Scope statements
Agriculture, Trade and Consumer Protection
Subject
Animal by-products (includes rules related to renderers, animal food processors, grease processors and carcass collectors).
Administrative code reference: Chapter
ATCP 57, Wis. Adm. Code (existing rule). This rule may also make minor changes to related rules, include chs.
ATCP 10-
12 (animal health), ATCP 55 (meat and meat food products) and ATCP 42 (animal feed).
Objective of the rule. This rule will update and reorganize current rules related to entities that collect and process animal carcasses, or process animal by-products for feed or other non-food use. Among other things, this rule may:
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Update and clarify current license requirements related to renderers, animal food processors, grease processors and carcass collectors. This rule will not increase license fees.
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Clarify and strengthen current rules to prevent non-food materials from entering the human food chain.
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Incorporate federal prohibitions against the sale or use of ruminant feed made from mammalian carcasses and carcass materials. This prohibition is designed to prevent BSE (“mad cow disease") and related diseases in ruminant animals. This rule may incorporate updated or expanded federal restrictions as necessary to remain consistent with federal law.
•
Clarify current rule provisions related to the collection, transportation, processing and handling of inedible carcasses and carcass materials, and the sale and labeling of processed products. Clear rules and accountability will facilitate compliance.
•
Make technical changes as needed.
Preliminary policy analysis
Wisconsin has a large rendering and animal food processing industry. This industry collects and processes animal carcasses, carcass materials and meat by-products (mainly from Wisconsin's large livestock and meat processing industries), and produces useful non-food products such as grease, tallow, blood meal, bone meal and animal feed.
DATCP currently regulates rendering plants, animal food processors, grease processors and carcass collectors under s.
95.72, Stats., and ch.
ATCP 57, Wis. Adm. Code. DATCP regulation is aimed at protecting public health and safety, preventing inedible by-products from entering the human food chain, promoting animal health, and ensuring the safety and proper labeling of animal feed.
With the advent of BSE and other new disease threats, there has been increased focus on the rendering and animal food processing industries. Federal regulations, enforced by DATCP under contract with federal agencies, prohibit the use of mammalian carcasses and carcass materials as feed for ruminant animals (to protect against BSE and related diseases). Renderers and animal food processors have also cooperated in state-federal BSE testing of dead or slaughtered animals.
Wisconsin has been a leader in food safety and animal disease control, but continued progress will require a clear and up-to-date regulatory framework. Current DATCP rules related to rendering plants, animal food processors, grease processors and carcass collectors were first adopted in 1975, and have not been updated since 1983. DATCP proposes to reorganize and update the current rules, incorporate recent law changes, incorporate applicable federal requirements, and make current rules more clear. DATCP also proposes to clarify the connections between this program and other regulatory programs, including food safety, meat inspection, animal health, commercial feed, captive wildlife, and livestock premises registration.
For the most part, this rule will merely restate current law and policy in a clearer, more organized way. New animal feed restrictions, if any, will be consistent with state and federal mandates. Clear rules will promote efficiency, accountability and sound administration, and will strengthen animal health and food safety protection.
Related federal law and program
ATCP cooperates with the United States Food and Drug Administration (FDA) in the regulation of commercial feed. DATCP cooperates with the United States Department of Agriculture (USDA) in the administration of meat inspection and animal health laws. Recently, DATCP has helped FDA implement ruminant feed restrictions to prevent the outbreak of BSE and related diseases. DATCP has also worked with USDA to conduct BSE testing at meat establishments, rendering plants and animal food processing plants.
Entities affected
The rule will primarily affect renderers, animal food processors, grease processors and carcass collectors. For the most part, this rule will merely codify current law and policy.
Policy alternatives
If DATCP takes no action, current rules will remain in effect. Current rules lack clarity, and are not fully consistent with other state and federal laws. This may frustrate effective public administration and private compliance. Current rules do not provide an adequate framework for the regulation of these key industries, which have an important bearing on animal disease control and public health.
Statutory alternatives
None at this time.
Staff time required
DATCP estimates that it will use approximately 0.50 FTE staff to develop this rule. This 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. The department may also need additional personnel to administer the programs.
DATCP Board authorization
DATCP may not begin drafting this rule until the Board of Agriculture, Trade and Consumer Protection (Board) approves this scope statement. The Board may not approve this scope statement sooner than 10 days after this scope statement is published in the Wisconsin Administrative Register. If the Board takes no action on the scope statement within 30 days after the scope statement is presented to the Board, the scope statement is considered approved. Before DATCP holds public hearings on this rule, the Board must approve the hearing draft. The Board must also approve the final draft rule before the department adopts the rule.
Controlled Substances Board
Subject
Classify as a schedule I controlled substance under state law alpha-methyltryptamine (AMT) and 5-methoxy-N,N-diisopropyltryptamine (5-MeO-DIPT), which have been classified as schedule I controlled substances under federal law.
Objective of the rule. By final rule of the Drug Enforcement Administration (DEA), adopted effective October 3, 2004, alpha-methyltryptamine (AMT) and 5-methosy-N,N-diisopropyltryptamine (5-MeO-DIPT) were classified as schedule I controlled substances under the federal Controlled Substances Act (CSA). Neither AMT nor 5-MeO-DIPT have been so scheduled under the Wisconsin Controlled Substances Act in Chapter
961, Wis. Stats. The objective of the rule is to bring the treatment of these drugs into conformity with that at the federal level.
Policy analysis
Drugs that are classified as “controlled substances" under federal and state laws are subject to higher civil and criminal penalties for their illicit possession, distribution and use. Health care providers are also subject to greater record keeping requirements respecting their obtaining, prescribing and dispensing of such drugs. This is due to the fact that certain drugs have a greater likelihood of abuse, addiction and adverse consequences to patient health if utilized inappropriately, than do other drugs. The National Forensic Laboratory Information System (NFLIS) registered 10 cases of AMT and 12 cases of 5-MeO-DIPT. The Drug Enforcement Agency (DEA) asserts that AMT shares pharmacological effects of amphetamine and LSD and that 5-MeO-DIPT copies the effects of MDMA, both Schedule I hallucinogens. Three deaths have been associated with its consumption. The DEA administers the Controlled Substances Act. This forms the basis for the DEA action. The policy alternative to not scheduling the indicated substances concurrent with federal scheduling will be that state prosecutions will not be available. Generally, state prosecutions at the local level rather than federal prosecutions, are more likely to occur where smaller amounts of a scheduled substance are involved.
Entities affected by rule
Enforcement agencies; the Department of Justice, District Attorney offices.
Comparison with federal requirements
(d) ***
(15) Alpha-methyltryptamine (other name: AMT) -7432
********
(19) 5-methoxy-N,N-diisopropyltryptamine (other name: 5-MeO-DIPT) - 7439
Statutory authority
Staff time required
It is estimated that 100 hours will be needed to promulgate the rule.
Health and Family Services
Subject
The Department of Health and Family Services proposes to amend ch.
HFS 124, rules relating to hospitals.
Policy analysis
The Department proposes to generally update ch.
HFS 124 to eliminate overly prescriptive regulations; clarify the Department's enforcement authority; and align ch.
HFS 124 with Medicare by requiring compliance with federal minimum standards of operation, maintenance and patient care. The proposed changes do not compromise the hospital consumer's care and safety.
Section
50.36 (1), Stats., gives the Department authority to establish and enforce rules and standards for hospitals for the construction, maintenance, and operation of the hospitals deemed necessary to provide safe and adequate care and treatment of patients and to protect the health and safety of both patients and employees. These rules and standards are promulgated in ch.
HFS 124, the state regulations relating to hospitals.
Through this rulemaking initiative, the Department proposes to clarify rule provisions relating to its enforcement authority because the existing enforcement language is subject to multiple interpretations and is a source of confusion to health care providers and the public. Current language in ch.
HFS 124 authorizes the Department to withhold, suspend, or revoke the certificate of approval for failure to comply with a requirement of the chapter. The Department is seeking language to require hospitals to submit a plan of correction for violations of the rule. Requiring submission of a plan of correction reflects current Department practice, and is a reasonable and effective means of achieving correction.
Federal requirements addressing standards of operation, maintenance, and patient care are more current than the comparable state regulations in ch.
HFS 124. Therefore, the Department is proposing to adopt the applicable federal standards. Current ch.
HFS 124 language details how a hospital's governing body must organize itself, details the qualifications of nursing staff, and prescribes requirements for staff orientation and training. Concerns have been expressed that the current state code limits the ability to implement new or innovative approaches to ensure quality patient care. The Department's intent is to streamline ch.
HFS 124 to allow for more efficient and effective regulation of hospitals.
Statutory authority
