NOTICES

INDEPENDENT REGULATORY REVIEW COMMISSION

Notice of Comments Issued

[34 Pa.B. 6732]

   Section 5(g) of the Regulatory Review Act (71 P. S. § 745.5(g)) provides that the 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final-form regulation must be submitted within 2 years of the close of the public comment period or it will be deemed withdrawn.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 Period	IRRC Comments Issued
7-391	Environmental Quality Board Concentrated Animal Feeding Operations and Other Agricultural    Operations 34 Pa.B. 4353 (August 7, 2004)	11/5/04	12/6/04
7-390	State Conservation Commission Nutrient Management 34 Pa.B. 4361 (August 7, 2004)	11/5/04	12/6/04
16-32	Bureau of Professional and Occupational Affairs Schedule of Civil Penalties 34 Pa.B. 5552 (October 9, 2004)	11/8/04	12/8/04
16A-4615	State Board of Dentistry Biennial Renewal Fees--Dentist, Restricted Anesthesia Permit II 34 Pa.B. 5596 (October 9, 2004)	11/8/04	12/8/04
16A-5412	State Board of Pharmacy Drug Therapy and Injectable Medications, Biologicals and    Immunizations 34 Pa.B. 5598 (October 9, 2004)	11/8/04	12/8/04
15-425	Department of Revenue Local Option Small Games of Chance 34 Pa.B. 5563 (October 9, 2004)	11/8/04	12/8/04

____

Environmental Quality Board Regulation # 7-391 (IRRC # 2412)

Concentrated Animal Feeding Operations and Other Agricultural Operations

December 6, 2004

   We submit for your consideration the following comments that include references to the criteria in the Regulatory Review Act (71 P. S. § 745.5b) which have not been met. The Environmental Quality Board (EQB) must respond to these comments when it submits the final-form regulation. The public comment period for this regulation closed on November 5, 2004. If the final-form regulation is not delivered within two years of the close of the public comment period, the regulation will be deemed withdrawn.

Chapter 91. General Provisions

1.  Section 91.1. Definitions.--Economic impact; Reasonableness; Clarity.

Earthen waste storage pond

   This definition allows the use of linings made of ''other material acceptable to the Department.'' The EQB should specify in the body of the regulation the criteria the Department uses to determine what other materials are acceptable. Also, how will the regulated community know what other materials have been approved for use?

Setback

   This definition states ''a specified distance from surface waters or potential conduits to surface waters where manure, litter and process wastewater may not be land applied.'' The same definition appears in Section 92.1. There are two concerns.

   First, the measuring points for setbacks are not clearly stated. Commentators are unsure of how to measure this distance and questioned whether the distance is measured from the edge of the surface water or the bank. To allow consistent measurement of setback distances, the regulation should establish where the distance to be measured begins.

   Second, the regulation does not specify what will be considered ''surface waters or potential conduits to surface waters.'' Commentators are concerned that this includes intermittent streams, natural swales and roadside drainage. We agree that ''potential conduits to surface waters'' would encompass any area where surface water drains. This in turn restricts the land area available for application of manure. A definition of ''surface waters or potential conduits to surface waters'' is needed to clarify the regulation's intent.

2.  Section 91.36. Pollution control and prevention at agricultural operations.--Protection of the public health, safety and welfare; Economic impact; Reasonableness.

Manure Management Manual and Pennsylvania Technical Guide

   Subsection (a)(1) requires compliance with the ''Manure Management Manual and the Pennsylvania Technical Guide.'' The Environmental Protection Agency (EPA) made the following comment:

Overall EPA is also concerned that many of the technical guidance documents use terms such as ''should'' that arguably do not require the permittee to implement those recommendations. EPA understands that many of these manuals were written as specific guidance for the agricultural community where cost share funds are available through USDA conservation programs and as such DEP may need to develop its own Technical Standards that are regulatory. Please describe further how these ''requirements'' can be made enforceable NPDES permit conditions consistent with federal requirements.

   The EQB should explain the following:

   *  Why does the regulation refer to the requirements in these documents rather than include the requirements directly in the regulation?

   *  Is compliance with the standards in these documents required or recommended?

   *  How will the regulated community receive notice of proposed amendments to these documents and offer input?

Clay-lined earthen waste storage pond

   Subsection (a)(3)(i)(A) establishes a water quality management permit requirement for a manure storage facility that is a ''clay-lined earthen waste storage pond.'' The definition of ''earthen waste storage pond'' allows the use of other liners such as plastic or concrete. Why is Subsection (a)(3)(i)(A) limited to clay linings?

Freeboard requirements

   Subsection (a)(5) includes minimum requirements for freeboards. Commentators believe that while these requirements are appropriate for outdoor storage facilities that may be subject to the elements, they are excessive for indoor storage facilities. The EQB should consider amending the freeboard requirements to differentiate between indoor and outdoor storage facilities.

Water quality management permit

   Subsection (a) concludes with Paragraph (7) which states:

The Department may require a water quality management permit for any manure storage facility, based on relevant criteria such as proximity to special protection waters or impaired waters under Chapter 93, or the risk of pollution.

   This requirement is vague because it does not directly specify or limit what ''relevant criteria'' the Department will use. The regulation should clearly establish the circumstances that will require a water quality management permit.

Appropriate vegetated buffers and setbacks

   Subsection (b)(2) requires that ''appropriate vegetated buffers and setbacks established by the Department shall be followed to protect and maintain water quality.'' The final-form regulation should cross-reference the portion of the regulation where the Department has established these requirements.

Timely review of permit applications

   These requirements will apply to existing operations and in certain instances will require permits. Commentators questioned how long it will take to get a permit approved and how to appeal the rejection of an application. The EQB should include in the regulation a cross-reference to the appeal procedures and explain how long it will take to review and approve permits.

Chapter 92. National Pollutant Discharge Elimination System Permitting, Monitoring and Compliance

3.  Section 92.1. Definitions.--Feasibility; Clarity.

CAFO--Concentrated animal feeding operation

   In the Preamble, the EQB states, ''The primary purpose of the proposed rulemaking is to allow the Commonwealth to maintain delegation of the National Pollutant Discharge Elimination System (NPDES) CAFO program, which was revised by the Federal government in 2003.'' However, the EQB did not adopt the federal definition. Instead, it explained several amendments to its existing Concentrated Animal Feeding Operation (CAFO) definition and asked for public comment on the amendments. Commentators, including the EPA, expressed concern that the proposed definition is not consistent with the federal definition. Many questioned why it does not include medium size facilities. The EQB should explain how Pennsylvania's definition of ''CAFO'' will maintain delegation of the NPDES CAFO program, and why Pennsylvania's definition needs to differ from the federal definition.

   Also, the definition includes ''any other agricultural operation designated as a CAFO by the Department based on risk of pollution of surface waters using relevant criteria such as the size, location and management plan of the operation.'' The definition should include cross-references to the ''relevant criteria'' the Department will review in consideration of whether to invoke the CAFO designation.

Poultry

   The term ''poultry'' should be defined because other definitions, such as ''AEU-Animal equivalent unit'' and ''Agricultural operation,'' use the phrase ''livestock or poultry.''

4.  Section 92.5a. CAFOs--Reasonableness; Economic impact.

   Subsection (d)(1)(i) requires a plan to include ''buffers and manure application setbacks for the CAFO of no less than 100 feet from downgradient surface water, or vegetated buffer no less than 35 feet in width.'' Why are these distances appropriate?

   Subsection (d)(1)(ii) references the requirements in Section 91.36(b)(2). However, as mentioned above, Section 91.36(b)(2) does not specify or cross-reference these requirements.

____

State Conservation Commission Regulation # 7-390 (IRRC # 2413)

Nutrient Management

December 6, 2004

   We submit for your consideration the following comments that include references to the criteria in the Regulatory Review Act (71 P. S. § 745.5b) which have not been met. The State Conservation Commission (SCC) must respond to these comments when it submits the final-form regulation. The public comment period for this regulation closed on November 5, 2004. If the final-form regulation is not delivered within two years of the close of the public comment period, the regulation will be deemed withdrawn.

1.  General.--Fiscal impact; Reasonableness; Clarity.

Funding

   In the preamble, the SCC notes that newly defined concentrated animal operations (CAOs) will have to develop and implement approved nutrient management plans. The SCC states that there will be funding for the development and implementation of the plans. Please describe the funding presently available and the funding expected to be available. Will all operations required to comply with the regulations qualify for funding?

Manure exporting

   The SCC estimates that this regulation will result in approximately 500 newly designated CAOs. Many of the existing 840 CAOs rely on the exportation of manure as a component of their nutrient management plans. With the addition of 500 new CAOs, does the SCC anticipate that there will be enough exporters to take the manure off-site for spreading at another location? If not, what options will be available for CAOs that cannot find another location to export the manure?

Phosphorous index

   Commentators have asserted that the phosphorous index does not provide adequate protection for water resources. Other commentators have suggested that a differentiation be made between phosphorous balancing and phosphorous indexing. Please explain why the phosphorous index is the best option, and how it will adequately protect water resources.

Incorporation by reference of other documents

   The regulation appears to incorporate by reference the standards and requirements in the following documents:

   *  Pennsylvania Technical Guide

   *  Manure Management Manual

   *  Pennsylvania Agronomy Guide

   *  Pennsylvania Soil and Water Conservation Technical Guide

   *  Agronomy Facts 54-Pennsylvania's Nutrient Management Act: Who Will Be Affected?, published by the Pennsylvania State University

   *  Recommended Soil Testing Procedures for the Northeastern United States, Bulletin # 493, published by the University of Delaware

   *  Soil Test Recommendations Handbook For Agronomic Crops, Penn State Agricultural Analytical Services Laboratory

   *  Penn State Fact Sheets F254 through F257

   *  NRAES-89 Liquid Manure Application System Design Manual

   *  Soil Test Recommendations Handbook For Agronomic Crops, Penn State Agricultural Analytical Services Laboratory

   The SCC should explain the following:

   *  Why does the regulation refer to the requirements in these documents rather than include the requirements directly in the regulation?

   *  Is compliance with the standards in these documents required or recommended?

   *  How will the regulated community receive notice of proposed amendments to these documents and offer input?

2.  Section 83.201. Definitions.--Reasonableness; Clarity.

Existing agricultural operation

   The last sentence of this definition refers to ''a significant increase in the scope or magnitude of the operation.'' How will an owner know when a significant increase in the scope or magnitude of the operation has occurred? The final-form regulation should specify the criteria the SCC will use to determine what qualifies as ''significant.''

Nutrient balance sheet

   This definition references the nitrogen needs of crops and the residual nitrogen from nutrient sources. Given that the regulation requires phosphorous to be included in the development of a nutrient management plan, why is phosphorous not referenced in this definition?

   This definition also contains the phrase ''using procedures acceptable to the Commission [SCC].'' The final-form regulation should cross-reference the sections of the SCC's regulations that contain these procedures.

3.  Section 83.202. Scope.--Clarity.

   Paragraph (1) includes new language, '' . . . or other agricultural operations directed by the Commission [SCC] or the Department to follow the CAO criteria established under the act.'' What are the ''other agricultural operations'' described in this paragraph? What criteria will the SCC or the Department use to decide if these other operations will be required to follow the CAO criteria?

4.  Section 83.261. General.--Clarity.

   Paragraph (7) provides that ''operators and specialists who sign plans may be subject to penalties for any false information contained in the plans.'' A cross-reference to the section containing the penalties should be added to the final-form regulation.

5.  Section 83.291. Determination of available nutrients.--Fiscal impact; Reasonableness; Clarity.

   Subsection (b)(3)(i) states, '' . . . manure analyses shall be performed using accepted manure sampling and chemical analysis methods as specified by the Commission [SCC].'' Are these accepted practices found in regulation? A cross-reference to the acceptable sampling and chemical analysis methods should be added to the final-form regulation.

   Commentators believe that annual manure tests required in Subsection (b)(3)(iii) will be costly, particularly for growers with multiple manure types. How much do these tests cost? What is the basis for requiring annual testing? Did the SCC include the cost of this testing in its fiscal analysis?

6.  Section 83.292. Determination of nutrients needed for crop production.--Clarity.

   Subsection (e)(1) includes the phrase, ''other Commission [SCC] approved procedures.'' What are these procedures? Are they located elsewhere in the SCC's regulation? The SCC should include a cross-reference to these materials in the final-form regulation.

7.  Section 83.294. Nutrient application procedures.--Conflict with existing regulations; Reasonableness; Clarity.

Subsection (f)

   This subsection contains setbacks that apply to manure spreading. Commentators have noted that to be consistent with federal regulations for concentrated animal farm operations (40 C.F.R. § 412.4(c)(5)), Pennsylvania's regulations must require a setback of 100 feet from sinkholes for manure spreading regardless of whether or not the manure is incorporated into the soil. Why wasn't this federal requirement included?

   Commentators have noted that the use of fertilizer within the 100-foot setback is not prohibited. Is commercial fertilizer use permitted within the 100-foot setback, and if so, why?

Subsection (g)

   This subsection addresses the winter application of manure. Several commentators have stated that spreading manure on frozen or snow-covered ground should be prohibited. Commentators assert that the nutrients are not sufficiently utilized for crop growth since there is no plant growth during the winter season. Since the nutrients are not absorbed by plants, they are concerned that winter application of manure could result in pollution of surface waters. Are the restrictions in the regulation sufficient to protect water quality?

Subsection (h)

   There are two concerns with this subsection. First, the language is vague. This subsection states that in-field stacking of manure is permissible if the manure is applied ''prior to the beginning of the next growing season.'' The final-form regulation should clearly specify for how long in-field stacking is permissible.

   Second, this subsection includes a vague reference to ''criteria approved by the Commission [ SCC ].'' A cross-reference to the approved criteria should be included in the final-form regulation.

8.  Section 83.301. Excess manure utilization for CAOs.--Reasonableness; Clarity.

   Subsection (a)(1) requires the plan to include signed agreements ''between the CAO and each importing operator agreeing to accept the manure from the exporting operation.'' Similarly, Subsection (b)(1) requires signed agreements between the CAO and the broker. Would the signed agreements be in place, and therefore available for inclusion in the plan, when the CAO submits the plan? If an agreement expires or the importer or broker goes out of business, is the CAO required to formally update the nutrient management plan?

   Subsection (a)(5) requires the plan to list the name of the commercial hauler/applicator that will be used. Is the specific hauler/applicator that will be used for the duration of the plan always known when the plan is drafted?

   Subsection (a)(5)(i) references ''other means acceptable to the Commission [ SCC ]'' for demonstrating knowledge of regulatory requirements. The final-form regulation should identify what qualifies as ''other means acceptable to the Commission [ SCC ].'' The same clarification should be made in Subsection (b)(1)(i).

   In Subsection (a)(5)(ii), the regulation should specify how ''substantial compliance'' is determined. The same clarification should be made in Subsection (b)(1)(ii).

   In Subsections (a)(5)(iv) and (b)(1)(iv), the regulation should specify what the ''other requirements'' are and where they can be found.

   Subsection (a)(6) refers to certification under ''a certification program approved by the Commission [ SCC ] or as required by statute.'' Subsection (b)(2) contains the same language. The final-form regulation should specify where the regulated community can access a list of the approved certification programs. Additionally, if there are statutory provisions which require certification under a certain program, citations to those statutory provisions should be included in the final-form regulation.

9.  Section 83.311. Manure Management.--Clarity.

Subsection (e)

   Paragraph (6) states ''Animal access to surface water in these areas shall be controlled.'' It is unclear if this provision is intended to completely prohibit animal access or to restrict it in some manner. The final-form regulation should specify the degree of control that is required.

Subsection (i)

   This subsection requires the siting, design and installation of manure storage facilities to meet the requirements in Section 83.351, the Manure Management Manual and the Pennsylvania Technical Guide, ''as they relate to water quality protection.'' Since these are large documents, specific citations to the water quality protection requirements would improve clarity.

10.  Section 83.312. Site specific emergency response plans.--Reasonableness; Clarity.

   Subsection (d) states, ''It is recommended that the operator provide a copy of the emergency response plan to the local emergency management agency that would assist during a major discharge, leak or spill event.'' This ''recommendation'' is a reasonable measure that could assist in containing a major discharge, spill or leak. However, as written, it is unenforceable because it is not mandatory. The SCC should revise this section to require that the plan be provided to the local emergency management agency.

11.  Section 83.321. Stormwater control.--Clarity.

   Subsection (a) authorizes the nutrient management specialist to confer with ''others with expertise with nutrient runoff control.'' The SCC should specify who ''others'' refers to and what level of expertise is required.

12.  Section 83.342. Recordkeeping relating to application of nutrients.--Reasonableness; Clarity.

   Subsection (b)(2) requires manure testing once a year for each manure group. How did the SCC determine that once a year is the appropriate interval for manure testing? What level of variance in manure analysis will require a plan update?

13.  Section 83.362. Plan implementation.--Clarity.

   Subsection (c) uses the phrase ''significantly changed'' in reference to nutrient content and soil tests. The final-form regulation should specify how ''significantly changed'' is determined.

14.  Section 83.371. Plan amendments.--Clarity.

   Subsection (a)(4) requires a plan amendment if figures used in the plan ''are inconsistent with those contained in the Pennsylvania Agronomy Guide and associated fact sheets and manuals.'' Clarity would be improved by specifically identifying the ''associated fact sheets and manuals.''

   Subsection (a)(8) requires a plan amendment if ''additional lands are brought into the operation.'' The final-form regulation should specify if a plan amendment is required when lands are sold or no longer available for lease or renting.

15.  Section 83.391. Identification of agricultural operations and acreage.--Reasonableness; Clarity.

Subsection (a)

   Paragraph (3) requires a signature ''which meets the signature requirements of the Commission [ SCC ].'' The signature requirements should be specified or cross-referenced in this section.

Subsection (d)

   This subsection requires the plan to include signed exporter/importer and exporter/broker agreements. Would the signed agreements be in place, and therefore available for inclusion when the voluntary animal operation (VAO) submits the plan? If an agreement expires or the importer or broker goes out of business, is the VAO required to formally update the plan?

16.  Section 83.401. Determination of available nutrients.--Clarity.

   Subsection (b)(3)(i) states, ''manure analyses shall be performed using accepted manure sampling and chemical analysis methods as specified by the Commission [ SCC ].'' Where are these methods specified? They should be included in the final-form regulation.

17.  Section 83.411. Alternative manure utilization plans.--Clarity.

   Subsection (a)(5)(i) references ''other means acceptable to the Commission [ SCC ]'' for demonstrating knowledge of regulatory requirements. The final-form regulation should identify what qualifies as ''other means acceptable to the Commission [ SCC ].'' The same clarification should be made in Subsection (b)(1)(i).

   In Subsection (a)(5)(ii), the regulation should specify how ''substantial compliance'' is determined. The same clarification should be made in Subsection (b)(1)(ii).

   In Subsections (a)(5)(iv) and (b)(1)(iv), the regulation should specify what the ''other requirements'' are and where they can be found.

18.  Section 83.421. Manure management.--Clarity.

   Subsection (a) contains the phrase ''or others with expertise with nutrient runoff control.'' The SCC should specify who the ''others'' may be and what level of expertise is required.

19.  Section 83.422. Site specific emergency response plans.--Reasonableness.

   Subsection (d) recommends providing the emergency response plan to the local emergency management agency. Consistent with our comment on Section 83.312(d), the SCC should revise this section to require that the plan be provided to the local emergency management agency.

20.  Section 83.481. Plan amendments.-- Clarity.

   Subsection (a)(3) requires a plan amendment if figures used in the plan ''are inconsistent with those contained in the Pennsylvania Agronomy Guide and associated fact sheets and manuals.'' The final-form regulation should specifically identify the ''associated fact sheets and manuals.''

   Subsection (a)(9) requires a plan amendment if ''additional lands are brought into the operation.'' The final-form regulation should specify if a plan amendment is required when lands are sold or no longer available for lease or renting.

21.  Miscellaneous clarity issues.

   *  As printed in the Pennsylvania Bulletin, in Section 83.204(b), there appears to be a bracket missing after the word ''requirements.'' The bracket should be inserted upon final publication in the Pennsylvania Bulletin.

   *  As printed in the Pennsylvania Bulletin, in Section 83.312(e), there appears to be a missing right parenthesis between the words ''facilities'' and ''shall.'' The parenthesis should be inserted upon final publication in the Pennsylvania Bulletin.

   *  In Sections 83.291(b)(2) and 83.401(b)(2), the term ''AEUs'' is deleted and replaced with ''animal units.'' We request the SCC explain why it is proposing this change.

____

Bureau of Professional and Occupational Affairs Regulation # 16-32 (IRRC # 2435)

Schedule of Civil Penalties

December 8, 2004

   We submit for your consideration the following comments that include references to the criteria in the Regulatory Review Act (71 P. S. § 745.5b) which have not been met. The Bureau of Professional and Occupational Affairs (Bureau) must respond to these comments when it submits the final-form regulation. The public comment period for this regulation closed on November 8, 2004. If the final-form regulation is not delivered within two years of the close of the public comment period, the regulation will be deemed withdrawn.

1.  Section 43b.8. Schedule of civil penalties--real estate and cemetery brokers, real estate schools.--Clarity.

   Section 43b.8 lists violations under 49 Pa. Code, Chapter 35, pertaining to real estate and cemetery brokers and real estate schools. This section references 49 Pa. Code § 35.305(c), and provides penalties for the ''failure of salesperson or associate broker to include the business name and telephone number of the broker in at least equal size on an advertisement.'' (Emphasis added.) The House Professional Licensure Committee (House Committee) indicated this phrase is confusing. It is unclear whether the name and phone number have to be in equal size to each other, or to the remainder of the advertisement. We share the House Committee's concern, and request that the Bureau clarify its intent in the final-form regulation.

2.  Section 43b.9. Schedule of civil penalties--vehicle manufacturers, dealers and salespersons.--Reasonableness.

   Section 43b.9 lists penalties for violations under 63 P. S. §§ 818.19(29) and 818.19(30). Under Section 818.19(29), a wholesale auction which permits an unlicensed or revoked or currently suspended dealer or vehicle business to buy, sell or represent a vehicle at auction is subject to a fine of $1000 for the third offense and formal action for subsequent offenses. However, under Section 818.19(30), a dealer who commits the same offense is subject to a $1000 fine for the second offense, and formal action for the third offense. The House Committee questioned the difference in penalties for auctions and dealers. We share the House Committee's concern and request that the Bureau explain the disparity.

____

State Board of Dentistry Regulation # 16A-4615 (IRRC # 2436)

Biennial Renewal Fees--Dentist, Restricted Anesthesia Permit II

December 8, 2004

   We submit for your consideration the following comments that include references to the criteria in the Regulatory Review Act (71 P. S. § 745.5b) which have not been met. The State Board of Dentistry (Board) must respond to these comments when it submits the final-form regulation. The public comment period for this regulation closed on November 8, 2004. If the final-form regulation is not delivered within two years of the close of the public comment period, the regulation will be deemed withdrawn.

1.  Section 33.3. Fees.--Fiscal impact; Reasonableness.

   In its Preamble, the Board states that there have been significant increases in actual expenses over estimated expenses in the areas of hearing expenditures, board administration, and legislative and regulatory analysis. To increase revenues for operating expenses, the Board is proposing to increase the biennial renewal fee for dentists from $100 to $250. The Board also notes that it is declining to raise licensure renewal fees for dental hygienists and expanded function dental assistants based on the assessment that additional fees, '' . . . can be more equitably borne by dentists rather than their employees. . . .'' The Board also indicated a need to cover the costs incurred through the Professional Health Monitoring Program, disciplinary hearings and other Board related programs. We question the Board's decision not to consider moderate increases for other license groups who impact program and disciplinary costs.

2.  Section 33.339. Fees for issuance of permits.--Consistency with existing regulations; Reasonableness; Clarity.

   The Board's Regulation # 16A-4614, submitted to this Commission on March 30, 2004, proposed revisions to Section 33.339 similar to the revisions in this proposal. Deletion of existing references in Section 339 is consistent with other amendments to Regulation # 16A-4614. Therefore, the Board should submit its final-form of Regulation # 16A-4614 concurrently with Regulation # 16A-4615.

   Additionally, we note the proposed fee renewal of a restricted permit II is set in the amount of $15 in Regulation # 16A-4614 and in the amount of $50 in Regulation # 16A-4615. The increased amount for the fee should be reflected in the final-form of # 16A-4614 when it is submitted in final-form.

   Finally, when the Commission submitted comments on Regulation #16A-4614, we noted that Paragraphs (1)(ii) and 2(ii) in Section 33.339 set the permit renewal fees at $200 for an unrestricted permit and a restricted permit I. Although these fees represent a $100 reduction from the renewal fees in the Board's existing regulations, the revised fee levels for renewals are still twice as much as the $100 fee for an initial unrestricted permit or restricted permit I. We questioned why the renewal fees are twice as much as the initial issuance fees. The question is applicable to this proposal as well.

____

State Board of Pharmacy Regulation # 16A-5412 (IRRC # 2437)

Drug Therapy and Injectable Medications, Biologicals and Immunizations

December 8, 2004

   We submit for your consideration the following comments that include references to the criteria in the Regulatory Review Act (71 P. S. § 745.5b) which have not been met. The State Board of Pharmacy (Board) must respond to these comments when it submits the final-form regulation. The public comment period for this regulation closed on November 8, 2004. If the final-form regulation is not delivered within two years of the close of the public comment period, the regulation will be deemed withdrawn.

1.  Comments from the House Professional Licensure Committee.--Consistency with the statute; Reasonableness; Implementation procedure; Need; Clarity.

   The House Professional Licensure Committee (House Committee), in a letter dated November 10, 2004, identified several concerns and questions with this regulation. We share many of the concerns identified by the House Committee. Some of these issues are also discussed further in the following paragraphs. The Board should carefully revise the final-form regulation in order to address the concerns and recommendations of the House Committee.

2.  Section 27.1. Definitions.--Consistency with the statute; Reasonableness; Need; Clarity.

Drug Order

   The House Committee noted that the existing regulations of the Board include a definition of the term ''drug order'' (see 49 Pa. Code § 27.1). In several places, the proposed regulation uses the term ''order.'' The House Committee recommends that if the term ''order'' has the same meaning as the defined term ''drug order,'' then the regulation should use the term ''drug order'' in place of ''order.'' We agree.

Institution

   The statutory definition of ''institution'' in Section 2(15) of the Pharmacy Act (63 P. S. § 390-2(15))(Act) reads:

''Institution'' means a health care facility as defined in section 103 of the act of July 19, 1979 (P. L. 130, No. 48), known as the ''Health Care Facilities Act,'' which offers care and medical treatment to patients who require food, board and overnight sleeping facilities. [ Emphasis added. ]

   The definition of this term in the proposed regulation does not mirror the definition in the Act. It includes ''ambulatory surgical facilities'' and ''cancer treatment centers using radiation therapy on an ambulatory basis.'' We question the basis for the inclusion of these facilities in this definition since the statutory definition in the Act limits the term ''institution'' to a facility that ''offers care and medical treatment to patients who require food, board and overnight sleeping facilities.'' The final-form regulation should use the definition in the Act or reference the statutory definition.

Use of statutory definitions

   In its comments, the House Committee recommended that a definition of ''managing drug therapy'' be added to this regulation. This term is defined in Section 2(14) of the Act (63 P. S. § 390-2(14)). In addition, the proposed regulation contains a definition of the ''practice of pharmacy'' that is practically, but not completely, identical to the statutory definition in Section 2(11) of the Act (63 P. S. § 390-2(11)). The final-form regulation should include the two definitions from the Act or reference the statutory definitions for these two terms.

3.  Section 27.301. Written protocol.--Protection of public health and safety; Reasonableness; Clarity.

   Subsections (a)(5) and (a)(6) require that the physician be notified within 72 hours of each intervention or ''changes in dose, duration or frequency of medication prescribed.'' The House Committee and Pennsylvania Academy of Family Physicians (PAFP) commented that this timeframe should be shortened given the effect these changes may have on a patient. Section 9.1(3)(9) of the Act requires that the Board by regulation:

Establish an appropriate time frame, not to exceed seventy-two hours, within which the licensed pharmacist must notify the licensed physician of any changes in dose, duration or frequency of medication prescribed. [ Emphasis added. ]

   Although the Act provides a maximum of 72 hours, we question whether the proposed timeframe is appropriate. PAFP states that the use of the maximum appears ''somewhat inconsistent with good medical documentation practices.'' The Board should shorten the timeframe or explain why its use of the maximum timeframe is consistent with good medical practice.

4.  Section 27.401. Qualifications for authority.-- Reasonableness, Implementation procedure; Clarity.

   Section 9.2(a) of the Act states that the Board must, by regulation, establish education and training standards and practice guidelines for pharmacists to be authorized to administer injectable medications. The House Committee expressed concern that Section 27.401(2) in the proposed regulation does not match the statutory requirement. We note that the language of Sections 27.401(2) and (3) are similar to Sections 9.2(a)(1) and (2) of the Act. However, Section 9.2(a)(1) of the Act begins as follows:

Satisfactory completion of an academic and practical curriculum approved by the Board that includes the current guidelines and recommendations of the Centers for Disease Control and Prevention [CDC] . . . the American Council on Pharmaceutical Education [ACPE] or a similar health authority or professional body. . . .

   The Act appears to envision an academic and practical curriculum established and approved by the Board. On the other hand, the proposed regulation simply requires completion of a course of education and training which includes the current guidelines of the CDC, or a similar body accredited by the ACPE or approved by the Board. We have two concerns.

   First, the Board needs to identify the specific minimum education and training requirements that must be included in an approved course. This type of provision could include specific topic contents for courses and minimum hour requirements for course work and training. Examples of these provisions can be found in existing regulations for other licensees seeking additional authority at 49 Pa. Code § 23.202 (relating to optometrists) and 49 Pa. Code § 21.283 (relating to certified registered nurse practitioners).

   Second, both the proposed regulation and the Board's existing regulations are silent concerning the procedure that a course provider would follow to apply for approval by the Board. Examples of such procedures can be found in the existing regulations at 49 Pa. Code § 39.13 (relating to nursing home administrators) and 49 Pa. Code § 23.84 (relating to optometrists). The Board should add procedures to its regulation that explain how course providers may apply for its approval.

5.  Section 27.402. Application and renewal procedures.--Clarity.

   Section 9.1(d) of the Act (63 P. S. § 390-9.1(d)) requires that pharmacists obtain and maintain professional liability insurance coverage in the minimum amount of $1 million when they are parties to written agreements for management of drug therapy. The House Committee recommends that this regulation require pharmacists to submit proof of insurance to the Board. Section 9.1(d)(2) of the Act identifies the types of evidence of insurance that would be satisfactory.

   Section 27.402 of the proposed regulation addresses application and renewal procedures for the authority to administer injectable medications. This section should be amended in the final-form regulation to reference the statutory requirements for liability coverage and require submittal of proof of insurance to the Board.

6.  Section 27.405. Recordkeeping.--Clarity.

   PAFP suggests amending the recordkeeping requirement from two years to seven years. It claims a seven-year period is more appropriate for medical records. The Board should make this change in the final-form regulation or justify the two-year requirement.

7.  Section 27.406. Notification requirements. Protection of public health and safety; Consistency with existing regulations; Reasonableness; Clarity.

   The House Committee recommended that the regulation require a physician be contacted as soon as possible when there is an adverse reaction by the patient. In addition, PAFP questioned the reasonableness of the timeframes of 72 hours under an order and 14 days under a written protocol. PAFP wrote that ''[n]either of the notification periods seems to be consistent with good medical care.''

   The proposed timeframes are also inconsistent with existing regulations for hospitals at 28 Pa.  Code § 109.65 (relating to recording of drugs administered). Section 109.65(b) reads in part:

Any medication error or apparent drug reaction shall be reported immediately to the practitioner who ordered the drug. Any entry of the medication given in error or the apparent drug reaction, or both, shall be properly recorded in the medical record of the patient. Any adverse drug reaction shall be immediately noted on the medical record of the patient in the most conspicuous manner possible, in order to notify everyone treating the patient throughout the duration of his hospitalization of his drug sensitivity and thereby prevent a recurrence of adverse reaction . . . . [ Emphasis added. ]

   We have two concerns with this Section 27.406 of the proposed regulation.

   First, the Board should change the timeframes in the proposed regulation to require a pharmacist to report an adverse reaction or medication error as soon as practicable, but no later than 24 hours.

   Second, the Board should consider reducing the 72-hour and 14-day time periods for notice as warranted to maintain good medical care.

Department of Revenue Regulation # 15-425
(IRRC # 2438)

Local Option Small Games of Chance

December 8, 2004

   We submit for your consideration the following comments that include references to the criteria in the Regulatory Review Act (71 P. S. § 745.5b) which have not been met. The Department of Revenue (Department) must respond to these comments when it submits the final-form regulation. The public comment period for this regulation closed on November 8, 2004. If the final-form regulation is not delivered within two years of the close of the public comment period, the regulation will be deemed withdrawn.

1.  Chapter 901.--Local Option Small Games of Chance.--Statutory authority; Reasonableness; Economic impact; Need for the regulation.

Applicability

   The existing regulations include provisions that require licensing authorities that do not adopt rules related to the administration of small games of chance to comply with Chapter 901. Those provisions are being deleted. The Department is now providing that certain sections of Chapter 901 are '' . . . for the benefit of and suggested use by the licensing authorities.''

   Section 319 of the Local Option Small Games of Chance Act (Act) (10 P. S. § 319) authorizes the Department to promulgate regulations on specific subject matters. Promulgating rules for licensing authorities is not one of the subject matters.

   The Department explained the historical basis for recommending regulations for use by licensing authorities and acknowledged that it cannot enforce these regulations. Since the Department does not have the statutory authority to promulgate regulations for licensing authorities, we recommend that those provisions be deleted from this proposed rulemaking and the rest of Chapter 901 as well.

   To provide guidance to licensing authorities, we suggest that the Department work with the licensing authorities to develop a model rule that addresses the provisions contained throughout the Chapter. This model rule could be distributed to the regulated community, and easily amended should the need arise.

Enforcement

   The provisions contained in Subchapter I, relating to enforcement, pertain to the Department, licensing authorities and district attorneys. The Act does not grant enforcement authority to the Department. As currently written, Subchapter I reiterates Subsection 323(a) of the Act relating to the powers of the district attorney. The remainder of the Subchapter provides guidance on actions that ''may'' be taken by the affected parties.

   We question the need for including enforcement provisions in the regulation. The Department has acknowledged that the provisions contained in Subchapter I are designed for informative purposes. The purpose of a regulation is to place specific duties or obligations on an agency and the regulated community. Subchapter I does not perform this function and should be deleted.

   If the Department believes the regulation should include enforcement provisions, we recommend that a section be added that simply references Section 323 of the Act.

Suspension

   Sections 901.117, 901.151 and 901.214 relate to the denial, suspension or revocation of licenses. These all include the following provision: ''There is no right to appeal a suspension.'' Section 901.168, relating to appeals, is being amended to delete the right to appeal a suspension. The Chair of the Senate Finance Committee submitted comments on behalf of the Senate Committee questioning the rationale of this policy. We agree and also question the reasonableness and economic impact of it. If a certificate or license is suspended, that entity could no longer conduct business until they remedy the situation, even if they disagree with the basis for the suspension. This would financially harm the holder of a certificate or license.

   We understand, through our discussion with the Department, another option is available. Rather than suspending a manufacturer's or distributor's license, the Department could send a notice of violation, describing the infraction and providing a time limit for its correction. This is a more reasonable approach, and it should be included in the final-form regulation.

Submittal of final-form regulation

   Our comments related to Applicability and Enforcement recommend the deletion of many of the sections contained in this proposed rulemaking and the remainder of Chapter 901 relating to licensing authorities and eligible organizations. If the Department decides to retain these sections, we have addressed concerns with the proposed language in these sections in the comments that follow.

2.  Section 901.1. Definitions.--Consistency with the act; Clarity.

''Fraternal organization,'' ''license,'' ''raffle'' and ''weekly drawing''

   These terms are inconsistent with the definitions found in Section 313 of the Act. For consistency, the final-form regulation should either include a citation to the Act for the definitions of these terms, or use the definitions of these terms found in the Act.

''Veteran's organization''

   The term ''home association'' is included in this definition. This term is unclear. Therefore, we recommend that this term be defined.

3.  Section 901.23. Restriction of sales.--Need; Clarity.

Subsections (a), (b) and (c)

   Subsection (a), relating to manufacturers, instructs applicants to register with the Department. Subsections (b) and (c), relating to distributors and eligible organizations, respectively, require them to obtain licenses, but do not explain where an applicant should apply. For consistency, the final-form regulation should add provisions to Subsections (b) and (c) that instruct applicants where to apply for licenses.

   Additionally, Subsection (a)(3) requires manufacturers to indicate on sales invoices that the games of chance have been approved by the Department. Since only games of chance that have been approved by the Department can be legally sold in Pennsylvania, we question the need for this provision.

4.  Section 901.28. Inspection of premises.--Reasonableness; Clarity.

   Subsection (a) allows a licensing authority, the Department, or their authorized representative to conduct inspections of manufacturers, distributors and eligible organizations. We have two questions.

   First, who are ''authorized representatives'' of the Department?

   Second will the entity have advanced notice from the licensing authority, the Department or the Department's authorized representative when its premises will be inspected?

5.  Section 901.31. Examination of records.--Reasonableness; Need; Clarity.

   Section 901.28(a)(3) limits the inspection of premises to matters, areas and records associated with games of chance. Under Section 901.31, is the examination of records limited to reports, books, accounts and inventory related to games of chance or all records? The final-form regulation should clearly indicate if this provision applies to all of the records of a manufacturer, distributor or eligible organization. If it does apply to all records, the Department should provide justification for inspecting material outside the scope of this regulation.

6.  Section 901.36. Federal withholding and reporting requirements.--Clarity.

Section 901.37. State withholding and reporting requirements.--Clarity.

   Section 901.36 references ''Internal Revenue Service rules'' for reporting and withholding gambling and lottery winnings. Section 901.37 references ''Commonwealth rules'' for reporting and withholding gambling and lottery winnings. The final-form regulation should provide more specific cross-references to the appropriate rules in both of these sections.

7.  Section 901.51. Powers and duties.-- Consistency with the Act; Clarity.

Subsection (a)

   This section lists the powers and duties of the Department under the Act. Subsection (a)(6) states the Department has the power and authority to ''Prescribe procedures for the suspension and revocation of licenses and certificates for violations of the act.'' Under Section 901.1, relating to definitions, ''license'' includes both distributor licenses, which are issued by the Department, and small games of chance licenses, which are issued by a licensing authority. The Act does not give the Department the authority to suspend or revoke small games of chance licenses. Therefore, this section should be amended to clarify that the Department can only suspend or revoke distributor licenses.

Subsection (b)

   This subsection begins with the phrase, ''Although not limited to the following . . . .'' This phrase, is nonregulatory language and should be deleted.

8.  Section 901.102. Registration and game approval forms.--Clarity.

   Under Subsection (b), a manufacturer seeking approval of a game of chance is required to submit a request to the Department. However, the criteria used to evaluate this request are not included in the regulation. The final-form regulation should include the criteria that will be used to evaluate requests.

9.  Section 901.103. Manufacturer registration application form contents.--Reasonableness; Clarity.

   This section establishes the information that must be contained in an application for registration as a manufacturer. Paragraph (12) requires a notarized affidavit for each dispensing machine indicating that the machine complies with the Act and the regulations of the Department. For clarity, the Department should indicate if this requirement applies to each machine or each type of machine sold by a manufacturer.

   In addition, the Senate Committee questioned the need for a notarized affidavit. We agree and request that the Department explain the need for affidavits and especially notarized affidavits.

10.  Section 901.143. Restriction on distributorship interest.--Consistency with the act.

   This section explains the restrictions on being a distributor in the Commonwealth. However, Section 317(g) of the Act contains further criteria. The Department should either add these criteria to this section in the final-form regulation, or include citations to the Act where the other criteria can be found.

11.  Section 901.168. Stay of appeal.--Reasonableness; Clarity.

   Under Subsection (a), ''Actions to revoke a registration, license or game approval will be stayed pending the decision of the Secretary when a petition has been filed with the Board.'' Subsection (b) states, ''During the pendency of the appeal, the certificate, game approval or license will be suspended.'' These provisions are unclear. Will a manufacturer or distributor be able to conduct business while they appeal an action? The Department should clarify its intent in the final-form regulation.

12.  Section 901.188. Location.--Clarity.

   Subsection (b) establishes the places eligible organizations may conduct games of chance. It includes the term ''historical basis.'' The Senate Committee commented that this term is unclear. We agree and recommend that the term be explained in this section.

13.  Section 901.192. Denial, suspension and revocation of an eligible organization license.--Clarity.

Subsections (a), (b) and (c)

   These subsections relate to the ''denial,'' ''suspension'' and ''revocation and denial'' of an eligible organization's license. The final-form regulation should include a cross-reference to the appeal procedures in Sections 901.214 and Section 901.215.

14.  Section 901.196. Limited occasion license requirements, limits and restrictions.--Clarity.

   Subsection (e) establishes a fee of $10 for a limited occasion license. As noted by the Senate Committee, Section 901.184 already sets the fee. To avoid redundancy, the fee should be deleted from one of these sections.

15.  Section 901.215. Appeals.--Reasonableness; Clarity.

   Subsection (b) relates to the timely filing of an appeal. It states that the date an appeal is received at the licensing authority is the filing date. Why isn't the postmark date acceptable?

16.  Section 901.504. Persons who may conduct games.--Clarity.

   Section 901.503, relating to compensation, states, ''A licensed eligible organization may not pay compensation to a person for conducting games of chance.'' Section 901.504 provides the list of those individuals that may conduct games for licensed eligible organizations. The list includes managers, officers, directors, bar personnel or bona fide members. We have two questions.

   First, since bar personnel are usually paid by the licensed eligible organization, is there a conflict between this section and Section 901.503 concerning who can conduct games of chance? The Department should explain.

   Second, would auxiliary members be allowed to conduct games of chance?

17.  Section 901.701. Games of chance permitted.--Clarity.

   

   Subsection (b) Subsection (b) states, ''A licensed eligible organization shall use games of chance proceeds exclusively for public interest purposes or for the purchase of games of chance permitted by the act or this part.'' Could licensed eligible organizations use games of chance proceeds to purchase prizes? The Department should explain.

18.  Section 901.702. Prize limits.--Clarity.

   Subsection (e) relates to prize limit exceptions for daily drawings. It provides an exception for daily drawings that are set up to pay out not less than 100% of the gross revenues generated from such drawing. The last sentence of this subsection states the following: ''The limitation in subsection (b) may be exceeded only by the amount of the daily drawing paying 100% of its gross revenues.'' This sentence is unclear. The language in Section 315(g) of the Act is clearer. Therefore, the final-form regulation should replace the confusing language in Subsection (e)(2) with the language from Section 315(g) of the Act.

19.  Section 901.708. Persons who may conduct games of chance.--Clarity.

   Similar to our questions related to Section 901.504, we request that the Department explain if allowing bar personnel to conduct games of chance creates a conflict with Section 901.707, and how this section applies to auxiliary members.

20.  Miscellaneous clarity.

Nonregulatory language

   Sections 901.107, 901.137 and 901.185 use the term ''should.'' The word ''should'' is non-regulatory language that implies the action is optional. The final-form regulation should replace the word ''should'' with ''shall.''

   Sections 901.148 and 901.149 state that a distributor ''will'' notify the Department of certain information. According to Section 6.8 of the Pennsylvania Code & Bulletin Style Manual, the word ''will'' should be used when the agency pledges to act. The word ''shall'' should be used when anyone else has a duty to act. Because the distributor has an obligation to act, these sections should be amended accordingly.

   Section 901.192 states that the licensing authority ''shall'' perform certain duties. In this circumstance the licensing authority is the agency. For the reasons noted above, this section should be amended by replacing ''shall'' with ''will.''

   Sections 901.905 and 901.906 relate to investigations. These sections state that the Department or licensing authority ''may'' investigate a manufacturer, distributor or licensing authority ''when it has reason to believe that a violation of the act or this part has occurred or is occurring.'' Section 901.907 relates to notice of investigations. It states that the Department and licensing authorities ''may'' provide information concerning an investigation to each other and the district attorney. The word ''may'' indicates that these provisions are optional. Since the subject matter of these sections is investigations of violations of the Act, these provisions should be mandatory. Therefore, the word ''may'' should be changed to ''shall'' throughout these sections.

''In this part''

   This proposed rulemaking and the existing language of Chapter 901 use the phrase ''in this part.'' As noted by the Senate Committee, this phrase should be replaced with the appropriate section or subsection of the regulation. Although the comments of the Senate Committee relate to Section 901.117, we recommend that the phrase ''in this part'' be replaced throughout Chapter 901.

''Substantially harmed'' and ''timely remedied''

   Sections 901.117, 901.151, 901.192 and 901.214 relate to the suspension, denial or revocation of certificates or licenses of manufacturers, distributors and eligible organizations. These sections contain the phrases ''substantially harmed'' and ''timely remedied.'' As noted by the Senate Committee, the phrase ''substantially harmed'' lacks the ability to be measured and thus enforced. We agree with this comment and believe the phrase ''timely remedied'' also lacks the ability to be measured. The final-form regulation should define the phrase ''substantially harmed'' or provide examples of what is meant by this phrase. In addition, it should provide specific time periods in which the violations must be remedied.

Forms

   Variants of the phrase ''forms prescribed by the Department'' are used throughout the proposed rulemaking and the existing language of Chapter 901. We recommend that the specific forms be referenced by name or number throughout Chapter 901. Additionally, will these forms be available on the Department's website?

Notification to district attorneys

   Sections 901.704, 901.709 and 901.751 require eligible organizations to notify district attorneys of certain actions. These sections do not specify when notification should take place. The final-form regulation should include time periods for these notifications.

Incomplete application forms

   Sections 901.102 and 901.132 pertain to application forms that must be submitted by manufacturers and distributors to the Department. The final-form regulation should include provisions that explain what will happen if the application forms are not complete.

Annual renewal applications of manufacturers, distributors and eligible organizations

   Sections 901.107, 901.137 and 901.185 have been amended to advise manufacturers, distributors and eligible organizations that they should file their annual applications a specific number of days prior to the expiration of their certificate or license. The original language of these sections required renewal applications to be filed by a certain date. The original language was clearer. Therefore, we recommend that the original language of these sections be retained.

Additional clarity concerns

   *  In the titles of Sections 901.117 and 901.192, there should be commas between ''Denial'' and ''suspension.''

   *  The title of Section 901.30 contains the phrase ''and the like.'' This phrase lacks clarity. The Department should either delete this phrase, or replace it with language found in this section. An example could be ''prizes and services'' or just ''services.''

   *  Section 901.188 includes a reference to Section 901.181, which is now reserved.

   *  Section 901.212 includes references to Section 901.211, which is now reserved.

   *  Section 901.781(g) should include a cross-reference to Section 901.784, relating to claiming prizes.

   *  Section 901.791(f) should include a cross-reference to Section 901.794, relating to claiming prizes.

   *  The title of Section 901.905 is ''Investigations of manufacturers, distributors and eligible organizations.'' The text of this section only relates to investigations of eligible organizations. The title should be amended to ''Investigations of eligible organizations.''

[Pa.B. Doc. No. 04-2265. Filed for public inspection December 17, 2004, 9:00 a.m.]

---

No part of the information on this site may be reproduced for profit or sold for profit.

This material has been drawn directly from the official Pennsylvania Bulletin full text database. Due to the limitations of HTML or differences in display capabilities of different browsers, this version may differ slightly from the official printed version.

---