: IC 16-42-5.2
Sec. 5.
"Accredited testing service" means a testing service that
				  meets the standards established by the Conference for Food Protection and has
				  met the Conference for Food Protection and the American National Standards
				  Institute standards for such examinations.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 22 - Certification of Food Handlers › Section 22-6 - "Certification document" defined

Current through July 10, 2024
Authority: IC
				  16-42-5.2-13
Affected: IC 16-42-5.2
Sec. 6.
"Certification document" means a certificate, letter, or
				  other document verifying the individual has passed an accredited examination
				  given by an accredited testing service.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 22 - Certification of Food Handlers › Section 22-7 - "Certified food handler" defined

Current through July 10, 2024
Authority: IC
				  16-42-5.2-13
Affected: IC 16-42-5.2
Sec. 7.
"Certified food handler" means a food handler who holds a
				  certificate recognized by the Conference for Food Protection or an equivalent
				  nationally recognized certification program as determined by the department.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 22 - Certification of Food Handlers › Section 22-8 - "Department" defined

Current through July 10, 2024
Authority: IC
				  16-42-5.2-13
Affected: IC 16-42-5.2
Sec. 8.
"Department" means the Indiana department of health.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 22 - Certification of Food Handlers › Section 22-9 - "Food establishment" defined

Current through July 10, 2024
Authority: IC
				  16-42-5.2-13
Affected: IC 16-42-5.2
Sec. 9.
"Food establishment" means any building, room, basement,
				  vehicle of transportation, cellar, or open or enclosed area occupied or used
				  for handling food.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 22 - Certification of Food Handlers › Section 22-10 - "Food handler" defined

Current through July 10, 2024
Authority: IC
				  16-42-5.2-13
Affected: IC 16-42-5.2
Sec. 10.
"Food handler" means an individual who is an owner, an
				  operator, a manager, or an employee of a food establishment and is responsible
				  for or oversees the storage, preparation, display, or serving of food to the
				  public.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 22 - Certification of Food Handlers › Section 22-11 - "Person-in-charge" defined

Current through July 10, 2024
Authority: IC
				  16-42-5.2-13
Affected: IC 16-42-5.2
Sec. 11.
"Person-in-charge" means an individual present at a food
				  establishment who is responsible for the food operation at the time of
				  inspection.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 22 - Certification of Food Handlers › Section 22-12 - "Prepackaged food" defined

Current through July 10, 2024
Authority: IC
				  16-42-5.2-13
Affected: IC 16-42-5.2
Sec. 12.
"Prepackaged food" means prior to service and/or receipt of a
				  food, the food is bottled, canned, cartoned, securely wrapped, whether packaged
				  in a food establishment or a food processing plant. Prepackaged does not
				  include a wrapper, carry-out box, or other nondurable container used to
				  containerize food with the purpose of facilitating food protection during
				  service and receipt of the food by the consumer.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 22 - Certification of Food Handlers › Section 22-13 - "Recertification" defined

Current through July 10, 2024
Authority: IC
				  16-42-5.2-13
Affected: IC 16-42-5.2
Sec. 13.
"Recertification" means requiring a precertified individual
				  to pass an accredited certification examination within five (5) years from the
				  date of issue of their most recent certificate issue date or complying with the
				  accredited testing service's written policy for recertification.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 22 - Certification of Food Handlers › Section 22-14 - "Regulatory authority" defined

Current through July 10, 2024
Authority: IC
				  16-42-5.2-13
Affected: IC 16-42-5.2
Sec. 14.
"Regulatory authority" means the local or state body or
				  authorized representative having jurisdiction over a food establishment.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 22 - Certification of Food Handlers › Section 22-15 - Certified food handler requirements

Current through July 10, 2024
Authority: IC
				  16-42-5.2-13
Affected: IC 16-42-5.2
Sec. 15.
(a) A
				corporation or local health department may not impose any registration,
				certification, or licensing requirements on food handling or food
				handlers.
(b) After December 31,
				2004, at least one (1) food handler at a food establishment must be a certified
				food handler. A food handler's certification must be recognized by the
				Conference for Food Protection or an equivalent nationally recognized
				certification examination as determined by the department.
(c) A food establishment shall have at least
				one (1) certified food handler responsible for all periods of the food
				establishment's operation. However, a certified food handler need not be
				present at the food establishment during all hours of operation. It shall be
				the responsibility of the certified food handler to provide the certificate,
				letter, or document for verification of passing the examination.
(d) A food establishment that begins
				operation or changes ownership shall comply with subsection (b) not later than
				six (6) months after beginning operation or changing ownership.
(e) If a food establishment does not have a
				certified food handler because the certified food handler terminates employment
				with the food establishment, the owner or operator of the food establishment
				shall comply with subsection (b) not later than three (3) months after the
				termination date of the previous certified food handler.
(f) If more than one (1) food establishment
				operated by the same individual is located on the same property or on
				contiguous properties, only one (1) certified food handler is required for the
				food establishments.
(g) Except as
				provided in subsection (h), the certified food handler requirement does not
				apply to a food establishment when the food establishment's food handling
				activities are limited solely to one (1) or more of the following:
(1) Heating or serving precooked
				foods.
(2) Preparing or serving a
				continental breakfast such as rolls, coffee, juice, milk, and cold
				cereal.
(3) Preparing or serving
				nonalcoholic or alcoholic beverages that are not potentially hazardous
				beverages or ice.
(4) Preparing or
				serving packaged or unpackaged foods that are not potentially hazardous foods,
				including elephant ears, funnel cakes, cotton candy, confectionaries, baked
				goods, popcorn, and chips and grinding coffee beans.
(5) Providing prepackaged food in its
				original package.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 22 - Certification of Food Handlers › Section 22-16 - Assignment of supervision and responsibility

Current through July 10, 2024
Authority: IC
				  16-42-5.2-13
Affected: IC 16-42-5.2
Sec. 16.
(a) The
				food establishment shall have a person-in-charge present at the food
				establishment during all hours of operation.
(b) From one (1) year beyond the effective
				date of this rule, any food establishment not exempted from the law shall
				maintain at least one (1) copy of this rule on premises at all times. Immediate
				electronic access to this rule shall be considered acceptable for meeting this
				requirement.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 22 - Certification of Food Handlers › Section 22-17 - Qualifications for certification

Current through July 10, 2024
Authority: IC
				  16-42-5.2-13
Affected: IC 16-42-5.2
Sec. 17.
In order to become a certified food handler an individual
				  must comply with the following:
(1)
				Successfully pass an accredited examination administered by an accredited
				testing service.
(2) Provide name,
				certification document (copies thereof), and photo identification card at the
				food establishment for the certified food handler. The certification document
				shall be made available by the person-in-charge for inspection by the
				regulatory authority at all times.
(3) The certification document shall be
				removed from the food establishment when the certified food handler terminates
				employment with the food establishment.
(4) No person shall be designated as a
				certified food handler or in any way represent himself or herself as a
				certified food handler unless they hold a certification document.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 22 - Certification of Food Handlers › Section 22-18 - Recertification

Current through July 10, 2024
Authority: IC
				  16-42-5.2-13
Affected: IC 16-42-5.2
Sec. 18.
(a) A
				person designated as the certified food handler for a food establishment must
				not allow their certification to expire. and
(b) The certified food handler shall become
				recertified as defined in section 13
[of this rule]
.
Indiana Administrative Code › Title 410 - INDIANA DEPARTMENT OF HEALTH › Article 7 - FOOD AND DRUGS › Rule 22 - Certification of Food Handlers › Section 22-19 - Penalties

Current through July 10, 2024
Authority: IC
				  16-42-5.2-13
Affected: IC 16-42-5.2
Sec. 19.
Unless adjusted by an administrative order, the following
				  schedule of monetary penalties shall be used if penalties are to be assessed:
Section 15(a), (b), (c), (d), (e), and (f) [Section
							 15(a) through 15(f) of this rule]
$0-100 per day per violation
Section 16(a) [of this rule]
$0-100 per day per violation
Section 16(b) [of this rule]
$0-50 per day per violation
Section 17(a), 1, 2, 3 and 4 [Section 17(1) through
							 17(4) of this rule]
$0-100 per day per violation