(225 ILCS 650/5.2)

Sec. 5.2. Type II licenses.

(a) Type II establishments licensed under this Act for custom slaughtering and custom processing shall:

(1) Be permitted to receive, for processing, meat products and poultry products from animals and poultry slaughtered by the owner or for the owner for his or her own personal use or for use by his or her household.

(2) Be permitted to receive live animals and poultry presented by the owner to be slaughtered and processed for the owner's own personal use or for use by his or her household.

(3) Be permitted to receive, for processing, inspected meat products and inspected poultry products for the owner's own personal use or for use by his or her household.

(4) Stamp the words "NOT FOR SALE-NOT INSPECTED" in letters at least 3/8 inches in height on all carcasses of animals and immediate poultry product containers for poultry slaughtered in such establishment and on all meat products and immediate poultry product containers for poultry products processed in that establishment.

(5) Conspicuously display a license issued by the Department and bearing the words "NO SALES PERMITTED".

(6) Keep a record of the name and address of the owner of each carcass or portion thereof received in such licensed establishment, the date received, and the dressed weight. Such records shall be maintained for at least one year and shall be available, during reasonable hours, for inspection by Department personnel.

(b) No custom slaughterer or custom processor shall engage in the business of buying or selling any poultry or meat products capable of use as human food, or slaughter of any animals or poultry intended for sale.

(c) Each Type II licensee shall develop, implement, and maintain written standard operating procedures for sanitation, which shall be known as Sanitation SOPs, in accordance with all of the following requirements:

(1) The Sanitation SOPs must describe all procedures that a Type II licensee shall conduct daily, before and during operations, sufficient to prevent direct contamination or adulteration of products.

(2) The Sanitation SOPs must be signed and dated by the individual with overall authority on-site or a higher level official of the establishment. This signature shall signify that the establishment shall implement the Sanitation SOPs as specified and maintain the Sanitation SOPs in accordance with the requirements of this subsection (c). The Sanitation SOPs must be signed and dated upon the initial implementation of the Sanitation SOPs and upon any modification to the Sanitation SOPs.

(3) Procedures set forth in the Sanitation SOPs that are to be conducted prior to operations must be identified as such and must address, at a minimum, the cleaning of food contact surfaces of facilities, equipment, and utensils.

(4) The Sanitation SOPs must specify the frequency with which each procedure in the Sanitation SOPs shall be conducted and identify the establishment employees responsible for the implementation and maintenance of the procedures.

(5) Prior to the start of operations, each licensee must conduct the pre-operational procedures in the Sanitation SOPs. All other procedures set forth in the Sanitation SOPs must be conducted at the frequencies specified.

(6) The implementation of the procedures set forth in the Sanitation SOPs must be monitored daily by the licensee.

(7) A licensee must routinely evaluate the effectiveness of the Sanitation SOPs and the procedures set forth therein in preventing direct contamination or adulteration of products and shall revise both as necessary to keep the Sanitation SOPs and the procedures set forth therein effective and current with respect to changes in facilities, equipment, utensils, operations, or personnel.

(8) A licensee must take appropriate corrective action when either the establishment itself or the Department determines that the Sanitation SOPs or the procedures specified therein or the implementation or maintenance of the Sanitation SOPs may have failed to prevent direct contamination or adulteration of products. Corrective actions include procedures to ensure appropriate disposition of products that may be contaminated, restore sanitary conditions, and prevent the recurrence of direct contamination or adulteration of products, such as appropriate reevaluation and modification of the Sanitation SOPs and the procedures specified therein or appropriate improvements in the execution of the Sanitation SOPs or the procedures specified therein.

(9) A licensee must maintain daily records sufficient to document the implementation and monitoring of the Sanitation SOPs and any corrective actions taken. The establishment employees specified in the Sanitation SOPs as being responsible for the implementation and monitoring of the procedures set forth in the Sanitation SOPs must authenticate these records with their initials and the date. The records required to be maintained under this item (9) may be maintained on computers, provided that the establishment implements appropriate controls to ensure the integrity of the electronic data. Records must be maintained for at least 6 months and made available to the Department upon request. All records must be maintained at the licensed establishment for 48 hours following completion, after which the records may be maintained off-site, provided that the records may be made available to the Department within 24 hours of request.

(10) The Department shall verify the adequacy and effectiveness of the Sanitation SOPs and the procedures specified therein by determining that they meet the requirements of this subsection (c). This verification may include the following:

(A) reviewing the Sanitation SOPs;

(B) reviewing the daily records documenting the implementation of the Sanitation SOPs and the procedures set forth therein and any corrective actions taken or required to be taken;

(C) direct observation of the implementation of the Sanitation SOPs and the procedures specified therein and any corrective actions taken or required to be taken; and

(D) direct observation or testing to assess the sanitary conditions within the establishment.

(d) Each Type II licensee that slaughters livestock must test for Escherichia coli Biotype 1 (E. coli). Licensees that slaughter more than one type of livestock or both livestock and poultry must test the type of livestock or poultry slaughtered in the greatest number. The testing required under this subsection (d) must meet all of the following requirements:

(1) A licensee must prepare written specimen collection procedures that identify the employees designated to collect samples and must address (i) locations of sampling, (ii) the ways in which sampling randomness is achieved, and (iii) the handling of samples to ensure sample integrity. This written procedure must be made available to the Department upon request.

(2) Livestock samples must be collected from all chilled livestock carcasses, except those boned before chilling (hot-boned), which must be sampled after the final wash. Samples must be collected in the following manner:

(A) for cattle, establishments must sponge or excise tissue from the flank, brisket, and rump, except for hide-on calves, in which case establishments must take samples by sponging from inside the flank, inside the brisket, and inside the rump;

(B) for sheep and goats, establishments must sponge from the flank, brisket, and rump, except for hide-on carcasses, in which case establishments must take samples by sponging from inside the flank, inside the brisket, and inside the rump;

(C) for swine carcasses, establishments must sponge or excise tissue from the ham, belly, and jowl areas.

(3) A licensee must collect at least one sample per week, starting the first full week of operation after June 1 of each year, and continue sampling at a minimum of once each week in which the establishment operates until June 1 of the following year or until 13 samples have been collected, whichever is sooner.

(4) Upon a licensee's meeting the requirements of item (3) of this subsection (d), weekly sampling and testing shall be optional, unless changes are made in establishment facilities, equipment, personnel, or procedures that may affect the adequacy of existing process control measures, as determined by the licensee or the Department. Determinations made by the Department that changes have been made requiring the resumption of weekly testing must be provided to the licensee in writing.

(5) Laboratories may use any quantitative method for the analysis of E. coli that is approved as an AOAC Official Method of the AOAC International (formerly the Association of Official Analytical Chemists) or approved and published by a scientific body and based on the results of a collaborative trial conducted in accordance with an internationally recognized protocol on collaborative trials and compared against the 3 tube Most Probable Number (MPN) method and agreeing with the 95% upper and lower confidence limit of the appropriate MPN index.

(6) A licensee must maintain accurate records of all test results, in terms of CFU/cm2 of surface area sponged or excised. Results must be recorded onto a process control chart or table showing at least the most recent 13 test results, by type of livestock slaughtered. Records shall be retained at the establishment for a period of 12 months and made available to the Department upon request.

(7) Licensees must meet the following criteria for the evaluation of test results:

(A) A licensee excising samples from carcasses shall be deemed as operating within the criteria of this item (7) when the most recent E. coli test result does not exceed the upper limit (M), and the number of samples, if any, testing positive at levels above (m) is 3 or fewer out of the most recent 13 samples (n) taken, as follows:

Evaluation of E. Coli Test Results

a Negative is defined by the sensitivity of the method used in the baseline study with a limit of sensitivity of at least 5 CFU/cm2 carcass surface area.

(B) A licensee sponging carcasses shall evaluate E. coli test results using statistical process control techniques.

(8) Test results that do not meet the criteria set forth in item (7) of this subsection (d) are an indication that the establishment may not be maintaining process controls sufficient to prevent fecal contamination. The Department shall take further action as appropriate to ensure that all applicable provisions of this Section are being met.

(e) Each Type II licensee that slaughters poultry shall test for Escherichia coli Biotype 1 (E. coli). Licensees that slaughter more than one type of poultry or poultry and livestock, shall test the type of poultry or livestock slaughtered in the greatest number. The testing required under this subsection (e) must meet all of the following requirements:

(1) A licensee must prepare written specimen collection procedures that identify the employees designated to collect samples and must address (i) locations of sampling, (ii) the ways in which sampling randomness is achieved, and (iii) the handling of samples to ensure sample integrity. This written procedure must be made available to the Department upon request.

(2) When collecting poultry samples, a whole bird must be taken from the end of the slaughter line. Samples must be collected by rinsing the whole carcass in an amount of buffer appropriate for that type of bird. Samples from turkeys or ratites also may be collected by sponging the carcass on the back and thigh.

(3) Licensees that slaughter turkeys, ducks, geese, guineas, squabs, or ratites in the largest number must collect at least one sample during each week of operation after June 1 of each year, and continue sampling at a minimum of once each week that the establishment operates until June 1 of the following year or until 13 samples have been collected, whichever is sooner.

(4) Upon a licensee's meeting the requirements of item (3) of this subsection (e), weekly sampling and testing shall be optional, unless changes are made in establishment facilities, equipment, personnel, or procedures that may affect the adequacy of existing process control measures, as determined by the licensee or by the Department. Determinations by the Department that changes have been made requiring the resumption of weekly testing must be provided to the licensee in writing.

(5) Laboratories may use any quantitative method for the analysis of E. coli that is approved as an AOAC Official Method of the AOAC International (formerly the Association of Official Analytical Chemists) or approved and published by a scientific body and based on the results of a collaborative trial conducted in accordance with an internationally recognized protocol on collaborative trials and compared against the 3 tube Most Probable Number (MPN) method and agreeing with the 95% upper and lower confidence limit of the appropriate MPN index.

(6) A licensee must maintain accurate records of all test results, in terms of CFU/ml of rinse fluid. Results must be recorded onto a process control chart or table showing the most recent 13 test results, by type of poultry slaughtered. Records must be retained at the establishment for a period of 12 months and made available to the Department upon request.

(7) A licensee excising samples under this subsection (e) shall be deemed as operating within the criteria of this item (7) when the most recent E. coli test result does not exceed the upper limit (M), and the number of samples, if any, testing positive at levels above (m) is 3 or fewer out of the most recent 13 samples (n) taken, as follows:

Evaluation of E. Coli Test Results

(8) Test results that do not meet the criteria set forth in item (7) of this subsection (e) are an indication that the establishment may not be maintaining process controls sufficient to prevent fecal contamination. The Department shall take further action as appropriate to ensure that all applicable provisions of this Section are being met.

(Source: P.A. 94-1052, eff. 1-1-07; 95-554, eff. 8-30-07.)