PART 1. DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 97. COMMUNICABLE DISEASES
SUBCHAPTER F. SEXUALLY TRANSMITTED DISEASES INCLUDING ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV)
25 TAC §§97.131 - 97.134
The Executive Commissioner of the Health and Human
Services Commission on behalf of the Department of State Health Services
(department) proposes amendments to §§97.131 - 97.134, concerning
the reporting of sexually transmitted diseases (STD), including Acquired
Immunodeficiency Syndrome (AIDS) and Human Immunodeficiency Virus (HIV).
BACKGROUND AND PURPOSE
The amendments are proposed to update and clarify the disease reporting
rules for STD, including HIV and AIDS and to make the STD reporting
process more efficient and effective in Texas in accordance with Health
and Safety Code, Chapter 81, amended by the 80th Legislature, 2007.
The proposed amendments would require the reporting of additional
types of STD laboratory tests: negative confirmatory tests for syphilis;
non-detectable HIV viral loads; negative HIV Polymerase Chain Reaction
(PCR) tests for infants up to three years of age; and HIV genotype
resistance tests. The proposed amendments would also change the level
of the reporting of CD4-T-Lymphyocyte (CD4) counts from the current
level of <200 cells/microliter or less than 14% to all CD4 counts,
regardless of level for adults and adolescents over the age of 12.
The proposed amendments would also change the timeframes for reporting
certain STD diagnoses and tests. The proposed amendments would have
great public health benefit by improving the completeness and timeliness
of STD reporting, resulting in increased number of cases of STD being
identified and earlier public health interventions to control the
spread of STD in Texas. The proposed amendments will also allow for
better monitoring of the care and treatment given for HIV infection.
Government Code, §2001.039, requires that each state agency
review and consider for readoption each rule adopted by that agency
pursuant to the Government Code, Chapter 2001 (Administrative Procedure
Act), according to the schedule in the statute. Sections 97.131 -
97.134 have been reviewed and the department has determined that reasons
for adopting the sections continue to exist because rules on this
subject are needed. Revisions are proposed to clarify the rules, improve
readability and better reflect the rules' statutory authority.
SECTION-BY-SECTION SUMMARY
Section 97.131.
Proposed amendments to §97.131(1) would add the acronym for
the Centers for Disease Control and Prevention (CDC), update the agency
and branch name, and update the mailing address for requesting publications
from the department.
Existing §97.131(2) is proposed to be deleted, and existing §97.131(3)
renumbered paragraph (7) with changes, because the STD defined here
would instead be defined by inserting a cross-reference to the federal
CDC definitions of those diseases. The acronym for Sexually Transmitted
Diseases is also proposed to be added.
New definitions are proposed in §97.131 as these new terms
are used in subsequent sections of rule text. The proposed new definitions
are as follows:
(2) Confirmatory Test--A second analytical test that is done to
detect disease, when an initial or screening test yields a preliminary
positive result, which is independent of the initial test and uses
a different technique and chemical principle in order to ensure reliability
and accuracy.
(3) FASTA File--An electronic data format used to store nucleotide
sequences of the Human Immunodeficiency Virus (HIV).
(4) HIV-Exposed Infant--Any infant born to an HIV-infected woman.
(5) Point of Care Tests--Diagnostic tests performed at or near
the site of patient care that increase the likelihood of the patient
receiving the results as well as referrals for treatment and support
services in a timely manner. These tests are usually performed in
emergency rooms, outpatient clinics and physician offices.
(6) Screening Test--An analytical test used to preliminarily detect
the presence of disease. Positive screening test results should be
followed by a confirmatory test to verify the presence of that disease.
Section 97.132.
Proposed changes to the introductory paragraph for §97.132
would clarify language by using the standard term "report." The amendments
would also add "HIV-exposed infants" to the list of what triggers
reporting because infants born to HIV-infected mothers are suspected
to have HIV infection and must be reported according to Health and
Safety Code, §81.042(b), which requires reporting of a patient
that has or is suspected of having a reportable disease. Proposed
amendments would also provide a cross-reference to §97.133 (relating
to Reporting Information for Sexually Transmitted Diseases) regarding
what must be reported, and would improve readability by using the
term STD instead of listing each reportable disease separately (this
tracks changes proposed for the definitions section of the rules).
Proposed amendments to §97.132(1) would better reflect the
requirements of Health and Safety Code, §81.042 regarding reporting
triggers as well as where the ultimate legal responsibility for reporting
lies, and would improve readability by using the acronym STD.
Proposed amendments to §97.132(2) would better reflect the
requirements of Health and Safety Code, §81.042, particularly
subsection (e). Proposed amendments would also change the word "patient"
to "person" because some of the persons reported will not be patients
of the reporting person.
Proposed amendments to §97.132(3) would add language to include
hospital laboratories as an entity required to report cases of STD,
to track corresponding language in Health and Safety Code, §81.042(d),
and would add the acronym for sexually transmitted diseases instead
of listing each reportable STD separately. Proposed amendments would
delete language about the type of tests and test results required
to be reported because that information is provided in more detail
in §97.133 and a cross-reference to §97.133 is already provided
in this section.
Proposed amendments to §97.132(4) would replace the terminology
"counseling and testing site or a community-based organization" with
the term "testing program," to make the language consistent with Health
and Safety Code, §85.002, and would add a reference to that section
in the rule text. Proposed amendments also clarify the reason for
the medical director or other physician to report cases of STD and
would use the acronym STD instead of listing each reportable STD separately.
Language regarding delegation of reporting duties would be deleted
so that the rule does not improperly imply that the statutorily-designated
persons can legally avoid their reporting responsibilities under the statute.
Proposed amendments to §97.132(5) would add language requiring
local school authorities to report a child attending school who is
suspected of having an STD, based on medical evidence. The amendments
would also add a cross-reference to Health and Safety Code, §81.003,
where the term "school authority" is defined. The proposed changes
to this section (along with the existing rule text in the department's
rule, §97.7) are necessary to be consistent with the requirements
of Health and Safety Code, §81.042(c).
Section 97.133.
The introductory paragraph for §97.133 is proposed to be amended
to remove an inappropriate qualifier statement, to add language that
clarifies the reporting "trigger" to reflect Health and Safety Code,
Chapter 81, and to use the acronym STD for sexually transmitted disease
instead of listing each reportable STD separately and to delete language
about the type of tests and test results required to be reported because
this information is provided in §97.133(2) and (3).
Proposed amendments to §97.133(1) would improve readability
and clarity by replacing language about how to report with a cross-reference
to §97.133(2) which contains the most recent information on that subject.
The text in existing §97.133(2) is proposed to be moved to §97.133(1)
as part of the reorganization of this section to improve flow and readability.
Existing subparagraphs in §97.133(1)(A) - (G) are proposed
to be deleted because the STD listed and the most current forms used
to report them will be in proposed new language in §97.133(2).
New language proposed for §97.133(2) would clearly state that
the referenced persons have to report as described in the subsequent
list in subparagraphs (A) - (E). The proposed amendments change the
reporting forms for adult and adolescent HIV/AIDS and pediatric HIV/AIDS
from CDC forms to department-specific forms (the department's Texas
HIV/AIDS Adult/Adolescent case report form and the department's Texas
HIV/AIDS pediatric case report form), and add the entire name of the
department's forms in addition to the number of the form for the reporting
forms that are not being changed. The proposed new language separates
reporting requirements for physicians and other persons specified
in amended §97.132(1), (2), (4), and (5) and laboratories as
specified in §97.133(3) into two different subsections to improve
clarity in the differences in reporting requirements for physicians
and laboratories. The proposed amendments to §97.133(2) will
also clarify that results from point of care tests must be reported.
Existing language at §97.133(3) is proposed to be replaced
with language requiring persons in charge of a laboratory or any other
facility described in §97.132(3) to report results, as described,
for each person who has or is suspected of having an STD and/or is
an HIV-exposed infant. The existing language in this section is proposed
to be deleted as unnecessary, since §97.134 specifies how reporting
should be done. The proposed new language in §97.133(3) lists
the specific types of tests and test results required to be reported.
The proposed new §97.133(3) would add language that clarifies
that positive or reactive STD test results, including screening tests,
are required to be reported. The proposed amendment changes the current
requirement that only detectable HIV viral loads are reported, making
both detectable and non-detectable HIV viral loads required to be
reported. The proposed new §97.133(3) changes the reporting of
CD4+T-lymphocytes (CD4s) from counts below 200 cells/microliter or
less than 14% to all CD4 counts, regardless of level for adults and
adolescents over 12 years of age. The proposed new §97.133(3)
revises the requirement to report PCR tests for HIV (DNA or RNA) on
all infants to include both positive and negative results for infants
from birth to three years of age, instead of the existing requirement
to report only positive PCR results. Adding a requirement to report
negative PCR results for infants will enable the State to determine
perinatal HIV transmission rates for Texas with more accuracy and
will also decrease the amount of time public health workers spend
on contacting health care providers to obtain negative PCR results
on HIV-exposed infants. Overall, these changes to reporting requirements
for HIV test results by laboratories and other listed entities will
greatly enhance completeness of reporting for HIV and increase the
number of new HIV cases reported, resulting in better data to target
prevention interventions and allocate scarce resources. These changes
will also result in better monitoring of severity of HIV disease and
the quality of HIV care in Texas. These changes will allow a more
accurate determination of the unmet needs for HIV care in Texas. The
proposed new §97.133(3) changes the required reporting of confirmatory
tests for syphilis from the existing requirement to only report positive
(reactive) results to the requirement to report both reactive and
non-reactive tests. This will allow public health personnel to spend
less time investigating positive screening tests with missing confirmatory
test results and decrease calls to physicians and laboratories to
provide this information. The proposed new §97.133(3) also adds
the requirement to report nucleotide sequences of HIV from resistance
testing, e.g. FASTA files, so that the State can obtain more complete
information for its HIV resistance surveillance activities, including
monitoring the level and types of HIV medication resistance in Texas.
Section 97.134.
Proposed amendments to §97.134(a) would add clarifying language
that specifies that case reports are confidential as provided by law,
and would remove vague language.
Proposed amendments to §97.134(b) would delete the word "region"
and replace it with "departmental regional office which covers the
area" for clarity on who should receive case reports in the absence
of a local health department director.
Proposed amendments to §97.134(c) would update the agency,
branch name and the mailing address for sending reports of STD. A
reference to the HIV/STD program website for obtaining additional
reporting information is proposed to be added, and the statement about
obtaining postage paid envelopes from the HIV/STD program is proposed
to be deleted because there have been no requests for such envelopes
for the past five years and the department is discontinuing that service.
Proposed amendments to §97.134(d) would specify data elements
required to be reported for cases of STD and HIV infection or AIDS,
to be consistent with amendments made to Health and Safety Code, §81.043
and §81.044 during the 80th Legislature, 2007. Text is proposed
to be added that updates the reference to the department's health
service regions, and text is proposed to be deleted that states forms
can be obtained from the department's HIV/STD program and the related
address since this entity does not provide reporting forms. Proposed
amendments add a reference to the HIV/STD program website for a list
of local health departments and the department's health service region
offices where reporting forms can be obtained.
Proposed amendments to §97.134(e) would require a shorter
reporting period for physicians and other referenced persons to submit
reports of primary or secondary syphilis by telephone (i.e., within
one working day of determining the diagnosis). Other STD retain the
existing requirement that reporting be made within seven calendar
days. The proposed amendment for reporting syphilis test results within
one working day will allow public health authorities to respond more
quickly to reported cases and interrupt the chain of transmission
earlier, thereby reducing the spread of the disease. Primary and secondary
(P&S) syphilis are the stages of syphilis where the disease is
most transmissible. In Texas, cases of P&S syphilis have steadily
increased from 398 in 2000 to 1,172 in 2007 indicating a need for
more aggressive intervention measures for syphilis, including earlier
disease reporting. The proposed amendment for reporting primary and
secondary syphilis would also put Texas in compliance with the CDC
syphilis surveillance recommendations. Currently, Texas is one of
only seven states that have a syphilis reporting timeframe of seven
calendar days; 29 states have syphilis reporting within one working day.
Proposed amendments to §97.134(f) would require any person
in charge of a clinical laboratory or other entity as specified by §97.132(3)
to submit syphilis test results within three working days of obtaining
the test result, which is a change from the existing rule that requires
weekly submission. Other STD retain the existing requirement that
test results be reported within seven calendar days in §97.134(f).
Syphilis is proposed to be treated separately for the same reasons
previously stated in this preamble regarding proposed changes to §97.134(e).
Laboratory reporting of syphilis tests is proposed to be within three
working days of obtaining the test result compared to within one working
day for physicians and other non-laboratory reporters. This timeframe
is proposed based on feedback from stakeholders that were concerned
that "within one day" reporting from laboratories could result in
a laboratory triggering a disease intervention specialist (DIS) contacting
a patient before the physician received the laboratory report. Feedback
from laboratory stakeholders was that a "within one day" reporting
time frame would be overly burdensome. A "within three-day" timeframe
for reporting syphilis is recommended because it shortens the reporting
timeframe but also allows a short time-lag for physicians to receive
results before a DIS contacts the patient. Laboratory stakeholders
also indicated that this timeframe would be not be as overly burdensome
as a "within one-day" timeframe. Proposed amendments to §97.134(f)
would add clarifying language that the requirement for laboratories
to report quarterly if they have no positive test results for that
calendar quarter is an additional requirement and does not replace
other reporting requirements.
Existing language at §97.134(g) is proposed to be deleted
in its entirety because a rule on the subject is not needed. New language
is proposed for subsection (g), which would require health authorities
to report each week to the department, using electronic or paper reports,
all STD cases, including HIV infection and AIDS, to be consistent
with amendments made to Health and Safety Code, §81.043, during
the 80th Legislature, 2007. The proposed new language will also include
the address for mailing paper reports and an email address to request
information on how to file electronic reports.
FISCAL NOTE - STATE GOVERNMENT
Casey S. Blass, Director, Infectious Disease Prevention Section,
has determined that for each of the first five years the sections
are in effect, there will be no fiscal implications to state government.
The proposed rule amendments will result in an increase in the volume
and type of STD reports received by the department; however, other
provisions in the proposed amendments would offset those resource
demands by decreasing the amount of time which needs to be spent on
case follow-up by department STD surveillance personnel. No new personnel
are anticipated to be needed under the proposed rules.
FISCAL NOTE - LOCAL GOVERNMENT
Mr. Blass has also determined that for each of the first five years
the sections are in effect, there will be no fiscal implications to
local government. The proposed rule amendments will result in an increase
in the volume and type of STD reports received by local health departments
and may increase the number of new cases needing disease intervention
services; however, other provisions in the proposed amendments should
offset those resource demands by decreasing the amount of time needed
for follow-up on preliminary positive STD results with a missing confirmatory
test and follow-up on HIV-exposed infants without test results indicating
final HIV status.
MICRO-BUSINESS AND SMALL BUSINESS IMPACT ANALYSIS
Once a person/entity is within the scope of these rule amendments,
then the proposed rules would provide for certain things that must
be done such that the impacts are definite (e.g., small business must
devote resources necessary to file reports). Since these impacts will
happen, the department analysis under Economic Impact Statement as
follows will also serve to satisfy the Small Business Impact Analysis
required by Government Code, §2006.002(a).
The Economic Impact Statement does not explicitly cover "micro-businesses,"
but Government Code, §2006.002(a), requires an analysis of the
impacts on such businesses. The department could not discern any difference
in the impact of these rules on small businesses versus micro-business
as defined in the statute, so the analysis will consider them both
together and refer to them collectively only as "small businesses."
There is no anticipated negative impact on local employment.
The definition of a "small business" for purposes of this requirement
was codified at Government Code, §2006.001(2). Under this definition,
a "small business" is an entity that is: for profit, independently
owned and operated; and has fewer than 100 employees or less than
$6 million in annual gross receipts. Independently owned and operated
businesses are self-controlling entities that are not subsidiaries
of other entities or otherwise subject to control by other entities
(and are not publicly traded).
Mr. Blass has determined that there may be an adverse economic
effect on those small businesses directly regulated by the proposed
rules. Therefore, the following two analyses have been performed:
--ECONOMIC IMPACT STATEMENT
The areas of possible impacts to small businesses regarding the
proposed rules involve reporting and the frequency of reporting. Possible
impacts are discussed on a section-by-section basis, below.
The proposed amendments to §97.132 do not add persons to the
list of those who must report beyond those mandated by existing statutory
language (see discussion in the Section-By-Section Summary of this
preamble). Because statutory provisions already require these persons
to report as indicated, there is no new legal burden created by more
clearly expressing at fact in §97.132.
The proposed amendments to §97.133 requiring the use of Texas
specific forms to report adult/adolescent and pediatric HIV/AIDS cases
will have no adverse effect on small businesses in Texas. The HIV/AIDS
case report forms are primarily used by the HIV/AIDS reporting sites,
which are all local or regional health departments, the Texas Department
of Criminal Justice, or by a limited number of larger volume HIV testing
sites and hospitals, all of which would be categorized as either nonprofit
organizations or large businesses. The Texas-specific case report
forms should be available free of charge from local and regional health
departments.
The proposed amendments to §97.133 requiring laboratories
that conduct HIV drug resistance testing to submit reports containing
the nucleotide sequence (e.g., FASTA file) to the department will
have no adverse effect on small business in Texas. HIV drug resistance
testing is a highly specialized laboratory procedure that appears
to be limited to a handful of large reference labs across the country.
In a telephone survey of select laboratories doing business in Texas
completed in March of 2009, only eight labs were identified that do
this type of testing, none of which would be classified as a small
business.
The proposed amendments to §97.133 requiring laboratories
to report all PCR test results for children less than three years
of age will have no adverse effect on small businesses in Texas. As
with HIV drug resistance testing, HIV PCR testing appears to be a
specialized test only performed in very large reference laboratories.
In March of 2009, an informal survey of HIV/AIDS reporting sites was
conducted to determine which labs reported positive PCR results, and
only four very large laboratories were named. This was further confirmed
through laboratory report information contained in STD*Management
Information System (STD*MIS), the state STD data reporting system
in Texas. None of the 107 positive PCR tests that were reported in
2007 through STD*MIS were from laboratories that would be classified
as a small business.
The proposed amendments to §97.133 requiring the reporting
of all levels of CD4 counts and percentages for adults and adolescents,
and all detectable and non-detectable HIV viral load tests, will not
have an effect on small businesses in Texas. STD*MIS laboratory report
data was used to determine how many labs conduct CD4 and HIV viral
load tests. In the first six months of 2008, 63 laboratories were
listed as having performed either CD4 or viral load tests, and none
of these would be classified as a small business.
The proposed amendments to §97.133 requiring laboratories
to report all confirmatory syphilis test results will have an overall
negligible effect on small business in Texas. To estimate the number
of laboratories performing syphilis tests that might be affected,
all syphilis lab reports from the first six months of 2008 were pulled
from STD*MIS. In that period, 265 facilities were listed as the laboratory
that performed any type of syphilis test with any result. After removing
laboratories from the list that would be classified as government
or nonprofit, and researching the size of the remaining businesses,
only 24 organizations were left that might qualify as small business.
Even if that number were doubled to account for small private facilities
that may not have had a syphilis test reported in STD*MIS in the six-month
period, this rule change should affect no more than 50 small businesses.
If one assumes that the difference between the number of positive
screening tests reported in STD*MIS from these 24 small labs and the
number of positive confirmatory tests reported were all negative confirmatory
tests, which are not currently reportable, the total additional volume
to be reported per year is estimated to be 60 to 120 negative confirmatory
test results. Since this total number of tests is spread across 50
estimated small laboratories, an average small lab will only be reporting
two or three negative syphilis confirmatory results per year. Any
extra costs associated with printing and mailing in these extra syphilis
test results is mitigated by the fact that under the current reporting
rule, local STD reporting sites are calling labs to follow up on positive
screening tests that were received without an accompanying confirmatory
test result. For small laboratories, having employees field calls
from the health department and look up negative confirmatory results
is presumed to be equally if not more costly to the business than
just routinely submitting the negative confirmatory test result along
with the positive screening test.
The proposed amendments to §97.134 revising the timeframe
for laboratories to report syphilis test results within three working
days of obtaining a result will have a nominal effect on small business
in Texas. As described previously, the number of small business laboratories
conducting syphilis tests in Texas is estimated at no more than 50.
Requiring small labs to report syphilis results in three days as opposed
to the current weekly rule will not have an effect on the number of
tests reported, only the frequency with which these results are submitted
to the health department. According to 2008 STD*MIS data, the average
small laboratory reports eight syphilis lab tests per year, so even
if each one of those tests required an individual transmittal to the
health department, the cost would be quite low per year, per lab.
One small business laboratory in Texas was consulted and they estimated
that it takes a lab technician no more than ten minutes to print and
mail out a test result. Lab technicians earn approximately $20 per
hour. Reporting a single test result might cost a lab a maximum of
$5, including man-hours, paper, envelope and postage. The total extra
cost per year for the average small lab should be no more than $40.
The proposed amendments to §97.134 revising the timeframe
and method for healthcare providers to report P&S syphilis diagnoses
would have a negligible effect on small business in Texas. According
to STD*MIS data, approximately 300 different healthcare providers
diagnosed P&S syphilis cases in the first six months of 2008.
Of that total, about half would clearly be classified as government,
nonprofit, or large business providers. Factoring in some extra providers
for a full year timeframe, the department estimates that 200 small
business providers may be impacted by this rule change. The total
number of P&S syphilis cases to be reported among these 200 healthcare
providers is estimated at 400 cases per year, for an average of two
cases per provider per year. While changing the timing of the case
report from within seven days to within one working day for a provider
may be slightly less convenient, the overall time and effort required
to make the report will not change for these small businesses. In
fact, with this proposed rule amendment also requiring diagnosing
facilities to report P&S syphilis cases by telephone, these small
businesses may incur less expense compared to the resources required
to report cases on paper. Under this rule amendment, the average small
business healthcare provider should be able to complete all of their
P&S case reports for a year with two five-minute phone calls.
The proposed amendments to §97.134 deleting the portion stating
that in addition to report forms, postage paid envelopes may be obtained
from the HIV/STD Epidemiology Division without charge will not have
an adverse effect on small business. The department has not provided
any postage paid envelopes to any individual or organization wishing
to report HIV/STD in the past five years or more. Making this change
in the reporting rules will have no adverse effect on small business
in Texas because no business is currently taking advantage of this
offer and has not for many years.
--REGULATORY FLEXIBILITY ANALYSIS
The department considered several alternative methods to achieve
the purpose of the rule change proposed for §97.134(e) - (f).
Initially, the proposal was to make all syphilis test results reportable
by laboratories within one day rather than three days. However, the
early feedback received from meetings with key HIV/STD laboratory
stakeholders in early 2009, was that one-day reporting would be excessively
burdensome to lab workflow. Another concern expressed by stakeholders
was that within one-day reporting from laboratories could result in
a laboratory report triggering a DIS contacting a patient before the
physician received the laboratory report. The three working-day time
period for laboratory reporting for syphilis is being proposed as
a compromise. Another alternative considered was to proscribe electronic
lab reporting. The department may provide limited technical assistance
to any laboratory that may be interested in moving towards the reporting
of lab test results through secure electronic file transfers. After
the initial set up, electronic reporting would reduce costs by eliminating
the paper and postage from the equation and reducing the time spent
by staff to complete the reporting process. However, it was determined
that the department does not have the statutory authority to mandate
electronic reporting from laboratories, and there are also technical
issues regarding compatibility of different electronic data systems.
Finally, the department also considered implementing a different timetable
for syphilis reporting among small laboratories (as opposed to those
that are not small businesses); however, this was not deemed to be
adequately protective of public health and safety. P&S syphilis
is increasing in Texas with case numbers tripling over the last eight
years. Moving to within three-day reporting of syphilis for all laboratories
will shorten the timeframe from its current reporting requirement,
which will in turn allow earlier public health intervention but not
be overly burdensome to laboratories.
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,
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 amendments do 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 BENEFIT
In addition, Mr. Blass has determined that for each year of the
first five years the sections are in effect, the public will benefit
from adoption of the sections. The public will benefit from adoption
of the proposed amendments because more complete and timely STD reporting
will result in enhanced STD data, increased identification of new
cases of STD and earlier public health interventions to control the
spread of STD in Texas. The enhanced data will allow public health
officials to better target prevention and treatment programs for individuals
at risk for HIV and other STD and will enable public health officials
to identify disease outbreaks in specific geographical areas or in
specific populations more quickly.
PUBLIC COMMENT
Comments on the proposal may be submitted to Nicole Hawkins, Department
of State Health Services, HIV/AIDS Epidemiology and Surveillance Branch,
MC 1873, P.O. Box 149347, Austin, TX 78714-9347, or by email to Nicole.Hawkins@dshs.state.tx.us.
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 Counsel, Lisa Hernandez,
certifies that the proposed rules have been reviewed by legal counsel
and found to be within the state agencies' legal authority to adopt.
STATUTORY AUTHORITY
The amendments are authorized by the Health and Safety Code, Subtitle
D, Chapter 81, Subchapter C, §§81.041 - 81.044, which grants
the Texas Board of Health authority to identify each communicable
disease or health condition that shall be reported under Chapter 81,
authority to maintain and revise as necessary the list of reportable
diseases, and authority to require reporting of HIV and AIDS. The
proposed amendments are also authorized by the other statutory citations
listed in the individual sections herein. The amendments are also
authorized by the 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 review of the rules implements Government
Code, §2001.039.
The amendments affect Health and Safety Code, Chapters 81 and 1001;
and Government Code, Chapter 531.
§97.131.Definitions.
The following words and terms when used in this chapter shall
have the following meanings unless the context clearly indicates otherwise.
(1) AIDS and HIV Infection--Acquired Immune Deficiency
Syndrome (AIDS) and Human Immunodeficiency Virus (HIV) infection are
as defined by the Centers for Disease Control and Prevention
(CDC) and
in accordance with the Health and Safety Code, §81.101. The publication
designating the most current definition may be requested from: Texas
Department of State Health Services, TB/HIV/STD [
(2) Confirmatory Test--A second analytical
test that is done to detect disease, when an initial or screening
test yields a preliminary positive result, which is independent of
the initial test and uses a different technique and chemical principle
in order to ensure reliability and accuracy.
(3) FASTA File--An electronic data
format used to store nucleotide sequences of the Human Immunodeficiency
Virus (HIV).
(4) HIV-Exposed Infant--Any infant
born to an HIV-infected woman.
(5) Point of Care Tests--Diagnostic
tests performed at or near the site of patient care that increase
the likelihood of the patient receiving the results as well as referrals
for treatment and support services in a timely manner. These tests
are usually performed in emergency rooms, outpatient clinics and physician
offices.
(6) Screening Test--An analytical
test used to preliminarily detect the presence of disease. Positive
screening test results should be followed by a confirmatory test to
verify the presence of that disease.
(7) [
§97.132.Who Shall Report Sexually Transmitted Diseases.
The following shall report [
(1) A physician or dentist shall report each patient
who has or is suspected of having an STD and/or is an HIV-exposed
infant [
(2) The following persons [
(A) a professional registered nurse;
(B) an administrator or director of
a public or private temporary or permanent child-care facility (as
defined in Title 40, Texas Administrative Code, Part 19, Chapter 746,
Subchapter A, §746.105);
(C) an administrator or director of
a nursing facility (as defined in Title 40, Texas Administrative Code,
Part 1, Chapter 18, Subchapter A, §18.2);
(D) an administrator or director of
a personal care facility (as defined in Title 40, Texas Administrative
Code, Part 19, Chapter 705, Subchapter A, §705.1001);
(E) an administrator or director of
an adult day-care facility (as defined in Title 40, Texas Administrative
Code, Part 1, Chapter 98, Subchapter A, §98.2(3));
(F) an administrator or director of
a maternity home (as defined in Texas Health and Safety Code, §249.001(3));
(G) an administrator or director of
an adult respite care center (as defined in Texas Health and Safety
Code, §242.181(3));
(H) an administrator of a home health
agency (as defined in Texas Insurance Code, §1351.001(2));
(I) an administrator or health official
of a public or private institution of higher education;
(J) an owner or manager of a restaurant,
dairy, or other food handling or processing establishment or outlet;
(K) a superintendent, manager, or
health official of a public or private camp, home, or institution;
(L) a parent, guardian, or householder;
(M) a health professional;
(N) an administrator or health official
of a penal or correctional institution; or
(O) emergency medical service personnel,
a peace officer, or a firefighter.
(3) Any person in charge of a clinical laboratory,
hospital laboratory, blood bank, mobile unit, or other facility in which
a laboratory examination of a blood specimen, or any specimen
derived from a human body, [
(4) The medical director or other physician responsible
for the medical oversight of a testing program, as defined in
Texas Health and Safety Code, §85.002, [
(5) A local school authority, as defined at Texas
Health and Safety Code, §81.003, shall report a child attending
school who is suspected, based on medical evidence, of having an STD
and/or is an HIV-infected infant. [
(6) (No change.)
§97.133.Reporting Information for Sexually Transmitted Diseases.
Reporting entities described in §97.132 of this title
(relating to Who Shall Report Sexually Transmitted Diseases) shall
report all information required by the department for each person
who has or is suspected of having an STD and/or is an HIV-exposed
infant and[
(1) The department has established the reporting procedures
required under Texas Health and Safety Code, §81.044, including
the designation of specific forms and methods of reporting [
(2) Physicians and other persons as
specified by §97.132(1), (2), (4), and (5) of this title are
required to report.
(A) All diagnoses of adult or adolescent HIV infection
and AIDS using all of the information found in the most current version
of the department's Texas HIV/AIDS Adult/Adolescent case report form
(available as specified in §97.134 of this title (relating to
How to Report Sexually Transmitted Diseases) and all diagnoses of
pediatric HIV infection and AIDS using all of the information from
the most current version of the department's Texas HIV/AIDS pediatric
case report form (available as specified in §97.134 of this title).
(B) Information on all HIV positive women giving birth
and HIV exposed infants using all of the elements from the most current
version of the department's Enhanced Perinatal HIV Surveillance form
adopted by the department (available as specified in §97.134
of this title).
(C) All chancroid, Chlamydia trachomatis, gonorrhea,
and syphilis infections using all of the information found in the
most current version of the department's Confidential Report of Sexually
Transmitted Diseases form (STD-27) for adults and adolescents (available
as specified in §97.134 of this title).
(D) All congenital syphilis infections using all of
the information found in the most current version of the department's
Confidential Report of Sexually Transmitted Diseases form (STD-27).
(E) Positive or reactive results from point of care
testing for STDs (including HIV) for adults, adolescents and HIV exposed
infants using all of the information found in the most current version
of the department's Confidential Report of Sexually Transmitted Diseases
form (STD-27).
(3) Any person in charge of a laboratory
or other facility as specified by §97.132(3) of this title is
required to report the results for each person who has or is suspected
of having an STD and/or is an HIV-exposed infant by providing all
of the information sought in the most current version of the department's
Notification of Laboratory Test Findings Indicating Presence of Chlamydia
trachomatis, Gonorrhea, Syphilis, Chancroid, HIV Infections or CD4
Counts form (STD-28) (available as specified in §97.134 of this
title), including the following.
(A) All positive or reactive STD test results, including
screening tests, all HIV viral loads (detectable and non-detectable),
and all CD4+T-lymphocyte cell counts and percentages for adults and
adolescents over 12 years of age.
(B) Polymerase Chain Reaction tests (PCR) for HIV (DNA
or RNA) on all infants from birth to three years of age, regardless
of the test findings (e.g., negative or positive).
(C) All confirmatory tests for syphilis, regardless
of result (e.g., reactive or non-reactive).
(D) HIV drug resistance testing that contains the resulting
nucleotide sequences of the HIV (e.g., FASTA file).
§97.134.How to Report Sexually Transmitted Diseases.
(a) All case reports received by the health authority
or the department are confidential
as provided by law [
(b) Reporting forms and/or information from all entities
required to report should be sent to the local health department director
where the physician's office, hospital, laboratory or medical facility
is located or, if there is no such facility, the reports should be
forwarded to the regional director in the department's health
service region office which covers the area [
(c) If any individual or entity is unsure where to
report any of the diseases mentioned in this subchapter [
(d) Reports of STD and/or HIV-exposed infants
shall contain all of the information found on the reporting forms
specified in §97.133(2) of this title (relating to Reporting
Information for Sexually Transmitted Diseases) including, but not
limited to (reporting [
(1) the patient's name, address, age,
sex, race, and occupation; the date of onset of the disease or condition;
the probable source of infection and the name of the attending physician
or dentist; and
(2) reports of HIV infection or AIDS
shall also contain the patient's ethnicity, national origin, and city
and county of residence.
(e) Physicians and other persons as specified
by §97.132(1), (2), (4), and (5) of this title must submit reports
of primary or secondary syphilis by telephone within one working day
of determining the diagnosis. All other reports [
(f) Any person in charge of a clinical laboratory
or other entity as specified by §97.132(3) of this title shall
submit syphilis test results within three working days of obtaining
the test result and shall submit all other test results within seven
calendar days. In addition to required reporting, if [
(g) A health authority shall report
each week to the department all cases reported to the authority during
the previous week of STD, including HIV infection and AIDS, using
electronic or paper reports. Information on how to submit electronic
reports can be obtained from the TB/HIV/STD Epidemiology and Surveillance
Branch through an email request to HIVSTDreporting@dshs.state.tx.us.
Paper reports should be mailed to the Texas Department of State Health
Services, TB/HIV/STD Epidemiology and Surveillance Branch, MC 1873,
P.O. Box 149347, Austin, TX, 78714-9347.
(h) - (i) (No change.)
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 20, 2009.
TRD-200902965
Lisa Hernandez
General Counsel
Department of State Health Services
Earliest possible date of adoption: August 30, 2009
For further information, please call: (512) 458-7111 x6972
The Executive Commissioner of the Health and Human Services
Commission on behalf of the Department of State Health Services (department)
proposes the amendments of §289.201, concerning general provisions
for radioactive material, §289.203, concerning radiation notices,
instructions, reports to workers, and inspection protocol, §289.251,
concerning exemptions, general licenses, and general license acknowledgements,
and §289.252, concerning licensing of radioactive material.
BACKGROUND AND PURPOSE
The amendments to §§289.201, 289.251, and 289.252 are
necessary primarily to comply with compatibility requirements of the
United States Nuclear Regulatory Commission (NRC). The amendments
are the result of the NRC's adoption of requirements for the revision
of skin dose limits and requirements for the expanded definition of
byproduct material. Other amendments are made to §§289.201,
289.251, and 289.252 to clarify program policies and procedures. The
amendments to §289.203 are necessary to incorporate requirements
for notice of violation documents that are related to increased control
violations and to update the Notice to Employees Form.
Government Code, §2001.039, requires that each state agency
review and consider for readoption each rule adopted by that agency
pursuant to the Government Code, Chapter 2001 (Administrative Procedure
Act). Sections 289.201, 289.203, 289.251, and 289.252 have been reviewed
and the department has determined that the reasons for adopting these
sections continue to exist because rules on this subject are needed.
SECTION-BY-SECTION SUMMARY
Section 289.201(b) adds a definition for "consortium" as an association
of medical use licensees and a Position Emission Tomography (PET)
radionuclide production facility, since the term is used in §289.252(kk)
regarding new requirements for the issuance of specific licenses for
a medical facility or educational institution to produce PET radioactive
drugs for noncommercial transfer to licensees in its consortium. The
definition of "shallow dose equivalent" is revised. These definitions
are items of compatibility with the NRC and as an agreement state,
Texas must adopt them. In addition, the definition of "residential
location" is added to define a term that is used in §289.252(x)
regarding specific terms and conditions of licenses.
The reference to the Texas Radiation Control Act is revised to
state the complete legal citation in §289.203(a).
The title for the referenced §289.202 rule section is corrected
in §289.203(b)(1)(A).
Section 289.203(b)(1)(D) restructures the sentence and adds the
words "not been labeled "withhold from public disclosure under Government
Code, §552.101," or equivalent phrase, in accordance with §289.252(ii)
of this title," to clarify that notices of violation involving radiological
working conditions or orders issued relating to increased security
controls that have been labeled to withhold from public disclosure,
shall not be posted.
The words "shall be posted by each licensee or registrant as required
by this section" are deleted at the end of the sentence and subsequently
the words, "Each licensee or registrant shall post" are added to the
beginning of the first sentence in §289.203(b)(3) to be consistent
with sentence structure used in this subsection. The term "Bureau
of Radiation Control (BRC)" is deleted and replaced with "RC" to be
consistent with the nomenclature for the applicable referenced form.
New language is added to §289.203(d)(2) in order to maintain
compatibility with the NRC and to be consistent with language used
in the related "Notice to Employees" form.
Section §289.203(i) adds "RC Form 203-1" after "The following
form," to be consistent with language used throughout the chapter.
In addition, to be consistent with language used throughout the chapter,
the Notice to Employees form, referenced as a figure in this subsection,
is revised with the following changes: form number now reads "RC Form
203-1;" corrects the department name and address, as applicable, throughout
the form; replaces "radiation" with "registration" in item 2 of "YOUR
EMPLOYER'S RESPONSIBILITY;" replaces "personnel monitoring" with "individual
monitoring devices" in item 3 of "WHAT IS COVERED BY THESE RULES;"
corrects the title of §289.202 in item 1 of "REPORTS ON YOUR
RADIATION EXPOSURE HISTORY" and in item 2 replaces "personnel monitoring"
with "individual monitoring devices" and deletes "is required by"
and replaces it with "are provided in accordance with."
Throughout §289.251, references are revised to reflect the
renumbering of subsequent subsections due to the deletion of §289.251(k)
regarding renewal of general license acknowledgements. Change is reflected
in new renumbered §289.251(k) concerning amendment of general
license acknowledgements and §289.251(l) concerning appendices.
Other typographical and minor grammatical corrections are made throughout
the section.
New §289.251(e)(1)(C) adds language to clarify that manufacturers,
processors, and producers must have an NRC license to introduce exempt
concentrations of radioactive material into a product or material
and then distribute it. This is an item of compatibility with the NRC.
Section 289.251(e)(2)(A) adds subparagraphs (D) and (F) to the
list of references to state all applicable references for the exemption
which is an item of compatibility with the NRC.
In §289.251(e)(2)(B), the words," or owns" are added after
"transfers" to maintain rules that are compatible with NRC.
New §289.251(e)(2)(F) adds the prohibition against combining
exempt concentrations of radioactive material to increase the radiation
level, except as specified. This is an item of compatibility with the NRC.
In §289.251(e)(3)(A)(i)(I)(-h-), the standard international
units are added to be consistent with the format used for units of
measure used throughout the chapter and the language is changed to
clarify that the exemption applies to intact timepieces. This requirement
is an item of compatibility with the NRC.
New §289.251(e)(3)(A)(i)(X) is added to include certain smoke
detectors as specified. Smoke detectors were previously exempted under
paragraph (3)(C) of this subsection. Modern smoke detector design
is very consistent and doses have been evaluated. Based on this, a
product-specific exemption is being added. This is also an item of
compatibility with the NRC.
New §289.251(e)(3)(C)(i)(III) is added to clarify that the
exemption includes gas and aerosol detectors manufactured or distributed
before November 30, 2007, in accordance with a specific license issued
by the department with comparable provisions to Title 10, Code of
Federal Regulations (CFR), §32.26 to maintain rules that are
compatible with NRC and as an agreement state.
Current §289.251(e)(3)(D) is deleted to remove resins containing
scandium-46 and designed for sand consolidation in oil wells from
the listing of exempt items. The exemption is deleted because it is
obsolete. No products are being distributed for use under the exemption.
This is also an item of compatibility with the NRC.
Section 289.251(f)(4)(H)(iv)(IX) adds language to allow transfer
or disposal of the device containing radioactive material by export
in accordance with Title 10, CFR, Part 110. This is also an item of
compatibility with NRC.
Concerning §289.251(f)(4)(H)(iv)(XI), language is added to
clarify the ability of a specific licensee to transfer radioactive
material for possession and use under its own specific license, under
certain conditions, without prior approval. This is an item of compatibility
with the NRC.
New §289.251(f)(4)(H)(iv)(XIX) adds a requirement to assure
that the general license acknowledgement holder comply with information
contained in the device safety evaluation.
New §289.251(f)(4)(K) adds requirements for a general license
for certain items and self-luminous products containing radium-226
such as antiquities, intact and non-intact timepieces, and luminous
items installed in air, marine or land vehicles. These requirements
are compatibility items with NRC.
Concerning §289.251(g)(1), 3.7 megabecquerels of radium-226
is added to the list of radioactive material that, if possessed, requires
filing an application for acknowledgement. This requirement is a compatibility
item with NRC.
Section 289.251(g)(1)(B) adds ", and serial number of the source"
after "label" to require that the serial number also be provided to
the department.
Clarifying language is added to §289.251(g)(3) to specify
that the General License Acknowledgement Form shall be completed in
accordance with the instructions contained in the form and that the
completed form shall be submitted to the department within 30 days
of receipt.
In §289.251(i)(2), language is added to clarify that radioactive
material shall not be used or stored in residential locations and
that each person holding a GLA issued by the department shall obtain
prior approval from the agency before storing or using radioactive
material in an area not previously authorized in the GLA.
Concerning §289.251(j), the subsection is revised to delete
the requirements for expiration and renewal of GLAs and only address
requirements for the termination of GLAs. The department has determined
that GLAs will no longer have an expiration date assigned to them
and will not require renewal since GLAs are primarily a tracking system.
Current §289.251(k) deletes the requirements for renewal of
GLAs as a result of the department's determination that GLAs will
no longer have an expiration date and therefore there is no longer
a need for GLA renewals. Subsequent subsections are renumbered as
reflected in new §289.251(k) and (l).
New §289.251(l)(1) and (l)(2), revises the table of exempt
concentrations to state the correct abbreviation of Tantalum (73),
Ytterbium (70), and Yttrium (39) and to be compatible with the NRC.
Throughout §289.252, references to §289.254 relating
to licensing of radioactive waste processing and storage facilities
and §289.260 relating to licensing of uranium recovery and byproduct
material disposal facilities are deleted. These rules have been repealed
as a result of Senate Bill 1604, 80th Legislative Session, 2007, that
amended Health and Safety Code, §401.011, and transferred the
regulatory authority for licensing and inspection of low-level waste
processing and uranium recovery and disposal from the department to
the Texas Commission on Environmental Quality (TCEQ). Other typographical,
minor grammatical, and rule reference citation corrections are made
throughout the section.
Concerning §289.252(d), "abandoned" is added after "denied"
to clarify that the agency has the option to abandon the specific
license application in addition to denying or issuing the license.
New §289.252(d)(11) is added to specify that action on a specific
license application will be considered abandoned if the applicant
does not respond within 30 days from the date of a request for any
information by the agency. In addition, the new paragraph clarifies
that abandonment of such actions does not provide an opportunity for
a hearing but that the applicant retains the right to resubmit the
application in accordance with paragraphs (1) through (7) of this
subsection.
Concerning §289.252(e)(9) the department added "and/or used"
after "stored" and deleted the word "storage" before "facility" to
clarify that the requirement applies to facilities used for storage
and/or use of radioactive material.
New §289.252(e)(11) adds a requirement that the applicant
be listed on the Secretary of State's website as authorized to conduct
business in the state in order for the department to verify this information
prior to issuing a license.
New §289.252(f)(3)(O) and (g)(11) respectively, add that a
specific duty of the radiation safety officer and the Radiation Safety
Committee is to have knowledge of and ensure compliance with federal
and state security measures for radioactive material to enhance awareness.
New §289.252(i)(5) adds the prohibition of the introduction
of exempt concentrations by all persons except for those authorized
by a license issued by NRC. This is an item of compatibility with
the NRC.
New §289.252(n)(2) adds a requirement for a dry wipe test
on each source containing more than 0.1 microcurie of americium-241
or radium-226 before transferring the source to a general licensee.
This is an item of compatibility with the NRC.
Section 289.252(o) adds a reference for calibration, transmission,
or reference sources used in medical settings. This requirement is
an item of compatibility with the NRC.
Concerning §289.252(p), the standard international units of
measure are added to be compatible with the NRC.
Section 289.252(r)(1)(A)(i) is revised to clarify that the applicant
provide evidence of being registered with the United Stated Food and
Drug Administration as the owner or operator of a drug establishment
that engages in the manufacture, preparation, propagation, compounding,
or processing of a drug in accordance with Title 21, CFR, §207.20(a).
This requirement is an item of compatibility with the NRC.
New §289.252(r)(1)(A)(iv) adds as an option for the information
required for a license, that the applicant provide evidence of operating
as a nuclear pharmacy within a federal medical institution. This requirement
is an item of compatibility with the NRC.
New §289.252(r)(1)(A)(v) adds as an option for the information
required for a license, that the applicant provide evidence that a
PET drug production facility be registered with a state agency. This
requirement is an item of compatibility with the NRC.
New §289.252(r)(3)(A) - (D) is added to recognize nuclear
pharmacists, who prepared only accelerator-produced radioactive drugs,
before the effective date of the rule, to work as authorized nuclear
pharmacists at a commercial nuclear pharmacy. This requirement is
an item of compatibility with the NRC.
Concerning §289.252(x)(3), language is added to clarify that
radioactive material shall not be used or stored in residential locations
unless specifically authorized by the agency.
New §289.252(x)(9) is added to require licensees to measure
strontium-82 and strontium-85 contamination before use of the first
eluate when eluting strontium-82/rubidium-82 generators. This requirement
is an item of compatibility with the NRC.
Section 289.252(y)(1) deletes the last sentence of the current
paragraph because this statement is addressed in §289.252(y)(2).
New §289.252(ee)(1)(F) is added to specify the documents that
out-of-state licensees shall have in their possession at all times
when conducting work in Texas and make available for agency review
upon request.
Concerning the table for §289.252(jj)(2), Calcium-45 is removed
from the list of radionuclides for the 0.1 microcurie limit used for
determining financial assurance for decommissioning to maintain compatibility
with the NRC.
Concerning footnote 2 to the table for §289.252(jj)(9)(D),
the words "with this Order" are deleted after "compliance" as they
are not applicable to this statement.
New §289.252(kk) established requirements for issuing specific
licenses for a medical facility or educational institution to produce
PET drugs for noncommercial transfer within its consortium. Language
is added to clarify that nothing in the authorization in accordance
with this subsection relieves the licensee from complying with FDA,
other federal, or state requirements for radioactive drugs, and includes
requirements associated with the labeling and production of PET radioactive
drugs by licensees authorized in accordance with this subsection to
produce PET radioactive drugs for the noncommercial transfer to medical
use licensees in their consortium. This new subsection also requires
licensees to use the notification process in §289.252(r) of this
title when permitting qualified authorized nuclear pharmacists to
work as authorized nuclear pharmacists. These changes are made to
maintain rules compatible with the NRC.
FISCAL NOTE
Susan E. Tennyson, Section Director, Environmental and Consumer
Safety Section, has determined that for each year of the first five-year
period that these sections are in effect, there will be no fiscal
implications to the state or local government as a result of enforcing
and administering the sections as proposed.
ECONOMIC IMPACT STATEMENT AND REGULATORY FLEXIBILITY ANALYSIS FOR
SMALL AND MICRO-BUSINESSES
Ms. Tennyson has also determined that there will be no adverse
economic impact on small businesses or micro-businesses required to
comply with §§289.201, 289.203, 289.251, and 289.252 as
proposed. This was determined by interpretation of the rules that
small businesses and micro-businesses will not be required to alter
their business practices in order to comply with the sections.
ECONOMIC COSTS TO PERSONS AND IMPACT ON LOCAL EMPLOYMENT
There are no anticipated economic costs to persons who are required
to comply with the sections as proposed because the amendments are
clarifying in nature and do not impose additional actions on the part
of those required to comply. There is no anticipated negative impact
on local employment.
PUBLIC BENEFIT
In addition, Ms. Tennyson has also determined that for each year
of the first five years the sections are in effect, the public will
benefit from adoption of the sections. The public benefit anticipated
as the result of enforcing or administering these sections is ensure
continued protection of the public, workers, and the environment from
unnecessary exposure to radiation by ensuring that rules are clear
and specific.
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.
TAKINGS IMPACT ASSESSMENT
The department has determined that the proposed amendments do 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 Cindy Cardwell, Radiation
Group, Policy/Standards/Quality Assurance Unit, Division of Regulatory
Services, Environmental and Consumer Safety Section, Department of
State Health Services, MC 1987, P.O. Box 149347, Austin, TX 78714-9347,
(512) 834-6770, extension 2239, or by email to Cindy.Cardwell@dshs.state.tx.us.
Comments will be accepted for 30 days following publication of the
proposal in the Texas Register.
PUBLIC HEARING
A public hearing to receive comments on the proposal will be scheduled
after publication in the Texas Register and
will be held at the Department of State Health Services, Exchange
Building, 8407 Wall Street, Austin, Texas 78754. The meeting date
will be posted on the Radiation Control website (www.dshs.state.tx.us/radiation).
Please contact Cindy Cardwell at (512) 834-6770, extension 2239, or
Cindy.Cardwell@dshs.state.tx.us if you have questions.
LEGAL CERTIFICATION
The Department of State Health Services General Counsel, Lisa Hernandez,
certifies that the proposed rules have been reviewed by legal counsel
and found to be within the state agencies' authority to adopt.
SUBCHAPTER D. GENERAL
25 TAC §289.201, §289.203
STATUTORY AUTHORITY
The amendments are authorized by Health and Safety Code, §401.051,
which provides the Executive Commissioner of the Health and Human
Services Commission with authority to adopt rules and guidelines relating
to the control of radiation; 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 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 review of the rules implements Government
Code, §2001.039.
The amendments affect the Health and Safety Code, Chapters 401
and 1001; and Government Code, Chapter 531.
§289.201.General Provisions for Radioactive Material.
(a) (No change.)
(b) Definitions. The following words and terms when
used in this chapter shall have the following meanings, unless the
context clearly indicates otherwise.
(1) - (21) (No change.)
(22) Consortium--An association of
medical use licensees and a Position Emission Tomography (PET) facility
in the same geographical area that jointly own or share in the operation
and maintenance costs of the PET radionuclide production facility
that produces PET radionuclides for use in producing radioactive drugs
within the consortium for noncommercial distributions among its associated
members for medical use. The PET radionuclide production facility
within the consortium shall be located at an educational institution
or a medical facility.
(23) [
(24) [
(25) [
(26) [
(A) release of the property for unrestricted use and/or
termination of license; or
(B) release of the property under alternate requirements
for license termination.
(27) [
(28) [
(29) [
(30) [
(31) [
(32) [
(33) [
(34) [
(35) [
(36) [
(37) [
(38) [
(39) [
(40) [
(41) [
(42) [
(43) [
(44) [
(45) [
(46) [
(47) [
(A) dose equivalent to an individual by the use of
individual monitoring devices; or
(B) committed effective dose equivalent to an individual
by bioassay or by determination of the time-weighted air concentrations
to which an individual has been exposed, that is, DAC-hours. (See
the definition for DAC-hours in §289.202(c) of this title); or
(C) dose equivalent to an individual by the use of survey data.
(48) [
(49) [
(50) [
(51) [
(52) [
(53) [
(54) [
(55) [
(56) [
(57) [
(58) [
(59) [
(A) LLRW is radioactive material that is:
(i) discarded or unwanted and is not exempt by rule
adopted under the Texas Radiation Control Act (Act), Health and Safety
Code, §401.106;
(ii) waste, as that term is defined in Title 10, CFR, §61.2; and
(iii) subject to:
(I) concentration limits established in Title 10, CFR, §61.55,
or compatible rules adopted by the agency or the Texas Commission
on Environmental Quality (TCEQ), as applicable; and
(II) disposal criteria established in Title 10, CFR,
or established by the agency or TCEQ, as applicable.
(B) LLRW does not include:
(i) high-level radioactive waste as defined by Title
10, CFR, §60.2;
(ii) spent nuclear fuel as defined by Title 10, CFR, §72.3;
(iii) byproduct material defined in the Act, Health
and Safety Code, §401.003(3)(B);
(iv) naturally occurring radioactive material (NORM)
waste that is not oil and gas NORM waste;
(v) oil and gas NORM waste; or
(vi) transuranics greater than 100 nanocuries per gram.
(60) [
(61) [
(62) [
(63) [
(64) [
(65) [
(66) [
(67) [
(68) [
(69) [
(70) [
(71) [
(72) [
(73) [
(74) [
(75) [
(76) [
(77) [
(78) [
(A) gamma and x rays; alpha and beta particles and
other atomic or nuclear particles or rays;
(B) emission of radiation from any electronic device
to such energy density levels as to reasonably cause bodily harm; or
(C) sonic, ultrasonic, or infrasonic waves from any
electronic device or resulting from the operation of an electronic
circuit in an electronic device in the energy range to reasonably
cause detectable bodily harm.
(79) [
(80) [
(81) [
(82) [
(83) [
(84) [
(85) [
(86) [
(87) [
(88) [
(89) [
(90) [
(A) theoretical analysis, exploration, or experimentation; or
(B) the extension of investigative findings and theories
of a scientific or technical nature into practical application for
experimental and demonstration purposes, including the experimental
production and testing of models, devices, equipment, materials, and processes.
(91) Residential location--Any area
where a structure or structures are located in which people lodge
or live, and the grounds on which these structures are located including,
but not limited to, houses, apartments, condominiums, and garages.
(92) [
(93) [
(94) [
(95) [
(96) [
(97) [
(98) [
(99) [
(100) [
(101) [
(A) uranium or thorium, or any combination thereof,
in any physical or chemical form; or
(B) ores that contain by weight 0.05% or more of uranium,
thorium, or any combination thereof; and
(C) does not include special nuclear material.
(102) [
(103) [
(A) It is either a single solid piece or is contained
in a sealed capsule that can be opened only by destroying the capsule;
(B) The piece or capsule has at least one dimension
not less than 5 millimeters (mm) (0.2 inch); and
(C) It satisfies the requirements specified by NRC.
A special form encapsulation designed in accordance with NRC requirements
in effect on June 30, 1983, and constructed prior to July 1, 1985,
may continue to be used. A special form encapsulation designed in
accordance with NRC requirements in effect on March 31, 1996, and
constructed prior to April 1, 1998, may continue to be used. A special
form encapsulation either designed or constructed after April 1, 1998,
must meet the requirements of this definition applicable at the time
of its design or construction.
(104) [
(A) plutonium, uranium-233, uranium enriched in the
isotope 233 or in the isotope 235, and any other material that NRC,
in accordance with the provisions of the Atomic Energy Act of 1954, §51
as amended, determines to be special nuclear material, but does not
include source material; or
(B) any material artificially enriched by any of the
foregoing, but does not include source material.
(105) [
(A) For each kind of special nuclear material, determine
the ratio between the quantity of that special nuclear material and
the quantity specified above for the same kind of special nuclear
material. The sum of such ratios for all of the kinds of special nuclear
material in combination shall not exceed "1" (i.e., unity).
(B) For example, the following quantities in combination
would not exceed the limitation and are within the formula:
Figure: 25 TAC §289.201(b)(105)(B)
[
(106) [
(107) [
(108) [
(109) [
(110) [
(111) [
(112) [
(113) [
(A) For non-fissile material packages, the number determined
by multiplying the maximum radiation level in millisievert per hour
(mSv/hr) at 1 meter (m) (3.3 feet) from the external surface of the
package by 100 (equivalent to the maximum radiation level in millirem
per hour (mrem/hr) at 1 m (3.3 feet); or
(B) For fissile material packages, the number determined
by multiplying the maximum radiation level in mSv/hr at 1 m (3.3 feet)
from the external surface of the package by 100 (equivalent to the
maximum radiation level in mrem/hr at 1 m (3.3 feet), or, for criticality
control purposes, the number obtained as described in 10 CFR 71.59,
whichever is larger.
(114) [
(115) [
(116) [
(117) [
(118) [
(119) [
(120) [
(121) [
(122) [
(123) [
(124) [
(125) [
(126) [
(c) - (o) (No change.)
§289.203.Notices, Instructions, and Reports to Workers; Inspections.
(a) Scope and purpose. This section establishes requirements
for notices, instructions, and reports by licensees or registrants
to individuals engaged in activities under a license or certificate
of registration, and options available to such individuals in connection
with agency inspections of licensees or registrants to ascertain compliance
with the provisions of the Texas Radiation Control Act (Act),
Health and Safety Code, Chapter 401, and rules, orders, licenses,
and certificates of registration issued thereunder regarding radiological
working conditions. The requirements in this section apply to all
persons who receive, possess, use, or transfer sources of radiation
licensed by or registered with the agency in accordance with this chapter.
(b) Posting of notices to workers.
(1) Each licensee or registrant shall post current
copies of the following documents:
(A) the requirements in this section and in §289.202
of this title (relating to Standards for Protection Against Radiation
from Radioactive Materials [
(B) - (C) (No change.)
(D) any notice of violation involving radiological
working conditions[
(i) been issued in accordance
with §289.201 of this title (relating to General Provisions for
Radioactive Material), §289.205 of this title (relating to Hearing
and Enforcement Procedures), and §289.231 of this title; and [
(ii) not been labeled "withhold from
public disclosure under Government Code, §552.101," or equivalent
phrase, in accordance with §289.252(ii) of this title (relating
to Licensing of Radioactive Material).
(2) (No change.)
(3) Each licensee or registrant shall post RC [
(4) (No change.)
(c) (No change.)
(d) Notifications and reports to individuals.
(1) Radiation exposure data for an individual and the
results of any measurements, analyses, and calculations of radioactive
material deposited or retained in the body of an individual shall
be made available [
(A) - (D) (No change.)
(2) Each licensee or registrant shall provide
an annual written report to advise each worker [
(3) - (5) (No change.)
(e) - (h) (No change.)
(i) Notice to employees. The following form, RC Form 203-1,
or an equivalent as stated in subsection (b)(3)
of this section, shall be posted.
Figure: 25 TAC §289.203(i) (.pdf)
[
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 20, 2009.
TRD-200902959
Lisa Hernandez
General Counsel
Department of State Health Services
Earliest possible date of adoption: August 30, 2009
For further information, please call: (512) 458-7111 x6972
25 TAC §289.251, §289.252
STATUTORY AUTHORITY
The amendments are authorized by Health and Safety Code, §401.051,
which provides the Executive Commissioner of the Health and Human
Services Commission with authority to adopt rules and guidelines relating
to the control of radiation; 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 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 review of the rules implements Government
Code, §2001.039.
The amendments affect the Health and Safety Code, Chapters 401
and 1001; and Government Code, Chapter 531.
§289.251.Exemptions, General Licenses, and General License Acknowledgements.
(a) - (d) (No change.)
(e) Exemptions for radioactive material other than source material.
(1) Exempt concentrations.
(A) Except as provided in subparagraph (B) of this
paragraph, any person is exempt from this section and §289.252
of this title if that person receives, possesses, uses, transfers,
or acquires products or materials containing radioactive material
in concentrations not in excess of those listed in subsection
(l)(1) [
(B) (No change.)
(C) A manufacturer, processor, or producer
of a product or material is exempt from the requirements for a license,
as specified in §289.252 of this title, if the manufacturer,
processor, or producer transfers radioactive material contained in
a product or material that does not exceed the concentrations specified
in subsection (l)(1) of this section, and that has been introduced
into the product or material by a licensee holding a specific license
issued by the NRC that expressly authorizes such introduction. The
exemption specified in this subparagraph does not apply to the transfer
of radioactive material contained in any food, beverage, cosmetic,
drug, or other commodity or product designed for ingestion or inhalation
by, or application to, a human being.
(2) Exempt quantities.
(A) Except as provided in subparagraphs (C), (D), and (F) [
(B) Any person who possesses radioactive material received
or acquired, prior to September 25, 1971, in accordance with the general
license provided in subsection (f)(4)(A) of this section is exempt
from the requirements for a license set forth in §289.252 of
this title if that person possesses, uses, [
(C) (No change.)
(D) No person may, for purposes of commercial distribution,
transfer radioactive material in quantities greater than the individual
quantities set forth in subsection (l)(2) [
(E) The schedule of quantities set forth in subsection (l)(2) [
(F) No person may, for purposes of
producing an increased radiation level, combine quantities of radioactive
material covered by this exemption so that the aggregate quantity
exceeds the limits set forth in subsection (l)(2) of this section,
except for radioactive material combined within a device placed in
use before May 3, 1999, or as otherwise permitted by the requirements
in this title.
(3) Exempt items.
(A) Certain items containing radioactive material.
(i) Except for persons who apply radioactive material
to, or persons who incorporate radioactive material into the following
products, any person is exempt from this chapter if that person receives,
possesses, uses, transfers, or acquires the following products:
(I) timepieces, hands, or dials containing not more
than the following specified quantities of radioactive material and
not exceeding the following specified levels of radiation:
(-a-) - (-g-) (No change.)
(-h-) 1 µCi (0.037 megabecquerel (MBq))
of radium-226 per timepiece in intact timepieces manufactured prior
to January 1, 1986 [
(II) - (VII) (No change.)
(VIII) ionizing radiation measuring instruments containing,
for purposes of internal calibration or standardization, a source
of radioactive material not exceeding the applicable quantity set
forth in subsection (l)(2) [
(IX) spark gap irradiators containing not more than
1 µCi of cobalt-60 per spark gap irradiator for use in electrically
ignited fuel oil burners having a firing rate of at least 3 gallons
per hour; or [
(X) ionization chamber smoke detectors
containing not more than 1 microcurie (µCi) of americium-241
per detector in the form of a foil and designed to protect life and
property from fires.
(ii) (No change.)
(B) (No change.)
(C) Gas and aerosol detectors containing radioactive material.
(i) Except for persons who manufacture, process, [
(I) detectors containing radioactive material shall
have been manufactured, imported, or transferred in accordance with
a specific license issued by the NRC in accordance with Title 10,
CFR, §32.26, or an agreement state or a licensing state in accordance
with §289.252(k) of this title; [
(II) the specific license issued in accordance with §289.252
of this title authorizes the initial transfer of the detectors
to persons who are exempt from regulatory requirements; and [
(III) this exemption also covers gas
and aerosol detectors manufactured or distributed before November
30, 2007, in accordance with a specific license issued in accordance
with §289.252 of this title or under comparable provisions to
Title 10, CFR, §32.26, authorizing distribution to persons exempt
from regulatory requirements.
(ii) - (iii) (No change.)
[
(4) (No change.)
(f) General licenses. In addition to the requirements
of this section, all general licenses, unless otherwise specified,
are subject to the requirements of §289.201 of this title (relating
to General Provisions for Radioactive Material), §289.202(ww)
and (xx) of this title (relating to Standards for Protection Against
Radiation from Radioactive Materials), §289.204 of this title
(relating to Fees for Certificates of Registration, Radioactive Material
Licenses, Emergency Planning and Implementation, and Other Regulatory
Services), §289.205 of this title (relating to Hearing and Enforcement
Procedures), and §289.257 of this title (relating to Packaging
and Transportation of Radioactive Material).
(1) - (3) (No change.)
(4) General licenses for radioactive material other
than source material.
(A) - (G) (No change.)
(H) General license for certain detecting, measuring,
gauging, or controlling devices and certain devices for producing
light or an ionized atmosphere.
(i) - (iii) (No change.)
(iv) Any person who receives, acquires, possesses,
uses, or transfers radioactive material in a device in accordance
with the general license in this subparagraph shall do the following:
(I) - (VI) (No change.)
(VII) immediately suspend operation of the device if
there is a failure of, or damage to, or any indication of a possible
failure of or damage to, the shielding of the radioactive material
or the "on-off" mechanism, or indicator, or upon the detection of
185 becquerels (0.005 µCi) or more of removable radioactive
material. The device shall not be operated until it has been repaired
by the manufacturer or other person holding a specific license from
the agency, the NRC, an agreement state, or a licensing state to repair
such devices. The device and any radioactive material from the device
may only be disposed of by transfer to a person authorized by a specific
license to receive the radioactive material in the device. A report,
prepared in accordance with §289.202(xx) and (yy) of this title,
containing a brief description of the event and the remedial action
taken and in the case of detection of 185 becquerels (0.005 µCi)
or more removable radioactive material or failure of, or damage to
a source likely to result in contamination of the premises or the
environs, a plan for ensuring that the premises and environs are acceptable
for unrestricted use shall be furnished to the agency within 30 days.
Under these circumstances, the requirements in §289.202(ddd)
of this title may be applicable, as determined by the agency on a
case-by-case basis;
(VIII) (No change.)
(IX) transfer or dispose of the device containing radioactive
material only by export in accordance with Title 10, CFR, Part
110, by transfer to another general licensee as authorized in
subclauses (XII) and (XVI) of this clause or to a person authorized
to receive the device by a specific license issued by the agency in
accordance with §289.252(l) of this title, or an equivalent specific
license issued by the NRC, an agreement state, or a licensing state,
or as otherwise approved under subclause (XI) of this clause;
(X) (No change.)
(XI) obtain written agency approval before transferring
the device to any other specific licensee not specifically identified
in subclause (IX) of this clause; however, a holder of a specific
license may transfer a device for possession and use under its own
specific license without prior approval, if, the holder:
(-a-) verifies that the specific license
authorizes the possession and use, or applies for and obtains an amendment
to the license authorizing the possession and use;
(-b-) removes, alters, covers, or clearly
and unambiguously augments the existing label (otherwise required
by clause (iv)(I) of this subparagraph) so that the device is labeled
in compliance with §289.202(cc) of this title; however the manufacturer,
model number, and serial number must be retained;
(-c-) obtains the manufacturer's or
initial transferor's information concerning maintenance that would
be applicable under the specific license (such as leak testing procedures); and
(-d-) reports the transfer under subclause
(X) of this clause.
(XII) - (XIII) (No change.)
(XIV) report changes to the mailing address for the
location of use (including change in name of general licensee) to
the agency within 30 days of the effective date of the change. If
it is a portable device, a report of address change is only required
for a change in the device's primary place of storage; [
(XV) not hold devices that are not in use for longer
than two years. If devices with shutters are not being used, the shutter
shall be locked in the closed position. The testing required by clause
(iv) of this subparagraph need not be performed during the period
of storage only. However, when devices are put back into service or
transferred to another person, and have not been tested within the
required test interval, they shall be tested for leakage before use
or transfer and the shutter tested before use. Devices kept in standby
for future use are excluded from the two-year time limit if the general
licensee performs quarterly physical inventories of these devices
while they are in standby. The licensee shall make and maintain, for
intervals of five years, records of the quarterly physical inventories
for inspection by the agency; [
(XVI) not export the device containing radioactive
material except in accordance with Title 10, CFR, Part 110; [
(XVII) comply with the provisions of §289.202(ww)
and (xx) of this title for reporting radiation incidents, theft or
loss of licensed material, but shall be exempt from the other requirements
of §289.202 and §289.203 of this title; [
(XVIII) respond to written requests from the agency
to provide information relating to the general license within 30 calendar
days of the date of the request, or other time specified in the request.
If the general licensee cannot provide the requested information within
the allotted time, it shall, within that same time period, request
a longer period to supply the information by providing the agency
a written justification for the request; and [
(XIX) assure that the device is used
in accordance with information contained in the device safety evaluation.
(I) - (J) (No change.)
(K) General license for certain items
and self-luminous products containing radium-226.
(i) A general license is hereby issued
to any person to acquire, receive, possess, use, or transfer radium-226
contained in the following products.
(I) Antiquities originally intended
for use by the general public. For purposes of this subclause, antiquities
are products distributed for use by the general public in the late
19th and early 20th centuries; such as radium emanator jars, revigators,
radium water jars, radon generators, refrigerator cards, radium bath
salts, and healing pads.
(II) Intact timepieces containing greater
than 1 µCi (0.037 MBq), nonintact timepieces, and timepiece
hands and dials no longer installed in timepieces.
(III) Luminous items installed in air, marine, or land vehicles.
(IV) All other luminous products, provided
that no more than 100 items are used or stored at the same location
at any one time.
(V) Small radium sources containing
no more than 1 µCi (0.037 MBq) of radium 226.
(ii) Any person who acquires, receives,
possesses, uses, or transfers radioactive material in accordance with
this subparagraph shall do the following.
(I) Provide to the agency within 30
days of any indication of possible damage to the product that could
result in a loss of the radioactive material. The report should include
a brief description of the event, and the remedial action taken.
(II) Not abandon products containing radium-226.
(-a-) The product, and any radioactive
material from the product, may only be disposed of according to §289.202
of this title or as otherwise approved by the agency.
(-b-) The product, and any radioactive
material from the product, may be transferred to a person authorized
by a specific license to receive the radium-226 or as otherwise approved
by the agency.
(III) The general license in this subparagraph
does not authorize the manufacture, assembly, disassembly, repair,
or import of products containing radium-226, except that timepieces
may be disassembled and repaired provided that paint containing radium-226
is not applied or removed.
(g) General license acknowledgements for radioactive
material other than source material. In addition to the requirements
of this section, all general license acknowledgement holders, unless
otherwise specified, are subject to the requirements of §§289.201,
289.202(ww) and (xx), 289.204, 289.205, and 289.257 of this title.
(1) Persons possessing a general license for devices
in accordance with subsection (f)(4)(H) of this section and being
in the possession of radioactive material in devices containing at
least 370 MBq (10 mCi) of cesium-137, 3.7 MBq (0.1 mCi) of strontium-90,
37 MBq (1 mCi) of cobalt-60, 3.7 MBq (0.1 mCi) of radium-226, 37
MBq (1 mCi) of americium-241, or any transuranic (for example, element
with atomic number greater than uranium (92)), based on the activity
indicated on the label on the device, shall file an application for
acknowledgement within 30 days of receipt, acquisition, or possession
of such a device. The application shall be on a form prescribed by
the agency to include the following information and any other information
specifically requested by the agency:
(A) (No change.)
(B) information about each device to include the manufacturer
(or initial transferor), model number, and serial number of the device,
and the radioisotope and activity (as indicated on the label),
and serial number of the source;
(C) - (G) (No change.)
(2) (No change.)
(3) Persons possessing [
(h) Issuance of general license acknowledgements.
(1) - (2) (No change.)
(3) The agency may request, and the licensee shall
provide, additional information after the general license acknowledgement
has been issued to enable the agency to determine whether the general
license acknowledgement should be modified in accordance with subsection
(k) [
(i) Specific terms and conditions.
(1) (No change.)
(2) Each person holding a general license acknowledgement
issued by the agency in accordance with this section shall confine
use and possession of the devices and radioactive material identified
in the general license acknowledgement to the locations specified
in the general license acknowledgement. Radioactive material
shall not be used or stored in residential locations unless authorized
by the agency. Each person holding a general license acknowledgement
issued by the agency shall obtain prior approval from the agency before
storing or using radioactive material in an area not previously authorized
in the general license acknowledgement.
(3) - (5) (No change.)
(j) Termination [
[
[
(1) [
[
(2) [
(A) terminate use of radioactive material;
(B) dispose of radioactive material
in accordance with this section and/or §289.202(ff) of this title;
and
(C) pay any outstanding fees in accordance
with §289.204 of this title.
[
[
[
[
[
[
(k) [
(1) The holder of the general license acknowledgement
required by subsection (g)(1) of this section shall report in writing
to the agency any changes in information furnished by the holder of
the general license acknowledgement. The report shall be submitted
within 30 days after the effective date of such change.
(2) Applications for amendments of a general license
acknowledgement shall be filed in accordance with subsection (g)(1)(A)
- (F) of this section, as applicable, and shall specify the respects
in which the holder of a general license acknowledgement desires a
general license acknowledgement to be amended.
(l) [
(1) Exempt concentrations.
[
(2) Exempt quantities.
[
§289.252.Licensing of Radioactive Material.
(a) Purpose. The intent of this section is as follows.
(1) (No change.)
(2) Unless otherwise exempted, no person shall receive,
possess, use, transfer, own, or acquire radioactive material except
as authorized by the following:
(A) a specific license issued in accordance with this
section and/or any of the following sections:
[
(i) [
(ii) [
(iii) [
(iv) [
>[
(B) (No change.)
(3) (No change.)
(b) Scope. In addition to the requirements of this
section, the following additional requirements are applicable.
(1) All licensees, unless otherwise specified, are
subject to the requirements in the following sections:
(A) (No change.)
(B) §289.202 of this title (relating to Standards
for Protection Against Radiation from Radioactive
Materials [
(C) - (F) (No change.)
(2) (No change.)
[
(3) [
(4) [
(5) [
(6) [
[
(c) (No change.)
(d) Filing application for specific licenses. The agency
may, at any time after the filing of the original application, require
further statements in order to enable the agency to determine whether
the application should be denied, abandoned or the license
should be issued.
(1) - (10) (No change.)
(11) Action on a specific license application
will be considered abandoned if the applicant does not respond within
30 days from the date of a request for any information by the agency.
Abandonment of such actions does not provide an opportunity for a
hearing; however, the applicant retains the right to resubmit the
application in accordance with paragraphs (1) - (7) of this subsection.
(e) General requirements for the issuance of specific
licenses. A license application will be approved if the agency determines that:
(1) - (3) (No change.)
(4) the applicant satisfied [
(5) - (6) (No change.)
(7) the applicant submitted [
(8) the applicant's permanent facility is located in
Texas (if the applicant's permanent facility is not located in Texas,
reciprocal recognition shall be sought as required by subsection (ee)
of this section); [
(9) the owner of the property is aware that radioactive
material is stored and/or used on the property, if the
proposed [
(10) there is no reason to deny the license as specified
in subsections (d)(10) or (x)(8) [
(11) the applicant is listed on the
Secretary of State's website as authorized to conduct business in
the state, unless the applicant is exempt. All applicants using an
assumed name in their application shall file an assumed name certificate
with the Secretary of State and/or the office of the county clerk
as required under the Business and Commerce Code, Chapter 71.
(f) Radiation safety officer.
(1) - (2) (No change.)
(3) The specific duties of the RSO include, but are
not limited to, the following:
(A) - (L) (No change.)
(M) to ensure that personnel are complying with this
chapter, the conditions of the license, and the operating, safety,
and emergency procedures of the licensee; [
(N) to serve as the primary contact with the agency;and [
(O) to have knowledge of and ensure
compliance with federal and state security measures for radioactive
material.
(4) - (5) (No change.)
(g) The duties and responsibilities of the Radiation
Safety Committee (RSC) include but are not limited to the following:
(1) - (8) (No change.)
(9) evaluating new uses of radioactive material; [
(10) reviewing and approving permitted program and
procedural changes prior to implementation; and [
(11) having knowledge of and ensuring
compliance with federal and state security measures for radioactive
material.
(h) Specific licenses for broad scope authorization
for multiple quantities or types of radioactive material for use in
research and development.
(1) - (2) (No change.)
(3) Unless specifically authorized, in accordance with
a separate license, persons licensed according to paragraph (1) of
this subsection shall not:
(A) receive, acquire, own, possess, use, or transfer
devices containing 100,000 curies (Ci) or more of radioactive
material in sealed sources used for irradiation of materials;
(B) conduct activities for which a specific license
issued by the agency in accordance with subsections (i) - (u) of this
section and §289.255, §289.256, and §289.259 [
(C) - (D) (No change.)
(i) Specific licenses for introduction of radioactive
material into products in exempt concentrations.
(1) - (4) (No change.)
(5) No person may introduce radioactive
material into a product or material knowing or having reason to believe
that it will be transferred to persons exempt in accordance with §289.251
of this title except as specified with a license issued by the NRC.
(j) Specific licenses for commercial distribution of
radioactive material in exempt quantities.
(1) Authority to transfer possession or control by
the manufacturer, processor, or producer of any equipment, device,
commodity, or other product containing source material or byproduct
material whose subsequent possession, use, transfer, and disposal
by all other persons are exempted from regulatory requirements may
be obtained only from the United States Nuclear Regulatory Commission
(NRC), Washington, DC 20555.
(2) (No change.)
(3) The license issued in accordance with paragraph
(2) of this subsection is subject to the following conditions.
(A) - (C) (No change.)
(D) In addition to the labeling information required
by subparagraph (C) of this paragraph, the label affixed to the immediate
container, or an accompanying brochure, shall:
(i) state that the contents are exempt from the NRC [
(ii) - (iii) (No change.)
(4) - (5) (No change.)
(k) - (m) (No change.)
(n) Specific licenses for the manufacture of calibration
sources containing americium-241, plutonium, or radium-226 for commercial
distribution to persons generally licensed in accordance with §289.251(f)(4)(D)
of this title.
(1) In addition to the requirements in
subsection (e) of this section, a specific license to manufacture
calibration sources containing americium-241, plutonium, or radium-226
to persons generally licensed in accordance with §289.251(f)(4)(D)
of this title will be issued if the agency approves the information
submitted by the applicant. The information shall satisfy the requirements
of Title 10, CFR, §§32.57, 32.58, 32.59, and 32.102, and
Title 10, CFR, §70.39 [
(2) Each person licensed in accordance
with this section shall perform a dry wipe test on each source containing
more than 0.1 µCi (3.7 kilobecquerels) of americium-241 or radium-226
before transferring the source to a general licensee in accordance
with §289.251(f)(4)(D) of this title. This test shall be performed
by wiping the entire radioactive surface of the source with a filter
paper with the application of moderate pressure. The radioactivity
on the paper shall be measured by using radiation detection instrumentation
capable of detecting 0.005 µCi (0.185 kilobecquerel) of americium-241
or radium-226. If removable contamination from any source wipe test
exceeds 0.005 µCi (0.185 kilobecquerels) of americium-241 or
radium-226, the source is deemed to be leaking and it shall not be
transferred to a general licensee.
(o) Specific licenses for the manufacture and commercial
distribution of sealed sources or devices containing radioactive material
for medical use. In addition to the requirements in subsection (e)
of this section, a specific license to manufacture and commercially
distribute sealed sources and devices containing radioactive material
to persons licensed in accordance with §289.256 of this
title for use as a calibration, transmission, or reference source
or for use of sealed sources listed in §289.256(rr),
(bbb), and (ddd) [
(1) - (4) (No change.)
(p) Specific licenses for the manufacture and commercial
distribution of radioactive material for certain
in vitro clinical or laboratory testing in accordance with
the general license. In addition to the requirements in subsection
(e) of this section, a specific license to manufacture or commercially
distribute radioactive material for use in accordance with the general
license in §289.251(f)(4)(G) of this title will be issued if
the agency approves the following information submitted by the applicant:
(1) documentation that the radioactive material
will be prepared for distribution in prepackaged units of:
(A) iodine-125 in units not exceeding 10 microcuries
(µCi) (0.37 megabecquerel) each;
(B) iodine-131 in units not exceeding 10 µCi (0.37
megabecquerel) each;
(C) carbon-14 in units not exceeding 10 µCi
(0.37 megabecquerel) each;
(D) hydrogen-3 (tritium) in units not exceeding 50 µCi
(1.85 megabecquerels) each;
(E) iron-59 in units not exceeding 20 µCi
(0.74 megabecquerel) each;
(F) cobalt-57 in units not exceeding 10 µCi
(0.37 megabecquerel) each;
(G) selenium-75 in units not exceeding 10 µCi
(0.37 megabecquerel) each; or
(H) mock iodine-125 in units not exceeding 0.05 µCi
(1.85 kilobecquerels) of iodine-129 and 0.005 µCi
(0.185 kilobecquerel) of americium-241 each;
(2) evidence that each prepackaged unit
will bear [
(A) identifying the radioactive contents as to chemical
form and radionuclide, and indicating that the amount of radioactivity
does not exceed 10 µCi (0.37 megabecquerel) of iodine-125,
iodine-131, carbon-14, cobalt-57, or selenium-75; 50 µCi
(1.85 megabecquerels) of hydrogen-3 (tritium); 20 µCi
(0.74 megabecquerel) of iron-59; or mock iodine-125 in units not exceeding
0.05 µCi (1.85 kilobecquerels) of iodine-129 and
0.005 µCi (0.185 kilobecquerel) of americium-241; and
(B) (No change.)
(3) - (4) (No change.)
(q) (No change.)
(r) Specific licenses for the manufacture, preparation,
or transfer for commercial distribution of radioactive drugs containing
radioactive materials for medical use.
(1) In addition to the requirements in subsection (e)
of this section, a specific license to manufacture, prepare, or transfer
for commercial distribution, radioactive drugs containing radioactive
material for use by persons authorized in accordance with §289.256
of this title will be issued if the agency approves the following
information submitted by the applicant:
(A) evidence that the applicant is at least one of the following:
(i) registered [
(ii) registered or licensed with a state agency as
a drug manufacturer; [
(iii) (No change.)
(iv) operating as a nuclear pharmacy
within a federal medical institution; or
(v) a positron emission tomography
(PET) drug production facility registered with a state agency.
(B) - (C) (No change.)
(2) A licensee shall possess and use instrumentation
to measure the radioactivity of radioactive drugs and shall have procedures
for the use of the instrumentation. The licensee shall measure, by
direct measurement or by a combination of measurements and calculations,
the amount of radioactivity in dosages of alpha, beta, or photon-emitting
radioactive drugs prior to transfer for commercial distribution. In
addition, the licensee shall:
(A) - (C) (No change.)
(3) A licensee described in paragraph (1)(A)(iii) or(iv)
of this subsection shall prepare radioactive drugs for
medical use as defined [
(A) Radioactive drugs shall be prepared
by either an authorized nuclear pharmacist, as specified in subparagraphs
(B) and (C) of this paragraph, or an individual under the supervision
of an authorized nuclear pharmacist as specified in §289.256(s)
of this title.
[
(B) A pharmacist shall be allowed to
work as an authorized nuclear pharmacist if:
(i) the individual qualifies as an
authorized nuclear pharmacist as defined in §289.256 of this
title;
(ii) the individual meets the requirements
specified in §289.256(k)(2) and (m) of this title, and the licensee
has received from the agency, an approved license amendment identifying
this individual as an authorized nuclear pharmacist; or
(iii) the individual is designated
as an authorized nuclear pharmacist in accordance with subparagraph
(C) of this paragraph.
(C) May designate a pharmacist, as
defined in §289.256 of this title, as an authorized nuclear pharmacist
if:
(i) the individual was a nuclear pharmacist
preparing only radioactive drugs containing accelerator-produced radioactive
material; and
(ii) the individual practiced at a
pharmacy at a government agency or federally recognized Indian Tribe
or at all other pharmacies prior to the effective date of this rule
as noticed by the NRC or the agency.
(D) Provide the following to the agency:
(i) a copy of each individual's certification
by a specialty board whose certification process has been recognized
by the NRC, agency, or an agreement state as specified in §289.256(k)(1)
of this title with the written attestation signed by a preceptor as
required by §289.256(k)(2)(C) of this title; or
(ii) the agency, NRC, or another agreement state license, or
(iii) the permit issued by a broad
scope licensee or the authorization from a commercial nuclear pharmacy
authorized to list its own authorized nuclear pharmacist; or
(iv) documentation that only accelerator-produced
radioactive materials were used in the practice of nuclear pharmacy
at a government agency or federally recognized Indian Tribe or at
all other locations of use prior to the effective date of this rule
as noticed by the NRC or the agency; and
(v) a copy of the Texas State Board
of Pharmacy licensure or registration, no later than 30 days after
the date that the licensee allows, in accordance with subparagraph
(B)(i) and (iii) of this paragraph, the individual to work as an authorized
nuclear pharmacist.
(E) [
(F) [
[
(4) Nothing in this subsection relieves the licensee
from complying with applicable FDA, or other federal[
(s) - (w) (No change.)
(x) Specific terms and conditions of licenses.
(1) - (2) (No change.)
(3) Each person licensed by the agency in accordance
with this section shall confine use and possession of the radioactive
material licensed to the locations and purposes authorized in the
license. Radioactive material shall not be used or stored in
residential locations unless specifically authorized by the agency.
(4) (No change.)
(5) Each licensee shall notify the agency's Radiation
Safety Licensing Branch [
(6) The notification in paragraph (5) [
(A) - (B) (No change.)
(7) - (8) (No change.)
(9) Each licensee preparing technetium-99m
radiopharmaceuticals from molybdenum-99/technetium-99m generators
or rubidium-82 from strontium-82/rubidium-82 generators shall test
the generator eluates for molybdenum-99 breakthrough or strontium-82
and strontium-85 contamination, respectively, in accordance with §289.256
of this title. The licensee shall record the results of each test
and retain each record for 3 years after the record is made for inspection
by the agency.
(y) Expiration and termination of licenses and decommissioning
of sites and separate buildings or outdoor areas.
(1) Except as provided in paragraph (2) of this subsection
and subsection (z)(2) of this section, each specific license expires
at the end of the day, in the month and year stated in the license.
[
(2) - (17) (No change.)
(z) - (dd) (No change.)
(ee) Reciprocal recognition of licenses.
(1) Subject to this section, any person who holds a
specific license from NRC, any agreement state, or any licensing state,
and issued by the agency having jurisdiction where the licensee maintains
an office for directing the licensed activity and at which radiation
safety records are normally maintained, is granted a general license
to conduct the activities authorized in such licensing document within
the State of Texas provided that:
(A) - (C) (No change.)
(D) the out-of-state licensee supplies such other information
as the agency may request; [
(E) the out-of-state licensee shall not transfer or
dispose of radioactive material possessed or used in accordance with
the general license provided in this subsection except by transfer
to a person:
(i) (No change.)
(ii) exempt from the requirements for a license for
such material in accordance with §289.251(e)(1) of this title
; and [
(F) The out-of-state licensee shall
have the following documents in their possession at all times when
conducting work in Texas, and make them available for agency review
upon request:
(i) a copy of the agency letter granting
the licensee reciprocal recognition of their out-of-state license;
(ii) a copy of the licensee's operating
and emergency procedures;
(iii) a copy of the licensee's radioactive
material license;
(iv) a copy of all applicable sections
of 25 TAC, Chapter 289; and
(v) a copy of the completed BRC Form
252-3 notifying the agency of the licensee's intent to work in Texas.
(2) - (3) (No change.)
(ff) - (hh) (No change.)
(ii) Increased controls (ICs). Licensees
possessing sources containing radioactive material, at any given time,
in quantities greater than or equal to the quantities of concern listed
in subsection (jj)(9) of this section shall:
(1) (No change.)
(2) limit access to such radioactive material and devices
to only approved individuals who require access to perform their duties.
(A) The licensee shall allow only trustworthy and reliable
individuals, approved in writing by the licensee, to have unescorted
access to radioactive material quantities of concern
(RAM QC) and devices.
(B) - (C) (No change.)
(D) Service providers shall be escorted unless determined
to be trustworthy and reliable by an NRC [
(E) The licensee shall document the basis for concluding
that there is reasonable assurance that an individual granted unescorted
access is trustworthy and reliable, and does not constitute an unreasonable
risk for unauthorized use of RAM QC [
(3) Each licensee shall have a documented program to
monitor and immediately detect, assess, and respond to unauthorized
access to RAM QC [
(A) - (E) (No change.)
(4) (No change.)
(5) For domestic highway and rail shipments, prior
to shipping licensed radioactive material that exceeds 100 times the
quantities in subsection (jj)(9) of this section per consignment,
the licensee shall:
(A) Notify the NRC Director, Office of Nuclear Material
Safety and Safeguards U.S. Nuclear Regulatory Commission, Washington,
DC 20555, in writing, at least 90 days prior to the anticipated date
of shipment. The NRC will issue the Order to implement the Additional
Security Measures (ASMs) for the transportation of
RAM QC [
(B) (No change.)
(6) - (8) (No change.)
(9) The licensee shall retain documentation required
by these ICs [
(A) - (D) (No change.)
(E) After the license is terminated or amended to reduce
possession limits below the quantities of concern, the licensee shall
retain all documentation required by these ICs [
(10) Detailed information generated by the licensee
that describes the physical protection of RAM QC [
(A) - (B) (No change.)
(jj) Appendices.
(1) (No change.)
(2) Isotope quantities (for use in subsection (gg) of this section).
Figure: 25 TAC §289.252(jj)(2)
[
(3) - (8) (No change.)
(9) Radionuclide quantities of concern. The following
methods shall be used to determine which sources of radioactive material
require ICs [
(A) - (C) (No change.)
(D) quantities of radioactive materials used to determine
quantities of concern. The following table contains quantities of
radioactive materials to be used in determining a quantity of concern.
Figure: 25 TAC §289.252(jj)(9)(D)
[
(kk) Requirements for the issuance
of specific licenses for a medical facility or educational institution
to produce Positron Emission Tomography (PET) radioactive drugs for
noncommercial transfer to licensees in its consortium.
(1) A license application will be approved
if the agency determines that an application from a medical facility
or educational institution to produce PET radioactive drugs for noncommercial
transfer to licensees in its consortium authorized for medical use
in accordance with §289.256 of this title includes:
(A) a request for authorization for
the production of PET radionuclides or evidence of an existing license
issued in accordance with this section, the NRC, or another agreement
states requirements for a PET radionuclide production facility within
its consortium from which it receives PET radionuclides;
(B) evidence that the applicant is
qualified to produce radioactive drugs for medical use by meeting
one of the criteria in subsection (r)(1)(A) of this section;
(C) identification of individual(s)
authorized to prepare the PET radioactive drugs if the applicant is
a pharmacy, and documentation that each individual meets the requirements
of an authorized nuclear pharmacist as specified in subsection (r)(3)(B)
of this section; and
(D) information identified in subsection
(r)(1)(B) of this section on the PET drugs to be noncommercially transferred
to members of its consortium.
(2) Authorization in accordance with
paragraph (1) of this subsection to produce PET radioactive drugs
for noncommercial transfer to medical use licensees in its consortium
does not relieve the licensee from complying with applicable FDA,
other federal, and state requirements governing radioactive drugs.
(3) Each licensee authorized in accordance
with paragraph (1) of this subsection to produce PET radioactive drugs
for noncommercial transfer to medical use licensees in its consortium shall:
(A) satisfy the labeling requirements
in subsection (r)(1)(C) of this section for each PET radioactive drug
transport radiation shield and each syringe, vial, or other container
used to hold a PET radioactive drug intended for noncommercial distribution
to members of its consortium; and
(B) possess and use instrumentation
meeting the requirements of §289.202(p)(2)(D) of this title to
measure the radioactivity of the PET radioactive drugs intended for
noncommercial distribution to members of its consortium and meet the
procedural, radioactivity measurement, instrument test, instrument
check, and instrument adjustment requirements in subsection (r)(2)
of this section.
(4) A licensee that is a pharmacy authorized
in accordance with paragraph (1) of this subsection to produce PET
radioactive drugs for noncommercial transfer to medical use licensees
in its consortium shall require that any individual that prepares
PET radioactive drugs shall be:
(A) an authorized nuclear pharmacist
that meets the requirements in subsection (r)(3)(B) of this section; or
(B) an individual under the supervision
of an authorized nuclear pharmacist as specified in §289.256(s)
of this title.
(5) A pharmacy, authorized in accordance
with paragraph (1) of this subsection to produce PET radioactive drugs
for noncommercial transfer to medical use licensees in its consortium
that allows an individual to work as an authorized nuclear pharmacist,
shall meet the requirements of subsection (r)(3)(D) of this section.
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 20, 2009.
TRD-200902960
Lisa Hernandez
General Counsel
Department of State Health Services
Earliest possible date of adoption: August 30, 2009
For further information, please call: (512) 458-7111 x6972
HIV/STD] Epidemiology and Surveillance Branch [
Division], P.O. Box 149347, [
1100 West 49th Street,] Austin, Texas 78714-9347 [
78756-3199].
[(2) Chancroid, Chlamydia trachomatis infection, gonorrhea and syphilis--These
diseases are as defined by the Centers for Disease Control and Prevention.
The publication designating the most current definition may be requested
from: Texas Department of Health, HIV/STD Epidemiology Division, 1100
West 49th Street, Austin, Texas 78756-3199.]
(3)] Sexually transmitted
disease (STD)--An infection, with or without symptoms or
clinical manifestations, that is or may be transmitted from one person
to another during or as a result of sexual relations, and that produces
or might produce a disease in, or otherwise impair, the health of
either person, or might cause an infection or disease in a fetus in
utero or a newborn. Acquired Immune Deficiency Syndrome (AIDS), chancroid,
Chlamydia trachomatis infection, gonorrhea, HIV infection, and syphilis
are sexually transmitted diseases reportable under these rules,
and each are as defined by CDC (see http://www.cdc.gov/ncphi/disss/nndss/casedef/case_definitions.htm).
provide information
on] cases of STD and HIV-exposed infants, as detailed in §97.133
of this title (relating to Reporting Information for Sexually Transmitted
Diseases) [AIDS, chancroid, Chlamydia trachomatis infection,
gonorrhea, HIV infection, or syphilis]:
that is diagnosed or treated for AIDS, chancroid,
Chlamydia trachomatis infection, gonorrhea, HIV infection, or syphilis].
A physician or dentist may designate an employee of the clinic, including
a school based clinic or physician's/dentist's office, to
serve as the reporting officer. However, it is ultimately the
responsibility of the [A] physician or dentist
to ensure [who can assure
] that [a designated or appointed person in] the
required reporting [clinic or office] is
submitted [regularly reporting
every occurrence of these diseases does not have to submit a duplicate
report].
chief administrative
officer of a hospital, medical facility, or penal institution]
shall report each person [patient] who has
or is suspected of having an STD and/or is an HIV-exposed infant,
if a report is not made as required by persons specified in paragraphs
(1), and (3) - (5) of this section: [is medically attended
at the facility and is diagnosed with AIDS, chancroid, Chlamydia trachomatis
infection, gonorrhea, HIV infection, or syphilis. The chief administrative
officer may designate an employee of the institution to serve as the
reporting officer. A chief administrative officer who can assure that
a designated or appointed person in the institution is regularly reporting
every occurrence of these diseases does not have to submit a duplicate
report. Hospital laboratories may report through the reporting officer
or independently in accordance with the hospital's policies and procedures.]
that] yields microscopic,
cultural, serological or any other evidence of an STD [AIDS,
chancroid, Chlamydia trachomatis infection, gonorrhea, HIV infection,
or syphilis, including a CD4+ T lymphocyte cell count below 200
cells/microliter or a CD4+ T lymphocyte percentage of less than
l4%,] shall report according to §97.133 of this title (relating
to Reporting Information for Sexually Transmitted Diseases).
counseling
and testing site or a community-based organization
] shall report each patient who has or is suspected of having an STD and/or
is an HIV-exposed infant. [that is diagnosed with AIDS,
chancroid, Chlamydia trachomatis infection, gonorrhea, HIV infection,
or syphilis. The medical director or clinic physician may designate
an employee of the counseling and testing site or community-based
organization to serve as the reporting officer. A medical director
or clinic physician who can assure that the designated reporting officer
is regularly reporting every occurrence of these diseases, in accordance
with §97.133 of this title, does not have to submit a duplicate
report.]
School administrators,
as defined in §97.1 of this title (relating to Definitions),
who are not medical directors meeting the criteria described in this
section, are exempt from reporting AIDS, chancroid, Chlamydia trachomatis
infection, gonorrhea, HIV infection or syphilis.]
, to the extent that the information is collected
by the reporting entity,] for any specimen derived from a human
body that yields microscopic, cultural, serological or any other evidence
of STD [AIDS, chancroid, chlamydia trachomatis
infection, gonorrhea, HIV infection or syphilis,
including a CD4+ T lymphocyte cell count below 200 cells/microliter
or a CD4+ T lymphocyte percentage of less than 14%].
which
may be in writing, by telephone, by electronic data transmission,
or by other means]. Completed written reports, electronic
reports, and telephone reports shall be made in accordance with §97.134
of this title (relating to How to Report Sexually Transmitted Diseases).
[(A) Reports of AIDS, HIV infection,
CD4+ T Lymphocyte cell count below 200 cells/microliter, or CD4+
T lymphocyte percentage of less than 14% shall be made using all of
the information collected by the reporting entity found in the most
current version of forms CDC 50.42B, CDC 50.42C, or STD-28.]
[(B) Reports of chancroid shall be
made using all of the information collected by the reporting entity
found in the most current version of form STD-27 or STD-28.]
[(C) Reports of chlamydia trachomatis
infection shall be made using all of
the information collected by the reporting entity found in the most
current version of form STD-27 or STD-28.]
[(D) Reports of gonorrhea shall be
made using all of the information collected by the reporting entity
found in the most current version of form STD-27 or STD-28.]
[(E) Reports of syphilis shall be
made using all of the information collected by the reporting entity
found in the most current version of form STD-27 or STD-28.]
[(F) Reports pertaining to congenital
syphilis shall be made using all of the elements found in the most
current version of the form adopted by the Bureau of HIV and STD Prevention.]
[(G) Reports pertaining to enhanced
perinatal HIV surveillance shall be made using all of the elements
found in the most current version of the form adopted by the Bureau
of HIV and STD Prevention.]
[(2) Completed written reports, electronic
reports, and telephone reports shall be made in accordance with §97.134
of this title (relating to How to Report Sexually Transmitted Diseases).]
[(3) Electronic reports shall be made
in accordance with §97.134(i) of this title.]
records
and not public records].
region]
where the physician's office, hospital, laboratory, or medical facility
is located.
title], the reports shall be placed in a sealed envelope addressed
as follows: Texas Department of State Health Services,
TB/HIV/STD [HIV/STD] Epidemiology
and Surveillance Branch [Division],
MC 1873, P.O. Box 149347, [1100 West 49th Street,
] Austin, Texas 78714-9347 [78756-3199
] and the envelope shall be marked "Confidential." The envelope
shall be delivered with the seal unbroken to the TB/HIV/STD
[HIV/STD] Epidemiology
and Surveillance Branch [Division
] office for opening and processing of the contents. Additional
reporting information can be obtained from the HIV/STD Program website
at http://www.dshs.state.tx.us/hivstd/default.shtm. [Postage
paid envelopes may be obtained by contacting the HIV/STD Epidemiology
Division and are provided without charge.]
Reporting
] forms can be obtained from local health departments
and department health service regions;[
, regional offices, and the Texas Department of Health,
HIV/STD Epidemiology Division, 1100 West 49th Street, Austin, Texas
78756-3199.] forms [Forms
] shall be provided without charge to individuals required to report;[.]
a list of local health departments and the department's health service
region offices that can provide reporting forms is available at http://www.dshs.state.tx.us/hivstd/healthcare/reporting/shtm):
Reports]
of STD [confirmed or suspected sexually transmitted
diseases] including AIDS and HIV from physicians and other
persons as specified by §97.132 of this title [
infection] must be submitted within seven calendar
days of the determination
of the existence of a reportable condition.
Laboratories shall submit information weekly. If], during any calendar quarter,
tests for chancroid, Chlamydia trachomatis infection, gonorrhea, HIV
infection and syphilis are performed and all test results are negative,
the person in charge of reporting for the laboratory shall submit
a statement to this effect on or before January 5, April 5, July 5,
and October 5 following that calendar quarter.
[(g) A local health director or regional
director may authorize one or more employees under his/her supervision
to receive the report from the physician by telephone and to physically
complete the form; use of this alternative, if authorized, is at the
option of the reporting physician. The local health department director
or regional director shall implement a method for verifying the identity
of the telephone caller when that person is unfamiliar to the employee.]
CHAPTER 289. RADIATION CONTROL(22)] Constraint (dose
constraint)--A value above which specified licensee actions are required.
(23)] Critical group--The
group of individuals reasonably expected to receive the greatest exposure
to residual radioactivity for any applicable set of circumstances.
(24)] Curie (Ci)--A unit
of measurement of radioactivity. One curie (Ci) is that quantity of
radioactive material that decays at the rate of 3.7 x 1010
disintegrations per second (dps). Commonly
used submultiples of the curie are the millicurie (mCi) and the microcurie
(µCi). One mCi = 1 x 10-3 Ci =
3.7 x 107 dps. One µCi = 1 x 10-6
Ci = 3.7 x 104 dps.
One nanocurie (nCi) = 1 x 10-9 Ci = 3.7
x 101 dps. One picocurie (pCi) = 1 x 10-12
Ci = 3.7 x 10-2 dps.
(25)] Decommission--To
remove a facility or site safely from service and reduce residual
radioactivity to a level that permits the following:
(26)] Deep dose equivalent
(Hd), that applies to external whole
body exposure--The dose equivalent at a tissue depth of 1 centimeter
(cm) (1,000 milligrams per square centimeter (mg/cm2)).
(27)] Depleted uranium--The
source material uranium in which the isotope uranium-235 is less than
0.711 weight percent of the total uranium present. Depleted uranium
does not include special nuclear material.
(28)] Discrete source--A
radionuclide that has been processed so that its concentration within
a material has been purposely increased for use for commercial, medical,
or research activities.
(29)] Distinguishable
from background--The detectable concentration of a radionuclide is
statistically different from the background concentration of that
radionuclide in the vicinity of the site, or, in the case of structures
or equipment, in similar materials using adequate measurement technology,
survey, and statistical techniques.
(30)] Distribution--The
physical conveyance and authorized transfer of commodities from producers
to consumers and any intermediate persons involved in that conveyance.
(31)] Dose--A generic
term that means absorbed dose, dose equivalent, effective dose equivalent,
committed dose equivalent, committed effective dose equivalent, total
organ dose equivalent, or total effective dose equivalent. For purposes
of this chapter, "radiation dose" is an equivalent term.
(32)] Dose equivalent (HT
)--The product of the absorbed dose
in tissue, quality factor, and all other necessary modifying factors
at the location of interest. The units of dose equivalent are the
sievert (Sv) and rem.
(33)] Dose limits--The
permissible upper bounds of radiation doses established in accordance
with this chapter. For purposes of this chapter, "limits" is an equivalent term.
(34)] Effective dose equivalent
(HE)--The sum of the products of the
dose equivalent to each organ or tissue (HT)
and the weighting factor (wT) applicable
to each of the body organs or tissues that are irradiated (HE
= Σ wTHT).
(35)] Embryo/fetus--The
developing human organism from conception until the time of birth.
(36)] Entrance or access
point--Any opening through which an individual or extremity of an
individual could gain access to radiation areas or to licensed sources
of radiation. This includes portals of sufficient size to permit human
access, irrespective of their intended use.
(37)] Exposure--The quotient
of dQ by dm where "dQ" is the absolute value of the total charge of
the ions of one sign produced in air when all the electrons (negatrons
and positrons) liberated by photons in a volume element of air having
mass "dm" are completely stopped in air. The SI unit of exposure is
the coulomb per kilogram (C/kg). The roentgen is the special unit
of exposure. For purposes of this chapter, this term is used as a noun.
(38)] Exposure rate--The
exposure per unit of time.
(39)] External dose--That
portion of the dose equivalent received from any source of radiation
outside the body.
(40)] Extremity--Hand,
elbow, arm below the elbow, foot, knee, and leg below the knee. The
arm above the elbow and the leg above the knee are considered part
of the whole body.
(41)] Generally applicable
environmental radiation standards--Standards issued by the United
States Environmental Protection Agency (EPA) under the authority of
the Atomic Energy Act of 1954, as amended, that impose limits on radiation
exposures or levels, or concentrations or quantities of radioactive
material, in the general environment outside the boundaries of locations
under the control of persons possessing or using radioactive material.
(42)] Gray (Gy)--The SI
unit of absorbed dose. One gray is equal to an absorbed dose of 1
joule per kilogram (J/kg) or 100 rad.
(43)] High radiation area--An
area, accessible to individuals, in which radiation levels from sources
of radiation external to the body could result in an individual receiving
a dose equivalent in excess of 0.1 rem (1 millisievert (mSv)) in one
hour at 30 cm from any source of radiation or from any surface that
the radiation penetrates.
(44)] Human use--The internal
or external administration of radiation or radioactive material to
human beings for healing arts purposes or research and/or development
specifically authorized by the agency.
(45)] Individual--Any human being.
(46)] Individual monitoring--The
assessment of:
(47)] Individual monitoring
devices--Devices designed to be worn by a single individual for the
assessment of dose equivalent. For purposes of this chapter, "personnel
dosimeter" and "dosimeter" are equivalent terms. Examples of individual
monitoring devices include, but are not limited to, film badges, thermoluminescence
dosimeters (TLDs), optically stimulated luminescence dosimeters (OSLs),
pocket ionization chambers (pocket dosimeters), electronic personal
dosimeters, and personal air sampling devices.
(48)] Inspection--An official
examination and/or observation including, but not limited to, records,
tests, surveys, and monitoring to determine compliance with the Act
and rules, orders, requirements, and conditions of the agency.
(49)] Internal dose--That
portion of the dose equivalent received from radioactive material
taken into the body.
(50)] Ionizing radiation--Any
electromagnetic or particulate radiation capable of producing ions,
directly or indirectly, in its passage through matter. Ionizing radiation
includes gamma rays and x rays, alpha and beta particles, high-speed
electrons, neutrons, and other nuclear particles.
(51)] Land disposal facility--The
land, buildings, and equipment that are intended to be used for the
disposal of low-level radioactive waste (LLRW) into the subsurface
of the land.
(52)] Lens dose equivalent--The
external dose equivalent to the lens of the eye at a tissue depth
of 0.3 cm (300 mg/cm2).
(53)] License--A form
of permission given by the agency to an applicant who has met the
requirements for licensing set out in the Act and this chapter.
(54)] Licensed material--Radioactive
material received, possessed, used, or transferred under a general
or specific license issued by the agency.
(55)] Licensee--Any person
who is licensed by the agency in accordance with the Act and this chapter.
(56)] Licensing state--Any
state with rules equivalent to the Suggested State Regulations for
Control of Radiation relating to, and having an effective program
for, the regulatory control of naturally occurring or accelerator-produced
radioactive material (NARM) and has been designated as such by the
Conference of Radiation Control Program Directors, Inc. For the purposes
of evaluation and/or distribution of sealed sources, this includes
Licensing State Status: Product Review Only.
(57)] Lost or missing
radioactive material--Radioactive material whose location is unknown.
This definition includes licensed material that has been shipped but
has not reached its planned destination and whose location cannot
be readily traced in the transportation system.
(58)] Low-level radioactive
waste (LLRW)--Radioactive material that meets the following criteria:
(59)] Manufacture--To
fabricate or mechanically produce.
(60)] Member of the public--Any
individual, except when that individual is receiving an occupational dose.
(61)] Minor--An individual
less than 18 years of age.
(62)] Monitoring--The
measurement of radiation, radioactive material concentrations, surface
area activities, or quantities of radioactive material and the use
of the results of these measurements to evaluate potential exposures
and doses. For purposes of this chapter, "radiation monitoring" and
"radiation protection monitoring" are equivalent terms.
(63)] NARM--Any naturally
occurring or accelerator-produced radioactive material except source
material or special nuclear material.
(64)] Natural radioactivity--Radioactivity
of naturally occurring nuclides whose location and chemical and physical
form have not been altered by man.
(65)] NRC--The United
States Nuclear Regulatory Commission or its duly authorized representatives.
(66)] Occupational dose--The
dose received by an individual in the course of employment in which
the individual's assigned duties involve exposure to sources of radiation
from licensed/registered and unlicensed/unregistered sources of radiation,
whether in the possession of the licensee/registrant or other person.
Occupational dose does not include dose received from background radiation,
from any medical administration the individual has received, from
exposure to individuals administered radioactive material and released
in accordance with this chapter, from voluntary participation in medical
research programs, or as a member of the public.
(67)] Particle accelerator--Any
machine capable of accelerating electrons, protons, deuterons, or
other charged particles in a vacuum and designed to discharge the
resultant particulate or other associated radiation at energies usually
in excess of 1 MeV.
(68)] Person--Any individual,
corporation, partnership, firm, association, trust, estate, public
or private institution, group, agency, local government, any other
state or political subdivision or agency thereof, or any other legal
entity, and any legal successor, representative, agent, or agency
of the foregoing, other than NRC, and other than federal government
agencies licensed or exempted by NRC.
(69)] Personnel monitoring
equipment (See definition for individual monitoring devices.)
(70)] Pharmacist--An individual
licensed by the Texas State Board of Pharmacy to compound and dispense
drugs, prescriptions, and poisons.
(71)] Physician--An individual
licensed by the Texas Medical Board.
(72)] Principal activities--Activities
authorized by the license that are essential to achieving the purpose(s)
for which the license was issued or amended. Storage during which
no licensed material is accessed for use or disposal and activities
incidental to decontamination or decommissioning are not principal
activities.
(73)] Public dose--The
dose received by a member of the public from exposure to sources of
radiation released by a licensee, or to any other source of radiation
under the control of a licensee/registrant. It does not include occupational
dose or doses received from background radiation, from any medical
administration the individual has received, from exposure to individuals
administered radioactive material and released in accordance with
this chapter, or from voluntary participation in medical research programs.
(74)] Quality factor (Q)--The
modifying factor listed in subsection (n)(1) and (2) of this section
that is used to derive dose equivalent from absorbed dose.
(75)] Quarter (calendar
quarter)--A period of time equal to one-fourth of the year observed
by the licensee, approximately 13 consecutive weeks, providing that
the beginning of the first quarter in a year coincides with the starting
date of the year and that no day is omitted or duplicated in consecutive quarters.
(76)] Rad--The special
unit of absorbed dose. One rad is equal to an absorbed dose of 100
ergs per gram (erg/g) or 0.01 J/kg (0.01 gray).
(77)] Radiation--One or more of the following:
(78)] Radiation area--Any
area, accessible to individuals, in which radiation levels could result
in an individual receiving a dose equivalent in excess of 0.005 rem
(0.05 mSv) in one hour at 30 cm from the source of radiation or from
any surface that the radiation penetrates.
(79)] Radiation machine--Any
device capable of producing ionizing radiation except those devices
with radioactive material as the only source of radiation.
(80)] Radiation safety
officer (RSO)--An individual who has a knowledge of and the authority
and responsibility to apply appropriate radiation protection rules,
standards, and practices, who must be specifically authorized on a
radioactive material license, and who is the primary contact with
the agency. Specific training and responsibilities for an RSO are
listed in §289.252 of this title (relating to Licensing of Radioactive
Material), §289.253 of this title (relating to Radiation Safety
Requirements for Well Logging Service Operations and Tracer Studies), §289.255
of this title (relating to Radiation Safety Requirements and Licensing
and Registration Procedures for Industrial Radiography), and §289.256
of this title (relating to Medical and Veterinary Use of Radioactive Material).
(81)] Radioactive material--Any
material (solid, liquid, or gas) that emits radiation spontaneously.
(82)] Radioactive waste--As
used in §289.254 of this title (relating to Licensing of Radioactive
Waste Processing and Storage Facilities), this term is equivalent to LLRW.
(83)] Radioactivity--The
disintegration of unstable atomic nuclei with the emission of radiation.
(84)] Radiobioassay (See
definition for bioassay.)
(85)] Registrant--Any
person issued a certificate of registration by the agency in accordance
with the Act and this chapter.
(86)] Regulation (See definition for rule.)
(87)] Regulations of the
United States Department of Transportation (DOT)--The requirements
in Title 49, CFR, Parts 100 - 189.
(88)] Rem--The special
unit of any of the quantities expressed as dose equivalent. The dose
equivalent in rem is equal to the absorbed dose in rad multiplied
by the quality factor (1 rem = 0.01 sievert (Sv)).
(89)] Research and development--Research
and development is defined as:
(90)] Residual radioactivity--The
radioactivity in structures, materials, soils, groundwater, and other
media at a site resulting from activities under the licensee's control.
This includes radioactivity from all licensed and unlicensed sources
used by the licensee, but excludes background radiation. It also includes
radioactive materials remaining at the site as a result of routine
or accidental releases of radioactive material at the site and previous
burials at the site, even if those burials were made in accordance
with the provisions of Title 30, Texas Administrative Code, §336.334.
(91)] Restricted area--An
area, access to which is limited by the licensee for the purpose of
protecting individuals against undue risks from exposure to sources
of radiation. Restricted area does not include areas used as residential
quarters, but separate rooms in a residential building may be set
apart as a restricted area.
(92)] Roentgen (R)--The
special unit of exposure. One roentgen (R) equals 2.58 x 10-4
C/kg of air. (See definition for exposure.)
(93)] Rule (as defined
in the Government Code, Chapters 2001 and 2002, as amended)--Any agency
statement of general applicability that implements, interprets, or
prescribes law or policy, or describes the procedure or practice requirements
of an agency. The term includes the amendment or repeal of a prior
section but does not include statements concerning only the internal
management or organization of any agency and not affecting private
rights or procedures. The word "rule" was formerly referred to as
"regulation."
(94)] Sealed source--Radioactive
material that is permanently bonded or fixed in a capsule or matrix
designed to prevent release and dispersal of the radioactive material
under the most severe conditions that are likely to be encountered
in normal use and handling.
(95)] Shallow dose equivalent
(Hs) (that applies to the external exposure
of the skin of the whole body or the skin of an extremity)--The
dose equivalent at a tissue depth of 0.007 cm (7 mg/cm2) [
averaged over an area of 1 square
centimeter (cm2)].
(96)] SI--The abbreviation
for the International System of Units.
(97)] Sievert--The SI
unit of any of the quantities expressed as dose equivalent. The dose
equivalent in sievert is equal to the absorbed dose in gray multiplied
by the quality factor (1 Sv = 100 rem).
(98)] Site boundary--That
line beyond which the land or property is not owned, leased, or otherwise
controlled by the licensee.
(99)] Source material--Source
material is defined as:
(100)] Source of radiation--Any
radioactive material, or any device or equipment emitting or capable
of producing radiation.
(101)] Special form radioactive
material--Radioactive material that satisfies the following conditions.
(102)] Special nuclear
material--Special nuclear material is defined as:
(103)] Special nuclear
material in quantities not sufficient to form a critical mass--Uranium
enriched in the isotope 235 in quantities not exceeding 350 grams
(g) of contained uranium-235; uranium-233 in quantities not exceeding
200 g; plutonium in quantities not exceeding 200 g; or any combination
of them in accordance with the following formula.
Figure: 25 TAC §289.201(b)(103)(B)]
(104)] Special units--The
conventional units historically used by licensees, for example, curie
(activity), rad (absorbed dose), and rem (dose equivalent).
(105)] Survey--An evaluation
of the radiological conditions and potential hazards incident to the
production, use, transfer, release, disposal, and/or presence of sources
of radiation. When appropriate, such survey includes, but is not limited
to, tests, physical examination of location of materials and equipment,
measurements of levels of radiation or concentration of radioactive
material present, and evaluation of administrative and/or engineered controls.
(106)] Termination--A
release by the agency of the obligations and authorizations of the
licensee under the terms of the license. It does not relieve a person
of duties and responsibilities imposed by law.
(107)] Test--A method
of determining the characteristics or condition of sources of radiation
or components thereof.
(108)] Texas Regulations
for Control of Radiation (TRCR)--All sections of Title 25 Texas Administrative
Code (TAC), Chapter 289.
(109)] Total effective
dose equivalent (TEDE)--The sum of the effective dose equivalent for
external exposures and the committed effective dose equivalent for
internal exposures.
(110)] Total organ dose
equivalent (TODE)--The sum of the deep dose equivalent and the committed
dose equivalent to the organ receiving the highest dose as described
in §289.202(rr)(1)(F) of this title.
(111)] Transport index--The
dimensionless number (rounded up to the next tenth) placed on the
label of a package, to designate the degree of control to be exercised
by the carrier during transportation. The transport index is determined
as follows:
(112)] Type A quantity--A
quantity of radioactive material, the aggregate radioactivity of which
does not exceed A1 for special form radioactive
material or A2 for normal form radioactive
material, where A1 and A2
are given in §289.257(ff) of this title
(relating to Packaging and Transportation of Radioactive Material)
or may be determined by procedures described in §289.257(ff)
of this title.
(113)] Type B quantity--A
quantity of radioactive material greater than a type A quantity.
(114)] Unrefined and
unprocessed ore--Ore in its natural form prior to any processing,
such as grinding, roasting, beneficiating, or refining.
(115)] Unrestricted area
(uncontrolled area)--An area, or access to, which is neither limited
nor controlled by the licensee. For purposes of this chapter, "uncontrolled
area" is an equivalent term.
(116)] Very high radiation
area--An area, accessible to individuals, in which radiation levels
from sources of radiation external to the body could result in an
individual receiving an absorbed dose in excess of 500 rads (5 grays)
in one hour at 1 meter (m) from a source of radiation or from any
surface that the radiation penetrates. At very high doses received
at high dose rates, units of absorbed dose, gray and rad, are appropriate,
rather than units of dose equivalent, Sv and rem.
(117)] Veterinarian--An
individual licensed by the Texas State Board of Veterinary Medical Examiners.
(118)] Waste--Low-level
radioactive wastes containing source, special nuclear, or byproduct
material that are acceptable for disposal in a land disposal facility.
For the purposes of this definition, low-level radioactive waste means
radioactive waste not classified as high-level radioactive waste,
transuranic waste, spent nuclear fuel, or byproduct material as defined
in paragraph (15)(B) - (E) of this subsection.
(119)] Week--Seven consecutive
days starting on Sunday.
(120)] Whole body--For
purposes of external exposure, head, trunk including male gonads,
arms above the elbow, or legs above the knee.
(121)] Worker--An individual
engaged in work under a license or certificate of registration issued
by the agency and controlled by a licensee or registrant, but does
not include the licensee or registrant.
(122)] Working level
(WL)--Any combination of short-lived radon daughters in 1 liter of
air that will result in the ultimate emission of 1.3 x 105
million electron volts (MeV) of potential
alpha particle energy. The short-lived radon daughters are--for radon-222:
polonium-218, lead-214, bismuth-214, and polonium-214; and for radon-220:
polonium-216, lead-212, bismuth-212, and polonium-212.
(123)] Working level
month (WLM)--An exposure to one working level for 170 hours--2,000
working hours per year divided by 12 months per year is approximately
equal to 170 hours per month.
(124)] Year--The period
of time beginning in January used to determine compliance with the
provisions of this chapter. The licensee may change the starting date
of the year used to determine compliance by the licensee provided
that the change is made at the beginning of the year and that no day
is omitted or duplicated in consecutive years.
Material]) or §289.231
of this title (relating to General Provisions and Standards for Protection
Against Machine-Produced Radiation), as applicable;
,] or order that has:
.]
Bureau of Radiation Control (BRC)] Form 203-1, "Notice to Employees,"
as contained in subsection (i) of this section, or an equivalent document
containing at least the same wording as RC [BRC]
Form 203-1 [, shall be posted by each licensee or registrant
as required by this section].
reported annually] to the
individual as specified in this section. The information reported
shall include data and results obtained in accordance with agency
requirements, orders, license or certificate of registration conditions,
as shown in records maintained by the licensee or registrant in accordance
with §289.202 or §289.231 of this title, as applicable.
Each notification and report shall:
annually]of the worker's dose as shown in records maintained by the licensee
or registrant in accordance with §289.202(rr) or §289.231(dd)
of this title, as applicable, if the individual requests his
or her annual dose report in writing.
Figure: 25 TAC §289.203(i)]
SUBCHAPTER F. LICENSE REGULATIONS(m)(1)] of this section.
subparagraph (C)] of this paragraph, any
person is exempt from these rules if that person receives, possesses,
uses, transfers, or acquires radioactive material in individual quantities,
each of which does not exceed the applicable quantity set forth in
subsection (l)(2) [(m)(2)] of this section.
or
] transfers, or owns such radioactive material.
(m)(2)]of this section, knowing or having reason to believe that such quantities
of radioactive material will be transferred to persons exempt in accordance
with this paragraph or equivalent regulations of the NRC, any agreement
state, or any licensing state, except in accordance with a specific
license issued by the NRC in accordance with Title 10, CFR, §32.18
or by the agency in accordance with §289.252(j) of this title,
which states that the radioactive material may be transferred by the
licensee to persons exempt in accordance with this paragraph or the
equivalent regulations of the NRC, any agreement state, or any licensing state.
(m)(2)] of this section applies only to radioactive
materials distributed as exempt quantities in accordance with a specific
license issued by the agency, another licensing state, or the commission.
Subsection (l)(2) [(m)(2)] of this section does
not apply to radioactive materials that have decayed from quantities
not originally exempt and does not make such material, or the sources
or devices in which the material is contained except from the licensing
requirements in this section or §289.252 of this title.
1 µCi of radium-226 per timepiece
in timepieces, hands, or dials manufactured or initially distributed
prior to January 1, 1986];
(m)(2)] of this
section or 0.05 µCi of americium-241; [or]
.]
or
] produce, or initially transfer gas and aerosol detectors
containing radioactive material, any person is exempt from this chapter
if that person receives, possesses, uses, transfers, owns, or acquires
radioactive material in gas and aerosol detectors designed to protect
life or property from fires and airborne hazards provided that:
and]
.]
(D) Resins containing scandium-46
and designed for sand consolidation in oil wells. Any person is exempt
from this chapter if that person receives, possesses, uses, transfers,
or acquires synthetic plastic resins containing scandium-46, which
are designed for sand consolidation in oil wells. Such resins shall
have been manufactured or imported in accordance with a specific license
issued by the NRC, or shall have been manufactured in accordance with
the specifications contained in a specific license issued by the agency
or any agreement state to the manufacturer of such resins in accordance
with licensing requirements equivalent to those in Title 10, CFR, §§32.16
and 32.17. This exemption does not authorize the manufacture of any
resins containing scandium-46.]
and]
.]
.]
.]
.]
in possession of
] a device meeting the criteria of paragraph (1) of this subsection
shall respond annually to the General License Acknowledgement Self
Evaluation Form provided by the agency. The form shall be completed
in accordance with the instructions contained in the form. The completed
form shall be submitted to the agency within 30 days of receipt. [
Response should be in accordance with the instructions on the form.]
(l)] of this section.
Expiration and termination
] of general license acknowledgements [
acknowledgement].
(1) Each general license acknowledgement
expires at the end of the day, in the month and year stated in the
general license acknowledgement.]
(2) Expiration of the general license
acknowledgement does not relieve the holder of the general license
acknowledgement of the requirements of this chapter.]
(3)] Each holder of a general
license acknowledgement shall notify the agency immediately, in writing,
and request termination of the general license acknowledgement when
the holder of the general license acknowledgement decides to terminate
all activities involving materials specified in the general license
acknowledgement.
(4) No less than 30 days before the
expiration date specified in a general license acknowledgement, the
holder of the general license acknowledgement shall submit an application
for general license acknowledgement renewal in accordance with subsection
(k) of this section.]
(5)] Each holder of a general
license acknowledgement shall, no less than 30 days before vacating
or relinquishing possession of control of premises that have been
used as a place of storage or use of radioactive material as a result
of general licensed activities, notify the agency in writing of intent
to vacate and do the following: [.]
(6) If a holder of a general license
acknowledgement does not submit an application for renewal in accordance
with subsection (k) of this section, such person shall on or before
the expiration date specified in the general license acknowledgement:]
(A) terminate use of radioactive material; and]
(B) dispose of radioactive material
in accordance with this section and/or §289.202(ff).]
(k) Renewal of general license acknowledgements.]
(1) Applications for renewal of general
license acknowledgements shall be filed in accordance with subsection
(g)(1) or (f)(4)(G)(iv) of this section, as applicable.]
(2) If a holder of a general license
acknowledgement has properly filed a renewal application for the same
activities at least 30 days before the expiration of the existing
general license acknowledgement in accordance with this section, such
existing general license acknowledgement shall not expire until the
application has been finally determined by the agency.]
(l)] Amendment of general
license acknowledgements.
(m)] Appendices.
Figure: 25 TAC §289.251(m)(1)]
Figure: 25 TAC §289.251(m)(2)]
(i) §289.254 of this title (relating
to Licensing of Radioactive Waste Processing and Storage Facilities);]
(ii)] §289.255 of
this title (relating to Radiation Safety[,] Requirements
and Licensing and Registration Procedures for Industrial Radiography);
(iii)] §289.256 of
this title (relating to Medical and Veterinary Use of Radioactive
Material);
(iv)] §289.258 of
this title (relating to Licensing and Radiation Safety Requirements
for Irradiators);
(v)] §289.259 of
this title (relating to Licensing of Naturally Occurring Radioactive
Material (NORM)); or
(vi) §289.260 of this title (relating
to Licensing of Uranium Recovery and Byproduct Material Disposal Facilities);
or]
Material]);
(3) Licensees engaged in radioactive
waste processing and/or storage are subject to the requirements of §289.254
of this title.]
(4)] Licensees engaged
in industrial radiographic operations are subject to the requirements
of §289.255 of this title.
(5)] Licensees using radioactive
material for medical or veterinary use are subject to the requirements
of §289.256 of this title.
(6)] Licensees using sealed
sources in irradiators are subject to the requirements of §289.258
of this title.
(7)] Licensees possessing
or using naturally occurring radioactive material are subject to the
requirements of §289.259 of this title.
(8) Licensees engaged in uranium recovery
and byproduct material disposal are subject to the requirements of §289.260
of this title.]
satisfies]
any applicable special requirement in this section and other sections
as specified in subsection (a)(2)(A) of this section;
submitsan
] adequate operating, safety, and emergency procedures [manual];
and]
storage] facility is not owned by the applicant.
The applicant shall provide a written statement from the owner, or
from the owner's agent, indicating such. This paragraph does not apply
to property owned or held by a government entity or to property on
which radioactive material is used under an authorization for temporary
job site use; [.]
subsection (d)(10)
or (x)(7)] of this section; and [.]
and]
.]
and]
.]
§§289.254, 289.255, 289.256, and §289.259] of
this title is required;
United States Nuclear Regulatory Commission (NRC)], agreement
state, or licensing state requirements;
10 CFR 70.39] or their equivalent.
§289.256(bb), §289.256(cc),
and §289.256(dd)] of this title will be issued if the agency
approves the following information submitted by the applicant:
bears] a durable, clearly visible label:
or licensed] with the United
States Food and Drug Administration (FDA) as
the owner or operator of a drug
establishment that engages in the manufacture,
preparation, propagation, compounding, or processing of a drug in
accordance with Title 21, CFR, §207.20(a) [manufacturer];
or]
described
] in §289.256
of this title with the following provisions. [:]
(A) radioactive drugs shall be prepared
by a nuclear pharmacist(s) designated in the application as the individual
user(s) who has completed the training and experience requirements
specified in §289.256 of this title;]
(B)] The [the]
radiopharmaceuticals for human use shall be processed and prepared
according to instructions that are furnished by the manufacturer on
the label attached to or in the FDA-accepted instructions in the leaflet
or brochure that accompanies the generator or reagent kit. [;]
(C)] If [if]
the authorized nuclear pharmacist elutes generators or processes radioactive
material with the reagent kit in a manner that deviates from instructions
furnished by the manufacturer on the label attached to or in the leaflet
or brochure that accompanies the generator or reagent kit or in the
accompanying leaflet or brochure, a complete description of the deviation
shall be made and maintained for inspection by the agency for a period
of three years. [; and]
(D) provide to the agency a copy of
each individual's certification by the Texas State Board of Pharmacy
or the permit issued by a licensee of broad scope, and a copy of the
state pharmacy license. If the licensee adds a nuclear pharmacist(s)
to the license, this shall be completed no later than 30 days after
the date that the licensee allows the individual(s) to work as a nuclear
pharmacist.]
,]
and state requirements governing radioactive drugs.
agency
], in writing, immediately
following the filing of a voluntary or involuntary petition for bankruptcy
by the licensee or its parent company, if the parent company is involved
in the bankruptcy.
(4)
] of this subsection shall include:
Expiration of the specific license does not relieve the licensee
of the requirements of this chapter.]
and]
.]
U.S. Nuclear Regulatory Commission (NRC)] required background investigation
as an employee of a manufacturing and distribution (M&D) licensee.
Written verification attesting to or certifying the person's trustworthiness
and reliability shall be obtained from the M&D [
manufacturing and distribution] licensee providing the service.
radioactive material
quantities of concern]. The licensee shall maintain a list of
persons approved for unescorted access to such radioactive material
and devices by the licensee.
radioactive material quantities
of concern] and devices in use or in storage. Enhanced monitoring
shall be provided during periods of source delivery or shipment, where
the delivery or shipment exceeds 100 times the values listed in subsection
(jj)(9) of this section.
Radioactive Material Quantities of Concern (RAM QC)]. The licensee
shall not ship this material until the ASMs for the transportation
of RAM QC are implemented or the licensee is notified otherwise, in
writing, by the NRC.
increased controls] for inspection
by the agency for three years after they are no longer effective.
increased controls] for three years.
radioactive material quantities of concern], is sensitive information and
shall be protected from unauthorized disclosure.
Figure: 25 TAC §289.252(jj)(2)]
increased controls (ICs)]:
Figure: 25 TAC §289.252(jj)(9)(D)]