Explanation of agency authority
The Department is required under s. 285.21 (1) (a), Stats., to promulgate by rule ambient air standards similar to, but not more restrictive than the national ambient air quality standards (NAAQS). The Department is also authorized under s. 285.11 (1) and (6), Stats., to promulgate rules and establish control strategies in order to prepare and implement the State Implementation Plan for the prevention, abatement and control of air pollution in the state.
Related statute or rule
There are no related statutes that are not identified above.
Plain language analysis
Chapter NR 404, Wis. Adm. Code, contains ambient air standards which are intended to be the same as the federal NAAQS promulgated by EPA, as is required under s. 285.21(1)(a), Stats. Chapter NR 438, Wis. Adm. Code, establishes requirements for submission of reports for owners or operators of air contaminant sources related to the ambient air standards that are employed by the Department. The Clean Air Act requires EPA to review the latest scientific information every five years and promulgate NAAQS which are designated to protect public and public welfare. In 2008, EPA strengthened the 8-hour ozone NAAQS to 0.075 ppm and revised the NAAQS for lead from 1.5 micrograms/cubic meter (mg/m3) to 0.15 mg/m3.
The Department is proposing to amend chs. NR 404 and 438, Wis. Adm. Code, to maintain consistency with the federal NAAQS. Specifically, the proposed rule revisions would: A) adopt the ozone and lead NAAQS into ch. NR 404, Wis. Adm. Code; and B) incorporate the corresponding lead reporting requirements into ch. NR 438, Wis. Adm. Code.
Comparison with federal regulations
The federally-enforced NAAQS are contained in Title 40, Part 50 of the Code of Federal Regulations (40 CFR Part 50). The purpose of these proposed rules is to make the State-enforced ambient air standards for ozone and lead in ch. NR 404, Wis. Adm. Code, consistent with the corresponding federal NAAQS, as required under s. 285.21(a), Stats.
Comparison with rules in adjacent states
These proposed rule revisions are designed to make Wisconsin's ambient air quality standards consistent with federal NAAQS, which are effective and enforced throughout the United States. Consequently, these proposed rules would be identical to the ambient air standard regulations in effect in the adjacent states.
Summary of factual data and analytical methodologies
The EPA, through its Clean Air Scientific Advisory Committee has conducted exhaustive reviews and assessments on the health science of air pollution impacts to human health and welfare. This research has yielded NAAQS that are based upon sound health science designed to protect public health and welfare. The Department is accepting this extensive federal research as this order's factual data and analytical methodologies. Information on the federal rule changes are obtained from the federal registers published on March 27, 2008 (Vol. 73, No. 60) for ozone and on November 12, 2008 (Vol. 73, No. 219) for lead.
Analysis and supporting documents used to determine effect on small business
In light of the statutory requirement to promulgate by rule new ambient air quality standards similar to but not more restrictive than the federal standards, the Department relies on the federal data and the analytical methodologies EPA used to develop and promulgate the national ambient air quality standards. EPA analysis establishes that NAAQS do not have significant impacts upon small entities, including small businesses because NAAQS themselves impose no regulations upon small entities. Information on the analysis and supporting documents used to determine effect on small entities are contained in the EPA's Regulatory Impact Analysis (RIA) docket EPA-HQ-OAR-2007-0225 for the ozone NAAQS and RIA docket EPA-HQ-OAR-2006-0735 for the lead NAAQS.
An economic impact report has not been requested.
Small Business Impact
The promulgation of the ozone and lead ambient air quality standards would not have any direct effect on businesses, including those defined as small business. Following the promulgation of the ozone and lead air quality standards, the EPA will determine if any areas in the state should be designated as nonattainment for either of the new air quality standards. The Department is required to develop an air quality management state implementation plan (SIP) to ensure that all ambient air quality standards are attained and maintained in all areas of the state. The future development of that SIP to address ozone and lead may result in emission limitations being developed for specific source categories or implementing emission control technologies which may affect businesses, including small businesses. Any prospective SIP revisions would occur through the development of additional rules, which would include analyses of the rules' potential effects on the private sector, including small businesses.
Environmental Analysis
The DNR has made a preliminary determination that adoption of the proposed rules would not involve significant adverse environmental effects and would not need an environmental analysis under ch. NR 150, Wis. Adm. Code. However, based on the comments received, the DNR may prepare an environmental analysis before proceeding. This analysis would summarize the DNR's consideration of the impacts of the proposal and any reasonable alternatives.
Fiscal Estimate
Summary
The proposed rules will not have any direct economic impact on the private sector. If, in the future, EPA were to designate any areas in the state as non-attainment areas for either of the proposed ambient air quality standards, it could become necessary to develop rules to control emissions of ozone precursors or lead. If such rules become necessary, any potential economic impact to the private sector will be evaluated at that time.
State fiscal effect
None.
Local government fiscal effect
None.
Notice of Hearing
Pharmacy Examining Board
NOTICE IS HEREBY GIVEN that pursuant to authority vested in the Pharmacy Examining Board in ss. 15.08 (5) (b), 227.11 (2) and 450.02 (3) (a), (b), (d) and (e), Stats., the Pharmacy Examining Board will hold a public hearing at the time and place indicated below to consider an order to amend sections Phar 6.08, 7.12 (2) (f) and 8.12 (2) (b), relating to security systems, utilization reviews, and prescription orders transmitted by facsimile.
Hearing Information
Date:   December 2, 2009
Time:   9:30 a.m.
Location:   1400 East Washington Avenue
  (Enter at 55 North Dickinson Street)
  Room 121A
  Madison, Wisconsin
Appearances at the Hearing and Submission of Written Comments
Interested persons are invited to present information at the hearing. Persons appearing may make an oral presentation but are urged to submit facts, opinions and argument in writing as well. Facts, opinions and argument may also be submitted in writing without a personal appearance by mail addressed to Pamela Haack, Paralegal, Department of Regulation and Licensing, 1400 East Washington Avenue, Room 152, P.O. Box 8935, Madison, Wisconsin 53708-8935, or by email to pamela.haack@wisconsin.gov. Comments must be received on or before December 2, 2009, to be included in the record of rule-making proceedings.
Copies of Proposed Rule
Copies of this proposed rule are available upon request to Pamela Haack, Paralegal, Department of Regulation and Licensing, Division of Board Services, 1400 East Washington Avenue, P.O. Box 8935, Madison, Wisconsin 53708, or by email at pamela.haack@wisconsin.gov.
Analysis Prepared by the Department of Regulation and Licensing
Statutes interpreted
Statutory authority
Sections 15.08 (5) (b), 227.11 (2) and 450.02 (3) (a), (b), (d) and (e), Stats.
Explanation of agency authority
The Pharmacy Examining Board has the authority under s. 450.02 (3) (d), Stats., to promulgate rules necessary for the administration of ch. 450, Stats., and under s. 450.02 (3) (a) to (c), Stats., relating to the distribution and dispensing of drugs; establishment of security standards for pharmacies, and establishment of minimum standards for the practice of pharmacy.
Related statute or rule
There are no other statutes or rules other than those listed above.
Plain language analysis
SECTION 1 amends s. Phar 6.08 to clarify that a pharmacy is required to have a centrally monitored alarm system. The current rules permit a pharmacy to have an alarm system in the immediate physical structure within which a pharmacy is located.
SECTION 2 amends s. Phar 7.12 (2) (f) to clarify that the reference to “drug initialization" used in the rule should read “drug utilization."
SECTION 3 amends s. Phar 8.12 (2) (b) to clarify that prescription orders may be transmitted by a facsimile machine in instances in which a patient “meets the eligibility requirements for placement in a long term care facility," but elects to reside at home. Under the current rules a pharmacist may not dispense a schedule II controlled substance pursuant to a prescription order transmitted by a facsimile machine unless certain conditions stated in s. Phar 8.12 (1) are satisfied and all the conditions set forth in s. Phar 8.12 (2) (a) to (c) are met.
Comparison with federal regulations
There is no existing or proposed federal regulation.
Comparison with rules in adjacent states
Illinois:
Pharmacy Alarms, Security.
Section 1330.75 Security Requirements. a) Whenever the pharmacy (prescription area) is not occupied by a registrant, the pharmacy (prescription area) must be secured and inaccessible to non-licensed persons (employees and public). This may be accomplished by measures such as walling off, locking doors, and electronic security equipment, as approved by the Division.
Utilization Review.
Not applicable. Rule corrects a drafting error.
Faxing Schedule II Controlled Substance Prescriptions.
Neither the statutes nor rules establish prima facie permission for pharmacists to dispense schedule II controlled substances faxed by a practitioner on behalf of patients residing in-home that are eligible for nursing home placement.
Iowa:
Pharmacy Alarms, Security.
657—6.7(124,155A) Security. While on duty, each pharmacist shall be responsible for the security of the prescription department, including provisions for effective control against theft of, diversion of, or unauthorized access to prescription drugs, records for such drugs, and patient records as provided in 657—Chapter 21.
6.7(1) Department locked. The prescription department shall be locked by key or combination so as to prevent access when a pharmacist is not on site except as provided in subrule 6.7(2).
6.7(2) Temporary absence of pharmacist. In the temporary absence of the pharmacist, only the pharmacist in charge may designate persons who may be present in the prescription department to perform technical and nontechnical functions designated by the pharmacist in charge. Activities identified in subrule 6.7(3) may not be performed during such temporary absence of the pharmacist. A temporary absence is an absence of short duration not to exceed two hours. In the absence of the pharmacist, the pharmacy shall notify the public that the pharmacist is temporarily absent and that no prescriptions will be dispensed until the pharmacist returns.
8.5(3) Secure barrier. The pharmacy department shall be surrounded by a physical barrier capable of being securely locked to prevent entry when the department is closed. A secure barrier may be constructed of other than a solid material with a continuous surface if the openings in the material are not large enough to permit removal of items from the pharmacy department by any means. Any material used in the construction of the barrier shall be sufficient strength and thickness that it cannot be readily or easily removed, penetrated, or bent. The plans and specifications of the barrier shall be submitted to the board for approval prior to the start of construction. The board may also require on-site inspection of the facility or pharmacy department prior to the pharmacy's opening or relocation. The pharmacy department shall be closed and secured in the absence of the pharmacist except as provided in rule 657—6.7(124,155A) or 657—7.6(124,155A). [4/4/2007]
Utilization Review.
Not applicable. Rule corrects a drafting error.
Faxing Schedule II Controlled Substance Prescriptions.
Neither the statutes nor rules establish prima facie permission for pharmacists to dispense schedule II controlled substances faxed by a practitioner on behalf of patients residing in-home that are eligible for nursing home placement.
Michigan:
Pharmacy Alarms, Security.
R 338.482 Housing of pharmacy.
(3) All pharmacies that occupy less than the entire area of the premises owned, leased, used, or controlled by the licensee shall be permanently enclosed by partitions from the floor to the ceiling. All partitions shall be of substantial construction and shall be securely lockable so that drugs and devices that can only be sold by a pharmacist are unobtainable during the absence of the pharmacist. Identification of this department by the use of the words “drug," “medicines," or “pharmacy" or by the use of a similar term or combination of terms shall be restricted to the area that is registered by the board. The pharmacy department shall be locked when the pharmacist is not in the establishment.
Utilization Review.
Not applicable. Rule corrects a drafting error.
Faxing Schedule II Controlled Substance Prescriptions.
Neither the statutes nor rules establish prima facie permission for pharmacists to dispense schedule II controlled substances faxed by a practitioner on behalf of patients residing in-home that are eligible for nursing home placement.
Minnesota:
Pharmacy Alarms, Security.
6800.0700 PHARMACY, SPACE, AND SECURITY.
Subpart 1 D. The pharmacy must be surrounded by a continuous partition or wall extending from the floor to the permanent ceiling, containing doors capable of being securely locked to prevent entry when the pharmacy is closed.
Utilization Review.
Not applicable. Rule corrects a drafting error.
Faxing Schedule II Controlled Substance Prescriptions.
Neither the statutes nor rules establish prima facie permission for pharmacists to dispense schedule II controlled substances faxed by a practitioner on behalf of patients residing in-home that are eligible for nursing home placement.
Summary of factual data and analytical methodologies:
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