Chapter ATCP 65

ATCP 65.922 ATCP 65.922 Enforcement actions taken in response to drug residue violations.

ATCP 65.922(1) (1) Warning notice. Whenever the division receives notice under s. ATCP 65.72 (9) that a milk producer milk sample has yielded a confirmed positive test result for drug residue, the division shall mail a warning notice to that milk producer. The warning notice takes effect 3 business days after it is mailed. The warning notice shall include all of the following:

ATCP 65.922(1)(a) (a) A description of the positive drug residue findings that caused the division to issue the notice.

ATCP 65.922(1)(b) (b) The deadlines and penalties specified in subs. (2), (4), or (5).

ATCP 65.922(1)(c) (c) Notice of the milk producer’s right to hearing under sub. (6).

ATCP 65.922(1)(d) (d) Notice that a division representative will conduct an investigation under sub. (3).

ATCP 65.922(2) (2) Deadlines and penalties after a first violation in 12 months.

ATCP 65.922(2)(a) (a) Grade A producer permit suspension; 21-day deadline. The warning notice under par. (a) shall state that, no less than 21 days after the effective date of the warning notice, the department will suspend the milk producer’s grade A producer permit unless, prior to that date, the milk producer certifies to the division that the milk producer has implemented a drug residue prevention program on the milk producer’s dairy farm in consultation with a licensed veterinarian.

ATCP 65.922(2)(b) (b) Notice suspending grade A producer permit. If the division does not receive a milk producer certification within the 21-day period specified under sub. (2) (a), the department shall mail a notice to the milk producer suspending the milk producer’s grade A producer permit. The suspension notice shall comply with s. ATCP 65.925. The suspension notice takes effect when the suspension notice is served under s. ATCP 65.925 (6). The division shall notify the dairy plant operator or milk contractor who procures milk from the milk producer of the suspension, and shall provide that dairy plant operator or milk contractor with a copy of the suspension notice.

ATCP 65.922(2)(c) (c) Grade A producer permit reinstatement. If the department suspends a milk producer’s grade A producer permit, under par. (a), the milk producer may request the department to reinstate the permit. Written notice of the reinstatement process shall be included in the suspension notice under par. (a), and shall also be provided to the milk producer at the time of suspension.

ATCP 65.922(2)(c)1. 1. The milk producer shall file the reinstatement request in writing, on a form provided by the department, under s. ATCP 65.925 (4). The request shall include a certification or attestation that the milk producer has implemented a drug residue prevention program on the milk producer’s dairy farm in consultation with a licensed veterinarian.

ATCP 65.922(2)(c)2. 2. Within 7 business days after the department receives a complete reinstatement request under subd. 1., the division shall inspect the milk producer’s dairy farm. The department shall charge a reinspection fee for the inspection, pursuant to s. ATCP 65.02 (19). If, upon inspection, it appears that all conditions potentially responsible for the positive drug residue finding have been corrected and the milk producer has implemented a qualified drug residue prevention program in consultation with a licensed veterinarian, the division representative shall reinstate the milk producer’s grade A producer permit and shall notify the dairy plant operator or milk contractor of the reinstatement within 24 hours.

ATCP 65.922(2)(c)3. 3. If a milk producer does not request reinstatement under subd. 1., within 6 months after the milk producer’s grade A producer permit is suspended under par. (a), the permit is revoked automatically at the end of the 6-month period. A permit, once revoked, may not be reinstated unless the milk producer files a new application under s. ATCP 65.02 (11). This subdivision does not apply if the milk producer contests the grade A producer permit suspension and the contested case proceeding is pending. The time limit for the reinstatement request is measured from the conclusion of the contested case proceedings concerning the suspension of the milk producer’s grade A producer permit.

ATCP 65.922(2)(d) (d) Milk producer license suspension; 45-day deadline. The warning notice under par. (a) shall state that, no less than 45 days after the effective date of the warning notice, the department will initiate action to suspend the milk producer’s license unless, prior to that date, the milk producer certifies to the division that the milk producer has implemented a drug residue prevention program on the milk producer’s dairy farm in consultation with a licensed veterinarian.

ATCP 65.922(2)(e) (e) Milk producer license suspension; failure to implement drug residue prevention program. If the division does not receive a milk producer certification within the 45-day period specified under par. (d), the division shall file a complaint asking the department to suspend the milk producer’s license until the milk producer implements a drug residue prevention program.

ATCP 65.922 Note Note: The drug residue prevention program under this section should conform to the “Milk and Dairy Beef Quality Assurance Program” published by Agri-Education, Inc. A copy of that manual is on file with the division and the legislative reference bureau and may be obtained from the Milk & Dairy Beef Quality Assurance Center, 801 Shakespeare Avenue, Stratford, Iowa, 50249, telephone [phone], website www.dqacenter.org/catalog.htm.

ATCP 65.922(3) (3) Investigation. After the division issues a warning notice under sub. (1), the division representative shall conduct an investigation to determine the cause of the drug residue violation and to identify milk producer actions that may be necessary to prevent future violations. The division may direct the dairy plant operator or milk contractor who procures milk from the milk producer to conduct the investigation as the division’s agent and report its findings to the division, in writing.

ATCP 65.922(4) (4) Deadline and penalties after a second violation within 12 months. If, at least 24 hours and not more than 12 months after a confirmed positive drug test result is reported to the division, the division receives a notice under s. ATCP 65.72 (9) of another confirmed positive drug residue test result on a milk sample from a shipment received from the dairy farm operating under the same milk producer license, a warning notice under sub. (1) (a) shall be mailed to the milk producer. The warning notice takes effect 3 business days after it is mailed and shall include the information under sub. (1) (a), (c), and (d). The warning notice shall state that the department shall suspend the milk producer license under s. ATCP 65.920 for at least 5 days unless the milk producer agrees within 15 days of the warning notice taking effect to do all of the following:

ATCP 65.922(4)(a) (a) Discard one shipment of milk, as defined by the department, pursuant to s. ATCP 65.72 (7), or pay a civil forfeiture for the maximum amount, under s. 97.72 (2), Stats., for one violation of this subsection.

ATCP 65.922(4)(b) (b) Attend and present a certificate of completion for a drug residue prevention course approved by the department within 180 days of the warning notice taking effect. The certificate of course completion shall be signed by the milk producer, a licensed veterinarian, and the field representative of the dairy plant to which the milk producer’s milk is shipped.

ATCP 65.922(5) (5) Deadline and penalties after a third violation within 12 months. If, at least 24 hours after a second confirmed positive drug residue test result is reported to the division under sub. (4), and not more than 12 months after a first confirmed positive drug residue test result is reported to the division under sub. (4), the division receives a notice under s. ATCP 65.72 (9) of another confirmed positive drug residue test result on a milk sample received from the dairy farm operating under the same milk producer license, a warning notice under sub. (1) (a) shall be mailed to the milk producer. The warning notice takes effect 3 business days after it is mailed and shall include the information under sub. (1) (a), (c), and (d). The warning notice shall state that the department shall suspend the milk producer’s grade A producer permit, under s. ATCP 65.920, for at least 10 days unless the milk producer agrees within 15 days of the warning notice taking effect to do all of the following:

ATCP 65.922(5)(a) (a) Discard two shipments of milk, as defined by the department, pursuant to s. ATCP 65.72 (7), or pay a civil forfeiture for the maximum amount, under s. 97.72 (2), Stats., for two violations of this subsection.

ATCP 65.922(5)(b) (b) Develop and implement a drug residue prevention program approved by the department and present documentation indicating that this program has been implemented for at least 90 days after the warning notice taking effect.

ATCP 65.922 Note Note: The drug residue prevention course shall cover proper administration of animal medications, be approved by the department, and require collaboration between the milk producer and a licensed veterinarian.

ATCP 65.922(6) (6) Right to informal hearing. If a milk producer receiving a warning notice under this section disputes the drug residue findings on which the notice is based, the milk producer may request an informal hearing to discuss the drug residue findings. A request for hearing does not automatically stay the warning notice. If the milk producer requests an informal hearing, the division shall hold an informal hearing at the division’s office or by telephone. The division shall hold the informal hearing within 20 days after the division receives the request for hearing, unless the milk producer agrees to a later hearing date. The division may withdraw a warning notice if it appears that the notice was not justified.

ATCP 65.922 History History: CR 14-073: cr. Register August 2016 No. 728, eff. 9-1-16; correction in (5) made under s. 35.17, Stats., Register August 2016 No. 728.

ATCP 65.925 ATCP 65.925 Suspension notice; requirements. Whenever the division suspends a milk producer license under s. ATCP 65.920 (3), or a grade A producer permit, under s. ATCP 65.920 (6) or 65.922 (2) or, the suspension notice shall comply with all of the following requirements:

ATCP 65.925(1) (1) Issued by authorized person. A suspension notice shall be issued by one of the following:

ATCP 65.925(1)(a) (a) The division administrator.

ATCP 65.925(1)(b) (b) A person that the division administrator designates in writing, by name or position.

ATCP 65.925(1)(c) (c) A division representative if the suspension notice is issued under s. ATCP 65.920 (6) (a) 4.

ATCP 65.925(2) (2) Reason for suspension. A suspension notice shall specify the reasons for which the suspension notice is issued.

ATCP 65.925(3) (3) Term of suspension; reinstatement requirement. A suspension notice shall indicate the term of the suspension or, if the suspension is for an indefinite term, the conditions that the milk producer must meet in order to obtain reinstatement of the milk producer license or grade A producer permit. Conditions for reinstatement shall be reasonably related to the reasons for which the license or permit is suspended. A summary license suspension notice under s. ATCP 65.920 (2) may authorize a dairy plant operator to receive milk from the suspended milk producer directly or via a milk contractor, on a conditional basis, pending full reinstatement of the milk producer’s license, provided that the dairy plant operator or milk contractor performs inspections or tests specified in the suspension order.

ATCP 65.925(4) (4) Reinstatement application form. A notice suspending a grade A producer permit, under s. ATCP 65.920 (6) (a), shall be accompanied by a reinstatement application form which may be used by the affected milk producer to apply for reinstatement of the milk producer’s grade A producer permit. The form shall include a statement, to be signed by the affected milk producer, that all requirements for the reinstatement of the grade A producer permit have been met to the best of the milk producer’s knowledge. If a milk producer requests a hearing on a suspension under s. ATCP 65.928, a request for reinstatement under this subsection does not constitute an admission or waiver by the milk producer with respect to any fact, issue or cause of action.

ATCP 65.925(5) (5) Notice of right to hearing. A suspension notice shall include a notice that the milk producer may request a hearing on the suspension, as provided under s. ATCP 65.928.

ATCP 65.925(6) (6) Service on milk producer. A suspension notice shall be served on the affected milk producer by one of the following methods:

ATCP 65.925(6)(a) (a) By delivering the notice in person to the milk producer or to a competent member of the milk producer’s household who is 14 years of age or older.

ATCP 65.925(6)(b) (b) By mailing the notice to the milk producer. Service may be proved by an affidavit of mailing or by a return receipt signed by the milk producer. Absent proof of later delivery, a notice served by mail is considered served three business days after the date of mailing.

ATCP 65.925(6)(c) (c) For a notice suspending a grade A producer permit, under s. ATCP 65.920 (6), by posting the suspension notice in a prominent location in the milk producer’s milkhouse. A notice posted in the milkhouse under this paragraph is considered served at the time of posting.

ATCP 65.925(7) (7) Copy provided to dairy plant operator. A copy of every suspension notice shall be mailed or delivered to the dairy plant operator or milk contractor who normally procures milk from the milk producer at least three days before the start of the suspension. Failure to mail or deliver a copy to the dairy plant operator or milk contractor does not invalidate a suspension notice.

ATCP 65.925 History History: CR 14-073: cr. Register August 2016 No. 728, eff. 9-1-16; correction in (intro.) made under s. 35.17, Stats., Register August 2016 No. 728.

ATCP 65.926 ATCP 65.926 Dairy plant license and grade A permit suspension or revocation.

ATCP 65.926(1) (1) The department may suspend or revoke a dairy plant license or grade A dairy plant permit, as provided in s. 93.06 (7), Stats., except as provided under sub. (2), the department may not suspend or revoke a dairy plant license or grade A dairy plant permit except by order of the secretary or the secretary’s designee, as provided in ch. ATCP 1, after notice and opportunity for hearing under subch. III of ch. 227, Stats. The division may file a written complaint with the department seeking the suspension or revocation of a dairy plant license or grade A dairy plant permit. Pending completion of the proceedings, the secretary or the secretary’s designee may issue interim orders as necessary to protect the public health, safety and welfare. If an inspection is required for the reinstatement of a dairy plant license or grade A dairy plant permit that is suspended or revoked under this section, the department shall charge a reinspection fee, under s. ATCP 65.02 (19), for the inspection.

ATCP 65.926(2) (2) The department may suspend or revoke a dairy plant license or grade A dairy plant permit, as provided under s. 93.06 (7), Stats., for cause including any of the following:

ATCP 65.926(2)(a) (a) A violation of this chapter or ch. ATCP 100.

ATCP 65.926(2)(b) (b) Interference with lawful inspection or sampling by the department or a certifying agency under s. ATCP 65.930, or refusal to permit lawful inspection or sampling by the department or a certifying agency under s. ATCP 65.930.

ATCP 65.926(2)(c) (c) Refusal to permit the lawful inspection or copying of documents under s. ATCP 65.44 (2).

ATCP 65.926(2)(d) (d) Failure to pay fees required under s. ATCP 65.04.

ATCP 65.926 Note Note: The procedure for suspending or revoking a dairy plant license or grade A permit is specified in ch. ATCP 1.

ATCP 65.926(3) (3) The suspension or revocation of a dairy plant license automatically suspends or revokes any grade A permit that the dairy plant operator holds for that dairy plant.

ATCP 65.926 Note Note: Violations of this chapter may also result in court prosecution under s. 97.72 or 97.73, Stats.

ATCP 65.926 History History: CR 14-073: cr. Register August 2016 No. 728, eff. 9-1-16; correction in (2) (c) made under s. 35.17, Stats., Register August 2016 No. 728.

ATCP 65.927 ATCP 65.927 Holding orders; identification and disposal of adulterated milk.

ATCP 65.927(1) (1) Holding order. Whenever a division representative has reasonable cause to believe that milk or a milk product examined by the division representative is adulterated or misbranded and is dangerous to health or misleading to the injury or damage of a purchaser or consumer, the division representative may issue a temporary holding order to allow for further testing or examination of the milk or milk product, pursuant to s. 97.12 (2), Stats. A holding order shall be written and shall identify the milk or milk product that is subject to the holding order. The division may extend or terminate a holding order by written notice, as provided in s. 97.12 (2), Stats. A notice extending a holding order shall be signed by the division administrator, or a person authorized in writing by the division administrator. A holding order and every notice extending a holding order shall include a notice of the recipient’s right to hearing under s. ATCP 65.928.

ATCP 65.927(2) (2) Disposal order. If analysis or examination shows that milk or a milk product is adulterated or misbranded and is dangerous to health or misleading to the injury or damage of a purchaser or consumer, the division may issue a summary disposal order under s. 97.12 (2) (c), Stats., requiring the disposal or other disposition of the milk or milk product. A disposal order may be issued by the division representative who examines the milk, or by the division administrator, or by a person whom the administrator designates in writing. Where appropriate, an order may require relabeling of misbranded milk in lieu of disposal. A holding order under sub. (1) is not a prerequisite to a disposal order under this subsection. A disposal order shall be issued in writing, and shall include a notice of the recipient’s right to hearing under s. ATCP 65.928.

ATCP 65.927(3) (3) Identification of adulterated milk. If milk is found to be adulterated and hazardous to health, a division representative may identify the milk for disposal or disposition in compliance with a notice under sub. (2). To identify the adulterated milk, the division representative may tag the milk container and may add a harmless food grade color to the milk to prevent its sale or use for human food purposes.

ATCP 65.927 History History: CR 14-073: cr. Register August 2016 No. 728, eff. 9-1-16.

ATCP 65.928 ATCP 65.928 Right of hearing.

ATCP 65.928(1) (1) Hearing request. A person adversely affected by any of the following division actions may ask the department to hold a hearing on that action:

ATCP 65.928(1)(a) (a) The denial of a milk producer license application or grade A producer permit application under s. ATCP 65.02.

ATCP 65.928(1)(b) (b) The summary suspension of a milk producer license, under s. ATCP 65.920 (3).

ATCP 65.928(1)(c) (c) The issuance of a warning notice, under s. ATCP 65.920 (5) (a).

ATCP 65.928(1)(d) (d) The suspension of a grade A producer permit, under s. ATCP 65.920 (6) (a).

ATCP 65.928(1)(e) (e) The denial of a reinstatement application, under s. ATCP 65.920 (5) (d) or (7).

ATCP 65.928(1)(f) (f) A holding order, disposal order, or other summary action, under s. ATCP 65.927.

ATCP 65.928(1)(g) (g) The suspension or revocation of a dairy plant license or grade A permit, under s. ATCP 65.926.

ATCP 65.928(2) (2) Form and timing of request; effect pending hearings. A person requesting an informal hearing, under sub. (3), shall make that request, in writing, within 10 days after the person receives notice of the division action. A request for hearing does not stay the effect of any action under this chapter. The filing deadline under this subsection is waived if the department fails to give the milk producer timely written notice of the filing deadline.

ATCP 65.928(3) (3) Informal hearing.

ATCP 65.928(3)(a) (a) Whenever the department receives a hearing request under sub. (2), the department shall conduct an informal hearing on the contested action. The hearing shall be conducted by a presiding officer who is a department employee or official who was not personally involved in the investigation or decision to take the contested action, and who has authority to withdraw or correct the action as necessary. The division shall conduct the informal hearing unless the contested action was taken by the division administrator. The division shall hold the informal hearing within 20 days after it receives the hearing request under sub. (2), unless the person requesting the hearing agrees to a later date. The division may hold the informal hearing by telephone or at the division’s office.

ATCP 65.928(3)(b) (b) The issue for hearing, held under par. (a), shall be limited to whether the division had adequate grounds for the contested action. Within 2 business days after the conclusion of the informal hearing, the presiding officer shall issue a brief written memorandum that summarizes the informal hearing, and any decision or action resulting from the informal hearing. A copy of the memorandum shall be provided to the person who requested the hearing. The memorandum shall include notice of the person’s right to request a full evidentiary hearing under sub. (4).

ATCP 65.928(4) (4) Full evidentiary hearing. If a person adversely affected by a division action either files a timely written request for hearing under sub. (2), and the matter is not resolved by an informal hearing under sub. (3), or does not want an informal hearing, the person may request a full evidentiary hearing before the department, pursuant to subch. III of ch. 227, Stats., and ch. ATCP 1. The person shall make the hearing request as specified in s. ATCP 1.06. A full evidentiary hearing, if any, shall be held before an administrative law judge appointed by the secretary. A request for a full evidentiary hearing does not stay any action under this chapter.

ATCP 65.928 History History: CR 14-073: cr. Register August 2016 No. 728, eff. 9-1-16.

ATCP 65.930 ATCP 65.930 Grade A dairy plants; compliance monitoring and inspection.

ATCP 65.930(1) (1) Audit surveys by certifying agency.

ATCP 65.930(1)(a) (a) Requirement. The division shall perform audit surveys of grade A dairy plants, and the dairy farms shipping milk to those dairy plants, to establish a grade A sanitation compliance rating under this chapter. The division shall survey a grade A dairy plant, and the farms shipping milk to that dairy plant, at all of the following times:

ATCP 65.930(1)(a)1. 1. Within 20 business days after the department first issues a grade A dairy plant permit to the dairy plant under s. ATCP 65.04.

ATCP 65.930(1)(a)2. 2. At least once every 2 years after the initial survey under subd. 1.

ATCP 65.930(1)(b) (b) Survey method. A survey, under par. (a), shall include an inspection of the grade A dairy plant, an inspection of a randomly selected statistically representative sample of dairy farms in a BTU shipping grade A milk to that dairy plant, and an evaluation of the division’s enforcement methods. A survey shall be conducted in compliance with “Methods of Making Sanitation Ratings of Milk Supplies,” 2013 revision, published by the Food and Drug Administration, Public Health Service, United States Department of Health and Human Services.

ATCP 65.930 Note Note: The “Methods of Making Sanitation Ratings of Milk Supplies” is on file with the division and the legislative reference bureau. Copies may be purchased from the Milk Safety Team, HFS-626, Food and Drug Administration, Public Health Service, United States Department of Health and Human Services, 5100 Paint Branch Parkway, College Park, MD 20740-3835. Also available online at http://www.fda.gov/food/guidanceregulation/federalstatefoodprograms/ucm2007965.htm.

ATCP 65.930(1)(c) (c) Survey rating. Based on a survey under par. (a), the division shall assign an overall grade A sanitation compliance rating to the dairy plant and the dairy farms in the BTU that ship milk to that dairy plant.

ATCP 65.930(1)(d) (d) Unsatisfactory survey rating; grade A permit suspension. The department may suspend or revoke a dairy plant’s grade A permit if the sanitation compliance rating for that dairy plant under par. (c) falls below 80%. This subsection does not prohibit the department from suspending or revoking a grade A dairy plant permit for any other reason.

ATCP 65.930 Note Note: Procedures, related to the suspension or revocation of a grade A dairy plant permit, are set forth in ch. ATCP 1. If a compliance rating falls below 80%, the department may also decertify the dairy plant as an interstate milk shipper. Decertification may prevent the dairy plant operator from shipping grade A dairy products in interstate commerce.

ATCP 65.930(2) (2) Inspection frequency.

ATCP 65.930(2)(a) (a) Except as provided in par. (b), the division shall inspect every grade A processing plant at least once every 3 months, every grade A receiving station at least once every 3 months, and every grade A transfer station at least once every 6 months.

ATCP 65.930(2)(b) (b) Paragraph (a) does not apply to a grade A processing plant, receiving station, or transfer station that the United States food and drug administration lists as being enrolled in the program described in PMO Appendix K.

ATCP 65.930 Note Note: PMO Appendix K describes a voluntary “hazard analysis-critical control point (HACCP)” program for dairy plants. The HACCP program serves as a partial alternative to traditional inspection. If a dairy plant is currently enrolled in the HACCP program, as indicated by the Interstate Milk Shippers List published by the United States food and drug administration, the department is not required to inspect the dairy plant with the normal frequency required under sub. (2)(a). If an enrolled dairy plant fails to comply with HACCP program standards in PMO Appendix H, the food and drug administration may ”de-list” the dairy plant from the HACCP program and the department must then inspect the dairy plant at the normal frequency required by sub. (2)(a). PMO Appendix K is on file with the division and the legislative reference bureau. Copies may be obtained from the department at cost or online at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Milk.

ATCP 65.930(3) (3) Dairy product sampling; frequency.

ATCP 65.930(3)(a) (a) Pasteurized milk and dairy products; sample testing. Except as provided in par. (c), the division in every consecutive 6-month period shall collect from every grade A dairy plant at least 4 samples of each pasteurized grade A dairy product produced by that dairy plant. The division shall collect each sample in a separate month, except that the division may collect 2 of the samples in the same month if it collects those 2 samples at least 20 days apart and collects the other two samples in two other months. Dairy plants producing pasteurized grade A dairy products on an intermittent basis shall notify the division of intended production schedules to facilitate sample collection under this paragraph. The division shall measure and record the temperature of each pasteurized grade A dairy product from which the samples are collected and shall test the samples for bacteria counts, coliform counts, and beta lactam drug residues. The division may collect additional samples and perform additional tests that the division considers necessary.

ATCP 65.930(3)(b) (b) Raw milk held at dairy plant; sample testing. During every consecutive 6-month period, the division shall collect at least 4 samples of commingled raw milk from each grade A dairy plant that receives raw milk. The division shall collect each sample in a separate month, except that the division may collect 2 of the samples in the same month if it collects those 2 samples at least 20 days apart and collects the other two samples in two other months. The division shall measure and record the temperature of the raw commingled milk from which the division collects each sample and shall test each sample for bacterial counts and beta lactam drug residues. The division may collect additional samples and perform additional tests that the division considers necessary.