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09500HB2820ham001 |
- 2 - |
LRB095 06449 RAS 33732 a |
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| household.
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| (3) Be permitted to receive, for processing, inspected |
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| meat
products and inspected poultry products for the |
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| owner's own
personal use or for use by his or her |
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| household.
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| (4) Stamp the words "NOT FOR SALE-NOT INSPECTED" in |
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| letters at least 3/8
inches in height on all carcasses of |
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| animals and immediate poultry product
containers for |
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| poultry
slaughtered in such establishment and on all meat |
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| products and
immediate poultry product containers for |
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| poultry products processed in that
establishment.
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| (5) Conspicuously display a license issued by the |
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| Department
and bearing the words "NO SALES PERMITTED".
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| (6) Keep a record of the name and address of the owner |
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| of
each carcass or portion thereof received in such |
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| licensed
establishment, the date received, and the dressed |
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| weight. Such
records shall be maintained for at least one |
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| year and shall be
available, during reasonable hours, for |
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| inspection by Department
personnel.
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| (b) No custom slaughterer or custom processor shall engage
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| in the business of buying or selling any poultry or meat |
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| products
capable of use as human food, or slaughter of any |
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| animals or
poultry intended for sale.
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| (c) Each Type II licensee shall develop, implement, and |
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| maintain written standard operating procedures for sanitation, |
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| which shall be known as Sanitation SOPs, in accordance with all |
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09500HB2820ham001 |
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LRB095 06449 RAS 33732 a |
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| of the following requirements: |
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| (1) The Sanitation SOPs must describe all procedures |
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| that a Type II licensee shall conduct daily, before and |
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| during operations, sufficient to prevent direct |
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| contamination or adulteration of products. |
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| (2) The Sanitation SOPs must be signed and dated by the |
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| individual with overall authority on-site or a higher level |
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| official of the establishment. This signature shall |
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| signify that the establishment shall implement the |
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| Sanitation SOPs as specified and maintain the Sanitation |
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| SOPs in accordance with the requirements of this subsection |
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| (c). The Sanitation SOPs must be signed and dated upon the |
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| initial implementation of the Sanitation SOPs and upon any |
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| modification to the Sanitation SOPs. |
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| (3) Procedures set forth in the Sanitation SOPs that |
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| are to be conducted prior to operations must be identified |
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| as such and must address, at a minimum, the cleaning of |
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| food contact surfaces of facilities, equipment, and |
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| utensils. |
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| (4) The Sanitation SOPs must specify the frequency with |
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| which each procedure in the Sanitation SOPs shall be |
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| conducted and identify the establishment employees |
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| responsible for the implementation and maintenance of the |
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| procedures. |
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| (5) Prior to the start of operations, each licensee |
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| must conduct the pre-operational procedures in the |
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09500HB2820ham001 |
- 4 - |
LRB095 06449 RAS 33732 a |
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| Sanitation SOPs. All other procedures set forth in the |
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| Sanitation SOPs must be conducted at the frequencies |
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| specified. |
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| (6) The implementation of the procedures set forth in |
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| the Sanitation SOPs must be monitored daily by the |
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| licensee. |
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| (7) A licensee must routinely evaluate the |
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| effectiveness of the Sanitation SOPs and the procedures set |
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| forth therein in preventing direct contamination or |
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| adulteration of products and shall revise both as necessary |
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| to keep the Sanitation SOPs and the procedures set forth |
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| therein effective and current with respect to changes in |
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| facilities, equipment, utensils, operations, or personnel. |
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| (8) A licensee must take appropriate corrective action |
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| when either the establishment itself or the Department |
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| determines that the Sanitation SOPs or the procedures |
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| specified therein or the implementation or maintenance of |
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| the Sanitation SOPs may have failed to prevent direct |
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| contamination or adulteration of products. Corrective |
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| actions include procedures to ensure appropriate |
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| disposition of products that may be contaminated, restore |
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| sanitary conditions, and prevent the recurrence of direct |
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| contamination or adulteration of products, such as |
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| appropriate reevaluation and modification of the |
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| Sanitation SOPs and the procedures specified therein or |
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| appropriate improvements in the execution of the |
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09500HB2820ham001 |
- 5 - |
LRB095 06449 RAS 33732 a |
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| Sanitation SOPs or the procedures specified therein. |
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| (9) A licensee must maintain daily records sufficient |
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| to document the implementation and monitoring of the |
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| Sanitation SOPs and any corrective actions taken. The |
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| establishment employees specified in the Sanitation SOPs |
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| as being responsible for the implementation and monitoring |
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| of the procedures set forth in the Sanitation SOPs must |
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| authenticate these records with their initials and the |
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| date. The records required to be maintained under this item |
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| (9) may be maintained on computers, provided that the |
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| establishment implements appropriate controls to ensure |
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| the integrity of the electronic data. Records must be |
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| maintained for at least 6 months and made available to the |
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| Department upon request. All records must be maintained at |
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| the licensed establishment for 48 hours following |
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| completion, after which the records may be maintained |
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| off-site, provided that the records may be made available |
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| to the Department within 24 hours of request. |
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| (10) The Department shall verify the adequacy and |
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| effectiveness of the Sanitation SOPs and the procedures |
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| specified therein by determining that they meet the |
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| requirements of this subsection (c). This verification may |
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| include the following: |
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| (A) reviewing the Sanitation SOPs; |
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| (B) reviewing the daily records documenting the |
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| implementation of the Sanitation SOPs and the |
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09500HB2820ham001 |
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LRB095 06449 RAS 33732 a |
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| procedures set forth therein and any corrective |
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| actions taken or
required to be taken; |
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| (C) direct observation of the implementation of |
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| the Sanitation SOPs and the procedures specified |
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| therein and any corrective actions taken or required to |
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| be taken;
and |
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| (D) direct observation or testing to assess the |
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| sanitary conditions within the establishment. |
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| (d) Each Type II licensee that slaughters livestock must |
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| test for Escherichia coli Biotype 1 (E. coli). Licensees that |
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| slaughter more than one type of livestock or both livestock and |
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| poultry must test the type of livestock or poultry slaughtered |
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| in the greatest number. The testing required under this |
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| subsection (d) must meet all of the following requirements: |
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| (1) A licensee must prepare written specimen |
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| collection procedures that identify the employees |
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| designated to collect samples and must address (i) |
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| locations of sampling, (ii) the ways in which sampling |
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| randomness is achieved, and (iii) the handling of samples |
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| to ensure sample integrity. This written procedure must be |
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| made available to the Department upon request. |
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| (2) Livestock samples must be collected from all |
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| chilled livestock carcasses, except those boned before |
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| chilling (hot-boned), which must be sampled after the final |
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| wash. Samples must be collected in the following manner: |
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| (A) for cattle, establishments must sponge or |
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09500HB2820ham001 |
- 7 - |
LRB095 06449 RAS 33732 a |
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| excise tissue from the flank, brisket, and rump, except |
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| for hide-on calves, in which case establishments must |
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| take samples by sponging from inside the flank, inside |
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| the brisket, and inside the rump; |
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| (B) for sheep and goats, establishments must |
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| sponge from the flank, brisket, and rump, except for |
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| hide-on carcasses, in which case establishments must |
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| take samples by sponging from inside the flank, inside |
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| the brisket, and inside the rump; |
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| (C) for swine carcasses, establishments must |
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| sponge or excise tissue from the ham, belly, and jowl |
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| areas. |
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| (3) A licensee must collect at least one sample per |
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| week, starting the first full week of operation after June |
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| 1 of each year, and continue sampling at a minimum of once |
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| each week in which the establishment operates until June 1 |
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| of the following year or until 13 samples have been |
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| collected, whichever is sooner. |
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| (4) Upon a licensee's meeting the requirements of item |
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| (3) of this subsection (d), weekly sampling and testing |
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| shall be optional, unless changes are made in establishment |
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| facilities, equipment, personnel, or procedures that may |
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| affect the adequacy of existing process control measures, |
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| as determined by the licensee or the Department. |
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| Determinations made by the Department that changes have |
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| been made requiring the resumption of weekly testing must |
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09500HB2820ham001 |
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LRB095 06449 RAS 33732 a |
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| be provided to the licensee in writing. |
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| (5) Laboratories may use any quantitative method for |
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| the analysis of E. coli that is approved as an AOAC |
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| Official Method of the AOAC International (formerly the |
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| Association of Official Analytical Chemists) or approved |
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| and published by a scientific body and based on the results |
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| of a collaborative trial conducted in accordance with an |
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| internationally recognized protocol on collaborative |
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| trials and compared against the 3 tube Most Probable Number |
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| (MPN) method and agreeing with the 95% upper and lower |
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| confidence limit of the appropriate MPN index. |
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| (6) A licensee must maintain accurate records of all |
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| test results, in terms of CFU/cm 2 of surface area sponged |
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| or excised. Results must be recorded onto a process control |
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| chart or table showing at least the most recent 13 test |
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| results, by type of livestock slaughtered. Records shall be |
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| retained at the establishment for a period of 12 months and |
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| made available to the Department upon request. |
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| (7) Licensees must meet the following criteria for the |
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| evaluation of test results: |
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| (A) A licensee excising samples from carcasses |
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| shall be deemed as operating within the criteria of |
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| this item (7) when the most recent E. coli test result |
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| does not exceed the upper limit (M), and the number of |
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| samples, if any, testing positive at levels above (m) |
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| is 3 or fewer out of the most recent 13 samples (n) |
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09500HB2820ham001 |
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LRB095 06449 RAS 33732 a |
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| taken, as follows:
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| Evaluation of E. Coli Test Results
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3 | | Type of
| Lower limit
| Upper limit
| Number
| Max number
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4 | | Livestock
| of marginal
| of marginal
| samples
| permitted
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5 | | | 6 | | | range
| range
| collected
| in marginal range
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| 7 | | | | | |
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8 | | | (m)
| (M) | (n)
| (c) |
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9 | | Cattle
| Negative a
| 100 CFU/cm 2
| 13
| 3
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10 | | Swine
| 10 CFU/cm 2
| 10,000 CFU/cm
| 13
| 3
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| a Negative is defined by the sensitivity of the method used in |
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| the baseline study with a limit of sensitivity of at least 5 |
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| CFU/cm 2 carcass surface area.
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| (B) A licensee sponging carcasses shall evaluate |
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| E. coli test results using statistical process control |
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| techniques.
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| (8) Test results that do not meet the criteria set |
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| forth in item (7) of this subsection (d) are an indication |
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| that the establishment may not be maintaining process |
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| controls sufficient to prevent fecal contamination. The |
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| Department shall take further action as appropriate to |
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| ensure that all applicable provisions of this Section are |
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| being met. |
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09500HB2820ham001 |
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LRB095 06449 RAS 33732 a |
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| (9) Inspection shall be suspended in accordance with |
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| the rules of practice adopted for such proceedings upon a |
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| finding by the Department that one or more provisions of |
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| items (1) through (6) of this subsection (d) have not been |
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| complied with and written notice of this noncompliance has |
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| been provided to the licensee.
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| (e) Each Type II licensee that slaughters poultry shall |
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| test for Escherichia coli Biotype 1 (E. coli). Licensees that |
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| slaughter more than one type of poultry or poultry and |
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| livestock, shall test the type of poultry or livestock |
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| slaughtered in the greatest number. The testing required under |
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| this subsection (e) must meet all of the following |
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| requirements:
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| (1) A licensee must prepare written specimen |
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| collection procedures that identify the employees |
16 |
| designated to collect samples and must address (i) |
17 |
| locations of sampling, (ii) the ways in which sampling |
18 |
| randomness is achieved, and (iii) the handling of samples |
19 |
| to ensure sample integrity. This written procedure must be |
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| made available to the Department upon request. |
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| (2) When collecting poultry samples, a whole bird must |
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| be taken from the end of the slaughter line. Samples must |
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| be collected by rinsing the whole carcass in an amount of |
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| buffer appropriate for that type of bird. Samples from |
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| turkeys or ratites also may be collected by sponging the |
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| carcass on the back and thigh. |
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09500HB2820ham001 |
- 11 - |
LRB095 06449 RAS 33732 a |
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| (3) Licensees that slaughter turkeys, ducks, geese, |
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| guineas, squabs, or ratites in the largest number must |
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| collect at least one sample during each week of operation |
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| after June 1 of each year, and continue sampling at a |
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| minimum of once each week that the establishment operates |
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| until June 1 of the following year or until 13 samples have |
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| been collected, whichever is sooner. |
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| (4) Upon a licensee's meeting the requirements of item |
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| (3) of this subsection (e), weekly sampling and testing |
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| shall be optional, unless changes are made in establishment |
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| facilities, equipment, personnel, or procedures that may |
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| affect the adequacy of existing process control measures, |
13 |
| as determined by the licensee or by the Department. |
14 |
| Determinations by the Department that changes have been |
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| made requiring the resumption of weekly testing must be |
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| provided to the licensee in writing. |
17 |
| (5) Laboratories may use any quantitative method for |
18 |
| the analysis of E. coli that is approved as an AOAC |
19 |
| Official Method of the AOAC International (formerly the |
20 |
| Association of Official Analytical Chemists) or approved |
21 |
| and published by a scientific body and based on the results |
22 |
| of a collaborative trial conducted in accordance with an |
23 |
| internationally recognized protocol on collaborative |
24 |
| trials and compared against the 3 tube Most Probable Number |
25 |
| (MPN) method and agreeing with the 95% upper and lower |
26 |
| confidence limit of the appropriate MPN index. |
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09500HB2820ham001 |
- 12 - |
LRB095 06449 RAS 33732 a |
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| (6) A licensee must maintain accurate records of all |
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| test results, in terms of CFU/ml of rinse fluid. Results |
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| must be recorded onto a process control chart or table |
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| showing the most recent 13 test results, by type of poultry |
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| slaughtered. Records must be retained at the establishment |
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| for a period of 12 months and made available to the |
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| Department upon request. |
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| (7) A licensee excising samples under this subsection |
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| (e) shall be deemed as operating within the criteria of |
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| this item (7) when the most recent E. coli test result does |
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| not exceed the upper limit (M), and the number of samples, |
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| if any, testing positive at levels above (m) is 3 or fewer |
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| out of the most recent 13 samples (n) taken, as follows:
|
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| Evaluation of E. Coli Test Results
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|
15 | | Type of
| Lower limit
| Upper limit
| Number of
| Number
|
|
16 | | poultry
| of marginal
| of marginal
| samples
| permitted
|
|
17 | | | 18 | | | range | range
| tested
| in marginal range
|
| 19 | | | | | |
|
20 | | | (m)
| (M)
| (n)
| (c)
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21 | | Chickens
| 100 CFU/ml
| 1,000 CFU/ml
| 13
| 3
|
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| (8) Test results that do not meet the criteria set |
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| forth in item (7) of this subsection (e) are an indication |
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09500HB2820ham001 |
- 13 - |
LRB095 06449 RAS 33732 a |
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| that the establishment may not be maintaining process |
2 |
| controls sufficient to prevent fecal contamination. The |
3 |
| Department shall take further action as appropriate to |
4 |
| ensure that all applicable provisions of this Section are |
5 |
| being met. |
6 |
| (9) Inspection shall be suspended in accordance with |
7 |
| the rules of practice adopted for such proceeding upon a |
8 |
| finding by the Department that one or more provisions of |
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| items (1) through (6) of this subsection (e) have not been |
10 |
| complied with and written notice of this noncompliance has |
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| been provided to the establishment.
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| (Source: P.A. 94-1052, eff. 1-1-07.)".
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