Analysis Prepared by the Department of Agriculture, Trade and Consumer Protection
This rule updates current rules related to safe production, processing, distribution and sale of milk and dairy products. This rule affects dairy farms, dairy plants, milk haulers, milk testing laboratories, buttermakers, cheesemakers and others. Among other things, this rule:
Brings Wisconsin rules into conformity with the Interstate Pasteurized Milk Ordinance (“PMO"). Milk and fluid milk products must be produced in compliance with the PMO, in order for Wisconsin to be able to ship those products in interstate commerce.
Updates current rules to accommodate new dairy industry technology and practices.
Clarifies current statutory prohibitions against the sale of raw milk to consumers, consistent with administrative law judge decisions.
Clarifies some rule provisions, so they will be easier to read and understand.
Statutory Authority
Statutes interpreted: ss.
93.09,
93.12,
97.02,
97.03,
97.09,
97.12,
97.17,
97.175,
97.20,
97.21,
97.22,
97.24,
97.50,
97.52,
98.145 and
98.146.
The Department of Agriculture, Trade and Consumer Protection (“DATCP") is responsible for administering Wisconsin food safety and labeling laws, including laws related to the safety of milk and dairy products. DATCP licenses and regulates dairy farms, dairy plants, milk haulers, milk testing laboratories and analysts, bulk milk weighers and samplers, and others. DATCP has broad authority to regulate these entities, to ensure safe and wholesome dairy products and fair business practices.
Milk and fluid milk products must be produced and distributed in compliance with “Grade A" standards under the Interstate Pasteurized Milk Ordinance (“PMO"). If Wisconsin fails to comply with the PMO, Wisconsin may be precluded from shipping milk and fluid milk products in interstate commerce. Under s.
97.24, Stats., DATCP must adopt “Grade A" rules that are in substantial accord with the PMO.
DATCP has broad authority, under s.
93.07(1), Stats., to adopt rules needed to interpret and implement laws under its jurisdiction. In addition, DATCP has the following rulemaking authority:
Under s.
93.07 (2), Stats., to prescribe forms used in connection with DATCP programs.
Under s.
93.09 (1), Stats., to adopt grading, packaging and labeling standards for food.
Under ss.
93.12 (3) and
(5), Stats., to adopt rules for laboratories testing milk and dairy products.
Under s.
97.09 (1), Stats., to adopt food standards of identity, composition and quality.
Under s.
97.09 (4), Stats., to regulate the production, processing, packaging, labeling, transportation, storage, handling, display, sale, and distribution of food to protect the public from adulterated or misbranded foods.
Under s.
97.24 (3), to adopt rules for the production, processing, pasteurization, distribution and testing of milk and dairy products. Rules for milk and fluid milk products must be in substantial accord with “Grade A" standards under the PMO.
Under s.
97.52, Stats., to establish sanitary standards for the production, handling and transportation, inspection and testing of milk and dairy products.
Background
The United States Food and Drug Administration (“FDA") recently completed an audit of Wisconsin's dairy regulatory program. FDA requested a number of changes in current DATCP rules, to make the rules more fully consistent with the current (2005) version of the PMO. This rule makes changes requested by FDA. This rule also makes other changes to update and clarify current rules, and to accommodate changing dairy industry technology, organization and practices. The changes in this rule are, for the most part, technical in nature. However, some rule changes may require significant changes by some dairy businesses (see Business Impact Analysis below).
DATCP and others have proposed major reforms to modernize and streamline the PMO. However, those reforms will require action at the national level and by other states. In the meantime, Wisconsin must comply with existing PMO requirements.
Rule Content
Dairy Farms
This rule updates and modifies current rules related to dairy farms. Among other things, this rule does all of the following:
• Incorporates PMO requirements related to gravity flow manure handling systems and liquid manure storage.
• Clarifies milk hauler responsibilities relating to mixing, sampling, and testing milk shipments.
• Spells out standards and procedures related to Wisconsin's performance-based dairy farm inspection system.
• Updates drug residue action levels and safe levels, consistent with the PMO.
• Clarifies dairy plant and DATCP responsibilities relating to testing milk from dairy farms, and reporting test results.
•Spells out new requirements related to the safety of water used in milking and processing operations.
• Clarifies milk temperature monitoring and recording requirements, and requires dairy farms to keep milk temperature records for at least 6 months (extended from 90 days under current rules).
Clarifies drug residue testing procedures, including requirements confirmation of positive screening tests and rejection of milk shipments pending follow-up testing to show that drug contamination has been eliminated.
• Clarifies producer and installer responsibilities for obtaining DATCP review of dairy farm remodeling plans.
•Expands rule coverage to include all “milking animals," not just cows, sheep and goats.
•Expands current requirements related to dairy farm and dairy plant cooling systems.
•Clarifies the current statutory prohibition related to the sale of unpasteurized “raw milk" to consumers, consistent with administrative law judge decisions. Raw milk sales have been implicated in a number of serious food-borne disease outbreaks in Wisconsin and elsewhere.
•Eliminates current requirement related to dairy plant testing for coarse sediment in milk.
Dairy Plants
This rule updates and modifies current rules related to dairy plants. Among other things, this rule does all of the following:
Strengthens water safety requirements and clarifies that DATCP, rather than the dairy plant operator, must perform certain water safety tests.
Clarifies cleaning and sanitizing requirements.
Clarifies milk testing requirements, including drug residue testing requirements. Among other things, this rule clarifies testing requirements for farms that milk directly to bulk milk tankers.
This rule eliminates coarse sediment testing requirements.
Updates and clarifies pasteurization standards, procedures and testing requirements.
Requires regular DATCP review of pasteurization records and “cleaned-in-place" equipment cleaning records.
Updates requirements related to calibration of automated milk component testing devices.
Updates dairy plant recordkeeping requirements. Dairy plants must retain certain cleaning and sanitizing records for at least 6 months. Dairy plants must keep for at least 3 years certain documents related to bulk milk shipments.
Milk Testing Laboratories
DATCP currently certifies laboratories that test milk, food or water for compliance with public health standards. This rule updates and clarifies current rules related to the certification of laboratories and lab analysts. Among other things, this rule:
Updates the list of tests for which certification is required.
Clarifies current certification and testing requirements related to drug residue testing in milk, including requirements for timely confirmation of positive screening test results.
Clarifies that test results reported by a certified laboratory are presumptively valid.
Milk Haulers and Bulk Milk Tankers
This rule updates and modifies current requirements related to milk haulers and bulk milk tankers. Among other things, this rule does all of the following:
Establishes standards for bulk milk tanker cleaning facilities at dairy plants.
Requires dairy plants to keep bulk milk tanker cleaning and sanitizing records for 15 days, rather than 90 days. When a dairy plant operator cleans a bulk milk tanker, the operator must remove the cleaning tag from the last cleaning and keep the removed tag for at least 15 days.
Clarifies that out-of-state bulk milk tankers with grade A permits from other jurisdictions are not required to hold Wisconsin grade A permits.
Requires grade A permit numbers to be clearly displayed on bulk milk tankers.
Clarifies the responsibilities of milk haulers (bulk milk weighers and samplers) related to weighing, measuring, and sampling milk shipments.
Buttermakers and Cheesemakers
This rule clarifies current professional licensing requirements for individuals engaged as buttermakers and cheesemakers. This rule gives license applicants more options for meeting training and experience qualifications.
Standards Incorporated by Reference
Pursuant to s.
227.21, Stats., DATCP will request permission from the attorney general and revisor of statutes to incorporate the following standards by reference in this rule without reproducing the publications in full. This rule updates titles, publication dates, and supporting information for the following publications:
• “Grade A Pasteurized Milk Ordinance," published by the Food and Drug Administration, Public Health Service, U.S. Department of Health and Human Services (2005 Revision).
•“3-A Accepted Practices for the Design, Fabrication and Installation of Milking and Milk Handling Equipment," document #3A606-05, published by “3-A Sanitary Standards, Inc. (November 2002).
•“3-A Sanitary Standards for Farm Milk Cooling and Holding Tanks," document #3A13-10, published by 3-A Sanitary Standards, Inc. (November 2003).
• “3-A Accepted Practices for the Sanitary Construction, Installation, Testing, and Operation of High-Temperature Short-Time and Higher-Heat Shorter-Time Pasteurizer Systems," document #3A603-07, published by 3-A Sanitary Standards, Inc. (November 2005).
• “3-A Sanitary Standards for Stainless Steel Automotive Transportation Tanks for Bulk Delivery and Farm Pick-Up Service," document #3A05-15, published by 3-A Sanitary Standards, Inc. (November 2002).
•“Official Methods of Analysis of AOAC International," published by AOAC International (18th Edition, 2005).
•“Milk and Dairy Beef Residue Prevention Protocol, 2005 Producer Manual of Best Management Practices," published by Agri-Education, Inc.
•“Standard Methods for the Examination of Dairy Products, published by the American Public Health Association (17th Edition, 2004).
•“Compendium of Methods for the Microbiological Examination of Foods, published by the American Public Health Association (4th Edition, 2001).
•“Bacteriological Analytical Manual," published by the Food and Drug Administration, Public Health Service, United States Department of Health and Human Services (8th Edition, Revision A, 1998).
•“Manual for the Certification of Laboratories Analyzing Drinking Water," published by the U. S. Environmental Protection Agency (5th Edition, 2005).
•“Standard Methods for the Examination of Water and Wastewater, published by the American Public Health Association, the American Water Works Association and the Water Environment Federation (20th Edition, 1998).
•“Methods of Making Sanitation Ratings of Milk Supplies," published by the Food and Drug Administration, Public Health Service, United States Department of Health and Human Services (2005 Revision).
•FDA 2400 Series Laboratory Evaluation Forms, published by the United States Department of Health and Human Services, Public Health Service, Food and Drug Administration (forms that are effective as of the effective date of this rule).
Copies of these publications will be on file with DATCP and the revisor of statutes. Rule notes explain how readers may obtain copies.
Fiscal Estimate
DATCP currently regulates dairy farms, dairy plants, bulk milk weighers and samplers, bulk milk tankers, milk testing laboratories, laboratory analysts, buttermakers and cheesemakers to protect consumers and facilitate the interstate shipment of Wisconsin grade A milk and dairy products.
This rule will not have a significant fiscal impact on state government. This rule updates current rules, but does not make major changes that will increase state government costs. This rule does not change current license fees, and does not have any impact on current state revenues.
Business Impact
DATCP currently regulates dairy farms, dairy plants, bulk milk weighers and samplers, bulk milk tankers, milk testing laboratories, laboratory analysts, buttermakers and cheesemakers to protect consumers and facilitate the interstate shipment of Wisconsin grade A milk and dairy products. Current regulations have an important impact on dairy industry operations, including small business operations. Most dairy farms, and some dairy processing operations, qualify as “small businesses" under s.
227.114, Stats.
This rule makes a large number of technical changes to existing regulations. For the most part, however, this rule will not have a significant impact on affected businesses.
Some rule changes may have a significant impact on some affected businesses. For example, this rule mandates certain pasteurization and cooling requirements that may require some dairy plants to install new or remodeled equipment. DATCP estimates that no more than 5 dairy plants will be affected by this particular requirement. The actual impact will depend on variable factors related to processing operations, current equipment and plant size. This rule delays the effective date of the requirement by one year, so that affected dairy plants will have time to make the necessary changes.
This rule changes current recordkeeping requirements, but the changes should not impose a significant burden on affected businesses. This rule will not require affected businesses to obtain any new professional skills or services.
Federal Regulations
