NOTICES
Notice of Comments Issued
[31 Pa.B. 3647] Section 5(d) and (g) of the Regulatory Review Act (71 P. S. § 745.5(d) and (g)) provide that the designated standing committees may issue comments within 20 days of the close of the public comment period, and the Independent Regulatory Review Commission (Commission) may issue comments within 10 days of the close of the committees' comment period. The Commission's Comments are based upon the criteria contained in section 5.1(h) and (i) of the Regulatory Review Act (71 P. S. § 745.5a(h) and (i)).
The Commission 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 by the date indicated.
Final-Form Submission Reg. No. Agency/Title Issued Deadline 16A-4910 State Board of
Medicine
Licensure,
Certification,
Examination And
Registration Fees06/21/01 05/21/03 31 Pa.B. 2181 (April 21, 2001) 10-166 Department of Health
Reporting of AIDS,
HIV Test Results,
CD4T-Lymphocyte
Counts and
Perinatal
Exposure of
Newborns to HIV06/21/01 05/21/03 31 Pa. B. 2126 (April 21, 2001) 10-164 Department of Health
Drug and Alcohol
Facilities and
Services-
Standards for
Approval of
Prevention and
Intervention
Activities06/21/01 05/21/03 31 Pa.B. 2124 (April 21, 2001) 6-273 State Board of
Education
Academic Standards
and Assessment06/21/01 05/21/03 31 Pa.B. 2136 (April 21, 2001)
State Board of Medicine
Regulation No. 16A-4910
Licensure, Certification, Examination and Registration Fees
June 21, 2001 We submit for consideration the following objections and recommendations regarding this regulation. Each objection or recommendation includes a reference to the criteria in the Regulatory Review Act (71 P. S. § 745.5a(h) and (i)) which have not been met. The State Board of Medicine (Board) must respond to these Comments when it submits the final-form regulation. If the final-form regulation is not delivered by May 21, 2003, the regulation will be deemed withdrawn.
1. Section 16.13. Licensure, certification, examination and registration fees.--Reasonableness; Clarity.
(a) Medical Doctor License
The existing renewal fee for a Graduate License is $15. A typographical error in the proposed regulation lists the existing fee for renewal of this license as $10. This fee is not being increased by this regulation. The typographical error should be corrected in the final-form regulation.
(c) Physician Assistant Certificate
This subsection contains a new fee for registration of additional supervisors. The House Professional Licensure Committee noted that this new fee was missing from the descriptions of fee changes in the Preamble. When the Board submits the final-form regulation, it should revise the Preamble to reflect this fee increase.
Department of Health
Regulation No. 10-166
Reporting of AIDS, HIV Test Results, CD4 T-Lymphocyte Counts and Perinatal Exposure of Newborns to HIV
June 21, 2001 We submit for consideration the following objections and recommendations regarding this regulation. Each objection or recommendation includes a reference to the criteria in the Regulatory Review Act (71 P. S. § 745.5a(h) and (i)) which have not been met. The Department of Health (Department) must respond to these Comments when it submits the final-form regulation. If the final-form regulation is not delivered by May 21, 2003, the regulation will be deemed withdrawn.
1. Identification of the individual by name and address.--Need; Reasonableness; Protection of the public health, safety and welfare.
Sections 27.22(c)(2)(i) and 27.32(b)(1) require reports to include ''The individual's name and the address, city, county and zip code of the individual's residence.'' Accordingly, the individual would be directly identified in reports to the Department's Bureau of Epidemiology and the Local Morbidity Reporting Office.
The Department claims that confidentiality will not be compromised. The Preamble states ''. . . the confidentiality of the information reported under these proposed regulations will be strictly maintained by the Department and local health departments.'' The Department also explains in the Preamble that:
* This requirement is consistent with recommendations from the United States Center for Disease Prevention and Control (CDC), and with requirements in 34 other states;
* Confidential name based reporting allows the most accurate tracking of Human Immunodeficiency Virus (HIV) disease and increases the opportunity for intervention; and
* Confidential name based reporting is needed for Pennsylvania to qualify for the highest levels of HIV grant money through the Ryan White Comprehensive AIDS Resources Emergency Act.
We have received extensive comment in favor of and against name based reporting. Senators Harold F. Mowery, Jr. and Timothy F. Murphy, Chairperson and Vice Chairperson of the Senate Public Health and Welfare Committee (Senate Committee), submitted a joint letter in support of the regulation, including support of name based reporting, as long as sufficient anonymous testing is available.
Representative Dennis M. O'Brien, Chairperson of the House Health and Human Services Committee (House Committee) submitted a letter stating the House Committee believes unique identifiers should be used as the means of tracking this epidemic. The House Committee believes the use of names in reporting will deter people from being tested, and hence, infected people may never receive treatment. Senator Vincent Hughes, Minority Chairperson of the Senate Committee, expressed similar concerns that ''names-based reporting will create an unnecessary risk of both reduced HIV testing and delayed treatment for those Pennsylvanians who are HIV+.'' Other commentators opposed to reporting the individual's name stated:
* This requirement will deter people from getting tested, and thus compromise treatment and prevention of HIV disease.
* A unique identifier, other than the individual's name and address, can meet all of the requirements and guidelines issued by federal funding agencies.
There are two concerns with including the individual's name and address in a report.
First, the Department should justify the need for the individual's name and address in the report and explain how these reports will be maintained.
Second, the Department should explain why a unique identifier would not accomplish the Department's objectives. Many supporters of name-based reporting also recognize that it may deter some persons from being tested. Hence, they also support anonymous testing to augment the name-based reporting. However, the use of unique identifiers could reduce the need for anonymous testing and reduce delays in treatment and prevention.
2. Reporting electronically.--Protection of the public health, safety and welfare; Economic impact; Reasonableness; Clarity.
Sections 27.22(d)(1) and 27.32(c) and (d) require information to be reported electronically. How can the Department assure the confidentiality of information reported electronically?
Additionally, these sections and Section 27.32a(b) require electronic reporting in a manner specified by the Department. The Regulatory Analysis Form states that the Department will provide training and software.
Yet, the regulation does not specify how electronic reporting will be done or how security will be maintained. What equipment and software are reporters required to use? How much training is involved and how often is training offered? How much will this cost? Who will incur the cost, the Department or the reporters?
3. Coordination of amendments to Chapter 27.--Clarity.
In the May 27, 2000 Pennsylvania Bulletin, the Department published proposed amendments to 28 Pa. Code Chapter 27 titled ''Communicable and Noncommunicable Diseases'' (Proposed Rulemaking #10-156). Included in that rulemaking are amendments to the same sections and lists of diseases being amended by this rulemaking, including Section 27.1 (definitions of District office, LMRO and Local health department), and Sections 27.2, 27.21, 27.22 and 27.32. How will the Department coordinate the amendments in these two rulemakings into a final-form regulation?
4. Section 27.1. Definitions.--Clarity.
Local health department
The last sentence for the definition of ''Local Health Department'' is substantive. For clarity, this should be moved to the body of the regulation.
Perinatal exposure of a newborn to HIV
Commentators questioned this definition because it indicates a need for a substantive judgment by a clinician. What is the intent of ''subjecting to risk of HIV infection'' and who is qualified to make this judgment? As this term is used in Section 27.32, a broad range of individuals may be required to report. Substantive questions involving risk should not be addressed in a definition. Reporters who are qualified to make this determination should be identified in the substantive provisions of the regulation.
5. Section 27.2. Reportable diseases.--Clarity.
This section, as well as Sections 27.32(a)(1) and 27.32(b), reference Acquired Immune Deficiency Syndrome (AIDS) ''as defined by the CDC case definition.'' A citation to the definition used by the CDC should be included.
6. Section 27.22. Reporting results indicative of certain infections or conditions by laboratories.--Reasonableness; Clarity.
Subsection (c)
Subsection (c)(2)(ix) is duplicative of the diseases required to be reported in Subsection (b). Subsection (b) adds CD4 T-lymphocyte test results with certain counts to be reported. Subsection (c)(2)(viii) requires that the results of the test be reported. Therefore, subsection (c)(2)(ix) should be deleted.
Subsection (d)
Paragraphs (4) and (5) require test results to be reported within 5 days. Is 5 days sufficient time for the laboratories to report?
7. Section 27.32. Reporting AIDS, HIV, CD4 T-lymphocyte counts, and perinatal exposure of newborns to HIV by physicians, hospitals, persons or entities, who diagnose AIDS or who receive or provide HIV and CD4 T-lymphocyte test results.--Fiscal impact; Reasonableness; Need; Implementation procedures; Clarity.
Subsection (a)--Entities and persons required to report
This subsection requires a broad range of persons or entities to report AIDS diagnoses, HIV or CD4 T-lymphocyte test results to the state or local health department. There are five related concerns.
Entities and persons who receive or provide test results
First, the Department should carefully delineate the types of entities, facilities or persons who are required to report and are covered by Section 27.32d(a). The types of persons and entities covered by this section appear to be broad and vague. According to the Preamble, the intent is to cover ''case management organizations, drug and alcohol abuse treatment facilities, mobile vans and small clinics that do not have a physician present on a continuous basis.''
Yet, nothing in this section of the regulation indicates that it covers only these types of facilities. Section 27.32(a) identifies a reporter as: ''A physician, hospital, or person or entity providing HIV services, who makes a diagnosis of AIDS or who receives HIV or CD4 T-lymphocyte test results or provides HIV or CD4 T-lymphocyte test results. . . .'' [Emphasis added] Commentators raised several questions concerning the meaning and application of the phrase that appears above in bold type. It is also found in the title of Section 27.32 and in the text of Section 27.32d(a).
Various parts of this phrase such as ''providing HIV services'' could include a broad range of persons and entities. The same is true for the use of the words that would cover anyone ''who receives'' test results ''or provides'' test results to patients. For example, the phrase could include laboratory personnel. The Preamble states that this section ''pertains to reporting by persons that are not laboratories,'' and Section 27.22 in this regulation sets forth reporting requirements for laboratories. However, nothing in Section 27.32 explicitly states that it does not cover a laboratory.
Licensed health care providers and facilities
Second, Subsection 27.32(a) may be duplicative of other reporting requirements in existing regulations. This proposed regulation amends the list of reportable diseases in Section 27.2 by clarifying the definition of AIDS and adding the three other conditions listed again in this section: HIV, CD4 T-lymphocyte test results below certain levels and perinatal exposure of newborns to HIV. Requirements pertaining to reportable diseases for physicians, hospitals, school nurses and other health care practitioners are currently set forth in existing regulations at Sections 27.21, 27.23, 27.24 and 27.25. Listing these conditions as reportable diseases and then creating a new set of reporting requirements for them in Section 27.32 may create unnecessary confusion.
To prevent confusion, the Department should amend existing sections relating to mandated reporters, such as physicians and other licensed health care providers, to include the new reporting requirements for AIDS and the three related conditions. This is the same approach that the Department used for laboratories.
Making a diagnosis of AIDS
Third, Subsection 27.32(a) should be written to make it clear that only a physician may diagnose. As written, the subsection links a ''hospital, or person or entity providing HIV services'' to the words ''makes a diagnosis.'' Commentators expressed concern that the regulation should be clear that only licensed physicians can diagnose a disease.
Responsible person
Fourth, the regulation should identify the persons who will be responsible for making reports for entities that provide HIV services. This section does not indicate who, within an entity, is responsible for making the report. In contrast, Section 27.22(a) states that a person who is in charge of a laboratory must report.
Fiscal impact of multiple reporters
Fifth, the fiscal impact and purpose of this requirement are unclear. For example, a social worker, homeless shelter staff member, mental health center staff member and laboratory director may all file reports on the same individual. What is the need for numerous reports of a single case? What are the costs to the private sector when multiple reporters prepare and file reports? What will be the costs of effectively processing data from thousands of reporters, eliminating duplicates and using the data to monitor, control and prevent disease?
Section 27.32(b)--Contents of report
Paragraphs (8) and (9)
Paragraphs (8) and (9) duplicate the list of reportable diseases in Subsection (a). Paragraphs (8) and (9) are not needed and should be deleted.
Paragraph (10)
Paragraph (10) requires the ''probable mode of transmission'' of the HIV virus as information included in the report to the Department. The Department plans to obtain this information from a report form that it will provide to reporters. However, the report form does not use the words ''probable mode of transmission.'' To avoid confusion, the regulation should use words similar to the form.
Paragraph (14)
Paragraph (14) requires ''other information the Department determines to be relevant.'' What ''other information'' will the Department consider to be relevant? If there is none, this phrase should be deleted. Otherwise, to facilitate compliance and improve clarity, this phrase should be replaced with the specific information required.
8. Section 27.32a. Confidential and anonymous testing.--Protection of the public safety and welfare; Need; Reasonableness; Implementation procedures; Clarity.
Subsection (a)--State-designated anonymous testing sites
This provision states that anonymous testing for HIV may only be provided at ''State-designated anonymous testing sites.'' The House Committee and Senators Mowery, Murphy and Hughes expressed concern regarding the availability of anonymous testing sites. Part of this concern is that the regulation does not describe the term ''State-designated anonymous testing sites.'' The Department should address these concerns by explaining how it will insure both access to and availability of anonymous testing. For example, will the locations and hours of operation of these sites be publicized?
Subsection (b)--Reporting anonymous testing results
This subsection requires anonymous test results to be reported in accordance with Section 27.32 without a patient name. Section 27.32 also includes other identifying information such as the address of the individual's residence, date of birth, sex and race. If this information is required, how is it anonymous? Did the Department intend to include certain categories of information in Section 27.32? Why is this information required in an anonymous test?
9. Section 27.32c. Department authority to require complete reporting.--Clarity
We have two concerns. First, this section is unclear because it is one long sentence. It would be clearer if it were broken into two shorter sentences.
Second, it appears there is a typographical error. This section should be designated as 27.32c, rather than 37.32c.
10. Section 27.32d. Record audits.--Clarity.
Subsection (b) states that the Department may require ''special reports of persons or entities required to report under this chapter.'' There are two concerns. First, what are ''special reports''? Second, Subsection (b) is missing a word. For clarity, the word ''to'' should be inserted between the words ''chapter'' and ''ensure.''
Department of Health
Regulation No. 10-164
Drug and Alcohol Facilities and Services--
Standards for Approval of Prevention and Intervention Activities
June 21, 2001 We submit for consideration the following objections and recommendations regarding this regulation. Each objection or recommendation includes a reference to the criteria in the Regulatory Review Act (71 P. S. § 745.5a(h) and (i)) which have not been met. The Department of Health (Department) must respond to these Comments when it submits the final-form regulation. If the final-form regulation is not delivered by May 21, 2003, the regulation will be deemed withdrawn.
1. General.--Protection of the public health; Reasonableness.
This proposed regulation repeals the standards for approval of prevention and intervention activities for drug and alcohol facilities and services. We question the impact on the public health and the reasonableness of deleting these regulations without proffering any proposed regulations to take their place. Item #16 of the Regulatory Analysis Form states that a workgroup was convened to develop an alternative to the current regulations. However, the alternative is not discussed in the Preamble to the proposed regulation.
With the repeal of these regulations, how will the Department provide oversight of drug and alcohol prevention services and programs? The Department should also explain what alternative will be in place when the Department submits its final-form rulemaking.
State Board of Education
Regulation No. 6-273
Academic Standards and Assessments
June 21, 2001 We submit for consideration the following objections and recommendations regarding this regulation. Each objection or recommendation includes a reference to the criteria in the Regulatory Review Act (71 P. S. § 745.5a(h) and (i)) which have not been met. The State Board of Education (Board) must respond to these Comments when it submits the final-form regulation. If the final-form regulation is not delivered by May 21, 2003, the regulation will be deemed withdrawn.
Science and Technology
1. Section VII. Table of Contents.--Clarity.
The table of contents lists the general subject areas and the specific categories for the academic standards. The text of the regulation labels each category with a capital letter. However, the table of contents does not contain corresponding labels. For ease of reference, the categories listed under each standard in the table of contents should be labeled with the corresponding letter that accompanies each item within the text of the regulation. For example:
Unifying Themes 3.1.
A. Systems
B. Models
C. Patterns
D. Scale
E. Change2. Section VIII. Introduction.--Clarity.
Under the descriptor for Section 3.2. Inquiry and Design, there is a typographical error as published in the Pennsylvania Bulletin. In the second sentence, after the word ''estimating'' the period should be changed to a comma in the final-form regulation.
3. Section 3.1. Unifying Themes.--Clarity.
Standard 3.1.4.D. states, ''Describe scale as a ratio (for example, pipe fittings).'' The use of ''pipe fittings'' as an example is confusing. The Board should consider using ''models'' or ''map scales'' as examples to illustrate the concept.
4. Section 3.2. Inquiry and Design.--Clarity.
The standards in this section include experimental design. Therefore, the title of this section should be changed to ''Inquiry and Experimental Design'' to accurately reflect the content of these standards.
Standard 3.2.10.A. states ''Know that science is limited to the study of observable aspects of the world and the universe.'' The term ''observable'' could be interpreted to mean ''directly visible.'' Since not all scientific phenomena can be ''seen'' directly, (for example, molecular structure) the term ''observable'' should be defined in Section IX. Glossary.
Standard 3.2.10.C. contains a typographical error. In the first sentence, ''to'' should be changed to ''of.''
5. Section 3.3. Biological Sciences.--Need; Clarity.
Standard 3.3.10.D. requires students to ''Analyze evidence of fossil records, similarities in body structures, embryological studies and DNA studies that support or do not support the theory of evolution.'' Standard 3.3.12.D. requires students to ''Analyze the impact of new scientific facts on the theory of evolution.'' We have two concerns.
First, the intent of these two standards is unclear. Numerous commentators have asserted that these standards will allow schools to teach ''creationism'' or ''intelligent design'' as part of the science curriculum. At the Senate Education Committee's June 5, 2001 public hearing, and the House Education Committee's June 6, 2001 meeting, a representative from the Board explained that these standards were not intended to permit the teaching of ''creationism'' or ''intelligent design'' in the public schools. They were intended to encourage critical thinking among students. However, the language in the regulation does not clearly convey the Board's intent.
Second, we question why these two particular standards are necessary. Within Section 3.2. Inquiry and Design, there are two standards which appear to encompass the requirements in Standards 3.3.10.D. and 3.3.12.D. Standard 3.2.10.A. requires students to ''Integrate new information into existing theories and explain implied results.'' Standard 3.2.12.A. requires students to ''Critically evaluate the status of existing theories.'' These standards in Section 3.2. set forth the requirements for examination of new data and critical evaluation of existing scientific theories. Therefore, it appears that Standards 3.3.10.D. and 3.3.12.D., referenced above, duplicate certain standards in Section 3.2. and could be deleted.
6. Section 3.4. Physical Science, Chemistry and Physics.--Reasonableness; Clarity.
Standard 3.4.4.D. requires fourth graders to ''Recognize the earth's place in the solar system'' and to explain ''. . . time (for example, days, seasons) major lunar phases and eclipses.'' Some commentators contend that these requirements are too abstract for fourth grade students to understand. The proposed regulation does not specify the depth of understanding of these concepts required in the fourth grade. The standards should be evaluated in relation to the developmental level of fourth graders, and the final-form regulation should specify the level of recognition and understanding required by these standards.
7. Section 3.5. Earth Sciences.--Reasonableness; Clarity.
Standard 3.5.7.C., relating to Meteorology for seventh graders, expects students to ''Identify how cloud types, wind directions and barometric pressure changes are associated with weather patterns. . . .'' Commentators have suggested that the comparable fourth grade standard should require students to at least identify the cloud types as a precursor to the standard for seventh grade. This approach would be consistent with the sequencing used among the grade levels throughout the standards. The Board should consider revising this standard accordingly.
Standard 3.5.4.D. requires fourth grade students to ''describe locations of fresh and salt water'' in or near Pennsylvania. Also, the tenth and twelfth grade standards require students to compare sources of water and analyze the historical development of water use in Pennsylvania. Commentators have stated that these standards should not be limited to bodies of water in Pennsylvania. Has the Board considered broadening the scope of these standards?
8. IX. Glossary.--Clarity.
In order to distinguish between the terms, the Board should define ''evolution'' and ''theory of evolution'' in this section. Additionally, the terms ''law,'' ''fact,'' ''hypothesis'' and ''theory'' should be defined.
Environment and Ecology
9. Section X. Table of Contents.--Clarity.
In the Pennsylvania Bulletin version of the proposed rulemaking, the title prefacing this section contains a misspelling. The word ''ecology'' should be correctly spelled in the final rulemaking.
Consistent with the comment on the Table of Contents section for the ''Science and Technology'' standards, the categories listed under each standard in the table of contents should be labeled with the corresponding letter that accompanies each item within the text of the regulation. For example:
Watersheds and Wetlands 4.1
A. Cycles
B. Physical Factors
C. Organisms and Ecosystems10. Section 4.4 Agriculture and Society.--Conflict with existing regulations; Reasonableness; Clarity.
The standards under this section focus on ''society's needs,'' ''agricultural systems'' and ''technology.'' There is no discussion of agriculture as a science.
Chapter 4 clearly establishes that planned instruction in the areas of Science and Technology and Environment and Ecology are to include ''instruction about agriculture and agricultural science.'' This explicit language is contained in Sections 4.21(f)(3) relating to science and technology at the elementary education level and (f)(4) relating to environment and ecology at the elementary education level and Sections 4.22(c)(3) relating to science and technology at the middle education level and (c)(5) relating to environment and ecology at the middle education level. Section 4.23(c)(3), relating to the planned instruction area of science and technology for high school education, also specifies ''agricultural sciences.''
Despite the explicit language in Sections 4.21 through 4.23 of Chapter 4, the proposed regulation does not include ''agricultural science'' under the Environment and Ecology standards. Further there is no standard for ''agriculture and agricultural science'' under the Science and Technology standards. Given the significant role that agriculture plays in Pennsylvania's economy, we urge the Board to more closely align the standards with the existing language in Chapter 4 by including ''agricultural science'' under the Science and Technology standards.
11. Section 4.8. Humans and the Environment.--Reasonableness.
The standard in 4.8.12.B. requires students to ''analyze how technology has improved agricultural productivity.'' This standard seems to be more consistent with the standards under Section 4.4.12 relating to ''Agriculture and Society.''
12. Section XII. Glossary.--Clarity.
The terms, ''risk management,'' ''consumer,'' ''shredder,'' ''decomposer,'' ''commodity,'' ''hazardous waste,'' ''environment,'' ''endangered species,'' ''extinct species'' and ''regulation'' are used throughout the standards, but are not defined. The Board should define these terms in this section.
JOHN R. MCGINLEY, Jr.,
Chairperson
[Pa.B. Doc. No. 01-1238. Filed for public inspection July 6, 2001, 9:00 a.m.]
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