PART 1. DEPARTMENT OF STATE HEALTH SERVICES

CHAPTER 97. COMMUNICABLE DISEASES

SUBCHAPTER B. IMMUNIZATION REQUIREMENTS IN TEXAS ELEMENTARY AND SECONDARY SCHOOLS AND INSTITUTIONS OF HIGHER EDUCATION

25 TAC §§97.61, 97.63 - 97.72

The Executive Commissioner of the Health and Human Services Commission (commission) on behalf of the Department of State Health Services (department) adopts amendments to §97.61 and §§97.63 - 97.72, concerning immunization requirements in Texas elementary and secondary schools and institutions of higher education. Sections 97.63, 97.64, and 97.66 are adopted with changes to the proposed text as published in the August 22, 2008, issue of the Texas Register (33 TexReg 6705). Sections 97.61, 97.65, and 97.67 - 97.72 are adopted without changes, and the sections will not be republished.

BACKGROUND AND PURPOSE

Government Code, §2001.039, requires that each state agency review and consider for readoption every four years each rule adopted by that agency pursuant to the Government Code, Chapter 2001. Sections 97.61 and 97.63 - 97.72 have been reviewed and the department has determined that reasons for proposing amendments to §97.61 and §§97.63 - 97.72 continue to exist because rules on this subject are needed. This rulemaking adoption makes various clarifying amendments designed to improve the efficiency and readability of these rule sections, and also makes certain substantive changes which the department believes are in the best interest of public health.

The substantive amendments to §97.63 are adopted in order to update the Texas elementary and secondary school immunization requirements so that they adhere more closely to the current version of the Centers for Disease Control and Prevention (CDC), Advisory Committee on Immunization Practices (ACIP) recommended immunization schedule (see http://www.dshs.state.tx.us/immunize/docs/6-105.pdf). These revisions amend the frequency of vaccinations and booster shots for diseases already covered in the rule, and also add vaccination requirements regarding meningococcal disease (see full discussion in the Section-By-Section Summary below).

The amendments to §97.64 are adopted in order to update, simplify and clarify the rule text regarding the vaccines required and the limited exceptions for students enrolled in the specified health-related and veterinary courses. The department intends for the adopted changes to address concerns expressed to the department in the past regarding a perceived lack of clarity in this rule section.

The department held a public meeting on Monday, May 12, 2008, which served as a forum to receive informal comments from interested persons regarding the rules; all comments received were in support of the proposed amendments. An official 30-day comment period was held between August 23 to September 22, 2008; a total of 31 comments were received from 19 commenters (see the full discussion in the Comments section of the preamble).

SECTION-BY-SECTION SUMMARY

From the proposed amendments to the final amendments adopted herein, the following changes were made to the rule text:

Concerning §97.63(1), the phrase ", and in the schedules in this section are," is added to more clearly show that the "four day rule" articulated in this provision is applicable to the schedules found in both of the referenced locations.

Concerning §97.63(2), the phrase "for diseases listed below" was moved within the provision for better readability. Also in this section, the phrase ", or institution of higher education" was deleted since those requirements are found under §97.64.

Concerning §97.63(2)(B), the clarifying phrase "according to the schedule listed" was added as a reference to the new schedule language listed below in that rule.

Concerning §97.63(2)(B)(i)(I), the title "Kindergarten entry" was added to the paragraph in order to help further clarify the applicability of intent.

Concerning §97.63(2)(B)(i)(I), the phrase "If any combination of four doses of OPV and IPV was received before four years of age, no additional dose is required" was removed. The phrase, "four doses of OPV or IPV in any combination by age 4 - 6 years old is considered a complete series, regardless of age at the time of the third dose" was added to improve readability and clarity concerning the intent of the rule; and the phrase, "if any combination of four doses of OPV and IPV was received before four years of age, no additional dose is required" is being deleted.

Concerning §97.63(2)(B)(ii)(I), the title "Kindergarten entry" was added to the paragraph in order to help further clarify the applicability of intent.

Concerning §97.63(2)(B)(ii)(II), the title "Students seven years of age or older" was added to the paragraph in order to help further clarify the applicability of intent.

Concerning §97.63(2)(B)(ii)(III), the section of the rule regarding Tdap requirements has been slightly reorganized in order to more clearly state what the requirements are for the school years at issue. A new provision (-a-) has been written to state the requirements for the current school year (and on through any 2009 summer sessions), versus the new requirements at provisions (-b-) and (-c-) that being with the 2009 - 2010 school year. This is to avoid the perception of a gap with no requirements from the date this adoption goes into effect through the start of the 2009 - 2010 school year.

Concerning §97.63(2)(B)(ii)(III)(-b-), the phrase, "(III) Tdap" was removed and the phrases, "Seventh grade" was added to clarify the provision, and the abbreviation "SY" was included to improve readability.

Concerning §97.63(2)(B)(ii)(III) regarding Tdap, the proposed rule language stated: "Beginning school year (SY) 2009 - 2010, students will be required to have one booster dose of a tetanus/diphtheria/pertussis-containing vaccine for entry into 7th grade..."; however, this rule language did not effectively communicate a clear, progressive schedule for implementation for students who are in the 8th grade through 12th grade. Consequently, §97.63(2)(B)(ii)(III)(-c-) was added to address this issue, which states the following: "Grades 8 - 12. Students who have not already received Tdap vaccine are required to receive one booster dose of Tdap when ten years have passed since the last dose of a tetanus-diphtheria-containing vaccine." This change addresses those students in grades 8 - 12 that would not meet the 7th grade requirement at the time of implementation.

Concerning §97.63(2)(B)(iii), the word "MMR" was added in order to provide clarity concerning the organization of the subsection. The section of the rule regarding MMR requirements has been slightly reorganized in order to more clearly state what the requirements are for the school years at issue. A new provision (I) has been written to state the requirements for the current school year (and on through any 2009 summer sessions), versus the new requirements at provision (II) that being with the 2009 - 2010 school year. This is to avoid the perception of a gap with no requirements from the date this adoption goes into effect through the start of the 2009 - 2010 school year.

Concerning §97.63(2)(B)(iii)(II) regarding MMR, the phrases "(iii) MMR. Students" and "upon kindergarten entry for the following grades and school years (The first dose shall be administered on or after the first birthday)" were removed and replaced with the phrase, "with the first dose received on or after the first birthday for the following grades and school years" to improve readability and clarity concerning the intent of the rule.

Concerning §97.63(2)(B)(iii)(II)(-b-) - (-m-) regarding MMR, the school grades listed per school year in a series were changed in order to provide clarity and readability by listing the grades in the following order: K - 2; K - 3; K - 4; K - 5; etc.

Concerning §97.63(2)(B)(iv)(I) regarding hepatitis B, the word, "upon" is deleted and the phrase "no later than" has been added in order to better capture the provision's intent.

Concerning §97.63(2)(B)(iv)(II) regarding hepatitis B, the phrase "an existing" is replaced with the word "this" to improve clarity and readability.

The section of the rule regarding varicella requirements has been slightly reorganized in order to more clearly state what the requirements are for the school years at issue. A new provision (I) has been written to state the requirements for the current school year (and on through any 2009 summer sessions), versus the new requirements at provision (II) that being with the 2009 - 2010 school year. This is to avoid the perception of a gap with no requirements from the date this adoption goes into effect through the start of the 2009 - 2010 school year.

Concerning §97.63(2)(B)(v)(II)(-b-) - (-g-) regarding varicella, the school grades listed per school year in a series were changed in order to provide clarity by listing the grades in the following order: K - 1; 7 - 8; K - 2; 7 - 9; etc.

Concerning §97.63(2)(B)(vi), the section of the rule regarding Hepatitis A requirements, has been slightly reorganized in order to more clearly state what the requirements are for the school years at issue. A new provision (I) has been written to state the requirements for the current school year (and on through any 2009 summer sessions), versus the new requirements at provision (II) that being with the 2009 - 2010 school year. This is to avoid the perception of a gap with no requirements from the date this adoption goes into effect through the start of the 2009 - 2010 school year.

Concerning §97.63(2)(B)(vi)(II) regarding the hepatitis A vaccine, the phrase "are required to have two doses of hepatitis A vaccine for the following grades and school years (The first dose shall be administered on or after the first birthday)" was removed and replaced with the phrase "with the first dose received on or after the first birthday for the following grades and school years" to improve readability and clarity concerning the intent of the rule.

Concerning §97.63(2)(B)(vi)(II)(-a-) - (-m-) regarding hepatitis A, the school grades listed per school year in a series were changed in order to provide clarity and improve readability by listing the grades in the following order: K - 2; K - 3; K - 4; K - 5; etc.

Concerning §97.63(2)(B)(vii)(II) - (VI) regarding meningococcal, the school grades listed per school year in a series were changed in order to provide clarity and improve readability by listing the grades in the following order: 7 - 8; 7 - 9; 7 - 10; etc.

Concerning §97.64(a), the phrase, "applicability for non-veterinary students" was replaced with the phrase "students enrolled in (non-veterinary) health-related courses" to improve readability and clarity concerning the applicability of the subsection.

Concerning §97.64(c)(1), the word, "with" was added to improve readability.

Concerning §97.64(c)(1) and (2), the word "subsection" was removed, the word, "subsections" was added, and the phrase "and/or (d)" was added in order to more clearly state that the opportunity for provisional enrollment, under the terms already given, and the requirements regarding documentation of immunizations, are applicable to veterinary students, described in subsection (d), as well as students covered under the subsection (a).

Concerning §97.64(c)(3), the word, "rule" was removed to improve readability.

Concerning §97.64(d)(1), the rule language states the following: "Serum antibody levels must be checked every two years, with a booster dose of rabies vaccine administered if the titer is inadequate." In order to clarify what is meant by the word "inadequate," the phrase "according to current Centers for Disease Control and Prevention guidance" is included.

Concerning §97.66, the rule section title was changed by adding the phrase "; Non-Veterinary" to the parenthetical to more clearly state that this rule section corresponds to the requirements of §97.63, not §97.64.

The following is a summary of the adopted amendments to each section that have not changed since being originally published as proposed on August 22, 2008:

Section 97.61.

These amendments to §97.61 revise the section title for clarity, and revise subsection (b) to update to the department's current name. Subsection (c) of the rule is updated by deleting the cross-reference to Texas Health and Safety Code, §81.002, because the term "instruction" is not contained in the current version of that statutory provision.

Section 97.63.

The amendments to §97.63 are adopted primarily in order to update the Texas elementary and secondary school immunization requirements to adhere more closely to the current version of the CDC, Advisory Committee on Immunization Practices (ACIP) recommended immunization schedule. The department agrees with these recommended changes from a public health perspective. These substantive changes to the rule section have been drafted so that they would become effective for the 2009 - 2010 school year, which should give school districts sufficient time to perform outreach/education regarding the new requirements and also for the required vaccinations to be administered. Changes are also adopted in this section to improve clarity and readability.

The department adopts the following amendments to become effective for the 2009 - 2010 school year:

Section 97.63(2)(B)(ii)(III) concerning Td/Tdap booster requirement:

-The current rule language provides that one booster dose of a tetanus/diphtheria containing-vaccine is required within the last 10 years.

-The adopted amendment provides that there be a Tdap requirement for students in 7th grade beginning in the 2009 - 2010 school year.

-For the 2008 - 2009 school year through the end of any Summer session of the 2008 - 2009 school year, students are required to have one dose of a tetanus-diphtheria containing vaccine within the last ten years.

-The rationale for the adopted rule amendment is the following:

(1) ACIP/CDC recommendation for adolescents (11 - 18 years) to receive a single booster dose of Tdap instead of Td (unless medically contraindicated);

(2) Preferred age for Tdap is 11 - 12 year old visit.

Section 97.63(2)(B)(iii) concerning measles, mumps, and rubella:

-The current rule language provides that two doses of a measles-containing vaccine are required, one dose of mumps and one dose of rubella for grades K - 12.

-The adopted rule amendment requires two doses of MMR, which is the current combination vaccine that is the recommended method to get the three individual vaccine components.

-For the 2008 - 2009 school year through the end of any summer session of the 2008 - 2009 school year, students are required to have two doses of a measles-containing vaccine, and one dose each of rubella vaccine and mumps vaccine.

-The rationale for the adopted rule amendment is the following:

(1) In order to align the Texas requirements with the most recent ACIP/CDC recommendations.

(2) Recent mumps outbreaks, January 1 through May 2, 2006, resulted in 2,597 cases of mumps in 11 states. The department wants to respond proactively before similar outbreaks occur in Texas.

Section 97.63(2)(B)(iv) concerning Hepatitis B:

The current rule language was written to phase-in a Hepatitis B vaccination requirement, and included a progressive schedule for certain grades by certain years. Now that the phase-in period has passed, the adopted amendment is written to articulate the requirement after the phase-in period and would delete the phase-in language.

Section 97.63(2)(B)(v) concerning varicella:

-The current rule language provides that one dose is to be received on/after first birthday for grades K - 12, according to the listed schedule.

-The adopted amendment provides that a progressive 2nd dose requirement for varicella at kindergarten and 7th grade entry be added (each subsequent school year, the next grade is added to the schedule).

-For the 2008 - 2009 school year through the end of any summer session of the 2008 - 2009 school year, students are required to have one dose of varicella vaccine received on or after the first birthday for grades K - 12.

-The rationale for the adopted amendment is the following:

(1) In order to align the Texas requirements with the most recent ACIP/CDC recommendations.

(2) With one-dose vaccination schedule, vaccine effectiveness of 85% has not been sufficient to prevent varicella outbreaks in highly-vaccinated school populations.

(3) In these school outbreaks, varicella vaccine coverage ranges from 96% to 100%, with vaccine effectiveness ranging from 72% to 85%.

(4) The peak age-specific incidence of varicella has shifted from 3 - 6 year old children in the pre-vaccine era to 9 - 11 year old children in the post-vaccine era, both for immunized and un-immunized children during these outbreaks.

(5) Studies show that the immune response after the 2nd dose of varicella vaccine demonstrate a greater than 10-fold boost.

(6) Approximately >99% of children achieve an antibody response after the 2nd dose of varicella vaccine compared with 76% - 85% of children with a single dose of varicella vaccine.

Section 97.63(2)(B)(vi) concerning Hepatitis A:

-The current rule language provides two doses of hepatitis A vaccine for grades K - 3 in 40 counties designated by the department.

-The adopted amendment requires that there be a statewide requirement for hepatitis A for kindergarten enterers in the 2009 - 2010 school year, and in subsequent years, the next grade level will be incorporated. The phrase "The first dose shall be administered on or after the first birthday" would be added to indicate when the series begins.

-For the 2008 - 2009 school year through the end of any summer session of the 2008 - 2009 school year, upon entry into kindergarten through third grade, two doses of hepatitis A vaccine are required for students attending a school located in a high incidence geographic area as designated by the department.

-The rationale for the adopted rule amendment is the following:

(1) In order to align the Texas requirements with the most recent ACIP recommendations.

(2) Majority of reported hepatitis A cases come from areas where hepatitis A vaccine is not required for children attending kindergarten through 3rd grade.

(3) A population of young children who may not have received hepatitis A vaccine still exist in counties where hepatitis A vaccine is not required for kindergarten attendance.

Section 97.63(2)(B)(vii) concerning meningococcal:

-Adds a 7th grade requirement for meningococcal vaccine on a schedule similar to Tdap in these adopted rules.

-The rationale for the adopted amendment is the following:

(1) In order to align the Texas requirements with the most recent ACIP/CDC recommendations.

(2) Adolescents and young adults are most likely to get meningococcal disease, especially those living in group settings such as college dorms.

(3) From 2000 - 2006, Texas averaged 106 cases and 4 deaths per year (excluding unknown ages).

(4) 27% of all cases occur in school aged children, 5 - 19 years.

(5) 35% of deaths occur among 10 - 29 year olds.

(6) Among infants aged <1 year of age, >50% of cases are caused by serogroup B, for which no vaccine is licensed nor available in the United States (US).

(7) For all reported cases of meningococcal disease among persons aged ≥11 years, 75% are caused by serogroups (C, Y, or W-135), which are included in vaccines licensed and available in the US.

Also, §97.63(1) and (2), is amended to improve clarity and readability. Section 97.63(2)(A) is amended to improve clarity and readability, to update the agency name and address, and to insert the relevant cross-reference to the department's Immunization Schedule. Section 97.63(2)(B) is amended to delete certain references to kindergartens because the rule's age-triggers in those places are sufficient to be protective of the public health. Section 97.63(2)(B)(i), (ii)(I), and (ii)(II), are also amended to improve readability. Section 97.63(2)(B)(ii)(IV) is amended by adding the phrase "(or prior to)" in order to clarify the schedule for this vaccination.

Section 97.64.

The adopted amendments to §97.64 reorganize the section to improve clarity and readability, in part in response to past concerns expressed to the department. Subsection (a) is rewritten to provide a clear statement of the section's applicability as to non-veterinary students, with a newly written subsection (d) covering section applicability as to veterinary students. Existing language at subsections (a) and (d) is deleted.

The adopted amendments to §97.64 also update and clarify the rule text regarding the vaccines required for students covered by the section. Existing language at subsection (b) is deleted, with new language being adopted which would describe the vaccines that are required. Subsections which currently contain language regarding required vaccines, subsections (d) through (k), are deleted, with subsections (d) and (e) replaced with entirely new language.

The following is a summary of the adopted substantive amendments to new §97.64(b) regarding required vaccines:

-Tetanus-diptheria:

One dose of a tetanus-diphtheria toxoid (Td) is required within the last 10 years. The booster dose may be in the form of a tetanus-diphtheria-pertussis containing vaccine (Tdap). The change to allow Tdap in lieu of Td reflects the recommendation by the ACIP for adults at high risk, such as students at post-high school educational institutions covered under this section.

-Measles, mumps, and rubella vaccines:

The adopted amendments to §97.64 would revise the section for measles, mumps, and rubella vaccines for clarity. The adopted reference to MMR reflects that vaccines for the 3 diseases are now commonly given in the 1 combination vaccine.

The adopted amendments to §97.64 also delete existing language in subsection (c) regarding provisional enrollment, and cover that issue through new subsection (c) language, which is stated in terms of "Limited Exceptions." This rewrite is designed to add consistency and clarity to the issue of what exceptions to the general requirements there are and how those exceptions work. The adopted language would allow students to participate in coursework activities described in subsection (a) if: (1) the student receives at least 1 dose of each specified vaccine prior to enrollment and completes the vaccination series according to the stated schedule (except that the student cannot participate in coursework activities involving the contact described in subsections (a) or (d) until the full vaccination series is completed); or (2) the student provides acceptable proof of serologic confirmation of immunity. The adopted language goes on to state that students claiming to have satisfied 1 of these 2 conditions cannot engage in the activities described in subsection (a) until they have provided acceptable proof.

New adopted language at §97.64(d) covers applicability of the rule section to students enrolled in schools of veterinary medicine. The existing requirement in subsection (a) for these students to obtain Hepatitis B vaccinations would be moved to subsection (d) as the new (d)(2).

New adopted language at §97.64(e) provides a cross-reference to §97.68 where requirements regarding "acceptable evidence" are found, since that term is used in this rule section.

Section 97.65.

The adopted amendments to §97.65 revise the section title for clarity. The adopted amendments to subsection (a) explicitly state that referenced laboratory report must be a valid one, and also move the word "either" in the sentence to improve clarity and readability. The adopted amendments to subsection (b) revise the rule text for clarity and readability, and specify that statement made by the referenced person should be in writing. Adopted changes to subsection (b) also state that a legal guardian or managing conservator may also make the referenced statement, if applicable. Adopted changes to this subsection also provide a reference to a form considered acceptable for a parent, legal guardian, managing conservator, or physician to complete, in lieu of a vaccine record, in order to attest to a child's positive history of varicella disease or varicella immunity.

Section 97.66.

The adopted amendment to §97.66 revises the section title for clarity, since the provisional enrollment for higher education students is located in §97.64.

Section 97.67.

The adopted amendments to §97.67 provide that all schools and child-care facilities are required to maintain immunization records sufficient for a valid audit "or other assessment" to be completed by the entities listed. The changes are adopted in order to reflect that not all records checks are full-blown audits, and also to explicitly state the various governmental officials who are authorized under other law to perform records checks, audits, etc.

Section 97.68.

The adopted amendments to §97.68 revise the section title and subsection (b) for clarity. Adopted amendments at subsection (c) delete the reference to a "registry" because in Texas today, not all immunization registries are owned by a state or local health department, and further private registries may emerge in the future. Currently, the Health and Safety Code does not acknowledge these private registries in this context, or make them equivalent to those it does reference which are owned by the state or local health departments. Adopted amendments to subsection (d) explicitly state that the referenced record must be an "official" record, and also revise the rule text for better readability.

Section 97.69.

The adopted amendments to §97.69 revise the section title for clarity.

Section 97.70.

The adopted amendments to §97.70 revise the section title for clarity and to improve readability. Additionally, §97.70 is amended to reflect the department's ability to view identified immunization records under the Texas Health and Safety Code and other law, and also to better state the purpose of the reviews in question. The adopted changes also improve readability.

Section 97.71.

The adopted amendments to §97.71 revise the section title for clarity.

Section 97.72.

The adopted amendments to §97.72 are made in order to clearly and accurately provide a cross-reference to statutory authority under which the department and/or a local health authority may require additional doses of vaccinations, beyond those contained in these rule sections, when circumstances warrant. The Texas Health and Safety Code, Chapter 81, Subchapter E establishes the statutory scheme where the state and local health authorities can issue control orders to prevent the spread of disease and protect the public health. Under this statutory scheme, the local health authority takes the lead role, but can be preempted by the department. The department can also initiate these actions on its own initiative. The adopted changes are better reflective of current statutory authority than the current rule language.

COMMENTS

The department, on behalf of the commission, has reviewed and prepared responses to comments received from 20 commenters during the official comment period regarding the proposed rules. The commenters were public health workers and entities, trade associations, advocacy groups, and/or concerned citizens.

Commenters who were in support of the rules in their entirety included the following: Texas Medical Association, Texas Academy of Family Physicians, Texas Pediatric Society--Texas Chapter of the American Academy of Pediatrics, Harris County Public Health and Environmental Services, and Houston Area Immunization Partnership.

Commenters who were somewhat supportive of the rules, but who included suggested recommendations for change as discussed in the summary of comments, include the following: University of Mary Hardin-Baylor, Gregg County Health Department, Grayson County Health Department, Wills Point High School, Ereckson Middle School, Garland ISD, Marshall ISD, Pharr-San Juan-Alamo ISD, Amarillo College, Alamo Community Colleges, Navarro College, Texas Administrators of Continuing Education (TACE), and Trinity Valley Community College. The department responses to these suggestions are given below, at each rule.

Commenters who were against the rules in their entirety included two concerned citizens who felt that no new immunization requirements were needed. One commenter gave no reasons for that position, but the second commenter suggested that anything that might reduce enrollment should not be done, and claimed that new immunization regulations aren't needed for "non-lethal" diseases. The second commenter went on to claim that some schools do not follow department regulations regarding provisional enrollment. This commenter goes on to claim that the agency's real motives in passing immunization requirements are to help vaccine manufacturers profit from the resulting sales. This commenter finishes by saying that the state should stay out of the issue of immunizations for school entry altogether and leave it to be handled by "doctors and persons that have the back ground and education to interpret such decisions and to be done so on a case by case basis."

Response: The commission disagrees. These rule amendments are based on the recommendations of the CDC and the ACIP, which have the full approval of the American Academy of Pediatrics, the American Medical Association, and the American Academy of Family Physicians. The department also worked with stakeholders prior to submitting these amendments for consideration. Stakeholders included physicians and nurses, and the general public through a public meeting. All of the following entities fully support these rule amendments: Texas Medical Association, Texas Academy of Family Physicians, Texas Pediatric Society-Texas Chapter of the American Academy of Pediatrics, Harris County Public Health and Environmental Services, and Houston Area Immunization Partnership, thus demonstrating a realization that the state needs comprehensive and consistent requirements as opposed to any "case-by-case" approach as advocated by the commenter. Vaccine requirements are appropriate measures to prevent and control disease outbreaks and are beneficial to the public health. Vaccines help prevent infectious diseases and save lives. Vaccines are responsible for the control of many infectious diseases that were once common in this country, including polio, measles, diphtheria, pertussis (whooping cough), rubella (German measles), mumps, tetanus, and Haemophilus influenzae type b (Hib). A recent study that examined birth cohorts who were given seven different childhood vaccines (DTaP, Td, Hib, Polio, MMR, hepatitis B, and varicella) found that nearly 33,000 lives are saved and approximately 14 million cases of disease are prevented for each birth cohort. This refutes the commenter's claim regarding "non-lethal" diseases. The adopted amendments are authorized by Health and Safety Code, §81.021, which requires the department to protect the public from communicable disease; §81.004 which allows the department to adopt rules for the effective administration of the Communicable Disease Act; and §161.004 and §161.0041 regarding statewide immunization of children and associated logistics; and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter 1001.

No change was made to the rule as a result of this comment.

Comments concerning §97.63:

Comment: Concerning §97.63, one commenter stated concern regarding those children that will arrive at school on the first day of their kindergarten and/or 7th grade years who may not have the proposed vaccines. The commenter expressed concern regarding whether these children will be kept out of school until the proposed vaccines are administered.

Response: While it is true that any immunization requirement could possibly result in children being kept out of school until proof of the required vaccines is provided, the department notes the availability of exceptions under §97.65, the provisions of Health and Safety Code, §161.004, and provisional enrollment under §97.66. No change was made to the rule as a result of this comment.

Comment: Concerning §97.63(2), one commenter suggested changing the rule language, "A child or student shall show acceptable evidence of vaccination prior, for diseases listed below, to entry, attendance or transfer..." to the following for the purpose of clarity: "For diseases listed below, a child or student shall show acceptable evidence of vaccination prior to entry, attendance, or transfer."

Response: The commission agrees because changing the rule language from "A child or student shall show acceptable evidence of vaccination prior, for diseases listed below, to entry, attendance or transfer..." to "For diseases listed below, a child or student shall show acceptable evidence of vaccination prior to entry, attendance, or transfer..." improves rule clarity. A change was made to the rule as a result of this comment.

Comment: Concerning §97.63(2)(B)(i)(I), one commenter stated that the rule language does not take into account the "recommended immunization schedule for persons aged 7 - 18 years - United States, 2008," which specifies that the three dose schedule only applies to all (inactivated poliovirus vaccine) IPV or all (oral poliovirus vaccine) OPV (http://www.cdc.gov/mmwr/PDF/wk/mm5701-Immunization.pdf, footnote 8), series.

Response: The commission disagrees with the comment. According to the CDC, all children should receive four doses of IPV at ages 6 - 18 months, 2 years old, 4 years old, and 4 - 6 years old. For more information, please refer to the following: "Poliomyelitis Prevention in the United States: Recommendations of the Advisory Committee on Immunization Practices (ACIP), MMWR 2000, 49 (No.RR-5), pp. 10 - 12)." No change was made to the rule as a result of this comment.

Comment: Concerning §97.63(2)(B)(i)(I), one commenter suggested that the rule language, "If any combination of four doses of OPV and IPV was received before four years of age, no additional dose is required" is not an accurate representation of the "recommended immunization schedule for persons aged 7 - 18 years - United States, 2008," which states in the footnotes that "If both OPV and IPV were administered as part of a series, a total of four doses should be administered, regardless of the child's current age." It does not specify that the doses were received before four years of age.

Response: The commission agrees that the language could be clearer, and so the rule language is amended to improve clarity in order to better represent the intent of the recommendations provided by the CDC's ACIP. A change was made to the rule as a result of this comment.

Comment: Concerning §97.63(2)(B)(ii)(I), one commenter suggested that rule language, "Students are required to have five doses of a diphtheria/tetanus/pertussis-containing vaccine - one of which must have been received on or after the fourth birthday. Or, if the fourth dose was administered on or after the fourth birthday, only four doses are required..." be clarified to state the following: "Students are required to have four doses (five doses preferred) of a diphtheria/tetanus/pertussis-containing vaccine, one of which must have been received on or after the fourth birthday."

Response: The commission disagrees with the specific suggested change because the department believes the current language is clear and reflects the five doses of diphtheria/tetanus/pertussis-containing vaccine that are required. However, the title "Kindergarten entry" has been added.

Comment: Concerning §97.63(2)(B)(ii)(III), four commenters stated that the rule language "Beginning school year (SY) 2009 - 2010, students will be required to have one booster dose of a tetanus/diphtheria/pertussis-containing vaccine for entry into 7th grade..." is not clear for a progressive schedule for implementation for students who are in the 8th grade through 12th grade.

Response: The commission agrees. Four commenters expressed concern regarding the Tdap rule for students in grades 8 - 12. The comments included suggested text to include students in grades 8 - 12. The department agrees that the proposed rule language is unclear for the requirement of a tetanus/diphtheria/pertussis-containing booster dose for students in grades 8 - 12. Therefore, the rule has been revised to address those concerns expressed by stakeholders. A change was made to the rule in order to provide more clarity concerning the intent of the rule and better articulate the requirements regarding those students in grades 8 - 12 that would not meet the 7th grade requirement at the time of implementation.

Comment: Concerning §97.63(2)(B)(ii)(III), three commenters expressed concern about the rule language as it pertains to the suggestion that a 7th grade requirement for Tdap would not be 10 years from the previous dose as the 7th grade is sooner than 10 years.

Response: The commission disagrees. The proposed rule language states that students will be required to have one booster dose of a tetanus/diphtheria/pertussis-containing vaccine for entry into the 7th grade, if at least five years have passed since the last dose of a tetanus-containing vaccine. If the five years have not elapsed since the last dose of a tetanus-containing vaccine at entry into the 7th grade, then this dose will become due as soon as the five year interval has passed. Therefore, the proposed rule includes a five-year interval, not a ten-year interval. No change was made to the rule as a result of these comments.

Comment: Concerning §97.63(2)(B)(ii)(III), one commenter argues that since meningitis peaks at 15 - 24 years of age and MCV4 has a ten year coverage span, the vaccine should be administered in conjunction with Tdap at the 14 - 15 year old range. According to the commenter, this would cover the child through age 24. Likewise, the commenter continues, giving MCV4 at 11 - 12 years would last through 21 years and leave three years with potentially decreased immunity which would require the parent to bring the child in only once versus at 11 - 12 years old (i.e., 7th grade) for MCV4 and again at 14 - 15 years old for Tdap.

Response: The commission disagrees. Both Tdap and meningococcal vaccines are proposed to be required in the 7th grade, which is in alignment with the current ACIP recommendation for an adolescent health visit at 11 - 12 years of age. The parent will only need to take the child for one adolescent health visit; thus, both vaccines may be administered within the appropriate recommended timeframes. No change was made to the rule as a result of this comment.

Comment: Concerning §97.63(2)(B)(iii), one commenter suggested that the rule language, "Students are required to have two doses of MMR vaccine upon kindergarten entry for the following grades and school years...(schedule follows.)" should be changed to reflect a two dose requirement at both kindergarten and 7th grade entry for the following reasons: (a) The commenter states that students most at risk for mumps and rubella are older students whose antibodies have waned over a period of 10 - 12 years since their first MMR; (b) commenter claims the availability of the combined MMR-varicella vaccine makes it logical to align the requirements for both vaccines; (c) commenter argues that the small number of older students needing their second MMR would not impact the vaccine supply; and (d) commenter asserts that parallel schedules for MMR and varicella vaccines would simplify the programming of school computer systems and would increase the efficiency of the school nurse.

Response: The commission disagrees. The purpose of these rule amendments is to bring them more into line with the CDC/ACIP medical recommendations. The recommendation for MMR vaccine is that it is to be given at one year of age and again at 4 - 6 years of age. The availability of a combination vaccine is not a sound basis for the timing of a vaccine requirement. In addition, the combination vaccine, MMR-varicella, has not been available for approximately a year due to manufacturing issues.

Comment: Concerning §97.63(2)(B)(iii)(II), one commenter suggested that rule language, "Students are required to have two doses of MMR vaccine...for the following grades and school years (The first dose shall be administered on or after the first birthday):" be changed to the following for the purpose of clarity: "Students are required to have two doses of MMR vaccine with the first dose received on or after the first birthday for the following grades and school years:"

Response: The commission agrees because changing the rule language from "Students are required to have two doses of MMR vaccine...for the following grades and school years (The first dose shall be administered on or after the first birthday):" to "Students are required to have two doses of MMR vaccine with the first dose received on or after the first birthday for the following grades and school years:" improves rule clarity. A change was made to the rule as a result of this comment, within the context of the slight reorganization of the provision at issue within the rule (see discussion above).

Comment: Concerning §97.63(2)(B)(iii)(II), one commenter suggested that the rule language, "upon kindergarten entry" could be deleted for the purpose of clarity.

Response: The commission agrees. The wording "upon kindergarten entry" was deleted as the requirements affect all grades. A change was made to the rule for the purpose of clarity as a result of this comment, within the context of the slight reorganization of the provision at issue within the rule (see discussion above).

Comment: Concerning §97.63(2)(B)(iii)(I) - (XIII), (2)(B)(v)(I) - (VII), (2)(B)(vi)(I) - (XIII), and (2)(B)(vii)(I) - (VI), one commenter suggested that these sections would be more rapidly interpreted by users and less cumbersome if the grades were listed, where applicable, as K - 2; K - 3; K - 2, 7 - 9; K - 3, 7 - 10; etc.

Response: The commission agrees. For the purpose of clarity and improved readability, the grades listed in these provisions are amended pursuant to the comment.

Comment: Concerning §97.63(2)(B)(iv)(I), one commenter stated that the rule language, "Students are required to have three doses of hepatitis B vaccine upon entry into kindergarten" seems to suggest that only students entering kindergarten are required to have hepatitis B vaccine, and students entering school at older grade levels are not required to have it. No other vaccine that is required at all grade levels contains the wording "upon entry into kindergarten." The commenter argues that replacing the wording with this statement "Students are required to have three doses of hepatitis B vaccine" would be clearer.

Response: The commission disagrees with the comment because removing the statement "upon entry into kindergarten" would be confusing-it would leave open a possible interpretation that, in the absence of a specific schedule for this immunization, a child could simply wait until the last grade that is covered by this rule section, 12th grade, to satisfy the requirement. And that would be counter to the intent of the rule. Under the wording adopted by the commission, a child must meet the requirement by the time stated, and if the child does not, then the child will have to catch up prior to enrollment. However, the phrase "no later than" has been added in order to further clarify the schedule.

Comment: Concerning §97.63(2)(B)(v), one commenter stated that the language in the rule text is inconsistent with the language in the rule preamble regarding varicella vaccine. On the highlight of proposed revisions under varicella vaccine, the rule language states that "beginning school year (SY) 2009 - 2010, two dose requirement for kindergarten and 7th grade entry"; however, language contained in the preamble under the section-by-section summary, §97.63(2)(B)(v)(II), only includes kindergarten entry.

Response: The commission agrees and has slightly reorganized the rule text, and has revised the preamble language to better describe the rule language at issue.

Comment: Concerning §97.63(2)(B)(vi), one commenter suggested that rule language, "Students are required to have two doses of hepatitis A vaccine for the following grades and school years (The first dose shall be administered on or after the first birthday):" be changed to the following for the purpose of clarity: "Students are required to have two doses of hepatitis A vaccine with the first dose received on or after the first birthday for the following grades and school years:"

Response: The commission agrees. Adding "Students are required to have two doses of hepatitis A vaccine with the first dose received on or after the first birthday for the following grades and school years:" to the rule language improves clarity and readability. A change has been made in response to this comment, within the context of the slight reorganization of the provision at issue within the rule (see discussion above).

Comment: Concerning §97.63(2)(B)(vi), one commenter stated that all children across the state should be vaccinated against hepatitis A. While the rule language requires two doses of hepatitis A vaccine for children in grades kindergarten through 3rd grade in high incidence geographic areas, the rule language only requires two hepatitis A vaccinations for remainder of the children across the state who would be attending in 2009 - 2010 school years. As a result, there will be children in other grades who will not be vaccinated. Therefore, the rule language should be changed to require that all children statewide in every school grade should be vaccinated against hepatitis A.

Response: The commission disagrees with the comment. The adopted rule language states that two doses of hepatitis A vaccine will be required over an incremental timeframe beginning with kindergarten in SY 2009 - 2010 and ending with grade 12 in SY 2021 - 2022. As a result, by the year 2021, all children in every grade will be required to have two doses of hepatitis A vaccine. From a practical standpoint, it is not feasible to require two doses of hepatitis A vaccine for every student in every grade at one time. Instead, the department places emphasis on students in grades with the highest incidence of disease for the first year. No change was made to the rule as a result of this comment.

Comment: Concerning §97.63(2)(B)(vii), one commenter perceives a contradiction between the language of the rule as proposed and the way the rule is described elsewhere. The commenter asserts that the rule language states, "Students are required to have one dose of meningococcal vaccine for the following grades and school years." Yet, in the earlier section of "Highlights of Proposed Revisions," it states that a new meningococcal vaccine (MCV4, Menactra) was licensed for use among individuals, ages 11 - 55 years, in January 2005. It is unclear (the commenter continues) if students who received the meningococcal polysaccharide vaccine (MPSV, Metamune) at an early age will meet the requirements of this section or if these students need to be reimmunized with the currently available vaccine.

Response: The commission disagrees with the comment. The section of "Highlights of Proposed Revisions" lays out the reasoning for the rule change and includes information about the vaccine's licensure. The fact that the new vaccine was licensed and recommended for routine use was a necessary factor before a requirement for vaccination against meningococcal disease could be considered. The previous vaccine that has been in use for a number of years, MPSV4, was not routinely recommended--this vaccine has been used only for high-risk children and outbreak control measures. The new vaccine carries a routine recommendation for individuals 11 - 55 years of age. The issue of revaccination is not an issue for this rule. The vaccination history of a child is not at issue because this rule requires vaccination against meningococcal disease prior to entry to the 7th grade. The rule does not specify which vaccine must be used and does not address the detail of revaccination. The reason that revaccination is not covered in this rule is due to the fact that a very small number of children need revaccination, while the overwhelming majority of children will receive their initial dose as they enter the 7th grade. No change was made to the rule as a result of this comment.

Comment: Concerning §97.63(2)(B)(vii), one commenter expressed concern regarding the cost of the meningococcal vaccine.

Response: The commission is confident that most required vaccinations will be covered under health insurance plans in Texas. However, if a student is uninsured or underinsured, the student may qualify for the Texas Vaccines for Children (TVFC) program. Under the TVFC program, children up to age 18 are eligible for free or discounted vaccines. The department will monitor the situation regarding the new meningococcal vaccine and the effects of cost upon the ability to ultimately comply with the requirement, and will consider proposing rule amendments if the department comes to believe that the situation warrants. No change was made to the rule as a result of this comment.

Comments concerning §97.64:

Comment: Concerning §97.64(a), one commenter stated that it appears, but is not clear, that the guidelines are divided into sections for "Health-related" and "Veterinary" students, with different guidelines for each type of student. The commenter recommended that §97.64(a) be renamed "Students enrolled in health-related courses" to be more consistent with the title of §97.64(d).

Response: The commission agrees that the title could be clearer, and thus §97.64(a) is renamed to "Students enrolled in (non-veterinary) health-related courses" in order to improve rule clarity and readability by differentiating between health-related and veterinary students.

Comment: Concerning §97.64, for the purpose of clarity, one commenter recommended that the §97.64(b) should be a subsection of §97.64(a).

Response: The commission disagrees with the comment since, according to the guidelines established by the Texas Register concerning rule section structures; there must be at least two designations in a subdivision. By making §97.64(b) a subsection of §97.64(a), the result would be only one designation in the subdivision. Further, the commission believes that the rule structure is clear and readable as adopted. No change was made to the rule as a result of this comment.

Comment: Concerning §97.64, one commenter stated that it is not clear if subsection (c) refers to both types of students (i.e., health-related and veterinary).

Response: The commission agrees that the applicability of subsection (c) to both types of students could be more clearly stated, and thus has revised subsection (c)(1) - (2) to better link to subsection (d).

Comment: Concerning §97.64(a), two commenters stated that the proposed amendment to the rule language specifying what healthcare students are covered by the rules remains insufficient to protect the entire healthcare student population. Healthcare programs (i.e. Nurse Aide, EMT-Basic) provided by institutions not traditionally categorized as "higher education" (i.e. nursing homes, career schools, private training centers) can be interpreted as not being covered by the immunization rules. Community and junior colleges are traditionally considered to be institutions of "higher education" and are clearly covered by the immunization rules. Given that the department has no authority to "police" compliance with the rules, the intent of the rules to protect the public is being applied inequitably across the state.

Response: The commission disagrees with this comment since Education Code, §51.933, provides that the department require immunizations for certain diseases and any additional diseases for students at any institution of higher education who are pursuing a course of study in a human or animal health profession. Institutions which are not legally considered "institutions of higher education" do not fall under the scope of the law; therefore, the department cannot address the concern via the adopted rule. The department would not be protecting the public health if it failed to establish vaccination requirements for those institutions it can regulate simply because there are other institutions it cannot regulate under Texas law. No change was made to the rule as a result of this comment.

Comment: Concerning §97.64, one commenter suggested that instead of changing paragraph (a) of §97.64 to a generic statement indicating the rule applies to "higher education programs," it seems more clear to specify the variety of types of programs that provide health care training courses which involve direct patient care.

Response: The commission disagrees. Previous rule language specified different types of programs that provide health care training; however, various stakeholders have voiced concerns regarding the perceived applicability of the rule to only the specified programs listed. Therefore, in order to avoid such confusion, the adopted rule language was written to encompass all students enrolled in health-related higher education courses (i.e., "institutions of higher education") which will involve direct patient contact with potential exposure to blood or bodily fluids in educational, medical, or dental care facilities. Thus, the adopted language allows for a broad range of programs with the possibility of direct patient contact with potential exposure to blood or bodily fluids. No change was made to the rule as a result of this comment.

Comment: Concerning §97.64(b)(3) and (c), five commenters expressed concerns regarding the time-frame for completing the hepatitis B vaccine series. The commenters stated that the timeframe does not allow for students to complete the required series before beginning direct patient care, if those students have not planned ahead sufficiently to have completed the series prior to enrollment. As a result, students at that point are unable to comply and therefore unable to enroll in various programs (because the direct patient contact begins soon after enrollment). The commenters argue that, as a result the health care programs are suffering with decreased enrollment with a commensurate impact on the state's health care workforce. Various commenters suggested modifying the provisional enrollment rule to allow students to enroll and begin direct patient care with one dose, then completing the remaining doses as the class continues.

Response: While the commission realizes that completion of the three-dose hepatitis B series prior to direct patient care, as stipulated in our rule, may impact class enrollments and perhaps also impact health care workforce, the commission believes that the public health necessity outweighs these concerns. The rule is reflective of the federal "Immunization of Health-Care Workers: Recommendations of the Advisory Committee of Immunization Practices (ACIP)" and the "Hospital Infection Control Practices Advisory Committee (HICPAC)." These recommendations state that among health-care professionals, risks for percutaneous and permucosal exposures to blood vary during the training and working career of each person but are often highest during the professional training period. Therefore, vaccination should be completed during training in schools of medicine, dentistry, nursing, laboratory technology, and other allied health professions, before trainees have contact with blood. The department is sensitive to this issue, and has in the past worked with the Texas Higher Education Coordinating Board (THECB) and others to increase awareness of this long-standing requirement so that fewer students find themselves unprepared at the moment of enrollment. The department remains committed to working with stakeholders to get the word out about this requirement. No change was made as a result of the comments.

Comment: Concerning §97.64, one commenter argues that this immunization requirement remains more stringent than the Occupational Safety and Health Administration (OSHA) rules for healthcare professions in the clinical setting. Commenter states that OSHA requires that immunizations be started within 10 days of employment thereby allowing for direct patient contact to occur before the Hepatitis B series is completed. Commenter claims that reports from Texas community colleges continue to include comments from their local healthcare industry partners as to why the state and OSHA requirements differ, and how the more stringent state immunization requirements continue to hamper the education and training of sufficient numbers of entry-level healthcare workers.

Response: The commission disagrees. Employers who have employees with reasonably anticipated exposure to blood or other potentially infectious material (OPIM) are required to provide the hepatitis B vaccination series at no cost to the employee (29 CFR §1910.1030(f)(2)(i)). The vaccination series must be provided in accordance with the recommendations of the U.S. Public Health Service current at the time of the vaccination (29 CFR §1910.1030(f)(1)(ii)(D)). The OSHA requirements also include training, such as information on the hepatitis B vaccine, including information on its efficacy, safety, method of administration, the benefits of being vaccinated, and that the vaccine and vaccination will be offered free of charge, and post-exposure evaluation. Thus, the OSHA requirements encompass more than the state requirements, which only stipulate vaccination of the student. The rule is reflective of the "Immunization of Health-Care Workers: Recommendations of the Advisory Committee of Immunization Practices (ACIP) and the Hospital Infection Control Practices Advisory Committee (HICPAC)", which call for vaccination of hepatitis B to be completed during training in schools of medicine, dentistry, nursing, laboratory technology, and other allied health professions, before direct patient contact as described in subsection (a). The department appropriately looks to CDC for public health recommendations, as opposed to OSHA. The CDCs are the public health experts in the federal government on these matters. No change was made to the rule as a result of this comment.

Comment: Concerning §97.64, one commenter stated that many community college students are "non-traditional students" choosing to enroll in entry-level healthcare programs later in life as a change in career, or as a first attempt at a college education. Many of these adults do not have the hepatitis B vaccine as part of childhood immunizations, and no longer have access to their immunization records to show as proof of the other required immunizations. These students face a confusing and time consuming process as they obtain new immunizations or serologic confirmation of immunity.

Response: Although the commission understands the challenges that adult students face in obtaining vaccinations and showing proof of such vaccinations, the commission believes the public health necessity for these required vaccinations outweighs the hurdles that students must face in order to show proof of vaccination. The department is committed to providing a safety net of vaccines, at no cost or low cost, to adults. The department is working with the THECB in identifying geographical areas in Texas where access to vaccinations is needed. Both agencies will provide information about clinic locations, hours of operation, and available vaccines for adults to all colleges that fall under the scope of THECB. Information will be mailed to all listed institutions as well as availability on both agencies websites. In addition to these issues of access and cost, the department continues to believe that effective outreach by the various institutions is the most effective way to get the word out about the vaccination requirements so the associated timeframes can be taken into account by potential students. No change was made to the rule as a result of this comment.

Comment: Concerning §97.64, one commenter claimed that reports continue from around the state that some healthcare providers are refusing to administer the 3rd hepatitis B injection, questioning the medical necessity, leaving the student unable to complete the series as required.

Response: Although the department has not been able to independently verify any such instances, it remains committed to work with healthcare providers in Texas to educate them about appropriate vaccination schedules, including hepatitis B vaccine. The Texas Vaccines for Children providers, as well as public health clinics, adhere to the standards of immunization practices which include, but are not limited to: making vaccinations available; administering and documenting vaccinations appropriately; and working with those in the community to increase awareness of vaccine requirements. No change was made to the rule as a result of this comment.

Comment: Concerning §97.64, one commenter argues that college staff (faculty and non-faculty staff) continue to be responsible for "interpreting" immunization records submitted by students, including detailed laboratory data from titers for students that don't have original immunization records available. Many colleges do not have the resources to maintain properly trained staff with the medical background to interpret such documents.

Response: The commission recognizes the challenges in enforcing the immunization requirements in childcare facilities, schools, and institutions of higher education. The department offers educational tools online at www.immunizetexas.com to understand the rules as well as operating a toll-free number to provide technical assistance at (800) 252-9152. It should be noted that while the entities that enforce the immunization requirements are the enforcers, these entities are not expected to interpret immunization records or laboratory data. The department is ready to assist with this type of review of records. Regional and local health departments also serve as a community resource for this purpose as well. The concerns expressed in this comment do not outweigh the public health concerns addressed by the requirement at issue, for all the reasons stated herein. No change was made in response to this comment.

Comment: Concerning §97.64(a), two commenters claim that the financial burden associated with obtaining the required immunizations or laboratory titers prevents many students from applying to healthcare programs at institutions that enforce the immunization rules. College financial aid programs will not pay for vaccinations or titers. Although local health departments now have the authority to offer the required vaccinations at low or no cost to adult healthcare students, many areas of Texas report that this service is not being offered consistently across communities. This frequently leaves the financial burden on the student. At times, the cost of all required immunizations (not only Hepatitis B) is higher than the actual cost of tuition/fees for the short-term healthcare program.

Response: While the commission realizes that this rule may have a financial burden for students, the public health necessity outweighs the financial barriers that students face. The department and THECB are working together to ensure that students and colleges are made aware of the adult vaccine safety-net program offered by the department, which provides vaccines at a low or discounted price to eligible students throughout the state. Additionally, both agencies will work with individual colleges by providing information about the possibility of purchasing vaccine for their students at the state-contracted price. No change was made to the rule as a result of this comment.

Comment: One commenter was generally supportive of the entire rule as proposed, but expressed a wish that Texas would require "meningitis vaccinations for college if not received prior to admittance," citing the availability of reduced-priced shots at county health departments.

Response: According to the Education Code, §51.933, subsection (b), "the Texas Board of Health may require immunizations against the diseases listed in subsection (a) and additional diseases for students at any institution of higher education who are pursuing a course of study in a human or animal health profession"; therefore, the department does not have the authority to establish immunization requirements for all students attending institutions of higher education. No change was made as a result of the comment.

Comment concerning §97.65:

Comment: Concerning §97.65, one commenter suggested deleting the rule language, "or varicella illnesses" in §97.65(a) for the purpose of clarity since the requirement in §97.65(a) that the "Evidence of...varicella illnesses must consist of a valid laboratory report..." seems to be contraindicated by the statement in §97.65(b) that a written statement is acceptable for evidence of varicella disease or immunity.

Response: The commission disagrees because a valid laboratory report indicating confirmation of either immunity or infection is acceptable; or, for varicella illness only, a written statement from the parent/guardian, physician, or school nurse is also acceptable. No change was made to the rule as a result of this comment.

LEGAL CERTIFICATION

The Department of State Health Services General Counsel, Lisa Hernandez, certifies that the rules, as adopted, have been reviewed by legal counsel and found to be a valid exercise of the agencies' legal authority.

STATUTORY AUTHORITY

The adopted amendments are authorized by Health and Safety Code, §81.021, which requires the department to protect the public from communicable disease; §81.004 which allows the department to adopt rules for the effective administration of the Communicable Disease Act; and §161.004 and §161.0041 regarding statewide immunization of children and associated logistics; and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter 1001. Review of the rules implements Government Code, §2001.039.

§97.63.Immunization Requirements in Texas Elementary and Secondary Schools.

Every child in the state shall be vaccinated against vaccine-preventable diseases caused by infectious agents, in accordance with the following immunization schedule.

(1) A vaccine administered up to four days prior to the deadline for that vaccine in the department Immunization Schedule, §97.221 of this title (relating to Department of State Health Services Immunization Schedule) and in the schedules in this section, are considered compliant with that deadline.

(2) For diseases listed below, a child or student shall show acceptable evidence of vaccination prior to entry, attendance, or transfer to a child-care facility or public or private elementary or secondary school.

(A) Children enrolled in child-care facilities, pre-kindergarten, or early childhood programs shall have the following immunizations (at the ages indicated) against: diphtheria, pertussis, tetanus, poliomyelitis, Haemophilus influenzae type b (Hib), measles, mumps, rubella, hepatitis B, hepatitis A, invasive pneumococcal, and varicella diseases in accordance with the department Immunization Schedule, §97.221 of this title. A copy of the current schedule is available at www.ImmunizeTexas.com or by mail to the Department of State Health Services, P.O. Box 149347, Austin, Texas 78714-9347.

(B) Students in kindergarten through twelfth grade shall have the following vaccines, according to the schedule listed.

(i) Poliomyelitis.

(I) Kindergarten entry. Students are required to have four doses of polio vaccine--one of which must have been received on or after the fourth birthday. Or, if the third dose was administered on or after the fourth birthday, only three doses are required. Four doses of oral polio vaccine (OPV) or inactivated poliovirus vaccine (IPV) in any combination by age four to six years old is considered a complete series, regardless of age at the time of the third dose.

(II) Polio vaccine is not required for persons eighteen years of age or older.

(ii) Diphtheria/Tetanus/Pertussis.

(I) Kindergarten entry. Students are required to have five doses of a diphtheria/tetanus/pertussis-containing vaccine-one of which must have been received on or after the fourth birthday. Or, if the fourth dose was administered on or after the fourth birthday, only four doses are required.

(II) Students seven years of age or older. Students seven years of age or older are required to have at least three doses of a tetanus/diphtheria-containing vaccine, provided at least one dose was administered on or after the fourth birthday. Any combination of three doses of a tetanus/diphtheria-containing vaccine will meet this requirement.

(III) Tdap.

(-a-) For the school year (SY) 2008 - 2009 through the end of any summer session of the SY 2008 - 2009, students are required to have one dose of a tetanus/diphtheria-containing vaccine within the last ten years.

(-b-) Seventh grade. Beginning SY 2009 - 2010, students will be required to have one booster dose of a tetanus/diphtheria/pertussis-containing vaccine for entry into the 7th grade, if at least five years have passed since the last dose of a tetanus-containing vaccine. If five years have not elapsed since the last dose of a tetanus-containing vaccine at entry into the 7th grade, then this dose will become due as soon as the five-year interval has passed. Td vaccine is an acceptable substitute, if Tdap vaccine is medically contraindicated.

(-c-) Grades 8 - 12. Beginning SY 2009 - 2010, students who have not already received Tdap vaccine are required to receive one booster dose of Tdap when ten years have passed since the last dose of a tetanus-diphtheria-containing vaccine.

(IV) Children who were enrolled in school, grades K - 12, prior to August 1, 2004, and who received a booster dose of DTaP or polio vaccine in the calendar month of (or prior to) their fourth birthday, shall be considered in compliance with clause (i)(I) (polio) and clause (ii)(I) (DTaP) of this subparagraph.

(iii) MMR.

(I) For the SY 2008 - 2009 through the end of any summer session of the SY 2008 - 2009, students are required to have two doses of a measles-containing vaccine, and one dose each of rubella vaccine and mumps vaccine.

(II) Beginning SY 2009 - 2010, students are required to have two doses of MMR vaccine with the first dose received on or after the first birthday for the following grades and school years:

(-a-) SY 2009 - 2010: K;

(-b-) SY 2010 - 2011: K - 1;

(-c-) SY 2011 - 2012: K - 2;

(-d-) SY 2012 - 2013: K - 3;

(-e-) SY 2013 - 2014: K - 4;

(-f-) SY 2014 - 2015: K - 5;

(-g-) SY 2015 - 2016: K - 6;

(-h-) SY 2016 - 2017: K - 7;

(-i-) SY 2017 - 2018: K - 8;

(-j-) SY 2018 - 2019: K - 9;

(-k-) SY 2019 - 2020: K - 10;

(-l-) SY 2020 - 2021: K - 11; and

(-m-) SY 2021 - 2022: K - 12.

(iv) Hepatitis B.

(I) Students are required to have three doses of hepatitis B vaccine no later than entry into kindergarten.

(II) In some circumstances, the United States Food and Drug Administration may officially approve in writing the use of an alternative dosage schedule for this vaccine. Such an alternative regimen may be used to meet the requirements under this section only when alternative regimens are fully documented. Such documentation must include vaccine manufacturer and dosage received for each dose of that vaccine.

(v) Varicella.

(I) For the SY 2008 - 2009 through the end of any summer session of the SY 2008 - 2009, students are required to have one dose of varicella vaccine received on or after the first birthday for grades K - 12.

(II) Beginning SY 2009 - 2010, students are required to have two doses of varicella vaccine received on or after the first birthday for the following grades and school years (Two doses are required if the child was thirteen years old or older at the time the first dose of varicella vaccine was received):

(-a-) SY 2009 - 2010: K, 7;

(-b-) SY 2010 - 2011: K - 1, 7 - 8;

(-c-) SY 2011 - 2012: K - 2, 7 - 9;

(-d-) SY 2012 - 2013: K - 3, 7 - 10;

(-e-) SY 2013 - 2014: K - 4, 7 - 11;

(-f-) SY 2014 - 2015: K - 5, 7 - 12; and

(-g-) SY 2015 - 2016: K - 12.

(vi) Hepatitis A.

(I) For the SY 2008 - 2009 through the end of any summer session of the SY 2008 - 2009, upon entry into kindergarten through third grade, two doses of hepatitis A vaccine are required for students attending a school located in a high incidence geographic area as designated by the department. The first dose shall be administered on or after the second birthday. A list of geographic areas, for which hepatitis A is mandated for this time period, is available at www.ImmunizeTexas.com, or by mail request at Department of State Health Services, P.O. Box 149347, Austin Texas 78714-9347.

(II) For SY 2009 - 2010, students are required to have two doses of hepatitis A vaccine with the first dose received on or after the first birthday for the following grades and school years:

(-a-) SY 2009 - 2010: K;

(-b-) SY 2010 - 2011: K - 1;

(-c-) SY 2011 - 2012: K - 2;

(-d-) SY 2012 - 2013: K - 3;

(-e-) SY 2013 - 2014: K - 4;

(-f-) SY 2014 - 2015: K - 5;

(-g-) SY 2015 - 2016: K - 6;

(-h-) SY 2016 - 2017: K - 7;

(-i-) SY 2017 - 2018: K - 8;

(-j-) SY 2018 - 2019: K - 9;

(-k-) SY 2019 - 2020: K - 10;

(-l-) SY 2020 - 2021: K - 11; and

(-m-) SY 2021 - 2022: K - 12.

(vii) Meningococcal. Students are required to have one dose of meningococcal vaccine for the following grades and school years:

(I) SY 2009 - 2010: 7;

(II) SY 2010 - 2011: 7 - 8;

(III) SY 2011 - 2012: 7 - 9;

(IV) SY 2012 - 2013: 7 - 10;

(V) SY 2013 - 2014: 7 - 11; and

(VI) SY 2014 - 2015: 7 - 12.

§97.64.Required Vaccinations for Students Enrolled in Health-related and Veterinary Courses in Institutions of Higher Education.

(a) Students enrolled in (non-veterinary) health-related courses. This section applies to all students enrolled in health-related higher education courses which will involve direct patient contact with potential exposure to blood or bodily fluids in educational, medical, or dental care facilities.

(b) Vaccines Required. Students must have the all the following vaccinations before they may engage in the course activities described in subsection (a) of this section:

(1) Tetanus-diphtheria. One dose of a tetanus-diphtheria toxoid (Td) is required within the last ten years. The booster dose may be in the form of a tetanus-diphtheria-pertussis containing vaccine (Tdap).

(2) Measles, Mumps, and Rubella Vaccines.

(A) Students born on or after January 1, 1957, must show, prior to patient contact, acceptable evidence of vaccination of two doses of a measles-containing vaccine administered since January 1, 1968 (preferably MMR vaccine).

(B) Students born on or after January 1, 1957, must show, prior to patient contact, acceptable evidence of vaccination of one dose of a mumps vaccine.

(C) Students must show, prior to patient contact, acceptable evidence of one dose of rubella vaccine.

(3) Hepatitis B Vaccine. Students are required to receive a complete series of hepatitis B vaccine prior to the start of direct patient care or show serologic confirmation of immunity to hepatitis B virus.

(4) Varicella Vaccine. Students are required to have received one dose of varicella (chickenpox) vaccine on or after the student's first birthday or, if the first dose was administered on or after the student's thirteenth birthday, two doses of varicella (chickenpox) vaccine are required.

(c) Limited Exceptions:

(1) Notwithstanding the other requirements in this section, a student may be provisionally enrolled in these courses if the student has received at least one dose of each specified vaccine prior to enrollment and goes on to complete each vaccination series on schedule in accordance with the Centers for Disease Control and Prevention's Recommended Adult Immunization Schedule as approved by the Advisory Committee on Immunization Practices (ACIP), American College of Obstetricians and Gynecologists (ACOG), the American Academy of Family Physicians (AAFP), and the American College of Physicians. However, the provisionally enrolled student may not participate in coursework activities involving the contact described in subsections (a) and/or (d) of this section until the full vaccination series has been administered.

(2) Students, who claim to have had the complete series of a required vaccination, but have not properly documented them, cannot participate in coursework activities involving the contact described in subsections (a) and/or (d) of this section until such time as proper documentation has been submitted and accepted.

(3) The immunization requirements in subsections (b) and (d) of this section are not applicable to individuals who can properly demonstrate proof of serological confirmation of immunity. Vaccines for which this may be potentially demonstrated, and acceptable methods for demonstration, are found in §97.65 of this title (relating to Exceptions to Immunization Requirements (Verification of Immunity/History of Illness)). Such a student cannot participate in coursework activities involving the contact described in subsection (a) of this section until such time as proper documentation has been submitted and accepted.

(d) Students enrolled in schools of veterinary medicine.

(1) Rabies Vaccine. Students enrolled in schools of veterinary medicine whose coursework involves direct contact with animals or animal remains shall receive a complete primary series of rabies vaccine prior to such contact. Serum antibody levels must be checked every two years, with a booster dose of rabies vaccine administered if the titer is inadequate according to current Centers for Disease Control and Prevention guidance.

(2) Hepatitis B Vaccine. Students enrolled in schools of veterinary medicine whose coursework involves direct contact with animals or animal remains shall receive a complete series of Hepatitis B vaccine prior to such contact.

(e) Requirements regarding acceptable evidence of vaccination are found at §97.68 of this title (relating to Acceptable Evidence of Vaccination(s)).

§97.66.Provisional Enrollment for (Non-Higher Education; Non-Veterinary) Students.

(a) The law requires that students be fully vaccinated against the specified diseases. A student may be enrolled provisionally if the student has an immunization record that indicates the student has received at least one dose of each specified age-appropriate vaccine required by this rule. To remain enrolled, the student must complete the required subsequent doses in each vaccine series on schedule and as rapidly as is medically feasible and provide acceptable evidence of vaccination to the school. A school nurse or school administrator shall review the immunization status of a provisionally enrolled student every 30 days to ensure continued compliance in completing the required doses of vaccination. If, at the end of the 30-day period, a student has not received a subsequent dose of vaccine, the student is not in compliance and the school shall exclude the student from school attendance until the required dose is administered.

(b) A student who is homeless, as defined by §103 of the McKinney Act, 42 USC §11302, shall be admitted temporarily for 30 days if acceptable evidence of vaccination is not available. The school shall promptly refer the student to appropriate public health programs to obtain the required vaccinations.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on February 13, 2009.

TRD-200900603

Lisa Hernandez

General Counsel

Department of State Health Services

Effective date: March 5, 2009

Proposal publication date: August 22, 2008

For further information, please call: (512) 458-7111 x6972