Wisconsin Legislature: ATCP 65.44(1)(j)

History: CR 14-073: cr. Register August 2016 No. 728, eff. 9-1-16.

ATCP 65.41 Low-acid or acidified dairy products packaged in hermetically sealed containers for non-refrigerated storage.

(1) Manufacturing of low-acid dairy products, that have a pH greater than 4.6 and a water activity greater than 0.85, and are packaged in a hermetically sealed container for non-refrigerated storage, shall be done in compliance with 21 CFR 108.35 and 113.

(2) Manufacturing of acidified dairy products, as defined in 21 CFR 114.3(b), that are packaged in a hermetically sealed container for non-refrigerated storage, shall be done in compliance with 21 CFR 108.25 and 114.

History: CR 14-073: cr. Register August 2016 No. 728, eff. 9-1-16.

ATCP 65.42 Recall plan.

(1) Plan required. An operator of a dairy plant at which dairy products are manufactured or processed shall prepare a written plan for identifying and recalling milk and dairy products processed at that dairy plant, and any other food processed at the facility, should a recall become necessary. The dairy plant operator shall update the plan as necessary and shall make it available to the division for inspection and copying upon request. This requirement does not apply to the operator of a receiving station or a transfer station.

(2) plan contents. A plan, written pursuant to sub. (1), shall do all of the following:

(a) Identify key individuals or positions that are responsible for planning, approving, and implementing recalls on behalf of the dairy plant operator.

(b) Identify key individuals or entities to be contacted or consulted in connection with a recall.

(c) Include procedures for the routine identification, dating, and tracking of milk and dairy product lots so that in a recall the affected lots can be identified and distinguished from unaffected lots.

(d) Include procedures to enable routine identification, dating, and tracking of milk and dairy product shipments from the dairy plant. Tracking shall identify shipment recipients and contents, cross-referenced to lots, so that in a recall recipients of affected lots can be contacted.

(e) Include procedures for determining the nature and scope of a recall, including affected milk and dairy product lots, shipments, and shipment recipients.

(f) Include procedures for identifying and communicating with affected persons, including suppliers, milk and dairy product shipment recipients, down-line buyers, consumers, government agencies, and others.

(g) Identify potential target audiences for recall information, including consumers, distributors, and government agencies.

(h) Identify potential methods for communicating with target audiences, under par. (g).

(i) Identify key information, including the identity of the affected milk and dairy products, the reason for the recall, and suggested actions to be taken by affected persons, that may be necessary to communicate to affected persons in a recall.

History: CR 14-073: cr. Register August 2016 No. 728, eff. 9-1-16.

ATCP 65.44 Dairy plant records.

(1) Mandatory records. A dairy plant operator, including a milk contractor that submits a milk producer license application on behalf of a milk producer and thereby certifies that the milk producer’s dairy farm and milking operations comply with applicable requirements under this chapter, shall keep all of the following records, as applicable to their operation, and shall retain those records for the period of time specified under this subsection:

(a) Records related to milk receipts and producer payrolls, as required by s. ATCP 100.32 (1). Records under this paragraph shall include milk collection records received from bulk milk weighers and samplers under s. ATCP 82.10 (10). Records under this paragraph shall be retained for at least 3 years.

(b) Records of all dairy product ingredients received at the dairy plant, including the sources from which the ingredients were received. Records under this paragraph shall be retained for at least two years.

(c) Daily records of all finished products produced at the dairy plant. Records under this paragraph shall be retained for at least one year.

(d) Records of all milk quality tests and sediment tests conducted on milk shipments received by the dairy plant operator, including but not limited to tests required under subch. V. Records under this paragraph shall be retained for at least 2 years.

(e) Records of all in-plant tests, performed by a dairy plant operator on milk and dairy products held or processed by the dairy plant operator, to determine bacterial counts or identify possible adulteration of that milk or those dairy products. Records under this paragraph shall be retained for at least 2 years.

(f) Records of private water supply tests, if any, conducted under s. ATCP 65.24 (8). Records under this paragraph shall be retained for at least 2 years.

(g) Cleaning and sanitizing records for all C-I-P systems, as required under s. ATCP 65.30 (2) (b). Records under this paragraph shall be retained for at least 2 years. Records may be stored in electronic form, with or without hard copy printouts, if the electronic records are readily accessible by a division representative.

(h) A record of every calibration, daily performance check, daily reference check, and hourly reference check performed on a milkfat or protein testing device, as required by s. ATCP 65.86 (3) (j). Records under this paragraph shall be retained for at least one year.

(i) Pasteurization records required under s. ATCP 65.66. Records under this paragraph shall be retained for at least 2 years.

(j) Cleaning and sanitizing records for bulk milk tankers cleaned and sanitized at a dairy plant, as required under s. ATCP 82.08 (4). Records under this paragraph shall be retained for at least 15 days.

(k) Temperature monitoring records made by the dairy plant operator, including records of dairy product temperatures, storage temperatures, and processing temperatures. Records under this paragraph shall be retained for at least 2 years.

(L) Inventory control records for vitamin fortification of fluid milk products, including vitamins used and the quantity of fortified fluid milk products produced. Records under this paragraph shall be retained for at least 2 years.

(m) Vitamin assay test results conducted on fortified dairy products under s. ATCP 65.74 (4). Records under this paragraph shall be retained for at least 2 years.

(n) Cleaning and sanitizing records required under s. ATCP 65.28 (7) (g). Records under this paragraph shall be retained for at least 2 years.

(o) Bills of lading or other shipping documents relating to the bulk shipment of dairy products from the dairy plant to another dairy plant, or to the dairy plant from another dairy plant. The dairy plant operator shall retain each shipping document for at least 3 years. Each shipping document shall include all of the following information:

1. The name, address, and license number of the dairy plant from which the shipment originates. If the dairy product is a grade A dairy product, the shipping document shall also include the dairy plant shipper identification number assigned under the PMO.

2. If grade A milk or dairy product was shipped in a bulk milk tanker, the bulk milk tanker grade A permit identification number, assigned under ch. ATCP 82 or the PMO, and the seal number on the bulk milk tanker inlet, outlet, wash connections, and vents.

3. The name of the dairy product shipped.

4. The weight of the dairy product shipped.

5. The temperature of the dairy product when loaded for shipment.

6. The date of shipment.

7. The name of the dairy regulatory agency at the shipment point of origin.

8. Whether the dairy product was raw, pasteurized, or treated with heat to an extent less than pasteurization.

9. The grade of product.

(p) Milk producer affidavits certifying that the milk producers do not use bovine somatotropin, as required under s. ATCP 83.02 (5) and (7).

(2) Accessibility of records; electronic records. Records under sub. (1) shall be kept at the dairy plant or, for records kept by a milk contractor that submits a milk producer license application on behalf of a milk producer and thereby certifies that the milk producer’s dairy farm and milking operations comply with applicable requirements under this chapter, at the milk contractor’s business location, and shall be made available to the division for inspection and copying upon request. Records may be kept in electronic form, with or without hard copy printouts, if the electronic records are readily accessible to a division representative and comply with the applicable provision of Appendix H, sections IV and V of the PMO.

History: CR 14-073: cr. Register August 2016 No. 728, eff. 9-1-16; correction in (1) (h) made under s. 13.92 (4) (b) 7., Stats., and correction in (1) (p) made under s. 35.17, Stats., Register August 2016 No. 728.

ATCP 65.46 Dairy plant reports to department.

(1) Reports related to licenses, permits, financial statements and milk quality. A dairy plant operator, including a milk contractor that submits a milk producer license application on behalf of a milk producer and thereby certifies that the milk producer’s dairy farm and milking operations comply with applicable requirements under this chapter, shall submit all of the following reports to the department:

(a) Reports required for the issuance or annual renewal of a dairy plant license or grade A permit under s. ATCP 65.02.

(b) Financial statements and reports required as part of an application for a milk contractor license under ch. ATCP 100, if any.

(c) Monthly milk quality test reports required under subch. V and dairy farm inspection reports required as part of a milk producer or grade A producer permit application under ss. ATCP 65.910 and 65.912.

(2) Reports related to results of product testing for microbial pathogens or toxins.

(a) Except as provided in par. (b), a dairy plant operator shall report to the division the result of any microbiological test or laboratory analysis that confirms the presence of a pathogenic organism or toxin in a ready-to-eat dairy product produced by the operator. The operator shall report to the division within 24 hours after the operator obtains the test result. The operator may report orally, electronically, or in writing.

(b) A dairy plant operator is not required to report a test result under par. (a) if all the following apply:

1. The ready-to-eat dairy product is identified by a product code or production lot number and remains under the control or custody of the dairy plant operator.

2. The operator does not sell or distribute any ready-to-eat dairy product that bears the product code or production lot number under subd. 1.

History: CR 14-073: cr. Register August 2016 No. 728, eff. 9-1-16.

ATCP 65.48 Confidential information.

(1) None of the following information, received by the department from a dairy plant operator, including a milk contractor that submits a milk producer license application on behalf of a milk producer and thereby certifies that the milk producer’s dairy farm and milking operations comply with applicable requirements under this chapter, is subject to public inspection under s. 19.35, Stats.

(a) Financial information protected from disclosure under s. 126.84 (1) (a), Stats.

(b) Information qualifying as a trade secret as defined in s. 134.90 (1) (c), Stats.

(2) None of the following information received by the department from a dairy plant operator, including a milk contractor that submits a milk producer license application on behalf of a milk producer and thereby certifies that the milk producer’s dairy farm and milking operations comply with applicable requirements under this chapter, is subject to public inspection under s. 19.35, Stats., unless the department determines that inspection is necessary to protect the public health, safety, or welfare:

(a) Information that identifies individual milk producers who deliver milk to the dairy plant operator, or sell milk to a milk contractor, if the information is in the form of a composite list identifying those producers with that dairy plant operator or milk contractor, except as provided under s. 126.70 (6) (b) and (c), Stats.

Note: See s. 97.20 (3m), Stats.

(b) Information pertaining to individual milk producer production and milk quality records if that information identifies the producer.

Note: See s. 97.22 (10), Stats.

History: CR 14-073: cr. Register August 2016 No. 728, eff. 9-1-16.

ATCP 65.50 Dairy product labeling.

(1) General. Dairy product labeling shall comply with applicable requirements in ch. 97, Stats., this chapter, and chs. ATCP 81, 83, 85, and 90.

(2) Products not for human consumption. No dairy plant operator may distribute any dairy product manufactured by that dairy plant operator unless any of the following applies:

(a) The dairy product complies with, and has been produced according to, this chapter and ch. ATCP 82.

(b) The dairy product is prominently labeled as animal feed according to ch. ATCP 42.

(c) The dairy product is prominently labeled as “NOT FOR HUMAN FOOD OR ANIMAL FEED” and is sold only for non-food and non-feed purposes. The label shall include the manufacturer’s name and address and the address of the location where the product was manufactured. The label may not include any dairy plant license or identification number issued by the department.

History: CR 14-073: cr. Register August 2016 No. 728, eff. 9-1-16.

Subchapter IV — Pasteurization

ATCP 65.52 Unpasteurized milk sales prohibited; exemptions. No person may sell or distribute unpasteurized milk or dairy products to consumers or to any person for resale or redistribution in unpasteurized form to consumers. This section does not prohibit any of the following:

(1) The sale or distribution of milk or dairy products that are heat sterilized in hermetically sealed containers.

(2) The distribution of unpasteurized fluid milk, produced on a dairy farm, to any of the following:

(a) The milk producer who is licensed under s. ATCP 65.02 (1) to operate that dairy farm, and who, as license holder, assumes legal responsibility for dairy farm and milking operations.

(b) An individual who has a bona fide ownership interest in the dairy farm and milking operation under par. (a), if the milk producer operating the dairy farm and milking operation is a legal entity other than an individual or married couple.

(c) A family member or nonpaying household guest who consumes the milk at the home of an individual milk producer or bona fide owner under par. (a) or (b).

(3) The sale or distribution of unpasteurized milk, produced on a dairy farm, to the employees of that dairy farm.

(4) The incidental sale of unpasteurized milk to a consumer at the dairy farm where the milk is produced. A sale is not incidental if the consumer subsequently sells the milk or distributes the milk, other than distribution for consumption by the consumer, the consumer’s family, or the consumer’s nonpaying household guests. A sale is not incidental if it is made in the regular course of business, or is preceded by any advertising, offer or solicitation made to the general public through any communications medium.

History: CR 14-073: cr. Register August 2016 No. 728, eff. 9-1-16.

ATCP 65.54 Pasteurization required.

(1) Except as provided under sub. (2), every dairy product shall be pasteurized at the dairy plant where that dairy product is manufactured.

(2) Subsection (1) does not apply to any of the following:

(a) A dairy product shipped in bulk to another dairy plant for use in manufacturing dairy products, provided that the shipment is accompanied by a bill of lading that identifies the dairy product as unpasteurized.