3. Statutory Authority for the Rule (Including the Statutory Citation and Language)
Statutory Authority: ss. 93.07 (1), 97.09 (4), 97.42 (4), 95.38, and 95.67, Stats.
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, Stats., 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.
97.42 Compulsory inspection of animals, poultry and carcasses.
(4) Rules. The department may issue reasonable rules requiring or prescribing any of the following:
(a) The inspection before and after slaughter of all animals and poultry killed or dressed for human consumption at any establishment.
95.38 Altering records; tampering with ear tags.
(1) It shall be unlawful for any person to in any manner change any test record, falsely record any test, misrepresent the identification of any animal or any other material fact on any test record, certificate of veterinary inspection, vaccination record, claim for indemnity, or any disease control report or application to the department. It shall be unlawful for any person to induce or to conspire with another, either directly or indirectly, to do any of the said prohibited acts.
(2) No person is permitted to in any way tamper with, insert or remove from the ear of any animal any ear tag or registration mark which is or may be used for identification in disease control work except upon authorization from the department.
(3) The department may adopt rules that are necessary to administer this section.
95.67 Proper use of animal care and disease control products. No person may use chemical, biological or disease control products in the treatment or care of food producing animals without substantially complying with instructions, warnings and directions for use on the product label. No animal or food product including milk of the animal shall be marketed for processing or use as food prior to the time specified on the label of a product used in the treatment or care of the animal. This section applies neither to licensed veterinarians who prescribe or administer drugs in conformity with federal restrictions nor to persons using drugs in a manner prescribed by a licensed veterinarian. This section shall not prevent a farmer from administering animal disease control products to livestock in compliance with instructions on the product label.
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 stakeholder meetings, holding public hearings, and otherwise 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
Consumers, meat establishment operators, and livestock producers will all benefit from the department having progressive enforcement capabilities for repeat tissue drug-residue violations.
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
Federal meat and poultry inspection regulations require meat and poultry processors to adopt Hazard Analysis and Critical Control Point (HACCP) systems. HACCP is an approach for preventing food safety hazards that involves identifying key food processing steps essential for ensuring safety. Plants must develop a plan to monitor and document that each of these key steps is functioning properly and minimizing food safety risks. As part of their HACCP plan, federally-inspected plants are required by 9 CFR 417.2 (a) (3) (v) to identify preventive measures for food safety hazards that could arise from drug residues. Drug residues include veterinary drugs, pesticides, and environmental contaminants.
One approach for minimizing drug residue risks is for producers to avoid purchasing animals from sources that have had drug residue violations in the past. Since past performance is often the best indicator as to whether an animal may have a drug residue problem, federal plants are expected to consult the federal Residue Repeat Violator List before purchasing animals for slaughter. The National Residue Program (NRP) at FSIS has collected data on drug residues in meat, poultry, and egg products since 1967. Producers who are found to have had more than one residue violation in the previous 12 months under this sampling program are placed on the federal Residue Repeat Violator List.
State meat inspection programs operate under a cooperative agreement with the United States Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS). Under this agreement, state meat inspection programs are required to adopt regulations that are “at least equal to" federal meat and poultry inspection regulations. In addition, Wisconsin is one of three states recently accepted into the Cooperative Interstate Shipment (CIS) program allowing certain selected meat establishments to ship their products in interstate commerce. States in the CIS program must adopt regulations that are the “same as" federal meat inspection regulations.
The proposed rule will ensure Wisconsin's state meat inspection program is consistent with federal regulations and expectations for minimizing the risk of drug residue violations at state-inspected meat plants. It will enhance the effectiveness of these procedures by adding an additional educational corrective action that would be implemented well before federal regulatory action is needed.
7. Anticipated Economic Impact
This rule change is anticipated to have no impact on the vast majority of livestock producers who follow existing regulations and have a strong working relationship with their veterinarian. There will be a minor short-term negative economic impact on livestock producers who must attend a workshop and improve documentation of animal medications as a result of the proposed rule. To the extent that the proposed rule prevents drug residue problems and condemnation of carcasses, there will be a positive long-term economic impact. The rule will not modify fees or have an economic impact on local governmental units or public utility taxpayers.
8. 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 October 11, 2013.
Rule No.
Chapter ATCP 142, Wis. Adm. Code (Existing).
Relating to
The Cranberry Marketing Order.
Rule Type
Permanent.
1. Description of the Objective of the Rule
This proposed rule would increase the maximum amount the Cranberry Marketing Order Board may assess cranberry growers to enable the Board to more effectively achieve the purposes of ch. 96, Stats., (the Agricultural Marketing Act) and particularly to more effectively maintain and expand the sale of cranberries.
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
History and background
The Cranberry Marketing Order that currently exists was adopted in 1983. It provides for a maximum annual assessment for each cranberry producer covered by the order of 10 cents per barrel of cranberries produced. The primary purpose of the marketing order is to maintain and expand the sale of cranberries. To that end, funds collected through assessments may be used by the marketing board for marketing research and development, industrial research and education programs that serve to meet the purpose of the marketing order.
Proposed policies
At the request of the Cranberry Marketing Board, DATCP will explore an increase to the maximum annual assessment sufficient to enable the Cranberry Marketing Board to continue the expansion of the sale of Wisconsin grown cranberries. Any amendment to the marketing order must be approved at a referendum of the growers.
Policy alternatives
Leave the current rule as it is with the same assessment maximum which has not increased since 1983. There has been tremendous growth of Wisconsin cranberry sales and the Board's use of assessment funds has played an important role in that growth. To maintain that success, the Cranberry Board is requesting the increase.
3. Statutory Authority for the Rule (Including the Statutory Citation and Language)
Sections 93.07 (1) and 96.15, Stats.
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.
96.15 Rules. The secretary may, in consultation with the appropriate marketing board or council, issue such rules as necessary to facilitate the administration and enforcement of this chapter.
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 0.20 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
This rule would affect cranberry growers. The proposed rule would increase the maximum annual assessment that the Cranberry Board may charge to growers from the current maximum of 10 cents per barrel. Any amendment to the marketing order including a proposal to increase the maximum annual assessment must be approved at referendum by a majority of all Wisconsin cranberry growers.
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
There is a federal cranberry marketing order program. The federal cranberry marketing order program serves to promote orderly and efficient marketing of cranberries in the United States. The state and federal programs are complementary and the state program works in close coordination with the federal program. The Department is not aware of any proposals pending to alter the federal cranberry marketing program.
7. Anticipated Economic Impact
DATCP expects the proposed rule to have minimal economic impact statewide and locally.
8. Contact Person
Noel Favia, Marketing order Program Coordinator
Phone: (608) 224-5140
Agriculture, Trade and Consumer Protection
This statement of scope was approved by the Governor on October 14, 2013.
Rule No.
Chapter ATCP 80, Wis. Adm. Code (Existing).
Relating to
Dairy plants, and affecting small business.
Rule Type
Permanent.
1. Description of the Objective of the Rule
The department proposes a comprehensive review and revision of ch. ATCP 80, relating to the food safety oversight of dairy plants in Wisconsin. The objective of this proposed rule is to modernize current dairy plant inspection rules in order to ensure compliance with federal Food and Drug Administration's (FDA) Pasteurized Milk Ordinance (PMO), accommodate advances in manufacturing dairy products, and continue ensuring the safety and quality of Wisconsin dairy products. The department will also determine whether and the extent to which revisions are needed to harmonize Wisconsin regulations with federal risk-based preventive controls regulations implemented under the Food Safety Modernization Act.
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 has more than 400 licensed dairy plants. Grade A dairy plants produce pasteurized fluid milk and milk products such as cottage cheese, cream, and yogurt made using Grade A milk from Grade A dairy farms. Grade A milk and milk products must be processed in accordance with standards in the FDA's PMO and are thereby eligible for interstate commerce. The PMO is a guidance document and ch. ATCP 80 is in substantial compliance with it. Ninety-eight percent of the milk produced in Wisconsin is Grade A. Chapter ATCP 80 (Dairy Plants) is a comprehensive rule designed to address the specific challenges of manufacturing milk and dairy products and ensuring that these products are high-quality and safe to consume. Chapter ATCP 80 establishes milk bacteriological and compositional quality standards, sets pasteurization requirements, requires milk testing to measure whether these standards are met, and establishes procedures for testing milk and recording results. Chapter ATCP 80 also requires dairy plants to keep records of information needed to monitor the safety of their products, and ensure proper financial reporting. The rule also establishes inspection and enforcement requirements, including a requirement that Grade A plants be periodically audited against federal sanitation compliance standards. Finally, ch. ATCP 80 includes labeling requirements for dairy products not sold for human food or animal feed.
Grade B dairy plants make products not covered under the PMO such as butter, ice cream, and cheese. Grade B products may be made from either Grade A or Grade B milk. Grade B milk comes from farms that have less stringent bacteriological requirements and are inspected less frequently.
FDA revises the PMO every two years. The current ch. ATCP 80 rules, although largely in compliance with the PMO, must be revised periodically to maintain the needed consistency with the latest version of the PMO and to adapt to new innovations in the dairy industry. For example, the most recently adopted PMO contains new requirements related to aseptic processing and packaging of dairy products which have not been incorporated in ch. ATCP 80.
The department will consider a variety of potential rule changes which mainly, but not exclusively, involve maintaining consistency with the PMO, and relate to topics such as: the statutory definition of a dairy product; delineation of financial responsibilities for milk contractors and dairy plant operators; equipment and facility standards; evaluation of a plant's water supply; microbiological standards for different products; limits for operating a pasteurizer after a seal has been broken; and variance procedures.
As part of its overall review of ch. ATCP 80, the department will explore provisions consistent with impending federal regulations (implemented under the Food Safety Modernization Act) that require food processing plants to conduct a hazard analysis and develop a risk-based system of preventive controls. The department may propose rule changes addressing this topic, as needed.
Policy alternatives
FDA revises the PMO every two years and the department must periodically revise ch. ATCP 80 to ensure substantial compliance with the PMO. If the department does not alter the current rule, the rule may not remain consistent with the PMO which could eventually lead to problems when the FDA audits the Wisconsin dairy inspection program for compliance. A failing regulatory audit score could jeopardize the ability of Wisconsin dairy producers and plants to participate in the Grade “A" program and to maintain Wisconsin's reputation as the Dairy State. Current regulations may not be adequate for addressing emerging food safety issues related to dairy processing.
3. Statutory Authority for the Rule (Including the Statutory Citation and Language)
Statutory Authority: ss. 93.07 (1), 97.09 (4), and 97.20 (4), Stats.
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.
97.20 Dairy plants.
(4) Rule making. The department may promulgate rules to establish the fees required under sub. (2) (c) to (2) (w) or to govern the operation of dairy plants. The rules may include standards for the safety, wholesomeness and quality of dairy products; the construction, maintenance and sanitary operation of dairy plants; the design, installation, cleaning and maintenance of equipment and utensils; personnel sanitation; storage and handling of milk and fluid milk products; pasteurization and processing procedures; sampling and testing; and reports and record keeping. The rules may also set forth duties of dairy plants to inspect dairy farms, collect and test producer milk samples and make reports to the department.
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