Permanent.
Detailed Description of the Objective of the Proposed Rule
The objective of this rule package is to revise language in chs.
NR 405 and
408 to maintain consistency with federal requirements and definitions. Additionally, sections of chs. NR 400 and 410 need to be repealed due to the repeal of ch. NR 411.
In May 2006, the Wisconsin Department of Natural Resources (WDNR) requested approval by the U.S. Environmental Protection Agency (USEPA) of rules promulgated by Wisconsin to incorporate federal New Source Review Reform requirements as a revision to the State Implementation Plan (SIP). The USEPA approved the SIP revisions, but subsequently requested changes to language in chs.
NR 405 and
408. The changes pertain to the fuel use prohibition that is part of the definition of “major modification".
Chapter
NR 405.02 (25i) defines “Regulated NSR air contaminant" and specifically identifies volatile organic compounds as a precursor for ozone. USEPA has requested inclusion of nitrogen oxides (NO
x) in the definition for clarification purposes. Similarly USEPA requires, through its 2008 New Source Review Rule, explicit identification of NO
x and sulfur dioxide (SO
2) as precursors to particulate matter with a diameter of 2.5 micrometers or less (PM
2.5) within the definition of “Regulated NSR air contaminant". The WDNR proposes to make the necessary rule changes to address these issues.
On April 27, 2011, the Joint Committee for Review of Administrative Rules (JCRAR) adopted a motion under s.
227.26 (2) (d), Wis. Stats., suspending ch.
NR 411. Subsequent passage of legislation introduced by JCRAR in support of the suspension (see
2011 Wisconsin Act 121), resulted in the repeal of ch.
NR 411. The primary purpose of ch.
NR 411 had been to control carbon monoxide emissions from indirect sources through conditions established in construction and operation permits. Therefore the WDNR proposes to repeal rules whose only purpose is in support of ch.
NR 411. Rules proposed for repeal include ss.
NR 400.02 (101) and
(106), and
410.03 (3). Sections
NR 400.02 (101) and
(106) define `modified indirect source' and `new indirect source' respectively. Section
NR 410.03 (3) establishes fees for the application and issuance of permits to construct or modify an indirect source under ch.
NR 411.
Description of the Existing Policies Relevant to the Rule, New Policies Proposed to be Included in the Rule, and an Analysis of Policy Alternatives
In a letter dated June 17, 2009, the USEPA notified the WDNR that the definition of the term “major modification" in s.
NR 405.02 was inadequate because it failed to identify permits issued under federal authority. Wisconsin's Prevention of Significant Deterioration (PSD) program was approved into its SIP on June 28, 1999. Before that, PSD construction permits were issued under federal authority. When ch.
NR 405.02 (21) (b) (5) was written, the references to federal authority were inadvertently left out. Because the federal citations were left out of the rule, USEPA identified that in a very limited situation, the current state definition would allow a source to make a change to use a different fuel or raw material without undergoing major new source permit review for the change, even though the change could be prohibited under a federal permit. The WDNR will amend this definition to ensure that it is consistent with USEPA rule and policy and recognizes all federally issued permits.
The alternative to this rule action is to keep the rules as they are which USEPA has already identified as an inconsistency with federal PSD program. However, in a Federal Register filed June 15, 2012, USEPA disapproved narrow portions of the SIP pertaining to permit requirements in NR 405 and 408 that would be addressed with this rulemaking. In the Federal Register, USEPA stated that they are under obligation to promulgate a Federal Implementation Plan (FIP) addressing the disapproved portions of the SIP within 2 years. The Federal Register states that the FIP will not be promulgated if WDNR rectifies the deficiencies within the 2 year timeframe.
The proposed clarifications of NOx as a precursor to ozone and NOx and SO2 as precursors to PM2.5 are not policy changes, but statements of fact. On June 15, 2012, USEPA disapproved a narrow portion of Wisconsin's SIP for the 1997 ozone National Ambient Air Quality Standard pertaining to air construction permitting. This was done because NOx was not identified as a precursor to ozone as part of PSD permit program requirements. The final disapproval triggered a requirement that USEPA promulgate a FIP addressing the deficiency no later than 2 years from the date of disapproval. In a federal register notice dated August 2, 2012, USEPA proposed to disapprove additional portions of Wisconsin's SIP submission for the 2006 PM2.5 NAAQS because PM2.5 precursors are not specifically identified. Section 110(a)(2)(c) of the Clean Air Act requires that precursors to PM2.5 are identified in the PSD program requirements. Final disapproval to portions of the SIP relating to identifying precursors of PM2.5 will also result in the promulgation of a FIP unless the deficiencies are addressed.
Not repealing sections of chs.
NR 400 and
410 in response to the repeal of ch.
NR 411 by the legislature would potentially create confusion and perpetuate an inconsistency with WDNR rules.
Detailed Explanation of Statutory Authority for the Rule (Including the Statutory Citation and Language)
Section
285.11 (17), Wis. Stat., requires WDNR to “Promulgate rules, consistent with the federal clean air act, that modify the meaning of the term `modification' as it relates to specified categories of stationary sources
…". The proposed rule to make the WDNR definition of “major modification" consistent with the federal definition is necessary to be consistent with the statutes and the federal clean air act.
Section
285.11 (1), Wis. Stats., establishes that the WDNR shall “Promulgate rules implementing and consistent with this chapter and s.
299.15.". Section
285.60 (11) (b), Stats., effective March 21, 2012, establishes that the WDNR may not require a permit under this chapter for an indirect source. The proposed repeal of rules whose sole purpose is to support the issuance of permits for indirect sources is therefore necessary to be consistent with the statutes and to establish consistency within the administrative code.
Estimate of Amount of Time that State Employees will Spend Developing the Rule and of Other Resources Necessary to Develop the Rule
Approximately 300 hours will be spent by WDNR staff.
List with Description of All Entities that may be Affected by the Proposed Rule
The WDNR believes that the number of major sources affected by the proposed rule changes to chs.
NR 405 and
408 will be small, if any. Under Wisconsin's Title V operation permit program all requirements that apply to a source are included in its operation permit. WDNR clearly recognizes that requirements contained in a federally issued major source construction permit apply to the source and are therefore included in the source's Title V operation permit issued by the WDNR, making the requirement fully enforceable under state and federal law. The WDNR is not aware of a single situation where this type of requirement existed in a federal construction permit and was not included the state Title V operation permit.
The addition of language to clarify that NOx is a precursor to ozone and NOx and SO2 are precursors to PM2.5 will have no impact on any entities.
No entities will be affected by the proposed repeal of rules related to indirect sources. Since ch. NR 411 has already been repealed through legislative action, rules whose only purpose was to support the implementation of ch. NR 411 are already moot. Therefore the proposed repeal of these rules will not have any effect.
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
The rule changes proposed to chs.
NR 405 and
408 are requested by USEPA to maintain consistency with federal major modification definitions.
The rule changes proposed to ch.
NR 405 with regard to precursor identification are required by USEPA to maintain consistency with federal definitions and avoid FIP promulgation with regard to portions of Wisconsin's infrastructure SIP.
Anticipated Economic Impact of Implementing the Rule (Note: if the Rule is Likely to have a Significant Economic Impact on Small Businesses)
The economic impact due to the changes proposed to chs.
NR 405 and
408 is expected to be minimal, in part because there are few permits that would be affected by this change. PSD sources are large emitters by definition and do not typically include small business, so the impact to small businesses should be minimal at most.
Chapter NR 411 has been repealed, and the department is now proposing to repeal rules whose only purpose was to support the implementation of ch.
NR 411. Therefore, the proposed repeal of these rules will have no economic impact.
Contact Person
Gail Good, Wisconsin Department of Natural Resources, 101 South Webster Street, PO Box 7921, Madison, WI 53707-7921, 608 267-0803,
gail.good@wisconsin.gov.
Safety and Professional Services —
Pharmacy Examining Board
This statement of scope was approved by the governor on August 23, 2012.
Rule No.
Phar 7.01 (1) (e).
Relating to
Delivery of prescription drugs.
Rule Type
Permanent.
Finding/Nature of Emergency (Emergency Rule Only)
N/A.
Detailed Description of the Objective of the Proposed Rule
The Wisconsin Pharmacy Examining Board seeks to modify s.
Phar 7.01 (1) (e) to allow the delivery of prescription medications to a location of the patient's choice. Under the current rule, a pharmacist, or pharmacist-intern under the direct supervision of a pharmacist, may only deliver prescription drugs directly to the patient at the pharmacy or the prescription drug may be delivered to patient's residence. If a patient wanted the prescription drug to be delivered elsewhere or if the pharmacy wanted to deliver elsewhere, the pharmacy was required to obtain a variance to the delivery pursuant to s.
Phar 7.01 (4). The proposed modification to s.
Phar 7.01 (1) (e) would allow the pharmacy, pharmacist, or pharmacist-intern to deliver the prescription drug to the location of a patient's choice without being required to first obtain a delivery variance from the Board.
Description of the Existing Policies Relevant to the Rule, New Policies Proposed to be Included in the Rule, and an Analysis of Policy Alternatives
The Board has determined that the rule, as it currently exists, does not grant enough flexibility for a patient to have the prescription medication delivered to a location of his or her choice because the rule does not permit pharmacies or pharmacists to deliver to a location of a patient's choice, without first obtaining a delivery variance from the Board. The Board has determined that permitting the delivery to a location of a patient's choice would be a helpful service to patients and to pharmacies/pharmacists without negatively impacting public safety. In addition, if the proposed modifications to the rule are enacted, the pharmacy or pharmacist would not need to wait until the board's next scheduled meeting for a determination on a delivery variance request, if previously submitted to the board.
Detailed Explanation of Statutory Authority for the Rule (Including the Statutory Citation and Language)
Section
450.02 (3) (a), Stats., authorizes the board to promulgate rules “[r]elating to the
…distribution and dispensing of prescription drugs." Under s.
450.01 (7), Stats., the definition of dispense “means to deliver a prescribed drug or device to an ultimate user
…"
Section
15.08 (5) (b), Stats., allows each examining board to “promulgate rules for its own guidance and for the guidance of the trade or profession to which it pertains and define and enforce professional conduct and unethical practices not inconsistent with the law relating to the particular trade or profession."
Estimate of Amount of Time that State Employees will Spend Developing the Rule and of Other Resources Necessary to Develop the Rule
20 hours.
List with Description of All Entities that may be Affected by the Proposed Rule
Pharmacies, pharmacists, and patients.
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
None.
Anticipated Economic Impact of Implementing the Rule (Note: if the Rule is Likely to have a Significant Economic Impact on Small Businesses)
No economic impact.
Contact Person
Kris Anderson, DSPS (608) 261-2385.
