NOTICES
Notice of Comments Issued
[40 Pa.B. 4361]
[Saturday, July 31, 2010]Section 5(g) of the Regulatory Review Act (71 P. S. § 745.5(g)) provides that the Independent Regulatory Review Commission (Commission) may issue comments within 30 days of the close of the public comment period. The Commission comments are based upon the criteria contained in section 5.2 of the Regulatory Review Act (71 P. S. § 745.5b).
The Commission has issued comments on the following proposed regulations. The agency must consider these comments in preparing the final-form regulation. The final-form regulation must be submitted within 2 years of the close of the public comment period or it will be deemed withdrawn.
Reg. No. Agency/Title Close of
the Public
Comment
PeriodIRRC
Comments
Issued57-273 Pennsylvania Public Utility Commission
Default Service Regulations
40 Pa.B. 2267, May 1, 20206/15/10 7/15/10 7-457 Environmental Quality Board
Ambient Water Quality Criterion; Chloride (CH)
40 Pa.B. 2246, May 1, 20106/15/10 7/15/20 12-74 Department of Labor and Industry
Unemployment Compensation; Employee Provisions
40 Pa.B. 2643, May 22, 20106/21/10 7/21/10 12-78 Department of Labor and Industry
Unemployment Compensation; Administration
40 Pa.B. 2639, May 22, 20106/21/10 7/21/10 16A-4931 State Board of Medicine
Perfusionist
40 Pa.B. 2652, May 22, 20106/21/10 7/21/10 16A-5320 State Board of Osteopathic Medicine
Perfusionist
40 Pa.B. 2660, May 22, 20106/21/10 7/21/10
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Pennsylvania Public Utility Commission
Regulation #57-273 (IRRC #2837)
Default Service Regulations
July 15, 2010 We submit for your consideration the following comments on the proposed rulemaking published in the May 1, 2010 Pennsylvania Bulletin. Our comments are based on criteria in section 5.2 of the Regulatory Review Act (RRA) (71 P. S. § 745.5b). Section 5.1(a) of the Regulatory Review Act (71 P. S. § 745.5a(a)) directs the Pennsylvania Public Utility Commission (Commission) to respond to all comments received from us or any other source.
1. Need for the regulation.
This proposed rulemaking amends the Commission's existing default service regulations found at 52 Pa. Code §§ 54.181—54.189. The Commission contends that the rulemaking is needed to align the existing regulations with Act 129 of 2008 (Act 129). Act 129 amended Pennsylvania's Electric Generation Customer Choice and Competition Act (Competition Act) (66 Pa.C.S.A. §§ 2801, et seq.) and the manner in which default service providers must purchase electricity for non-shopping customers.
In the Preamble to this proposal, the Commission notes that ''the proposed regulations generally adopt Act 129 procurement requirements verbatim.'' In addition, the Commission is seeking comment on 16 questions and how Act 129 should be interpreted ''to ensure adequate and reliable service at the least cost to customers over time, and on how the proposed regulations should be revised to reflect the interpretation recommended by the person filing the comments.'' The Office of Consumer Advocate has noted that ''the Commission's questions identify the critical issues that must be answered before finalizing any changes to the existing regulation.'' Listed below are examples of the questions:
• What is meant by ''least cost to customers over time?''
• What time frame should the Commission use when evaluating whether a DSP's procurement plan produces the least cost to customers over time?
• Which approach to supply procurement—a managed portfolio approach or a full requirements approach—is more likely to produce the least cost to customers over time?
• What is a ''prudent mix'' of spot, long-term, and short-term contracts?
• Does a ''prudent mix'' mean that the contracts are diversified and accumulated over time?
• Should there be qualified parameters on the prudent mix? For instance, should the regulations preclude a DSP from entering into all of its long-term contracts in one year?
• Should the DSP be restricted to entering into a certain percentage of contracts per year?
• Is the ''prudent mix'' standard a different standard for each different customer class?
We note that extensive comments and reply comments were filed on the proposed rulemaking and the vast majority of the comments and reply comments focused on the 16 questions, not the text of the rulemaking.
We are concerned with the approach the Commission has taken for the promulgation of this rulemaking. We believe the Commission should have posed the 16 questions to the regulated community, accepted comments on those questions, drafted a proposed rulemaking based on the feedback received, and then commenced the formal rulemaking process. Under the approach taken by the Commission, the regulated community, the designated standing committees and the Independent Regulatory Review Commission (IRRC) will not have an opportunity to see or provide comment on the Commission's interpretation of Act 129 and the procurement of electricity for non-shopping customers.
Act 129 does not require the Commission to promulgate revised default service regulations within a specific time period. In addition, the statutory language of the Competition Act and Act 129 would take precedence over the Commission's existing default service regulations. We acknowledge that some commentators support the Commission's approach to promulgating this rulemaking because it provides flexibility to the Commission and electric distribution companies as they work to implement procurement plans. However, we believe the purpose of a regulation is for an agency to exercise its delegated legislative authority to create a mandatory standard of conduct to fill in the gaps that are often present in statutes.
Since this proposed rulemaking uses, to a large degree, verbatim language from Act 129, we do see the value of promulgating the regulation in this form and at this time. We recommend the Commission withdraw the proposed rulemaking, evaluate the feedback provided by the various segments of the regulated community on the 16 questions, in order to draft a proposed regulation that does more than simply recite the Act 129 revisions, and reintroduce the rulemaking to the regulatory review process as a new proposed rulemaking. This would allow all parties involved with the rulemaking the opportunity to review the Commission's interpretation of Act 129 and to provide feedback on that language. If the Commission proceeds with its current approach for promulgating this rulemaking, interested parties will not see meaningful regulatory language until the rulemaking is submitted in final-form.
If the Commission does not withdraw the proposed regulation as suggested, we suggest that an Advanced Notice of Final Rulemaking be developed and shared with the commentators. This would allow the interested parties to provide feedback on the language that may become a permanent regulation. 2
2. Determining whether the regulation is in the public interest.
Section 5.2 of RRA (71 P. S. § 745.5b) directs IRRC to determine whether a regulation is in the public interest. When making this determination, the Commission considers criteria such as economic or fiscal impact and reasonableness. The Commission also considers the information a promulgating agency is required to provide under § 745.5(a) in the Regulatory Analysis Form (RAF).
The Commission has provided valuable information, such as the statutory and regulatory history of the Competition Act, Act 129 and the existing default service regulations in the Preamble to the proposed rulemaking. However, the Commission's responses to questions on the RAF are lacking and accordingly prevent IRRC from determining whether the regulation is in the public interest. For example, the RAF asks the following questions: ''Describe who and how many people will be adversely affected by the regulation. How are they affected?'' and ''How does this regulation compare with those of other states?'' The Commission answered the first question in the following manner: ''No one should be adversely affected by the regulations'' and did not respond to the second question. If the regulation is submitted in final-form, we ask the Commission to provide more detailed responses to all questions in the RAF, as required by § 745.5(a) of the RRA, and as provided by the Commission when the original default service regulations were promulgated several years ago.
3. Comments on Annex A of the proposed rulemaking.—Possible conflict or duplication of statutes or existing regulations; Reasonableness; Need; Clarity and lack of ambiguity.
If the Commission does not withdraw the proposal, we offer the following comments on the text of the rulemaking.
''Prevailing market prices'' versus ''least cost to customers over time''
As noted by the Commission in the Preamble to this proposal, ''Act 129 explicitly repealed the prevailing market prices standard, and declared instead that the utilities' generation service must be designed to ensure adequate and reliable service at the least cost to customers over time.'' Some commentators have suggested that the phrase ''prevailing market price'' be replaced with the phrase ''at the least cost to customers over time'' throughout the entirety of the Commission's default service regulations. Another commentator believes that replacing the prevailing market price standard with the least cost standard in every instance would not be appropriate. We ask the Commission to identify every section of its existing default service regulations that uses the phrase ''prevailing market price'' and explain why it decided to retain that phrase.
Section 54.184. Default service provider obligations.
We have two concerns with this section. First, a commentator has noted that the new language added to Subsection (a) does not acknowledge that other entities may be assigned to the default service provider role. The commentator is also concerned with new language that contemplates keeping the electric distribution company as the default service provider until 100 percent customer migration is reached. In the Preamble to the final-form regulation, we ask the Commission for a more detailed explanation of why this language was included in the rulemaking.
Second, to be consistent with 66 Pa.C.S.A §§ 2807(e)(3.1)(III)(A) and (B), the word ''or'' should be added at the end of Subsection (c)(3)(i).
Section 54.186. Default service procurement and implementation plans.
Subsection (e) pertains to the Commission's evaluation of a default service provider's procurement plan. A commentator believes that language should be added to Subsection (1) referencing the fact that the procurement process was competitive. They believe this language is needed to keep the procurement process open and transparent and consistent with the Competition Act. They raise a similar concern with § 54.188(d)(1). Has the Commission considered adding language to the rulemaking to reflect the fact that the procurement process must be competitive?
Section 54.187. Default service rate design and the recovery of reasonable costs.
We have four concerns with this section. First, to be consistent with 66 Pa.C.S.A § 2807(e)(3.8), the word ''or'' should be included at the end of (a)(1).
Second, 66 Pa.C.S.A. § 2807(e)(3.9) states that a default service provider ''shall'' have the right to recover costs pursuant to a reconcilable automatic adjustment clause. However, Subsection (b) states that costs ''may'' be recovered through those mechanisms. Commentators believe this change conflicts with the Competition Act. What is the reason for this deviation from the statutory language? We suggest that the final-form regulation be amended to be consistent with Competition Act.
Third, the proposed rulemaking amends Subsection (b) to incorporate the language of 66 Pa.C.S.A. § 2807(e)(3.9). A commentator has noted that some words appear to be missing before the phrase ''all reasonable costs'' in the first sentence. The missing words are, ''on a full and current basis.'' What is the reason for excluding these words from the rulemaking?
Fourth, Subsection (i) has been amended to state, in part, that ''Default service rates shall be adjusted on a quarterly basis. . . .'' A commentator believes that this language should be amended to mirror 66 Pa.C.S.A. § 2807(e)(7) to state that ''Default service rates shall be adjusted no more frequently than on a quarterly basis. . . .'' (Emphasis added). We agree with the commentator and suggest that the regulation be amended accordingly. The commentator has the same concern with § 54.188(f) of the existing regulation and suggests that a similar change be made to this section of the rulemaking.
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Environmental Quality Board
Regulation #7-457 (IRRC #2841)
Ambient Water Quality Criterion; Chloride (Ch)
July 15, 2010 We submit for your consideration the following comments on the proposed rulemaking published in the May 1, 2010 Pennsylvania Bulletin. Our comments are based on criteria in section 5.2 of the Regulatory Review Act (71 P. S. § 745.5b). Section 5.1(a) of the Regulatory Review Act (71 P. S. § 745.5a(a)) directs the Environmental Quality Board (Board) to respond to all comments received from us or any other source.
Section 93.7. Specific water quality criteria.
This rulemaking amends Subsection (a) and Table 3 of the Board's regulations by adding numeric limits for chloride. The amendments include a four-day average for chloride of 230 mg/l and a one-hour average standard of 860 mg/l. The chloride standards included in the proposed rulemaking are the current national chloride criteria for the protection of aquatic life recommended by the United States Environmental Protection Agency in its 1988 publication Ambient Water Quality Criteria for Chloride (1988 criteria). We have five concerns that relate to the criteria contained in the Regulatory Review Act.
Reasonableness
Commentators representing business and industry and commentators representing environmental interests have questioned the reasonableness of basing the new chloride criteria on the 1988 criteria. The commentators have argued that better and more recent scientific studies prove that the 1988 criteria are flawed. Commentators representing environmental interests are especially concerned about the recent efforts to extract natural gas from the Marcellus Shale formation, the large volumes of wastewater that extraction requires, and the various compounds containing chloride that may be in the wastewater. They do not believe the 1988 criteria adequately protect Pennsylvania waterways and aquatic life from the potential harms of Marcellus Shale wastewater.
We agree that basing the new criteria on outdated data when more recent data is available is not reasonable. Given the amount of opposition to the inclusion of the 1988 criteria in this rulemaking, we recommend the Board withdraw the proposed rulemaking and reevaluate the current state of scientific and technological knowledge of chloride and the effects it has on Pennsylvania's waterways and aquatic life. We encourage the Board to work with the various segments of the regulated community to develop a regulatory package that reflects the most recent science, adequately protects Pennsylvania's waterways and aquatic life, and keeps Pennsylvania business and industry competitive with the surrounding states.
If the Board does not withdraw the rulemaking, we recommend that it issue an Advanced Notice of Final Rulemaking to fully vet the changes that may be made to the regulation. This would provide the regulated community an opportunity to provide input on the scientific basis for the chloride standards, review any changes that have been made to the rulemaking, evaluate the impact it would have, and provide the Board with additional feedback.
Economic or fiscal impact of the regulation
Commentators representing business and industry in Pennsylvania have serious concerns with the potential fiscal impact of this regulation throughout the Commonwealth. They correctly note that the Regulatory Analysis Form (RAF) and the Preamble provide little analysis on the impact the regulation will have on the regulated community.
While we acknowledge the Board's attempt to quantify the cost of treating wastewater using several techniques, a detailed analysis of the overall fiscal impact the rulemaking could have throughout Pennsylvania is lacking. In fact, the Board has stated in Section 17 of the RAF that the fiscal savings and costs to the regulated community are ''not measurable.'' Without a more detailed fiscal analysis, this Commission is unable to determine if the regulation is in the public interest. For example, what are the capital costs and annual operation and maintenance costs associated with installing the facilities needed to treat wastewater? What are the costs for the increased monitoring required by the rulemaking? What are the costs of dealing with treatment residuals? We urge the Board to work with the regulated community to calculate the full fiscal impact the regulation will have throughout the Commonwealth, not just the per gallon cost for treating wastewater that was included with this proposal.
In the Preamble and RAF submitted with the final-form rulemaking, we request the Board provide a detailed fiscal impact analysis taking into consideration the above-noted concerns of commentators and this Commission.
Possible conflict with statutes
According to the Board, this rulemaking is being promulgated, in part, under Sections 5(b)(1) and 402 of the Clean Streams Law (Law) (35 P. S. §§ 691.5(b)(1) and 691.402). While we do not question the Board's authority under these provisions, we do question whether the regulation is consistent with Section 5(a) of the Law (35 P. S. § 691.5(a)). That section of the Law requires the following factors to be considered, where applicable, when adopting rules and regulations:
1. Water quality management and pollution control in the watershed as a whole;
2. The present and possible future uses of particular waterways;
3. The feasibility of combined or joint treatment facilities;
4. The state of scientific and technological knowledge; and
5. The immediate and long-range economic impact upon the Commonwealth and its citizens. (Emphasis added)
Commentators believe the rulemaking is inconsistent with the fourth and fifth provision of Section (5)(a) of the Law. In regard to the fourth provision, and as noted above, commentators believe that the science associated with the 1988 criteria is outdated, no longer accurate, and not specific to Pennsylvania waterways and aquatic life. In regard to the fifth provision, and as noted above, commentators believe that the Board has failed to properly analyze the economic impact the regulation will have on industry in Pennsylvania.
If the Board does not withdraw the regulation as suggested, we ask for a more detailed explanation of why the science behind the 1988 criteria is valid and appropriate for Pennsylvania. This explanation should include discussion of the various studies of the science included with the comments submitted on the rulemaking. In addition, the Board should explain how and why the material submitted with the proposal adequately analyzes the immediate and long-range economic impact of the regulation on Pennsylvania.
Need; Possible conflict with existing regulations
Some commentators have argued that there is no need for the rulemaking. They argue that the Board's adoption of the final regulation pertaining to total dissolved solids (Board regulation #7-446, titled ''Wastewater Treatment Requirements'' (TDS regulation)) is more stringent than this rulemaking. Once the TDS regulation is formally promulgated, what is the need for this rulemaking? Will it conflict with the TDS regulation in any way?
In addition, the Board has stated that the rulemaking is needed for ''protection of aquatic life due to increasing concerns about the Statewide impact of natural gas extractions from the Marcellus Shale formation.'' What is the Board's rationale for imposing this new standard on industry not involved with natural gas extraction from the Marcellus Shale formation? What problems will be fixed by imposing the rulemaking on all industries in Pennsylvania?
Implementation procedures
Under questions 15 and 16 of the RAF, the Board has indicated that persons proposing ''new or expanded activities or projects which result in impacts to the waters of the Commonwealth'' will be affected by the rulemaking. Several commentators disagree with this statement and believe that ''all NPDES permit holders will be subject to the regulation.'' Will this rulemaking affect all NPDES permit holders? In the final-form regulation, the Board should clarify what qualifies as ''new or expanded activities or projects.''
Adverse effects on prices of goods and services, productivity or competition
Under question 25 of the RAF, the Board has explained that other states, including Virginia, West Virginia and New Jersey have already adopted the 1988 criteria. The Board believes that the proposed amendments will not put Pennsylvania at a competitive disadvantage to other states. Commentators disagree with the Board's position on this matter. They believe that competitors in other states will not be required to comply with similar standards and this will put Pennsylvania businesses at a competitive disadvantage with other states.
We ask the Board to provide a more detailed description of how this regulation compares to other states. In particular, we ask the Board to identify all the states that use the 1988 criteria. For the states that do use the 1988 criteria, are there any exceptions to how those standards are implemented? Are the standards implemented in the same way as proposed in Pennsylvania?
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Department of Labor and Industry
Regulation #12-74 (IRRC #2846)
Unemployment Compensation; Employee Provisions
July 21, 2010 We submit for your consideration the following comments on the proposed rulemaking published in the May 22, 2010 Pennsylvania Bulletin. Our comments are based on criteria in section 5.2 of the Regulatory Review Act (71 P. S. § 745.5b). Section 5.1(a) of the Regulatory Review Act (71 P. S. § 745.5a(a)) directs the Department of Labor and Industry (Department) to respond to all comments received from us or any other source.
1. Section 65.41. Filing methods.—Reasonableness; Implementation procedures; Clarity.
Subsection (a)
This subsection allows an application for benefits to be filed in one of four ways: by phone, via the internet, by mail or by facsimile machine. Subsection (b) allows a claim for compensation to be made by phone or via the internet. Why doesn't Subsection (b) allow claims for compensation to be made by mail or facsimile machine?
Subsections (d) and (e)
Subsections (a), (b) and (c) of this section specify acceptable methods for filing applications for benefits, claims for compensation and how filing dates will be determined. The requirements of these subsections establish a binding norm for both the regulated community and the Department. We believe the language in Subsections (d) and (e) inappropriately deviates from that binding norm. Subsection (d) would allow the Department to prescribe additional methods for filing applications and claims and would allow the Department to designate the date on which the application or claim is filed. Subsection (e) would allow the Department to suspend the use of the filing methods for various reasons. If the Department wants to change the filing methods and how filing dates will be determined, that must be done through the rulemaking process. Therefore, the Department should delete Subsections (d) and (e).
If these subsections are not deleted, we ask the Department why Subsection (e) references Subsections (a), (b) and (d), but does not reference Subsection (c).
2. Section 65.43a. Extended filing.—Reasonableness; Implementation procedures.
Subsection (e) lists reasons for which extended filing will be allowed. A commentator has stated that extended filing should be allowed for people with limited English proficiency and has suggested that language barriers be specifically listed in this subsection. We recognize that one of the reasons in which extended filing would be allowed is, ''Other, if the claimant makes all reasonable and good faith efforts to file timely but is unable to do so through no fault of the claimant.'' However, it is unclear whether a person with limited English proficiency could be granted an extension based on the reason quoted above. The Department should consider addressing limited English proficiency in the final-form regulation.
3. Section 65.73. Full-time work.—Reasonableness; Implementation procedures.
Subsection (a) explains how a claimant's full-time work will be determined. A commentator believes that Subsections (a)(2) and (3) work to the disadvantage of the claimant and questions how the provisions could be administered. In the Preamble to the final-form regulation, we ask the Department to explain the rationale for these provisions and how it will implement them.
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Department of Labor and Industry
Regulation #12-78 (IRRC #2847)
Unemployment Compensation; Administration
July 21, 2010 We submit for your consideration the following comments on the proposed rulemaking published in the May 22, 2010 Pennsylvania Bulletin. Our comments are based on criteria in section 5.2 of the Regulatory Review Act (71 P. S. § 745.5b). Section 5.1(a) of the Regulatory Review Act (71 P. S. § 745.5a(a)) directs the Department of Labor and Industry (Department) to respond to all comments received from us or any other source.
1. Section 61.12. Reimbursable items.—Clarity.
The amended language in Subsection (a) states, in part, that an individual ''who is entitled to reimburse- ment . . . may be paid compensation and expenses by the Department.'' We recognize the fact that the language being deleted from this subsection includes the use of the words ''entitled'' and ''may.'' However, it is our understanding that individuals subject to the provisions of this section are not necessarily ''entitled'' to be paid compensation and expenses, but may be eligible to be paid compensation and expenses. We suggest that the final-form regulation be amended to reflect the fact that the payment of compensation and expenses is authorized, but not mandated in every situation.
2. Section 61.25. Confidentiality of information and fees.—Consistency with federal law; Need; Implementation procedures; Clarity.
Subsection (a)
This subsection addresses rules for confidentiality of unemployment compensation information. We have three concerns.
First, a commentator has stated, that under current practice, information obtained by an applicant during an unemployment compensation proceeding is often used in other legal forums. The commentator questions whether such ''redisclosure'' is permitted under Section 61.25, noting that Subsections (a)(2)(ii), (a)(4)(ii) and (a)(5) are unclear. The Department should clarify its intent on this issue and revise the regulation accordingly.
Second, under Subsection (a)(3)(ii), two commentators recommend that language be added to allow disclosure of information to ''the claimant's or employer's representative.'' Commentators are concerned that without this language advocates representing claimants at hearings will have difficulty accessing case files. The Department should add this language in the final-form regulation, or explain why it should not be included.
Third, a commentator has noted that obtaining releases from claimants for unemployment compensation information can be difficult and impedes access to needed information. It was noted that federal regulations on this topic allow release of unemployment compensation to an ''agent'' under certain circumstances. However, in order for this provision to be operable, it must be authorized by state law. Are these releases already permitted by statute? Would the Unemployment Compensation Law permit the Department to adopt the approach allowed by 20 CFR 605?
Subsection (b)
This subsection pertains to the fees that may be charged to a person seeking documents or information. It states the following:
Fees. Except as provided in section 702 of the law (43 P. S. § 862), the Department or the Board may charge a fee to a person seeking documents or information from the Department or the Board. The fee will be an amount sufficient to compensate the Department or the Board for the costs to process the request and, if the requested documents or information are available, the cost to provide the documents and information. The amount of the fee will be calculated by the Department within its discretion.We have three concerns.
First, it is unclear as to what the Department or Board is charging for. What type of documentation or information would require the charging of a fee? For example, will a person be charged for making a telephone inquiry?
Second, the last sentence of this section is not regulatory language and does not set a binding norm. A regulation has the full force and effect of law and the last sentence does not establish a standard that could be predicted by the regulated community. We recommend that the amount of any fee that may be charged be included in the final-form rulemaking.
Finally, a commentator has pointed out that, under Federal regulation, ''grant funds may be used to pay costs associated with any disclosure of UC information if not more than an incidental amount of staff time and no more than nominal processing costs are involved in making the disclosure.'' See 20 CFR 603.8(b). If the Department receives grant funds, how will the Federal regulation work in conjunction with this subsection?
3. Miscellaneous clarity.
• Under § 61.1, the Department is amending the definition of ''Bureau'' from ''The Bureau of Employment Security of the Commonwealth'' to ''The Department.'' Throughout the rulemaking, the term ''Bureau'' is being replaced by the term ''Department.'' We note that the term ''Department'' is already defined in § 61.1. What is the need for the revised definition of ''Bureau''? We recommend the Department delete this term.
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State Board of Medicine
Regulation #16A-4931 (IRRC #2848)
Perfusionist
July 21, 2010 We submit for your consideration the following comments on the proposed rulemaking published in the May 22, 2010 Pennsylvania Bulletin. Our comments are based on criteria in section 5.2 of the Regulatory Review Act (71 P. S. § 745.5b). Section 5.1(a) of the Regulatory Review Act (71 P. S. § 745.5a(a)) directs the State Board of Medicine (Board) to respond to all comments received from us or any other source.
1. Comments of the House Professional Licensure Committee.—Consistency with statute; Reasonableness; Protection of the public welfare; Implementation procedure; Clarity.
On June 23, 2010, the House Professional Licensure Committee (Committee) voted to submit the following comments to the Board:
• The Committee brings to the Board's attention that proposed Regulation 16A-4931 was published in the May 22, 2010 issue of the Pennsylvania Bulletin, approximately 101 days past the eighteen (18) months from the effective date of Act 19 of 2008.
• The Committee requests an explanation as to how the Board will enforce Section 13.3 (a) of the Act. It reads: ''[T]wo years after the effective date of this section, it shall be unlawful for any person to hold himself out to the public as a perfusionist or to practice or offer to practice perfusionist unless the person holds a valid, current license issued by the board or the State Board of Osteopathic Medicine.'' What happens in the likely circumstance that final rulemaking does not occur before August 11, 2010?
• The Committee requests an explanation of how the Board is notified when a temporary graduate perfusionist fails the Nationally-recognized certifying agency's certification examination upon which failure the license expires.
• The Committee brings to the Board's attention that in § 18.535(c), Application for temporary provisional perfusionist license, there is a reference to an application for certification as a perfusionist. Act 19 of 2008 which amended the Medical Practice Act of 1985 provides for the licensure of perfusionists not certification.
• The Committee recommends that, for consistency, language referring to various jurisdictional entities read ''another state (even though, Commonwealth is used), U.S. territory or possession, the District of Columbia or another country'' with similar descriptions for the courts.
• The Committee requests an explanation as to how continuing education other than category I credit hours are quantified since it can include, in particular, reading or viewing medical journals, audio-visual, or other educational materials, participation in electronic forums.
• The Committee questions why ''working as a clinical or didactic instructor in an accredited school of perfusion'' should earn continuing education credit. How many hours can be earned? Can a full-time instructor complete the entire amount of continuing education by working as a clinical or didactic instructor?
• The Committee requests a rationale for not allowing some minimum amount of surplus continuing education credits from being carried over into the next biennial registration period.
• The Committee requests an explanation as to how the Board will handle the implementation of Section 13.3(g) of the Medical Practice Act of 1985. It permits licensure of an applicant who was not a graduate of an accredited program prior to 1981, but met the then-current eligibility requirements for certification as a certified clinical perfusionist and subsequently was certified within two years of the effective date of the Act which basically creates a ''grandfather clause.'' Act 19 became effective on August 11, 2008, and the statutory two years expire on August 11, 2010. The time frame for notice and issuing licenses to those who may wish to take advantage of this opportunity is closing in quickly.
We will review the Board's responses to these issues in our determination of whether the final regulation is in the public interest.
2. Section 18.534. Application for temporary graduate perfusionist license.—Clarity.
Supervision
Section 18.534 does not include the statutory requirement for supervision under 63 P. S. § 422.13c(h)(1)(ii) which states, ''. . . authorization to practice perfusion is granted only under supervision and direction of a perfusionist licensed under this act.'' We recommend including this limitation in the regulation.
Cross-reference
Paragraph (b)(1) cross-references ''section 13.3(h)(1)(i) of the act (63 P. S. § 422.13c(h)(1)(i).'' This cross-reference does not appear to be broad enough. Did the Board intend to require the applicant to satisfy several requirements included in 63 P. S. § 422.13c(h)(1), or only the single requirement in Subparagraph (i) relating to examination?
3. Section 18.536. Registration of temporary emergency perfusionist service.—Statutory authority; Consistency with statute; Clarity.
''Another state, the District of Columbia or a territory of the United States''
The phrase ''. . . another state, the District of Columbia or a territory of the United States. . . .'' is used in the statute (63 P. S. § 422.13c(j)(1)). The statute also uses the phrase ''out-of-State'' in 63 P. S. § 422.13c(j)(1)(i), (2) and (3). The regulation uses the phrase ''out-of-State'' in Subsections (a), (b) and (d). We question whether the phrase ''out-of-State'' could be misinterpreted to allow licenses from other countries, whereas the phrase ''another state, the District of Columbia or a territory of the United States'' provides clearer direction. For clarity, the Board should consider using the phrase ''another state, the District of Columbia or a territory of the United States'' throughout this section of the regulation.
Electronic means
The statute (63 P. S. § 422.13c(j)(1)(i) and (ii)) provides for submittal ''by electronic means.'' The regulation, and in particular Subsection (b), does not include this statutory provision. How will an applicant submit, and how will the Board accept or reject submissions by electronic means? Given the circumstances that would necessitate an emergency exemption, we recommend that the Board include in the regulation its interpretation of submittal by electronic means.
''A one-time emergency perfusionist service''
Under 63 P. S. § 422.13c(j)(1), a perfusionist licensed in another state, the District of Columbia or a territory of the United States ''may provide a one-time emergency perfusionist service in this Commonwealth. . . .'' Subsection (c) of the regulation states services are not limited to ''a single procedure or single patient or group of related patients.'' The Board should explain how the regulation is consistent with the statutory language.
4. Miscellaneous Clarity.
• Section 18.535(a) concludes with the phrase ''temporary graduate perfusionist license.'' This should be corrected to ''temporary provisional perfusionist license.''
• In Paragraph 18.537(a)(3), the word ''trail'' should be corrected to ''trial.''
• The first sentence of Paragraph 18.538(a)(1) should be reviewed for clarity.
• The word ''earning'' should be replaced with ''earned'' in Paragraph 18.540(c)(2).
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State Board of Osteopathic Medicine
Regulation #16A-5320 (IRRC #2849)
Perfusionist
July 21, 2010 We submit for your consideration the following comments on the proposed rulemaking published in the May 22, 2010 Pennsylvania Bulletin. Our comments are based on criteria in section 5.2 of the Regulatory Review Act (71 P. S. § 745.5b). Section 5.1(a) of the Regulatory Review Act (71 P. S. § 745.5a(a)) directs the State Board of Osteopathic Medicine (Board) to respond to all comments received from us or any other source.
1. Comments of the House Professional Licensure Committee.—Consistency with statute; Reasonableness; Protection of the public welfare; Implementation procedure; Clarity.
On June 23, 2010, the House Professional Licensure Committee (Committee) voted to submit the following comments to the Board:
• The Committee brings to the Board's attention that proposed Regulation 16A-5320 was published in the May 22, 2010 issue of the Pennsylvania Bulletin, approximately 101 days past the eighteen (18) months from the effective date of Act 20 of 2008.
• The Committee requests an explanation as to how the Board will enforce Section 13.3 (a) of the Act. It reads: ''[T]wo years after the effective date of this section, it shall be unlawful for any person to hold himself out to the public as a perfusionist or to practice or offer to practice perfusion unless the person holds a valid, current license issued by the board or the State Board of Medicine.'' Act 20 became effective on August 11, 2008, and the statutory two years expire on August 11, 2010.
• The Committee requests an explanation of how the Board is notified when a temporary graduate perfusionist fails the Nationally-recognized certifying agency's certification examination upon which failure the license expires.
• The Committee brings to the Board's attention that in § 25.615(c), Application for temporary provisional perfusionist license, there is a reference to an application for certification as a perfusionist. Act 20 of 2008 which amended the Osteopathic Medical Practice Act of 1978 provides for the licensure of perfusionists not certification.
• The Committee recommends that, for consistency, language referring to various jurisdictional entities read ''another state (even though, Commonwealth is used), U.S. territory or possession, the District of Columbia or another country'' with similar descriptions for the courts.
• The Committee requests an explanation as to how continuing education other than category I credit hours are quantified since it can include, in particular, reading or viewing medical journals, audio-visual, or other educational materials, participation in electronic forums.
• The Committee questions why ''working as a clinical or didactic instructor in an accredited school of perfusion'' should earn continuing education credit. How many can be earned? Can a full-time instructor complete the entire amount of continuing education by working as a clinical or didactic instructor?
• The Committee requests a rationale for not allowing some minimum amount of surplus continuing education credits from being carried over into the next biennial renewal period.
• The Committee requests an explanation as to how the Board will handle the implementation of Section 13.3(g) of the Osteopathic Medical Practice Act. It permits licensure of an applicant who was not a graduate of an accredited program prior to 1981, but met the then-current eligibility requirements for certification as a certified clinical perfusionist and subsequently was certified within two years of the effective date of the Act which basically creates a ''grandfather clause.'' The Act 20 became effective on August 11, 2008 and the statutory two years expire on August 11, 2010. The time frame for notice and issuing licenses to those who may wish to take advantage of this opportunity is closing in quickly.
We will review the Board's responses to these issues in our determination of whether the final regulation is in the public interest.
2. Section 25.814. Application for temporary graduate perfusionist license.—Clarity.
Supervision
Section 25.814 does not include the statutory requirement for supervision under 63 P. S. § 271.13c(h)(2) which states, ''. . . authorization to practice perfusion is granted only under the supervision and direction of a perfusionist licensed under this act.'' We recommend including this limitation in the regulation.
Cross-reference
Paragraph (b)(1) cross-references ''section 13.3(h)(1)(i) of the act (63 P. S. § 271.13c(h)(1)(i)).'' This cross-reference does not appear to be correct. Did the Board intend to require the applicant to satisfy several requirements included in 63 P. S. § 271.13c(h)?
3. Section 25.816. Registration of temporary emergency perfusionist service.—Statutory authority; Consistency with statute; Clarity.
''Another state, the District of Columbia or a territory of the United States''
The phrase ''. . . another state, the District of Columbia or a territory of the United States. . . .'' is used in the statute (63 P. S. § 271.13c(j)(1)). The statute also uses the phrase ''out-of-State'' in 63 P. S. § 271.13c(j)(1)(i), (2) and (3). The regulation uses the phrase ''out-of-State'' in Subsections (a), (b) and (d). We question whether the phrase ''out-of-State'' could be misinterpreted to allow licenses from other countries, whereas the phrase ''another state, the District of Columbia or a territory of the United States'' provides clearer direction. For clarity, the Board should consider using the phrase ''another state, the District of Columbia or a territory of the United States'' throughout this section of the regulation.
Electronic means
The statute (63 P. S. § 271.13c(j)(1)(i) and (ii)) provides for submittal ''by electronic means.'' The regulation, and in particular Subsection (b), does not include this statutory provision. How will an applicant submit, and how will the Board accept or reject submissions by electronic means? Given the circumstances that would necessitate an emergency exemption, we recommend that the Board include in the regulation its interpretation of submittal by electronic means.
''A one-time emergency perfusionist service''
Under 63 P. S. § 271.13c(j)(1), a perfusionist licensed in another state, the District of Columbia or a territory of the United States ''may provide a one-time emergency perfusionist service in this Commonwealth. . . .'' Subsection (c) of the regulation states services are not limited to ''a single procedure or single patient or group of related patients.'' The Board should explain how the regulation is consistent with the statutory language.
4. Miscellaneous Clarity.
• Section 25.815(a) concludes with the phrase ''temporary graduate perfusionist license.'' This should be corrected to ''temporary provisional perfusionist license.''
• The first sentence of Paragraph 25.818(a)(1) should be reviewed for clarity.
• The word ''earning'' should be replaced with ''earned'' in Paragraph 25.820(c)(2).
ARTHUR COCCODRILLI,
Chairperson
[Pa.B. Doc. No. 10-1411. Filed for public inspection July 30, 2010, 9:00 a.m.]
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