PROPOSED RULEMAKING
DEPARTMENT OF HEALTH
[28 PA. CODE CH. 23]
School Immunization
[30 Pa.B. 4591] The Department of Health (Department), with the approval of the State Advisory Health Board (Board), proposes to amend § 23.83 (relating to immunization requirements). The proposed amendment is set forth in Annex A.
A. Purpose of the Proposed Amendment
The proposed amendment sets out immunization requirements that children seeking to enter and attend school in this Commonwealth must meet. The proposed amendment is based upon recommendations of the Advisory Committee on Immunization Practices (ACIP), an advisory committee of the Federal Centers for Disease Control and Prevention (CDC). The proposed amendment would reverse the order of subsections and add explanatory language to the current regulation for the sake of clarity, add new requirements for chickenpox (varicella) immunity, and expand requirements for hepatitis B immunization. The Department is proposing this amendment to ensure that the school environment, known to be an ideal setting for the transmission of communicable diseases, particularly when children are susceptible due to lack of immunity, is made more safe. Hepatitis B and chickenpox, as well as the already listed diseases, carry the risk of serious morbidity, lifelong disability and death.
Children attending schools are known to be a group at high risk for contracting communicable and potentially dangerous diseases. Requiring immunity before a child enters school in first grade or kindergarten, or before the child is permitted to attend a school in the Commonwealth, protects that child before the child enters an environment which readily lends itself to the transmission of disease.
Ensuring that children are appropriately immunized carries with it advantages for the public as a whole, including other high-risk populations, as well as for the child. Vaccinated children who will not contract these diseases will not miss school and suffer discomfort from contracting hepatitis B or chickenpox. In addition, their parents will not be required to take time off from their jobs to care for a sick child, or pay medical bills related to their illness. There is less chance of other persons contacting a highly infectious disease if children are vaccinated. If outbreaks of highly communicable diseases are prevented by immunizations before they occur, public health officials and physicians need not treat or contain an outbreak, and public funds need not be spent on disease intervention activities.
B. Requirements of the Proposed Amendment
Section 23.83. Immunization requirements.
In conjunction with the substantive amendment of this section, the Department is proposing to make minor changes for the purposes of clarity. The Department proposes to reverse the current order of subsections (a) and (b) so that the list of immunizations now required for school entry would appear in subsection (a) and come before the list of immunizations currently required for school attendance, which would now appear in subsection (b). This would place the immunization requirements in appropriate chronological order.
The current regulation relating to religious exemptions remains in effect, and is not affected by this proposed amendment.
Subsection (a). Required for entry.
This subsection is substantially the same as current subsection (b), with some changes. Subsection (a) would clarify that the vaccinations required for children attending school in this Commonwealth are also required for children entering school for the first time. It would remain substantially the same, therefore, with three main additions. Subsection (a) would include the german measles (rubella) vaccination and the mumps vaccination as immunizations required for school entry. This is already the practice, but the Department believes it is necessary to specifically include german measles (rubella) and mumps in subsection (a).
Subsection (a) would also allow hepatitis B immunity to be proven by seriological evidence of antibody to hepatitis B. This requirement would acknowledge that some children may have developed immunity to hepatitis B. Allowing proof of immunity by laboratory testing will avoid unnecessary vaccination for those children.
Further, subsections (a) and (b) currently recommend the combined DTP immunization for the purposes of immunizing against diphtheria and pertussis, and the combined MMRII vaccine for the purposes of immunizing against measles, mumps and german measles (rubella). The Department is proposing not to retain this language in subsection (a), as it is a recommendation, and not a regulatory standard. The Department does believe that the combined MMRII vaccine should be recommended for children under the age of 7 years. The Department would, however, recommend the combined DTaP vaccine in place of the combined DTP vaccine. DTaP is a newer and improved vaccine. Although the risk for side effects with either vaccine is minimal when weighed against the benefits of immunization, DTaP is associated with fewer side effects than DTP, and reduces the risk of convulsions and high fever.
The Department is also proposing to add chickenpox (varicella) immunity to the list of requirements for entry in kindergarten or first grade. In lieu of this vaccination, subsection (a)(8) would permit a parent, guardian or physician to provide a written statement of history of chickenpox immunity, or would permit the child's history of immunity to be proved by laboratory testing.
Chickenpox is a highly contagious disease that may result in discomfort, severe illness and death to the child. The disease may cause absence from school, which could have a deleterious effect on the child's school career. A child's illness from chickenpox can result in a parent or guardian expending money to treat an otherwise preventable disease, as well as causing worry and absence from work to care for the child. There is also the possibility of an outbreak of the disease in a susceptible population, for example, nonimmunized school-age children, multiplying the effect throughout the community. The May 28, 1999, Morbidity and Mortality Weekly Report (MMWR), a publication of the CDC, reported that chickenpox (varicella) incidence is highest among children aged 1--6 years. Therefore, implementing immunity requirements for school entry will have a great effect on reducing the incidence of disease. The CDC noted in a 1997 study that for every dollar spent for chickenpox (varicella) vaccine, $5.40 is saved in indirect health benefit costs (work lost) and direct medical costs. Requiring chickenpox (varicella) immunity will therefore save money for both the Commonwealth and the public.
The Department, with the approval of the Board, has determined that it is more effective for the prevention and control of the spread of disease, and in the interests of the children of this Commonwealth, as well as other susceptible populations, to require immunization for this disease. Both the American Academy of Pediatrics and the ACIP recommend that this vaccination be given. The Department, with the approval of the Board, has chosen to follow that recommendation.
Subsection (b). Required for attendance.
This subsection is substantially the same as current subsection (a). The Department is proposing some changes to this subsection as well as repositioning it. Subsection (b) would make clear that a child in school in this Commonwealth who has not received immunizations as listed in subsection (a), for whatever reason, would be required to receive the immunizations listed in subsection (b) as a condition of continued attendance.
As in proposed subsection (a), the Department is proposing to add language permitting laboratory proof of hepatitis B in lieu of a vaccination. The Department is also proposing not to retain language recommending the use of the combined DTP vaccine and the combined MMRII vaccine.
Subsection (c). Required for entry into the seventh grade.
This subsection is new. The Department is proposing to delete the current text of subsection (c) as unnecessary. Subsection (c) currently requires that two doses of the measles (rubeola) immunization be an all-grades requirement beginning in the school year 2000--2001. The requirement for this immunization would be included in subsections (a) and (b).
Subsection (c), as amended, would require that three properly spaced doses of the hepatitis B vaccine be given upon entry into the seventh grade or, in a nongraded system, at the time a child is 12 years of age if the child did not previously receive the immunization. Hepatitis B is also a serious and highly contagious disease. Section 3 of the Newborn Child Testing Act (35 P. S. § 623) requires vaccination for the disease at school entry. Section 2 of that law (35 P. S. § 622) also requires the Department to implement a program of hepatitis B prevention through immunization of children. The MMWR for November 22, 1996, reported that in the United States, most persons with hepatitis B contracted the virus as young adults or adolescents. In that November MMWR, ACIP recommended that adolescents at 11 and 12 years of age, who have not been previously vaccinated for the virus, should be vaccinated against hepatitis B. Based on this recommendation, the Department, with the approval of the Board, is proposing to expand its regulation to require the hepatitis B vaccination in the seventh grade, or, in an ungraded class, in the year in which the child is 12 years of age, as part of its hepatitis B prevention program.
Subsection (c) would also require that the chickenpox (varicella) vaccination be given to children in the seventh grade, or, in an ungraded class, in the year in which the child is 12 years of age, if the child has not already acquired immunity. This proposal is based upon ACIP recommendations, and has the approval of the Board. Subsection (c)(2)(i) and (ii) would set out proper dosages for different age groups. As in subsection (a)(8)(i), subsection (c)(2)(iii) would accept a history of chickenpox immunity proved by laboratory testing, or would allow a parent, guardian or physician to provide a statement of history of chickenpox disease, in lieu of the immunization. Subsection (c)(2)(iii) would also permit an emancipated child to provide this statement.
C. Affected Persons
This proposed amendment would affect children entering school for the first time in kindergarten or first grade in this Commonwealth, and those children attending school in this Commonwealth who have not yet been vaccinated for hepatitis B or chickenpox (varicella). The proposed amendment would also affect their parents or guardians. The proposed amendment would also affect school districts and their employes, since school districts are required to ensure that children attending school have the appropriate vaccinations. To the extent that physicians would be requested by parents and guardians to provide vaccination histories or other proof of vaccination, physicians would also be affected tangentially.
D. Cost and Paperwork Estimate
Cost
Commonwealth
The Commonwealth would incur some costs for the purchase and administration of the additional vaccines. The savings, however, in terms of the amount of funds that would not be needed to coordinate disease outbreak investigations and control measures, would outweigh the additional program and vaccine costs.
Local Government
There would be no additional cost to local governments. Local governments should see some cost savings from the prevention of disease outbreaks, since local governments do bear some of the cost of disease outbreak investigations and control measures.
Regulated Community
Families whose children's vaccinations are covered by their insurance plans (public or private) under State law should not see any out-of-pocket cost for the vaccinations. Families whose insurance plans do not cover these vaccinations, or who do not have insurance, will need to seek other assistance to pay for vaccinations, or pay out-of-pocket. In general, there is other assistance provided for vaccinations from the Department, if no third-party payer is available. The Department provides vaccinations either free of charge, or charges a fee based on a sliding fee scale according to the family's income. The savings in prevention of childhood illness would outweigh the minimal cost of the vaccine.
School districts already have mechanisms in place for determining whether or not children have been appropriately immunized, and taking action based on that determination. This proposed amendment would add two additional immunizations to review, which should not add to the current cost of ensuring immunizations are up to date. Again, the savings in prevention of an outbreak of a childhood illness in a school district should outweigh the minimal cost in staff time to review two additional immunizations.
General Public
The general public should not see an increase in cost.
Paperwork Estimates
Commonwealth and the Regulated Community
There would be minimal additional paperwork requirements for the Commonwealth and the regulated community. The requirement that school districts report the number of immunizations is already in place. The proposed amendment would merely add two additional immunization requirements to the current list of required immunizations.
Although physicians could be requested by a parent or guardian to provide an immunization history for varicella, the Department would not be mandating that physicians provide an immunization history. The proposed amendment merely states that the Department would accept this history in lieu of the actual vaccination requirement.
Parents and guardians would need to present information relating to varicella immunity when children enter school for the first time in this Commonwealth in kindergarten or the first grade. Parents, guardians and emancipated children would need to present information relating to hepatitis B immunity when entering the seventh grade.
Local Government
There is no additional paperwork requirement for local government.
General Public
There is no additional paperwork requirement for the general public.
E. Statutory Authority
The Department obtains its authority to promulgate regulations relating to immunizations in schools from several sources. Generally, the Disease Prevention and Control Law (35 P. S. §§ 521.1--521.21) (act) provides the Board with the authority to issue rules and regulations on a variety of issues relating to communicable and noncommunicable diseases, including what control measures are to be taken with respect to which diseases, provisions for the enforcement of control measures, requirements concerning immunization and vaccination of persons and animals, and requirements for the prevention and control of disease in public and private schools. Section 16(b) of the act (35 P. S. § 521.16(b)) gives the Secretary of Health (Secretary) the authority to review existing regulations and make recommendations to the Board for changes the Secretary considers to be desirable.
The Department also finds general authority for the promulgation of its regulations in section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)), which gives the Department this general authority. Section 2111(b) of The Administrative Code of 1929 (71 P. S. § 541(b)) provides the Board with additional authority to promulgate regulations deemed by the Board to be necessary for the prevention of disease, and for the protection of the lives and the health of the people of this Commonwealth. That section further provides that the regulations of the Board shall become the regulations of the Department.
The Department's specific authority for promulgating regulations relating to school immunizations is found in The Administrative Code of 1929 and in the Public School Code of 1949 (24 P. S. §§ 1-101). Section 2111(c.1) of The Administrative Code of 1929 (71 P. S. § 541(c.1)) provides the Board with the authority to make and revise a list of communicable diseases against which children are required to be immunized as a condition of attendance at any public, private or parochial school, including kindergarten. The section requires the Secretary to promulgate the list, along with any rules and regulations necessary to insure the immunizations are timely, effective and properly verified.
Section 1303a of the Public School Code of 1949 (24 P. S. § 13-1303a) provides that the Board will make and review a list of diseases against which children must be immunized, as the Secretary may direct, before being admitted to school for the first time. The section provides that the school directors, superintendents, principals or other persons in charge of any public, private, parochial or other school including kindergarten, shall ascertain whether the immunization has occurred, and certificates of immunization will be issued in accordance with rules and regulations promulgated by the Secretary with the sanction and advice of the Board.
The Hepatitis Prevention Act (35 P. S. §§ 630.1--630.3) provides the Department with authority to implement a program for the prevention of hepatitis B through immunization of children consistent with ACIP's recommendations. (See 35 P. S. § 630.2).
F. Effectiveness/Sunset Dates
The proposed amendment will become effective upon final publication in the Pennsylvania Bulletin. No sunset date has been established. The Department will continually review and monitor the effectiveness of this regulation.
G. Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on August 23, 2000, the Department submitted a copy of this proposed amendment to the Independent Regulatory Review Commission (IRRC) and to the Chairpersons of the House Health and Human Services Committee and the Senate Public Health and Welfare Committee. In addition to submitting the proposed amendment, the Department has provided IRRC and the Committees with a copy of a Regulatory Analysis Form prepared by the Department in compliance with Executive Order 1996-1, ''Regulatory Review and Promulgation.'' A copy of this material is available to the public upon request.
If IRRC has objections to any portion of the proposed amendment, it will notify the Department within 10 days of the close of the Committees' review period. The notification shall specify the regulatory review criteria which have not been met by that portion. The Regulatory Review Act specifies detailed procedures for review, prior to final publication of the regulation by the Department, the General Assembly and the Governor, of objections raised.
H. Contact Person
Interested persons are invited to submit written comments, suggestions or objections regarding the proposed amendment to Alice Gray, Director, Division of Immunization, Department of Health, P. O. Box 90, Harrisburg, PA 17108, (717) 787-5681, within 30 days after publication of this notice in the Pennsylvania Bulletin. Persons with a disability who wish to submit comments, suggestions or objections regarding the proposed amendment may do so by using V/TT (717) 783-6514 for speech or hearing impaired persons or the Pennsylvania AT&T Relay Service at (800) 654-5984[TT]. Persons who require an alternative format of this document may contact Ms. Gray so that necessary arrangements may be made.
ROBERT S. ZIMMERMAN, Jr.,
SecretaryFiscal Note: 10-162. No fiscal impact; (8) recommends adoption. Funding for the childhood immunization program comes from the Federal government in the form of a grant. Funding is available to serve children receiving publicly funded vaccines from the Department of Health. The Department of Public Welfare through its Medical Assistance program is currently providing coverage for immunizations established by the Advisory Committee on Immunization Practices which include the Hepatitis B and chicken pox vaccinations.
Annex A
TITLE 28. HEALTH AND SAFETY
PART III. PREVENTION OF DISEASES
CHAPTER 23. SCHOOL HEALTH
Subchapter C. IMMUNIZATION § 23.83.
Immunization requirements. (a) [Required for attendance. The following immunizations are required as a condition of attendance at school in this Commonwealth.
(1) Diphtheria. Three or more properly spaced doses of diphtheria toxoid, which may be administered as a single antigen vaccine, in combination with tetanus toxoid or in combination with tetanus toxoid and pertussis vaccine. The Department recommends the combined DTP vaccine for children under 7 years of age.
(2) Tetanus. Three or more properly spaced doses of tetanus toxoid, which may be administered as a single antigen vaccine, in combination with diphtheria toxoid or in combination with diphtheria toxoid and pertussis vaccine. The Department recommends the combined DTP vaccine for children under 7 years of age.
(3) Poliomyelitis. Three or more properly spaced doses of either oral polio vaccine or enhanced inactivated polio vaccine, but if a child received any doses of inactivated polio vaccine prior to 1988, a fourth dose of inactivated polio vaccine is required.
(4) Measles (rubeola). One dose of live attenuated measles vaccine administered at 12 months of age or older or a history of measles immunity proved by serological evidence showing antibody to measles determined by the hemagglutination inhibition test or a comparable test. Measles vaccine may be administered as a single antigen vaccine. The Department recommends the combined MMRII vaccine.
(5) German measles (rubella). One dose of live attenuated rubella vaccine administered at 12 months of age or older or a history of rubella immunity proved by serological evidence showing antibody to rubella determined by the hemagglutination inhibition test or a comparable test. Rubella vaccine may be administered as a single antigen vaccine. The Department recommends the combined MMRII vaccine.
(6) Mumps. One dose of attenuated mumps vaccine administered at 12 months of age or older or a physician diagnosis of mumps disease indicated by a written record signed by the physician or the physician's designee. Mumps vaccine may be administered as a single antigen vaccine. The Department recommends the combined MMRII vaccine.] Required for entry. The following immunizations are required for entry into school for the first time at the kindergarten or first grade level, at a public, private or parochial school in this Commonwealth, including special education and home education programs.
(1) Hepatitis B. Three properly-spaced doses of hepatitis B vaccine or a history of hepatitis B immunity proved by laboratory testing.
(2) Diphtheria. Four or more properly-spaced doses of diphtheria toxoid, which may be administered as a single antigen vaccine, in combination with tetanus toxoid or in combination with tetanus toxoid and pertussis vaccine. One dose shall be administered on or after the 4th birthday.
(3) Tetanus. Four or more properly-spaced doses of tetanus toxoid, which may be administered as a single antigen vaccine, in combination with diphtheria toxoid or in combination with diphtheria toxoid and pertussis vaccine. One dose shall be administered on or after the 4th birthday.
(4) Poliomyelitis. Three or more properly-spaced doses of a combination of oral polio vaccine or enhanced inactivated polio vaccine.
(5) Measles (rubeola). Two properly-spaced doses of live attenuated measles vaccine, the first dose administered at 12 months of age or older, or a history of measles immunity proved by serological evidence showing antibody to measles as determined by the hemagglutination inhibition test or a comparable test. Each dose of measles vaccine may be administered as a single antigen vaccine.
(6) German measles (rubella). One dose of live attenuated rubella vaccine, administered at 12 months of age or older or a history of rubella immunity proved by serological evidence showing antibody to rubella determined by the hemagglutination inhibition test or a comparable test. Rubella vaccine may be administered as a single antigen vaccine.
(7) Mumps. One dose of live attenuated mumps vaccine, administered at 12 months of age or older or a physician diagnosis of mumps disease indicated by a written record signed by the physician or the physician's designee. Mumps vaccine may be administered as a single antigen vaccine.
(8) Chickenpox (varicella). One of the following:
(i) One dose of varicella vaccine, administered at 12 months of age or older.
(ii) A history of chickenpox immunity proved by laboratory testing or a written statement of history of chickenpox disease from a parent, guardian or physician.
(b) [Required for entry. The following immunizations are required for entry into school for the first time at the kindergarten or first grade level, at any public, private or parochial school, including special education and home education programs.
(1) Hepatitis B. Three properly-spaced doses of hepatitis B vaccine.
(2) Diphtheria. Four or more properly-spaced doses of diphtheria toxoid, which may be administered as a single antigen vaccine, in combination with tetanus toxoid or in combination with tetanus toxoid and pertussis vaccine. The Department recommends the combined DTP vaccine. One dose shall be administered on or after the 4th birthday.
(3) Tetanus. Four or more properly-spaced doses of tetanus toxoid, which may be administered as a single antigen vaccine, in combination with diphtheria toxoid or in combination with diphtheria toxoid and pertussis vaccine. The Department recommends the combined DTP vaccine. One dose shall be administered on or after the 4th birthday.
(4) Poliomyelitis. Three or more properly-spaced doses of any combination of oral polio vaccine or enhanced inactivated polio vaccine.
(5) Measles (rubeola). Two properly-spaced doses of live attenuated measles vaccine, the first dose administered at 12 months of age or older, or a history of measles immunity proved by serological evidence showing antibody to measles as determined by the hemagglutination inhibition test or a comparable test. Each dose of measles vaccine may be administered as a single antigen vaccine. The Department recommends the combined MMRII vaccine.] Required for attendance. The following immunizations are required as a condition of attendance at school in this Commonwealth if the child has not received the immunizations required for school entry listed in subsection (a):
(1) Diphtheria. Three or more properly spaced doses of diphtheria toxoid, which may be administered as a single antigen vaccine, in combination with tetanus toxoid or in combination with tetanus toxoid and pertussis vaccine.
(2) Tetanus. Three or more properly spaced doses of tetanus toxoid, which may be administered as a single antigen vaccine, in combination with diphtheria toxoid or in combination with diphtheria toxoid and pertussis vaccine.
(3) Poliomyelitis. Three or more properly spaced doses of either oral polio vaccine or enhanced inactivated polio vaccine, but if a child received any doses of inactivated polio vaccine administered prior to 1988, a fourth dose of inactivated polio vaccine is required.
(4) Measles (rubeola). Two properly spaced doses of live attenuated measles vaccine, administered at 12 months of age or older or a history of measles immunity proved by serological evidence showing antibody to measles determined by the hemagglutination inhibition test or a comparable test. Each dose of measles vaccine may be administered as a single antigen vaccine.
(5) German measles (rubella). One dose of live attenuated rubella vaccine, administered at 12 months of age or older or a history of rubella immunity proved by serological evidence showing antibody to rubella determined by the hemagglutination inhibition test or any comparable test. Rubella vaccine may be administered as a single antigen vaccine.
(6) Mumps. One dose of live attenuated mumps vaccine, administered at 12 months of age or older or a physician diagnosis of mumps disease indicated by a written record signed by the physician or the physician's designee. Mumps vaccine may be administered as a single antigen vaccine.
(c) [Required for the school year 2000/2001. The following immunization shall be an all-grades requirement at the beginning of the 2000/2001 school year (August/September 2000) for attendance at school in this Commonwealth:
Measles (rubeola). Two properly-spaced doses of attenuated measles vaccine, the first dose administered at 12 months of age or older, or a history of measles immunity, proved by serological evidence showing antibody to measles as determined by the hemagglutination inhibition test or a comparable test. Each dose of measles vaccine may be administered as single antigen. The Department recommends the combined MMRII vaccine.] Required for entry into 7th grade. In addition to the immunizations listed in subsection (b), the following immunizations are required at any public, private, parochial or vocational school in this Commonwealth, including special education and home education programs, as a condition of entry for students entering the seventh grade; or, in an ungraded class, for students in the school year that the student is 12 years of age:
(1) Hepatitis B. Three properly-spaced doses of hepatitis B vaccine or a history of hepatitis B immunity proved by laboratory testing.
(2) Chickenpox (varicella). One of the following:
(i) One dose of varicella vaccine, administered at 12 months of age or older.
(ii) Two properly-spaced doses of varicella vaccine for children 13 years of age and older.
(iii) A history of chickenpox immunity proved by laboratory testing, or a written statement of history of chickenpox disease from the parent, guardian, emancipated child or physician.
[Pa.B. Doc. No. 00-1502. Filed for public inspection September 1, 2000, 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.
