INDEPENDENT REGULATORY REVIEW COMMISSION
Notice of Comments Issued
[52 Pa.B. 3395]
[Saturday, June 11, 2022]
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final-form regulation must be submitted within 2 years of the close of the public comment period or it will be deemed withdrawn.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
16A-6411 State Board of Auctioneer Examiners
52 Pa.B. 1736 (March 26, 2022)
4/25/22 5/25/22 7-569 Environmental Quality Board
Safe Drinking Water PFAS MCL Rule
52 Pa.B. 1245 (February 26, 2022)
4/27/22 5/27/22 16A-5726 State Board of Veterinary Medicine
52 Pa.B. 1980 (April 2, 2022)
5/2/22 6/1/22 16A-7104 State Board of Crane Operators
Licensure by Endorsement—Crane Operators
52 Pa.B. 1978 (April 2, 2022)
State Board of Auctioneer Examiners
Regulation # 16A-6411 (IRRC # 3337)
May 25, 2022
We submit for your consideration the following comments on the proposed rulemaking published in the March 26, 2022 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 (RRA) (71 P.S. § 745.5a(a)) directs the State Board of Auctioneer Examiners (Board) to respond to all comments received from us or any other source.
1. Economic or fiscal impacts; Need for the regulation; and Reasonableness of the requirements, implementation procedures and timetables for compliance by the public and private sectors.
The Board states in the Preamble that at the end of Fiscal Year (FY) 2020-2021, the Board is projected to have a deficit of $46,136.32. It explains that the majority of its general operating expenses are borne by the licensee population through revenues generated through the biennial renewal of licenses while a small percentage comes from application fees. Therefore, this proposed rulemaking proposes graduated increases for eleven application fees and five biennial renewal fees. The proposed fee schedule in Section 1.41 (relating to schedule of fees) is projected to produce biennial revenues that will allow the deficit balance to decrease through FY 2023-2024 and therefore, the Board to meet or exceed its projected expenditures through at least FY 2026-2027.
The application fees for auctioneer, auction company, trading assistant, and trading assistant company are increased from 20% to 383% over the current fee schedule and will be effective upon final-form publication in the Pennsylvania Bulletin. Subsequent increases to these application fees will be implemented on July 1, 2025 and July 1, 2027. The Board provides in the Preamble and Regulatory Analysis Form (RAF), a description of the formula that was used to determine subsequent fee increases for applications (FY-2023-2024 through FY 2026-2027). However, it did not detail how the proposed application fees, to be implemented during the first phase, were calculated.
The Board also does not explain how it calculated the fee increases for biennial renewal of licenses for auctioneer, apprentice auctioneer, auction company, trading assistant and trading assistant company which will take effect beginning with the March 1, 2023, March 1, 2025 and March 1, 2027 biennium renewal periods. Similar to the application fee increases, these adjustments represent significant increases over the current fee schedule. Therefore, the Board should explain how it determined that the proposed fee increases to be implemented during the first phase, including those for applications and renewals for these five categories of licenses, are both appropriate and reasonable. It should also explain how the implementation schedule, particularly the first phase, is reasonable.
In a letter dated May 20, 2022, the House Professional Licensure Committee observes that the proposed fee increases contained in this regulation for initial licensure and renewal for auctioneers are significantly higher than surrounding states that license auctioneers. (RAF # 12) Specifically, it is concerned about the potential impact this could have on Pennsylvania's ability to compete with other states and question the need to increase the fees to the amounts outlined in the regulation. We will review the Board's response to the Committee's concern in our determination of whether or not the regulation is in the public interest.
2. Compliance with the provisions of the RRA and the regulations of IRRC.
Section 5.2 of the RRA (71 P.S. § 745.5b) directs IRRC to determine whether a regulation is in the public interest. When making this determination, IRRC considers criteria such as economic or fiscal impact and reasonableness. To make that determination, IRRC must analyze the text of the proposed regulation and the reasons for the new or amended language. IRRC also considers the information a promulgating agency is required to provide under Section 5 of the RRA in the RAF (71 P.S. § 745.5(a)).
There are instances where the Board's responses to RAF questions are incomplete. We ask the Board to provide additional information as directed below.
RAF question # 21 asks the agency to provide a specific estimate of the costs and/or savings to state government associated with the implementation of the regulation and to explain how the dollar estimates were derived. The Board states in its response to RAF question # 21 that it will incur a minimal cost to update its print and online application forms and online renewal platform to indicate the increased fees. However, the Board does not provide a dollar estimate for this cost to implement the regulation. The Board should provide an updated RAF that includes a dollar estimate or explain why it is not possible to do so.
RAF question # 26 requires the promulgating agency to include a description of any alternative regulatory provisions which have been considered and rejected and a statement that the least burdensome acceptable alternative has been selected. The Board's response to RAF # 26 includes a statement that it considers the regulation to be least burdensome and acceptable alternative, consistent with public health and safety, but does not elaborate on any alternative regulatory provisions which were considered and rejected. When the Board submits the final version of this rulemaking, it should provide that information.
The Board explains, in its response to RAF question # 28, that it relied upon the data contained in the BFO Financial Report and fee report forms as the basis for the rulemaking. However, the fee report forms that provide a breakdown of costs for processing applications were not part of the regulatory documents submitted to this Commission. The receipt and review of this information will assist this Commission in evaluating the fiscal impact and reasonableness of the fee schedule when determining if the regulation is in the public interest. Therefore, we ask the Board that it provide the fee report forms for each application and biennial renewal fee in Section 1.41 (relating to schedule of fees) when it submits the final rulemaking package.
The Board should revise its response to RAF question # 30 to remove any meeting dates have that passed.
Environmental Quality Board Regulation # 7-569 (IRRC # 3334)
Safe Drinking Water PFAS MCL Rule
May 27, 2022
We submit for your consideration the following comments on the proposed rulemaking published in the February 26, 2022 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 RRA (71 P.S. § 745.5a(a)) directs the Environmental Quality Board (Board) to respond to all comments received from us or any other source.
1. Determining whether the regulation is in the public interest; Economic or fiscal impacts; Protection of the public health, safety, and welfare; Reasonableness; Implementation; Acceptable data.
This proposed regulation from the Board amends Chapter 109 (relating to safe drinking water) to set maximum contaminant level goals (MCLG) and maximum contaminant levels (MCL) in drinking water for two chemicals—perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), which are part of a larger group of perfluoroalkyl and polyfluoroalkyl substances (PFAS). The proposed rulemaking also establishes monitoring requirements for public water systems to demonstrate compliance with the PFOA and PFOS standards. These contaminants presently are not regulated in drinking water at the federal level or in Pennsylvania. Currently, the United States (U.S.) Environmental Protection Agency (EPA) has established a lifetime health advisory level (HAL) for PFOA and PFOS of 70 parts per trillion (ppt) combined.
In December 2019, the Department of Environmental Protection (DEP) Safe Drinking Water Program executed a toxicology services contract with Drexel University (Drexel) to review other state and federal agency work on MCLs, independently review the data, science, and studies, and develop recommended MCLGs for select PFAS. MCLGs are nonenforceable, developed solely based on health effects and do not take into consideration other factors, such as technical limitations and cost. MCLGs are the starting point for determining MCLs. Drexel provided an MCLG report, ''MCLG Drinking Water Recommendations for PFAS in the Commonwealth of Pennsylvania,'' developed by the Drexel PFAS Advisory Group, a multidisciplinary team of experts in toxicology, epidemiology, and drinking water standards, and risk assessment. Based on the recommendations from the Drexel PFAS Advisory Group, the Board is proposing an MCL of 14 nanograms per liter (ng/L) for PFOA and an MCL of 18 ng/L for PFOS. The Board states that implementation of these proposed drinking water standards will protect Pennsylvanians from the adverse health effects of these contaminants.
This proposal from the Board has generated significant interest from the regulated community, including environmental groups, health advocates, water companies, local governments, and various trade associations, as well as, the House Environmental Resources and Energy Committee (Committee), 31 members of the General Assembly, a member of the U.S. Congress, and the EPA. We address the comments of the Committee and those of the legislators which relate to our criteria throughout the pertinent sections below. We note that all commenters support the concept of safe drinking water in varying degrees, from those strongly supporting the proposal and expressing the need to make the final regulation even more protective to those expressing concerns related to issues such as economic or fiscal impacts, implementation, and acceptable data.
Protection of the public health, safety, and welfare
A commenter points out that numerous scientific institutions support grouping PFAS as a class given shared hazard traits. The commenter states that Vermont has an MCL of 20 ppt for the combined levels of five different PFAS, and both Maine and Massachusetts similarly have a 20 ppt MCL for the sum of six PFAS, recognizing that PFAS compounds target the same health endpoints. We ask the Board to explain the reasonableness of addressing PFOA and PFOS as individual compounds rather than as a class.
Implementation: forthcoming federal regulation
We note that the Board states in the Preamble, ''With the proposed amendments, the Commonwealth would move ahead of the [EPA] in addressing PFOA and PFOS in drinking water and join a small group of states that have set MCLs for select PFAS in drinking water.'' Regarding the EPA, in response to Question 9 of the Regulatory Analysis Form (RAF), the Board states,HALs are not enforceable standards, but the Department has the regulatory authority to require corrective actions if HALs are exceeded, as well as having the statutory authority to set state [MCLs] in drinking water. Current research indicates that the HAL is not sufficiently protective of public health. On February 22, 2021, EPA issued final regulatory determinations for contaminants of the fourth Contaminant Candidate List, which included a final determination to regulate PFOA and PFOS in drinking water. This determination was published in the Federal Register on March 3, 2021 (86 FR 12272), which starts a 24-month time clock for EPA to publish a proposed rulemaking. In the meantime, one of the goals of the PFAS Action Team in Pennsylvania, created by Executive Order 2018-08 signed in September 2018 by Governor Wolf, is the establishment of a state MCL in drinking water. Until EPA publishes a final rulemaking for PFOA and PFOS, a state drinking water standard is needed to improve public health protection. (Emphasis added.)
Commenters raise concerns regarding the timing and alignment of this regulatory package and the forthcoming federal regulation. A commenter states that, according to EPA's PFAS Strategic Roadmap, the agency plans to propose a National Primary Drinking Water Regulation (NPDWR) for PFOA and PFOS in the fall of 2022, with a final regulation expected in the fall of 2023. The commenter notes that there is a distinct possibility that EPA's NPDWR could be promulgated before the effective date of this final-form regulation. Other commenters express concern that the overlap of the two rulemakings could cause confusion among the regulated community. Commenters raise questions, including:
• Has the Board engaged the EPA regarding the nearly simultaneous development of MCLs for PFOA and PFOS at the federal and state levels?
• Has the Board considered delaying implementation to avoid conflicting requirements and duplicate sampling?
• How will the Board address a situation where EPA's drinking water standards for PFOA and/or PFOS are either more stringent or less stringent than the Board's corresponding final standards for PFOA and/or PFOS?
We ask the Board to address commenters' implementation concerns regarding the promulgation of potentially overlapping and potentially differing state and federal regulations related to PFOA and PFOS in the Preamble to the final-form regulation.
Commenters further note that the EPA sampling is anticipated to occur simultaneously with initial monitoring requirements of this rulemaking and ask the Board to use the EPA data for compliance with the initial monitoring period. Commenters also question whether there may be a shortage of certified laboratories to perform testing due to the overlap in timing of the federal and state regulations. In response to Question 19 of the RAF, the Board explains its staggered approach to implementation based on the population served. The Board further explains the intention is ''to evenly split initial monitoring across two years in order to ease laboratory capacity issues and allow small systems more time to prepare for compliance monitoring.'' (Emphasis added.) We ask the Board to provide information on the number and capacity of laboratories certified to perform required testing for implementation of the final regulation.
A commenter states that drinking water facilities are passive entities that are subject to this regulation due to the action of others. The commenter further notes that ''[m]ost, if not all, of these facilities were not designed to treat emerging contaminants such as PFAS.'' The commenter urges the Department to undertake regulatory initiatives that address, at a minimum, source control requirements related to PFAS to eliminate or substantially reduce, among other things, the costs of PFAS treatment, management, and monitoring that will be directly borne by the regulated community. We ask the Board to address the impact of other regulatory initiatives related to PFAS source control requirements on the economic impacts of the final regulation.
A commenter notes that the Board's cost estimate purports to include capital costs, monitoring, sampling, and annual operation and maintenance costs associated with the rulemaking but fails to fully explain the basis for these figures. The commenter further notes that the proposal identifies a few sources of funding, but does not address whether the funding will be sufficient to enable public water systems to afford the costs. The commenter states that the proposal fails to address whether public water systems will need to make rate adjustments to accommodate the additional capital and operational costs or explain how rate adjustments will affect ratepayers. We note that in response to RAF Question 15, the Board acknowledges that ''complying with this rule will result in some cost increases to [public water systems], which may be passed on to the customers they serve.'' We ask the Board to amend the RAF to the final-form regulation to address the basis for the cost-estimate figures and the economic or fiscal impacts on water systems if insufficient funding is available for implementation. Also, we ask the Board to amend its response to RAF Question 17 relating to the financial and economic impact of the regulation on individuals to include ratepayers.
A commenter advocates for greater clarity related to costs of treatment and monitoring. The commenter notes the following from the Preamble: ''Treatment cost estimates are based on the costs to install and maintain treatment for a 1 [million gallons per day (MGD)] treatment plant. The actual costs would be expected to be proportionally less for a treatment plant with a smaller design capacity.'' The commenter questions what data, other than the proportional calculations provided in the proposal, form the basis for this assumption. The commenter further questions if the same proportional analysis would be valid for treatment plants with a design capacity above 1 MGD. We ask the Board to amend the Preamble and RAF to the final-form regulation to address these concerns and provide greater clarity related to economic and fiscal impacts of treatment and monitoring.
A commenter raises concerns related to byproducts of treatment technologies, noting that ''treatment technologies for PFAS are still being developed, and there is limited capacity for the disposal of byproducts from newly-developed technologies.'' The commenter notes that the regulated community will need to safely dispose of the byproducts of such treatment technologies used to treat PFAS in drinking water. The commenter states that ''[t]his is another area where [the EPA] is taking action, both to expand research and accelerate deployment of treatment, remediation, destruction, disposal, and control technologies for PFAS. The [Board] should await guidance from [the EPA] on these issues before taking actions that could stress limited PFAS treatment and disposal capacity.'' We ask the Board to address implementation concerns related to byproducts of treatment technologies for PFAS.
In response to RAF Question 17 addressing the cost/benefit of the regulation, the Board states, ''Improved health benefits expected to result from implementation of the proposed rule include a reduction in instances of developmental effects (including neurobehavioral and skeletal effects) and decreased immune response.'' A commenter notes that the Board does not quantify or estimate these benefits. Other commenters assert that the benefits indicated by the Board are overstated and the costs understated. These commenters seek clarification regarding the Board's conclusion that ''[c]ompared to the HAL, the proposed MCL of 14 ppt for PFOA represents a 90 percent increase in public health protection and the proposed MCL of 18 ppt for PFOS represents a 93 percent increase in health protection.''
Commenters also seek clarification on the basis for selection of 90 percent as a goal. They assert that the Board does not adequately explain the basis for the figures, providing no citation for this formula or any basis for such an assumption. Specifically, the commenters argue that ''the [Board] assumes a linear improvement in health protection between the [HAL] and the [Drexel PFAS Advisory Group]-recommended MCLG but provides no scientific support for assuming a linear improvement'' and that the Board ''has not identified any data or information demonstrating that increasingly stringent MCLs yield corresponding increases in health protection.'' Another commenter similarly states that the Board unreasonably relies on a flawed analysis of cost-effectiveness. This commenter argues that the benefits of setting MCLs at levels equal to the recommended MCLGs would vastly exceed costs. Did the Board consider the cost/benefit of setting MCLs at MCLG levels? The commenter also asserts that the Board does not follow the Department's guidance document for drinking water standards, which provides that a cost-benefit analysis for a proposed action involves an evaluation of the costs versus benefits to society. We ask the Board to address these concerns regarding the Board's method of cost/benefit analysis, including clarifying the basis for selection of 90 percent as a goal, in the Preamble to the final-form regulation. We also ask the Board to explain how increasingly stringent drinking water values affect health outcomes and provide supporting data. We also ask the Board to provide data for and explain the reasoning behind its assumption of linear improvement.
The Board states in the Preamble that ''PFAS are considered emerging contaminants because research is ongoing to better understand the potential impacts PFAS pose to human and animal health and the environment.'' (Emphasis added.) Commenters note ''conflicting toxicology information from an evolving state-of-the-science'' and assert that the EPA's Science Advisory Board PFAS Review Panel in 2021 and other state approaches to regulating PFOA and PFAS point to disagreement on what the standards should be. Another commenter states that the proposed regulation ''is based on problematic studies that do not reflect the weight of scientific evidence regarding PFOS and PFOA. As a result, the proposed MCLs are overly conservative and technically flawed.'' Other commenters raise questions such as:
• Was additional independent peer review undertaken with respect to the conclusions set forth in the proposed regulation?
• Were there documents (e.g., health, toxicological, epidemiological) that the Board reviewed, but for some reason, chose not to include in its evaluation process?
• Is the EPA HAL unsafe for public drinking water?
• Does the Board plan to review additional information that may not have been available during the time that the regulation was being drafted as it prepares the final-form regulation?
We ask the Board to address commenters' concerns related to acceptable data, and explain how the data supporting the final regulation protects the public health, safety, and welfare. We also ask the Board to explain how it will revise standards based on improved scientific understanding about exposure, dose, and toxicology.
Additionally, a commenter questions whether members of the Drexel PFAS Advisory Group have sufficient expertise in the toxicological properties of PFAS or with regulatory risk assessment. The commenter argues that for PFOA, ''the advisory group focused on the reports of developmental effects in laboratory animals exposed to a single dose which severely limits the ability to assess dose-response. For PFOS, the group selected a study reporting immune system effects in laboratory animals despite the fact the results conflict with the findings of other researchers.'' Similarly, another commenter states that ''[t]here are major technical concerns associated with these two published studies [selected as the critical studies for PFOA] with respect to their use in any human risk assessment.'' The commenter further asserts that the Drexel PFAS Advisory Group excluded numerous relevant studies from its analysis without explanation. We ask the Board to address these concerns related to the source of the data and basis for the MCL standards in the final-form regulation, and explain how the data provided as the basis for the final regulation is acceptable.
We will review the Board's responses to these concerns related to economic or fiscal impacts, protection of the public health, safety, and welfare, reasonableness, implementation, and acceptable data in order to make a determination as to whether the final regulation is in the public interest.
2. Comments, objections, or recommendations of a committee.
On May 24, 2022, the House Environmental Resources and Energy Committee (Committee) voted in favor of sending a comment to express ''concerns with [the Department's] pursuit of this regulation, particularly considering the federal government's actions in this area.'' The comment is signed by nearly all majority members and one minority member. The Committee states, ''As [the Department] has acknowledged, this would be the first time that they would be setting a [MCL] in our state's history. This is an action that has always been taken by the EPA in the past, with Pennsylvania adopting the standards set at the federal level.'' The Committee further asserts that ''EPA's far greater resources will allow them to more accurately estimate the health impacts of an MCL, more accurately assess the water treatment technologies available to address PFAS, and more accurately estimate the cost of various treatment and monitoring systems to our water providers throughout the Commonwealth.'' The Committee urges the Board and Department to ''rethink their approach and to defer to the EPA's experience and expertise to provide certainty to the regulated community.''
One criterion of the RRA that this Commission must consider when determining if a regulation is in the public interest is the comments, objections, or recommendations of a committee. As noted, the Committee has expressed concerns with the regulation. If the Board proceeds with this rulemaking, we note that the concerns raised by the Committee could be the basis for a disapproval by this Commission. However, a goal of the RRA and the regulatory review process is the resolution of objections to a regulation and reaching of consensus among this Commission, the designated standing committees, interested parties, and the promulgating agency. We ask the Board to work with all parties with an interest in this rulemaking, particularly the Committee and members of the Legislature, to create a regulatory environment that is consistent with the intent of the General Assembly, is reasonable, provides certainty to the regulated community, and is protective of the public health, safety, and welfare.
3. Section 109.202. State MCLs, (Maximum Residual Disinfectant Level) and treatment technique requirements.—Protection of the public health, safety, and welfare; Acceptable data.
Subparagraph (4)(ii)(A) provides for an MCLG of 8 ng/L and an MCL of 14 ng/L for PFOA, and Subparagraph (4)(ii)(B) provides for an MCLG of 14 ng/L and an MCL of 18 ng/L for PFOS. Legislators and other commenters argue that drinking water standards should be more protective of children. These commenters assert that the proposed MCL standards for PFOA and PFOS are flawed when considering Cambridge Environmental Consulting's (CEC) toxicological analysis recommendations. The commenters quote the following from the CEC report:CEC's recommendation of a MCL of 1 ppt is consistent with the values found pursuant to the immunotoxic epidemiologic study and/or animal studies showing adverse developmental effects. However, if these values are excluded, the CEC has identified that the PFOA MCL should be no greater than 6 ppt to assure protection of children.
These commenters encourage the Board to emulate the CEC's findings by making the PFOA MCL 1 ppt but not to exceed 6 ppt and making the PFOS MCL no greater than 5 ppt. We ask the Board to address the concern that the CEC findings seem to indicate that the Board's proposed levels would not be protective of children. Some commenters assert that the MCLs should not be greater than the MCLGs, while others recommend that the levels be non-detectable. The Board states in the Preamble that the proposed MCLs for PFOA and PFOS are based on the health effects and proposed MCLGs, occurrence data, technical feasibility, and costs and benefits. We ask the Board to address commenters' concerns related to acceptable data and explain how it determined that the MCLs for PFOA and PFOS in the final regulation protect the health, safety, and welfare of children, particularly young children.
4. Section 109.301. General monitoring requirements.—Economic impacts; Protection of the public health, safety, and welfare; Clarity; Reasonableness; Implementation.
Paragraph (16)(i) requires monitoring to begin January 1, 2024, for systems serving more than 350 persons, and January 1, 2025 for systems serving 350 or fewer persons. Legislators and many commenters assert that the final rulemaking should be implemented immediately upon finalization. These commenters argue that it will be another two to three years before verifiably clean drinking water is available for Pennsylvania residents. We ask the Board to explain how it determined that the effective dates in the final regulation balance protection of the public, health, safety, and welfare with the economic impacts of implementation.
Subparagraph (16)(ii)(A) addresses repeat monitoring for entry points at which at least one of the PFAS with an MCL is detected, stating, ''Monitoring for compliance with the MCLs for PFAS established under [Section] 109.202(a) shall be repeated quarterly, beginning the quarter following the detection, until reduced monitoring is granted in accordance with this subparagraph.'' Legislators and commenters assert that for systems with detections over the MCL, the Board should require monthly sampling until the levels are reduced below the MCL. Did the Board consider a shorter monitoring timeframe following detection? Also, could a water system remain in this state of repeat monitoring, never reaching compliance? We ask the Board to explain how the frequency of monitoring required in the final regulation is reasonable and protects the public health, safety, and welfare. We also ask the Board to explain how it will ensure compliance is achieved by water systems.
Subparagraph (16)(ii)(B) states, ''The Department may decrease the quarterly monitoring requirement specified in clause (A) if it has determined that monitoring results are reliably and consistently below all MCLs for PFAS established under [Section] 109.202(a).'' (Emphasis added.) We ask the Board to amend this provision to use the term defined in Section 109.1, ''reliably and consistently below the MCL,'' for clarity. (Emphasis added.) Otherwise, we ask the Board to amend the final-form regulation to clarify what standards would be applied to measure ''reliably and consistently'' relevant to reduced frequency of repeat monitoring.
Paragraph (16)(iv) provides for waivers. Legislators and many commenters urge the Board to amend the rulemaking to require all water systems to be monitored on at least an annual basis with no waivers being granted. These commenters argue that PFOA and PFOS are highly mobile in water and persistent in the environment, making their migration from a source of contamination a threat that is unpredictable and can occur rapidly. We ask the Board to explain how it determined that the granting of waivers will not negate the protection of the public health, safety, and welfare afforded by consistent testing.
Subparagraph (16)(viii)(A) addresses invalidation of PFAS samples, stating, ''The Department may invalidate results of obvious sampling errors.'' What are the standards for determining an ''obvious'' sampling error and how will the samples be evaluated consistently? We ask the Board to clarify implementation related to the invalidation of PFAS samples.
Subparagraph (16)(ix)(A) states, ''For systems monitoring more than once per year, compliance with the MCL is determined by a running annual average of all samples taken at each entry point.'' We ask the Board to clarify how compliance determination will be implemented for water systems choosing to sample more frequently than required.
Subparagraph (16)(ix)(C) states, ''If any sample result will cause the running annual average to exceed the MCL at any entry point, the system is out of compliance with the MCL immediately.'' We ask the Board to clarify implementation of the final regulation and explain whether the determination of ''out of compliance'' will begin with the first sampling done following the effective date of the regulation.
5. Section 109.303. Sampling requirements.—Economic impacts; Clarity; Implementation.
Subparagraph (a)(6)(ii) states, ''Samples shall be collected by a person properly trained by a laboratory accredited by the Department to conduct PFAS analysis.'' We ask the Board to amend the final regulation to address the following concerns:
• Does this provision require a trained member of the accredited laboratory to conduct compliance sampling on behalf of the water system? If so, we ask the Department to address implementation concerns related to laboratory staff capacity, geographic availability, and the economic impact of associated costs.
• Does this provision indicate that a water system's sample collection staff can obtain training from an accredited laboratory in order to collect samples? If so, we ask the Department to address the economic impacts of training costs, and clarify any certification or documentation needed for a trainee.
6. Section 109.304. Analytical requirements.—Need; Reasonableness.
A commenter recommends analytical requirements be removed from the final rulemaking and instead be placed in guidance documents. The commenter states,[T]there are now places to consolidate and capture standardized analytical requirements, such as through 25 Pa. Code [Section] 252 and [National Environmental Laboratory Accreditation Conference] Institute standards, which are overseen in Pennsylvania by [the Department's] Laboratory Accreditation Program. Including analytical requirements in a Chapter 109 rule may lead to confusion and discrepancies between other laboratory rule requirements. As analytical methods and lab practice requirements may change over time, it is better for those to be addressed in the rules and standards that environmental laboratories are already subject to, without also then needing to update the relevant section(s) in Chapter 109.
We ask the Board to explain the need for and reasonableness of retaining analytical requirements in the final regulation.
7. Section 109.602. Acceptable design.—Economic impacts; Clarity; Implementation.
Under Paragraph (j)(1), the Department identifies a list of treatment technologies that are acceptable for achieving compliance with the MCLs for PFAS. A commenter questions if the use of one of the listed methods indicates that a water system can move forward with that treatment technology, or would the Board require piloting systems in order to have a construction permit accepted and reviewed by the Department? The commenter notes that requiring a pilot system is costly, adding $100,000—$125,000 to design costs per treatment unit, and delays the installation of treatment. We ask the Board to clarify if piloting systems for the listed accepted treatment technologies will be required, and if so, to amend the Preamble and RAF to the final-form regulation to take these costs and economic impacts into consideration.
Under Paragraph (j)(2), the Board states that other treatment technologies may be approved by the Department if the applicant demonstrates the alternate technology is capable of providing an adequate and reliable quantity and quality of water to the public. What standards would determine whether adequacy has been demonstrated? We ask the Board to clarify in the final regulation how this provision will be implemented.
State Board of Veterinary Medicine
Regulation # 16A-5726 (IRRC # 3336)
June 1, 2022
We submit for your consideration the following comments on the proposed rulemaking published in the April 2, 2022 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 Veterinary Medicine (Board) to respond to all comments received from us or any other source.
1. Section 31.102. Definitions.—Clarity.
The ''supervisor of animal care services'' is defined as an ''individual who is generally onsite at the shelter facility.'' (Emphasis added.) ''Generally'' is nonregulatory language that does not set a clear standard of compliance for an animal protection organization. The Board should clarify this definition to set a clear, enforceable standard.
2. Section 31.104. Schedule of fees.—Economic or fiscal impacts; Reasonableness of requirements, implementation procedures and timetables for compliance by the public and private sectors; Need.
A euthanasia technician is required to pay an $81 fee for an application for approval of employment change. We have four questions and concerns. First, a euthanasia technician is required to provide notice of a change in employment under Section 31.124(a)(3) (relating to reports to be filed with the Board). However, Subchapter B (relating to animal protection organizations and euthanasia technicians) does not require or set forth a procedure for a euthanasia technician to re-apply for licensure upon a change of employment. Second, Section 31.107(a)(2) (relating to authority of certificate holders to purchase, possess and administer controlled substances; limitations on authority) provides for a euthanasia technician to be under contract with an animal protection organization. Is a contracted euthanasia technician required to apply for approval for change in employment? Third, this fee may have a significant economic impact upon euthanasia technicians, given that the Board acknowledges in Regulatory Analysis Form (RAF) Question # 19 that there may be a relatively high rate of turnover of euthanasia technicians due to the emotional drain of this occupation. Fourth, the process may impede a euthanasia technician from accepting a new employment opportunity. We ask the Board to explain why the approval of employment change is needed, why the fee is reasonable and the expected economic impact on the regulated community. Further, should the Board determine that it is necessary to approve a change in employment, this requirement, along with implementation procedures, should be added in the final-form regulation.
CERTIFICATE OF REGISTRATION FOR ANIMAL PROTECTION ORGANIZATIONS
3. Section 31.106. Qualifications for a certificate of registration; duty to update certification information.—Economic or fiscal impacts; Need; Implementation procedures; Reasonableness.
Subsection (a)(2) requires an animal protection organization to demonstrate that the supervisor of animal care services has completed the didactic portion of the euthanasia technician certification course. We have two issues. First, the Board does not explain in the Preamble why it is requiring unlicensed employees to complete this component of the euthanasia technician certification course. Second, the regulation does not directly require the supervisor of animal care services to take this portion of the certification course. We ask the Board to explain the need for this provision. We also ask the Board to consider clarifying the final-form regulation to require the supervisor of animal care services to complete this portion of the certification course.
This comment also applies to Section 31.108(b)(1) (relating to duties of certificate holders).
Under subsection (d), an animal protection organization will be inspected by agents of the Board during the application process to determine if the equipment and facilities are in compliance with Subchapter B. A commentator suggested that inspections be completed by the Department of Agriculture (Department) during its regular inspection process, noting that there ''is a simple check list'' under Section 31.109 (relating to area used for animal euthanasia; required equipment and supplies). Section 304(d) of the Animal Destruction Method Authorization Law (act) provides for the Board to ''enter into a memorandum of understanding with the [D]epartment and designate the [D]epartment to act as its authorized agent for the limited purposes of inspecting and monitoring animal protection organizations.'' 3 P.S. § 328.304(d).
RAF Question # 13 states that the Department's Bureau of Dog Law Enforcement inspects kennels and that the Board intends to work with the Department regarding areas of mutual interest and co-enforcement efforts. We ask the Board to explain if the Department and the Board will work together to meet the standards set forth in the act and Subchapter B. Further, should the Board and the Department enter into a memorandum of understanding, we ask the Board to review and revise Subchapter B to include the Department where necessary.
Under subsection (f), an application is active for 12 months from the date the application is signed and verified. The Board will deem an application withdrawn if it is dormant for more than 12 months. An applicant who wishes to continue the registration process will be required to submit a new application and application fee. The Board does not explain why it will deem an application to be dormant. We ask the Board to explain how it determined that 12 months is a reasonable time for an application to remain active, what factors it considered in determining that an application will become dormant after that time, and the fiscal impact upon applicants who will be required to pay a second application fee.
This comment also applies to the euthanasia technician application process in Section 31.122 (relating to qualifications for licensure).
Subsection (g) requires an applicant to update the application should information change prior to issuance of the certificate of registration. The Preamble and this provision do not include implementation procedures. Does an updated application impact the active period in subsection (f)? We ask the Board to explain the process for updating an application and the impact upon the application timeline.
4. Section 31.107. Authority of certificate holders to purchase, possess and administer controlled substances; limitations on authority.—Clarity.
Under subsection (b)(1), an animal protection organization may not ''[p]urchase, possess or administer any controlled substance or any other legend drug which is not a drug for euthanasia.'' However, the Preamble states that this paragraph does not prohibit an animal protection organization that employs a staff veterinarian from possessing drugs used for other purposes acquired under the authority of the staff veterinarian's license and United States Drug Enforcement Administration (DEA) registration. We ask the Board to clarify this paragraph to include the allowance for an animal protection organization who employs a veterinarian.
5. Section 31.108. Duties of certificate holders.—Possible conflict with statutes; Reasonableness; Clarity.
Under subsection (a)(1), an animal protection organization is required to ensure a euthanasia technician is ''clinically competent to humanely administer euthanasia.'' Under Section 304(c) of the act, the Board is required to determine that an applicant satisfies licensure standards, not an animal protection organization. Why is the Board requiring an animal protection organization to assess competency? We ask the Board explain why it is reasonable and necessary for an animal protection organization to make this determination. We also ask the Board to consider revising this subsection to eliminate the requirement placed upon an animal protection organization.
Subsection (a)(6) requires an animal protection organization to provide the Board with a hard copy of the controlled substance log for drugs for euthanasia every 60 days, along with a summary report containing the notifications in subsection (b).
The House Professional Licensure Committee (Committee) seeks clarification as to why records documenting the purchase, receipt and disposal of drugs for euthanasia must be kept in hard copy. The Committee recommends the Board consider allowing an animal protection organization to maintain digital records given the requirements to provide the controlled substance log every 60 days and for records to be maintained in a readily retrievable file under Section 31.112 (relating to maintenance of records and inventories of drugs for euthanasia).
In addition, a commentator opined that the requirement to provide the controlled substance log and summary report every 60 days is burdensome. The commentator also suggested these provisions should mirror the DEA's retention requirement, which allows for an inspection by agents at any time.
We ask the Board to address the concerns expressed by the Committee and the commentator, as well as explain why the 60-day reporting requirement is reasonable and necessary. We further ask the Board to consider clarifying the record retention provisions as suggested.
Subsection (b)(5) requires an animal protection organization to include in the 60-day summary notification of a ''[c]hange in the physical location or significant changes to shelter, and if applicable, demonstration that a new DEA Certificate of Registration has been obtained for the new address.'' Subsection (a)(4) requires a separate certificate of registration from the Board and the DEA for each address where euthanasia drugs are stored or administered. Given the need for separate certificates and inspections, notification of these changes does not seem to correspond with procedures for registration as an animal protection organization. We ask the Board to revise the regulation to add procedures for when an animal protection organization changes physical locations or makes significant changes to areas used for euthanasia.
6. Section 31.109. Area used for animal euthanasia; required equipment and supplies.—Economic or fiscal impacts; Need; Reasonableness.
Subsection (a)(4) requires an animal protection organization to provide an area used for animal euthanasia that has ''adequate ventilation to prevent the accumulation of odors, including at least one exhaust fan.'' A commentator asked for an explanation of why an animal protection organization is required to provide adequate ventilation given the expense. We ask the Board to explain why this provision is needed, why it is reasonable and the fiscal impact upon animal protection organizations.
7. Section 31.112. Maintenance of records and inventories of drugs for euthanasia.—Implementation procedures.
Subsection (j) requires an animal protection organization who surrenders certification to send a copy of drug disposal documentation to the Board. A timeframe is not specified. We ask the Board to revise this subsection to include implementation procedures for sending documentation.
8. Section 31.114. Grounds for refusal, suspension, revocation or imposition of other disciplinary sanction.—Implementation procedures; Need.
Under subsection (d), the Board will discipline an animal protection organization who does not admit agents of the Department to conduct investigations or inspections. We have two concerns, similar to those addressed in Comment # 3. First, Section 31.108(a)(7) only requires an animal protection organization to cooperate with the Board and its agents. Second, the Department may only need to be included in this subsection if a memorandum of understanding is entered into with the Department. We ask the Board to address these issues in the Preamble to the final-form regulation and revise this subsection as necessary.
9. Section 31.115. Disciplinary sanctions.—Possible conflict with statutes; Clarity.
Subsection (c) states that the Board ''may summarily revoke the certificate'' of an animal protection organization when the Department revokes a license. (Emphasis added.) Under Section 304(a)(3) of the act, when the Department ''suspends or revokes a kennel license of an animal protection organization. . .the authorization to purchase, possess and administer drugs approved for euthanasia. . .shall be immediately revoked.'' (Emphasis added.) This subsection does not meet the statutory obligation requiring the revocation of a certificate. We ask the Board to revise and clarify this subsection to delete discretionary language and align it with the requirements in Section 304(a)(3) of the act.
10. Section 31.122. Qualifications for licensure.—Protection of the public health, safety and welfare; Implementation procedures; Reasonableness.
Under subsection (a)(2), an applicant for a euthanasia technician license who has not received a high school diploma or an equivalent ''may submit at least three letters or recommendation attesting to applicant's ability to perform the functions of a euthanasia technician, including at least one recommendation from a veterinarian licensed in this Commonwealth or another state.'' The Board explains in the Preamble that a euthanasia technician's duties include ''calculating the correct dosage of drugs to administer to animals based on the strength of the drug, the animal's weight and condition, and the desired effect.'' We have three questions and concerns. First, how will the Board evaluate the letters and recommendations to determine that the applicant has the necessary skills to perform the duties of a euthanasia technician? Second, why is it reasonable to lower the educational requirements for this license given the skills needed to perform this work? Third, how does this provision protect the public health, safety and welfare given the use of controlled substances? We ask the Board to respond to these questions and consider revising this paragraph to delete the provision allowing for an exception to minimum education requirements.
11. Section 31.123. Educational programs and examinations for euthanasia technicians.—Consistency with statute.
Subsection (c)(2) lists the curriculum that must be included in a euthanasia technician certification course. This paragraph does not include ''knowledge of the Commonwealth's statutes and regulations relating to euthanasia'' as required by Section 304(c)(1)(i) of the act. We ask the Board to revise this paragraph to include the statutorily required eligibility criteria.
12. Regulatory Analysis Form—Economic or fiscal impacts.
The Board states in RAF Question # 15 that an applicant for licensure as a euthanasia technician will have to complete a euthanasia technician certification course at an estimated cost of $225. In addition, the supervisor of animal care services is required to complete the didactic portion of the certification course. The estimates in RAF Questions # 19 and 23 do not include the cost of certification courses for euthanasia technicians and supervisors of animal care services. We ask the Board to include these cost estimates in the RAF submitted with the final-form regulation.
RAF Question # 20 does not include cost estimates for local governments. A municipality may be certified to operate an animal shelter. We ask the Board to provide an estimate of costs for local governments in RAF Questions # 20 and 23 or explain why it is not possible to do so.
The Board states in RAF Question # 21 that it will recoup the cost of implementing the regulation through fees. However, these costs are not stated in RAF Questions # 21 and 23. We ask the Board to update the RAF submitted with the final-form regulation to include its costs.
13. Miscellaneous clarity.
• The defined term ''small domestic animals'' and the undefined term ''animal'' are used interchangeably throughout Subchapter B. We ask the Board to review and revise the regulations to ensure the consistent use of the defined term.
• Sections 31.127(b)(6) and 31.128(e) (relating to duties of euthanasia technicians; and standards for euthanasia of small domestic animals) contain different tests for confirming death. These standards should be revised to be consistent.
State Board of Crane Operators
Regulation # 16A-7104 (IRRC # 3338)
Licensure by Endorsement—Crane Operators
June 1, 2022
We submit for your consideration the following comments on the proposed rulemaking published in the April 2, 2022 Pennsylvania Bulletin. Our comments are based on criteria in Section 5.2 of the Regulatory Review Act (Act) (71 P.S. § 745.5b). Section 5.1(a) of the Act (71 P.S. § 745.5a(a)) directs the State Board of Crane Operators (Board) to respond to all comments received from us or any other source.
1. Comments, objections, or recommendations of a committee.
The House Professional Licensure Committee (Committee) submitted the following comments on the proposed regulation:
1. Section 6.16(b)(1)(i)—This section requires an applicant to submit a copy of the current law and regulations along with scope of practice requirements in the jurisdiction that issued a license, certificate, registration, or permit. Act 41 of 2019 does not explicitly state this requirement and the committee recommends changes that remove this responsibility from the applicants and applies it to Board Counsel.
2. Section 6.16(b)(4)—This section states that an applicant must not have any discipline by the jurisdiction that issued the license, certificate, registration, or permit. The committee recommends clarifying this section to specify the types of discipline (i.e., formal discipline or complaint) and the timeframe when such discipline occurred.
3. Section 6.17(b)(1)—This section would give the Board authority to issue a provisional license for less than a year. It is unclear under what circumstances the Board would need to exercise this authority. The Committee asks for clarification.
4. Section 6.17(d)—This section states that the Board will not issue subsequent provisional licenses after the provisional licenses expires. We believe this section is unintentionally vague. Further, Act 41 of 2019 does not specifically state that the Board shall only issue one provisional license. The Committee believes this section should be amended to correct the unintended harm of limiting provisional licenses and would further suggest incorporating a time frame to re-apply.
Under the RRA, the comments, objections, or recommendations of a Committee is one of the criteria the Commission must consider when determining if a regulation is in the public interest. When this proposed regulation is delivered as a final-form regulation to this Commission and the Committees for review, the issues raised by the Committee, and the Board's response to those issues, will be one of the criteria used by this Commission to determine if the regulation is in the public interest.
2. Sections 6.16. Licensure by endorsement.—Economic impact; Protection of the public health, safety, and welfare.
Subparagraphs (a)(1)(i) requires that an applicant must submit a copy of the current applicable law, regulation or other rule governing licensure. certification, registration, or permit requirements and scope of practice in the jurisdiction that issued the license, certificate, registration, or permit. Subparagraphs (a)(1)(iii) requires that the copy of the applicable law, regulation, or other rule must include enactment date of law, regulation, or other rule. These provisions seem to place a substantial burden and possible costs on applicants. Paragraph (a)(2) provides for showing competency by practice in two of the past five years in a ''substantially equivalent jurisdiction or jurisdictions.'' What standard determines whether a jurisdiction is substantially equivalent? This provision, too, seems to place an additional burden on the applicant and/or the Board to prove equivalency since the experience does not have to be in the jurisdiction that the applicant is using for endorsement and also can be in multiple jurisdictions. Has the Board considered, at least for the jurisdictions in the United States, creating and publishing an annual determination of those jurisdictions which have law and regulations substantially equivalent to Pennsylvania? We ask the Board to explain how these provisions in the final regulation balance protection of the public health, safety, and welfare with the burden and cost to applicants and the Board.
3. Compliance with the RRA.
Section 5.2 of the RRA (71 P.S. § 745.5b) directs this Commission 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. To make that determination, the Commission must analyze the text of the proposed regulation and the reasons for the new or amended language. The Commission also considers the information a promulgating agency is required to provide under Section 5 of the RRA in the Regulatory Analysis Form (RAF) (71 P.S. § 745.5(a)). The information contained in the RAF is not sufficient to allow this Commission to determine if the regulation is in the public interest.
We ask the Board to amend the citation for its statutory authority in RAF Question 8. The cited 63 Pa.C.S § 3111 does discuss the Board's obligation in issuing these licenses, but only mentions regulations ''established by the licensing board.'' We ask the Board to identify the specific statutory authority which provides for its actual authority to promulgate these regulations in the final RAF.
RAF Question 14 requires the promulgating agency to describe the communications with and solicitation of input from the public, any advisory council/group, small businesses and groups in the development and drafting of the regulation. It also requires the agency to list the specific persons and/or groups that were involved. The Board's response states that it solicited comments from ''stakeholders and interested parties'' in July of 2020. We ask the Board to provide an updated RAF that includes a list of specific persons and/or groups involved in the development and drafting of the proposal.
To be issued a license by endorsement under 63 Pa.C.S. Section 3111 (relating to licensure by endorsement) as a professional crane operator, an applicant shall provide, among other things, a copy of the current applicable law, regulation, or other rule governing licensure, certification, registration, or permit requirements and scope of practice in the jurisdiction that issued the applicant's license, certificate, registration, or permit. Under Section 6.16(a)(1)(ii), if the applicable law, regulation, or rule is in a language other than English, the document must be translated, at the applicant's expense, by a professional translation service and verified to be complete and accurate. The Board's response to RAF Question 19 does not provide a specific estimate of the costs to the regulated community for translation of an applicable law, regulation or rule. Also, in response to RAF Questions 17, 19, and 23 regarding the financial impact on or cost to the applicant, the Board does not address the cost of a Criminal History Records Check. We ask the Board, when it submits the final version of this rulemaking, to provide an updated RAF that estimates the costs associated with translation and a Criminal History Records Check.
GEORGE D. BEDWICK,
[Pa.B. Doc. No. 22-874. Filed for public inspection June 10, 2022, 9:00 a.m.]
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