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.
94.64 Fertilizer.
* * *
(9) Rules. The department may promulgate rules:
* * *
(b) Regulating the sale and labeling of fertilizer, including warning or caution statements or directions for use in connection with the labeling of fertilizer.
(c) Governing methods of sampling, testing, examining and analyzing fertilizer.
(d) Prescribing tolerances for deficiencies found in percentages of plant nutrient guaranteed to be present.
* * *
(f) Establishing standards of identity and purity for fertilizer materials.
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 0.5 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
Fertilizer manufacturers and labelers. This rule revision may change the criteria currently being used to establish whether the nutrient contents of fertilizer meets the fertilizer's label guarantees of those nutrients and could include modification of the economic value formula. While this rule revision will not affect any nutrient percentage guarantees that the fertilizer industry makes on fertilizer labels, it may reduce the instances in which tested fertilizer products fail to meet existing labeling criteria in s.
ATCP 40.14.
Consumers of fertilizer products. This rule revision may benefit fertilizer product consumers because the criteria that ensure accurate labeling of guaranteed amounts of nutrient content in fertilizer products will be reexamined and updated if needed.
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 no significant federal regulation of fertilizers, although there is a long history of regulation by states.
7. Anticipated economic impact
DATCP expects the proposed rule revision to have minimal to no negative economic impact statewide or locally.
DATCP Board Authorization
DATCP may not begin drafting this rule revision 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.
Contact Person
Amy Basel, Feed and Fertilizer Program Supervisor, DATCP; Phone (608) 224-4541.
Controlled Substances Board
This statement of scope was approved by the governor on November 12, 2014.
Rule No.
Relating to
Scheduling suvorexant as a schedule IV controlled substance.
Rule Type
Permanent.
1. Finding/Nature of Emergency (Emergency Rule Only)
N/A
2. Detailed Description of the Objective of the Proposed Rule
The objective of the proposed rule is to schedule suvorexant as a Schedule IV controlled substance.
3. Description of the Existing Policies Relevant to the Rule, New Policies Proposed to be Included in the Rule, and an Analysis of Policy Alternatives
On August 28, 2014, the United States Food and Drug Administration, Drug Enforcement Administration published its final rule in the Federal Register placing suvorexant into Schedule IV of the federal Controlled Substances Act. The scheduling action was effective September 29, 2014. The Controlled Substances Board did not receive an objection to similarly treat suvorexant as a schedule IV under ch.
961, Stats., within 30 days of the date of publication in the federal register of the final order designating tramadol as a controlled substance.
Pursuant to s.
961.11 (4), Stats., the Controlled Substances Board took affirmative action to similarly treat suvorexant under ch.
961, Stats., by creating the following:
CSB 2.38 Addition of suvorexant to schedule IV. Section
961.20 (2) (mr), Stats., is created to read:
961.20 (2) (mr) Suvorexant
The Affirmative Action order, dated October 8, 2014, will take effect on November 1, 2014 to allow for publication in the Administrative Register and expires upon promulgation of a final rule.
4. Detailed Explanation of Statutory Authority for the Rule (Including the Statutory Citation and Language)
961.11 (2) After considering the factors enumerated in sub. (1m), the controlled substances board shall make findings with respect to them and promulgate a rule controlling the substance upon finding that the substance has a potential for abuse.
961.11 (4) If a substance is designated, rescheduled or deleted as a controlled substance under federal law and notice thereof is given to the controlled substances board, the board by affirmative action shall similarly treat the substance under this chapter after the expiration of 30 days from the date of publication in the federal register of a final order designating the substance as a controlled substance or rescheduling or deleting the substance or from the date of issuance of an order of temporary scheduling under
21 USC 811 (h), unless within that 30-day period, the board or an interested party objects to the treatment of the substance. If no objection is made, the board shall promulgate, without making the determinations or findings required by subs. (1), (1m), (1r) and (2) or s.
961.13,
961.15,
961.17,
961.19 or
961.21, a final rule, for which notice of proposed rulemaking is omitted, designating, rescheduling, temporarily scheduling or deleting the substance. If an objection is made the board shall publish notice of receipt of the objection and the reasons for objection and afford all interested parties an opportunity to be heard. At the conclusion of the hearing, the board shall make a determination with respect to the treatment of the substance as provided in subs. (1), (1m), (1r) and (2) and shall publish its decision, which shall be final unless altered by statute. Upon publication of an objection to the treatment by the board, action by the board under this chapter is stayed until the board promulgates a rule under sub. (2).
5. Estimate of Amount of Time that State Employees Will Spend Developing the Rule and of Other Resources Necessary to Develop the Rule
25 hours
6. List with Description of all Entities that may be Affected by the Proposed Rule
Pharmacists, prescribers, courts, police, and the Controlled Substances Board.
7. Summary and Preliminary Comparison with any Existing or Proposed Federal Regulation that is Intended to Address The Activities to be Regulated by the Proposed Rule
On July 2, 2014, the United States Food and Drug Administration, Drug Enforcement Administration published its final rule in the Federal Register placing suvorexant into Schedule IV of the federal Controlled Substances Act. The scheduling action was effective September 29, 2014.
8. Anticipated Economic Impact of Implementing the Rule (Note if the Rule is Likely to Have a Significant Economic Impact on Small Businesses)
None to minimal. It is not likely to have a significant economic impact on small businesses.
Contact Person
Sharon Henes, Administrative Rules Coordinator, (608) 261-2377
Controlled Substances Board
This statement of scope was approved by the governor on November 12, 2014.
Rule No.
Relating to
Scheduling tramadol as a schedule IV controlled substance.
Rule Type
Permanent.
1. Finding/Nature of Emergency (Emergency Rule Only)
N/A
2. Detailed description of the objective of the proposed rule
The objective of the proposed rule is to schedule tramadol as a Schedule IV controlled substance.
3. Description of the Existing Policies Relevant to the Rule, New Policies Proposed to be Included in the Rule, and an Analysis of Policy Alternatives
On July 2, 2014, the United States Food and Drug Administration, Drug Enforcement Administration published its final rule in the Federal Register placing tramadol into schedule IV of the federal Controlled Substances Act. The scheduling action was effective August 18, 2014. The Controlled Substances Board did not receive an objection to similarly treat tramadol as a schedule IV under ch.
961, Stats., within 30 days of the date of publication in the federal register of the final order designating tramadol as a controlled substance.
Pursuant to s.
961.11 (4), Stats., the Controlled Substances Board took affirmative action to similarly treat tramadol under chapter 961, Stats., by creating the following:
CSB 2.36 Addition of tramadol to schedule IV. Section
961.20 (4) (e), Stats., is created to read:
961.20 (4) (e) Tramadol, including any of its isomers and salts of isomers.
The Affirmative Action order, dated August 14, 2014, took effect on September 1, 2014 to allow for publication in the Administrative Register and expires upon promulgation of a final rule.
4. Detailed Explanation of Statutory Authority for the Rule (Including the Statutory Citation and Language)
961.11 (2) After considering the factors enumerated in sub. (1m), the controlled substances board shall make findings with respect to them and promulgate a rule controlling the substance upon finding that the substance has a potential for abuse.
961.11 (4) If a substance is designated, rescheduled or deleted as a controlled substance under federal law and notice thereof is given to the controlled substances board, the board by affirmative action shall similarly treat the substance under this chapter after the expiration of 30 days from the date of publication in the federal register of a final order designating the substance as a controlled substance or rescheduling or deleting the substance or from the date of issuance of an order of temporary scheduling under
21 USC 811 (h), unless within that 30-day period, the board or an interested party objects to the treatment of the substance. If no objection is made, the board shall promulgate, without making the determinations or findings required by subs. (1), (1m), (1r) and (2) or s.
961.13,
961.15,
961.17,
961.19 or
961.21, a final rule, for which notice of proposed rulemaking is omitted, designating, rescheduling, temporarily scheduling or deleting the substance. If an objection is made the board shall publish notice of receipt of the objection and the reasons for objection and afford all interested parties an opportunity to be heard. At the conclusion of the hearing, the board shall make a determination with respect to the treatment of the substance as provided in subs. (1), (1m), (1r) and (2) and shall publish its decision, which shall be final unless altered by statute. Upon publication of an objection to the treatment by the board, action by the board under this chapter is stayed until the board promulgates a rule under sub. (2).
5. Estimate of Amount of Time that State Employees Will Spend Developing the Rule and of Other Resources Necessary to Develop the Rule
25 hours
6. List with Description of all Entities that may be Affected by the Proposed Rule
Pharmacists, prescribers, courts, police, and the Controlled Substances Board
7. Summary and Preliminary Comparison with any Existing or Proposed Federal Regulation that is Intended to Address the Activities to be Regulated by the Proposed Rule
On July 2, 2014, the United States Food and Drug Administration, Drug Enforcement Administration published its final rule in the Federal Register placing tramadol into Schedule IV of the federal Controlled Substances Act. The scheduling action was effective August 18, 2014.
8. Anticipated Economic Impact of Implementing the Rule (Note if the Rule is Likely to Have a Significant Economic Impact on Small Businesses)
