93.07 Department duties. It shall be the duty of the department:
(1) Regulations. To make and enforce such regulations, not inconsistent with law, as it may deem necessary for the exercise and discharge of all the powers and duties of the department, and to adopt such measures and make such regulations as are necessary and proper for the enforcement by the state of chs.
93 to
100, which regulations shall have the force of law.
97.09 Rules.
(4) The department may, by rule, establish and enforce standards governing the production, processing, packaging, labeling, transportation, storage, handling, display, sale, including retail sale, and distribution of foods that are needed to protect the public from the sale of adulterated or misbranded foods.
97.29 Food processing plants.
(1) Definitions. In this section:
(g) “Food processing" means the manufacture or preparation of food for sale through the process of canning, extracting, fermenting, distilling, pickling, freezing, baking, drying, smoking, grinding, cutting, mixing, coating, stuffing, packing, bottling or packaging, or through any other treatment or preservation process. “Food processing" includes the activities of a bakery, confectionary or bottling establishment, and also includes the receipt and salvaging of distressed food for sale or use as food. “Food processing" does not include any of the following:
8. Any other activity exempted by the department by rule.
97.30 Retail food establishments.
(1) Definitions. In this section:
(b) Exemptions. 1. A license is not required under this section for any of the following:
c. A retail food establishment which is exempted from licensing by the department by rule. If a restaurant or other establishment for which a permit has been issued under s.
254.64 is incidentally engaged in operating a retail food establishment at the same location, the department may exempt by rule the restaurant or establishment from licensing under this section. Rules under this subd. 1. c. shall conform to a memorandum of understanding between the department and the department of health services, under which the department of health services agrees to inspect the retail food establishment operations on behalf of the department.
5. Estimate of the Amount of Time that State Employees will Spend to Develop the Rule and of Other Resources Necessary to Develop the Rule
DATCP estimates that it will use approximately 0.50 FTE staff to develop this rule. That includes time required for investigation and analysis, rule drafting, preparing related documents, coordinating advisory committee meetings, holding public hearings, and communicating with affected persons and groups. DATCP will use existing staff to develop this rule.
6. Description of all Entities that may be Impacted by the Rule
This rule will affect Wisconsin egg processors who sell eggs at locations other than where the eggs were produced. It will provide clear guidance for persons seeking to begin an egg business.
7. Summary and Preliminary Comparison of any Existing or Proposed Federal Regulation that is Intended to Address the Activities to be Regulated by the Rule
In general, rules designed to ensure egg safety and consistent egg quality cover activities that include ensuring the health of a flock and sanitation at the farm; egg grading, sanitation, temperature control, packaging, and labeling at egg processing facilities; and safe transportation, handling, and storage of eggs for the retail sale. Federal egg regulations consist of a patchwork of rules involving several agencies that are each responsible for different portions in the continuum of activities designed to promote egg safety and consistent egg quality. One objective of this rulemaking process will be to more clearly differentiate Wisconsin's role from the jurisdiction of federal agencies in regulating egg packaging and sales.
Federal egg regulations
The Egg Products Inspection Act (Title 21 USC, Chapter
15) authorized USDA to create regulations (
7 CFR Part 57) for egg processing operations. Egg processing operations generally make products other than shell eggs, such as pasteurized whole eggs and dried egg whites. Additional USDA regulations created under this act authorize at least yearly inspection of hatcheries and at least quarterly inspection of businesses that pack shell eggs for the ultimate consumer. As part of these inspections, USDA assures that egg packages are labeled “Keep Refrigerated" and stored at 45
°F or less. For eggs moving in interstate or foreign commerce, federal law and regulations pre-empt state law and regulations relating to temperature control, quality, or grade, condition, weight, or quantity. A voluntary egg grading service is administered by USDA, using essentially the same egg grading standards currently contained in ATCP 88. Regulations governing the voluntary grading of shell eggs are found in Title 7, Part 56 of the Code of Federal Regulations.
Under the Federal Food, Drug, and Cosmetic Act (Title 21 USC, Chapter
9), and the Public Health Service Act (Title 42 USC, Chapter
264), the FDA has enacted egg safety regulations that apply to shell egg producers (
21 CFR 118) with 3,000 or more laying hens at a particular farm who are not selling all of the eggs directly to consumers. These regulations require egg producers to register with FDA and to develop a written
Salmonella enteritidis prevention plan for each farm. The plan must address procurement of chicks, environmental testing, cleaning and disinfection, biosecurity, pest control, and egg refrigeration. The regulations also require testing of eggs for
Salmonella enteritidis.
Federal and state regulatory roles
Various federal agencies regulate egg quality and safety. Within USDA, the Animal and Plant Health Inspection Service (APHIS) is responsible for activities related to disease control in flocks of laying hens; the Agricultural Marketing Service (AMS) is responsible for quality grading for shell eggs and the Shell Egg Surveillance program, which ensures eggs for sale meet Grade B or better standards; and the Food Safety and Inspection Service (FSIS) is responsible for inspecting egg products sold in interstate commerce and re-inspecting imported egg products. The U.S. Food and Drug Administration (FDA), on the other hand, is responsible for ensuring sanitation and safety control measures at the farm, monitoring safe handling and good manufacturing practices in shell egg packaging plants that do not use USDA's shell egg grading service, and for issuing recalls involving shell eggs or egg products inspected by either FDA or USDA.
State and local agencies typically are responsible for working in cooperation with FDA to inspect shell egg packaging plants that do not use USDA's shell egg grading service and for inspecting retail food establishments. Wisconsin currently regulates voluntary egg grading in plants that do not use USDA's shell egg grading service, egg packaging and warehouse activities, and retail sales of eggs.
8. Anticipated Economic Impact
DATCP expects the proposed rule to have only a positive economic impact statewide and locally. The rule revision is expected to assist both new and existing egg production businesses by clarifying licensing and inspection requirements. Since most egg businesses that wash, pack, or sell eggs are already licensed and inspected, rule revisions are expected to result in no or minimal costs to these establishments. The rule will not increase licensing fees for egg washing, packaging, or sales and the department will continue to exempt from licensing eggs sold directly to a household consumer on the premises where the eggs are produced. The expected rule revisions will have no economic impact on local governmental units or public utility taxpayers.
Contact Person
Steve Ingham, Division of Food Safety Administrator, DATCP; Phone (608) 224-4701.
Agriculture, Trade and Consumer Protection
This statement of Scope was approved by the governor on June 14, 2013.
Rule No.
Revises Chapter
ATCP 82, Wis. Adm. Code.
Relating to
Partial collection of milk from bulk tanks on dairy farms and affecting small business.
Rule Type
Emergency.
1. Description of the Objective of the Rule
The department proposes an emergency rule adopting a provision of the Food and Drug Administration's (FDA) Pasteurized Milk Ordinance (PMO) allowing milk haulers to make partial collections of milk from bulk tanks on dairy farms under certain conditions. Currently, Wisconsin Administrative Code requires that bulk milk tanks must be emptied each time milk is collected. The department also plans to propose permanent rule changes to ch.
ATCP 82 to incorporate this, along with other, rule changes.
2. Description of Existing Policies Relevant to the Rule and of New Policies Proposed to be Included in the Rule and an Analysis of Policy Alternatives; the History, Background, and Justification for the Proposed Rule
Wisconsin ranks second nationally in milk production and operates the nation's largest state dairy inspection program. Wisconsin has by far the largest number of dairy farms operated by licensed dairy producers; the milk from each of these farms is shipped to one of the 400+ licensed dairy plants in the state, or to a licensed dairy plant in another state. Milk must be collected from each farm in a licensed bulk milk tanker, and a licensed bulk milk weigher sampler must properly record the amount of milk collected and sample the milk on each farm for testing.
Current Wisconsin regulations in ch.
ATCP 82 require that all milk present in a bulk tank must be collected when a collection is made, i.e. partial collection is forbidden. The intent of this regulation was to ensure that a dairy producer's bulk tank(s) was regularly cleaned and sanitized, and to ensure that collection-to-collection transfers of illegal drug residues did not occur, which could result in increased financial losses to dairy producers forced to dump multiple loads of milk.
The requirement prohibiting partial collection of milk from a bulk tank is outdated. Farm sanitation methods have improved since Wisconsin's rule was first adopted. More frequent testing allows dairy plants to catch issues regarding bulk tank cleanliness faster than in the past. At the same time, the number of dairy farms has decreased, farms have become larger and per cow milk production has risen and many farms have purchased larger bulk tanks, creating new challenges for managing milk collection. For example, some farms now have bulk milk tanks that hold 7,000 or more gallons of milk, while other farms may have several smaller tanks. The average milk truck carries approximately 6,000 gallons of milk. Allowing partial collection of milk from bulk tanks will give dairy plants the tools they need to better manage milk collection from these farms and load trucks to full capacity. This rule will reduce the number of trips required to haul milk, thus saving fuel and reducing wear and tear on the roadway and potentially resulting in significant cost savings.
The PMO allows partial collection of milk provided that the bulk tank is emptied, cleaned and sanitized within at least 72 hours. The PMO also requires an acceptable temperature-recording device to be installed and operating on any bulk tank from which partial collections are made. The bulk milk weigher sampler, and regulatory personnel are required to observe temperature records to be sure that loss of temperature control, which can lead to unacceptable bacterial growth, did not occur following a partial collection. In absence of a temperature-recording device, partial pickups are permitted under the PMO as long as the bulk tank is emptied completely, cleaned and sanitized prior to the next milking. This proposed emergency rule adopts the PMO standards in order to allow partial collections, increase flexibility for managing milk pickups, and potentially save fuel costs and decrease roadway damage.
Policy Alternatives
If the department does not alter the current rules, Wisconsin dairy plants will continue to lack the same flexibility as dairy plants in other states that adopt the PMO standard and allow plants to collect partial loads of milk. They will be prevented from managing their milk hauling practices in the most cost efficient and profitable manner and will be required to continue to empty bulk tanks each time they make a pickup, even if that means trucks are not filled to capacity or they have to dump over-capacity milk. Not changing this policy has the potential to negatively impact dairy plant and producer costs, causing companies to incur unnecessary fuel and other costs associated with hauling milk, putting them at an economic disadvantage to dairy producers in other states that have adopted the PMO standard. These unnecessary trips also may damage Wisconsin roads.
3. Statutory Authority for the Rule (Including the Statutory Citation and Language)
93.07 Department duties. It shall be the duty of the department:
(1) Regulations. To make and enforce such regulations, not inconsistent with law, as it may deem necessary for the exercise and discharge of all the powers and duties of the department, and to adopt such measures and make such regulations as are necessary and proper for the enforcement by the state of chs.
93 to
100, which regulations shall have the force of law.
97.09 Rules.
(4) The department may, by rule, establish and enforce standards governing the production, processing, packaging, labeling, transportation, storage, handling, display, sale, including retail sale, and distribution of foods that are needed to protect the public from the sale of adulterated or misbranded foods.
97.21 Milk haulers and milk distributors.
(6) Rule making. The department may promulgate rules to establish amounts of fees required under sub. (4) or to regulate bulk milk tanker operators and milk distributors. The rules may include standards for the construction, maintenance and sanitary operation of bulk milk tankers, milk distribution vehicles and milk distribution facilities; the design, installation, cleaning, and maintenance of equipment and utensils; personnel sanitation; storage and handling of milk and fluid milk products; identification of bulk milk tankers and milk distribution vehicles; and record keeping.
4. Estimate of the Amount of Time that State Employees will Spend to Develop the Rule and of Other Resources Necessary to Develop the Rule
DATCP estimates that it will use approximately 0.10 FTE staff to develop this rule. That includes time required for investigation and analysis, rule drafting, preparing related documents, coordinating advisory committee meetings, holding public hearings and communicating with affected persons and groups. DATCP will use existing staff to develop this rule.
5. Description of all Entities that may be Impacted by the Rule
Dairy producers will gain increased flexibility regarding volume of any bulk milk tanks they purchase to store increased milk volumes. For example, a producer may choose to install a second, smaller bulk tank (to reduce capital equipment costs) because the milk hauler could collect all the milk in the larger tank on the existing schedule and collect the additional milk accumulated in the smaller tank less often. Under the proposed rule, milk haulers will also gain increased flexibility in scheduling collections. For example, fewer milk tanker trips could be necessary for a producer who has two bulk tanks, one of which is completely emptied on the existing schedule and the other one which is used to “top up" a tanker for two consecutive days and is then emptied completely into a second tanker every third day. Reducing the number of milk tanker trips in situations like this could reduce damage to roadways and hauling costs for the dairy plant. Dairy producers and milk haulers would also benefit in the situation where the amount of milk in the farm bulk tank exceeds the remaining capacity of a milk tanker. Currently, the excess milk must be dumped. Under the proposed rule, the milk tanker could be filled to its limit, and the remaining milk held over for an additional collection by a truck with appropriate capacity.
6. Summary and Preliminary Comparison of any Existing or Proposed Federal Regulation that is Intended to Address the Activities to be Regulated by the Rule
The proposed rule would adopt federal PMO regulations related to partial collection of milk from bulk tanks. The federal guidelines in the PMO allow partial collection of milk, but compliance with the PMO is a voluntary effort by state regulatory agencies. Wisconsin's current regulations are more stringent than the PMO and do not allow for partial collection of milk from bulk tanks.
7. Anticipated Economic Impact
This proposed rule change is anticipated to have no negative impact, but rather a positive economic impact for Wisconsin's dairy industry. It will make Wisconsin's regulations regarding partial collection of milk from bulk tanks consistent with practices in other states, including those elsewhere in the Upper Midwest. It will allow dairy plants to manage their milk hauling practices more efficiently and profitably. Although the proposed rule will allow partial collection of bulk milk, it is not anticipated to be a widespread practice, but one tool that a dairy plant may use to manage milk hauling practices. The rule will not modify fees or have an economic impact on local governmental units or public utility taxpayers.
Contact Person
Steve Ingham, Division of Food Safety Administrator, DATCP; Phone (608) 224-4701.
Agriculture, Trade and Consumer Protection
This statement of Scope was approved by the governor on June 14, 2013.
Rule No.
Revises Chapter
ATCP 82, Wis. Adm. Code.
Relating to
Milk haulers and affecting small business.
Rule Type
Permanent.
1. Finding/Nature of Emergency (Emergency Rule Only)
N/A.
2. Description of the Objective of the Rule
Chapter
ATCP 82 (Milk Haulers) regulates bulk milk tanker licensing, construction, maintenance, cleaning and sanitizing requirements; bulk milk weigher sampler requirements, and mandatory procedures for collecting milk from dairy farms, collecting milk samples for testing, and delivering milk from a dairy farm to a dairy plant. The department proposes a rule in ch.
ATCP 82 adopting a provision of the Food and Drug Administration's (FDA) Pasteurized Milk Ordinance (PMO) which would allow milk haulers to make partial collections of milk from bulk tanks on dairy farms under certain conditions. Currently, bulk milk tanks must be emptied each time milk is collected. The proposed revision would allow partial collections and would necessarily also entail revision of requirements for milk agitation and cooling, bulk tank milk temperature measurement, the cessation of pumping milk to a bulk tank when a partial collection is being made from that tank, bulk tank cleaning and sanitizing, and the applicability of a positive drug residue test result to all partial loads containing milk from the same milking. The department also proposes to make other changes to ch.
ATCP 82 dealing with an exemption of Wisconsin license requirements for trucks holding a Grade “A" permit from another state, exemption of tanker Grade “A" permit requirements for employees of an already permit-holding bulk milk tanker owner, bulk milk weigher sampler license renewal requirements, re-inspection of bulk milk weigher samplers, washing and sanitizing of bulk milk tankers and associated hoses and pumps, thermometer calibration, rinsing of bulk tank volume measurement rods, supplies required for milk collection and sampling, and sealing of the bulk milk tanker access port. The other changes proposed would be made to ensure consistency between ch.
ATCP 82 and the PMO, and would reflect evolving industry standards.
2. Description of Existing Policies Relevant to the Rule and of New Policies Proposed to be Included in the Rule and an Analysis of Policy Alternatives; the History, Background, and Justification for the Proposed Rule
Wisconsin ranks second nationally in milk production and operates the nation's largest state dairy inspection program. Wisconsin has by far the largest number of dairy farms operated by licensed dairy producers; the milk from each of these farms is shipped to one of the 400+ licensed dairy plants in the state, or to a licensed dairy plant in another state. Milk must be collected from each farm in a licensed bulk milk tanker, and a licensed bulk milk weigher sampler must properly record the amount of milk collected and sample the milk on each farm for testing.
Current Wisconsin regulations in ch.
ATCP 82 require that all milk present in a bulk tank must be collected when a collection is made, i.e. partial collection is forbidden. The original intent of this regulation was to ensure that a dairy producer's bulk tank(s) was regularly cleaned and sanitized, and to ensure that collection-to-collection transfers of illegal drug residues did not occur, which could result in increased financial losses to dairy producers forced to dump multiple loads of milk.
Despite the worthwhile intentions which led to it being written, the requirement prohibiting partial collection of milk from a bulk tank is outdated. Farm sanitation methods have improved since Wisconsin's rule was first adopted. Frequent testing allows dairy plants to quickly address problems related to bulk tank cleanliness. As the number of dairy farms has decreased, farms have become larger, and per cow milk production has risen, many farms have purchased larger bulk tanks, creating new challenges for managing milk collection. For example, some farms now have bulk milk tanks that hold 7,000 or more gallons of milk, while other farms may have several smaller tanks. A typical milk truck carries approximately 6,000 gallons of milk. Allowing partial collection of milk from bulk tanks will give dairy plants the tools they need to more efficiently manage milk collection from these farms and avoid loading trucks beyond legal capacity. In the long run, increased flexibility for collection of milk could result in fewer trips required to haul milk, with associated fuel savings, and less wear and tear on roadways.
The PMO allows partial collection of milk provided that the bulk tank is emptied, cleaned and sanitized within at least 72 hours. The PMO also requires an acceptable temperature-recording device to be installed and operating on any bulk tank from which partial collections are made. The bulk milk weigher sampler, and regulatory personnel are required to observe temperature records to be sure that loss of temperature control, which can lead to unacceptable bacterial growth, did not occur following a partial collection. In absence of a temperature-recording device, partial pickups are permitted under the PMO as long as the bulk tank is emptied completely, cleaned and sanitized prior to the next milking. This proposed rule adopts these PMO standards.
Approximately 4,000 bulk milk tankers from Wisconsin and other states deliver milk to Wisconsin dairy plants. By regulation each of these trucks must be licensed in Wisconsin and, if carrying Grade “A" milk, hold a Grade “A" permit. It is logistically challenging to license all of these tankers, particularly those which are infrequently in Wisconsin. The department will consider removing the licensing requirement and fee while accepting Grade “A" permits issued by any state and instituting a Grade “A" permit inspection fee for bulk milk tankers based in Wisconsin. This change would benefit the milk hauling industry and allow re-assignment of department sanitarians to other tasks. The department will also consider removing a confusing exemption of tanker Grade “A" permit requirements for employees of an already permit-holding bulk milk tanker owner. Removal of this exemption will bring Wisconsin requirements in line with the PMO and create a level playing field for milk haulers.
The department currently licenses about 3,700 bulk milk weigher samplers, who measure the weight of milk collected and obtain a representative sample of each producer's milk for mandatory testing. The PMO requires a biennial field examination of each bulk milk weigher sampler before license renewal to ensure that s/he is using proper sample collection technique. Wisconsin regulations make the field examination optional. In order to improve consistency with the PMO, the department will consider changing the current bulk milk weigher sampler examination regulations, along with the re-inspection procedure used to evaluate bulk milk weigher samplers who have been found to be in violation of Wisconsin food safety law.
The department will also consider updating requirements for washing and sanitizing of bulk milk tankers and associated hoses and pumps, thermometer calibration, rinsing of bulk tank volume measurement rods, supplies required for milk collection and sampling, and sealing of the bulk milk tanker access port. These updates will improve consistency between Wisconsin rules and the PMO, while reflecting current industry standard practices.
Policy alternatives
If the department does not alter the current rules, Wisconsin dairy plants will lack the flexibility dairy plants have in other states that adopt the PMO standard and allow plants to collect partial loads of milk. Dairy plant operators will be prevented from managing their milk hauling practices in the most cost efficient and profitable manner and will be required to continue to empty bulk tanks each time they make a pickup, even if that means trucks are not filled to capacity or over-capacity milk is dumped. Not changing this policy has the potential to negatively impact dairy plant and producer costs, causing companies to incur unnecessary fuel and other costs associated with hauling milk, putting them at an economic disadvantage to dairy producers in other states that have adopted the PMO standard. These unnecessary trips also may damage Wisconsin roads. In addition, failure to update requirements, such as those related to tanker permits, bulk milk weigher sampler examination and re-inspection, and washing and sanitizing of bulk milk tankers and associated hoses and pumps, decreases the department's flexibility in assigning work while increasing the likelihood of obtaining an unacceptable score when the department's milk regulatory program is evaluated for PMO-compliance by the FDA.
3. Statutory Authority for the Rule (Including the Statutory Citation and Language)
