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

SOURCE: Filed as amended June 13, 1972, effective June 26, 1972 and August 14, 1972; codified at 8 Ill. Reg. 18491; Part repealed, new Part adopted at 11 Ill. Reg. 2356, effective February 1, 1987; amended at 17 Ill. Reg. 14027, effective August 15, 1993; amended at 19 Ill. Reg. 12295, effective August 10, 1995; amended at 25 Ill. Reg. 12634, effective September 25, 2001.

SUBPART A: DEFINITIONS

 

Section 785.100  Meaning of Words

 

Words used in the singular form shall be deemed to impart the plural, and vice versa, as the case may demand.

 

Section 785.110  Definitions

 

"Act" means the Illinois Food, Drug and Cosmetic Act. (Ill. Rev. Stat. 1991, ch. 56½, pars. 501 et seq.) [410 ILCS 620]

 

"Acceptable Milk" means milk that qualifies under Section 785.210 as to sight and odor and that is classified No. 1 or No. 2 for sediment content Section 785.220 and No. 1 or No. 2 for bacterial estimate Section 785.230.

 

"Atmosphere Relatively Free from Mold" means no more than 10 mold colonies per cubic foot of air as determined in Standard Methods.

 

"Bulk Milk Pick-up Tanker" means a vehicle, including the truck, tank and those appurtenances necessary for its use, used by a milk hauler to transport bulk raw milk from a dairy farm for manufacturing purposes.

 

"C-I-P or Cleaned-In-Place" means the procedure by which sanitary pipelines or pieces of dairy equipment are mechanically cleaned in place by circulation.

 

"Dairy Farm or Farm" means a place or premise where one or more milking cows or goats are kept, a part or all of the milk produced thereon being delivered, sold, or offered for sale to a plant for manufacturing purposes.

 

"Dairy Plant or Plant" means any place, premise, or establishment where milk or dairy products are received or handled for processing or manufacturing and/or prepared for distribution.  When "plant" is used in connection with the production, transportation, grading, or use of milk, it means any plant that handles or purchases milk for manufacturing purposes; when used in connection with requirements for plants or licensing of plants, it means only those plants that manufacture dairy products.

 

"Dairy Products" means evaporated milk, condensed skim milk, condensed milk, concentrate milk, nonfat dry milk, dry milk, dry cream, dry whey, dry buttermilk, butter, buttermilk, cheese, cheese products, ice cream, ice milk, sherbet, frozen dessert, dairy confections, or novelties, related dairy products (products with butter fat or milk solids substitutions or milk and dairy product imitations) and other such dairy products for human consumption not regulated under 77 Ill. Adm. Code 775.  All dairy products shall meet the applicable definitions and standards of identity as promulgated under the Federal Food Drug, and Cosmetic Act and published in Chapter 1, Title 21 of the Code of Federal Regulations.

 

"Department" means the Illinois Department of Public Health.

 

"Drug" means: articles recognized in the official United States Pharmocopeia, official Homeopathic Pharmacopeia of the United States, or official National Formulary, or any supplement to any of them; articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; articles (other than food) intended to affect the structure or any function of the body of man or other animals; and articles intended for use as a component of any article specified in this definition; however, drugs do not include devices or their components, parts or accessories.

 

"Excluded Milk" means all of a producer's milk excluded from the market by the provisions of Section 785.260.

 

"Farm Licensing" means licensing by the Department that a producer's herd, milking facility and housing, milking procedure, cooling, milkhouse or milkroom, utensils and equipment and water supply have been found to meet the requirements of Subpart C of this Part for the production of milk to be used for manufacturing purposes.

 

"Field Representative" means a person qualified and trained in the sanitary methods of production and handling of milk as set forth herein, and generally employed by a processing or manufacturing plant for the purpose of doing quality control work.

 

"Inspector" means a qualified, trained person employed by the Illinois Department of Public Health to perform dairy farm or plant inspections, raw milk grading, and sampling processed dairy products.

 

"Laboratory" means the official laboratory operated by the Department and State approved laboratories authorized to do official work by the Department, or a milk industry laboratory designated by the Department for the examination of dairy farm producers samples of raw milk for processing and commingled milk tank truck samples of raw milk for drug, pesticide, herbicide, and mycotoxin residues and bacterial tests.

 

"License" means a license issued under the Act by the Illinois Department of Public Health.

 

"Milk":  Milk is the lacteal secretion, free from colostrum, obtained by the complete milking of one or more healthy cows. Goat milk is the lacteal secretion, free from colostrum, obtained by the complete milking of one or more healthy goats.  Goat milk shall only be used to manufacture dairy products when legally provided for in the Code of Federal Regulations Title 21, traditional products using common or usual names. The word "milk" used herein includes only milk for manufacturing purposes.

 

"Milk for Manufacturing Purposes" means milk produced for processing and manufacturing into products for human consumption but not subject to Grade A requirements.

 

"Milk Hauler-Sampler" means a person licensed by the Department as described in Section 785.1170(b) who is qualified and trained for the grading and sampling of raw milk in accordance with the quality standards and procedures of Subparts B and K.

 

"Official Methods" means 15^th edition of Official Methods of Analysis of the Association of Official Analytical Chemists, a publication of the Association of Official Analytical Chemists, Box 540, Benjamin Franklin Station, Washington, DC. 

 

"Probational Milk" means milk classified No. 3 for sediment content Section 785.220 or milk classified "Undergrade" for bacterial estimate Section 785.230 that may be accepted by plants for specific time periods.

 

"Producer" means the person or persons who exercise control over the production of the milk delivered to a processing plant or receiving station and those who receive payment for this product.  A "new producer" is one who has only recently started producing milk for the market.  A "transfer producer" is one who has been shipping milk to one plant and transfers his shipments to another plant.

 

"Quality Assurance Program" means the Milk and Dairy Beef Quality Assurance Program, Boeckman, Steve and Carlson, Keith R., Agri-Education Inc., Stratford, Iowa 50249 or equivalent as determined by the Department.

 

"Reciprocity" means milk, cream, and dairy products from outside the State of Illinois may be sold in the State of Illinois upon certification from the state of origin in which the product is produced, processed, packaged, and stored under regulations which are equivalent to the rules of this Part and provided further that the governmental unit concerned accepts Illinois dairy products on a reciprocity basis.

 

"Reject Milk" means milk that does not qualify under Section 785.210 as to sight and odor, or that is classified No. 4 for sediment content Section 785.220, which is rejected by the plant by the provisions of Section 785.240.

 

"Sanitary conditions" and "sanitary manner" means under circumstances or prepared in such a manner as to be clean and free from contamination.

 

"Sanitizing Treatment" means application of any effective method or sanitizing agent to a clean surface for the destruction of pathogens and other organisms.  The sanitizing agents used shall comply with the Federal Food, Drug, and Cosmetic Act 40 C.F.R. Parts 150-189, Section 162.3(ff)(2)(i)(B).

 

"Standard Methods" means the 15^th Edition of Standard Methods for the Examination of Dairy Products, a publication of the American Public Health Association, 1015 – 15^th, N.W., Washington, D.C. 20036.

 

"Violative drug residue" means a drug residue at or above the tolerance level set forth in 21 CFR 556 (1991) and/or safe levels as established by the federal Food and Drug Administrative for drugs for which tolerance levels have not been set.

 

"3-A Sanitary Standards" means the standards for dairy equipment formulated by the 3-A Sanitary Standards Committees representing the International Association of Milk, Food and Environmental Sanitarians, the U.S. Public Health Service, and the Dairy Industry Committee.  Published by the International Association of Milk, Food and Environmental Sanitarians, Box 701 Ames, Iowa 50010.

 

(Source:  Amended at 17 Ill. Reg. 14027, effective August 15, 1993)

 

Section 785.120  Incorporated Materials

 

a)         The following materials are incorporated or referenced in this Part:  

 

1)         The Standard Methods for the Examination of Dairy Products, 15^th Edition, 1985 American Public Health Association, 1015 – 15^th Street, N.W., Washington, D.C. 20036).  (See Section 785.110)

 

2)         Official Methods of Analyses of the Association of Official Analytical Chemists (15^th Edition 1990, Association of Official Analytical Chemists, P.O. Box 540, Ben Franklin Station, Washington, D.C. 20044).  (See Section 785.110)

 

3)         Illinois Plumbing Code – 77 Ill. Adm. Code 890 (See Section 785.405 – 785.410)

 

4)         Illinois Pesticide Act of 1979 – (See Ill. Rev. Stat. 1991, ch. 5, pars. 801 et seq. [415 ILCS 60] and 8 Ill. Adm. Code 250).  (See Section 785.405 – 785.920)

 

5)         Standards for Approval of Milk Laboratories – 77 Ill. Adm. Code 463.  (See Section 785.230 – 785.405)

 

6)         Rules for Drinking Water Systems – 77 Ill. Adm. Code 900. (See Section 785.360,  785.370,  and 785.410)

 

7)         Illinois Bovine Tuberculosis Eradication Act (Ill. Rev. Stat. 1991, ch. 8, par. 87 et seq.) [510 ILCS 35], Bovine Brucellosis Eradication Act (Ill. Rev. Stat. 1991, ch. 8, par. 134 et seq.) [510 ILCS 30]. (See Section 785.300)

 

8)         Illinois Food, Drug and Cosmetic Act (Ill. Rev. Stat. 1991, ch. 56½, pars. 501 et seq.) [410 ILCS 620]. (See Section 785.445)

 

9)         Section 10-65 of the Illinois Administrative Procedure Act (Ill. Rev. Stat. 1991, ch. 127, par. 1010-65) [5 ILCS 100/10-65].  (See Section 785.1170)

 

10)         Producing Culinary Steam for Processing Milk and Milk Products (Published by the National Association of Dairy Equipment Manufacturers, Washington D.C. April 1963).  (See Section 785.410)

 

11)         7 CFR 58, Subpart T.  (See Section 785.220)

 

12)         21 CFR 133, 135, 173, 193 and 556.  (See Section 785.110, 785.290, 785.300,   785.410, 785.415 and 785.440)

 

13)         40 CFR 163.  (See Section 785.110)

 

14)         Illinois Food Service Sanitation Code (77 Ill. Adm. Code 750).  (See Section 785.970)

 

15)         The Veterinary Medicine and Surgery Practice Act of 1983 (Ill. Rev. Stat. 1991, ch. 111, pars. 7001 et seq.) [225 ILCS 115]

 

b)         All incorporation by reference refers to the materials on the date specified and do not include any additions or deletions subsequent to the date specified.

 

c)         All citations to federal regulations in this Part concern the specified regulation in the 1991 Code of Federal Regulations, unless another date is specified.

 

d)         Copies of all incorporated materials are available for inspection and copying by the public at the Department's Central Office, Division of Food, Drugs and Dairies (525 West Jefferson, Springfield, Illinois 62761).

 

(Source:  Amended at 17 Ill. Reg. 14027, effective August 15, 1993)

SUBPART B: ILLINOIS QUALITY REQUIREMENTS FOR MILK FOR MANUFACTURING PURPOSES

 

Section 785.200  Basis

 

Raw milk for manufacturing purposes from all individual producers shall be based on the following:  organoleptic examination (appearance and odor), quality control tests for sediment content, bacterial estimate, somatic cell count, and drugs.

 

(Source:  Amended at 17 Ill. Reg. 14027, effective August 15, 1993)

 

Section 785.210  Appearance and Odor

 

The appearance of acceptable raw milk shall be normal and free of sediment when examined visually or by test procedure.  It shall not show any abnormal condition (including, but not limited to curdled, ropy, bloody or mastitic condition), as indicated by sight or other test procedures.  The milk shall be free from objectionable feed and other off-odors.

 

Section 785.220  Sediment Content Classification

 

Milk in farm bulk tanks shall be classified for sediment content as noted in Table 220.

 

TABLE 220

 

ILLINOIS SEDIMENT STANDARD

 

Sediment-content classification
No. 1	(acceptable).......................................................	Not to exceed 0.50 mg. or equivalent.
No. 2	(acceptable).......................................................	Not to exceed 1.50 mg. or equivalent.
No. 3	(probational)......................................................	Not to exceed 2.50 mg. or equivalent.
No. 4	(reject)...............................................................	Over 2.50 mg. or equivalent.

 

a)         Method of Testing:  Methods for determining sediment content of milk shall be those described in the 15th edition of Standard Methods for the Examination of Dairy Products.  Sediment content shall be based on comparison with applicable charts of the United States Department of Agriculture Sediment Standard for Milk and Milk Products (7 C.F.R. Part 58, Subpart T).

 

b)         Frequency of Tests:  At least once each month at irregular intervals, the milk from each producer's farm bulk tank or tanks shall be tested for sediment content and the results forwarded to the Department within 15 days from the date of test.

 

c)         Acceptance or Rejection of Milk:  When the milk of any producer has been tested and the sediment disc is graded number 4 the milk shall be rejected, and no further milk of that producer shall be picked up, accepted, or delivered until the sediment test discloses a sediment disc grade of number of 3 or better.  Whenever milk has been tested and the sediment disc graded number 3 the Department shall notify the producer that the milk is of borderline quality and that if any subsequent test discloses a sediment disc grade of number 4, the milk will be rejected.

 

d)         Retests:  On test of the next shipment, milk classified as No. 1, No. 2 or No. 3, may be accepted, but No. 4 milk shall be rejected.  Retests of bulk milk classified as No. 4 shall be made at the farm before pickup.  The producers of No. 3 and No. 4 milk shall be notified, furnished sediment discs and the next shipment tested.  This procedure of retesting successive shipments and accepting probational (No. 3) milk and rejecting No. 4 milk may be continued for not to exceed 10 calendar days.  If at the end of this time all of the producer's milk does not meet the acceptable sediment content classification (No. 1 or No. 2) it shall be excluded from the market.

 

 

Section 785.230  Bacterial Estimate Classification

 

Milk shall be classified for bacterial estimate as follows by one of the methods listed in Table 230:  

 

TABLE 230

 

Bacterial Estimate Classification	Direct Microscopic Count Standard Plate Count, or Plate Loop Count.
No. 1	Not over 200,000 per ml
No. 2	Not over 1,000,000 per ml
Under Grade	Over 1,000,000 per ml

 

a)         Method of Testing:  Methods for determining the bacterial estimate of milk shall be those described in the 15th edition of Standard Methods for the Examination of Dairy Products.  Samples shall be analyzed at an official State laboratory or at a laboratory approved by the Department. (See 77 Ill. Adm. Code 463)

 

b)         Frequency of Tests:  At least once a month at irregular intervals, a mixed sample of each producer's milk shall be tested and results submitted to the Department.

 

c)         Acceptance of Milk:  If the sample of milk is classified as No. 1 or No. 2, the producer's milk shall be accepted without qualification.  If the sample is classified as "Undergrade" (probational) the producer's milk shall be accepted for a temporary period of 4 weeks.  The producer of "Undergrade" milk shall be notified by the Department.

 

d)         Retests:  Additional samples shall be tested and classified at least weekly.  The producer and the Department will be notified of the results. This procedure of testing at least weekly and accepting "Undergrade" milk shall be continued for a time period not exceeding 4 weeks.  If at the end of this time the producer's milk does not meet the acceptable bacterial estimate requirements (No. 1 or No. 2), it shall be excluded from market by notification from the Department in writing.  If the first or second weekly tests are acceptable, routine monthly testing may begin.

 

Section 785.240  Rejected Milk

 

a)         A plant shall reject specific milk from a producer if it fails to meet the requirements for sight and odor (Section 785.210), or if it is classified No. 4 for sediment content, or if it fails to meet the provisions of Section 785.290.

 

b)         All reject milk shall be identified with a reject tag.

 

Section 785.250  Excluded Milk

 

A plant shall not accept milk from a producer for use in products:  

 

a)         If a new producer's milk does not meet the requirements for acceptable milk (Section 785.220 and 785.230) or;

 

b)         If the milk has been in a probational (No. 3) sediment content classification for more than 10 calendar days (Section 785.220); or

 

c)         If the milk has been classified "Undergrade" for bacterial estimate for more than 4 successive weeks and has been notified by the Department (Section 785.230).

 

Section 785.260  Quality Testing of Milk from New Producers

 

An examination shall be made by the laboratory on the first shipment of milk from producers shipping milk to a plant for the first time or after 60 days of nonshipment.  The milk shall meet the requirements for "acceptable milk".  (See Section 785.220 and 785.230).  Thereafter, the milk shall be tested in accordance with 785.210, 785.220 and 785.230.

 

Section 785.270  Record of Tests

 

Accurate records, listing the results of quality tests of each producer, shall be kept on file at the receiving plant where performed and shall be submitted to the Department not later than 15 days after the tests are conducted.

 

Section 785.280  Field Service

 

A representative of the plant shall arrange to visit each producer shipping milk which does not meet the requirements for acceptable milk, for the purpose of inspecting the equipment, utensils, and facilities at the farm and to offer assistance for improvements in the quality of the milk.  A representative of the plant shall visit each producer as often as practicable to assist in and encourage the production of high quality milk.

 

Section 785.290  Abnormal Milk

 

a)         Mastitic Milk

 

1)         A laboratory examination for the presence of somatic cells shall be made on all producers' milk at least 4 times in each 6-month period at irregular intervals.  Samples shall be analyzed at an official laboratory or at a laboratory approved by the Department.

 

2)         Confirmatory testing will be done on milk when a herd milk sample exceeds any of the following screening test results:  

 

A)        California Mastitis Test - Weak positive (CMT 1+).

 

B)        Modified Whiteside Test − Positive (1+).

 

C)        Wisconsin Mastitis Test − WMT value of 18 mm.

 

3)         A confirmatory test for somatic cell count shall be made on that sample using any of the following methods:  

 

A)        Direct Microscopic Somatic Cell Count (Single Strip Procedure). Pyronin Y - methyl green stain shall be used for goat's milk.

 

B)        Electronic Somatic Cell Count.

 

C)        Optical Somatic Cell Count.

 

D)        Membrane Filter DNA Somatic Cell Count - The results of the confirmatory test shall be the official result.

 

4)         Whenever the confirmatory somatic cell count indicates the presence of more than 750,000 somatic cells per ml, the following procedures shall be applied:  

 

A)        The producer shall be notified in writing by the milk plant with a warning of the excessive somatic cell count.

 

B)        Whenever records reveal two of the last four consecutive somatic cell counts exceed 750,000 per ml, the Department shall send a written notice to the producer.  This notice shall be in effect so long as two of the last four consecutive samples exceed 750,000 per ml.

 

5)         A third milk sample shall be taken after a lapse of 3 days and within 21 days.  If this sample also indicates a high somatic cell count, the producer's milk shall be rejected until compliance is obtained.  A temporary license shall be approved by the Department whenever an additional sample of herd milk is tested and found to conform to requirements.  The producer shall be fully reinstated when three out of four consecutive tests have counts of 750,000 or less somatic cells per ml.  The samples shall be taken at a rate of not more than two per week on separate days within a 3-week period.

 

b)         Drugs

 

1)         At least four times in 6 months, at irregular intervals, a separate or commingled sample of each producer's milk shall be tested for drug residues.  Whenever a producer's milk shows a violative drug residue, this milk shall be removed from all markets and the Department immediately notified by the industry certified laboratory.  The producer's license shall not be reinstated until provisions of Section 785.1220 (Drug Residue Monitoring and Farm Surveillance) are met.

 

2)         All bulk milk pick-up tankers or milk received directly from the farm bulk tank shall be sampled and tested in accordance with Section 785.1220. Methods that have been evaluated by Association of Official Analytical Chemists (AOAC) and recommended by the Food and Drug Administration at currently referenced levels shall be used for regulatory action for each drug of concern. FDA shall review the AOAC evaluations for each test kit and make a determination as to the acceptability of the use of the method.  Regulatory action shall be taken on all violative results (see Section 785.1220). A result shall be considered violative if it has been obtained by using a method that has been evaluated and deemed acceptable by FDA at levels established in memoranda transmitted periodically by FDA as required by Section 785.1220(c) and the test completed by a qualified individual as approved by the Department.

 

c)         Radionuclides

            When notified by Illinois Department of Nuclear Safety, composite milk samples shall be collected from selected areas and tested for biologically significant radionuclides.

 

d)         Pesticides and Herbicides

            Composite milk samples shall be tested for pesticides and herbicides at a frequency of once every six months, which the Department determines to be adequate to protect the consumer.  If a sample exceeds established Food and Drug Administration limits (21 CFR 193 and 40 CFR 180), procedures set forth in Section 785.1210 shall be followed.

 

e)         Added Water

            The presence of added water in raw or pasteurized milk constitutes adulteration.  The presence of added water is indicated by a milk cryoscope reading of -.524 Hortvet or -.507 Centigrade or higher when tested. After two occurrences of adulterated milk within a six-month period, the plant or producer will be required to show cause and reason for the addition of water.  After a third occurrence, the Department will institute administrative proceedings to revoke the plant or producer's permit.

 

f)         Farm Milk Collection

            Milk from producers shall be collected at intervals not exceeding four calendar days except in emergency situations where roads are impassible, in which delivery time may be extended an additional day.  Milk determined to contain over 200,000 bacteria per ml shall be collected every two calendar days.   It is the duty of the dairy plant to notify bulk milk hauler-samplers whenever a maximum two day pick-up and delivery is required.

 

(Source:  Amended at 25 Ill. Reg. 12634, effective September 25, 2001)

SUBPART C: REQUIREMENTS FOR FARMS PRODUCING MILK FOR MANUFACTURING

 

Section 785.300  Health of Herd

 

a)         General Health:  All animals in the herd shall be maintained in a healthy condition, and shall be properly fed and kept.

 

b)         Tuberculin Test:  Cows shall be located in a Modified Accredited Area, Accredited Free State, or an Accredited Free Herd as determined by the U.S. Department of Agriculture (USDA).  Goats shall be located in States meeting the current USDA Uniform Methods and Rules – Tuberculosis Eradication for domestic bovine, or an Accredited Free Goat Herd.  If the animals are not located in such areas, they shall be tested annually under the jurisdiction of the foresaid program.  All additions to the herd shall be from an area or from herds meeting those same requirements. (See Ill. Rev. Stat. 1991, ch. 8, par. 87 et seq. [510 ILCS 35].)

 

c)         Brucellosis Test:  The cows shall be located in States meeting class B status, or Certified-Free Herds, or milk ring test program, or blood testing program of the current USDA Brucellosis Eradication Uniform Methods and Rules.  All additions to the herd shall be from a State or from herds meeting these same requirements. (See Ill. Rev. Stat. 1991, ch. 8, par. 134 et seq. [510 ILCS 30].)

 

d)         Abnormal Milk:  Milk from cows known to be infected with mastitis or milk containing violative drug residue(s), or milk containing pesticides or other chemical residues exceeding the Department limits shall not be sold or offered for sale for human food (21 CFR 193 and 40 CFR 180).  The milk shall be disposed of in a manner approved by the Department.

 

(Source:  Amended at 17 Ill. Reg. 14027, effective August 15, 1993)

 

Section 785.310  Milking Facility and Housing

 

a)         A milking barn or milking parlor of adequate size and arrangement shall be provided to permit sanitary milking operations in accordance with this Part.  It shall be well lighted and ventilated, and the floors and gutters in the milking area shall be constructed of concrete or other material that can be kept clean and is washable.  The facility shall be kept clean, the manure removed daily and stored to prevent access of cows to accumulation thereof; and no swine or fowl shall be permitted in any part of the milking area.

 

b)         If milk is exposed during straining or transferring in the milking areas it shall be protected from falling particles from areas above milk facility.

 

c)         The yard or loafing area shall be of ample size to prevent overcrowding, shall be drained to prevent forming of standing water pools, insofar as practicable, and shall be kept clean.

 

Section 785.320  Milking Procedure

 

a)         The udders and flanks of all milking cows shall be kept clean.  The udders and teats shall be washed or piped immediately before milking with a clean, damp cloth or paper towel moistened with a sanitizing solution and wiped dry, or by any other sanitary method.

 

b)         The milker's outer clothing shall be clean and his hands clean and dry.  No person with an infected cut or open sores on their hands or arms shall milk cows, or handle milk or milk containers, utensils or equipment.

 

c)         Cows which secrete abnormal milk shall be milked last or with separate equipment.  This milk shall be excluded from the supply as required in Section 785.300(d).

 

d)         Milk stools, surcingles and antikickers shall be kept clean and properly stored.  Dusting operations shall not be conducted immediately before or during milking.  Strong flavored feeds should only be fed after milking.

 

Section 785.330  Cooling

 

Raw milk in farm bulk tanks shall be cooled to 45º F or less within two hours after milking; provided that the blend temperature after the first milking and subsequent milkings does not exceed 50º F.

 

Section 785.340  Milkhouse or Milkroom

 

a)         A milkhouse or milkroom conveniently located and properly constructed, lighted, and ventilated shall be provided for handling and cooling milk and for washing, handling, and storing the utensils and equipment.  Other products shall not be handled in the milkroom which would be likely to contaminate milk, or otherwise create a public health hazard (such as gasoline, pesticides, liquid chemicals).

 

b)         It shall be equipped with wash and rinse vat, utensil rack, milk cooling facilities and have an adequate supply of hot water available for cleaning milking equipment.  If a part of the barn or other building, it shall be partitioned and sealed to prevent the entrance of dust, flies, or other contamination.  Concentrates and feed, if stored in the building, shall be kept in a tightly covered box or bin.  The floor of the building shall be of concrete or other clean/washable material and graded to provide drainage.  The walls and ceilings shall be constructed of smooth easily cleaned material.  All outside doors shall open outward and be self-closing, unless they are provided with tight-fitting screens doors that open outward or unless other means are provided to prevent the entrance of flies.

 

c)         The farm bulk tank shall be located in the milkhouse or milkroom with access to all areas for cleaning and servicing.  It shall not be located over a floor drain or under a ventilator.  Lighting fixtures shall not be located directly over bulk tank openings.

 

d)         A small platform or slab constructed of concrete or other clean/washable material shall be provided outside the milkhouse, properly centered under a hose port opening in the wall for milkhouse connections. The opening shall be fitted with a tight, self-closing door.  The truck approach to the milkhouse or milkroom shall be properly graded and surfaced to prevent mud or pooling of water at point of loading.

 

e)         The milkhouse or milkroom and appurtenances shall be kept clean and free of trash, animals, and fowl.  Pesticides shall not be stored in this room and when used shall be used in accordance with label instructions so as to prevent contamination of the milk.

 

Section 785.350  Utensils and Equipment

 

a)         Utensils, milking machines (including pipeline systems), and other equipment used in the handling of milk shall be maintained in good conditions, shall be free from rust, open seams, milkstone, or any unsanitary condition and shall be washed, rinsed, and drained after each milking, stored on racks, and sanitized immediately before use with at least 50 p.p.m. chlorine solution or its equivalent (such as 100 p.p.m. acid anionics, 50 p.p.m. quaternary ammonium compounds or 25 p.p.m. iodophors).  All new utensils and equipment shall comply with applicable 3-A Sanitary Standards.

 

b)         Farm bulk tanks shall meet 3−A Sanitary Standards for construction at the time of installation and shall be installed in accordance with Section 785.1190(d).

 

c)         Single service articles shall be stored in a covered container and shall not be reused.

 

Section 785.355  Protection from Contamination

 

a)         Equipment used to administer drugs and medicines shall not be cleaned in the wash vats and shall be stored so as not to contaminate the milk or milk contact surfaces of equipment.

 

b)         Drugs and medicines shall be stored in such a manner that they cannot contaminate the milk or milk product contact surface of the equipment, containers or utensils.  Such products shall be properly labeled to include:

 

1)         The name and address of the manufacturer or distributor (for O.T.C. drugs and medicines), or veterinary practitioner dispensing the product (for Rx and Extra-Label use drugs and medicines);

 

2)         Directions for use, and prescribed withholding times;

 

3)         Cautionary statements, if needed; and

 

4)         Active ingredient(s) in the drug product.

 

c)         Unapproved and/or improperly labeled drugs and medicines shall not be used to treat dairy animals and shall not be stored in the milkhouse, milking barn, stable or parlor.  Drugs and medicines intended for treatment of non-lactating dairy animals shall be segregated from those drugs and medicines used for lactating animals.  (Separate shelves in cabinets, refrigerators, or other storage facilities satisfy this item.)

 

d)         Topical antiseptics, wound dressings (unless intended for direct injection into the teat), vaccines and other biologics, and dosage form vitamins and/or mineral products are exempt from labeling and storage requirements except when it is determined that they are stored in such a manner that they may contaminate the milk or milk product surfaces of containers or utensils.

 

(Source:  Added at 17 Ill. Reg. 14027, effective August 15, 1993)

 

Section 785.360  Water Supply

 

The dairy farm water supply shall be properly located, constructed, and operated, and shall be easily accessible, ample, and of safe, sanitary quality for the cleaning of dairy utensils and equipment.  The water supply shall come from a source which is approved by the Department ( 77 Ill. Adm. Code 900), sampled once every three years and the laboratory report kept on file at the dairy plant.

 

Section 785.370  Sewage Disposal

 

House, milkhouse or milkroom and toilet wastes shall be disposed of in a manner that will not pollute the soil surface, contaminate any water supply, or be exposed to insects (77 Ill. Adm. Code 905).

 

Section 785.380  Qualifications for Farm Licensing

 

Farm licensing requires satisfactory compliance with the requirements in Subpart C.

SUBPART D: REQUIREMENTS FOR LICENSED DAIRY PLANTS

 

Section 785.400  General Requirements

 

a)         Premises:  The premises shall be kept in a clean and orderly condition, and shall be free from strong or foul odors, or smoke. Construction and maintenance of driveways and adjacent plant traffic areas shall be of concrete, asphalt, or similar material to keep dust and mud to a minimum.

 

b)         Surroundings:  The adjacent surroundings shall be free from refuse, rubbish, and waste materials to prevent harborage of rodents, insects, and other vermin.

 

c)         Drainage:  A suitable drainage system shall be provided which will allow rapid drainage of all water from plant buildings and driveways, including surface water around the plant and on the premises, and all such water shall be disposed of in such a manner as to prevent a nuisance or health hazard (Ill. Rev. Stat. 1985, ch. 111 ½, par. 1003(b)).

 

Section 785.405  Buildings

 

The building or buildings shall be of sound construction and shall be kept in good repair to prevent the entrance or harboring of rodents, birds, insects, vermin, dogs, and cats.  All service pipe openings through outside walls shall be sealed around the opening or provided with tight metal collars.

 

a)         Outside Doors, Windows, Openings:  All openings to the outer air including doors, windows, skylights, and transoms shall be protected or screened against the entrance of flies and other insects, rodents, birds, dust, and dirt.  All outside doors opening into processing rooms shall be in good condition and fit properly.  All hinged, outside screen doors shall open outward.  All doors and windows shall be kept clean and in good repair.  Outside conveyor openings and other special-type outside openings shall be effectively protected to prevent the entrance of flies and rodents, by the use of doors, screens, flaps, fans, or tunnels.  Outside openings for sanitary pipelines shall be covered when not in use.  On new construction, window sills shall be slanted downward at a 45º angle.

 

b)         Walls, Ceilings, Partitions, and Posts:  The walls, ceilings, partitions, and posts of rooms in which milk or dairy products are processed, manufactured, handled, packaged, or stored (except dry storage of packaged finished products and supplies) or in which utensils are washed and stored, shall be smooth with material that is light colored, resistant to moisture, and easy to keep clean.

 

c)         Floors

 

1)         The floors of all rooms in which milk or dairy products are processed, manufactured, packaged, or stored or in which utensils are washed shall be constructed of tile laid with impervious joint material, concrete, or other equally impervious material.  The floors shall be smooth, kept in good repair, graded so that there will be no pools of standing water or milk products after flushing, and all openings to the drains shall be equipped with traps properly constructed and kept in good repair.  On new construction bell-type traps shall not be used (Ill. Plumbing Code, 77 Ill. Adm. Code 890).

 

2)         Sound, smooth wood floors which can be kept clean, may be used in rooms where new containers and supplies and packaged finished products are stored.

 

d)         Lighting and Ventilation

 

1)         Light shall be ample, natural or artificial, or both, of good quality and well distributed.  All rooms in which dairy products are manufactured or packaged or where utensils are washed shall have at least 30 foot-candles of light intensity on all working surfaces and at least 50 foot-candles of light intensity in areas where dairy products are graded or examined for condition and quality.  In all other rooms there shall be provided at least 5 foot-candles of light intensity when measured at a distance of 30 inches from the floor.  Where contamination of product by broken glass is possible, light bulbs, fluorescent tubes, fixtures, skylight, or other glass suspended over the product shall be protected against breakage.

 

2)         There shall be adequate heating, ventilation, or air conditioning for all rooms and compartments to permit maintenance of sanitary conditions. Exhaust or inlet fans, vents, hoods, or temperature and humidity control facilities shall be provided where and when needed, to minimize or eliminate uncomfortable room temperatures, odors, moisture condensation, or mold.  Inlet fans should be provided with an adequate air filtering device to eliminate dirt and dust from the incoming air.  Ventilation systems shall be cleaned periodically as needed and maintained in good repair. Exhaust outlets shall be screened or provided with self-closing louvers to prevent the entrance of insects when not in use.

 

e)         Rooms and Compartments:  Rooms and compartments in which any raw material, packaging, ingredient supplies, or dairy products are handled, manufactured, packaged, or stored shall be so designed, constructed, and maintained as to assure comfortable room temperatures and clean and orderly operating conditions free from odors and vapors.  Enclosed bulk milk receiving rooms when present shall be separated from the processing rooms by a partition.  Processing rooms shall be kept free from equipment and materials not regularly used.

 

1)         Coolers and Freezers:  Coolers and freezers where dairy products are stored shall be clean, dry and maintained at a uniform temperature and humidity to protect the product from deterioration, and minimize the growth of mold.  Circulation of air shall maintain uniform temperature and humidity at all times.  They shall be free from rodents, insects, and pests.  Shelves shall be kept clean and dry.  Refrigeration units shall have provisions for collecting and disposing of condensate.

 

2)         Supply Room:  The supply rooms used for the storing of packaging materials, containers, and miscellaneous ingredients shall be kept clean, dry, orderly, free from insects, rodents, and mold and maintained in good repair.  Such items stored therein shall be adequately protected from dust, dirt, or other extraneous matter and so arranged on racks, shelves, or pallets to permit access to the supplies and cleaning and inspection of the room.  Insecticides, rodenticides and cleaning compounds shall be properly labeled (Ill. Pesticide Act of 1979 – Ill. Rev. Stat. 1985, ch. 5, par. 801 et seq. and 8 Ill. Adm. Code 250) and segregated, and stored in a separate room or cabinet away from milk, dairy products, ingredients, or packaging supplies.

 

3)         Boiler and Tool Rooms:  The boiler and tool rooms shall be separated from other rooms where milk and dairy products are processed, manufactured, packaged, handled, or stored.  Such rooms shall be kept orderly and reasonably free from dust and dirt.

 

4)         Toilet and Dressing Rooms:  Toilet and dressing room facilities shall be conveniently located (Ill. Plumbing Code, 77 Ill. Adm. Code 890).

 

A)        Toilet rooms shall not open directly into any room in which milk or dairy products are processed, manufactured, packaged, or stored; floors shall be self-closing; ventilation shall be provided by mechanical means or screened openings to the outer air; fixtures shall be kept clean and in good repair.

 

B)        All employees shall be furnished with a locker or other facilities and the lockers and dressing rooms shall be kept clean and orderly. Hand-washing facilities shall be provided and durable, legible signs shall be posted conspicuously in each toilet or dressing room directing employees to wash their hands before returning to work.

 

5)         Laboratory:  Consistent with the size and type of plant and the volume of dairy products manufactured, an adequately equipped laboratory shall be maintained and properly staffed with qualified and trained personnel for quality control and analytical testing.  A central laboratory serving more than one plant may be acceptable if conveniently located to the dairy plants and if samples and results can be transmitted without delay (I.D.P.H. Division of Laboratories Manual of Services).

 

6)         Starter Facilities:  Sanitary facilities shall be provided for the handling of starter cultures.

 

Section 785.410  Facilities

 

a)         Water Supply

 

1)         There shall be an ample supply of both hot and cold water of safe and sanitary quality, with adequate facilities for its proper distribution throughout the plant, and protection against contamination and pollution. Water from other facilities, when officially approved, may be used for boiler feed water and condenser water provided that such waterlines are completely separated from the waterlines carrying the sanitary water supply, and the equipment is so constructed and controlled as to preclude contamination of product contact surfaces.  There shall be no cross connection between the safe water supply and any water supply not provided for under (77 Ill. Adm. Code 900), or any other source of pollution through which contamination of the safe water supply is possible. Bacteriological examination shall be made of the sanitary water supply at least twice a year, or as often as necessary to determine purity and suitability for use in manufacturing dairy products.  Such tests shall be made by the Department except for supplies that are regularly tested for purity and bacteriological quality, and approved by the other agencies. The results of all water tests shall be kept on file at the plant for which the test was performed (Rules for Drinking Water Systems, 77 Ill. Adm. Code 900 and Ill. Plumbing Code, 77 Ill. Adm. Code 890).

 

2)         The location, construction and operation of any well shall comply with regulations of the Department (See 77 Ill. Adm. Code 900, 915, 920, 925 and 930.).

 

b)         Drinking Water Facilities:  Drinking water facilities shall be provided in the plant and shall be conveniently located.

 

c)         Hand-washing Facilities:  Hand-washing facilities shall be provided, including hot and cold running water, soap or other detergents, and sanitary single-service towels or air dryers.  Such accommodations shall be located in or adjacent to toilet and dressing rooms and also at such other places in the plant as may be essential to the cleanliness of all personnel handling products.  Vats for washing equipment or utensils shall not be used as hand-washing facilities.  Self-closing metal or plastic containers shall be provided for used towels and other wastes.

 

d)         Steam:  Steam shall be supplied in sufficient volume and pressure for operation of each applicable piece of equipment.  Culinary steam used in direct contact with milk or dairy products shall be free from harmful substances or extraneous materials and only nontoxic boiler compounds shall be used, or secondary steam generator shall be used in which soft water is converted to steam and no boiler compounds are used.  Steam traps, strainers, and condensate traps shall be used wherever applicable to insure a satisfactory and safe steam supply.  Culinary steam shall comply with the recommended practices for "Producing Culinary Steam for Processing Milk and Milk Products" published by the National Association of Dairy Equipment Manufacturers, Washington, D.C., April 1963 (21 C.F.R. 173.310).

 

e)         Air Under Pressure:  The method for supplying air under pressure which comes in contact with milk or dairy products or any product contact surface shall comply with the 3-A Accepted Practices for Supplying Air Under Pressure.  The air used at the point of application shall be free from volatile substances, which may impart any flavor or odor to the products, and extraneous or harmful substances (such as dust, smoke, carbon monoxide, oil, gasoline, or chemicals).

 

f)         Disposal of Wastes:  Dairy wastes shall be properly disposed of from the plant and premises.  The sewer system shall have sufficient slope and capacity to readily remove all waste from the various processing operations.  Where a public sewer is not available, all wastes shall be properly disposed of so as not to contaminate milk equipment or to create a nuisance or public health hazard.  Containers used for the collection and holding of wastes shall be constructed of metal, plastic, or other equally impervious material and kept covered with tight-fitting lids and placed outside the plant on a concrete slab or on a rack raised at least 12 inches.  Alternatively waste containers may be kept inside a enclosed, clean and flyproof room.  Solid wastes shall be disposed of at regular intervals to prevent the unsanitary accumulation of waste.  The paper shall be burned at the plant in an incinerator constructed in accordance with Ch. 111½, Par. 1003, or compressed or bagged and hauled away (Ill. Plumbing Code, 77 Ill. Adm. Code 890).

 

Section 785.415  Equipment and Utensils

 

a)         General Construction, Repair, and Installation

 

1)         The equipment and utensils used for processing milk and manufacture of dairy products shall be constructed to be easily demountable where necessary for cleaning and sanitizing.  The product contact surfaces of all utensils and equipment such as holding tanks, pasteurizers, coolers, vats, agitators, pumps, sanitary piping, and fittings or any specialized equipment shall be constructed of stainless steel, or other equally corrosion-resistant material.  Nonmetallic parts other than glass having product contact surfaces shall meet 3-A Sanitary Standards for Plastic or Rubber and Rubberlike Materials.

 

2)         All equipment and piping shall be designed and installed so as to be easily accessible for cleaning, and shall be kept in good repair, free from cracks and corroded surfaces.  New or rearranged equipment shall be set away from any wall or spaced in such a manner as to facilitate cleaning and to maintain good housekeeping.  All parts or interior surfaces of equipment, pipes (except certain piping cleaned in place) or fittings, including valves and connections, shall be accessible for inspection.  Milk and dairy product pumps shall be of a sanitary type and easily dismantled for cleaning or shall be of approved construction to allow effective cleaning in place in accordance with 3-A Sanitary Standards.

 

3)         All CIP systems shall comply with the 3-A Sanitary Practices for permanently Installed Sanitary Product, Pipelines, and Cleaning Systems.

 

b)         Weigh Cans and Receiving Tanks:  Weigh cans and receiving tanks shall meet the 3-A Sanitary Standards and shall be easily accessible for cleaning both inside and outside and shall be elevated above the floor and protected sufficiently with covers and baffles to prevent contamination from splash, condensate, and drippage.  When necessary to provide easy access for cleaning of floors and adjacent wall areas, the receiving tank shall be equipped with wheels or casters to allow easy removal.

 

c)         Can Washers:  Can washers shall have sufficient capacity and ability to discharge a clean, dry can and cover and shall be kept properly timed in accordance with the instructions of the manufacturer.  The water and steam lines supplying the washer shall maintain a uniform pressure and be equipped with pressure regulating valves.

 

d)         Product Storage Tanks or Vats:  Storage tanks or vats shall be fully enclosed or tightly covered and well insulated.  The entire interior surface, agitator and all appurtenances shall be accessible for thorough cleaning and inspection.  Any opening at the top of the tank or vat including the entrance of the shaft shall be protected against the entrance of dust, moisture, insects, oil, or grease.  The sight glasses, if used, shall be sound, clear, and in good repair.  Vats which have hanged covers shall be so designed that moisture or dust on the surface cannot enter the vat when the covers are raised.  If the storage tanks or vats are equipped with air agitation, the system shall be of an approved type and properly installed in accordance with the 3-A Accepted Practices for Supplying air Under Pressure.  Storage tanks or vats intended to hold product for longer than approximately 8 hours shall be equipped with refrigeration and/or have insulation.  All new storage tanks or vats shall meet the appropriate 3-A Sanitary Standards and shall be equipped with thermometers in good operating order.

 

e)         Separators:  All product contact surfaces of separators shall be free from rust and pits and insofar as practicable shall be a stainless steel or other equally noncorrosive metals.

 

f)         Coil or Dome-type Batch Pasteurizers:  Coil or dome-type batch pasteurizers shall be stainless steel lined and if the coil is not stainless steel or other equally noncorrosive metal it shall be tinned over the entire surface.  Sanitary seal assemblies at the shaft ends of coil vats shall be of the removable type, except that existing equipment not provided with this type gland will be acceptable if the packing glands are maintained and operated without contaminating the milk or milk products.  New or replacement units shall be provided with removable packing glands. Dome-type pasteurizer agitators shall be stainless steel except that any nonmetallic parts shall meet 3-A Sanitary Standards for Plastic or Rubber and Rubberlike Materials, as applicable.  Each pasteurizer used for heating product at 165º F. or lower for 30 minutes or less shall be equipped with space heating equipment and the necessary thermometers to insure a temperature at least 5º F. above that required for pasteurization of the product.  There shall be a means of controlling the temperature of the heating medium.  Batch pasteurizers shall have temperature indicating and recording devices.

 

g)         High-temperature, Short-time (HTST) Pasteurizers:  When pasteurization is intended or required, an approved timing pump or device recorder-controller, automatic flow diversion valve and holding tube or its equivalent, if not a part of the existing equipment, shall be installed on all HTST equipment used for pasteurization, to assure complete pasteurization (21 CFR 133 and 135).  The entire facility shall meet the 3-A Accepted Practices for the Sanitary Construction, Installation, Testing, and Operation of High-Temperature, Short-Time Pasteurizers.  After the HTST unit has been tested according to the 3-A Accepted Practices, the timing pump or device and the recorder controller shall be sealed at the correct setting to assure pasteurization.  Sealing of the HTST unit shall be performed by the Department.  The H.T.S.T. pasteurizer shall be tested initially and annually by the Department, also whenever any alteration or replacement is made which affects the proper operation of the instrument or device.  When direct steam pasteurizers are used, the steam, prior to entering the product, shall be conducted through a steam strainer and a steam purifier equipped with a steam trap and only steam meeting the requirements for culinary steam shall be used (See Section 785.410(d)).

 

h)         Thermometers and Recorders

 

1)         Indicating Thermometers:  

 

A)        Long-stem indicating thermometers which are accurate within 0.5º F., plus or minus, for the applicable temperature range, shall be provided for checking the temperature of pasteurization and cooling of products in vats and checking the accuracy of recording thermometers.

 

B)        Short-stem indicating thermometers, which are accurate within 0.5º F., plus or minus, for the applicable temperature range, shall be installed in the proper stationary position in all HTST, and dome-type pasteurizers. Storage tanks where temperature readings are required shall have thermometers which are accurate within 2.0º F., plus or minus.

 

C)        Air-space indicating thermometers, where applicable, which are accurate within 1.0º F., plus or minus, for the proper temperature range shall also be installed above the surface of the products pasteurized in vats, to make certain that the temperature of the foam and/or air above the products pasteurized also received the required minimum temperature treatment.

 

2)         Recording Thermometers:  

 

A)        HTST recording thermometers that are accurate within 1º F., plus or minus, for the applicable temperature range shall be used on each heat treating, pasteurizing, or sterilizing unit to record the heating process.

 

B)        Additional use of recording thermometers accurate within 2º F., plus or minus, shall be required where a record of temperature or time of cooling and holding is of significant importance.

 

i)          Surface Coolers:  Surface coolers shall be equipped with hinged or removable covers, for the protection of the product.  The edges of the fins shall be so designed as to divert condensate on nonproduct contact surfaces away from product contact surfaces.  All gaskets or swivel connections shall be leak proof.

 

j)          Plate-type Heat Exchangers:  Plate-type heat exchangers shall meet the 3-A Sanitary Standards for Construction and Installation.  All gaskets shall be tight and kept in good operating order.  Plates shall be opened for inspection by the operator at sufficiently frequent intervals to determine if the equipment is clean and in good repair (e.g. free of dents, holes, broken gaskets and cracks).  A cleaning regimen shall be posted to insure cleaning procedures between inspection periods.

 

k)         Internal Return Tubular Heat Exchangers:  Internal return tubular heat exchangers shall meet the 3-A Sanitary Standards for Construction and Installation.

 

l)          Pumps:  Pumps used for milk and dairy products shall be of the sanitary type and constructed to meet 3-A Sanitary Standards.  Unless pumps are specifically designed for effective cleaning in place they shall be disassembled and thoroughly cleaned after use.

 

m)        Homogenizers:  Homogenizers and high pressure pumps of the plunger type shall meet the 3-A Sanitary Standards.

 

n)         New Equipment and Replacements:  New equipment and replacements, including all plastic parts and rubber and rubberlike materials for parts and gaskets having product contact surfaces, shall meet the 3-A Sanitary Standards.  If equipment or replacements are not approved by 3-A Sanitary Standards, such equipment and replacements shall meet the general requirements of this section.

 

o)         Vacuum Chamber:  The vacuum chamber, as used for flavor control, shall be made of stainless steel or other equally noncorrosive metal.  The unit shall be constructed to facilitate cleaning and all product contact surfaces shall be accessible for inspection.  It shall be equipped with a vacuum breaker and a check valve at the product discharge line.  Only steam which meets the requirements for culinary steam shall be used (See Section 785.410(d)).  The incoming steam supply shall be regulated by an automatic solenoid valve which will cut off the steam supply in the event the flow diversion valve of the HTST pasteurizer is not in the forward flow position.  Condensers when used shall be equipped with a water level control and an automatic safety shutoff valve.

 

Section 785.420  Personnel Cleanliness

 

All employees shall wash their hands before beginning work and upon returning to work after using toilet facilities, eating smoking, or otherwise soiling their hands.  They shall keep their hands clean and follow good hygienic practices while on duty.  Expectorating or use of tabacco in any form shall be prohibited in each room and compartment where any milk, dairy product, or supplies are prepared, stored, or otherwise handled.  Clean white or light-colored washable other garments and caps (paper caps or hair nets acceptable) shall be worn by all persons engaged in receiving, testing, processing milk, manufacturing, packaging, or handling dairy products.

 

Section 785.425  Personnel Health

 

No person afflicted with a communicable disease shall be permitted in any room or compartment where milk and dairy products are prepared, manufactured, or otherwise handled.  No person who has a discharging or infected wound, sore or lesion on hands, arms, or other exposed portion of the body shall work in any dairy processing rooms or in any capacity resulting in contact with milk or dairy products.

 

Section 785.430  Protection and Transportation of Raw Milk and Cream

 

a)         Equipment and Facilities – Farm Bulk Tanks:  New farm bulk tanks shall meet 3-A Sanitary Standards for construction and shall be installed in accordance with this Part.

 

b)         Transporting Milk or Cream

            Vehicles:  Bulk milk tank trucks, used for the transportation of milk from the farm to the plant, or plant to plant, shall not be used for any other purpose except as set forth in 77 Ill. Adm. 775.110.  The exterior shell shall be clean and free from open seams or cracks which would permit liquid to enter the jacket.  The interior shell shall be stainless steel and so constructed that it will not buckle, sag, or prevent complete drainage.  All product contact surfaces shall be smooth, easily cleaned, and maintained in good repair.  The pump and hose cabinet shall be fully enclosed with tight fitting doors and the inlet and outlet shall be provided with dust covers to give adequate protection from road dust.  New and replacement milk tank trucks shall meet 3-A Sanitary Standards for Milk Tank Trucks.

 

c)         Facilities for Cleaning and Sanitizing:  Enclosed or covered facilities shall be available for washing and sanitizing of milk tank trucks, piping and accessories, at central locations or at all plants that receive or ship milk or milk products in milk tank trucks.

 

d)         Transfer of Milk to Milk Tank Trucks:  Milk shall be transferred under sanitary conditions from milk tank trucks through stainless steel piping or approved tubing in accordance with 3-A Sanitary Standards.  The sanitary piping and tubing shall be capped when not in use.

 

Section 785.435  Raw Product Storage

 

a)         All milk shall be held and processed under conditions and at temperatures that will avoid contamination and rapid deterioration.  Raw milk in storage tanks within the dairy plant shall be handled in such a manner as to minimize bacterial increase and shall be maintained at 45º F. or lower until processing begins.  This does not preclude holding milk at higher temperatures for a period of time, where applicable to particular manufacturing or processing practices.

 

b)         The bacteriological quality of commingled raw milk in storage tanks shall be 2 million or lower for all manufactured dairy products except frozen desserts.  The bacteriological quality for raw milk and milk products as ingredients for frozen desserts shall be 500,000/gr or lower as commingled before pasteurization.

 

Section 785.440  Pasteurization or Sterilization

 

When pasteurization or sterilization is intended or required, or when a product is designated "pasteurized" or "sterilized" ever particle of the product shall be subjected to such temperatures and holding periods as will assure proper pasteurization or sterilization of the product in accordance with 21 CFR 133 and 135.  The heat treatment by either process shall be sufficient to insure public health safety and to assure adequate keeping quality, yet retaining the most desirable flavor and body characteristics of the finished product.  The phenol value of test samples of pasteurized finished product shall be no greater than the maximum specified for the particular product as determined and specified by the phosphatase test method prescribed in the 15th Edition of Standard Methods.

 

Section 785.445  Composition and Wholesomeness

 

All necessary precautions shall be taken to prevent contamination or adulteration of the milk or dairy products during manufacturing in accordance with this Part.  All substances and ingredients used in the processing or manufacturing of any dairy product shall be subject to inspection and shall be wholesome and practically free from impurities. The finished product shall comply with the requirements of the Illinois Food, Drug and Cosmetic Act (Ill. Rev. Stat. 1985, ch. 56 ½, par. 501 et seq., in particular 502, 506, 509, 510, 511, 512, 513, and 521) as to their composition and wholesomeness.

 

Section 785.450  Cleaning and Sanitizing Treatment

 

a)         Equipment and Utensils

 

1)         The equipment, sanitary piping and utensils used in receiving and processing of the milk, and manufacturing and handling of the product shall be maintained in a sanitary condition.  Sanitary seal assemblies shall be removable on all agitators, pumps and vats, and shall be inspected at regular intervals and kept clean.  Unless other provisions are recommended in the following supplemental sections, all equipment not designed for C.I.P. cleaning shall be disassembled after each day's use for thorough cleaning.  Dairy cleaners, detergents, wetting agents, sanitizing agents or other similar materials which will not contaminate or adversely affect the products may be used.  Steel wool or metal sponges shall not be used in the cleaning of any dairy equipment or utensils.  All product contact surfaces shall be subjected to an effective sanitizing treatment immediately prior to use, except where dry cleaning is permitted in accordance with Subpart E.  Utensils and portable equipment used in processing and manufacturing operations shall be stored above the floor in clean, dry locations and in a self draining position on racks constructed of impervious corrosion-resistant material.

 

2)         C.I.P. cleaning, including sprayball systems, shall be used only on equipment and pipeline systems which have been designed and engineered for that purpose.  When such cleaning is used, careful attention shall be given to the proper procedures to assure satisfactory cleaning.  All C.I.P. installations and cleaning procedures shall be in accordance with 3-A Suggested Methods for the Installation and Cleaning of Cleaned-In-Place Sanitary Milk Pipelines for Milk and Milk Products Plants.  The established cleaning procedure shall be posted and followed.  Following the circulation of the cleaning solution the equipment and lines shall be thoroughly rinsed with lukewarm water and checked for effectiveness of cleaning.  All caps, plugs, special fittings, valve seats, cross ends, pumps, plates, and the ends shall be opened or removed and brushed clean. Immediately prior to starting the product flow, the product contact surfaces shall be given bactericidal treatment.

 

b)         Milk Tank Trucks:  A covered or enclosed wash dock and cleaning and sanitizing facilities shall be available to all plants that receive or ship milk in milk tank trucks.  Milk tank trucks, sanitary piping, fittings, and pumps shall be cleaned and sanitized at least once each day, after use:  Provided, that if they are not to be used immediately after emptying a load of milk, they shall be washed promptly after use and given bactericidal treatment immediately before use.  After being washed and sanitized, each milk tank truck shall be identified by a tag attached to the outlet valve, bearing the following information:  Plant and specific location where cleaned, date and time of day of washing and sanitizing, and name of person who washed and name of person who sanitized the milk tank truck.  The tag shall not be removed until the milk tank truck is again washed and sanitized.

 

c)         Building:  All windows, glass, partitions, and skylights shall be washed as often as necessary to keep them free from dust and debris.  The material picked up by the vacuum cleaners shall be disposed of by burning or other proper methods to destroy any insects that might be present.

 

Section 785.455  Insect and Rodent Control Program

 

In addition to any commercial pest control service, if one is utilized, a specially designated employee shall be made responsible for the performance of a regularly scheduled insect and rodent control program.  Poisonous substances, insecticides, and rodenticides shall be labeled, and shall be handled, stored, and used in such a manner as not to create a public health hazard.

 

Section 785.460  Plant Records

 

Plant records shall be maintained of all tests required by this Part on all raw milk receipts.  Such records shall be available for examination by the Department.  The following are the records which shall be maintained for examination at the plant or receiving station where performed.

 

a)         Sediment and bacterial test results on raw milk from each producer:  Retain for 12 months.

 

1)         Routine tests and monthly summary of all producers showing number and percent of total in each class.

 

2)         Retests, if initial test places milk in probationary status.

 

3)         Rejections of raw milk over No. 3 in quality.

 

b)         Pasteurization recorder charts:  Retain for 6 months.

 

c)         Water supply test certificate:  Retain current copy for 6 months.

 

Section 785.465  Packaging and General Identification

 

a)         Containers:  

 

1)         The size, style, and type of packaging used for dairy products shall be packaged in materials which will cover and protect the quality of the contents during storage and regular channels of trade and under conditions of handling.  The weights and shape within each size or style shall be as nearly uniform as is practical.

 

2)         Packaging materials for dairy products shall be selected which will provide sufficiently low permeability to air and vapor to prevent the formation of mold growth and surface oxidation.  In addition, the wrapper shall be resistant to puncturing, tearing, cracking, or breaking under normal conditions of handling, shipping, and storage.  When special-type packaging is used, the instructions of the manufacturers shall be followed closely as to its application and methods of closure.

 

b)         Packaging and Repackaging:  Packaging dairy products or cutting and repackaging all styles of dairy products shall be conducted under rigid sanitary conditions.  The atmosphere of the packaging rooms, the equipment and packaging material shall be free from mold and bacterial contamination.  Methods for checking the level of contamination shall be as prescribed by the 15^th edition of Standard Methods.

 

c)         General Identification:  All commercial bulk packages containing dairy products manufactured under the provisions of this subpart shall be adequately and legibly marked with the name of the product, name and address of processor or manufacturer or other assigned plant identification, lot number, and any other identification as may be required.  Consumer packaged products shall be legibly marked with the name of the product, name and address of packer, manufacturer, or distributor.

 

Section 785.470  Storage of Finished Product

 

a)         Dry Storage:  The product shall be stored at least 18 inches from the wall in aisles, rows, or sections and lots, in such a manner as to be orderly and easily accessible for inspection.  Rooms should be cleaned regularly.  Care shall be taken in the storage of any other product foreign to dairy products in the same room, in order to prevent impairment or damage to the dairy product from mold, absorbed odors, or vermin or insect infestation.  Control of humidity and temperature shall be maintained at all times to prevent conditions detrimental to the product and container.

 

b)         Refrigerated Storage:  The finished product shall be placed on shelves, dunnage, or pallets and identified (See Section 785.465(c)).  It shall be stored under temperatures that will best maintain the initial quality.  The product shall not be exposed to anything from which it might absorb any foreign odors or be contaminated by drippage or condensation.

 

Section 785.475  Qualification for Plant Licensing

 

Plant licensing requires satisfactory compliance with the applicable requirements in Subpart D.

SUBPART E: SUPPLEMENTAL REQUIREMENTS FOR PLANTS MANUFACTURING, PROCESSING AND PACKAGING INSTANT NONFAT DRY MILK, NONFAT DRY MILK, DRY WHOLE MILK, DRY BUTTERMILK, DRY WHEY, AND OTHER DRY MILK PRODUCTS

 

Section 785.500  Rooms and Compartments − Dry Storage of Product

 

Storage rooms for the dry storage of product shall be adequate in size, kept clean, orderly, free from rodents, insects, and mold, and maintained in good repair.  They shall be adequately lighted and ventilated (See Section 785.405).  The ceilings, walls, beams, and floors shall be free from structural defects and areas which may harbor insects.

 

Section 785.503  Packaging Room for Bulk Products

 

A separate room or area shall be provided for filling bulk bins, drums, bags, or other bulk containers and shall be constructed in accordance with Section 785.405.  The number of control panels and switchboxes in this area shall be kept to a minimum.  Control panels shall be mounted a sufficient distance from the walls to facilitate cleaning or shall be mounted in the wall and provided with tight-fitting removable doors to facilitate cleaning.  An exhaust system shall be provided to minimize the accumulation of product dust within the packaging room and, where needed, a dust collector shall be provided properly maintained to keep roofs and outside areas free of dry product.  Only packaging materials that are used within a day's operation may be kept in the packaging area.  These materials shall be kept on metal racks or tables at least 6 inches off the floor. Unnecessary fixtures, equipment, or areas which may collect dust and harbor insects, shall not be allowed in the packaging room.

 

Section 785.506  Hopper or Dump Room

 

A separate room shall be provided for the transfer of bulk dry dairy products from bags or drums to the hoppers and conveyors which lead to the fillers.  This room shall meet the same requirements for construction and facilities as the bulk packaging operation.  Areas and facilities provided for the transfer of dry dairy products from portable bulk bins will be acceptable if gasketed surfaces or direct connections are used that eliminate the escape of product into the area.

 

Section 785.509  Repackaging Room

 

A separate room shall be provided for the filling of small packages and shall meet the same requirements for construction and facilities as the bulk packaging operation (See Section 785.503).

 

Section 785.512  Equipment and Utensils − General Construction, Repair, and Installation

 

All equipment and utensils necessary to the manufacture of dry milk products, including pasteurizer, timing pump or device, flow diversion valve and recorder controller, shall meet the same general requirements as outlined in Section 785.415.  In addition, for certain other equipment the following requirements shall be met.

 

Section 785.515  Preheaters

 

The preheaters shall be of stainless steel or other equally corrosion-resistant material, cleanable, accessible for inspection and shall be equipped with automatic temperature controls.

 

Section 785.518  Hotwells

 

The hotwells shall be enclosed or covered and equipped with indicating thermometers either in the hotwell or in the hot milk inlet line to the hotwell and if used for holding high heat products they shall also have recorders.

 

Section 785.521  Evaporators and/or Vacuum Pans

 

Open-type evaporators and/or vacuum pans shall be equipped with an automatic condenser water level control, barometric leg, or so constructed so as to prevent water from entering the product, and shall meet the applicable 3-A Sanitary Standards.  When enclosed-type condensers are used, no special controls are needed to prevent water from entering the product.

 

Section 785.524  Surge Tanks

 

If surge tanks are used for hot milk and temperatures of product, including foam being held in the surge tank during processing is not maintained at a minimum of 150º F., then two or more surge tanks shall be installed with cross connections to permit flushing and cleaning during operation.  Covers easily removable for cleaning shall be provided and used at all times.

 

Section 785.527  High Pressure Pumps and Lines

 

High pressure lines may be cleaned in place and shall be of such construction that deadends, valves and the high pressure pumps can be disassembled for hand cleaning.  New high pressure pumps shall meet the 3-A Sanitary Standard Covering Homogenizers and High Pressure Pumps of the Plunger Type.

 

Section 785.530  Dryers

 

a)         Spray Dryers:  Spray dryers shall be of a continuous discharge type and all product contact surfaces shall be of stainless steel or other equally corrosion-resistant material.  All joints and seams in the product contact surfaces shall be welded and ground smooth.  All dryers shall be constructed so as to facilitate ease in cleaning and inspection.  Sight glasses or ports of sufficient size shall be located at strategic positions to assure proper drying operations.  Dryers shall be equipped with air intake filters and with air intake and exhaust recording thermometers.  The filter system shall consist of filtering media or devices that prevent the entrance of foreign substances into the drying chamber.  The filtering system shall be cleaned or component parts replaced as often as necessary to maintain a clean air supply.  In gas-fired dryers, precautions shall be taken to assure complete combustion.  Air shall be drawn into the dryer from sources free from odors and smoke, dust, or dirt.

 

b)         Roller Dryers:   

 

1)         The drums of a roller dryer shall be smooth, readily cleanable and free of pits and rusts.  The knives shall be maintained in such condition so as not to cause scoring of the drums.

 

2)         The end boards shall have an impervious surface and be readily cleanable.  They shall be provided with a means of adjustment to prevent leakage and accumulation of milk solids.  The stack, hood, the drip pan inside of the hood and related shields shall be constructed of stainless steel and be readily cleanable.  The lower edge or the hood shall be constructed so as to prevent condensate from entering the product zone. The hood shall be located and the stack of adequate capacity to remove the vapors.  The stack shall be closed when the dryer is not in operation.  The augers shall be of stainless steel or properly plated, and readily cleanable.  All air entering the dryer room shall be filtered to eliminate dust and dirt.  The filter system shall consist of filtering media or device that prevent the entrance of foreign substances into the drying room.  The filtering system shall be cleaned or component parts replaced as often as necessary to maintain a clean air supply.  All dryer adjustments shall be made and the dryer operating normally before food grade powder can be collected from the dryer.

 

Section 785.533  Collectors and Conveyors

 

Collectors shall be made of stainless steel or equally noncorrosive material and shall be constructed to facilitate cleaning and inspection. Filter sack collectors, if used, shall be in good condition and the system shall be of such construction that all parts are accessible for cleaning and inspection.  Conveyors shall be of stainless steel or equally corrosion-resistant material and shall be constructed to facilitate thorough cleaning and inspection.

 

Section 785.536  Dry Dairy Product Cooling Equipment

 

Cooling equipment shall be provided with sufficient capacity to cool the product to 110º F. or lower immediately after removal from dryer and prior to packaging.  If bulk bins are used, the product should be cooled to approximately 90º F. but shall be not more than 110º F.  A dry filtered air supply shall be provided where air cooling and conveying is used.

 

Section 785.539  Special Treatment Equipment

 

All special equipment such as in sanitizing system, flakers, pulverizers or hammer mills used to further process dry milk products shall be of sanitary construction and all parts shall be accessible for cleaning and inspection in accordance with 3-A Sanitary Standards.

 

Section 785.542  Sifters

 

All newly installed sifters used for dry milk and dry milk products shall meet the 3-A Sanitary Standards for Sifters for Dry Milk and Dry Milk Products.  All other sifters shall be constructed of stainless steel or other equally noncorrosive material and shall be of sanitary construction and accessible for cleaning and inspection in accordance with 3-A Sanitary Standards.  The mesh size of sifter screen used for various dry dairy products shall be those recommended in the appendix of the 3-A Standard for sifters.

 

Section 785.545  Portable and Stationary Bulk Bins

 

Bulk bins shall be constructed of stainless steel, aluminum or other equally corrosion resistant materials, free from cracks and seams and must have an interior surface that is smooth and easily cleanable.  All product contact surfaces shall be easily accessible for cleaning.

 

Section 785.548  Automatic Sampling Device

 

If automatic sampling devices are used, they shall be constructed in such a manner as to prevent contamination of the product, and all parts must be readily accessible for cleaning in accordance with 3-A Sanitary Standards.

 

Section 785.551  Dump Hoppers, Screens, Mixers and Conveyors

 

The product contact surfaces of dump hoppers, screens, mixers, and conveyors which are used in the process of transferring dry products from bulk containers to fillers for small packages or containers, shall be of stainless steel or equally corrosion resistant material and designed to prevent contamination in accordance with 3-A Sanitary Standards.  All parts shall be accessible for cleaning.  The dump hoppers shall be of such height above floor level as to prevent foreign material or spilled product from entering the hopper.

 

Section 785.554  Filler and Packaging Equipment

 

All filling and packaging equipment shall be of sanitary construction and all parts, including valves and filler heads, accessible for cleaning in accordance with 3-A Sanitary Standards.

 

Section 785.557  Heavy Duty Vacuum Cleaners

 

Each plant handling dry milk products shall be equipped with a heavy duty industrial vacuum cleaner.  Regular scheduling shall be established for its use in vacuuming applicable areas.

 

Section 785.560  Clothing and Shoe Covers

 

Clean clothing and shoe covers shall be provided exclusively for the purpose of cleaning the interior of the drier when it is necessary to enter the drier to perform the cleaning operation.

 

Section 785.563  Operations and Operating Procedures – Pasteurization  

 

a)         All milk, buttermilk and whey used in the manufacture of dry dairy products shall be pasteurized at the plant where dried, except that condensed whey and acidified buttermilk containing 40 percent or more solids may be transported to another plant for drying without repasteurization.  Milk or skim milk to be used in the manufacture of nonfat dry milk shall be heated prior to condensing to at least the minimum pasteurization temperature of 161º F. for at least 15 seconds or its equivalent in bacterial destruction.  Condensed skim made from pasteurized skim milk may be transported to a drying plant, provided that it shall be repasteurized at the drying plant, prior to drying, at not less than 175º F. for 25 seconds or its equivalent in bacterial destruction.

 

b)         All buttermilk or cream from which it is derived shall be pasteurized prior to condensing at a temperature of 185º F. for 15 seconds or its equivalent in bacterial destruction.

 

c)         All cheese whey or milk from which it is derived shall be pasteurized prior to condensing at a temperature of 161º F. for 15 seconds or its equivalent in bacterial destruction.

 

Section 785.566  Condensed Surge Supply

 

Surge tanks or balance tanks if used between the evaporators and dryer shall be used to hold only the minimum amount of condensed product necessary for a uniform flow to the dryers.  Such tanks holding product at temperatures below 150º F. shall be completely emptied and washed after each 4 hours of operation or less.  Alternate tanks shall be provided to permit continuous operation during washing of tanks.

 

Section 785.569  Condensed Storage Tanks

 

a)         Excess production of condensed product over that which the dryer will take continuously from the pans shall be by-passed through a cooler into a storage tank at 50º F. or lower and held at this temperature until used.

 

b)         Product cut-off points shall be made at least every 24 hours and the tank completely emptied, washed, and sanitized before reuse.

 

Section 785.572  Drying

 

Each dryer should be operated at not more than the manufacturer's rated capacity for the highest quality dry product.  This does not preclude the remodeling or redesigning of dryers after installation.  The dry products shall be removed from the drying chamber continuously during the drying process.

 

Section 785.575  Cooling Dry Products

 

Prior to packaging and immediately following removal from the drying chamber the dry product shall be cooled to a temperature not exceeding 110º F.  Section 785.578 Packaging, Repackaging and Storage

 

a)         Containers:  Packages or containers used for the packaging of nonfat dry milk or other dry milk products shall be any clean container or packaging material which will protect the contents through the regular channels of trade, without impairment of quality with respect to flavor, wholesomeness or moisture content under the normal conditions of handling. In no instance will containers which have previously been used for nonfood items be allowed to be use for the bulk handling of dairy products.

 

b)         Filling:  Empty containers shall be protected at all times from possible contamination and containers which are to be lined shall not be prepared more than 1 hour in advance of filling.  Every precaution shall be taken during the filling operation to minimize product dust and spillage. When necessary a mechanical shaker shall be provided; the tapping or pounding of containers shall be prohibited.  The containers shall be closed immediately after filling and the exterior shall be vacuumed or brushed when necessary to render them free of product remnant before being transferred from the filling room to the palleting or dry storage areas.

 

c)         Repackaging:  The entire repackaging operation shall be conducted in a sanitary manner with all precautions taken to prevent contamination and to minimize dust.  All exterior surfaces of individual containers shall be free of product before overwrapping or packing in shipping containers (See Section 785.465).  The flow shall be kept free of dust accumulation, waste, cartons, liners, or other refuse.  Conveyors, packaging and cartonmaking equipment shall be vacuumed frequently during the operating day to prevent the accumulation of dust.  No bottles or glass materials of any kind shall be permitted in the repackaging or hopper room.  The inlet openings of all hoppers and bins shall be screened, and placed well above the floor level. The room and all packaging equipment shall be cleaned as often as necessary to maintain a sanitary operation.  Close attention shall be given to cleaning points of equipment where residues of the dry product may accumulate.   A thorough cleanup including windows, doors, walls, light fixtures, and ledges, shall be performed as frequently as is necessary to maintain cleanliness and sanitation.  All waste dry dairy products including dribble product at the fillers shall be identified and disposed of as animal feed.

 

d)         Storage

 

1)         Product:  The packaged dry milk product shall be stored or so arranged in aisles, rows, or sections and lots at least 18 inches from any wall and in such a manner as to be orderly, easily accessible for inspection or for cleaning of the room.  All bags and small containers of product shall be placed on pallets elevated approximately 6 inches from the floor.  The storage room shall be kept clean and dry and all openings protected against entrance of insects and rodents.

 

2)         Supplies:  All supplies shall be placed on dunnage or pallets and arranged in an orderly manner for accessibility and cleaning of the room. Supplies shall be kept enclosed in their original wrapping material until used.  After removal of supplies from their original containers they shall be kept in an enclosed metal cabinet, bins, or on shelving and if not enclosed shall be protected from powder and dust or other contamination. The room shall be vacuumed as often as necessary and kept clean and orderly.

 

 

Section 785.578  Packaging, Repackaging and Storage

 

a)         Containers:  Packages or containers used for the packaging of nonfat dry milk or other dry milk products shall be any clean container or packaging material which will protect the contents through the regular channels of trade, without impairment of quality with respect to flavor, wholesomeness or moisture content under the normal conditions of handling.  In no instance will containers which have previously been used for nonfood items be allowed to be used for the bulk handling of dairy products.

 

b)         Filling:  Empty containers shall be protected at all times from possible contamination and containers which are to be lined shall not be prepared more than 1 hour in advance of filling.  Every precaution shall be taken during the filling operation to minimize product dust and spillage.  When necessary a mechanical shaker shall be provided; the tapping or pounding of containers shall be prohibited.  The containers shall be closed immediately after filling and the exteriors shall be vacuumed or brushed when necessary to render them free of product remnant before being transferred from the filling room to the palleting or dry storage areas.

 

c)         Repackaging:  The entire repackaging operation shall be conducted in a sanitary manner with all precautions taken to prevent contamination and to minimize dust.  All exterior surfaces of individual containers shall be free of product before overwrapping or packing in shipping containers (See Section 785.465).  The flow shall be kept free of dust accumulation, waste, cartons, liners, or other refuse.  Conveyors, packaging and carton making equipment shall be vacuumed frequently during the operating day to prevent the accumulation of dust.  No bottles or glass materials of any kind shall be permitted in the repackaging or hopper room.  The inlet openings of all hoppers and bins shall be screened and placed well above the floor level.  The room and all packaging equipment shall be cleaned as often as necessary to maintain a sanitary operation.  Close attention shall be given to cleaning points of equipment where residues of the dry product may accumulate.  A thorough cleanup, including windows, doors, walls, light fixtures, and ledges, shall be performed as frequently as is necessary to maintain cleanliness and sanitation.  All waste dry dairy products including dribble product at the fillers shall be identified and disposed of as animal feed.

 

d)         Storage

 

1)         Product:  The packaged dry milk product shall be stored or so arranged in aisles, rows, or sections and lots at least 18 inches from any wall and in such a manner as to be orderly, easily accessible for inspection or for cleaning of the room.  All bags and small containers of product shall be placed on pallets elevated approximately 6 inches from the floor.  The storage room shall be kept clean and dry and all openings protected against entrance of insects and rodents.

 

2)         Supplies:  All supplies shall be placed on dunnage or pallets and arranged in an orderly manner for accessibility and cleaning of the room. Supplies shall be kept enclosed in their original wrapping material until used. After removal of supplies from their original containers, they shall be kept in an enclosed metal cabinet, bins, or on shelving and if not enclosed shall be protected from powder and dust or other contamination.  The room shall be vacuumed as often as necessary and kept clean and orderly.

 

(Source:  Added at 17 Ill. Reg. 14027, effective August 15, 1993)

 

Section 785.581  Product Adulteration

 

All necessary precautions shall be taken throughout the entire operation to prevent the adulteration of one product with another (See Subpart D and E).  The commingling of one type of liquid or dry product with another shall be considered as an adulteration of that product.  This does not prohibit the standardization of like products or the production of specific products for special uses, provided labeling requirements are met (21 C.F.R. Part 133 and 135).

 

Section 785.584  Checking Quality

 

All milk products, and dry milk products shall be subject to inspection and analysis by the dairy plant for quality and condition throughout each processing operation.  Line samples shall be taken as an aid to quality control in addition to the regular routine analysis made on the finished products.

 

Section 785.587  Requirements for Instant Nonfat Dry Milk

 

a)         Sampling and Testing:  All instant nonfat dry milk offered for sale shall be sampled and tested by the Department monthly for the purpose of assuring that the product meets the requirements of Section 785.587(b) in accordance with Standard Methods.  In addition the dry milk plant shall have each sublot of approximately 4,000 pounds tested and analyzed prior to being packaged or offered for sale.  Product not meeting the requirements of Section 785.587(b) shall not be offered as Extra Grade.

 

b)         Requirements for Extra Grade Instant Nonfat Dry Milk

 

1)         Flavor and Odor:  The flavor and odor shall be sweet, pleasing and desirable but may possess the following flavors to a slight degree:  Chalky, cooked, feed, flat.

 

2)         Physical Appearance:  The physical appearance shall possess a uniform white to light cream natural color; shall be free-flowing and free from lumps except those that readily break up with very slight pressure.

 

3)         Bacterial Estimate:  The standard plate count shall not be more than 30,000 per gram.

 

4)         Coliform Count:  The coliform count shall not be more than 10 per gram.

 

5)         Milkfat Content:  The milkfat shall not be more than 1.25 percent.

 

6)         Moisture Count:  The moisture shall not be more than 4.5 percent.

 

7)         Scorched Particle Content:  Scorched particles shall not be more than 15 mg.

 

8)         Solubility Index:  The solubility index shall not be more than 1 ml.

 

9)         Titratable Acidity:  The titratable acidity shall not be more than 0.15 percent.

 

10)         Dispersibility:  The dispersibility shall not be less than 85 percent.

 

11)         Direct Microscopic Clump Count:  The direct microscopic clump count shall not be more than 75 million per gram.

 

Section 785.590  Cleaning of Dryers, Conveyors, Sifters, and Storage Bins

 

This equipment shall be cleaned as often as is necessary to maintain such equipment in a clean and sanitary condition.  The kind of cleaning procedure either wet or dry and the frequency of cleaning shall be based upon observation of actual operating results and conditions.

 

Section 785.593  Insect and Rodent Control Program

 

In addition to any commercial pest control pest control service, if one is utilized, a specially designated employee shall be made responsible for the performance of a regularly scheduled insect and rodent control program.

SUBPART F: SUPPLEMENTAL REQUIREMENTS FOR PLANTS MANUFACTURING, PROCESSING AND PACKAGING BUTTER AND RELATED PRODUCTS

 

Section 785.600  Rooms and Compartments - Coolers and Freezers

 

The coolers and freezers shall be equipped with facilities for maintaining temperature and humidity conditions to protect the quality and condition of the products during storage or during tempering prior to further processing.  Coolers and freezers shall be kept clean, orderly, free from insects, rodents, and mold, and maintained in good repair.  They shall be adequately lighted and proper circulation of air shall be maintained at all times (See Section 785.405).  The floors, walls, and ceilings shall be of such construction as to permit thorough cleaning.

 

Section 785.605  Churn Rooms

 

Churn rooms in addition to proper construction and sanitation shall be so equipped that the air is kept free from odors and vapors by means of adequate ventilation and exhaust systems or air conditioning and heating facilities (See Section 785.405(b)(2) and (e)(1)).

 

Section 785.610  Print and Bulk Packaging Rooms

 

Room used for packaging print or bulk butter and related products shall, in addition to proper construction and sanitation, provide an atmosphere relatively free from mold (no more than 10 mold colonies per cubic foot of air), dust or other airborne contamination and be maintained at a reasonable room temperature.

 

Section 785.615  Equipment and Utensils − General Construction, Repair, and Installation

 

All equipment and utensils necessary to the manufacture of butter and related products shall meet the same general requirements as outlined in Section 785.415.  In addition for certain other equipment, the following requirements shall be met.

 

Section 785.620  Continuous Churn

 

All product contact surfaces shall be of noncorrosive material.  All nonmetallic product contact surfaces shall comply with 3-A Standards for Plastic, Rubber, and Rubber-Like Materials.  All product contact surfaces shall be readily accessible for cleaning and inspection.

 

Section 785.625  Conventional Churn

 

Churns shall be constructed of aluminum, stainless steel or equally corrosion resistant metal, free from cracks, and in good repair.  All gasket material shall be fat resistant, nontoxic and durable.  Seals around the doors shall be tight.

 

Section 785.630  Bulk Butter Trucks, Boats and Packers

 

Bulk butter trucks, boats and packers shall be constructed of aluminum, stainless steel or equally corrosion resistant metal free from cracks, seams and must have a surface that is smooth and easily cleanable.

 

Section 785.635  Butter, Frozen or Plastic Cream Melting Machine

 

Shavers, shredders or melting machines used for rapid melting of butter, frozen or plastic cream shall be of stainless steel or equally corrosion resistant metal, sanitary construction, and readily cleanable in accordance with 3-A Sanitary Standards.

 

Section 785.640  Printing Equipment

 

All printing equipment shall be designed to be readily demountable for cleaning of product contact surfaces.  All product contact surfaces shall be aluminum, stainless steel or equally corrosion resistant metal, or plastic, rubber and rubber like material which meet 3-A Standards, except that conveyors may be constructed of material which can be properly cleaned and maintained in good repair.

 

Section 785.645  Brine Tanks

 

Brine tanks used for the treating of parchment liners shall be constructed of noncorrosive material and have an adequate and safe means of heating the salt solution for the treatment of the liners (See Section 785.665).  The tank shall also be provided with a drainage outlet.

 

Section 785.650  Starter Vats

 

Bulk starter vats shall be of stainless steel or equally corrosion-resistant metal and constructed according to applicable 3-A Sanitary Standards.  The vats shall be in good repair, equipped with tight-fitting lids, and have temperature controls.

 

Section 785.655  Operations and Operating Procedures – Pasteurization

 

The milk or cream shall be pasteurized at the plant where the milk or cream is processed into the finished product.

 

a)         Cream for Buttermaking:  (785.415(f)(g)(h))

 

1)         The cream for buttermaking shall be pasteurized at a temperature of not less than 165º F. and held continuously in a vat at such temperature for not less than 30 minutes; or pasteurized by HTST method at a minimum temperature of not less than 185º F. for not less than 15 seconds; or by any other equivalent time and temperature combination.  Additional heat treatment above the minimum pasteurization requirement is advisable to insure improved keeping-quality characteristics.

 

2)         Adequate pasteurization control shall be used and the diversion valve shall be set to divert at no less than 185º F. with a 15 second holding time or its equivalent in time and temperature to assure pasteurization. If the vat or holding method of pasteurization is used, vat covers shall be closed prior to holding period to assure temperature of air space reaching the minimum temperature before holding time starts.  Covers shall also be kept closed during the holding and cooling period.

 

b)         Cream for Plastic or Frozen Cream:  The pasteurization of cream for plastic or frozen cream shall be accomplished in the same manner as in (a) above, except, that the temperature for the vat method shall be not less then 170º F. for not less than 30 minutes, or not less than 190º F. for not less than 15 seconds or by any other temperature and holding time which will assure adequate pasteurization and quality characteristics.

 

Section 785.660  Composition and Wholesomeness

 

All ingredients used in the manufacture of butter and related products shall be subject to inspection and shall be wholesome and free from impurities.  Chlorinating facilities shall be provided for butter wash water if needed and all other precautions shall be taken to prevent contamination of products.  All finished products shall comply with the requirements of the Illinois Food, Drug, and Cosmetic Act, as to composition and wholesomeness.

 

Section 785.665  Containers

 

a)         Containers used for the packaging of butter and related products shall be containers or packaging material that will protect the quality of the contents in regular channels of trade.  Caps or covers which extend over the lip of the container shall be used on all cups or tubs containing 2 pounds or less, to protect the product from contamination during subsequent handling.

 

b)         Liners and Wrappers:  

 

1)         Supplies of parchment liners, wrappers, and other packaging material shall be protected against dust, mold, and other possible contamination.

 

2)         Prior to use, parchment liners for bulk butter packages shall be completely immersed in a boiling salt solution in a container constructed of stainless steel or other equally noncorrosive material.  The liners shall be maintained in the solution for not less than 30 minutes.  The solution should consist of at least 15 pounds of salt for every 85 pounds of water and shall be strengthened or changed as frequently as necessary to keep the solution full strength and in good condition.

 

3)         Other liners such as polyethylene shall be treated or handled in such a manner as to prevent contamination of the liner prior to filling.

 

c)         Filling Bulk Butter Containers:  The lined butter containers shall be protected from possible contamination prior to filling.

 

Section 785.670  Printing and Packaging

 

Printing and packaging of consumer size containers of butter shall be conducted under sanitary conditions.

 

Section 785.675  General Identification

 

Commercial bulk shipping containers shall be legibly marked with the name of the product, net weight, name and address of manufacturer, processor or distributor or other assigned plant identification (manufacturer's lot number, churn number, etc.).  Packages of plastic or frozen cream shall be marked with the percent of milkfat.

 

Section 785.680  Storage of Finished Product in Coolers

 

All products shall be kept under refrigeration at temperatures of 40º F. or lower after packaging and until ready for distribution or shipment.  The products shall not be placed directly on floors or exposed to foreign odors or conditions such as drippage due to condensation which might cause package or product damage.

 

Section 785.685  Storage of Finished Product in Freezer

 

a)         Sharp Freezers:  Plastic cream or frozen cream intended for storage shall be placed in quick freezer rooms immediately after packaging, for rapid and complete freezing within 24 hours.  The packages shall be piled or spaced in such a manner that air can freely circulate between and around the packages.  The rooms shall be maintained at -10º F. or lower and shall be equipped to provide sufficient high-velocity air circulation for rapid freezing.  After the products have been completely frozen, they may be transferred to a freezer storage room for continued storage.

 

b)         Freezer Storage:  

 

1)         the room shall be maintained at a temperature of 0º F. or lower. Adequate air circulation is desirable (785.470(b)).

 

2)         Butter intended to be held more than 30 days shall be placed in a freezer room as soon as possible after packaging.  If not frozen before being placed in the freezer, the packages shall be spaced in such a manner as to permit rapid freezing and replied, if necessary, at a later time.

SUBPART G: SUPPLEMENTAL REQUIREMENTS FOR PLANTS MANUFACTURING AND PACKAGING CHEESE

 

Section 785.700  Rooms and Compartments − Starter Room

 

Starter rooms or areas shall be properly equipped and maintained for the propagation and handling of starter cultures.  All necessary precautions shall be taken to prevent contamination of starter, of the room, equipment, and the air therein (such as filtered air, locked doors, and entry of only specified personnel).

 

Section 785.705  Make Room

 

The room in which the cheese is manufactured shall be of adequate size, and the vats adequately spaced to permit movement around the vats and presses for proper cleaning and satisfactory working conditions.  Adequate ventilation shall be provided.

 

Section 785.710  Drying Room

 

If cheese is to be paraffined, a drying room of adequate size shall be provided to accommodate the maximum production of cheese during the flush period.  Shelving and air circulation shall be provided for proper drying. Temperature and humidity control facilities shall be provided.

 

Section 785.715  Paraffining Room

 

For rind cheese, a separate room or compartment shall be provided for paraffining and boxing the cheese.  The room or compartment shall be of adequate size and the temperature maintained near the temperature of the drying room to avoid sweating of the cheese prior to paraffining.

 

Section 785.720  Rindless Block Wrapping Area

 

For rindless blocks a space shall be provided for proper wrapping and boxing of the cheese.  The area shall be free from dust, condensation, mold or other conditions which may contaminate the surface of the cheese or contribute to an unsatisfactory packaging of the cheese.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.725  Coolers or Curing Rooms

 

Coolers or curing rooms where cheese is held for curing or storage shall be clean and maintained at the uniform temperature and humidity to protect the cheese.  Circulation of air shall be maintained at all times.  The rooms shall be free from rodents, insects, and pests.  The shelves shall be kept clean and dry.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.730  Cutting and Packaging Rooms

 

When small packages of cheese are cut and wrapped, separate room shall be provided for the cleaning and preparation of the bulk cheese and a separate room shall be provided for the cutting and wrapping operation.  The rooms shall be well lighted, ventilated, and provided with filtered air.  Air movement shall be outward to minimize the entrance of unfiltered air into the cutting and packaging room.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.735  Equipment and Utensils − General Construction, Repair, and Installation

 

All equipment and utensils necessary to the manufacture of cheese and related products shall meet the same general requirements as outlined in Section 785.415.  In addition, for certain other equipment the following requirements shall be met.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.740  Starter Vats

 

Bulk starter vats shall be of stainless steel or equally corrosion-resistant metal and shall be in good repair, equipped with tight-fitting lids and have adequate temperature controls such as valves, indicating and/or recording thermometers.  New vats shall be constructed according to the applicable 3-A Sanitary Standards.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.745  Cheese Vats

 

a)         The vats used for making cheese shall be of metal construction with adequate jacket capacity for uniform heating in accordance with 3-A Sanitary Standards.  The inner liner shall be minimum 16-gage stainless steel or other equally corrosion-resistant metal, properly pitched from side to center and from rear to front for adequate drainage.  The liner shall be smooth, free from excessive dents or creases and shall extend over the edge of the outer jacket.  The outer jacket, when metal, shall be constructed of stainless steel or other metal which can be kept clean and sanitary.  The junction of the liner and outer jackets shall be constructed so as to prevent milk or cheese from entering the inner jacket.

 

b)         The vat shall be equipped with a suitable sanitary outlet valve. Effective valves shall be provided and properly maintained to control the application of heat to the vat.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.750  Mechanical Agitators

 

The mechanical agitators shall be of sanitary construction.  The carriage and track shall be so constructed as to prevent the dropping of dirt or grease into the vat.  Metal blades, forks, or stirrers shall be constructed of stainless steel and of material approved in the 3-A Sanitary Standards for Plastic and Rubber or Rubberlike Materials and shall be free from rough or sharp edges which might scratch the equipment or remove metal particles.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.755  Curd Mill and Miscellaneous Equipment

 

Knives, hand rakes, shovels, paddles, strainers, and miscellaneous equipment shall be stainless steel or of material approved in the 3-A Sanitary Standards for Plastic and Rubberlike Material.  The product contact surfaces of the curd mill shall be of stainless steel.  All pieces of equipment shall be so constructed that they can be kept clean.  The wires in the curd knives shall be stainless steel, kept tight and replaced when necessary.  All guards shall be in place.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.760  Hoops and Followers

 

The hoops, forms, and followers shall be constructed of stainless steel, heavy tinned steel, or other approved suitable material in accordance with 3-A Sanitary Standards.  If tinned, they shall be kept tinned and free from rust.  All hoops, forms, and followers shall be kept in good repair.  Drums or other special forms used to press and store cheese shall be clean and sanitary.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.765  Press

 

The cheese press shall be constructed of stainless steel and all joints welded and all surfaces, seams, and openings readily cleanable.  The pressure advice shall be the continuous type.  Press cloths shall be maintained in good repair and in a sanitary condition.  Single-service press cloths shall be used only once.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.770  Rindless Cheese Press

 

The press used to heat seal the wrapper applied to rindless cheese shall have square interior corners, reasonably smooth interior surface and have controls that shall provide uniform pressure and heat equally to all surfaces.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.775  Paraffin Tanks

 

The metal tank shall be adequate in size, have wood rather than metal racks to support the cheese, have heat controls and an indicating thermometer. The cheese wax shall be kept clean.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.780  Operations and Operating Procedures − Cheese from Pasteurized Milk

 

a)         If the cheese is labeled as pasteurized, the milk shall be pasteurized by subjecting every particle of milk to a minimum temperature of 161º F. for not less than 15 seconds.

 

b)         HTST pasteurization units shall be equipped with the proper controls and equipment to assure pasteurization.  If the milk is held more than 2 hours between time of receipt or heat treatment and setting, it shall be cooled to 45º F. or lower until time is setting.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.785  Cheese from Unpasteurized Milk

 

If the cheese is labeled as "heat treated," "unpasteurized," "raw milk," or "for manufacturing," the milk may be raw or heated at temperatures below pasteurization.  If the milk is held more than 2 hours between time of receipt or heat treatment and setting, it shall be cooled to 45º F. or lower until time of setting.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.790  Whey Disposal

 

a)         Adequate sanitary facilities shall be provided for the disposal of whey.  If outside, necessary precautions shall be taken to minimize flies, insects, and development of objectionable odors.

 

b)         Whey or whey products intended for human food shall at all times be handled in a sanitary manner in accordance with the procedures of this subpart as specified for handling milk and dairy products.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.794  Packaging and Repackaging

 

Packaging rindless cheese or cutting and repackaging all styles of bulk cheese shall be conducted under sanitary conditions.  The atmosphere of the packaging rooms, the equipment and the packaging material shall be free from mold and bacterial contamination.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.797  General Identification

 

Each bulk cheese shall be legibly marked with the name of the product, code or date of manufacture, vat number, officially designated code number or name and address of manufacturer.  Each consumer sized container shall be plainly marked with the name and address of the manufacturer, packer, or distributor, net weight of the contents and name of product.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

SUBPART H: SUPPLEMENTAL REQUIREMENTS FOR PLANTS MANUFACTURING, PROCESSING, AND PACKAGING PASTEURIZED PROCESS CHEESE AND RELATED PRODUCTS

 

Section 785.800  Equipment and Utensils − General Construction, Repair, and Installation

 

The equipment and utensils used for the handling and processing of cheese products shall be as specified in Section 785.415.  In addition, for certain other equipment the following requirements shall be met.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.810  Conveyors

 

Conveyors shall be constructed of material which can be cleaned, will not rust, or otherwise contaminate the cheese, and shall be maintained in good repair.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.820  Grinders or Shredders

 

The grinders or shredders used in the preparation of the trimmed and cleaned natural cheese for the cookers shall be adequate in size.  Product contact surfaces shall be of corrosion resistant material, and of such construction as to prevent contamination of the cheese and to allow through cleaning of all parts and product contact surfaces.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.830  Cookers

 

The cookers shall be the steam jacketed or direct steam type.  They shall be constructed of stainless steel or other equally corrosion-resistant material.  All product contact surfaces shall be readily accessible for cleaning.  Each cooker shall be equipped with an indicating thermometer, and a temperature recording device.  The recording thermometer stem may be placed in the cooker if satisfactory time charts are used; if not, the stem shall be placed in the hotwell or filler hopper.  Steam check valves on direct steam type cookers shall be mounted flush with cooker wall, be constructed of stainless steel and designed to prevent the backup of product into the steam line, or the steam line shall be constructed of stainless steel pipes and fittings which can be readily cleaned.  If direct steam is applied to the product only culinary steam shall be used.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.840  Fillers

 

The hoppers of all fillers shall be covered but the cover may have sight ports.  If necessary, the hopper may have an agitator to prevent buildup on side wall.  The filler valves and head shall be kept in good repair, capable of accurate measurements.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.850  Operations and Operating Procedures − Trimming and Cleaning

 

The natural cheese shall be cleaned free of all nonedible portions. Paraffin and bandages as well as rind surface, mold, or unclean areas or any other part which could contaminate or adulterate the product shall be removed.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.860  Cooking the Batch

 

Each batch of cheese within the cooker, including the optional ingredients shall be thoroughly commingled and the contents pasteurized at a temperature of at least 158º F. and held at that temperature for not less than 30 seconds.  Care shall be taken to prevent the entrance of cheese particles or ingredients after the cooker batch of cheese has reached the final heating temperature.  After holding for the required period of time, the hot cheese shall be emptied from the cooker as quickly as possible.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.870  Forming Containers

 

Containers either lined or unlined shall be assembled and stored in a sanitary manner to prevent contamination in accordance with 3-A Sanitary Standards.  The handling of containers by filler crews shall be done with extreme care and observance of personal cleanliness.  Preforming and assembling of pouch liners and containers shall be kept to a minimum and the supply rotated to limit the length of time exposed to possible contamination prior to filling.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.880  Filling Containers

 

Hot fluid cheese from the cookers may be held in hot wells or hopper to assure a constant and even supply of processed cheese to the filler or slice former.  Filler valves shall effectively measure the desired amount of product into the pouch or containers in a sanitary manner and shall cut off sharply without drip or drag of cheese across the opening.  A system shall be used to maintain weight control.  Damaged packages shall be removed from production, and the cheese may be salvaged into sanitary containers, and added back to cookers.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.890  Closing and Sealing Containers

 

Pouches, liners, or containers having product contact surfaces after filling shall be folded or closed and sealed in a sanitary manner, preferably by mechanical means, so as to assure against contamination. Each container shall be coded in such a manner as to be easily identified as to date of manufacture by lot or sublot number.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

SUBPART I: SUPPLEMENTAL REQUIREMENTS FOR PLANTS MANUFACTURING AND PACKAGING FROZEN DESSERTS

 

Section 785.900  Pasteurization of Frozen Dessert Mix

 

After formulation the entire mix except for flavoring ingredients shall be pasteurized in accordance to the following minimum time and temperature standards and requirements for (non-coil batch pasteurization − 155º F. for 30 minutes) (H.T.S.T. pasteurization − 175º F. for 25 seconds).  This does not prohibit the use of any other process which is equally as effective in the pasteurization of product and approved by the Department.  Pasteurized mix or frozen desserts shall not be permitted to come in contact with equipment or containers with which, unpasteurized mix, frozen desserts, milk or milk products have been in contact, unless such equipment has first been washed and subjected to a bactericidal treatment.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.910  Cooling

 

Processed fluid milk products including mix, except sterilized mix in hermetically sealed containers, shall be cooled promptly after heat treatment or pasteurization to 45º F. or lower and maintained thereat until used.  This does not preclude holding fluid milk products at higher temperatures for a short period of time immediately prior to freezing.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.920  Storage

 

a)         Utensils and portable equipment used in processing operations shall be stored above the floor in clean, dry locations, and in self-draining position on racks constructed of impervious, corrosion-resistant material.

 

b)         Raw Milk and Cream:  Bulk milk, cream and fluid dairy products within the processing plant or receiving station shall be handled in such a manner as to minimize bacterial increase and shall be maintained at 45º F. or lower until processing begins.

 

c)         Overflow and Spillage:  Product drip or spilled mix of frozen desserts or their ingredients, shall not be sold for human consumption.

 

d)         Nonrefrigerated Products:  Dairy products, mix or frozen dessert ingredients in dry storage shall be arranged in aisles, rows, sections, or lots or in such a manner as to be orderly and easily accessible for inspection and to permit cleaning of the room.  Dunnage or pallets shall be used when applicable.  Dairy products, mix or frozen dessert ingredients shall not be stored with any product that would damage them or impair their quality.  Open containers shall be protected from contamination.

 

e)         Refrigerated Products:  All products requiring refrigeration except where otherwise specified, shall be stored under such temperatures and humidity as will maintain their quality and condition.  Products shall not be placed directly on wet floors or be exposed to foreign odors or conditions such as dripping or condensation that might cause package or product damage.

 

f)         Supplies (Illinois Pesticide Act of 1979 – Ill. Rev. Stat. 1985, ch. 5, par. 801):  Items in supply rooms shall be kept clean and protected and be so arranged as to permit inspection of supplies and cleaning and spraying of the room.  Insecticides and rodenticides shall be properly labeled, segregated, and stored in a separate room or cabinet away from milk or dairy products or packaging supplies.  Caps, parchment papers, wrappers, liners, gaskets and single service sticks, spoons, covers, and containers for frozen desserts, mix or their ingredients shall be purchased and stored only in sanitary tubes, wrappings, or cartons; shall be kept therein in a clean, dry place until used; and shall be handled in a sanitary manner.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

Section 785.930  Laboratory Control Tests

 

Quality control tests shall be made by the plant laboratory on flow samples as often as necessary to check the effectiveness of processing in order to correct processing deficiencies.  Routine analyses shall be made on raw materials and finished products to assure composition and quality control.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.940  Packaging and Labeling

 

a)         Packaging:  Frozen desserts and mix shall be packaged in containers and packaging material that will protect the quality of the contents in regular channels of trade.  Metal containers shall be free from rust, cracks, or unsanitary conditions.  Prior to use, closures, covers, wrappers and containers shall be protected against dust, mold and other possible contamination.  The packaging, cutting, molding, dispensing and other handling or preparation of mix or frozen desserts and their ingredients shall be done in a sanitary manner.

 

b)         Labeling:  Mix in commercial bulk shipping containers shall be tagged or legibly marked with the name of the product, pasteurization date or code, net contents, name and address of processor, manufacturer or distributor and plant license number if applicable.  Containers for frozen desserts shall be labeled in accordance with the provisions of the Illinois Food Service Sanitation (77 Illinois Administrative Code 750).

 

Section 785.950  Returns

 

Mix or frozen desserts in broken, opened or partially full containers may after delivery be returned to the plant for inspection, but shall not be sold or used for making mix or frozen desserts.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.955  Lubricants

 

Lubricants approved for use on milk product contact surfaces that are applied to filling machine pistons and cylinders, pumps, and valves shall be sterile (U.S.D.A. approved) and shall be applied in a sanitary manner.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.960  Vehicles

 

All vehicles used for the transportation of mix, frozen desserts, cream, milk and dairy products shall be constructed and operated so as to protect their contents from heat, sun and contamination.  Such vehicles shall be kept clean, and no substance capable of contaminating mix, frozen desserts, cream, milk and dairy products shall be transported therein.  Vehicles transporting frozen desserts and/or mix to wholesale or retail outlets shall have the name of the distributor prominently displayed thereon.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.970  Frozen Desserts Retail Establishments

 

Frozen desserts retail establishments including commissaries and depots, shall be exempt from the provisions of Subparts B and C of this standard. However, such establishments shall comply with the State of Illinois Food Service Sanitation 77 Illinois Administrative Code 750.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.980  Product Test Procedures and Quality Requirements

 

a)         At irregular intervals during any 6 month period at least four samples of frozen desserts, pasteurized mix, and milk, cream and dairy ingredients from each plant, shall be taken and examined by the Department.  Samples of the frozen desserts or mix may be taken at any time prior to final delivery.  Samples of milk, cream, and dairy products shall be taken at the frozen desserts plant.

 

b)         The products shall be tested in accordance with tests and examinations contained in the 15th edition of Standard Methods for the Examination of Dairy Products or 14th edition of Official Methods of Analysis of the Association of Official Analytical Chemists.

 

c)         No ingredients shall be used in processing frozen desserts which are adulterated within the meaning of the Ill. Food, Drug, and Cosmetic Act (Ill. Rev. Stat. 1985, ch. 56 ½, pars. 501 et seq.).

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.990  Quality Standards for Raw and Pasteurized Dairy Ingredients, Mix, or Frozen Desserts

 

Pasteurized mix, raw dairy ingredients and frozen desserts shall comply with the standards of Table 990.  The phenol value shall be no greater than the minimum specified for the particular product, as determined by the phosphatase test in the 15^th edition of "Standard Methods."

 

TABLE 990

 

Bacteria count standard plate count not more than

Coliform determination not more than

Storage temerature

 

Mix....................................................	50,000/gr......................	10/gr.....................	45º F.
Frozen Dessert (Plain).......................	50,000/gr......................	10/gr.....................	Frozen
Frozen Dessert (Flavored).................	50,000/gr......................	20/hr.....................	Frozen
Raw Milk and Milk Products as........ Ingredients	500,000/gr ................... As commingled Prior to Pasteurization		45º F.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

SUBPART J: SUPPLEMENTAL REQUIREMENTS FOR PLANTS MANUFACTURING, PROCESSING, AND PACKAGING EVAPORATED, OR CONDENSED MILK PRODUCTS

 

Section 785.1000  Equipment and Utensils − General Construction, Repair and Installation

 

The equipment and utensils used for processing and packaging evaporated, condensed, or sterilized milk products shall be as specified in Section 785.415.  In addition, for certain other equipment, the following requirements shall be met.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.1010  Evaporators and Vacuum Pans

 

All equipment used in the removal of moisture from milk or milk products for the purpose of concentrating the solids shall meet the requirements of the 3-A Sanitary Standards for Milk and Milk Products Evaporators and Vacuum Pans.  All new or used replacements for this type of equipment shall meet the appropriate 3-A Sanitary Standards.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.1020  Fillers

 

Both gravity-and vacuum-type fillers shall be of sanitary design and all product contact surfaces, if metal, shall be made of stainless steel or equally corrosion-resistant material; except that certain evaporated milk fillers having brass parts shall be approved if free from corroded surfaces and kept in good repair.  Nonmetallic product contact surfaces shall meet the requirements for 3-A Sanitary Standards for Rubber and Rubberlike Materials or for Multiple-Use Plastic Materials.  Fillers shall be designed so that they in no way will contaminate or detract from the quality of the product being packaged.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.1030  Batch or Continuous In-Containers Sterilizers

 

Shall be equipped with accurate temperature controls and effective valves of regulating the sterilization process.  The equipment shall be maintained in such a manner as to assure control of the length of time of processing, and to minimize the number of damaged containers.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.1040  Homogenizers

 

Homogenizers where applicable shall be used to reduce the size of the fat particles and to evenly disperse them in the product.  New homogenizers shall meet the applicable 3-A Sanitary Standards.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.1050  Operations and Operating Procedures − Preheat and Pasteurization

 

When pasteurization is intended or required by either the vat method, HTST method, or by the UHT method it shall be accomplished by systems and equipment meeting the requirements outlined in Section 785.415.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.1060  Filling Containers

 

a)         The fillingof small containers with product shall be done in a sanitary manner.  The containers shall not contaminate or detract from the quality of the product in any way.  After filling, the container shall be hermetically sealed.

 

b)         Bulk containers for unsterilized product shall protect the product from contamination in storage or transit.  The bulk container (including bulk tankers) shall be cleaned and sanitized before filling, and filled and closed in a sanitary manner.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.1070  Storage

 

Facilities shall be provided for the storage and handling of finished product.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

SUBPART K: ADMINISTRATIVE PROCEDURES

 

Section 785.1100  Licenses

 

No person may establish, maintain, conduct or operate a manufactured dairy farm, manufactured dairy plant to process milk for manufacturing purposes or manufactured dairy products or haul or sample milk for manufacturing purposes within Illinois State without a license from the Department. (Ill. Rev. Stat. 1985, ch. 56½, par. 521.2)

 

a)         A license shall be granted to and renewed for persons, who maintain, conduct, or operate a manufactured milk plant within the state of Illinois by the Department upon completion of an inspection which establishes compliance with the Act and this Part and upon payment of the fee required by Section 21.2 of the Act.

 

b)         An initial license shall be granted to a Milk Hauler when the following conditions are met:

 

1)         An inspection establishes that the hauler's equipment is in compliance with the provision of the Act and rules of this Part,

 

2)         The hauler has successfully completed an examination administered by the Department, and

 

3)         The hauler has paid the fee required by Section 21.2 of the Act.

 

c)         A renewal license shall be granted to a Milk Hauler when an inspection establishes that the hauler's equipment and sampling procedures are in compliance with the provision of the Act and this Part and upon payment of the fee required by Section 21.2 of the Act.

 

d)        

 

1)         An initial manufactured dairy farm license is necessary when a farm does not presently hold a license, a change of ownership occurs and only the farm owner's name was on the license, and when a change of tenant occurs and only the former tenant's name was on the license.

 

2)         An initial manufactured dairy farm license shall be granted to a dairy farm upon the completion of an inspection which establishes compliance with the Act and the rules of this Part.  The inspection includes procedures for the establishment of a quality record.  The quality record is established by the results of four samples taken at a rate of not more than two per week and on separate days within a three week period.

 

Section 785.1110  Inspection

 

Each farm shall be inspected by the Department.  If the farm meets the applicable requirements for licensure described in Subpart C, as indicated by the Farm Inspection Report Form the farm shall be licensed as described in Section 785.1120.  If the farm does not meet the requirements for licensure, it shall be reinspected within 30 days after the initial inspection.  If the farm then meets the requirements for licensure, it shall be licensed.  If the farm does not meet the requirements for licensure, it shall not be licensed, and the producer's authorization to sell milk for human food from that farm shall be withheld by the Department until such time as the farm qualifies for licensing.  Each completed Farm Inspection Report Form shall be kept by the Department and a copy shall be given to the producer.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.1120  Licensure

 

The Department shall license farms that meet the requirements of Subpart C as applicable, based upon the inspection procedure described in Section 785.1110. Farm licensure shall authorize the sale from that farm of milk for manufacturing purposes that meets the quality standards of Sections 785.210 through 785.230 as determined by the procedures described in Sections 785.210 through 785.290.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.1130  Expiration and Revocation of License

 

Farm licensure shall expire and become renewable by an annual inspection 1 year from the date of licensure unless revoked earlier by the Department and no license shall be transferable.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.1140  Reinstatement

 

If, after a period of withholding, probation, or revocation of farm license, a producer makes the necessary corrections at the farm, he may make application for reinspection.  When conditions have been corrected, the farm shall be reinspected by the Department.  When the Department determines that requirements for licensing have been met, he shall relicense the farm.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.1150  Licensing Plants, and Milk Hauler/Samplers

 

a)         Every plant receiving or processing milk for the manufacture of dairy products shall be inspected and licensed as provided in Sections 785.1155, 785.1160, 785.1170(a) and 785.1180.  A new plant shall be inspected and licensed as provided in Sections 785.1155, 785.1160, 785.1170(a) and 785.1180 before buying or processing any milk for the manufacture of dairy products.  No unlicensed plant shall handle, purchase, or receive milk or manufacture dairy products.

 

b)         All licensed plants shall be inspected annually after issuance of the initial license to determine eligibility for license renewal.  The inspectionprocedure for license renewal shall be the same as that for initial licensing.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.1155  Application for License

 

Applications to the Department for a new or renewal license for dairy plants, and milk hauler/sampler shall contain the name and address of the applicant and such other pertinent information as required by Section 21.2 of the Act.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.1160  Plant Inspection

 

a)         Each plant shall be inspected by the Department.  If upon initial inspection, the Department finds that the plant meets the requirements for licensing described in Subparts D through J, as indicated by the Plant Inspection Report Form a license shall be issued to the plant as described in Section 785.1170(a).  If the plant does not meet the requirements for licensing, the plant shall be reinspected by the Department within 30 days of the initial inspection.  A longer time may be allowed if major changes or new equipment is required (See Section 785.1110).  If at this time the plant meets the requirements for licensing, a license shall be issued.  If the plant does not meet the requirements for licensing or receive milk or to manufacture dairy products therefore shall be withheld until such time as the plant qualified for a license.

 

b)         Each completed Plant Inspection Report Form shall be kept by the Department, and a copy shall be given to the plant operator.

 

Section 785.1170  Suspension of License

 

The Department shall suspend licenses in accordance with the provisions of the Act and the Rules of this Part and the following:  

 

a)         All suspensions, except summary suspensions, shall be preceded by the notice and opportunity for a hearing in accordance with Section 785.1200 of this Part.  All summary suspension shall be based upon violations of the Act, or the rules of this part which constitute a finding that the public interest, safety or welfare imperatively requires such action in accordance with Section 16(c) of the Illinois Administrative Procedures Act (Ill. Rev. Stat. 1985, ch. 127, par. 1016(c)).  In addition, all summary suspensions shall be followed by notice and an opportunity for a hearing in accordance with Section 785.1200 of this Part.

 

b)         If a manufactured dairy farm, milk hauler, or manufactured dairy plant receives two suspensions in six months, an informal conference will be held to discuss corrective measures.  If the violations resulting in the most recent suspension are not corrected after this conference, administrative hearing proceeding will be initiated pursuant to Section 785.1200 of this Part.

 

c)         When successive inspection disclose violations of the same requirement that directly reflect on the health of the public such as unclean equipment and improper temperature requirements the suspension policy shall be enforced.

 

d)         The suspension policies may be waived as determined by the inspector's professional judgement dependent upon the amount of time required for the license holder to make the necessary corrections, the reasonableness of requiring corrections prior to the next inspection and the potential for a health hazard created by the violation.

 

Section 785.1175  Expiration, Suspension and Revocation of License

 

a)         Dairy plant licenses shall expire and become renewable December 31st of each year unless revoked earlier.  Milk hauler/sampler licenses shall expire and become renewable March 31st of each year.  No license shall be transferable.

 

b)         The Department may suspend or revoke licenses of milk hauler/samplers for any violation of these regulations of the Act in accordance with the provisions of Section 22.3 of the Act.  An opportunity for a hearing shall be provided any licensee before suspension or revocation of his license.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.1180  Reinstatement

 

a)         If, after a period of withholding, probation or revocation of a plant license, the operator makes the necessary corrections at the plant, he may apply, in writing, to the Department for reinspection and reinstatement. When the Department determines that requirements for licensing have been met the Department shall issue a license to the plant.

 

b)         The reinstatement of licenses for milk hauler/samplers which have been suspended or revoked shall be made only after satisfying the requirements for initial licensure.

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.1190  Supervision – Department

 

The Illinois Department of Public Health to insure compliance with the provisions of the Act and the rules and regulations shall:  

 

a)         Inspect each dairy farm, dairy plant, receiving station, and transfer station whose milk or milk products are intended for consumption within the State of Illinois or its jurisdiction and each milk hauler/sampler who collects samples of raw milk for processing, for bacterial, chemical, or temperature standards and hauls milk from dairy farm to a dairy plant, transfer station, or receiving station and his bulk milk pickup tank and its appurtenances shall be inspected by the Department prior to the issuance of a license.  Following the issuance of a license the Department will inspect all facilities and operators at the following minimum frequencies:

 

1)         Dairy Farms                                                                    – 12 Months

 

2)         Dairy Plants, Receiving Stations, Transfer Stations      – 12 Months

 

3)         Milk Hauler/Sampler Truck and Appurtenances           – 12 Months

Sampling Procedures                                                      – 24 Months

 

b)         Four times every six months the Department will collect samples of dairy products from each licensed dairy plant.  Samples will be taken any time prior to final delivery and delivered to an official State of Illinois laboratory.  Samples will be tested in accordance with tests and examinations contained in the 15^th edition of Standard Methods for the Examination of Dairy Products or the 14^th edition of the Official Methods of Analysis of the Association of Official Analytical Chemists.

 

c)        

 

1)         Whenever two of the last four consecutive bacterial counts, coliform determinations, or cooling temperatures taken on separate days, exceed the limit of the standard for raw commingled milk and/or dairy products, the Department shall sent a written notice thereof to the person concerned. This notice shall be in effect so long as two of the last four consecutive samples exceed the limit of the standard.  An additional sample shall be taken within 21 days of the sending of such notice, but not before the lapse of three days.  Immediate suspension of the plant license, in accordance with these rules Section 785.1130, shall be instituted whenever the standard is violated by three of the last five bacterial counts, coliform determinations, or cooling temperatures.

 

2)         Whenever the license suspension has been due to a violation of any of the bacterial, coliform, or cooling-temperature standards, the Department within one week after the receipt of notification for reinstatement of the license, shall issue a temporary license after determining by an inspection of the facilities and operating methods that the conditions responsible for the violation have been corrected.  The Department will then resample the product and if the results are satisfactory, the license will remain on a temporary status pending three satisfactory test results before full license reinstatement can be granted.

 

d)         All plans for the construction, reconstruction, or alterations other than those to repair or perform maintenance on existing facilities of a dairy farm's milking facilities, transfer stations, receiving stations, cleaning and sanitizing facilities, and dairy plants regulated under these rules must be submitted to the Department for approval before work is begun.  The Department shall approve plans which meet the requirements of the Act and this Part within 30 days of submission.

 

Section 785.1200  Administrative Hearings

 

All administrative hearings held pursuant to the Act and rules of this Part shall be conducted in accordance with the Department's Rules of Practice and Procedure in Administrative Hearings. (77 Ill. Adm. Code 100)

 

(Source:  Adopted at 11 Ill. Reg. 2356, effective February 1, 1987)

 

 

Section 785.1210  Pesticide, Herbicide and Mycotoxin Residue Control Program

 

a)         The following describes the Department's Pesticide, Herbicide and Mycotoxin Residue Control Program for raw milk under Section 785.290.

 

1)         If the analysis of a sample from a bulk tank truck shows a level of any of the pesticides, herbicides or mycotoxins above the action levels contained in subsection (b) of this Section, then an individual sample is collected from each producer's milk that was in the tank truck to determine which producer or producers have created or contributed to the problem.

 

2)         When the individual resampling is complete and the test indicates high pesticide residue levels equal to or above action level, another sample will be taken within 15 days to determine whether this adulteration is continual or has been a one-time situation.

 

3)         If the second sample under subsection (a)(2) of this Section shows an action level equal to or greater than those contained in subsection (b) of this Section, then all of the producer's milk will be removed from the market and not offered for sale for human consumption until an official sample test shows the residue falls below the action level.

 

4)         The milk supply will then be provisionally reinstated for human use and samples will be taken on a monthly basis.  Should the next sample be above action level, the milk will again be removed from the market and not offered for sale for human consumption.

 

5)         When two consecutive monthly samples are below the action level, the producer's supply shall be fully reinstated.

 

b)         The following action levels have been established for the Pesticide, Herbicide and Mycotoxin Residue Control Program (PPM = parts per million; PPB = parts per billion):

 

1)         Aldrin                                                              – 0.3 PPM

 

2)         Dieldrin                                                           – 0.3 PPM

 

3)         Endrin                                                             – 0.3 PPM

 

4)         Lindane                                                           – 0.3 PPM

 

5)         Heptachlor or Heptachlor Epoxide                 – the action level for either or both combined is 0.1 PPM

 

6)         PCB                                                                – 1.5 PPM

 

7)         Aflatoxin                                                         – 0.5 PPM

 

8)         D.D.T.                                                             – 1.25 PPM    

 

(Source:  Added at 17 Ill. Reg. 14027, effective August 15, 1993)

 

Section 785.1220  Drug Residue Monitoring and Farm Surveillance

 

This Section describes the Department's Drug Residue Monitoring and Farm Surveillance Program.  It is established to reference safe levels and/or tolerances and to assure milk supplies are in compliance with these safe levels or established tolerances for drug residues in milk.

 

a)         Industry Responsibilities

 

1)         Monitoring and Surveillance

 

A)        Industry shall screen all bulk milk pick-up tankers for beta lactam drug residues.  Additionally, other drug residues shall be screened for by employing a random sampling program on bulk milk pick-up tankers.  The random bulk milk pick-up tanker sampling program shall represent and include, during any six months, at least four samples collected in at least four separate months.  Samples shall be analyzed as specified by the Department.

 

B)        Bulk milk pick-up tanker testing shall be completed prior to processing the milk.  Bulk milk pick-up tanker samples found to have a violative drug residue shall be retained as determined necessary by the Department.  Industry shall also record all sample results and retain those records for a period of six months.

 

2)         Reporting and Farm Traceback

 

A)        When a bulk milk pick-up tanker is found to have a violative drug residue, the Department shall be immediately notified of the results and the ultimate disposition of the raw milk.

 

B)        The individual sample collected from each producer's milk that was in the bulk milk pick-up tanker that was found to have a violative drug residue shall be immediately tested to determine which producer or producers have created or contributed to the drug residue.

 

C)        Further pickups of the violative individual producer or producers shall be immediately discontinued until such time that subsequent tests no longer indicate violative drug residues and enforcement requirements of subsection (b)(2) of this Section have been met.

 

b)         Department Responsibilities

 

1)         Monitoring and Surveillance

 

A)        The Department shall monitor industry surveillance activities by making unannounced on-site inspections to collect samples from bulk milk pick-up tankers and to review industry records of the random sampling program.

 

B)        The Department shall also perform routine sampling and testing for drug residues determined to be necessary.

 

2)         Enforcement

 

A)        If testing reveals violative drug residues, the milk shall be disposed of in a manner that removes it from the human or animal food chain except where reconditioned under Department approval.

 

B)        When the individual testing as required in subsection (a)(2)(B) of this Section is complete and the tests indicate any drug residue at or above the tolerance and/or safe levels, the producer's permit will be summarily suspended.  Another sample will be taken from milk produced after corrections have been made to determine whether this adulteration is continual.   For the third occurrence of a drug residue in any 12 month period, the Department shall initiate administrative procedures pursuant to revocation of the producer's permit.

 

C)        If the resample shows no violative drug residue, the permit will then be conditionally reinstated until such time as the producer and a licensed veterinarian have completed a quality assurance program, but in no case for longer than 30 days.

 

D)        When the field representative has transmitted to the Department a copy of the quality assurance program completion certificate signed by the producer and a licensed veterinarian, the producer's manufactured raw milk permit shall be fully reinstated.

 

3)         The following describes the penalty procedures for the Department's drug residue control program for manufactured raw milk.

 

A)        These procedures shall be followed when individual sample testing for drug residues has been completed, test results indicate a violative drug residue, and the producer's or producers' manufactured raw milk permit is summarily suspended in accordance with subsection (b)(2)(B) of this Section.  The producer or producers shall submit to the Department an equivalent penalty to the 96 hour period following the violative shipment for the second and third occurrences in any 12 month period.   The equivalent penalty for the second and third occurrences shall be $4.00 per hundred weight of the milk produced during 96 hours following the violative shipment.  The penalty shall be paid to the Department by the first buyer of the milk, by the last day of the month immediately following the violation.  Following the third occurrence of drug residue violation in any 12 month period, the Department shall initiate administrative procedures, pursuant to Section 785.1200, to permanently revoke the producer's permit.

 

B)        The producer's manufactured raw milk permit will be conditionally reinstated for up to 30 days when a subsequent sample of the producer's milk does not contain a violative drug residue.  The producer and a licensed veterinarian must complete a quality assurance (QA) program within the 30 day conditional reinstatement of the manufactured raw milk permit.

 

C)        When the field representative has transmitted to the Department a copy of the quality assurance program completion certificate signed by the producer and a licensed veterinarian, the producer's manufactured raw milk permit shall be fully reinstated.

 

4)         All monies collected through the drug residue control program shall be deposited in the Food and Drug Safety Fund and will be dedicated to drug residue prevention efforts, producer education and providing information for the prevention of drug residue.

 

c)         Established Tolerances and/or Safe Levels of Drug Residues

 

1)         Tolerances for drug residues that may result in milk are set forth in 21 CFR 556 (1999).

 

2)         "Safe levels" are used by the Department for prosecutorial discretion. They do not legalize residues found in milk that are below the safe level. Safe levels as established by the Federal Food and Drug Administration will be transmitted by the Department via Technical Releases.

 

(Source:  Amended at 25 Ill. Reg. 12634, effective September 25, 2001)