Room 139
718 West Clairemont Ave.
EauClaire, WI 54701
Handicapped accessible
Analysis Prepared by the Dept. of Agriculture, Trade and Consumer Protection
Statutory authority: ss. 93.07 (1), 97.09 (4), 97.20 (4), 97.22 (8) and 97.23
Statutes interpreted: ss. 97.20, 97.22 and 97.23
This rule modifies current rules under ch. ATCP 60, Wis. Adm. Code, related to follow-up testing of producer milk samples when a bulk tanker load of milk tests positive for a drug residue. This rule also clarifies how a dairy plant must dispose of milk that tests positive for a drug residue.
Follow-up Testing of Producer Milk Samples
Under current rules, a milk hauler must collect a sample of milk from every dairy farm milk shipment before loading that shipment onto a bulk milk tanker. The dairy plant operator receiving the bulk milk tanker load must perform a drug residue screening test on that tanker load. If the tanker load tests positive for any drug residue, the dairy plant operator must perform a drug residue test on each of the milk samples drawn from the producer milk shipments comprising the tanker load. If a producer sample tests positive for drug residue, the dairy plant operator may hold that producer financially responsible for contaminating the bulk load. Current rules do not require confirmatory tests on producer samples that test positive for drug residues.
This rule requires a dairy plant operator to perform a confirmatory test in duplicate on each producer milk sample that tests positive for any drug residue. Under this rule, the dairy plant operator must perform a confirmatory test using the same test method and producer sample. The operator must perform the confirmatory test in duplicate, with single positive and negative controls. If one or both confirmatory test results are positive for a drug residue, the milk producer's sample is considered positive for that drug residue.
Disposing of Contaminated Milk
This rule also clarifies how a dairy plant must dispose of milk that tests positive for a drug residue. Current rules require a dairy plant operator to reject a bulk tanker load of milk that tests positive for drug residue. A rejected bulk load may not be used for human food. This rule clarifies that a dairy plant operator must either dispose of a rejected bulk load or denature it before transferring it to any other person.
Fiscal Estimate
The proposed rule changes incorporates orders given to the Division of Food Safety by the Department secretary and deputy in three contested case decisions. These changes include the following:
1. Requires the dairy plant operator to conduct confirmation testing using positive and negative controls on a producer milk sample that screens positive for the presence of a drug residue.
2. Places the responsibility on the dairy plant operator to either dispose of or denature a bulk load of raw milk that tests positive for the presence of a drug residue.
The changes do not require any additional regulatory activity or recordkeeping by the Department. Therefore, there is no fiscal effect attributed to the adoption of these rule changes, except for one-time costs associated with the rule-making of approximately $500, consisting of printing, mailing and costs of holding hearings
.
Initial Regulatory Flexibility Analysis
The modifications to ch. ATCP 60, Wis. Adm. Code, Dairy Farms, will not have a fiscal impact on small businesses as defined in s. 227.114 (1) (a), Stats. There are approximately 110 dairy plants currently licensed and inspected by the Department that meet the definition of a small business.
The testing of every bulk load of raw milk for a drug residue received by a dairy plant operator is required under the dairy farm rule. A dairy plant operator is also required to test each of the producer milk samples collected for a bulk load that tests positive for a drug residue in order to identify the violative producer or producers.
A dairy plant operator is required to reject a bulk load of raw milk that tests positive for a drug residue. The rejected bulk load cannot be shipped to another dairy plant or used for human food.
The proposed changes to ch. ATCP 60, Wis. Adm. Code, are:
1. Clarify and standardize the testing procedures for the producer milk samples collected for a bulk load of raw milk that tested positive for a drug residue.
2. Clarify who is responsible for insuring that a bulk load of raw milk that tested positive for a drug residue is not used for human food.
The impact of the proposed rule changes on small business is negligible. It would not be necessary for licensed dairy plants to provide additional laboratory facilities or staff, or retain additional testing services to comply with these changes.
Notice of Hearings
Agriculture, Trade and Consumer Protection
The State of Wisconsin Department of Agriculture, Trade and Consumer Protection announces that it will hold public hearings on proposed amendments to ch. ATCP 77, Wis. Adm. Code, relating to certification fees for laboratories engaged in public health testing of milk, water and food.
Written Comments
The hearings will be held at the times and places shown below. The public is invited to attend the hearings and make comments on the proposed rule. Following the public hearings, the hearing record will remain open until June 30, 1999, for additional written comments.
Copies of Rule and Contact Information
A copy of this rule may be obtained free of charge, from the Wisconsin Department of Agriculture, Trade and Consumer Protection, Division of Food Safety, 2811 Agriculture Drive, P.O. Box 8911, Madison WI 53708, or by calling (608)224-4700. Copies will also be available at the public hearings.
An interpreter for the hearing impaired will be available on request for these hearings. Please make reservations for a hearing interpreter by July 15, 1999 either by writing to Debbie Mazanec, 2800 Agriculture Drive, P.O. Box 8911, Madison, WI 53708, (608- 224-4712), or by contacting the message relay system (TTY) at 608-266-4399 to forward your call to the Department at 608-224-5058. Handicap access is available at the hearings.
Hearing Information
Three (3) hearings are scheduled. The hearings will be held simultaneously by videoconferencing at the following locations on Friday, June 18, 1999, from 9:00 a.m. - 10:30 a.m.
Locations:
Wis. Dept. of Agriculture, Trade &
Consumer Protection
Room 472
2811 Agriculture Drive
Madison, WI 53704
Handicapped accessible
State of Wis. Office Building
Room 618
200 North Jefferson St.
Green Bay, WI 54301
Handicapped accessible
State of Wis. Office Building
Room 139
718 West Clairemont Ave.
Eau Claire, WI 54701
Handicapped accessible
Analysis Prepared by the Dept. of Agriculture, Trade and Consumer Protection
Statutory authority: ss. 93.07 (1) and 93.12 (4) and (7)
Statute interpreted: s. 93.12 (4) and (7)
The 1995-97 biennial budget act, 1995 Wis. Act. 27, transferred administration of Wisconsin's laboratory certification program for milk, food and water laboratories from the Department of Health and Family Services to the Department of Agriculture, Trade and Consumer Protection (“Department"), effective July 1, 1996.
Under this program, the Department is now responsible for certifying laboratories that test milk, food or water for compliance with public health standards prescribed by federal, state or local laws. Under 1995 Wis. Act 27, the Department's public health lab certification program must be funded by certification fees paid by the certified laboratories. The Department must establish these fees by rule.
The Department adopted the current fees in 1996. Under current rules, a laboratory operator must pay an annual certification fee of $216 for each test at each laboratory for which the operator is certified. If a laboratory operator performs a test for less than a full calendar year, the annual certification fee is prorated at $18 per month for each full month of certification for that test. Under current rules, milk and food laboratories pay the same fees as water laboratories.
This rule amends the current fee structure to account for cost differences between different types of laboratories. Certification of milk and food laboratories requires more time than certification of water laboratories. In a milk or food laboratory, the Department must also certify each individual analyst who performs any milk or food test. In a water laboratory, the Department is only required to certify one analyst who performs the water test for which the Department is certifying the laboratory.
This rule increases lab certification fees to provide sufficient program revenue to fund the lab certification program. It also creates a variable fee schedule that more closely reflects the time required to conduct on-site certification visits in different types of labs and, when required, determine the competency of individual analysts to conduct specific tests.
Under the proposed rule, a certified laboratory must pay the following applicable fees:
• Water tests. An annual certification fee of $276 for each test which detects microbiological contaminants in drinking water. If the Department certifies a water laboratory to perform a test for less than a full calendar year, the lab operator must pay a fee of $23 for each full month of certification.
• Milk or food tests. An annual certification fee of $336 for each milk or food test. If the Department certifies a milk or food laboratory to perform a test for less than a full calendar year, the lab operator must pay a fee of $28 for each full month of certification.
• Certified analysts who perform milk or food tests. An annual certification fee of $25 for each analyst who performs one or more milk or food tests. An analyst's certification is valid for an entire year, even if the analyst is no longer employed at the laboratory where the analyst was employed when the Department last granted or renewed the analyst's certification.
Additional analyst certification. A supplemental fee of $150 for each requested certification of one or more analysts to conduct any milk or food test, if the certification occurs at any time other than during a mandatory inspection.
Fiscal Estimate
The proposed rule increases fees for laboratory certification to offset the costs of this program as required in s. 93.12, Wis. Stats.
The Department certifies approximately 180 milk, food and water laboratories in Wisconsin. Currently, the laboratory certification program is underfunded. Portions of this program are mandatory. The Federal Pasteurized Milk Ordinance (PMO) requires laboratories examining milk and water for the grade A dairy industry to be certified. In order for grade A dairy plants to ship fluid milk and milk products out of state, the milk they process and the water they use must be examined at a laboratory certified under this program. About 85% of milk produced in Wisconsin is shipped out of state.
Certain local health departments and local units of government operate certified laboratories. These may be milk and water laboratories or water only laboratories. These are currently certified by the Department. These laboratories currently pay laboratory certification fees unless they are exempted from paying fees by being an agent of the Department for the retail food inspection program.
As stated above, this program is underfunded.
A. During the current fiscal year the Department collected $123,000.
B. The program is authorized 2.5 FTE's (Full-Time Equivalents) requiring $160,000 annual funding.
C. Proposed fees will likely generate $182,000 annually, which should support the program for four (4) years without any additional fee increases.
The proposed annual fee schedule is as follows:
A. Milk or food test - $336
B. Water test - $276
C. Analyst fee - $ 25
D. New analyst fee - $150
Initial Regulatory Flexibility Analysis
This rule establishes fees for certification of laboratories examining milk, food or water for the protection of public health. The 1995-97 biennial budget act transferred much of the administration of Wisconsin's laboratory certification program from the Department of Health and Family Services (DHFS) to the Department of Agriculture, Trade and Consumer Protection (DATCP). Shortly after that transfer, DATCP proposed rules establishing fees to offset the costs of certification of laboratories as required in s. 93.12, Wis. Stats. These fees are based on recovering 100% of the costs of this program from the industry affected by the program. Those rules also required the DATCP to evaluate laboratory certification fees by FY 2000 and make appropriate adjustments to the fees.
The approximately 180 laboratories currently certified range from small, one person laboratories to large facilities with dozens of analysts. This rule will have a fiscal impact on “small businesses" as defined in s. 227.114 (1) (a) Wis. Stats. Annual laboratory fees are increased as compared to the $216 per test fee currently charged by DATCP. This fee increase is due to the fact that the laboratory certification program is inadequately funded. Inadequate funding occurs because the number of laboratories requiring certification has decreased. Costs of the program have actually been reduced in the past two years by reducing program support activities.
The proposed rule will increase costs for laboratories that test milk, food or water. These laboratories currently pay a fee of $216 per test. Fees under the proposed rule range from $336 for one milk or food test to $3,360 for 10 tests. Fees for water laboratories under the proposed rule range from $276 for one test to $1104 for four tests.
