AUTHORITY: Implementing and authorized by the Illinois Food, Drug and Cosmetic Act [410 ILCS 620].

SOURCE: Filed November 12, 1969, effective January 12, 1970; codified at 8 Ill. Reg. 16832; amended at 35 Ill. Reg. 14187, effective August 2, 2011; amended at 40 Ill. Reg. 9201, effective June 21, 2016; amended at 41 Ill. Reg. 5808, effective May 11, 2017.

SUBPART A: GENERAL PROVISIONS

 

Section 730.1000  Definitions

 

The definitions and interpretations contained in section 201 of the Federal Food, Drug and Cosmetic Act (21 USC 321) and Section 502 of the Illinois Food, Drug and Cosmetic Act [410 ILCS 620] are applicable to terms used in this Part.  Additional terms are defined as follows:

 

"Adequate" means that which is needed to accomplish the intended purpose in keeping with good public health practice.

 

"Plant" means the building or buildings or parts thereof used for, or in connection with, the manufacturing, processing, packaging, labeling or holding of human food.

 

"Sanitize" means adequate treatment of surfaces by a process that is effective in destroying vegetative cells of pathogenic bacteria and in substantially reducing other micro-organisms.  This treatment shall not adversely affect the product and shall be safe for the consumer.

 

(Source:  Amended at 40 Ill. Reg. 9201, effective June 21, 2016)

 

Section 730.1005  Incorporated and Referenced Materials

 

a)         The following federal guidelines and regulations are incorporated by reference:

 

1)         21 CFR 123:  Fish and Fishery Products (April 1, 2012); https://www.gpo.gov/fdsys/pkg/CFR-2012-title21-vol2/pdf/CFR-2012-title21-vol2-part123.pdf.

 

2)         21 CFR 120:  Hazard Analysis and Critical Control Point (HACCP) Systems (April 1, 2012); https://www.gpo.gov/fdsys/granule/CFR-2012-title21-vol2/CFR-2012-title21-vol2-part120.

 

3)         21 CFR 146:  Canned Fruit Juices (April 1, 2011); https://www.gpo.gov/

fdsys/granule/CFR-2011-title21-vol2/CFR-2011-title21-vol2-part146.

 

4)         21 CFR 163:  Cacao Products (April 11, 2011); https://www.gpo.gov/

fdsys/pkg/CFR-2011-title21-vol2/pdf/CFR-2011-title21-vol2-part163.pdf.

 

5)         Guide for the Control of Molluscan Shellfish 2013 Revision. U.S. Food and Drug Administration, Office of Food Safety, Division of Food Safety, HFS-325, 5100 Paint Branch Parkway, College Park MD 20740-3835; http://www.fda.gov/downloads/Food/GuidanceRegulation/Federal

StateFoodPrograms/UCM415522.pdf. 

 

6)         21 CFR 117:  Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food (September 17, 2015); http://www.gpo.gov/fdsys/pkg/FR-2015-09-17/pdf/2015-21920.pdf.

 

b)         All incorporations by reference of federal guidelines and regulations refer to the materials on the date specified and do not include any amendments or editions subsequent to the date specified.

 

(Source:  Amended at 41 Ill. Reg. 5808, effective May 11, 2017)

 

Section 730.1006  Compliance with National Standards

 

No person shall engage in the wholesale handling of shellfish, or operate or conduct an establishment for shipping, post-harvest processing, shucking, repacking or wet storage of shellfish, except in compliance with the requirements of the Guide for the Control of Molluscan Shellfish 2013 Revision.

 

(Source:  Amended at 40 Ill. Reg. 9201, effective June 21, 2016)

 

Section 730.1010  Adequate (Repealed)

 

(Source:  Repealed at 40 Ill. Reg. 9201, effective June 21, 2016)

 

Section 730.1020  Plant (Repealed)

 

(Source:  Repealed at 40 Ill. Reg. 9201, effective June 21, 2016)

 

Section 730.1030  Sanitize (Repealed)

 

(Source:  Repealed at 40 Ill. Reg. 9201, effective June 21, 2016)

SUBPART B: CURRENT GOOD MANUFACTURING PRACTICE (SANITATION)

 

Section 730.2010  Scope

 

The criteria in Subparts C through H shall apply in determining whether the facilities, methods, practices, and controls used in the manufacture, processing, packing, or holding of food are in conformance with or are operated or administered in conformity with good manufacturing practices to assure that food for human consumption is safe and has been prepared, packed, and held under sanitary conditions.

SUBPART C: PLANT AND GROUNDS

 

Section 730.3010  Grounds

 

The grounds about a food plant under the control of the operator shall be free from conditions which may result in the contamination of food including, but not limited to, the following:

 

a)         Improperly stored equipment, litter, waste, refuse, and uncut weeds or grass within the immediate vicinity of the plant buildings or structures that may constitute an attractant, breeding place, or harborage for rodents, insects, and other pests.

 

b)         Excessively dusty roads, yards, or parking lots that may constitute a source of contamination in areas where food is exposed.

 

c)         Inadequately drained areas that may contribute contamination to food products through seepage or foot-borne filth and by providing a breeding place for insects or micro-organisms. If the plant grounds are bordered by grounds not under the operator's control of the kind described in subsections (a) through (c) of this paragraph, care must be exercised in the plant by inspection, extermination, or other means to effect exclusion of pests, dirt, and other filth that may be a source of food contamination.

 

Section 730.3020  Plant Construction and Design

 

Plant buildings and structures shall be suitable in size, construction, and design to facilitate maintenance and sanitary operations for food-processing purposes.  The plant and facilities shall:

 

a)         Provide sufficient space for such placement of equipment and storage of materials as is necessary for sanitary operations and production of safe food.  Floors, walls, and ceilings in the plant shall be of such construction as to be adequately cleanable and shall be kept clean and in good repair.  Fixtures, ducts, and pipes shall not be so suspended over working areas that drip or condensate may contaminate foods, raw materials, or food-contact surfaces.  Aisles or working spaces between equipment and between equipment and walls shall be unobstructed and of sufficient width to permit employees to perform their duties without contamination of food or food-contact surfaces with clothing or personal contact.

 

b)         Provide separation by partition, location, or other effective means for those operations which may cause contamination of food products with undesirable micro-organisms, chemicals, filth, or other extraneous material.

 

c)         Provide adequate lighting to hand-washing areas, dressing and locker rooms, and toilet rooms and to all areas where food or food ingredients are examined, processed, or stored and where equipment and utensils are cleaned.  Light bulbs, fixtures, skylights, or other glass suspended over exposed food in any step of preparation shall be of the safety type or otherwise protected to prevent food contamination in case of breakage.

 

d)         Provide adequate ventilation or control equipment to minimize odors and noxious fumes or vapors (including steam) in areas where they may contaminate food.  Such ventilation or control equipment shall not create conditions that may contribute to food contamination by airborne contaminants.

 

e)         Provide, where necessary, effective screening or other protection against birds, animals, and vermin (including, but not limited to, insects and rodents).

SUBPART D: EQUIPMENT AND UTENSILS

 

Section 730.4010  Suitable for Intended Use

 

All plant equipment and utensils shall be suitable for their intended use.

 

Section 730.4020  Cleanable

 

All plant equipment and utensils shall be so designed and of such material and workmanship as to be adequately cleanable.

 

Section 730.4030  Maintenance

 

All plant equipment and utensils shall be properly maintained.

 

Section 730.4040  Prevents Contamination

 

The design, construction, and use of such equipment and utensils shall preclude the adulteration of food with lubricants, fuel, metal fragments, contaminated water, or any other contaminants.

 

Section 730.4050  Installation

 

All equipment should be so installed and maintained as to facilitate the cleaning of the equipment and of all adjacent spaces.

SUBPART E: SANITARY FACILITIES AND CONTROLS

 

Section 730.5000  Adequate Sanitary Facilities and Accommodations

 

Each plant shall be equipped with adequate sanitary facilities and accommodations including, but not limited to, the requirements of Sections 730.5010 through 730.5060.

 

Section 730.5010  Water Supply

 

The water supply shall be sufficient for the operations intended and shall be derived from an adequate source.  Any water that contacts foods or food-contact surfaces shall be safe and of adequate sanitary quality.  Running water at a suitable temperature and under pressure as needed shall be provided in all areas where the processing of food, the cleaning of equipment, utensils, or containers, or employee sanitary facilities require.

 

Section 730.5020  Sewage Disposal

 

Sewage disposal shall be made into an adequate sewerage system or disposed of through other adequate means.

 

Section 730.5030  Plumbing

 

Plumbing shall be of adequate size and design and adequately installed and maintained to:

 

a)         Carry sufficient quantities of water to required locations throughout the plant.

 

b)         Properly convey sewage and liquid disposable waste from the plant.

 

c)         Not constitute a source of contamination to foods, food products or ingredients, water supplies, equipment, or utensils or create an insanitary condition.

 

d)         Provide adequate 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.

 

Section 730.5040  Toilet Facilities

 

Each plant shall provide its employees with adequate toilet and associated handwashing facilities within the plant. Toilet rooms shall be furnished with toilet tissue.  The facilities shall be maintained in a sanitary condition and kept in good repair at all times. Doors to toilet rooms shall be self-closing and shall not open directly into areas where food is exposed to airborne contamination, except where alternate means have been taken to prevent such contamination (such as double doors, positive air-flow systems, etc.). Signs shall be posted directing employees to wash their hands with cleaning soap or detergents after using toilet.

 

Section 730.5050  Hand-washing Facilities

 

Adequate and convenient facilities for hand washing and, where appropriate, hand sanitizing shall be provided at each location in the plant where good sanitary practices require employees to wash or sanitize and dry their hands.  Such facilities shall be furnished with running water at a suitable temperature for hand washing, effective hand-cleaning and sanitizing preparations, sanitary towel service or suitable drying devices, and where appropriate, easily cleanable waste receptacles.

 

Section 730.5060  Waste Disposal

 

Rubbish and any offal shall be so conveyed, stored, and disposed of as to minimize the development of odor, prevent waste from becoming an attractant harborage or breeding place for vermin, and prevent contamination of food, food-contact surfaces, ground surfaces, and water supplies.

SUBPART F: SANITARY OPERATIONS

 

Section 730.6010  General Maintenance

 

Buildings, fixtures, and other physical facilities of the plant shall be kept in good repair and shall be maintained in a sanitary condition.  Cleaning operations shall be conducted in such a manner as to minimize the danger of contamination of food and food-contact surfaces.  Detergents, sanitizers, and other supplies employed in cleaning and sanitizing procedures shall be free of significant microbiological contamination and shall be safe and effective for their intended uses.  Only such toxic materials as are required to maintain sanitary conditions, for use in laboratory testing procedures, for plant and equipment maintenance and operation, or in manufacturing or processing operations shall be used or stored in the plant.  These materials shall be identified and used only in such manner and under conditions as will be safe for their intended uses.

 

Section 730.6020  Animal and Vermin Control

 

No animals or birds, other than those essential as raw material, shall be allowed in any area of a food plant. Effective measures shall be taken to exclude pests from the processing areas and to protect against the contamination of foods in or on the premises by animals, birds, and vermin (including, but not limited to, rodents and insects).  The use of insecticides or rodenticides is permitted only under such precautions and restrictions as will prevent the contamination of food or packaging materials with illegal residues.

 

Section 730.6030  Sanitation of Equipment and Utensils

 

All utensils and product-contact surfaces of equipment shall be cleaned as frequently as necessary to prevent contamination of food and food products. Nonproduct-contact surfaces of equipment used in the operation of food plants should be cleaned as frequently as necessary to minimize accumulation of dust, dirt, food particles, and other debris.  Single-service articles (such as utensils intended for one-time use, paper cups, paper towels, etc.) should be stored in appropriate containers and handled, dispensed, used, and disposed of in a manner that prevents contamination of food or food-contact surfaces.  Where necessary to prevent the introduction of undesirable micro-biological organisms into food products, all utensils and product-contact surfaces of equipment used in the plant shall be cleaned and sanitized prior to such use and following any interruption during which such utensils and contact surfaces may have become contaminated.  Where such equipment and utensils are used in a continuous production operation, the contact surfaces of such equipment and utensils shall be cleaned and sanitized on a predetermined schedule using adequate methods for cleaning and sanitizing.  Sanitizing agents shall be effective and safe under conditions of use.  Any facility, procedure, machine, or device may be acceptable for cleaning and sanitizing equipment and utensils if it is established that such facility, procedure, machine, or device will routinely render equipment and utensils clean and provide adequate treatment.

 

Section 730.6040  Storage and Handling of Cleaned Portable Equipment and Utensils

 

Cleaned and sanitized portable equipment and utensils with product-contact surfaces should be stored in such a location and manner that product-contact surfaces are protected from splash, dust, and other contamination.

SUBPART G: PROCESSES AND CONTROLS

 

Section 730.7000  Adequate Sanitation Principles

 

All operations in the receiving, inspecting, transporting, packaging, segregation, preparing, processing, and storing of food shall be conducted in accord with adequate sanitation principles.  Overall sanitation of the plant shall be under the supervision of an individual assigned responsibility for this function.  All reasonable precautions, including those described in Sections 730.7010 through 730.7100, shall be taken to assure that production procedures do not contribute contamination such as filth, harmful chemicals, undesirable microorganisms, or any other objectionable material to the processed product.

 

Section 730.7010  Raw Material Inspection, Storage, and Preparation

 

Raw material and ingredients shall be inspected and segregated as necessary to assure that they are clean, wholesome, and fit for processing into human food and shall be stored under conditions that will protect against contamination and minimize deterioration.  Raw materials shall be washed or cleaned as required to remove soil or other contamination.  Water used for washing, rinsing, or conveying of food products shall be of adequate quality, and water shall not be reused for washing, rinsing, or conveying products in a manner that may result in contamination of food products.

 

Section 730.7020  Raw Material Carrier Inspection

 

Containers and carriers of raw ingredients should be inspected on receipt to assure that their condition has not contributed to the contamination or deterioration of the products.

 

Section 730.7030  Potable Ice

 

When ice is used in contact with food products, it shall be made from potable water and shall be used only if it has been manufactured in accordance with adequate standards and stored, transported, and handled in a sanitary manner.

 

Section 730.7040  Cross Contamination

 

Food-processing areas and equipment used for processing human food should not be used to process nonhuman food-grade animal feed or inedible products unless there is no reasonable possibility for the contamination of the human food.

 

Section 730.7050  Equipment Cleaning

 

Processing equipment shall be maintained in a sanitary condition through frequent cleaning including sanitization where indicated.  Insofar as necessary, equipment shall be taken apart for thorough cleaning.

 

Section 730.7060  Proper Processing

 

All food processing, including packaging and storage, should be conducted under such conditions and controls as are necessary to minimize the potential for undesirable bacterial or other microbiological growth, toxin formation, or deterioration or contamination of the processed product or ingredients.  This may require careful monitoring of such physical factors as time, temperature, humidity, pressure, flow-rate and such processing operations as freezing, dehydration, heat processing, and refrigeration to assure that mechanical break-downs, time delays, temperature fluctuations, and other factors do not contribute to the decomposition or contamination of the processed products.

 

Section 730.7070  Testing Procedures

 

Chemical, microbiological, or extraneous-material testing procedures shall be utilized where necessary to identify sanitation failures or food contamination, and all foods and ingredients that have become contaminated shall be rejected or treated or processed to eliminate the contamination where this may be properly accomplished.

 

Section 730.7080  Packaging

 

Packaging processes and materials shall not transmit contaminants or objectionable substances to the products, shall conform to any applicable food additive regulation and should provide adequate protection from contamination.

 

Section 730.7090  Products Coded and Records Retained

 

Meaningful coding of products sold or otherwise distributed from a manufacturing, processing, packing, or repacking activity should be utilized to enable positive lot identification to facilitate, where necessary, the segregation of specific food lots that may have become contaminated or otherwise unfit for their intended use. Records should be retained for a period of time that exceeds the shelf life of the product, except that they need not be retained more than 2 years.

 

Section 730.7100  Product Storage and Carriers

 

Storage and transportation of finished products should be under such conditions as will prevent contamination, including development of pathogenic or toxigenic micro-organisms, and will protect against undesirable deterioration of the product and the container.

SUBPART H: PERSONNEL

 

Section 730.8000  Management Responsibilities

 

The plant management shall take all reasonable measures and precautions to assure compliance with Sections 730.8010 through 730.8040.

 

Section 730.8010  Disease Control

 

No person affected by disease in a communicable form, or while a carrier of such disease, or while affected with boils, sores, infected wounds, or other abnormal sources of microbiological contamination, shall work in a food plant in any capacity in which there is a reasonable possibility of food or food ingredients becoming contaminated by such person, or of disease being transmitted by such person to other individuals.

 

Section 730.8020  Cleanliness

 

All persons, while working in direct contact with food preparation, food ingredients, or surfaces coming into contact therewith shall:

 

a)         Wear clean outer garments, maintain a high degree of personal cleanliness, and conform to hygienic practices while on duty, to the extent necessary to prevent contamination of food products.

 

b)         Wash their hands thoroughly (and sanitize if necessary to prevent contamination by undesirable micro-organism) in an adequate handwashing facility before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated.

 

c)         Remove all insecure jewelry and, during periods where food is manipulated by hand, remove from hands any jewelry that cannot be adequately sanitized.

 

d)         If gloves are used in food handling, maintain them in an intact, clean, and sanitary condition.  Such gloves should be of an impermeable material except where their usage would be inappropriate or incompatible with the work involved.

 

e)         Wear hairnets, headbands, caps, or other effective hair restraints.

 

f)         Not store clothing or other personal belongings, eat food or drink beverages, or use tobacco in any form in areas where food or food ingredients are exposed or in areas used for washing equipment or utensils.

 

g)         Take any other necessary precautions to prevent contamination of foods with microorganisms or foreign substances including, but not limited to, perspiration, hair, cosmetics, tobacco, chemicals, and medicants.

 

Section 730.8030  Education and Training

 

Personnel responsible for identifying sanitation failures or food contamination should have a background of education or experience, or a combination thereof, to provide a level of competency necessary for production of clean and safe food.  Food handlers and supervisors should receive appropriate training in proper food-handling techniques and food-protection principles and should be cognizant of the danger of poor personal hygiene and insanitary practices.

 

Section 730.8040  Supervision

 

Responsibility for assuring compliance by all personnel with all requirements of this regulation shall be clearly assigned to competent supervisory personnel.

SUBPART I: EXCLUSIONS

 

Section 730.9010  Operations Excluded

 

The following operations are excluded from coverage under these general regulations, however, the Director will issue special regulations when he believes it necessary to cover these excluded operations:  Establishments engaged solely in the harvesting, storage, or distribution of one or more raw agricultural commodities, as defined in Section 201(r) of the Federal Act, 21 U.S.C. 321r, and Section 502.18 of the Illinois Food, Drug and Cosmetic Act, Ill. Rev. Stat., 1983, ch. 56˝, par. 502.18, which are ordinarily cleaned, prepared, treated or otherwise processed before being marketed to the consuming public.