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PROPOSED RULEMAKING

DEPARTMENT OF HEALTH

[ 28 PA. CODE CH. 23 AND 27 ]

Communicable and Noncommunicable Diseases

[38 Pa.B. 750]
[Saturday, February 9, 2008]

   The Department of Health (Department), with the approval of the State Advisory Health Board (Board), proposes to amend 28 Pa. Code Chapter 23, Subchapter C (relating to immunization) and 28 Pa. Code § 27.77 (relating to immunization requirements for children in child care group settings). The proposed amendments are set forth in Annex A.

A.  Purpose of the Regulation

   The proposed amendments would revise § 23.83 (relating to immunization requirements) to combine immunization requirements for school entry into kindergarten or first grade with immunization requirements for school attendance in all grades; and to add two new immunization requirements for entry into the seventh grade. The Department has developed these proposed amendments following review of the recommendations of the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP). The Department has determined that certain of ACIP's recommendations would serve to meet the needs of the Commonwealth with respect to requirements for school immunizations. The proposed amendments would require that students before entering school be immunized with the hepatitis B vaccine (previously required for entry into either kindergarten or first grade and entry into the seventh grade); and would require that students entering the seventh grade be immunized with the tetanus, diphtheria and acellular pertussis (Tdap) vaccine, if at least 5 years has elapsed since their last tetanus and diphtheria immunization, and be immunized with the meningococcal conjugate vaccine (MCV).

   Finally, the proposed amendments would institute ACIP recommendations regarding an additional dose requirement for mumps vaccine and for varicella vaccine. The proposed amendments would change the existing requirement for varicella immunity upon school entry and for entry into the seventh grade into an all-grades requirement, but would phase in the 2-dose requirement. Children entering school in kindergarten or first grade would be required to have 2 properly-spaced doses of the vaccine. The Department's requirement that children who are 13 years of age or older have 2 properly-spaced doses for entry into the seventh grade would become a requirement for school attendance for those children. The Department would then require 2 properly-spaced doses of the varicella vaccine for all grades beginning school year 2010/2011. The proposed amendments would not alter the existing option that varicella immunity may be proven by either a written history from a parent, guardian or physician or by laboratory confirmation of the disease.

   Further, the proposed amendments are also intended to clarify what immunization requirements apply to children under the age of 5 years attending child care group settings located in a school. In addition, the proposed amendments are intended to clarify that children in a school district operated prekindergarten program, early intervention program operated by a contractor or subcontractor (this includes districts, intermediate units and private vendors), and in a private academic preschool are required to obtain appropriate immunizations as a condition of attending those programs.

   Finally, the proposed amendments would also add a 4-day grace period for vaccine administration, also in accordance with recommendations of ACIP, and would revise the Department's requirements for school reporting of immunizations in § 23.86 (relating to school reporting).

B.  Requirements of the Regulation

CHAPTER 23. SCHOOL HEALTH

Subchapter C. IMMUNIZATION

§ 23.82. Definitions.

   The Department proposes to clarify the definition for ''attendance at school.'' It proposes to add a sentence to that definition that clarifies that attendance at school does not include the attendance of children in child care group settings located in schools. The term ''child care group setting,'' and the requirements for immunizations relating to those settings are included in the Department's regulations relating to communicable and noncommunicable diseases in § 27.1 (relating to definition) and § 27.77(d). Section 27.77(d) states that children attending kindergarten, elementary school or higher school and children known to the care giver to be 5 years of age or to attend a kindergarten are to follow the requirements in § 28.83. The Department promulgated these exceptions to § 27.77 because some immunizations required in § 27.77 are not age-appropriate for these children. Immunization requirements should be applied based on age, not on the location of the child. The requirements in § 23.83 are those that are appropriate for a child older than the age of 5 years, and are those recommended by ACIP for children in those age groups.

   Although § 27.77 is clear on which immunizations are appropriate by age in a child care group setting, there is no comparable language in § 23.83. This has resulted in some confusion when a child care group setting is located in a school, or where a school has a K-4 class, that is, kindergartens that accept children at the age of 4 years. The Department is proposing to add a new subsection (d) to § 23.83 to clarify that children attending child care group settings located in schools are to follow the immunization requirements included in § 27.77. These requirements are specifically geared towards children under the age of 5 years. It would be medically inappropriate and contrary to the recommendations of ACIP for these children to be required to have some doses of certain immunizations listed in § 23.83. If a child attending that child care group setting is older than 5 years of age, the school immunization requirements would apply regardless of the child's location.

   To take into account the attendance of children younger than 5 years of age in kindergarten classes, the Department is also proposing to make changes to § 27.77(d). Those revisions would reflect this change in the ages of children attending kindergartens, and ensure that the immunizations required to be given to children are age-appropriate, regardless of the setting in which the child is located.

§ 23.83. Immunization requirements.

Subsection (a). Duties of a school director, superintendent, principal or other person in charge of a public, private, parochial or nonpublic school.

   The Department proposes to combine subsection (a), which addresses immunizations required for entry into kindergarten or first grade, with subsection (b), which addresses immunizations required for attendance in all grades. Because there should be no difference between the list of immunizations required for school entry, and those required for school attendance, there is no need for two separate subsections addressing those immunization requirements. The Department proposes to create a new subsection (a), relating to duties of a school director, superintendent, principal, or other person in charge of a public, private, parochial or nonpublic school. New subsection (a) would include the statutory requirement that a school director, the superintendent, principal, or other person in charge of public, private, parochial or other nonpublic schools within this Commonwealth must ascertain whether children are immunized in accordance with the list of immunizations developed by the Department. That list is set out in proposed subsection (b).

   These amendments would make no change to the regulation that permits provisional enrollment of students who have received at least 1 dose of the required immunization for a disease. A child may enter school with 1 dose of a vaccine series, but is then required to obtain all the necessary doses to continue in attendance. See § 23.85 (relating to responsibilities of schools and school administrators).

Subsection (b). Required for attendance.

   The Department proposes to revise subsection (b) of this section to add hepatitis B immunizations (see proposed paragraph (7)) and chickenpox (varicella) immunity (see proposed paragraph (8)), now required for entry into kindergarten or first grade, to those immunizations required for school attendance. The Department chose to phase in the requirements for hepatitis B immunizations and varicella immunity of all students attending school by requiring those immunizations first be obtained upon school entry into kindergarten or first grade and into the seventh grade, rather than requiring immediate compliance in all grade levels. This allowed schools to gradually require compliance of their student populations. In 1998, the hepatitis B immunization requirement and the 4th dose of tetanus/diphtheria immunization requirement were added to school entry into kindergarten or first grade. In 2002, the chickenpox (varicella) immunity requirement was added to school entry into kindergarten or first grade; and the hepatitis B immunization and varicella immunity requirements were added to entry into the seventh grade. Those children initially affected by the 1998 requirements are now in grade 8 and those children initially affected by the 2002 regulation are now in grades 4 and 11. Therefore, there are not many children that remain to ''catch up'' with one or both of these requirements.

   In addition to making varicella immunity an all-grades requirement, the Department is proposing to revise the requirements for vaccination, in accordance with ACIP recommendations. ACIP recommends that children receive 2 doses of the varicella vaccine for them to be appropriately immunized. To meet this recommendation without placing undue burden on either parents and guardians, who must obtain these vaccinations for their children, or on schools, which must determine whether children have met these requirements to attend school, the Department has elected to phase in the 2 varicella dose requirement. The Department proposes that until the school year 2010/2011, in order to enter school in kindergarten or first grade, children must have 2 properly-spaced doses of varicella vaccine administered after 12 months of age. (See proposed paragraph (8)(i)(A).) Children 13 years of age or older would also be required to have 2 properly-spaced doses to attend school. This requirement had been in place solely for children entering the seventh grade; the proposed amendments would make it a requirement for school attendance for children 13 years of age or older. (See proposed paragraph (8)(i)(B).) At the beginning of school year 2010/2011, all children will be required to have 2 properly-spaced doses of varicella vaccine to attend school. (See proposed paragraph (8)(i)(C).)

   Finally, the Department has not altered the provision allowing immunity to be proven by laboratory evidence or laboratory confirmation of the disease or by the statement from a physician, parent or guardian of a history of disease, rather than by evidence of a vaccination. (See proposed paragraph (8)(ii).)

   The Department is also proposing to revise subsection (b), paragraphs (4) and (5), which state what is required to show a history of immunity from measles (rubeola) and from German measles (rubella). In both those paragraphs, a history of immunity may be shown by ''serological evidence showing antibody determined by the hemagglutination inhibition test or any comparable test.'' Because of changing technology, however, the Department is reluctant to continue to require a specific test for this particular purpose. The Department, therefore, is proposing to replace the language in both paragraphs with the requirement that a history of immunity be shown by ''laboratory testing.'' (See proposed subsection (b)(4) and (5).) This allows the most effective test for this purpose to be used, without dictating what test is being required.

   Finally, the Department is also proposing to amend subsection (b), paragraphs (1), (2) and (6) to add new dosage requirements relating to diphtheria/tetanus and mumps. Paragraphs (1) and (2) currently only require 3 doses of diphtheria/tetanus; the Department proposes to require a 4th dose after the child's 4th birthday. Paragraph (6) currently requires only 1 dose of live attenuated mumps vaccine for children at 12 months of age or older for attendance at school. (28 Pa. Code § 23.83(b)(6).) In response to recent outbreaks of mumps in school-age children who had been previously vaccinated, ACIP recently revised recommendations for mumps immunizations to recommend 2 doses of mumps vaccine instead of 1 dose for school-aged children, that is, children attending school in kindergarten through the 12th grade. Observation of the recent mumps outbreaks in schools suggests that 1 dose of the mumps vaccine or MMR (measles, mumps, rubella) vaccine is not sufficient to prevent mumps outbreaks in school-age children. The Department is proposing to adopt ACIP's recommendation, and proposing to add the requirement of an additional dose of live attenuated mumps vaccine to prevent future outbreaks of mumps in schools in this Commonwealth.

Subsection (c). Required for entry into the 7th grade.

   The Department proposes to revise subsection (c), which lists those immunizations required for entry into the seventh grade, to delete the hepatitis B immunization and varicella immunity requirements and to include tetanus and diphtheria toxoid and acellular pertussis vaccine (Tdap) and meningococcal conjugate vaccine (MCV) immunizations. The proposed amendment would require 1 dose of Tdap vaccine, if at least 5 years have elapsed since the last dose of a vaccine containing tetanus and diphtheria toxoid, and 1 dose of MCV.

   Pertussis is the most prevalent vaccine preventable disease among older children, adolescents and adults. The number of adolescents and adults diagnosed with pertussis has increased five-fold over the past 14 years. In 2003 in the United States, persons 11-18 years of age made up 36% of the total reported pertussis cases. In 2004, there were 342 cases of pertussis in this Commonwealth with 91 of those cases in the 10-14 year old age group. Children complete their routine series of tetanus/diphtheria/pertussis vaccine at 4 to 6 years of age; data suggest that immunity declines 5 to 10 years after the last childhood vaccination.

   Pertussis is easily transmitted and carries risks in older age groups, as well as for unimmunized or partially immunized infants. In older age groups, risks include prolonged coughing, vomiting and missed school or work. The clinical presentation of pertussis in adolescents ranges from mild cough illness to serious and prolonged coughing lasting for weeks to months. Pertussis outbreaks in schools with adolescents are disruptive and lead to significant public health control efforts. Studies have reported that parents lose an average of 6 days of work to care for an ill child with pertussis. This translates to an average cost of $767 in lost productivity. Adolescents miss an average of 5.5 days of school with pertussis. When pertussis is transmitted to unimmunized or partially immunized infants, the complications can be serious.

   The Federal Food and Drug Administration (FDA) licensed two Tdap vaccines in 2005 to provide protection against these diseases in adolescents and adults. On June 30, 2005, ACIP recommended the routine use of Tdap vaccine in adolescents 11-18 years of age. ACIP's preferred age for the Tdap immunization is 11-12 years of age. The Department is proposing to follow these recommendations by making the Tdap immunization required for entry into the 7th grade or at 12 years of age in an ungraded class if at least 5 years have elapsed since the last dose of a vaccine containing tetanus and diphtheria toxoid has been received.

   The proposed amendments would also require 1 dose of MCV for entry into the 7th grade or at 12 years of age in an ungraded class. (See proposed subsection (c)(2).) This newly licensed meningococcal conjugate vaccine, licensed as of January 14, 2005, by the FDA for use in persons 11-55 years of age, offers longer protection against meningococcal disease than previous meningococcal vaccines.

   Meningococcal disease strikes up to 3,000 Americans, killing approximately 300 people every year. Ten to 12% of people with meningococcal disease die and among survivors up to 15% may suffer long-term permanent disabilities including hearing loss, limb amputation or brain damage. Meningococcal disease is particularly dangerous because it progresses rapidly and can kill within hours. Although the incidence of invasive meningococcal disease is highest in infants, the case fatality rate is highest in adolescents. The incidence of invasive meningococcal disease peaks in infants younger than 12 months, but a second peak occurs during adolescence.

   The General Assembly has recognized the dangers of meningococcal disease. In response to these concerns, it passed the College and University Student Vaccination Act (35 P. S. §§ 633.1--633.3), which prohibits a student from residing in a college or university dormitory or housing unit unless the student has a one-time vaccination against meningococcal disease. (See 35 P. S. § 633.3.)

   ACIP has recommended routine vaccination of adolescents (defined as persons 11-12 years of age) at a preadolescent health-care visit. For those adolescents who have not previously received MCV, ACIP recommends vaccination before high school entry (at approximately 15 years of age) and for college freshmen living in dormitories. The Department has reviewed ACIP's recommendations relating to MCV, and has determined that they are acceptable to meet the needs of this Commonwealth. Therefore, the Department is basing its proposed amendment on ACIP's recommendations.

Subsection (d). Child care group settings.

   This subsection is new. It is intended to clarify questions raised because some child care group settings are located in schools, and some schools now have kindergarten classes including children who are younger than 5 years of age. Because the ACIP recommendations for children younger than 5 years of age differ from those recommended for most children of the ages attending kindergarten, elementary school or higher school, only a child in a child care group setting who is 5 years of age or older should receive the immunizations included in § 23.83. Children younger than 5 years of age should still continue to receive the immunizations included in § 27.77, regardless of where their child care group setting is located, or whether they are in a kindergarten class.

   By proposing to add subsection (d), the Department is proposing to clarify that children younger than 5 years of age attending child care group settings located in schools are not to follow the immunization requirements for school attendance, but are to follow the requirements for immunizations in child care group settings included in the Department's regulations relating to communicable and noncommunicable diseases. (See § 27.77.) These regulations are specifically directed at children younger than the age of 5 years, and require immunizations appropriate to those younger age groups. The Department is also proposing changes to § 27.77(d) to reflect that children younger than 5 years of age are now attending kindergartens, and to ensure that age appropriate immunizations are provided to children regardless of the location of their setting.

Subsection (e). Prekindergarten programs, early intervention programs and private academic preschools.

   This subsection is new. It would make it clear that children in prekindergarten programs, early intervention programs and private academic preschools are required to comply either with the immunization requirements for school attendance, or those required for attendance at child care group settings, depending upon the age of the child. This clarification is important because children who are not yet attending kindergarten or first grade but who are still surrounded by other children, both older and younger, may contract disease as easily as those who are attending school in kindergarten or the first grade. It is important for the health of the child and the health of this Commonwealth that the spread of potentially dangerous and debilitating disease be prevented or at least contained through the use of immunization in educational settings.

   It is equally important that the immunizations received by the child be age-appropriate, as mentioned previously. Therefore, the Department is proposing that children younger than 5 years of age would be required to comply with the Department's regulation in § 27.77. Children 5 years of age or older would be required to comply with the requirements of subsection (b) of the proposed amendments.

Subsection (f). Grace period.

   This subsection is new. The Department is proposing to include a 4-day grace period for the administration of required vaccines in accordance with ACIP recommendations and with the notice of its intention to amend its regulations published at 32 Pa.B. 1305 (March 9, 2002).

   There is no scientific basis for concluding that if a vaccine is not given with a strict interval between doses or at an exact age, the vaccine is ineffective or unsafe. The CDC published recommendations in the February 8, 2002, Morbidity and Mortality Weekly Report (MMWR) which would allow vaccines to be given at a time less than or equal to 4 days prior to the recommended minimal interval between dosages and before the appropriate age for vaccine is reached and still be counted as a valid dose of vaccine. The Pennsylvania Chapter of the American Academy of Pediatrics supported ACIP's recommendations of allowing a 4-day grace period for dose interval and age limit. The recommendation, however, conflicts with the Commonwealth's school immunization requirement in this section for measles, mumps, rubella and varicella vaccines, which states that these vaccines must be administered on or after a child turns 12 months old for the vaccine to be accepted as a valid dose. With respect to varicella, the Department's regulations for entry into seventh grade require either 1 dose of vaccine at 12 months of age or older, or 2 doses of vaccine at 13 years of age or older. (See current subsection (c)(2)(i) and (ii).)

   After consideration of ACIP's February 8, 2002, recommendation and review of the relevant information relating to that recommendation, the Department agreed with ACIP's determination that administering a vaccine dose 4 days earlier than the minimum interval or age limit would be unlikely to have a significant negative effect on the immune response to that dose. After discussion with and agreement from the Pennsylvania Department of Education (PDE), the Department published a notice at 32 Pa.B. 1305 (March 9, 2002) to that effect. That notice stated that the Department intended to amend its regulations to reflect this ACIP recommendation. The Department now proposes to do so.

§ 23.86. School reporting.

   The Department is proposing to revise this section to address requirements for reporting immunization data placed on the Department by the CDC. The CDC requests annual school immunization coverage reports from the Department as part of the Federal Immunization Grant process. In the last few years, the CDC has requested that the Department provide to the CDC information relating to individual vaccine dose coverages. To comply with this request, the Department has been estimating individual vaccine dose coverage by schools' self-reports and validation audits for up-to-date status for all required vaccines. The CDC may not accept the Commonwealth's estimated vaccine coverage rates in the future. The Department is proposing to amend this section to allow it to meet the CDC's reporting requirements and to ensure that the Department continues to receive grant funding for immunizations.

CHAPTER 27. COMMUNICABLE AND NONCOMMUNICABLE DISEASES

Subchapter C. QUARTINE AND ISOLATION

Communicable Diseases in Children and Staff Attending Schools and Child Care Group Settings

§ 27.77. Immunization requirements for children in child care group settings.

   The Department is proposing to amend subsection (d) of this section. Subsection (d) excludes children 5 years of age and older attending kindergarten, elementary school or higher school and children known to the care giver to attend a kindergarten from the immunization requirements of § 27.77, and requires them to follow the school immunization requirements in § 28.83. Because more children are now attending school based settings under the age of 5 years, this language will work to require children younger than 5 years of age that are in child care group settings located in schools to obtain immunizations appropriate for their age. The Department, therefore, is proposing to revise this subsection to ensure that those children younger than 5 years of age in school based settings such as prekindergarten, are required to obtain immunizations that are age appropriate.

C.  Affected Persons

   The proposed amendments would affect children attending school in this Commonwealth and entering the seventh grade or at 12 years of age in an ungraded class who have not received tetanus and diphtheria toxoid immunizations within the last 5 years or who have not received the MCV immunization. The proposed amendments would also affect those students who missed the school entry requirement for hepatitis B vaccination, varicella immunity and the 4th dose of the tetanus and diphtheria vaccinations. In addition, the proposed amendments would affect those students who missed the seventh grade entry requirements for hepatitis B vaccination and varicella immunity. Finally, the proposed amendments would affect those children who need to receive a second dose of varicella and mumps vaccines.

   The proposed amendments would also affect the parents or guardians of these students, since they would have to ensure that the children receive these vaccinations, and may be required to pay out-of-pocket for them. However, because requiring these immunizations would protect children from contracting tetanus, diphtheria, pertussis and meningitis, chickenpox and mumps, their parents or guardians would not have to miss work, worry, or pay medical bills related to these diseases. Physicians and health care providers would not have to treat sick children. Department staff would not need to become involved in the prevention of outbreaks as they do now.

   Those children who suffer the rare adverse reaction to a required immunization and their parents or guardians would also be affected. Conversely, children who might otherwise have become ill, or perhaps died, from meningitis, pertussis, diphtheria, tetanus, hepatitis B, chickenpox or mumps, are also affected beneficially by these proposed amendments.

   The proposed amendments would affect school districts and their employees, since school districts are required to ensure that children attending school have the appropriate vaccinations, and to report that information to the Department according to the Department's revised reporting requirements. The impact would be slight, however, in that school districts already have systems in place to document immunization status of students, and because the recommendation by ACIP that a grace period be provided in determining the immunization status of students was initially made in 2002.

D.  Cost and Paperwork Estimate

1.  Cost

   a.  Commonwealth

   The Commonwealth would incur some costs for the purchase of Tdap and meningococcal conjugate vaccines, as well as additional hepatitis B and varicella vaccines; and the MMR, through the expenditure of Federal immunization grant funds. The Commonwealth would also incur costs through the Medical Assistance Program, which pays for administering the vaccines for eligible persons. The Department makes vaccines available at no cost to private providers enrolled in the Vaccines For Children (VFC) Program for children through 18 years of age who have no insurance, who are Medicaid eligible or who are Alaskan Native or American Indian. In addition, VFC Program vaccine is also made available to other public clinic sites (Federally Qualified Health Centers and Rural Health Clinics) for the same population but also for underinsured children through 18 years of age. Vaccines are made available to schools at no cost through the Department's School Based Catch-Up Program for those students who have no medical home or are unable to seek the immunization through a public clinic site. The Commonwealth should realize savings, at the same time, based on the amount of funds that would not be needed to control the outbreak of the disease the vaccine prevents.

   The inclusion of a grace period into the regulations should add no cost for the Commonwealth, including either the Department or PDE. The 4-day grace period is intended to allow a vaccine dose administered 4 days before the minimum interval between doses or before the appropriate age is reached to be counted as a valid dose. Since there is no scientific basis for taking a position that a vaccine must be given with a strict interval between doses or at an exact age or the vaccine is ineffective or unsafe, the grace period would merely allow schools to accept vaccines provided within this period for purposes of determining compliance with the Department's regulations relating to school attendance.

   b.  Local Government

   There would be no fiscal impact on local governments. Local governments could see a slight cost savings, since local governments do bear some of the cost of disease outbreak investigations and control measures. (The Department addresses the potential impact of these proposed amendments on school districts, which may be considered to be local government, under the heading of ''Regulated Community.'')

   c.  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 added vaccines. Families whose insurance plans do not cover these vaccinations, or who do not have insurance, will need to seek other assistance to pay for the vaccines, 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, through its State health centers, provides vaccinations. The Department also provides vaccines to providers for certain eligible children through the VFC Program, and to schools through its Catch-Up Program. The savings in prevention of childhood illness would outweigh the minimal cost of the vaccine.

   The inclusion of a grace period should not add cost for school districts. School districts currently decide which children are appropriately immunized, and which are not appropriately immunized and so should be excluded from attendance. The inclusion of a 4-day grace period, which is intended to allow a vaccine dose administered 4 days before the minimum interval between doses or before the appropriate age is reached to be counted as a valid dose, would now have to be taken into consideration in making this determination. This proposed amendment should not add significantly to the cost of determining whether children are appropriately immunized, since this recommendation has been in place since the Department published its notice in 2002.

   These proposed amendments would add 2 additional immunizations for school officials to review, 2 additional vaccine doses to account for (2 doses of varicella and 2 doses of mumps), and could increase the amount of follow-up needed to ensure that provisionally enrolled students in all grades receive the necessary doses in the series for all required immunizations prior to the expiration of the 8-month provisional enrollment deadline. Provisional enrollment allows for a child who has not had all the required vaccine doses described in § 23.83 to continue attendance at school if the child has had at least 1 dose of each required vaccine and there is a plan for that child obtaining all required immunizations. (§ 23.85(e).) A child provisionally admitted to school must have completed the immunizations required by § 23.83 within an 8-month period from the date of the child's provisional admission, or the school administrator may neither admit the child to school, nor permit the child's continued admission. Again, the savings in the 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 and to follow-up on provisional enrollments.

   No additional cost should be added to the regulated community by the Department's proposal to delete the requirements that the hemagglutination test or a comparable test be used to show a history of immunity to measles or German measles, and to replace that requirement with a more current test. Even without any amendment to the regulations, there would be a cost associated with choosing this particular method of showing immunity--the cost of the hemagglutination test. Since the amendment would not prohibit that particular test from being used in the future, no cost beyond that of the hemagglutination test would be incurred, and the cost of the regulations in this regard should remain stable. Future tests may, in fact, decrease in price, which could provide a cost savings for affected persons. Further, use of this method of proving immunity is not required.

   Lastly, no additional cost should be added by the Department's clarification regarding children in child care group settings located in schools. The requirements for attendance at school and school reporting should not apply to those children. The regulations that would apply are those immunization requirements that are already in place that deal with child care group settings in § 27.77.

   d.  General Public

   The general public should not see an increase in cost. The general public should see a decrease in costs resulting from a reduction in medical treatment needed to treat the disease and a reduction in the loss of work in order to stay home with a sick child. The general public may see a benefit in the reduction of vaccine preventable diseases, such as pertussis, chickenpox, mumps and meningitis. Since the school environment is conducive to the contracting and transmission of diseases among children with no immunity, failure to immunize properly not only puts children at risk for contracting these debilitating diseases, it also places the public at risk since these diseases are then easily spread by staff and children outside the school setting and into the general public.

2.  Paperwork Estimates

   a.  Commonwealth and the Regulated Community

   Schools would need to report in accordance with the new reporting requirements, which would require them to report the number of doses of individual antigens that have been administered to students. The Department would need to review and include those new reported numbers in its report to the CDC. Schools are currently required to report immunization coverage status for their students to the Department for the Department to satisfy CDC requirements relating to reporting of immunizations. The additional paperwork requirements for the Commonwealth, including both the Department and PDE, and the regulated community would be minimal, however, since school districts already complete this annual report regarding the number of immunizations and follow up on provisional enrollment. School nurses, who perform recordkeeping and reporting requirements in the schools, currently maintain and report this information. The CDC, however, is in the process of changing these requirements. The Department would provide reporting forms to schools, as it currently does, and the reports would be sent to the same Department office as the current reports. Schools also have the option of electronic reporting.

   b.  Local Government

   There is no additional paperwork requirement for local government. (The Department has included school districts, which may be considered to be local government, under the heading of ''Regulated Community.'')

   c.  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 of 1955 (35 P. S. §§ 521.1--521.21) (act) provides the Advisory Health Board (Board) with the authority to issue rules and regulations on a variety of matters 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. (See 35 P. S. § 521.16(a).) 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 The Administrative Code of 1929 (Administrative Code) (71 P. S. § 51--732). Section 2102(g) of The Administrative Code (71 P. S. § 532(g)) gives the Department this general authority. Section 2111(b) of the Administrative Code (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 and in the Public School Code of 1949 (Code) (24 P. S. §§ 1-101--27-2702). Section 2111(c.1) of The Administrative Code (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 Code (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.

F.  Effectiveness/Sunset Dates

   The proposed amendments will become effective upon their publication in the Pennsylvania Bulletin as final rulemaking. No sunset date has been established. The Department will continually review and monitor the effectiveness of these regulations.

G.  Regulatory Review

   Under section 5(a) of the Regulatory Review Act (act) (71 P. S. § 745.5(a)), the Department submitted a copy of this proposed rulemaking on January 24, 2008, 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 amendments, the Department has provided IRRC and the Committees with a copy of a Regulatory Analysis Form. A copy of this material is available to the public upon request.

   If IRRC has any objections to any portion of the proposed amendments, it will notify the Department by April 9, 2008. The notifications shall specify the regulatory review criteria which have not been met by that portion. The act specifies detailed procedures for review, prior to final publication of the regulations 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 regulation to Heather Stafford, Director, Division of Immunization, Department of Health, 7th and Forster Streets, Harrisburg, PA 17120, (717) 787-5681, by March 10, 2008. Persons with a disability who wish to submit comments, suggestions or objections regarding the proposed rulemaking may do so by using the previous number or address. Speech or hearing, or both, impaired persons may use V/TT (717) 783-6514 or the Pennsylvania AT&T Relay Service at (800) 654-5984 (TT). Persons who require an alternative format of this document may contact Heather Stafford so that necessary arrangements may be made.

CALVIN B. JOHNSON, M. D., M.P.H.,   
Secretary

   Fiscal Note: 10-181 proposed. No fiscal impact; (8) recommends adoption.

Annex A

TITLE 28. HEALTH AND SAFETY

PART III. PREVENTION OF DISEASES

CHAPTER 23. SCHOOL HEALTH

Subchapter C. IMMUNIZATION

§ 23.82. Definitions.

   The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise:

*      *      *      *      *

   Attendance at school--The attendance at a grade, or special classes, kindergarten through 12th grade, including public, private, parochial, vocational, intermediate unit and home education students. The term does not include the attendance of children at a child care group setting, defined in § 27.1 (relating to definitions), located in a public, private or vocational school, or in an intermediate unit.

*      *      *      *      *

§ 23.83. Immunization requirements.

   (a)  [Required for entry.] Duties of a school director, superintendent, principal or other person in charge of a public, private, parochial or nonpublic school. [The following immunizations are required for entry into school for the first time at the kindergarten or first grade level, at public, private or parochial schools 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 any combination or 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 any 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 a history of chickenpox disease from a parent, guardian or physician.]

   Each school director, superintendent, principal or other person in charge of a public, private, parochial or nonpublic school in this Commonwealth, including vocational schools, intermediate units, and special education and home education programs, shall ascertain that a child has been immunized in accordance with subsections (b), (c) and (e) prior to admission to school for the first time.

   (b)  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] Four or more [properly spaced] 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.

   (2)  Tetanus. [Three] Four or more [properly spaced] 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)  Measles (rubeola). Two [properly spaced] 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] laboratory testing. 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] laboratory testing. Rubella vaccine may be administered as a single antigen vaccine.

   (6)  Mumps. [One dose] Two properly-spaced doses 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.

   (7)  Hepatitis B. Three properly-spaced doses of hepatitis B vaccine, unless a child receives a vaccine as approved by the Food and Drug Administration for a 2-dose regimen, or a history of hepatitis B immunity proved by laboratory testing.

   (8)  Chickenpox (varicella). One of the following:

   (i)   Varicella vaccine.

   (A)  Required for school entry in kindergarten or the first grade until the school year 2010/2011, 2 properly-spaced doses of varicella vaccine, the first dose administered at 12 months of age.

   (B)  Required for school attendance until the school year 2010/2011, 2 properly-spaced doses of varicella vaccine for children 13 years of age or older.

   (C)  Required for school attendance as of the school year 2010/2011, 2 properly-spaced doses of varicella vaccine.

   (ii)  Evidence of immunity. Evidence of immunity may be shown by one of the following:

   (A)  Laboratory evidence of immunity or laboratory confirmation of disease.

   (B)  A written statement of a history of chickenpox disease from a parent, guardian or physician.

   (c)  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] nonpublic school in this Commonwealth, including vocational schools, intermediate units and special education and home education programs, as a condition of entry for students entering the 7th 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 a parent, guardian, emancipated child or physician.]

   Tetanus and diphtheria toxoid and acellular pertussis vaccine (Tdap). One dose if at least 5 years have elapsed since the last dose of a vaccine containing tetanus and diphtheria as required in subsection (b).

   (2)  Meningococcal Conjugate Vaccine (MCV). One dose of Meningococcal Conjugate Vaccine.

   (d)  Child care group setting. Attendance at a child care group setting located in a public, private or vocational school, or in an intermediate unit is conditional upon the child's satisfaction of the immunization requirements in § 27.77 (relating to immunization requirements for children in child care group settings), unless the child is 5 years of age or older. Attendance of a child who is 5 years of age or older at a child care group setting is conditional upon the child's satisfaction of the immunization requirements in this subchapter.

   (e)  Prekindergarten programs, early intervention programs and private academic preschools. Attendance at a prekindergarten program operated by a school district, an early intervention program operated by a contractor or subcontractor including intermediate units, school districts and private vendors, or at private academic preschools is conditional upon the child's satisfaction of the immunization requirements in § 27.77. If a child is 5 years of age or older, the child's attendance shall be conditional upon the child's satisfaction of the immunization requirements set out in subsection (b).

   (f)  Grace period. A vaccine dose administered within the 4-day period prior to the minimum age for the vaccination or prior to the end of the minimum interval between doses shall be considered to be a valid dose of the vaccine for purposes of this chapter.

§ 23.86. School reporting.

   (a)  A public, private [or], parochial or nonpublic school in this Commonwealth, including vocational schools, intermediate units and special education and home education programs, shall report immunization data to the Department by October 15 of each year, using forms provided by the Department.

   (b)  The school administrator or the administrator's designee shall forward the reports to the [Immunization Program, Bureau of Communicable Diseases, Post Office Box 90, Harrisburg, Pennsylvania 17108] Department as indicated on the reporting form provided by the Department.

*      *      *      *      *

   (d)  The school administrator or the administrator's designee shall ensure that the school's identification information, including the name of the school, school district, county and school address, is correct, and shall make any necessary corrections, prior to submitting the report.

   (e)  [Content] The content of the reports [ shall ] must include the following information:

   (1)  [The identification of the school including the name of the school, the school district, the county, the intermediate unit and the type of school.

   (2)] The month, day and year of report.

   [(3)] (2)  The number of students attending school [by] in each grade-level, or in an ungraded school, in each age group, as indicated on the reporting form.

   [(4)  The number of students attending school by grade-level who were completely immunized.]

   (3)  The immunization status by doses of individual antigens of every enrolled student in each grade-level, or in an ungraded school, in each age group, as indicated on the reporting form.

   [(5)] (4)  The number of students attending school [by grade-level] who were classed as medical exemptions in each grade-level, or in an ungraded school, in each age group, as indicated on the reporting form.

   [(6)] (5)  The number of students attending school [by grade-level] who were classed as religious exemptions in each grade-level, or in an ungraded school, in each age group, as indicated on the reporting form.

   [(7)] (6)  The number of students provisionally admitted to any grade or, in an ungraded school, in any age group.

   [(8)] (7)  The number of [children] students in any grade level who were denied admission because of [their] the student's inability to qualify for provisional admission or, in an ungraded school, in any age group.

   [(9)] (8)  Other information [as] required by the Department.

   [(e)  For purposes of reporting the immunization status of a school's students to the Department, the following grade-levels will be used: kindergarten, grades 1-6, 7-9, 10-12 and special education.]

CHAPTER 27. COMMUNICABLE AND NONCOMMUNICABLE DISEASES

Subchapter C. QUARANTINE AND ISOLATION

COMMUNICABLE DISEASES IN CHILDREN AND STAFF ATTENDING SCHOOLS AND CHILD CARE GROUP SETTINGS

§ 27.77. Immunziation requirements for children in child care group settings.

*      *      *      *      *

   (d)  Exemptions.

   (1)  This section does not apply to the following:

   (i)  [Kindergarten] Children attending kindergarten, elementary school or higher school who are 5 years of age or older. These caregivers shall comply with §§ 23.81--23.87 (relating to immunization).

   (ii)  Children who are known by the caregiver to be [6] 5 years of age or older or known to attend a kindergarten, elementary school or high school.

*      *      *      *      *

[Pa.B. Doc. No. 08-217. Filed for public inspection February 8, 2008, 9:00 a.m.]



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