25 TAC §97.63
The Executive Commissioner of the Health and Human Services
Commission, on behalf of the Department of State Health Services (department),
proposes an amendment to §97.63, concerning the statewide immunization
requirements in Texas elementary and secondary schools and institutions of
higher education.
BACKGROUND AND PURPOSE
In accordance with the requirements of House Bill 1316 of the 79th Regular
Session of the Texas Legislature (2005), which amended the Human Resources
Code, §42.043, the amendment to 25 TAC, §97.63, provides that children
enrolled in child-care facilities, pre-kindergarten, or early childhood programs
are required to receive two additional age-appropriate disease vaccinations,
hepatitis A and invasive pneumococcal. In addition, the five-dose diphtheria-tetanus-pertussis
containing vaccine requirement is clarified by providing that upon entry into
kindergarten, 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.
SECTION-BY-SECTION SUMMARY
Section 97.63(2)(A)(i) would provide that hepatitis A and invasive pneumococcal
disease be included in the list of age-appropriate vaccinations provided to
children enrolled in child-care facilities, pre-kindergarten, or early childhood
programs, as required by HB 1316.
Section 97.63(2)(A)(ii), which provides that hepatitis A be provided to
children in only high incidence geographic areas as mandated, would be deleted.
Deletion is necessary to give full effect to HB 1316. Section 97.63(2)(B)(ii)(I)
proposes new language that provides that upon entry into kindergarten, 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. This is a clarification of the existing requirement.
Section 97.63(2)(B)(ii)(II) would include that students seven years of
age or older are required to have at least three doses of tetanus-diphtheria
containing vaccine; the amendment would propose that the phrase, "who started
their vaccinations after age" be deleted from the section. This is part of
the clarification referenced above at §97.63(2)(B)(ii)(I). Additionally,
the amendment to §97.63 provides corrections to the rule based upon the
current department organizational structure.
FISCAL IMPACT
Casey S. Blass, Section Director, Disease Prevention and Intervention Section,
has determined that for each year of the first five years that the section
will be in effect, the additional costs associated with enforcing and administering
the section as proposed are primarily vaccine costs. The funds to purchase
these vaccines were funded through a portion of an exceptional item by the
79th Regular Session of the Texas Legislature. Reimbursement of vaccine administration
fees is available through Medicaid and CHIP for children who receive benefits
through those programs. For other children, an out-of-pocket administration
fee may be charged to cover administration costs. Children may not be denied
vaccines for a family's inability to afford the administration fee and local
health departments may incur a cost for those children.
SMALL AND MICRO-BUSINESS IMPACT ANALYSIS
Mr. Blass has also determined that there will be no effect on small businesses
or micro-businesses required to comply with the section as proposed. This
was determined by interpretation of the rule that small businesses and micro-businesses
will not be required to alter their business practices in order to comply
with the section. There are no anticipated economic costs to persons who are
required to comply with the section as proposed. There is no anticipated negative
impact on local employment.
PUBLIC BENEFIT
In addition, Mr. Blass has also determined that for each year of the first
five years the section is in effect, the public will benefit from adoption
of the section. The public benefit anticipated as a result of enforcing or
administering the section as proposed is to provide age-appropriate vaccinations
for hepatitis A and invasive pneumococcal disease to children enrolled in
child-care facilities, pre-kindergarten, or early childhood programs. The
public will also benefit from the proposed clarifications, since these changes
would make the rule requirements easier to understand.
REGULATORY ANALYSIS
The department has determined that this proposal is not a "major environmental
rule" as defined by Government Code, §2001.0225. "Major environmental
rule" is defined to mean a rule the specific intent of which is to protect
the environment or reduce risk to human health from environmental exposure
and that may adversely affect, in a material way, the economy, a sector of
the economy, productivity, competition, jobs, the environment or the public
health and safety of a state or a sector of the state. This proposal is not
specifically intended to protect the environment or reduce risks to human
health from environmental exposure.
TAKINGS IMPACT ASSESSMENT
The department has determined that the proposed amendment does not restrict
or limit an owner's right to his or her property that would otherwise exist
in the absence of government action and, therefore, do not constitute a taking
under Government Code, §2007.043.
PUBLIC COMMENT
Comments on the proposal may be submitted to Tim Hawkins, Disease Prevention
and Intervention Section, Department of State Health Services, 1100 West 49th
Street, Austin, Texas 78756, (512) 458-7111 extension 3394, or (800) 252-9152.
Comments will be accepted for 30 days following publication of this proposal
in the
Texas Register
.
LEGAL CERTIFICATION
The Department of State Health Services General Council, Cathy Campbell,
certifies that the proposed rule has been reviewed by legal counsel and found
to be within the state agencies' authority to adopt.
STATUTORY AUTHORITY
The amendment is proposed under House Bill 1316 of the 79th Regular Session
of the Texas Legislature (2005), and Health and Safety Code, §81.023,
which requires the department to develop immunization requirements for children;
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.
The amendment affects Health and Safety Code, §81.023; Texas Education
Code, §38.001 and §51.933; and Human Resources Code, §42.043.
§97.63. Immunization Requirements in Texas Elementary and Secondary Schools and Institutions of Higher Education [ Required Immunizations ].
Every child in the state shall be immunized against vaccine preventable
diseases caused by infectious agents in accordance with the following immunization
schedule.
(1)
In accordance with the
Department of State Health
Services
[
Texas Department of Health
] Immunization Schedule
as informed by the Advisory Committee on Immunization Practices' (ACIP) recommendations
and adopted by the
Executive Commissioner of the Health and Human Services
Commission
[
Texas Board of Health
] and published in the Texas Register
annually, for all vaccines herein,
vaccine doses administered less than or equal to four days before the minimum
interval or age shall be counted as valid.
(2)
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, or institution of higher education.
(A)
Children enrolled in child-care facilities, pre-kindergarten,
or early childhood programs shall have the following
immunizations:
[
.
]
[
(i)
]
Age-appropriate vaccination against diphtheria,
pertussis, tetanus, poliomyelitis,
Haemophilus influenzae
type b, measles, mumps, rubella, hepatitis B,
hepatitis A, invasive
pneumococcal disease,
and varicella in accordance with the [
Texas
] Department of
State
Health
Services
Immunization
Schedule as informed by the Advisory Committee on Immunization Practices'
(ACIP) recommendations and adopted by the
Executive Commissioner of the
Health and Human Services Commission
[
Texas Board of Health
]
and published in the
Texas Register
annually.
A copy of the current schedule is available at www.ImmunizeTexas.com or by
mail to the
Department of State Health Services
[
Texas Department
of Health
], 1100 West 49th Street, Austin, Texas 78756.
[
(ii)
Hepatitis A. Age-appropriate
vaccination against hepatitis A for children attending a child-care facility,
pre-kindergarten or early childhood programs located in a high incidence geographic
area as designated by the department. A list of geographic areas for which
hepatitis A is mandated shall be published in the
Texas Register
on an annual basis and is available at www.ImmunizeTexas.com
or by mail to the Texas Department of Health, 1100 West 49th Street, Austin,
Texas 78756.]
(B)
Students in kindergarten through twelfth grade shall have
the following vaccines.
(i)
Poliomyelitis.
(I)
Upon entry into kindergarten, 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. If any combination of four
doses of OPV and IPV was received before four years of age no additional dose
if required.
(II)
Polio vaccine is not required for persons eighteen years
of age or older.
(ii)
Diphtheria/Tetanus/Pertussis.
(I)
Upon entry into kindergarten, 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.
[
in any combination unless the fourth
dose was received on or after the fourth birthday in which case only four
doses are required.
]
(II)
Students [
who started their vaccinations after age
] seven
years of age or older
are required to have at least
three doses of a tetanus-diphtheria containing vaccine. Any combination of
three doses of a tetanus-diphtheria containing vaccine will meet this requirement.
One dose of a tetanus-diphtheria containing vaccine is required within the
last ten years.
(iii)
Measles. Two doses of measles-containing vaccine are
required. The first dose shall be administered on or after the first birthday.
(iv)
Rubella. One dose of rubella vaccine received on or after
the first birthday is required.
(v)
Mumps. One dose of mumps vaccine received on or after the
first birthday is required.
(vi)
Hepatitis B.
(I)
Three doses of hepatitis B vaccine are required for the
following grades for the following school years:
(-a-)
2004 - 2005 for kindergarten through fifth grade and
seventh through tenth grade;
(-b-)
2005 - 2006 for kindergarten through eleventh grade;
and
(-c-)
thereafter, beginning in school year 2006 - 2007, for
all students in grades kindergarten through twelfth grade.
(II)
In some circumstances, the United States Food and Drug
Administration may approve the use of an alternative dosage schedule for an
existing vaccine. These alternative regimens may be used to meet this requirement
only when alternative regimens are fully documented. Such documentation must
include vaccine manufacturer and dosage received for each dose of that vaccine.
(vii)
Varicella. One dose of varicella vaccine received on
or after the first birthday is required for the following grades for the following
school years:
(I)
2004 - 2005 for kindergarten through fourth grade and seventh
through tenth grade;
(II)
2005 - 2006 for kindergarten through fifth grade and seventh
through eleventh grade; and
(III)
thereafter, beginning in school year 2006 - 2007, for
all students in grades kindergarten through twelfth grade. Two doses are required
if the child was thirteen years old or older at the time the first dose of
varicella vaccine was received.
(viii)
Hepatitis A. 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 shall be published
in the
Texas Register
on an annual basis and
is available at www.ImmunizeTexas.com, or by mail request at
Department
of State Health Services
[
Texas Department of Health
], 1100
West 49th Street, Austin, Texas 78756.
This agency hereby certifies that the proposal
has been reviewed by legal counsel and found to be within the agency's legal
authority to adopt.
Filed with the Office of
the Secretary of State on July 14, 2006.
TRD-200603765
Cathy Campbell
General Counsel
Department of State Health Services
Earliest possible date of adoption: August 27, 2006
For further information, please call: (512) 458-7111 x6972