Part 1. DEPARTMENT OF STATE HEALTH SERVICES

Chapter 100. IMMUNIZATION REGISTRY

The Executive Commissioner of the Health and Human Services Commission on behalf of the Department of State Health Services (department) proposes amendments to §§100.1 - 100.6, repeal of §100.7 and §100.8, and new §§100.7 - 100.10, concerning the Texas Immunization Registry (the Registry).

BACKGROUND AND PURPOSE

Government Code, §2001.039, requires that each state agency review and consider for readoption every 4 years each rule adopted by that agency pursuant to the Government Code, Chapter 2001. Sections 100.1 - 100.8 have been reviewed and the department has determined that reasons for adopting the sections continue to exist because rules on this subject are needed, although current language in §100.7 and §100.8 is being renumbered as §100.9 and §100.10 (respectively), with minor changes, so that entirely new language can be proposed as new §100.7 and §100.8. This rulemaking also proposes amendments that would implement portions of Senate Bill (SB) 11, 80th Legislature, Regular Session (2007), which amended Health and Safety Code (the Code), Chapter 161. This rulemaking proposal would also make various clarifying amendments designed to improve the efficiency and readability of these rules sections.

The proposed amendments, repeal, and new sections update the agency, division, section, and branch names, reorder text and sections to improve rule clarity and efficiency, and implement SB 11 requirements.

SECTION-BY-SECTION SUMMARY

Section 100.1(2) is proposed to be amended to clarify that a managing conservator or legal guardian can also grant the requisite consent. Section 100.1(3) is proposed to be amended to reflect the language of the Code, §161.0001(1), including amendments made by SB 11. Section 100.1(4) is proposed to be amended to reflect the current name of the department. Existing §100.1(5) is proposed to be renumbered as §100.1(9) and to be amended by changing "child" to "person" to reflect SB 11 requirements. Existing §100.1(6) and (7) are proposed to be renumbered as §100.1(10) and (11), respectively. Existing §100.1(8) is proposed to be deleted as confusing and unnecessary language, and is proposed to be replaced with a new definition for "immediate family member" to reflect the requirements of SB 11. Existing paragraphs (9), (10), and (11) in §100.1 are proposed to be renumbered to §100.1(12), (14), and (17), respectively. Existing §100.1(12) is proposed to be renumbered to §100.1(18), with "a person" replacing "children" in order to reflect SB 11 requirements. New definitions are proposed to be numbered as paragraphs (5) - (8), (13), (15), and (16) to implement SB 11 requirements.

Section 100.2(a) is proposed to be amended to reflect amendments made to the Code, §161.0073(a) by SB 11, and is also proposed to be amended by adding language to reflect that a managing conservator or legal guardian may also offer the required consent. Section 100.2(b) is proposed to be amended by adding a statement which expressly states that Registry information may only be accessed by the persons listed in rule, for the purposes enumerated in the rule. Further amendments are proposed to reflect the new classes of persons brought into the regulatory scheme by SB 11. Amendments are also proposed at subsection (b) to reflect that a managing conservator or legal guardian may also offer the required consent.

Section 100.3 is proposed to be amended by changing the section title to reflect that "guardian" is a reference to a "legal guardian." Section 100.3(a) is proposed to be amended to add managing conservators and legal guardians to the list of those to be informed under the requirement, along with a cross-reference to the method to be used. The subsection is also proposed to be amended by adding language that reflects changes to §161.007(a) of the Code made by SB 11. Section 100.3(b) is proposed to be amended to add managing conservators and legal guardians to the list of persons that will receive the referenced materials. Section 100.3(c) is proposed to be amended to add managing conservators and legal guardians to the list of persons that may receive the referenced notices. Section 100.3(d) is proposed to be amended to add managing conservators and legal guardians to the list of persons that will receive the referenced notices. Section 100.3(d)(6) is proposed to be amended to add managing conservators and legal guardians to the list of persons regarding reporting the referenced violation, and to insert "alleged" in front of "violation" to reflect that such a violation will not have been proven at that point of the process.

Section 100.4 is proposed to be amended by changing the section title, and subsection (a), to reflect that this rule section is only applicable to Registry consent and withdrawal relating to minors, since these same issues will be dealt with separately in new §100.7 and §100.8 regarding SB 11 requirements as to certain adults. Section 100.4(a)(2) is proposed to be amended by updating the current name and contact information of the department. Existing subsection (b) is proposed to be renumbered as subsection (c), with a new subsection (b) proposed to be inserted which describes the consent process by which information on minors is included in the Registry. In the new subsection (b), the cross-reference to new §100.7 is necessary because SB 11 provides for inclusion of information regarding minors into the Registry without consent (and therefore without consent needing to be verified) in the limited situations described in the new rule section. New subsection (b) would also specify how the department will handle consent verifications in situations involving minors where such verification is required, which is authorized under the authority given to the department under changes to the Code, §161.007(a)(5) made by SB 11. This process is designed to maximize efficiency of Registry operations. Existing subsection (c) is proposed to be renumbered as new subsection (d), and is proposed to be amended to add managing conservators and legal guardians to the list of persons regarding withdrawal of consent, and is also proposed to be amended by adding a cross-reference to new §100.7 to reflect the exception to the ability to withdraw consent, per SB 11. Existing subsection (d) is proposed to be renumbered as new subsection (e), and is proposed to be amended to add managing conservators and legal guardians to the list of persons who may request exclusion of the information, while paragraph (2) updates the department's current name and contact information and also includes a cross-reference to new §100.7 to reflect the exception to the ability to request exclusion, per SB 11.

Section 100.5 is proposed to be amended by renumbering the existing subsection (a) as a new subsection (b), with changes that: reflect the new classes of persons brought into the Registry via SB 11; clarify that managing conservators and legal guardians are included in the list of persons who can submit the referenced information; improve readability; and expressly state that submissions of the referenced information must be according to department requirements. A new subsection (a) is proposed which would provide an updated comprehensive list of the classes of persons who will have information contained in the Registry, given SB 11 requirements. Existing subsection (b) is proposed to be renumbered as new subsection (c), with changes that reflect the new classes of persons brought into the Registry via SB 11, as well as changes to improve readability. Existing subsection (c) is proposed to be renumbered as new subsection (e), with changes that: effectively reflect the statutory scheme for release of immunization records; expressly states the limitations of use (if any) for each class of person listed, to prohibit parties allowed direct access to the Registry from viewing records beyond those they are authorized to see, given state and federal confidentiality laws; and expressing the limitation of direct electronic access to the Registry, which is necessary due to resource constraints of the department and is advisable to help preserve confidentiality. Existing subsection (d) is proposed to be renumbered as subsection (h), with changes that better express liability limitations by cross-referencing the applicable Code provision, rather than attempting to paraphrase statutory language. A new subsection (d) is proposed to concisely set out the methods the department has to choose from when verifying consent, under the authority granted the department under §161.007(a)(5) of the Code as amended by SB 11. Existing subsection (e) is proposed to be renumbered as new subsection (i), with changes to reflect the new classes of persons brought into the Registry via SB 11. New subsection (f) is proposed to provide a cross-reference to new §100.7 regarding release of information under the scenarios described in that rule. New subsection (g) is proposed to provide a cross-reference to new §100.8 relating to release of information regarding first responders and their immediate family under that rule.

Section 100.6 is proposed to be amended by adding language to the section title which states that the section covers medical verifications as well, and that the entire section is applicable only to minors (as opposed to adults added to the Registry scheme under SB 11, which will be covered elsewhere in the rules). Subsection (a) is proposed to be amended for readability and clarity. Subsection (b) is proposed to be amended by deleting confusing and outdated text and replacing it with a clear statement regarding the providers' obligation to submit the required data elements to the department within the stated 30 day deadline. Subsection (c) is proposed to be amended in a manner similar to subsection (b), except that (c) is applicable to applicable payors as opposed to providers. Subsection (d) is proposed to be amended by adding managing conservator and legal guardian to the list of persons who can provide a child's immunization history to the department. Existing subsection (e) is proposed to be deleted because its subject matter will be covered under other provisions under this section as reorganized. Existing subsection (f) is proposed to be renumbered as subsection (e), with changes to improve clarity. Existing subsection (g) is proposed to be renumbered as subsection (f).

The text in existing §100.7 and §100.8 is proposed to be moved to §100.9 and §100.10, respectively, with changes as part of the reorganization of this subchapter (see discussion of proposed changes as follows).

New §100.7 is being proposed to implement changes to the Code, Chapter 161, amended by SB 11 regarding the following scenarios: potential and declared disasters; public health emergencies; terrorist attacks; hostile military or paramilitary actions; and/or extraordinary law enforcement emergency events. SB 11 mandates a major expansion in the existing scope of the Registry. Under that legislation, the Registry must contain specified information regarding persons who receive an immunization, antiviral, and/or other medication administered to prepare for, and/or in response to, the listed scenarios--as stated in proposed new subsection (a) of the section. The provider deadline to submit data elements is set at 30 days in the new subsection (b). This will allow the Registry to reflect an accurate picture of the immunizations, etc. being administered in the emergency so that information will be available to those who need it. SB 11 amends §161.00705 of the Code to include requirements for the department to track adverse reactions in these situations, and proposed new rule subsection (c) implements this requirement. The rule language states that such tracking will be based on reports the department receives from health care providers, as opposed to being based on an impractical attempt by the department to proactively contact all providers who were active in any given disaster/emergency. The statute does not make such reporting mandatory for providers, and the agency does not have the resources to attempt to identify and contact all these providers who administered health care during the emergency. SB 11 provides that consent is not necessary for the health care information at issue to be included in the Registry, but goes on to charge the agency with determining the time period following the disaster/emergency event after which consent would be required for continued inclusion. Department Preparedness Program staff have analyzed this situation, using their long expertise in public health and emergency management in Texas, and have determined that the appropriate time period is five years after the end date of the emergency scenario. Reasons for choosing this time period are based on public health needs:

(1) The five year period is commonly used as the interval for when boosters are recommended (e.g., tetanus, pneumonia if >64 years). To avoid over-immunizing individuals under proposed §100.7, and to avoid the costs of revaccinating persons who don't keep personal records, a five-year period in the Registry would be sufficient for record-checking purposes.

(2) Adequate time is needed to track individuals with adverse reactions that are reported to the department by the providers at issue. It is currently unknown how many adverse reactions will result from use of antiviral drugs, antibiotics, vaccines, or emergency use authorization (EUA) drugs that may be used during a scenario described in proposed §100.7. The department tracking of adverse reactions following such a scenario may take years, especially if a large number of individuals are affected. Five years is a minimal time in which to examine trends.

New §100.7(d) specifies the details of how this post-emergency transition period will work. Since the Texas Legislature did not define the various emergency terms used in SB 11, and did not include an explicit method for determining their duration, the proposed new subsection (d) states that: for types of emergencies where existing statutes provide for the duration, that will be the controlling trigger date; for types of emergencies where the law does not so provide, the department will determine the end date and post it on the department website. The department will use its expertise in public health and emergency management to make the latter determinations, and the website posting should be an effective method of getting this information disseminated. Once the time period referenced in subsection (d) has passed, consent is required under SB 11 and proposed new subsection (e) details the mechanics of that process. Proposed new subsection (f) pertains to department release of the information, and implements SB 11 changes to the Code, §161.00705(g).

New §100.8 implements changes to the Code, Chapter 161, amended by SB 11 regarding immunization information of first responders and their immediate families. SB 11 contains a second major expansion in the existing scope of the Registry. Under that legislation, first responders (and immediate family members, as defined, over 18) may request that a provider who administers an immunization to the person provide information regarding that immunization to the department for inclusion in the Registry, as described in proposed new rule subsection (a). Unlike the scenarios described in proposed new §100.7, the new legislation does not make this requirement mandatory. Rather, it is an available option for the persons covered. Proposed new subsection (b) requires the provider to submit that information, upon receiving such a request, as mandated by SB 11 through amendments to §161.00706(b) of the Code. The language in this subsection goes on to articulate deadlines and mechanics for how this works, including the logistics and methodologies for verification of the request for inclusion in the Registry. Proposed new subsection (c) describes the logistics of making the request. Proposed subsection (d) covers the issue of medical verification regarding information submitted under this section, and lists documents that will be acceptable for that purpose. Proposed new subsection (e) details when the department can release such information, and this language tracks SB 11 amendments to §161.00706(d) of the Code. Proposed new subsection (f) details the ability of the person to have their information removed from the Registry, and this language tracks SB 11 amendments to §161.00706(e) of the Code.

New §100.9 provides the definition for an official immunization record, and is merely the language from existing §100.7 moved as part of the reorganization of this subchapter.

New §100.10 provides instructions for filing complaints about the Registry, and details the department's associated reporting requirements. This is the language from existing §100.8 moved as part of the reorganization of this subchapter, but with changes that: insert "alleged" in front of "failure to comply" to reflect that such a violation will not have been proven at that point of the process; improve readability; and include new reporting requirements associated with SB 11.

FISCAL NOTE

Casey S. Blass, Section Director, Disease Prevention and Intervention Section, has determined that for each year of the first five-year period the sections are in effect, there will be no fiscal implications to state or local governments. The department or state costs associated with the Immunization Registry rule amendments required by Senate Bill 11 for IT programming, operational changes, and first responder education will be absorbed within available resources and new funding will not be requested. Also, Mr. Blass has determined that there would be some new burdens placed on certain health care providers by the regulations being proposed, given that SB 11 expands the scope of patients who will have health care information placed in the Registry and therefore inherently expands the types of providers who care for those patients. Some of these impacted providers may be small or micro-businesses (see the following small and micro-business impact analysis as follows).

SMALL AND MICRO-BUSINESS IMPACT ANALYSIS

Once a provider is within the scope of proposed rules, then the rules provide for certain things that must be done such that the impacts are definite (e.g., provider must devote resources necessary to file reports). Since these impacts will happen, the department analysis under Economic Impact Statement of this preamble will also serve to satisfy the Small Business Impact Analysis required by Government Code, §2006.002(a).

The Economic Impact Statement of this preamble does not explicitly cover "micro-businesses," but Government Code, §2006.002(a), requires an analysis of the impacts on such businesses. The department believes that many of the health care providers impacted by the proposed rules will be "micro-businesses" as well as "small businesses," and thus the department's analyses regarding the latter will also be applicable to the former. While it is true that a micro-business may be inherently somewhat less able to absorb new regulatory burdens than a small business, the department believes that the reporting, etc. requirements in the proposed rules would be minimal enough to not place an undue burden on these "micro-business" providers.

There is no anticipated negative impact on local employment.

Government Code, Chapter 2006, was amended by the 80th Legislative Regular Session (House Bill 3430) to require that, before adopting a rule that may have an adverse economic effect on small businesses, a state agency must first prepare an Economic Impact Statement and a Regulatory Flexibility Analysis.

The definition of a "small business" for purposes of this requirement was codified in 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

There are two major areas of possible impact regarding the proposed rules. The first area of impact is regarding the new system that would allow health care providers and birth registrars, if they chose, to affirm consent for persons online in the Registry. The second area of impact is regarding new reporting requirements mandated by SB 11 and implemented by this rulemaking package. This second area can be subdivided into two subsets. The first subset is health care providers who already report immunization information regarding children in Texas, but who would now have to also report data regarding any patients they have covered by proposed new rules §100.7 and §100.8. The second subset is healthcare providers who currently do not give immunizations to children, and thus do not report under existing rules, but who may give immunizations to adults under proposed new rules §100.7 and §100.8 and would thus be required to do certain Registry reporting as to patients covered under those rule sections.

The proposed changes to §100.4, pursuant to SB 11, would allow the department to implement a process for the health care providers in question to affirm consent for their patient's Registry participation if that affirmation has not already been done by another allowable person under the rule (birth registrars are discussed separately as follows). Current law requires all providers to report to the Registry immunizations administered to children under 18 years of age. The department is required to verify consent prior to inclusion of the information in the Registry. Currently, a significant number of providers fax or mail the completed consent forms to the department, and they are verified via a manual evaluation of each form by department staff. The proposed rules would allow the department to verify consent by providing a process for providers to affirm consent for their patients, and then to indicate that this has been done electronically in the Registry. This standardized affirmation process would allow for significantly quicker creation of new client records in the Registry, with concurrent faster realization of all the benefits that come with data inclusions in the Registry.

If a provider elects to use it, the new affirmation process would require that a provider site, if not already registered and reporting to the Registry, submit a registration application for Registry participation (access to the Registry has always required registration). The registration application is free of charge and can be completed and submitted by a provider or provider staff in approximately 10 to 15 minutes. A provider site may include one or more physicians in that practice in its registration. A provider/provider site that is approved for Registry participation may access the Registry free of charge at any time. A computer with Internet access is required for access to the Registry, and basic computer skills are necessary. Actual economic cost will vary depending on the provider staff assigned to completion of the registration application (e.g., office manager, nurse, physician). However, the department believes that the current state of health care practice in Texas, given the complexities of various governmental and private insurance coverages, is such that the providers impacted by this proposed rule will already have the technological capability to facilitate Registry access and will possess (or have staff that possess) the requisite skills for registering for, and entering information into, the Registry (if they are not already doing so).

The new affirmation process would be necessary only for the addition of new clients who are not already enrolled in the Registry. The vast majority of newborns are currently enrolled in the Registry during the birth registration process. It is estimated that over 90% of Texas children under age 6 are currently enrolled in the Registry. The affirmation process, when necessary, will require approximately 7 to 12 minutes of provider staff time to perform a client search, print the Registry consent form for signature, get the form filled out and signed, and perform the online affirmation that a signed consent form has been obtained. Immediately after affirmation, the provider may enter immunization data into the Registry for that patient. Actual economic cost will vary depending on the provider staff resources to obtain and affirm consent and enter data into the Registry (e.g., nurse, office manager, medical records or clerical staff), but the additional burden should be minimal. Those providers who are currently mailing or faxing consent forms to the department should actually experience improved efficiency, given that currently the provider must wait until the department verifies consent before the provider can enter information into the Registry for that patient. Under the proposed rules, the provider could log on to the Registry, affirm consent, and immediately begin entering information on the immunizations the provider just administered.

The approximate number of small businesses (health care providers and provider sites) potentially impacted by the changes to §100.4 is 9,000 to 14,000 (including pediatricians, general practice physicians, family practice physicians and family medicine physicians).

Proposed changes to §100.4 would also allow the department to implement a process (similar to the one described previously) for a birth registrar to affirm consent for a newborn's Registry participation. Currently, a birth registrar in possession of a completed consent form for a newborn child faxes or mails the form to the department for verification of consent. The proposed rules would allow the department to verify consent by providing a process for a birth registrar to affirm electronically that consent has been obtained from the parent/managing conservator/legal guardian. The difference between this process and the one described previously for health care providers is that birth registrars would use the Texas Electronic Registrar system (an existing database which birth registrars use to enter vital statistic data) as a portal to affirm consent. This standardized affirmation process would allow for significantly quicker creation of new client records in the Registry, with concurrent faster realization of all the benefits that come with data inclusion in the Registry. Electronic integration of the Registry consent affirmation process with the Texas Electronic Registrar system would require a minor change in birthing center workflow but will not require additional time or staff resources, compared to the current process--birth registrars would be able to facilitate enrollment of a child into the Registry more quickly than is the case today with the registrar currently faxing or mailing consent forms to the department, given the inherent lag time for processing before the child is approved for Registry inclusion.

Changes to §100.7 require that health care providers report immunizations, antivirals, and other medications administered to individuals to prepare for, or in response to, a list of events related to disasters and emergencies. Because of the inherent time imperatives in the emergency/disaster-related scenarios covered in SB 11, the process for reporting to the Registry would require that a provider site, if not already registered and reporting to the Registry, submit a one-time registration application for Registry participation. The registration application is free of charge and can be completed and submitted by a provider or provider staff in approximately 10 to 15 minutes. Registration is required for each provider site (facility) that will report information to the Registry or access Registry data. A provider site may include one or more physicians in that practice in its registration. A provider/provider site that is approved for Registry participation may access the Registry free of charge at any time. A computer with Internet access is required for access to Registry data, and basic computer skills are necessary. Actual economic cost will vary depending on the provider staff assigned to completion of the registration application (e.g., office manager, nurse, physician). The department realizes that the new reporting requirements will fall on some providers who do not treat children and therefore have had no experience with the Registry. There will unavoidably be a higher learning curve for these provider sites than for those sites already working with the Registry. As a general matter, the department also realizes that there will be a small impact on all providers who must comply with the new reporting requirements required by SB 11 and reflected in the proposed rule. However, the department believes that the current state of health care practice in Texas, given the complexities of various governmental and private insurance coverages, is such that the providers impacted by this proposed rule will already have the technological capability to facilitate Registry access and will possess (or have staff that possess) the requisite skills for registering for, and entering information into, the Registry (if they are not already doing so). The infrequency of the disaster/emergency scenarios referenced in the rule should minimize the frequency of reporting that has to be done under proposed §100.7.

In the event of a disaster or emergency, a health care provider administering immunizations, antivirals, and/or other medications to individuals to prepare for, or in response to, the disaster/emergency scenario will be required to report information to the Registry. Reporting will be performed using Internet Registry access, as prescribed by the department. It is estimated that reporting of a patient's data elements to the Registry can be performed in approximately 2 to 4 minutes, including performing a client search and data entry of required information. SB 11 (and thus the proposed rule) does not require that consent be granted for data inclusion in the Registry until a certain time period, described in proposed §100.7(d), has passed. However, SB 11 provides that consent must be granted and verified for the information to remain in the Registry after that date. In the event that a patient wishes to grant consent for retention of data in the Registry, beyond the period described previously, the provider may print the Registry consent form for the patient's completion and signature and then perform the online affirmation that proper consent has been obtained. At this point, the affirmation process is similar to that described for proposed §100.4 in this preamble, and the potential impacts should also be similar.

SB 11 states that the health care providers at issue here may report adverse reactions to the immunizations, antivirals, and other medications to the department, and the proposed rules reflect this language. Because the provider has a choice in whether to make such reports, and thus is completely in control of whether any economic impact associated with such reporting is incurred, the department does not analyze those possible impacts here.

The approximate number of small businesses (health care providers and provider sites) potentially impacted by the changes to §100.7 is 10,000 to 16,000 (including pediatricians, general practice physicians, family practice physicians, family medicine physicians and emergency medicine physicians). Impacts will be lesser, as discussed previously, for the subset of these providers who are already working with the Registry when one of these scenarios begins, as opposed to those who have no familiarity with it. Potential impact to these providers may vary depending on the nature, extent and duration of the disaster/emergency. Impacts to these providers may be minimized because the department expects that public health facilities (e.g., local health departments; department regional clinics) will play the initial and primary role in disaster/emergency response. A limited number of small business providers may become involved in initial disaster response activities, although they will likely perform a larger role in response activities if the event increases in severity or duration.

Proposed changes to §100.8, pursuant to SB 11 requirements, would require that health care providers report data elements regarding immunizations to the Registry at the request of a first responder or an immediate family member of a first responder (the first responder or immediate family member may elect to submit immunization information directly to the department for inclusion in the Registry). The process for provider reporting to the Registry requires that a provider site, if not already registered and reporting to the Registry, submit a one-time registration application for Registry participation. The registration application is free of charge and can be completed and submitted by a provider or provider staff in approximately 10 to 15 minutes. Registration is required for each provider site (facility) that will report information to the Registry or access Registry data. A provider site may include one or more physicians in that practice in its registration. A provider/provider site that is approved for Registry participation may access the Registry free of charge at any time. A computer with Internet access is required for access to Registry data, and basic computer skills are necessary. Actual economic cost will vary depending on the provider staff assigned to completion of the registration application (e.g., office manager, nurse, physician), and whether the provider site is already working with the Registry.

The department is required to verify the request from a first responder or immediate family member prior to inclusion of the client's information in the Registry. The proposed rules allow the department to verify the request for inclusion by providing an online process for a provider to electronically affirm that such a request has been received. This standardized affirmation process would allow for immediate creation of new client records in the Registry and will facilitate immediate reporting of immunizations by providers. The affirmation process, when necessary, will require approximately 2 to 5 minutes of provider staff time to enter client information into the Registry and perform the online affirmation that a request for inclusion has been obtained. Immediately after affirmation of the request, the provider may enter immunizations relating to first responders or immediate family members into the new client's record. It is estimated that the actual reporting of a client's data elements into the Registry can be performed in approximately 2 to 4 minutes. Actual economic cost will vary depending on the provider staff assigned to affirm the request for inclusion and enter data into the Registry (e.g., nurse, office manager, medical records or clerical staff). Some minor resource impact will be felt by these providers who must follow the new reporting requirements, with lesser impacts on those providers who are already working with the Registry (similar to the situation with impacts regarding proposed new §100.7). Presumably the type of patients described in proposed new §100.8 will make up a small percentage of a provider's over-all practice, which should function to minimize this reporting burden.

The approximate number of small businesses (health care providers and provider sites) potentially impacted by the changes to §100.8 is 7,000 to 10,000 (including general practice physicians, family practice physicians, family medicine physicians and emergency medicine physicians). The impact to these providers may be minimized because the proposed rules allow a first responder or immediate family member to submit immunization information directly to the department for inclusion in the Registry. The department is also evaluating a process that would allow a first responder or immediate family member to submit a request for Registry inclusion, as well as immunization information, through the department Health Service Region offices and through participating local health departments.

REGULATORY FLEXIBILITY ANALYSIS

Government Code, Chapter 2006, was amended by the 80th Legislative Regular Session, (House Bill 3430), 2007 to require, as part of the rulemaking process, state agencies to prepare a Regulatory Flexibility Analysis that considers alternative methods of achieving the purpose of the rule. There is an exception to this requirement, however. An agency is not required to consider alternatives that, while possibly minimizing adverse impacts on small businesses, would not be protective of the "health, safety and environmental and economic welfare of the state." When the proposed rules are merely an implementation of legislative directives because of statutory changes, that proposed rule language becomes per se consistent with the health, safety, or environmental and economic welfare of the state, and therefore the department need not consider alternative methodologies as part of the preamble small business impact analysis. Of the two categories of potential impacts discussed herein, the first group (related to consent verification through an online system) only occur if the regulated party chooses to take upon himself the burden of helping the other person demonstrate consent to the agency. It is not a mandatory burden on the provider or birth registrar. Only the second major group of impacts is mandatory, and those are the reporting impacts. SB 11 mandates that providers report the listed data elements for those patients, and in those scenarios, described in proposed new rules §100.7 and §100.8.

PUBLIC BENEFIT

Mr. Blass has determined that for each year of the first five years that the sections are in effect, the public will benefit from adoption of the sections. The public benefit anticipated as a result of enforcing or administering the sections as proposed is to operate the program to ensure the safety of the public, and to clarify processes. Inclusion of medical information in the Registry is inherently good for both the health of the individual patient and for public health in general. Individual patients are benefited by their health care providers having compiled and concise health care information readily available concerning that patient, so that health care can be delivered in an informed and proactive manner which avoids the negative health outcomes possible when providers do not have a full knowledge of what care other providers have given the patient. The Registry also facilitates vaccination reminder notifications, which should increase the number of persons who are properly immunized. Public health is benefited because better health care to individual patients reduces the chance of disease outbreaks in the public. The public at large is also benefited by improvements in efficiency in the delivery of health care. Such efficiencies should help to contain health care costs. Because the proposed rules bring more people within the scope of the Registry, there should be a commensurate expansion in the health (and other) benefits that the Registry provides. These benefits should be particularly significant regarding health care administered before, during and after public emergencies (see proposed new rule at §100.7), given the public health challenges inherent in such events.

Proposed rule changes designed to clarify processes regarding the Registry should make the rules more efficient and easier to understand, which should in turn increase the number of persons agreeing to submit information into the Registry.

REGULATORY ANALYSIS

The department has determined that this proposal is not a "major environmental rule" as defined by Government Code, §2001.0225. "Major environmental rule" is defined to mean a rule the specific intent of which is to protect the environment or reduce risk to human health from environmental exposure and that may adversely affect, in a material way, the economy, a sector of the economy, productivity, competition, jobs, the environment or the public health and safety of a state or a sector of the state. This proposal is not specifically intended to protect the environment or reduce risks to human health from environmental exposure.

TAKINGS IMPACT ASSESSMENT

The department has determined that the proposed rules 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 proposed rules may be submitted to Victoria Brice, Disease Prevention and Intervention Section, Division of Prevention and Preparedness, Department of State Health Services, 1100 West 49th Street, MC-1946, Austin, Texas 78756, (512) 458-7111, extension 6658, or by e-mail to Victoria.Brice@dshs.state.tx.us. Comments will be accepted for 30 days following publication of the 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' authority to adopt.

25 TAC §§100.1 - 100.10

STATUTORY AUTHORITY

The proposed amendments and new rules are authorized by Health and Safety Code, §81.021, which requires the department to protect the public from communicable disease; §81.004, which allows the department to adopt rules for the effective administration of the Communicable Disease Act; and Chapter 161, concerning the Immunization Registry; and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter 1001. Review of the sections implements Government Code, §2001.039.

The amendments and new rules affect Health and Safety Code, Chapters 81, 161, 826, and 1001; and Government Code, Chapter 531.

§100.1.Definitions.

The following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise.

(1) Child--The person or individual younger than 18 years of age to whom a vaccine has been administered.

(2) Consent--A statement signed by a parent, managing conservator, or legal guardian agreeing that the child's immunization history can be included in the registry and that the child's immunization record may be released from the registry.

(3) Data elements--The information:

(A) consistent with 42 U.S.C., §300aa-25, as amended, defined as the information a provider who administers a vaccine is required to record in a medical record, including:

(i) the date the vaccine is administered;

(ii) the type of vaccine administered, vaccine manufacturer and lot number;

(iii) the name, address, and if appropriate, the title of the provider administering the vaccine; and

(iv) any adverse or unexpected events for a vaccine; and

(B) relating to an immunization, antiviral, and/or other medication administered to prepare for a potential disaster, public health emergency, terrorist attack, hostile military or paramilitary action, or extraordinary law enforcement emergency or in response to a declared disaster, public health emergency, terrorist attack, hostile military or paramilitary action, or extraordinary law enforcement emergency.

[(3) Data elements--Consistent with 42 U.S.C. §300aa-25, as amended, data elements are defined as the information a provider who administers a vaccine is required to record in a medical record, including:]

[(A) the date the vaccine is administered;]

[(B) the type of vaccine administered, vaccine manufacturer and lot number; and]

[(C) the name, address, and, if appropriate, the title of the provider administering the vaccine.]

(4) Department--The Department of State Health Services [ Texas Department of Health].

(5) Extraordinary Law Enforcement Emergency--Within the context of a public health emergency, a situation which requires extra staffing, overtime and/or extra-jurisdictional law enforcement forces.

(6) First Responder--As defined by Government Code, §421.095.

(7) Hostile Military or Paramilitary Act--An attack or other use of force by an armed force of a nation or an organized unofficial group, against forces, property and/or infrastructure of the United States, state or local government.

(8) Immediate family member--The parent, spouse, child, or sibling of a person who resides in the same household as the person.

(9) [(5)] Immunization history--An accounting of all vaccines that a person [child] has received, or evidence of immunity, and other identifying information.

(10) [(6)] Immunization record--A record containing the name and date of birth of the person to whom a vaccine was administered; dates of vaccine administration; types of vaccine administered; and name and address of the provider that administered the vaccines; or other evidence of immunity to a vaccine-preventable disease.

(11) [(7)] Immunization registry--The database or single repository that contains immunization histories, which include necessary personal data for identification. This database is confidential, and access to content is limited to authorized users.

[(8) Parent--A parent, managing conservator, or legal guardian.]

(12) [(9)] Payor--An insurance company, a health maintenance organization, or another organization that pays a health care provider to provide health care benefits, including the administration of vaccines to a person younger than 18 years of age.

(13) Potential disaster--An incident or event capable of causing widespread or severe damage, injury, or loss of life or property resulting from any natural or man-made cause, including fire, flood, earthquake, wind, storm, wave action, oil spill or other water contamination, volcanic activity, epidemic, air contamination, blight, drought, infestation, explosion, riot, hostile military or paramilitary action, or other public calamity requiring emergency action, or energy emergency.

(14) [(10)] Provider--Any physician, health care professional, or facility personnel duly licensed or authorized to administer vaccines.

(15) Public health emergency--An occurrence or imminent threat of an illness or health condition, caused by bioterrorism, epidemic or pandemic disease, or novel and highly fatal infectious agent or biological toxin, that poses a substantial risk of a significant number of human fatalities or incidents of permanent or long-term disability. Such illness or health condition includes, but is not limited to, an illness or health condition resulting from a natural disaster.

(16) Terrorist attack--An activity that is dangerous to human life and/or potentially destructive of critical infrastructure or key resources and is intended to intimidate or coerce the civilian population, or influence or affect the conduct of a government by mass destruction, assassination, and/or kidnapping.

(17) [(11)] User--An entity or individual authorized by the department to access immunization registry data.

(18) [(12)] Vaccine--Includes toxoids and other immunologic agents which are administered to a person [children ] to elicit an immune response (immunization) and thus protect against infectious diseases.

§100.2.Confidentiality.

(a) Except as provided by Health and Safety Code, Chapter 161, Subchapter A, §161.00705, information [ Information] that individually identifies a child or other individual, and is received by the department for the immunization registry, is confidential and may be used by the department for registry purposes only. Unless specifically authorized by Health and Safety Code, Chapter 161, Subchapter A, the department may not release registry information to any individual or entity without the written consent of the person or, if a minor, the parent , managing conservator, or legal guardian.

(b) A written confidentiality statement shall be signed by an authorized representative of the user. Any user of the registry shall protect the confidentiality of all immunization histories, records, and reports. Registry information may only be accessed by the limited persons, and used for the limited stated purposes, detailed at §100.5(e) of this title (relating to Receipt and Release of Registry Data). A person required to report information to the department for registry purposes or authorized to receive information from the registry may not disclose individually identifiable information of a child or other individual to any individual or entity without the written consent of the individual [person] or, if a child [minor], the parent, managing conservator or legal guardian, or except as provided by the Occupations Code, Chapter 159, or the Insurance Code, Article 28B.04.

(c) Registry information is not subject to discovery, subpoena, or other means of legal compulsion for release to any person or entity, except as provided by Health and Safety Code, Chapter 161, Subchapter A. Registry information is not admissible in any civil, administrative, or criminal proceeding.

§100.3.Informing Parent, Managing Conservator, or Legal Guardian.

(a) A parent , managing conservator or legal guardian of a patient younger than 18 years of age shall be informed, via the methodology described at subsection (b) of this section, that the department has established and maintains an immunization registry for the primary purpose of establishing and maintaining a single repository of immunization records to be used in aiding, coordinating, and promoting efficient and cost-effective childhood vaccine-preventable disease prevention and control efforts.

(b) The department shall provide written materials and forms to providers for the purpose of informing a parent, managing conservator or legal guardian about the immunization registry and specific information collected in that registry.

(c) The department and providers may use the registry to provide notices by mail, telephone, personal contact, or other means to a parent, managing conservator or legal guardian regarding his or her child who may be due or overdue for a particular vaccine according to the department's immunization schedule.

(d) The first time the department receives registry data, from a person other than the child's parent, managing conservator or legal guardian, for a child for whom the department has received consent to be included in the registry, the department shall send a written notice to the parent , managing conservator or legal guardian disclosing:

(1) that providers and payors may be sending the child's immunization information to the department;

(2) the information that is included in the registry;

(3) the persons to whom the information may be released;

(4) the purpose of the registry;

(5) the procedure to exclude a child from the registry; and

(6) the procedure to report an alleged [a] violation if a parent , managing conservator or legal guardian discovers a child is included in the registry after exclusion has been requested.

§100.4.Registry Consent and Withdrawal Relating to a Minor .

(a) A parent , managing conservator or legal guardian of a patient younger than 18 years of age may consent to the inclusion of the child's immunization history in the immunization registry by doing one of the following:

(1) indicating consent at birth certificate registration, including by electronic signature;

(2) submitting written notification to the department in a format prescribed by the department or substantially similar and mailed to the Department of State Health Services [Texas Department of Health], Immunization Branch [Division ], 1100 West 49th Street, MC-1946, Austin, Texas 78756, or by calling the Immunization Branch [Division] at (800) 252-9152 to request a consent form; [or]

(3) completing written consent to be submitted to a heath care provider, birth registrar, regional health information exchange, or local immunization registry, who may review that consent and affirm that consent has been obtained via an affirmation process as directed by the department [by a provider or payor].

(b) Unless otherwise provided by §100.7 of this title (relating to Potential and Declared Disasters, Public Health Emergency, Terrorist Attack, Hostile Military or Paramilitary Action, and Extraordinary Law Enforcement Emergency Event), the department shall verify consent before including the reported information regarding the child in the immunization registry. Under Health and Safety Code, §161.007(a)(5), the department may elect to verify consent by receiving affirmation from a health care provider, birth registrar, regional health information exchange, or local immunization registry that consent has been obtained. The department shall provide notice to a provider that submits data elements for a person for whom consent cannot be verified. The notice shall contain instructions for obtaining and affirming consent and resubmitting the data elements to the department.

(c) [(b)] Consent is required to be obtained only one time, and is valid until the child becomes 18 years of age, unless the consent is withdrawn in writing.

(d) [(c)] A parent , managing conservator or legal guardian of a patient younger than 18 years of age may withdraw consent for the child to be included in the registry at any time by submitting written notification to the department in a format prescribed by the department or substantially similar and mailed to the Department of State Health Services [ Texas Department of Health], Immunization Branch [ Division], 1100 West 49th Street, MC-1946, Austin, Texas 78756, or by calling the Immunization Branch [Division] at (800) 252-9152 to request a consent withdrawal form. Unless otherwise provided by §100.7 of this title, the [The] department shall remove information from the immunization registry for any person for whom consent has been withdrawn, and the department shall send the parent, managing conservator or legal guardian a written confirmation of the removal of the information. The department may not retain individually identifiable information about any person for whom consent has been withdrawn except as provided for by §100.7 of this title.

(e) [(d)] A parent , managing conservator or legal guardian may request exclusion of a [ the] child's immunization history from the immunization registry by doing one of the following:

(1) indicating the request for exclusion at birth certificate registration, including by electronic signature; or

(2) submitting written notification to the department in a format prescribed by the department or substantially similar and mailed to the Department of State Health Services [Texas Department of Health], Immunization Branch [Division ], 1100 West 49th Street, MC-1946, Austin, Texas 78756, or by calling the Immunization Branch [Division] at (800) 252-9152 to request an exclusion form. Unless otherwise provided by §100.7 of this title, on [On] receipt of a written request to exclude a child's immunization records from the registry, the department shall send the parent , managing conservator or legal guardian a written confirmation of receipt of the request, and shall exclude the child's records from the registry. The department may not retain individually identifiable information about any person for whom an exclusion has been requested , unless otherwise allowed under §100.7 of this title.

§100.5.Receipt and Release of Registry Data.

(a) The immunization registry must contain information on the immunization history obtained by the department under this chapter regarding:

(1) a person who is younger than 18 years of age and for whom consent has been obtained;

(2) persons immunized to prepare for or in response to an event under §100.7 of this title (relating to Potential and Declared Disasters, Public Health Emergency, Terrorist Attack, Hostile Military or Paramilitary Action, and Extraordinary Law Enforcement Emergency Event); and

(3) first responders and/or their immediate family members for whom a request has been submitted, as described at §100.8 of this title (relating to First Responder Immunization Information).

(b) [(a)] The department may obtain the data constituting an immunization record for a person [child ] from a public health district, a local health department, the [child's] parent , managing conservator or legal guardian of a patient younger than 18 years of age, a physician [to the child], a payor, or from any health care provider licensed (or otherwise legally authorized) to administer vaccines. Submission of this information must be according to the procedures and in the format prescribed by the department.

(c) [(b)] Except as provided by §100.7 and §100.8 of this title [Effective January 1, 2005], the department shall verify consent before including information received under subsection (b) of this section [ from a person other than the child's parent ] in the immunization registry. The [Effective January 1, 2005, the] department may not retain individually identifiable information about a person for whom consent cannot be verified.

(d) When the department verifies consent under subsection (c) of this section, it may do so by any of the following, at its discretion:

(1) manual or electronic review of the consent form document signed (including by electronic signature) by a parent, managing conservator or legal guardian at birth certificate registration;

(2) manual or electronic review of a consent form signed by a parent, managing conservator or legal guardian and submitted to the department by mail to the Department of State Health Services, Immunization Branch, 1100 West 49th Street, MC-1946, Austin, Texas 78756 (consent forms may also be received by facsimile);

(3) affirmation by a health care provider, birth registrar, regional health information exchange, or local immunization registry that consent has been obtained, as described in Health and Safety Code, §161.007(a)(5), and in a manner prescribed by the department.

(e) [(c)] Except as limited by subsections (f) and (g) of this section, the [The] department may release the data constituting an immunization record: [for a child to any entity that is described by subsection (a) of this section to a school or child care facility in which the child is enrolled, or to a state agency having legal custody of the child.]

(1) to the parent, managing conservator, and/or legal guardian of a person younger than 18 years of age; and/or

(2) to the following entities, with those entities subject to the stated limitations:

(A) a Texas public health district or a Texas local health department, for public health purposes within their areas of jurisdiction;

(B) a physician or any health care provider licensed (or otherwise legally authorized) to administer vaccines in Texas, for treating the child as a patient;

(C) a Texas school or Texas child care facility, for a child enrolled in that school or child care facility;

(D) a payor currently authorized by the Texas Department of Insurance to operate in Texas, for immunization records related to the specific person in Texas covered under the payor's policy; and/or

(E) a state agency having legal custody of a child.

(3) Direct electronic access to the immunization registry information shall be limited to entities described in paragraph (2) of this subsection, for use under the stated limitations and subject to registration and access requirements as provided by the department.

(f) For persons immunized to prepare for, or in response to, an event covered by §100.7 of this title, the department may release information from the registry as provided in §100.7(f) of this title.

(g) For first responders and/or their immediate family members 18 years of age or older, the department may release information from the registry as provided in §100.8(e) of this title.

(h) [(d)] Health and Safety Code, §161.0105, provides limited liability protections, as described in those provisions. [A person, including a provider, a payor, or an employee of the department, that submits in good faith an immunization history or data to or obtains in good faith an immunization history or data from the department in compliance with this section is not liable for any civil damages.]

(i) [(e)] The department may release nonidentifying summary statistics related to the registry that do not individually identify an individual [a child].

§100.6.Reporting to the Registry , and Medical Verification, relating to a Minor .

(a) Data elements regarding an immunization record provided to the department under this section, whether electronically or by other means, shall be submitted in a format and manner prescribed by the department.

(b) Except as otherwise provided by §100.7 of this title (relating to Potential and Declared Disasters, Public Health Emergency, Terrorist Attack, Hostile Military or Paramilitary Action, and Extraordinary Law Enforcement Emergency Event), [ Effective January 1, 2005, ] a health care provider who administers an immunization to a person younger than 18 years of age shall provide data elements regarding an immunization to the department within 30 days of administration of the vaccine. [Effective January 1, 2005, the department shall verify consent before including the reported information in the immunization registry, and the department may not retain individually identifiable information about a person for whom consent cannot be verified. For immunizations administered prior to January 1, 2005, providers shall provide an immunization history for persons for whom consent to participate in the registry has been obtained unless the immunization history is submitted to a payor.]

(c) A [Effective January 1, 2005, a] payor that receives data elements from a provider who administers an immunization to a person younger than 18 years of age shall provide the data elements to the department within 30 days of receipt of the data elements from a provider. [Effective January 1, 2005, the department shall verify consent before including the reported information in the immunization registry, and the department may not retain individually identifiable information about a person for whom consent cannot be verified. For immunizations administered prior to January 1, 2005, payors shall provide an immunization history for persons for whom consent to participate in the registry has been obtained.]

(d) A parent, managing conservator or legal guardian may provide evidence of a child's immunization history [, in a format provided by the department or one substantially similar, ] directly to the department for inclusion in the registry. The department shall ensure that the immunization history submitted by a parent , managing conservator or legal guardian is medically verified immunization information by requiring the parent, managing conservator or legal guardian to submit evidence that includes a copy of one or more of the following:

(1) the child's medical record indicating the immunization history and including a provider's signature and the name and address of the provider;

(2) A vaccine-specific invoice from a health care provider for the immunization;

(3) vaccine-specific documentation showing that a claim for the immunization was paid by a payor;

(4) an immunization record signed by a school official; or

(5) an immunization history provided by a local or state immunization registry.

[(e) The department shall provide notice to a provider that submits an immunization history for a person for whom consent cannot be verified. The notice shall contain instructions for obtaining consent and resubmitting the immunization history to the department.]

(e) [(f)] A provider shall, upon request of the department, provide additional information to clarify data elements [an immunization history] submitted to the department.

(f) [(g)] The department shall provide instruction and education to providers about the immunization registry provider application and enrollment process and expedite processing of provider applications.

§100.7.Potential and Declared Disasters, Public Health Emergency, Terrorist Attack, Hostile Military or Paramilitary Action, and Extraordinary Law Enforcement Emergency Event.

(a) The immunization registry shall contain information regarding persons who receive an immunization, antiviral, and/or other medication administered:

(1) to prepare for a potential disaster, public health emergency, terrorist attack, hostile military or paramilitary action, and/or an extraordinary law enforcement emergency event, as those terms are defined in §100.1 of this title (relating to Definitions);

(2) in response to a declared disaster, public health emergency, terrorist attack, hostile military or paramilitary action and/or extraordinary law enforcement emergency event, as those terms are defined in §100.1 of this title.

(b) A health care provider who administers an immunization, antiviral, and/or other medication as described in subsection (a) of this section shall provide the data elements to the department, within 30 days of that medical treatment, in a format and manner prescribed by the department.

(c) The department shall track, in the immunization registry, adverse reactions to an immunization, antiviral, and/or other medication administered as described in subsection (a) of this section. A health care provider who administers such an immunization, antiviral, and/or other medication may provide data related to adverse reactions to the department, in a format and manner prescribed by the department, for inclusion in the immunization registry. Department tracking will be based on the reports it receives under this subsection.

(d) Unless consent is obtained and verified, the individually identifiable information collected in the registry under this section shall only be retained in the registry for a period of 5 years following the end of the event as described in subsection (a) of this section. The end date of these occurrences shall be as specifically provided for by law. In the absence of law which specifically determines the end date, the department shall determine such an end date and post that date on its website.

(e) An individual or, if a child, the child's parent, managing conservator or legal guardian, may consent in writing to the continued inclusion of the person's information collected under this section in the registry past the retention time period specified in subsection (d) of this section by:

(1) mailing (or faxing) written notification to the department, in a format prescribed by the department, at: Department of State Health Services, Immunization Branch, 1100 West 49th Street, MC-1946, Austin, Texas 78756, (a consent form may be obtained by calling the Immunization Branch at (800) 252-9152, or online at www.ImmTrac.com); or

(2) completing a consent form document, which must be verified by affirmation by a health care provider in a manner prescribed by the department.

(f) The department may release the information collected in the registry under this section with consent of the individual or, if a child, the child's parent, managing conservator or legal guardian, or to a state agency or health care provider for:

(1) the purposes outlined in Health and Safety Code, Chapter 161, Subsection A; and/or

(2) the purpose of aiding and coordinating communicable disease prevention and control efforts during an event as described in subsection (a) of this section.

§100.8.First Responder Immunization Information.

(a) A person 18 years of age or older who is a first responder or an immediate family member of a first responder may request that a health care provider who administers an immunization to the person provide the data elements regarding the immunization to the department for inclusion in the registry.

(b) A health care provider, on receipt of a request under subsection (a) of this section, shall submit the data elements to the department within 30 days of administration of the vaccine in a format and manner prescribed by the department. The department shall verify the request before including the information in the registry. The department may elect to verify the request for inclusion in the registry by obtaining an affirmation from the health care provider that a request has been received.

(c) A person 18 years of age or older who is a first responder or an immediate family member of a first responder may request inclusion of that person's immunization history in the registry by:

(1) mailing written notification to the department, in a format prescribed by the department, at: Department of State Health Services, Immunization Branch, 1100 West 49th Street, MC-1946, Austin, Texas 78756, (a request form may be obtained by calling the Immunization Branch at (800) 252-9152, or online at www.ImmTrac.com); or

(2) completing a written request to the person's health care provider, to be verified by affirmation (in a manner prescribed by the department) by the health care provider that such a request has been received.

(d) The department shall ensure that the immunization history submitted by the individual under subsection (c)(1) of this section is medically verified immunization information by requiring the individual to submit evidence that includes a true and accurate copy of one or more of the following:

(1) the individual's medical record indicating the immunization history and including a provider's signature and the name and address of the provider;

(2) a vaccine-specific invoice from a health care provider for the immunization;

(3) vaccine-specific documentation showing that a claim for the immunization was paid by a payor;

(4) an immunization record signed by a school official; or

(5) an immunization history provided by a local or state immunization registry.

(e) The department may release the information collected in the registry under this section with consent of the individual or to any health care provider licensed or otherwise authorized to administer vaccines.

(f) A person whose immunization records are included in the registry under this section may request in writing that the department remove the information from the registry. The department shall remove the person's immunization records from the registry not later than the 10th day after receiving a request.

§100.9.Official Immunization Record.

An immunization record obtained from the immunization registry shall be accepted as an official immunization record of the individual.

§100.10.Complaints.

(a) A person may file a complaint with the department related to the department's alleged failure to comply with a request for exclusion of an individual from the registry by mailing such a complaint to: Manager, Immunization Branch, Department of State Health Services, 1100 West 49th Street, MC-1946, Austin, Texas 78756; or by e-mail to the attention of Manager, Immunization Branch at feedback.ImmDirector@dshs.state.tx.us. The department shall respond to the written complaint within 30 days of that receipt of that complaint.

(b) A person may report an incident of discrimination for requesting exclusion of an individual from the registry, or for using an exemption for a required immunization, by mailing written notification to: Manager, Immunization Branch, Department of State Health Services, 1100 West 49th Street, MC-1946, Austin, Texas 78756; or by e-mail to the attention of Manager, Immunization Branch at feedback.ImmDirector@dshs.state.tx.us. The department shall respond to the written notification within 30 days of receipt of that notification.

(c) The department shall report to the Legislative Budget Board, the governor, the lieutenant governor, the speaker of the House of Representatives, and appropriate committees of the legislature not later than September 30 of each even-numbered year. The report shall:

(1) include the number of complaints received by the department related to the department's alleged failure to comply with requests for exclusion of individuals from the registry;

(2) identify all reported incidents of discrimination for requesting exclusion of individuals from the registry or for using an exemption for a required immunization;

(3) include the number of complaints received by the department related to the department's alleged failure to remove information from the registry as required by §100.7 of this title (relating to Potential and Declared Disasters, Public Health Emergency, Terrorist Attack, Hostile Military or Paramilitary Action, and Extraordinary Law Enforcement Emergency Event) after an event described in that section; and

(4) include the number of complaints received by the department related to the department's alleged failure to comply with written requests for the removal of information relating to first responders and their immediate family under §100.8 of this title (relating to First Responder Immunization Information).

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 March 10, 2008.

TRD-200801365

Lisa Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: April 20, 2008

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

25 TAC §100.7, §100.8

(Editor's note: The text of the following sections proposed for repeal will not be published. The sections may be examined in the offices of the Department of State Health Services or in the Texas Register office, Room 245, James Earl Rudder Building, 1019 Brazos Street, Austin.)

STATUTORY AUTHORITY

The proposed repeals are authorized by Health and Safety Code, §81.021, which requires the department to protect the public from communicable disease; §81.004, which allows the department to adopt rules for the effective administration of the Communicable Disease Act; and Chapter 161, concerning the Immunization Registry; and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter 1001. Review of the sections implements Government Code, §2001.039.

The repeals affect Health and Safety Code, Chapters 81, 161, 826, and 1001; and Government Code, Chapter 531.

§100.7.Official Immunization Record.

§100.8.Complaints.

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 March 10, 2008.

TRD-200801366

Lisa Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: April 20, 2008

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 amendment of §289.204, concerning fees for certificates of registration, radioactive material licenses, emergency planning and implementation, and other regulatory services, the amendment of §289.226, concerning registration of radiation machine use and services, the amendment of §289.232, concerning radiation control regulations for dental radiation machines, the amendment of §289.233, concerning radiation control regulations for radiation machines used in veterinary medicine, and amendment of §289.301, concerning registration and radiation safety requirements for lasers and intense-pulsed light devices.

BACKGROUND AND PURPOSE

The amendment of §289.204 is necessary to clarify that although House Bill (HB) 2285 (80th Legislature, 2007) amending Health and Safety Code, §12.0112(b)(2), removed the two-year term for radiation permits, the fees will continue to be paid every two years. As a result of Senate Bill (SB) 1604 (80th Legislature, 2007) amending Health and Safety Code, §401.011, the section is revised to delete the applicable fees, definition, rule requirements, and rule citations related to the licensing and inspection of low-level waste processing and uranium recovery and disposal since the regulatory authority for these items has been transferred from the department to the Texas Commission on Environmental Quality (TCEQ). In addition, the fee amounts for the industrial radiographer certification and examinations that were previously revised in §289.255 of this title (relating to Radiation Safety Requirements and Licensing and Registration Procedures for Industrial Radiography) in 2007, are being updated in this revised section to be consistent with §289.255 of this title. As a result of HB 2285 amending Health and Safety Code, §401.301(f), the department is prohibited from assessing fees on local law enforcement agencies for the registration of x-ray machines used for security screening therefore resulting in a loss of revenue to the state. The department has determined that it is able to absorb the lost revenues and will not attempt to recoup the loss by increasing fees for the remaining industrial x-ray machine registrants. Other minor grammatical changes are also made.

Section 289.226 is being amended as a result of HB 2285 remove the administrative review and two-year term requirements of radiation permits and, therefore, reinstate the previous requirements for renewal of certificates of registration for radiation machines. In addition, the section is revised to update the names of several Texas medical and professional boards, update the titles of a few referenced sections, and correct referenced citations. Other minor grammatical changes are also made.

Due to HB 2285, the amendment of §289.232 is necessary to remove the administrative review and two-year term requirements of radiation permits and therefore reinstate the previous requirements for renewal of certificates of registration for radiation machines used in dentistry. This revised section also updates the department name and the names of several Texas medical and professional boards and corrects referenced citations. Several definitions, requirements concerning enforcement and hearings procedures, and a form are also revised to be consistent with language used throughout this chapter. Additionally, the fee amounts for certificates of registration for radiation machines used in dentistry that were previously revised in §289.204 of this title in 2006, are being updated in this revised section to be consistent with §289.204 of this title. The table concerning the half-value layer for selected kilovolt peaks is revised to state the correct values, and other minor grammatical corrections are also made.

Due to HB 2285, §289.233 is revised to remove the administrative review and two-year term requirements of radiation permits and therefore reinstate the previous requirements for renewal of certificates of registration for radiation machines used in veterinary medicine. Section 289.233 updates the department name and the names of several Texas medical and professional boards, clarifies a couple of radiation machine requirements, and corrects referenced citations. Several definitions, requirements concerning enforcement and hearings procedures, and a form are also revised to be consistent with language used throughout this chapter. Additionally, the fee amounts for certificates of registration for radiation machines used in veterinary medicine that were previously revised in §289.204 of this title in 2006, are being updated in this revised section to be consistent with §289.204 of this title. Other minor grammatical changes are also made.

The amendment of §289.301 is necessary to remove the administrative review and two-year term requirements of radiation permits and, therefore, reinstate the previous requirements for renewal of certificates of registration for laser machines, due to HB 2285. Section 289.301 is also revised to update the names of several Texas medical and professional boards, clarify requirements for protection against Class 3b or 4 lasers and intense-pulsed light device radiation, and correct reference citations and a few minor grammatical inconsistencies.

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 289.204, 289.226, 289.232, 289.233, and 289.301 have been reviewed and the department has determined that the reasons for adopting these sections continue to exist because rules on these subjects are needed.

SECTION-BY-SECTION SUMMARY

Due to SB 1604 amending Health and Safety Code, §401.011, the regulatory authority for the applicable licensing and inspection of low-level waste processing and uranium recovery and disposal responsibilities have been transferred from the department to the TCEQ and, therefore, the following changes have been made: §289.204(b)(1)(A) deletes reference to §289.254 of this title (relating to Licensing of Radioactive Waste Processing and Storage Facilities), and §289.260 of this title (relating to Licensing of Uranium Recovery and Byproduct Material Disposal Facilities); the definition of "post closure" in §289.204(c)(6) is deleted; §289.204(d)(1) and (2) deletes reference to "subsection (m)"; and current §289.204(m) regarding the schedule of fees for uranium recovery and byproduct material disposal facility licenses, §289.204(n) regarding adjustments to fees for uranium recovery and byproduct material disposal facility licenses, and §289.204(o) regarding one-time fee adjustments for uranium recovery and byproduct material disposal facility licenses are deleted, therefore renumbering the subsequent subsection.

Although HB 2285 removed the two-year term for radiation permits, the fees for radiation permits will continue to be paid every two years and therefore, the following changes have been made: Section 289.204(d)(2) revises the second and third sentences to read "The fee shall be paid every two years based on the month listed as the expiration month on the license or general license acknowledgement and shall be paid in full on or before the last day of the expiration month;" in §289.204(d)(3), the second and third sentences are revised to read "The fee shall be paid every two years based on the month listed as the expiration month on the certificate of registration and shall be paid in full on or before the last day of the expiration month;" and §289.204(l)(2) is changed to read "In any case where the agency finds that a licensee or registrant has failed to pay a fee prescribed by this section by the due date, the agency may implement compliance procedures as provided in §289.205 of this title (relating to Hearing and Enforcement Procedures)."

In §289.204(h)(2) relating to fees for accreditation of mammography facilities, current subparagraph (G) is deleted because the department no longer incurs a cost for replacement of thermoluminescent dosimeters. Subsequent subparagraphs are renumbered.

In §289.204(i), the fee amounts for the industrial radiographer certification and examinations that were previously revised in §289.255 of this title in 2007, are being updated in this revised section to be consistent with §289.255 of this title. In §289.204(j), the sentence "As of the effective date of this section, the fees for the dental radiographic only category and the veterinary category, as specified in the following schedule, are the applicable fees for those categories." is deleted because the fees addressed in this sentence are now included specifically in §289.232 and §289.233.

In §289.226(b)(3) and (5), the titles of several referenced sections are updated to state the correct titles. The following subsections are revised to update the names of several Texas medical and professional boards: §289.226(b)(11), (f)(7), and (t)(1)(B)(i)(II)(-g-)(-1-) and (-3-). Section 289.226(i)(4) updates the rule citation to be consistent with the recently revised §289.255 of this title. The words "that results in a change in inventory as specified in subsection (m)(1)(C) of this section" are added to §289.226(n)(2) to clarify the notification requirements to the department for persons who sell, lease, lend, dispose, assemble, install, or otherwise transfer radiation machines in the state.

Due to HB 2285, §289.226(o) and (q) are revised and renumbered to reflect the deletion of all requirements relevant to the administrative review and two-year term requirements of radiation permits and, therefore, reinstate the previous requirements for renewal of certificates of registration for radiation machines.

Section 289.232(b)(3) changes the referenced rule citations to state the correct citations. The following subsections and definitions are revised and/or deleted to change the department name from "Texas Department of Health" to "Department of State Health Services", and/or to change the Radiation Control Program name from "Bureau of Radiation Control" to "Radiation Control" as a result of the 2004 department and Radiation Control Program name changes and reorganization: §289.232(c)(7); current (c)(15); new (c)(19) and (27); §289.232(e)(1); §289.232(g)(1)(D); figure for §289.232(i)(5)(B)(iii); figure for §289.232(j)(1)(L)(i)(II); and subsequent definitions are renumbered. In addition, the following subsections of the section are deleted and/or changed to be consistent with language used in other sections of this chapter: current §289.232(c)(31); new §289.232(c)(48); renumbered §289.232(c)(71); language and figure for §289.232(i)(5)(B)(iii); §289.232(j)(2)(C)(iii); §289.232(k)(2)(C)(i), (v), and (vi); §289.232(k)(2)(D)(iii)(III) and (IV); §289.232(k)(2)(E)(ii)(I)(-d-) and (-f-); §289.232(k)(2)(E)(ii)(II)(-a-) through (-c-); and §289.232(k)(2)(G)(iv).

In §289.232(g)(1)(A) - (C), the fee amounts for certificates of registration for radiation machines used in dentistry that were previously revised in §289.204 of this title in 2006, are being updated in this revised section to be consistent with §289.204 of this title. Section 289.232(g)(1)(B)(ii) and (1)(C), (h)(1)(D), and (i)(6)(L) update the referenced citations to state the correct citations.

Although HB 2285 removed the two-year term for radiation permits, the fees for radiation permits will continue to be paid every two years and therefore, the following changes have been made: §289.232(g)(1)(B) revises the second and third sentences to read "The fee shall be paid every two years based on the month listed as the expiration month on the certificate of registration and shall be paid in full on or before the last day of the expiration month" and §289.232(g)(2)(B) is changed to read "In any case where the agency finds that a registrant has failed to pay a fee prescribed by this section by the due date, the agency may implement compliance procedures as provided in subsection (k)(2)(C) of this section."

Due to HB 2285, §289.232(h)(6) and new (8) are revised and renumbered to reflect the deletion of all requirements relevant to the administrative review and two-year term requirements of radiation permits and therefore reinstate the previous requirements for renewal of certificates of registration for radiation machines used in dentistry. Subsequent paragraphs are renumbered.

Current §289.232(i)(5)(C) is deleted as this information is redundant with language in §289.232(i)(5)(B)(iii) of the section. Subsequent subparagraphs are renumbered. The table for §289.232(i)(6)(E)(i)(I) concerning the half-value layer for selected kilovolt peaks is revised to state the correct values. Additionally, §289.232(i)(6)(I) deletes the word "interval" and replaces it with "output" before "reproducibility" to be technically correct. Section 289.232(j)(2)(C)(i)(II)(-e-) adds the words "certificate of" before the word "registration" to be consistent with language used throughout this section.

Section 289.233(c) adds language to be consistent with other sections of this chapter. The following subsections and definitions are revised and/or deleted to change the department name from "Texas Department of Health" to "Department of State Health Services" and/or to change the Radiation Control Program name from "Bureau of Radiation Control" to "Radiation Control" as a result of the 2004 department and Radiation Control Program name changes and reorganization: §289.233(c)(7); current (c)(17); new (c)(20); §289.233(e)(1); §289.233(g)(1)(D); figure for §289.233(i)(3)(F)(vii); figure for §289.233(i)(4)(B)(iii); figure for §289.233(j)(1)(K)(i)(II); and subsequent definitions are renumbered. In addition, the following subsections are deleted and/or changed to be consistent with language used in other sections of this chapter: current §289.233(c)(34); new §289.233(c)(52); renumbered §289.233(c)(68); §289.233(g)(1)(A); language and figure for §289.233((i)(4)(B)(iii); §289.233(j)(3)(C)(iii); §289.233(k)(2)(C)(i), (v), (vi), and (vii); §289.233(k)(2)(D)(iii)(III) and (IV); §289.233(k)(2)(E)(ii)(I)(-d-) and (-f-); and §289.233(k)(2)(E)(ii)(II)(-a-) through (-c-).

In §289.233(g)(1)(A) through (C), the fee amounts for certificates of registration for radiation machines used in veterinary medicine that were previously revised in §289.204 of this title in 2006, are being updated in this revised section to be consistent with §289.204 of this title. Section §289.233(g)(1)(C) updates the referenced citation to state the correct citations.

Although HB 2285 removed the two-year term for radiation permits, the fees for radiation permits will continue to be paid every two years and therefore, the following changes have been made: §289.233(g)(1)(B) revises the second and third sentences to read "The fee shall be paid every two years based on the month listed as the expiration month on the certificate of registration and shall be paid in full on or before the last day of the expiration month", and §289.233(g)(2)(B) is changed to read "In any case where the agency finds that a registrant has failed to pay a fee prescribed by this section by the due date, the agency may implement compliance procedures as provided in subsection (k)(2) of this section."

Due to HB 2285, §289.233(h)(6) and new (8) are revised and renumbered to reflect the deletion of all requirements relevant to the administrative review and two-year term requirements of radiation permits and therefore reinstate the previous requirements for renewal of certificates of registration for radiation machines used in veterinary medicine. Subsequent paragraphs are renumbered.

Section §289.233(i)(5)(H)(iv)(II) deletes the words "for circular image receptors" after the words "image receptor" to be technically correct. Language is added as new §289.233(i)(5)(N)(v) to clarify that fluoroscopic x-ray systems shall comply with the additional requirements stated in §289.233(i)(6). Section 289.233(j)(3)(C)(i)(II)(-e-) adds the words "certificate of" before the word "registration" to be consistent with language used throughout this section.

In §289.301(a)(2) the word "laser" is replaced with the word "lasers" to be grammatically correct. The definition for "continuous wave" in §289.301(d)(14) replaces ">=" with "=" to correctly represent the mathematical symbol. The definition for §289.301(d)(36) updates the names of two Texas medical and professional boards. Section 289.301(j)(3) adds "Class 3B and 4" before the word "lasers" to clarify the type of lasers in their possession that should be inventoried. Section 289.301(j)(3)(E) and (4)(B) replaces "in accordance with subsection (d)(35)" with "as defined in subsection (d)(38)" to be grammatically correct and to state the correct rule citation.

Due to HB 2285, §289.301(k) and (m) are revised and renumbered to reflect the deletion of all requirements relevant to the administrative review and two-year term requirements of radiation permits and therefore reinstate the previous requirements for renewal of certificates of registration for laser machines.

Section 289.301(r)(2) adds the words "presently being used or listed on the registrant's current inventory," before the words "shall be provided" to clarify which lasers the registrant needs to provide written instructions for safe use. The sentence "The instructions to personnel shall be maintained in accordance with subsection (ee) of this section for inspection by the agency." is added at the end of this paragraph to direct the registrant to maintain records of the written instructions for safe use for inspection by the agency.

Section 289.301(t)(1)(E) and (w) add language to inform the registrant of where in the section recordkeeping intervals are listed for the maintenance of records required in this section. Section 289.301(x) adds language to clarify that the registrant shall maintain current records/documents required by this subsection for inspection by the agency. In addition, the figure for §289.301(ee) is revised to add language to clarify which lasers the registrant needs to provide written instructions for safe use.

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 §289.226, §289.232, §289.233, and §289.301 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. However, concerning §289.204, Ms. Tennyson has determined that there will be fiscal implications to state government which will be a decrease in revenue to the state of $11,691 for calendar years 2008, 2010, and 2012 and a decrease in revenue to the state of $3,486 for calendar years 2009 and 2011, due to the department being prohibited from assessing fees on local law enforcement agencies for the registration of x-ray machines used for security screening, as a result of HB 2285 amending Health and Safety Code, §401.301(f). The department has determined that it is able to absorb the lost revenues and will not attempt to recoup the loss by increasing fees for the remaining industrial x-ray machine registrants. Implementation of proposed §289.204 will not result in any fiscal implications for local governments.

SMALL AND MICRO-BUSINESS IMPACT ANALYSIS

Ms. Tennyson has also determined that there will be no effect on small businesses or micro-businesses required to comply with the sections 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. There are no anticipated economic costs to persons who are required to comply with the sections as proposed. There is no anticipated negative impact on local employment.

STATEMENT OF NO ADVERSE ECONOMIC IMPACT

Pursuant to the requirement of §2006.002(c) of the Government Code (amended by HB 3430, 80th Legislature), the department has determined that none of the proposed changes "may have an adverse economic effect on small businesses subject to the proposed rule." This determination is made because there will be no adverse economic impact to any regulated entity subject to the proposed rule as further discussed in the Small and Micro-Business Economic Impact Analysis above.

PUBLIC BENEFIT

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 §289.204, §289.226, §289.232, §289.233, and §289.301 is to ensure continued protection of the public, workers, and the environment from unnecessary exposure to radiation by ensuring that the department is able to properly enforce the state's radiation protection rules.

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 for Regulatory Services, Environmental and Consumer Safety Section, Department of State Health Services, 1100 West 49th Street, Austin, Texas 78756, (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 §289.204

STATUTORY AUTHORITY

The proposed amendment is authorized by Health and Safety Code, §12.0111, which requires the department to charge fees for issuing or renewing a license; Health and Safety Code, §401.301, which allows the department to collect fees for radiation control licenses and registrations that it issues; 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 proposed amendment affects the Health and Safety Code, Chapters 12, 401, and 1001; and Government Code, Chapters 531 and 2001.

§289.204.Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services.

(a) (No change.)

(b) Scope. Except as otherwise specifically provided, the requirements in this section apply to any person who is the following:

(1) an applicant for, or holder of:

(A) a radioactive material license issued in accordance with §289.252 of this title (relating to Licensing of Radioactive Material), [§289.254 of this title (relating to Licensing of Radioactive Waste Processing and Storage Facilities),] or §289.259 of this title (relating to Licensing of Naturally Occurring Radioactive Material (NORM))[, or §289.260 of this title (relating to Licensing of Uranium Recovery and Byproduct Material Disposal Facilities) ]; or

(B) - (C) (No change.)

(2) - (3) (No change.)

(c) Definitions. The following words and terms when used in this section shall have the following meaning, unless the context clearly indicates otherwise.

(1) - (5) (No change.)

[(6) Post-closure--The time period after which closure activities have been completed by the conventional mill licensee and prior to transfer of land ownership of tailings disposal sites to the State of Texas or the United States of America and termination of the license or after which confirmatory surveys have been conducted by the agency of an in-situ facility and before termination of the license or site.]

(6) [(7)] Processor of radioactive material [Radioactive Material]--A manufacturer/distributor who converts normal form radioactive material into special form or a manufacturer/distributor of radioactive sealed sources.

(d) Payment of fees.

(1) Each application for a specific license, general license acknowledgement, or certificate of registration for which a fee is prescribed in subsections (e), (g), or (j)[, or (m) ] of this section shall be accompanied by a nonrefundable fee equal to the appropriate fee. Each request for evaluation of a sealed source and/or device shall be accompanied by a nonrefundable fee prescribed in subsection (f) of this section. Each application for accreditation of a mammography facility shall be accompanied by a nonrefundable fee prescribed in subsection (h) of this section. Each application for an industrial radiographer certification and an industrial radiographer examination shall be accompanied by a nonrefundable and non-transferable fee prescribed in subsection (i) of this section.

(A) - (C) (No change.)

(2) A nonrefundable fee, in accordance with subsection (e) [and (m)] of this section shall be paid for each radioactive material license and/or for each general license acknowledgement. The fee shall be paid every two years based on the month listed as the expiration month on [for the two-year term of] the license or general license acknowledgement and [. The fee ] shall be paid in full on or before the last day of the expiration month [and year of the license or general license acknowledgement]. In the case of a single license that authorizes more than one category of use, the fee shall be the prescribed fee for the highest license category plus 25% of the applicable prescribed fee for each additional license category authorized.

(3) A nonrefundable fee, in accordance with subsection (j) of this section, shall be paid for each certificate of registration for radiation machines and/or services, or sources of laser radiation. The fee shall be paid every two years based on the month listed as the expiration month on [for the two-year term of] the certificate of registration and [. The fee] shall be paid in full on or before the last day of the expiration month [and year of the certificate of registration].

(4) - (9) (No change.)

(e) - (g) (No change.)

(h) Fees for accreditation of mammography facilities.

(1) (No change.)

(2) Fees for accreditation of mammography facilities are as follows.

(A) - (F) (No change.)

[(G) The fee for replacement of thermoluminescent dosimeters (TLD) is $75.]

(G) [(H)] Each facility for which a targeted clinical image review is required will be charged for actual expenses to the agency arising from the visit.

(H) [(I)] Each facility for which an on-site visit due to three denials of accreditation is required will be charged for actual expenses to the agency arising from such visit.

(I) [(J)] Payment of the fees in subparagraphs (G) and (H) [(H) and (I)] of this paragraph shall be made within 60 days following the date of invoice.

(i) Fees for industrial radiographer certification and for radiographer certification examinations.

(1) The nonrefundable and non-transferable application fee for examination shall be $120 [$25] and shall be submitted to the agency with the application for examination.

(2) The nonrefundable application fee for radiographer certification shall be $110 [$100] and shall be submitted to the agency with the application for radiographer certification.

(j) Schedule of fees for certificates of registration for radiation machines, lasers, and services. The following schedule contains the fees for certificates of registration for radiation machines, lasers, and services. [As of the effective date of this section, the fees for the dental radiographic only category and the veterinary category, as specified in the following schedule, are the applicable fees for those categories.]

Figure: 25 TAC §289.204(j) (No change.)

(k) (No change.)

(l) Failure to pay prescribed fees.

(1) (No change.)

(2) In any case where the agency finds that a licensee or registrant has failed to pay a fee prescribed by this section by the due date, [ the license or certificate of registration expires and ] the agency may implement compliance procedures as provided in §289.205 of this title (relating to Hearing and Enforcement Procedures).

(3) (No change.)

[(m) Schedule of fees for uranium recovery and byproduct material disposal facility licenses. The following schedule contains the fees for uranium recovery and byproduct material disposal facility licenses:]

[Figure: 25 TAC §289.204(m)]

[(n) Adjustments to fees for uranium recovery and byproduct material disposal facility licenses.]

[(1) If additional noncontiguous uranium recovery facility sites are authorized under the same license, the appropriate fee shall be increased by 25% for each additional site for an operational year and 50% for closure only.]

[(2) If an authorization for disposal of byproduct material is added to a license, the appropriate fee shall be increased by 25%.]

[(o) One-time fee adjustments for uranium recovery and byproduct material disposal facility licenses. For the addition of the following items after an environmental assessment has been completed on a facility, a one-time fee corresponding to the item shall be paid:]

[(1) $28,658 for in situ wellfield on noncontiguous property;]

[(2) $71,651 for in situ satellite;]

[(3) $11,235 for wellfield on contiguous property;]

[(4) $50,756 for non-vacuum dryer; or]

[(5) $71,651 for disposal (including processing, if applicable) of byproduct material.]

(m) [(p)] Fees for Texas Online participation. For all applications and renewal applications, the department is authorized to collect subscription and convenience fees, in amounts determined by the Texas Online Authority, to recover costs associated with application and renewal application processing through Texas Online.

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 March 6, 2008.

TRD-200801331

Lisa Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: April 20, 2008

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

25 TAC §§289.226, 289.232, 289.233

STATUTORY AUTHORITY

The proposed amendments are authorized by Health and Safety Code, §12.0111, which requires the department to charge fees for issuing or renewing a license; Health and Safety Code, §401.301, which allows the department to collect fees for radiation control licenses and registrations that it issues; 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 proposed amendments affect the Health and Safety Code, Chapters 12, 401, and 1001; and Government Code, Chapters 531 and 2001.

§289.226.Registration of Radiation Machine Use and Services.

(a) (No change.)

(b) Scope.

(1) - (2) (No change.)

(3) Registrants using analytical and other industrial radiation machines, such as x-ray equipment used for cathodoluminescence, ion implantation, gauging, or electron beam welding, are subject to the requirements of §289.228 of this title (relating to Radiation Safety Requirements for [Analytical and Other] Industrial Radiation Machines).

(4) (No change.)

(5) Registrants using mammography radiation machines are also subject to the requirements of §289.230 of this title (relating to Certification of Mammography Systems and Mammography Machines Used for Interventional Breast Radiography) and §289.234 of this title (relating to Mammography Accreditation) [ Accreditation of Mammography Facilities)].

(6) - (10) (No change.)

(11) For purposes of this section, a practitioner of the healing arts is a person licensed to practice healing arts by either the Texas Medical Board [Texas State Board of Medical Examiners ] as a physician, the Texas Board of Chiropractic Examiners, or the Texas State Board of Podiatric Medicine [ Texas State Board of Podiatry Examiners].

(c) - (e) (No change.)

(f) Application for registration for human use of radiation machines. In addition to the requirements of subsection (e) of this section, each applicant shall comply with the following.

(1) - (6) (No change.)

(7) An application for accelerators or therapeutic radiation machines for human use shall be signed by a practitioner licensed by the Texas Medical Board [Texas State Board of Medical Examiners]. The signature of the administrator, president, or chief executive officer will be accepted in lieu of a licensed practitioner's signature if the facility has more than one licensed practitioner who may direct the operation of radiation machines. The application shall also be signed by the RSO if the RSO is someone other than the licensed practitioner. Each applicant shall submit operating and safety procedures as described in §289.229(h)(1)(D) of this title and a description of the proposed facilities in accordance with the following:

(A) - (B) (No change.)

(g) (No change.)

(h) Application for registration of healing arts screening and medical research.

(1) (No change.)

(2) In addition to the requirements of subsections (e) and (f) of this section, any research using radiation machines on humans shall be approved by an Institutional Review Board (IRB) as required by Title 45, Code of Federal Regulations (CFR) [CFR ], Part 46 and Title 21, CFR, Part 56. The IRB shall include at least one practitioner of the healing arts to direct any use of radiation in accordance with §289.231(b)(1) of this title.

(i) Application for registration of radiation machines for non-human use, including use in morgues. In addition to the requirements of subsection (e) of this section, each applicant shall comply with the following.

(1) - (3) (No change.)

(4) Each applicant for use of radiation machines in industrial radiographic operations shall submit the information required in §289.255(t)(1) [§289.255(u)(7)] of this title before beginning use of the machine(s).

(5) (No change.)

(j) Application for registration of radiation machine services. In addition to the requirements of subsection (e) of this section, each applicant shall comply with the following.

(1) Each person who intends to provide radiation services described in subsection [subsections] (b)(10) of this section shall apply for and receive a certificate of registration from the agency before providing such service.

(2) - (8) (No change.)

(k) - (m) (No change.)

(n) Sale, lease, loan, installation, assembly, disposal, and transfer of radiation machines.

(1) (No change.)

(2) Any person who sells, leases, lends, disposes, assembles, installs, or otherwise transfers radiation machines in the state that results in a change in inventory as specified in subsection (m)(1)(C) of this section shall notify the agency of the following information within 30 days of such action:

(A) - (C) (No change.)

(3) (No change.)

(o) Expiration of certificates of registration [and administrative renewal].

(1) [Effective September 1, 2004, the term of the certificate of registration is two years. ] Except as provided by subsection (q) of this section, each certificate of registration expires at the end of the day, in the month and year stated in the certificate of registration. [Except for subsection (q)(5) of this section, upon payment of the fee required by §289.204 of this title and if the agency does not deny the renewal in accordance with subsection (l)(4) of this section, the certificate of registration will be administratively renewed. The requirements in this subsection are subject to the provisions of Government Code, §2001.054.]

[(2) If the fee is not paid and the certificate of registration is not renewed in accordance with paragraph (1) of this subsection, the certificate of registration expires, and the registrant is in violation of the requirements in this chapter and is subject to administrative penalties in accordance with §289.205 of this title.]

[(A) If the registrant pays the fee required by §289.204 of this title within 30 days after expiration of the certificate of registration, the certificate of registration will be reinstated and the registrant will not be required to file an application in accordance with subsection (e) of this section.]

[(B) If the registrant fails to pay the fee within 30 days after expiration of the certificate of registration, the registrant shall file an application in accordance with subsection (e) of this section.]

(2) [(3)] If a registrant does not submit an application for renewal of [fails to pay the fee required by §289.204 of this title and ] the certificate of registration in accordance with subsection (q) of this section, as applicable [is not renewed], the registrant shall on or before the expiration date specified in the certificate of registration :

(A) terminate use of all radiation machines and/or terminate radiation machine servicing or radiation services; [and ]

(B) submit to the agency a record of the disposition of the radiation machines, if applicable, and if transferred, to whom it was transferred, within 30 days following the expiration date; and [.]

(C) pay any outstanding fees in accordance with §289.204 of this title.

(3) [(4)] Expiration of the certificate of registration does not relieve the registrant of the requirements of this chapter.

(p) (No change.)

(q) Renewal [Technical renewal] of certificate of registration.

(1) An [If required by the certificate of registration, an] application for [technical] renewal of a certificate of registration shall be filed in accordance with subsection (e) of this section and applicable paragraphs of subsections (f) - (j) of this section. [ An application for a technical renewal of a certificate of registration shall be submitted to the agency by the date specified in the certificate of registration. If the registrant fails to apply and pay the fee required by §289.204 of this title, or the agency does not approve the application in accordance with subsection (k)(1) of this section, the certificate of registration expires and the registrant is in violation of the requirements in this chapter and is subject to administrative penalties in accordance with §289.205 of this title. The registrant shall comply with the requirements of subsection (o)(3)(A) - (B) of this section.]

[(2) Expiration of the certificate of registration does not relieve the registrant of the requirements of this chapter.]

(2) [(3)] If a registrant files an application for a [technical] renewal in proper form before the existing certificate of registration expires [and pays the fee required by §289.204 of this title], such existing certificate of registration shall not expire until the application status has been determined by the agency.

[(4) An application for technical renewal of a certificate of registration will be approved if the agency determines that the requirements of subsection (e) of this section and applicable paragraphs of subsections (f) - (j) of this section have been satisfied.]

[(5) When the date for administrative renewal in accordance with subsection (o)(1) of this section and the date for the technical renewal in accordance with paragraph (1) of this subsection occur at the same time, the certificate of registration will be renewed if the fee required by §289.204 of this title is paid, the technical renewal is approved by the agency in accordance with paragraph (4) of this subsection, and the agency does not deny the renewal in accordance with subsection (l)(4) of this section.]

[(6) When the date for the administrative renewal in accordance with subsection (o)(1) of this section and the date for the technical renewal in accordance with paragraph (1) of this subsection occur at the same time, the certificate of registration renewal may be denied by the agency if any one of the following conditions apply:]

[(A) the fee required by §289.204 of this title is not paid;]

[(B) the agency denies the renewal in accordance with subsection (l)(4) of this section; or]

[(C) the agency does not approve the technical renewal in accordance with paragraph (4) of this subsection.]

[(7) The requirements in this subsection are subject to the provisions of Government Code, §2001.054.]

(r) - (s) (No change.)

(t) Appendices.

(1) Requirements for RSOs for registrants.

(A) (No change.)

(B) Specific requirements for RSOs by facility are as follows.

(i) Healing arts facilities shall have:

(I) (No change.)

(II) non-practitioner RSOs with the following:

(-a-) - (-f-) (No change.)

(-g-) evidence of:

(-1-) registration with the Texas Medical Board [ Texas State Board of Medical Examiners] performing radiologic procedures under a physician's instruction and direction;

(-2-) (No change.)

(-3-) registration with the Texas State Board of Podiatric Medicine [ Texas State Board of Podiatry Examiners ] performing radiologic procedures under a podiatrist's instruction and direction; and

(-4-) (No change.)

(-h-) - (-j-) (No change.)

(ii) - (iii) (No change.)

(C) (No change.)

(2) - (4) (No change.)

§289.232.Radiation Control Regulations for Dental Radiation Machines.

(a) (No change.)

(b) Scope.

(1) - (2) (No change.)

(3) Dental radiation machines located in a facility that also has other healing arts radiation machines will be inspected at the intervals specified in §289.231(ll)(2) [ §289.231(ll)(1) ] of this title (relating to General Provisions and Standards for Protection Against Machine-Produced Radiation) and equipment performance evaluations shall be performed at the interval specified for a medical facility in [subsection] §289.227(o)(1) [§289.227(q)(1) ] of this title (relating to Use of Radiation Machines in the Healing Arts [and Veterinary Medicine]).

(4) - (5) (No change.)

(c) Definitions. The following words and terms when used in this section shall have the following meaning, unless the context clearly indicates otherwise.

(1) - (6) (No change.)

(7) Agency--The Department of State Health Services [ Texas Department of Health] or its successor.

(8) - (14) (No change.)

[(15) Board--The Texas Board of Health or its successor.]

(15) [(16)] Certificate of registration--A form of permission given by the agency to an applicant who has met the requirements for registration set out in the Texas Radiation Control Act and this section.

(16) [(17)] Certified equipment--Equipment that has been certified in accordance with Title 21, Code of Federal Regulations.

(17) [(18)] Coefficient of variation or C--The ratio of the standard deviation to the mean value of a population of observations. It is estimated using the following equation:

Figure: 25 TAC §289.232(c)(17)

[Figure: 25 TAC §289.232(c)(18)]

(18) [(19)] Collective dose--The sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation.

(19) Commissioner--The Commissioner of the Department of State Health Services.

(20) - (26) (No change.)

(27) Director--The director of the radiation control program under the agency's jurisdiction.

(28) [(27)] Dose--For external exposure to x-ray radiation from radiation machines, a generic term that means absorbed dose, dose equivalent, or total effective dose equivalent. For purposes of this section, "radiation dose" is an equivalent term.

(29) [(28)] Dose equivalent--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.

(30) [(29)] 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.

(31) [(30)] Embryo/fetus--The developing human organism from conception until the time of birth.

[(31) Enforcement conference--A meeting held by the agency with a person to discuss the following:]

[(A) safety, safeguards, or environmental problems;]

[(B) compliance with regulatory or registration condition requirements;]

[(C) proposed corrective measures including, but not limited to, schedules for implementation; and]

[(D) enforcement options available to the agency.]

(32) - (47) (No change.)

(48) Informal conference--A meeting held by the agency with a person to discuss the following:

(A) safety, safeguards, or environmental problems;

(B) compliance with regulatory or registration condition requirements;

(C) proposed corrective measures including, but not limited to, schedules for implementation; and

(D) enforcement options available to the agency.

(49) [(48)] Inspection--An official examination and/or observation including, but not limited to, records, tests, surveys, and monitoring to determine compliance with the Texas Radiation Control Act and agency rules, orders, requirements, and conditions of the certificate of registration.

(50) [(49)] Institutional Review Board--Any board, committee, or other group formally designated by an institution to review, approve the initiation of, and conduct periodic review of biomedical research involving human subjects.

(51) [(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.

(52) [(51)] kV--Kilovolt.

(53) [(52)] kVp--Kilovolt peak (See definition for peak tube potential).

(54) [(53)] kWs--Kilowatt-second. It is equivalent to 10 E 3 watt-second, where 1 watt-second = 1 kilovolt x 1 milliampere x 1 second.

(55) [(54)] Lead equivalent--The thickness of lead affording the same attenuation, under specified conditions, as the material in question.

(56) [(55)] Leakage radiation--Radiation emanating from the diagnostic assembly except for the useful beam and radiation produced when the exposure switch or timer is not activated.

(57) [(56)] Lens dose equivalent--The external dose equivalent to the lens of the eye at a tissue depth of 0.3 centimeters (300 milligrams per square centimeter).

(58) [(57)] License--A form of permission given by the agency to an applicant who has met the requirements for licensing set out in the Texas Radiation Control Act and this chapter.

(59) [(58)] Licensed material--Radioactive material received, possessed, used, or transferred under a general or specific license issued by the agency.

(60) [(59)] Licensed medical physicist--An individual holding a current Texas license under the Medical Physics Practice Act, Texas Occupations Code, Chapter 602.

(61) [(60)] Licensee--Any person who is licensed by the agency in accordance with the Texas Radiation Control Act and this chapter.

(62) [(61)] 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.

(63) [(62)] mA--Milliampere.

(64) [(63)] mAs--Milliampere-second.

(65) [(64)] Medical research--The investigation of various health risks and diseases.

(66) [(65)] Member of the public--Any individual, except when that individual is receiving an occupational dose.

(67) [(66)] Minor--An individual less than 18 years of age.

(68) [(67)] Mobile service operation--The provision of radiation machines and personnel at temporary sites for limited time periods. The radiation machines may be fixed inside a motorized vehicle or may be a portable radiation machine that may be removed from the vehicle and taken into a facility for use.

(69) [(68)] Monitoring--The measurement of radiation 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.

(70) [(69)] Non-certified equipment--Equipment manufactured and assembled prior to certification requirements of Title 21, Code of Federal Regulations (CFR), effective as specified in Title 21, CFR, §1020.30(a).

(71) [(70)] Notice of violation--A written statement prepared by the agency of one or more alleged infringements of a legally binding requirement. [The notice requires the person receiving the notice to provide a written statement describing the following:]

[(A) corrective steps taken by the person and the results achieved;]

[(B) corrective steps to be taken to prevent recurrence; and]

[(C) the projected date for achieving full compliance. The agency may require responses to notices of violation to be under oath.]

(72) [(71)] Occupational dose--The dose received by an individual in the course of employment in which the individual's assigned duties involve exposure to 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 or from voluntary participation in medical research programs, or as a member of the public.

(73) [(72)] Order--A specific directive contained in a legal document issued by the agency.

(74) [(73)] Party--A person designated as such by the ALJ. A party may consist of the following:

(A) the agency; and

(B) an applicant, licensee, registrant, accredited mammography facility, or certified industrial radiographer.

(75) [(74)] Patient--An individual subjected to dental examination, diagnosis, or treatment.

(76) [(75)] Peak tube potential--The maximum value of the potential difference in kilovolts across the x-ray tube during an exposure.

(77) [(76)] 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 the United States Nuclear Regulatory Commission, and other than federal government agencies licensed or exempted by the United States Nuclear Regulatory Commission.

(78) [(77)] Personnel monitoring equipment--(See definition for individual monitoring devices).

(79) [(78)] Phototimer--A method for controlling radiation exposures to image receptors by the amount of radiation that reaches a radiation monitoring device. The radiation monitoring device is part of an electronic circuit that controls the duration of time the tube is activated (See definition for automatic exposure control).

(80) [(79)] Portable x-ray equipment--(See definition for x-ray equipment).

(81) [(80)] Primary protective barrier--(See definition for protective barrier).

(82) [(81)] Protective barrier--A barrier of radiation absorbing materials used to reduce radiation exposure. The types of protective barriers are as follows:

(A) Primary protective barrier--A barrier sufficient to attenuate the useful beam to the required degree; or

(B) Secondary protective barrier--A barrier sufficient to attenuate the stray radiation to the required degree.

(83) [(82)] Public dose--The dose received by a member of the public from exposure to radiation from licensed/registered and unlicensed/unregistered sources of radiation, whether in the possession of the licensee/registrant or other person. 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, or as a member of the public.

(84) [(83)] Rad--The special unit of absorbed dose. One rad is equal to an absorbed dose of 100 ergs per gram or 0.01 joule per kilogram (0.01 gray).

(85) [(84)] Radiation--One or more of the following:

(A) gamma and x rays; alpha and beta particles and other atomic or nuclear particles or rays;

(B) radiation emitted to energy density levels that could reasonably cause bodily harm from an electronic device; 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.

(86) [(85)] 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 millisievert) in one hour at 30 centimeters from the radiation machine or from any surface that the radiation penetrates.

(87) [(86)] Radiation machine--Any device capable of producing ionizing radiation except those devices with radioactive material as the only source of radiation.

(88) [(87)] Radiation safety officer--An individual who has a knowledge of and the authority and responsibility to apply appropriate radiation protection rules, standards, and practices, who shall be specifically authorized on a certificate of registration, and who is the primary contact with the agency.

(89) [(88)] Radiograph--An image receptor on which the image is created directly or indirectly by an x-ray exposure and results in a permanent record.

(90) [(89)] Registrant--Any person issued a certificate of registration by the agency in accordance with the Texas Radiation Control Act and this chapter.

(91) [(90)] Regulation (See definition for rule).

(92) [(91)] 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).

(93) [(92)] Remote inspection--An examination by the agency of information submitted by the registrant on a form provided by the agency.

(94) [(93)] Research and development--Research and development is defined as:

(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.

(95) [(94)] Restricted area--An area, access to which is limited by the registrant for the purpose of protecting individuals against undue risks from exposure to 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.

(96) [(95)] Roentgen (R)--The special unit of exposure. One roentgen (R) equals 2.58 x 10^-4 coulombs per kilogram of air. (See definition for exposure.)

(97) [(96)] Rule--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."

(98) [(97)] Scattered radiation--Radiation that has been deviated in direction during passage through matter.

(99) [(98)] Secondary protective barrier (See definition for protective barrier).

(100) [(99)] Severity level--A classification of violations based on relative seriousness of each violation and the significance of the effect of the violation on the occupational or public health or safety.

(101) [(100)] Shallow dose equivalent--The dose equivalent at a tissue depth of 0.007 centimeters (7 milligrams per square centimeter) that applies to the external exposure of the skin of the whole body or the skin of an extremity.

(102) [(101)] SI--The abbreviation for the International System of Units.

(103) [(102)] 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 sievert = 100 rem).

(104) [(103)] Source of radiation--Any radioactive material, or any device or equipment emitting or capable of producing radiation.

(105) [(104)] Source-to-image receptor distance--The distance from the source to the center of the input surface of the image receptor.

(106) [(105)] Source-to-skin distance--The distance from the source to the skin of the patient.

(107) [(106)] Special units--The conventional units historically used by registrants, i.e., rad (absorbed dose), and rem (dose equivalent).

(108) [(107)] Stationary x-ray equipment--(See definition for x-ray equipment).

(109) [(108)] Stray radiation--The sum of leakage and scattered radiation.

(110) [(109)] Supervision--The delegating of the task of applying radiation in accordance with this section to persons not licensed in dentistry, who perform tasks under the dentist's control. The dentist assumes full responsibility for these tasks and shall assure that the tasks will be administered correctly.

(111) [(110)] Survey--An evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, and/or disposal of radiation machines. When appropriate, such survey includes, but is not limited to, tests, physical examination of location of equipment or radiation machines, and measurements of levels of radiation present, and evaluation of administrative and/or engineered controls.

(112) [(111)] Technique chart--A chart that provides all necessary generator control settings and geometry needed to make clinical radiographs when the radiation machine is in manual mode.

(113) [(112)] Technique factors--The conditions of operation that are specified as follows:

(A) for capacitor energy storage equipment, peak tube potential in kilovolt and quantity of charge in milliampere-second;

(B) for field emission equipment rated for pulsed operation, peak tube potential in kilovolt and number of x-ray pulses; and

(C) for all other equipment, peak tube potential in kilovolt and either tube current in milliamperes and exposure time in seconds or the product of tube current and exposure time in milliampere-second.

(114) [(113)] Termination--A release by the agency of the obligations and authorizations of the registrant under the terms of the certificate of registration. It does not relieve a person of duties and responsibilities imposed by law or rule.

(115) [(114)] Texas Regulations for Control of Radiation (TRCR)--All sections of Title 25 Texas Administrative Code, Chapter 289.

(116) [(115)] Total effective dose equivalent--For external exposures only to x-ray radiation from radiation machines, the total effective dose equivalent is equal to the deep dose equivalent.

(117) [(116)] Traceable to a national standard--This indicates that a quantity or a measurement has been compared to a national standard, for example, the National Institute of Standards and Technology, directly or indirectly through one or more intermediate steps and that all comparisons have been documented.

(118) [(117)] Tube--An x-ray tube, unless otherwise specified.

(119) [(118)] Tube housing assembly--The tube housing with tube installed. It includes high-voltage and/or filament transformers and other appropriate elements when such are contained within the tube housing.

(120) [(119)] Unrestricted area (uncontrolled area)--An area, access to which is neither limited nor controlled by the registrant. For purposes of this section, "uncontrolled area" is an equivalent term.

(121) [(120)] Useful beam--Radiation that passes through the window, aperture, core, or other collimating device of the source housing. Also referred to as the primary beam.

(122) [(121)] Violation--An infringement of any rule, license or registration condition, order of the agency, or any provision of the Texas Radiation Control Act.

(123) [(122)] X-ray control--A device that controls input power to the x-ray high-voltage generator and/or the x-ray tube. It includes components such as timers, phototimers, automatic brightness stabilizers, and similar devices that control the technique factors of an x-ray exposure.

(124) [(123)] X-ray equipment--An x-ray system, subsystem, or component thereof. For the purposes of this rule, types of x-ray equipment are as follows:

(A) portable x-ray equipment--x-ray equipment mounted on a permanent base with wheels and/or casters for moving while completely assembled or equipment designed to be hand-carried; or

(B) stationary x-ray equipment--x-ray equipment that is installed in a fixed location.

(125) [(124)] X-ray field--That area of the intersection of the useful beam and any one of the set of planes parallel to and including the plane of the image receptor, whose perimeter is the locus of points at which the exposure rate is one-fourth of the maximum in the intersection.

(126) [(125)] X-ray high-voltage generator--A device that transforms electrical energy from the potential supplied by the x-ray control to the tube operating potential. The device may also include means for transforming alternating current to direct current, filament transformers for the x-ray tubes, high-voltage switches, electrical protective devices, and other appropriate elements.

(127) [(126)] X-ray system--An assemblage of components for the controlled production of x rays. It includes minimally an x-ray high-voltage generator, an x-ray control, a tube housing assembly, a beam-limiting device, and the necessary supporting structures. Additional components that function with the system are considered integral parts of the system.

(128) [(127)] X-ray subsystem--Any combination of two or more components of an x-ray system.

(129) [(128)] X-ray tube--Any electron tube that is designed to be used primarily for the production of x rays.

(130) [(129)] Whole body--For purposes of external exposure, head, trunk including male gonads, arms above the elbow, or legs above the knee.

(131) [(130)] Worker--An individual engaged in work under a certificate of registration issued by the agency and controlled by a registrant, but does not include the registrant.

(132) [(131)] Year--The period of time beginning in January used to determine compliance with the provisions of this chapter. The registrant may change the starting date of the year used to determine compliance by the registrant provided that the change is made at the beginning of the year and that no day is omitted or duplicated in consecutive years.

(d) (No change.)

(e) Communications.

(1) Except where otherwise specified, all communications and reports concerning this chapter and applications filed under them should be mailed by postal service to [the Bureau of ] Radiation Control, Department of State Health Services [ Texas Department of Health ], 1100 West 49th Street, Austin, Texas, 78756-3189. Communications, reports, and applications may be delivered in person to the agency's office located at 8407 Wall Street, Austin, Texas.

(2) (No change.)

(f) (No change.)

(g) Fees for Certificates of Registration for Dental Facilities.

(1) Payment of fees.

(A) Each application for a certificate of registration shall be accompanied by a nonrefundable fee of $330 [$300 ]. No application will be accepted for filing or processed prior to payment of the full amount specified.

(B) A nonrefundable fee of $330 [$300] shall be paid for each certificate of registration for radiation machines used in dentistry. The fee shall be paid every two years based on the month listed as the expiration month on [for the two-year term of] the certificate of registration and [. The fee ] shall be paid in full on or before the last day of the expiration month [ and year of the certificate of registration ].

(i) (No change.)

(ii) In the case of a single certificate of registration that authorizes more than one category of use, the category listed in §289.204(j) [§289.204(h)] of this title (relating to Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services) and assigned the higher fee will be used. If this certificate of registration also has additional authorized use sites, the registrant shall pay an additional 30% of the highest fee category.

(C) Each application for reciprocal recognition of an out-of-state registration in accordance with subsection (h)(10) [(h)(9) ] of this section shall be accompanied by the $330 [$300 ] fee, provided that no such fee has been submitted within 24 months of the date of commencement of the proposed activity.

(D) Fee payments shall be in cash or by check or money order made payable to the Department of State Health Services [ Texas Department of Health ]. The payments may be made by personal delivery to the central office, [Bureau of ] Radiation Control, Department of State Health Services [ Texas Department of Health ], 1100 West 49th Street, Austin, Texas, or mailed to the [Bureau of] Radiation Control, Department of State Health Services [ Texas Department of Health], 1100 West 49th Street, Austin, Texas, 78756-3189.

(2) Failure to pay prescribed fees.

(A) (No change.)

(B) In any case where the agency finds that a registrant has failed to pay a fee prescribed by this section by the due date, [the certificate of registration expires and] the agency may implement compliance procedures as provided in subsection (k)(2)(C) of this section.

(3) (No change.)

(h) Registration of Radiation Machine Use.

(1) Application for registration.

(A) - (C) (No change.)

(D) A radiation safety officer shall be designated on each application form. The qualifications of that individual shall be submitted to the agency with the application. The radiation safety officer shall meet the applicable requirements of paragraph (11) [(10)] of this subsection and carry out the responsibilities of paragraph (12) [(11)] of this subsection.

(E) - (K) (No change.)

(2) - (5) (No change.)

(6) Expiration of certificates of registration.

(A) Except as provided by paragraph (8) of this subsection, each [Effective September 1, 2004, the term of the certificate of registration is two years. Each ] certificate of registration expires at the end of the day, in the month and year stated in the certificate of registration. [Upon payment of the fee required by subsection (g)(1)(B) of this section, and if the agency does not deny the renewal in accordance with subsection (h)(4)(F) of this section, the certificate of registration will be renewed.]

[(B) If the fee is not paid and the certificate of registration is not renewed in accordance with subparagraph (A) of this paragraph, the certificate of registration expires, and the registrant is in violation of the requirements in this chapter and is subject to administrative penalties in accordance with §289.205 of this title.]

[(i) If the registrant pays the fee required by §289.204 of this title within 30 days after expiration of the certificate of registration, the certificate of registration will be reinstated and the registrant will not be required to file an application in accordance with subsection (h) of this section.]

[(ii) If the registrant fails to pay the fee within 30 days after expiration of the certificate of registration, the registrant shall file an application in accordance with subsection (h) of this section.]

(B) [(C)] If a registrant does not submit an application for renewal of the certificate of registration in accordance with paragraph (8) of this subsection, as applicable, the registrant shall on or before the expiration date specified in the certificate of registration [pay the fee required by subsection (g) of this section and the certificate of registration is not renewed, the registrant shall]:

(i) terminate use of all radiation machines within 30 days following the expiration date; [and]

(ii) submit to the agency a record of the disposition of the radiation machines and if transferred, to whom transferred, within 30 days following the expiration date ; and [.]

(iii) pay any outstanding fees in accordance with subsection (g) of this section.

(C) [(D)] Expiration of the certificate of registration does not relieve the registrant of the requirements of this chapter.

(7) (No change.)

(8) Renewal of certificate of registration.

(A) An application for renewal of registration shall be filed in accordance with paragraph (1) or (2) of this subsection, as applicable.

(B) If a registrant files an application in proper form before the existing certificate of registration expires, such existing certificate of registration shall not expire until the application status has been determined by the agency.

(9) [(8)] Modification, suspension, and revocation of certificate of registration.

(A) The terms and conditions of all certificates of registration shall be subject to revision or modification. A certificate of registration may be suspended or revoked by reason of amendments to the Act, by reason of requirements of this chapter or orders issued by the agency.

(B) Any certificate of registration may be revoked, suspended, or modified, in whole or in part, for any of the following:

(i) any material false statement in the application or any statement of fact required under provisions of the Act;

(ii) conditions revealed by such application or statement of fact or any report, record, or inspection, or other means that would warrant the agency to refuse to grant a certificate of registration on an original application;

(iii) violation of, or failure to observe any of the terms and conditions of the Act, this chapter, the certificate of registration, or order of the agency; or

(iv) existing conditions that constitute a substantial threat to the public health or safety or the environment.

(C) Each certificate of registration revoked by the agency ends at the end of the day on the date of the agency's final determination to revoke the certificate of registration, or on the revocation date stated in the determination, or as otherwise provided by the agency order.

(D) Except in cases in which the occupational and public health or safety requires otherwise, no certificate of registration shall be suspended or revoked unless, prior to the institution of proceedings therefore, facts or conduct that may warrant such action shall have been called to the attention of the registrant in writing and the registrant shall have been afforded an opportunity to demonstrate compliance with all lawful requirements.

(10) [(9)] Reciprocal recognition of out-of-state certificates of registration.

(A) Whenever any radiation machine is to be brought into the state for any temporary use, the person proposing to bring the machine into the state shall apply for and receive a notice from the agency granting reciprocal recognition prior to beginning operations. The request for reciprocity shall include the following:

(i) completed BRC Form 226-1 (Business Information Form);

(ii) completed BRC Form 252-3 (Notice of Intent to Work in Texas Under Reciprocity);

(iii) name and Texas licensing board number of the dentist if the radiation machines are used to irradiate humans;

(iv) copy of the applicant's current state certificate of registration or equivalent document;

(v) copy of the applicant's current operating and safety procedures pertinent to the proposed use;

(vi) the fee as specified in subsection (g)(2) of this section; and

(vii) qualifications of personnel who will be operating the machines.

(B) Upon a determination that the request for reciprocity meets the requirements of the agency, the agency may issue a notice granting reciprocal recognition authorizing the proposed use.

(C) Once reciprocity is granted, the out-of-state registrant shall file a BRC Form 252-3 with the agency prior to each entry into the state. This form shall be filed at least three working days before the radiation machine is to be used in the state. If, for a specific case, the three-day period would impose an undue hardship, the out-of-state registrant may, at the determination of the agency, obtain permission to proceed sooner.

(D) When radiation machines are used as authorized under reciprocity, the out-of-state registrant shall have the following in its possession at all times for inspection by the agency:

(i) completed BRC Form 252-3;

(ii) copy of the notice from the agency granting reciprocity;

(iii) copy of the out-of-state registrant's operating and safety procedures; and

(iv) copy of the applicable rules as specified in the notice granting reciprocity.

(E) If the state from which the radiation machine is proposed to be brought does not issue certificates of registration or equivalent documents, a certificate of registration shall be obtained from the agency in accordance with the requirements of this section.

(F) The agency may withdraw, limit, or qualify its acceptance of any certificate of registration or equivalent document issued by another agency upon determining that such action is necessary in order to prevent undue hazard to occupational and public health and safety.

(G) Reciprocal recognition will expire one year from the date it is granted. A new request for reciprocity shall be submitted to the agency each year. Reciprocity requests made after the initial request shall include only the following:

(i) completed BRC Form 226-1 (Business Information Form);

(ii) completed BRC Form 252-3 (Notice of Intent to Work in Texas Under Reciprocity);

(iii) name and Texas licensing board number of the dentist if the radiation machines are used to irradiate humans;

(iv) copy of the applicant's current state certificate of registration or equivalent document;

(v) copy of the applicant's current operating and safety procedures pertinent to the proposed use;

(vi) the fee as specified in subsection (g)(1) of this section; and

(vii) qualifications of personnel who will be operating the machines.

(H) Radiation services provided by a person from out-of-state will not be granted reciprocity. Whenever radiation services are to be provided by a person from out-of-state, that person shall apply for and receive a certificate of registration from the agency before providing radiation services. The application shall be filed in accordance with this subsection, as applicable.

(11) [(10)] A radiation safety officer (RSO) shall be designated on each application form. The qualifications of that individual shall be submitted to the agency with the application.

(A) The RSO shall have the following qualifications:

(i) knowledge of potential hazards and emergency precautions; and

(ii) completed educational courses related to ionizing radiation safety or a radiation safety officer course; or

(iii) experience in the use and familiarity of the type of equipment used; and

(B) In addition to the qualifications in subparagraph (A) of this paragraph, documentation of the following shall be submitted to the agency:

(i) dentist radiation safety officers shall provide documentation of licensing board number and their signature on the application; or

(ii) non-practitioner radiation safety officers shall provide any one of the following:

(I) evidence of a valid general certificate issued under the Medical Radiologic Technologist Certification Act, Texas Occupations Code, Chapter 601, and at least two years of supervised use of radiation machines;

(II) evidence of a valid limited general certificate issued under the Medical Radiologic Technologist Certification Act, Texas Occupations Code, Chapter 601, and at least four years of supervised use of radiation machines;

(III) evidence of registry by the American Registry of Radiologic Technologists (ARRT) or the American Registry of Clinical Radiologic Technologists (ARCRT) and at least two years of supervised use of radiation machines;

(IV) evidence of associate degree in radiologic technology, health physics, or nuclear technology, and at least two years of supervised use of radiation machines;

(V) evidence of registration with the Board of Nurse Examiners as a Registered Nurse or a Registered Nurse with an extended scope of practice (Nurse Practitioner) performing radiologic procedures, and at least two years of supervised use of radiation machines in the respective practitioners' specialty;

(VI) evidence of registration with the Texas State Board of Physician Assistant Examiners, and at least two years of supervised use of radiation machines in the respective practitioners' specialty;

(VII) evidence of:

(-a-) registration with the Texas State Board of Dental Examiners to perform radiologic procedures under a dentist's instruction and direction or evidence of a valid certificate as a registered dental hygienist; and

(-b-) at least four years of supervised use of radiation machines in the respective dentists' specialty;

(VIII) evidence of bachelor's (or higher) degree in a natural or physical science, health physics, radiological science, nuclear medicine, or nuclear engineering; or

(IX) evidence of a current Texas license under the Medical Physics Practice Act, Texas Occupations Code, Chapter 602, in medical health physics, diagnostic radiological physics, or medical nuclear physics for diagnostic x-ray facilities.

(C) Academic institutions and/or research and development facilities shall have radiation safety officers who are faculty or staff members in radiation protection, radiation engineering, or related disciplines. (This individual may also serve as the radiation safety officer over the dental section of the facility).

(D) The radiation safety officer identified on a certificate of registration issued before September 1, 1993, need not comply with the qualification requirements in this subsection.

(12) [(11)] Responsibilities of radiation safety officers. Specific duties of the radiation safety officer include, but are not limited to, the following:

(A) establishing and overseeing operating and safety procedures that maintain radiation exposures as low as reasonably achievable, and to review them regularly to ensure that the procedures are current and conform with this section;

(B) investigating and reporting to the agency each known or suspected case of radiation exposure to an individual or radiation level detected in excess of limits established by this section and each theft or loss of radiation machines, determining the cause, and taking steps to prevent its recurrence;

(C) having a thorough knowledge of management policies and administrative procedures of the registrant;

(D) assuming control and having the authority to institute corrective actions including shut-down of operations when necessary in emergency situations or unsafe conditions;

(E) maintaining records as required by this section; and

(F) ensuring that personnel are adequately trained and complying with this section, the conditions of the certificate of registration, and the operating and safety procedures of the registrant.

(i) Use of Dental Radiation Machines.

(1) - (4) (No change.)

(5) Facility requirements.

(A) (No change.)

(B) Posting of notices to workers.

(i) - (ii) (No change.)

(iii) The following form, BRC [Bureau of Radiation Control (BRC)] Form 232-1, "Notice to Employees," which is found at the end of the section, [as contained in subparagraph (C) of this paragraph, ] or an equivalent document containing at least the same wording as BRC Form 232-1, shall be posted by each registrant as required by this section.

Figure: 25 TAC §289.232(i)(5)(B)(iii) (.pdf)

(iv) (No change.)

[(C) Notice to employees. The following form, or an equivalent as stated in subparagraph (B)(ii) of this paragraph, shall be posted.]

[Figure: 25 TAC §289.232(i)(5)(C)]

(C) [(D)] Posting requirements. The registrant shall post each radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, RADIATION AREA."

(D) [(E)] Exceptions to posting requirements. Registrants are exempt from the posting of the radiation area requirements in subparagraph (C) [(D)] of this paragraph provided that the operator has continuous surveillance and access control of the radiation area.

(6) Radiation machine requirements.

(A) - (D) (No change.)

(E) Beam quality. The following requirements apply to beam quality.

(i) Half-value layer.

(I) The half-value layer of the useful beam for a given x-ray tube potential shall not be less than the values shown in the following Table I. If it is necessary to determine such half-value layer at an x-ray tube potential that is not listed in Table I, linear interpolation may be made.

Figure: 25 TAC §289.232(i)(6)(E)(i)(I)

[Figure: 25 TAC §289.232(i)(6)(E)(i)(I)]

(II) (No change.)

(ii) - (iii) (No change.)

(F) - (H) (No change.)

(I) Exposure output [interval] reproducibility. When all technique factors are held constant, including control panel selections associated with automatic exposure control systems, the coefficient of variation of exposure for both manual and automatic exposure control systems shall not exceed 0.05. This requirement applies to clinically used techniques.

(J) - (K) (No change.)

(L) Collimation. Field limitation shall meet the requirements of paragraphs (11) and (12) [paragraph (12)] of this subsection.

(M) - (N) (No change.)

(7) - (16) (No change.)

(j) Records and reports.

(1) General provisions for records and reports.

(A) - (K) (No change.)

(L) Any person who submits written information or data to the agency and requests that the information be considered confidential, privileged, or otherwise not available to the public under the Texas Public Information Act, shall justify such request in writing, including statutes and cases where applicable, addressed to the agency.

(i) Documents containing information that is claimed to fall within an exception to the Texas Public Information Act shall be marked to indicate that fact. Markings shall be placed on the document on origination or submission.

(I) (No change.)

(II) The following wording shall be placed at the bottom of the front cover and title page, or first page of text if there is no front cover or title page:

Figure: 25 TAC §289.232(j)(1)(L)(i)(II)

[Figure: 25 TAC §289.232(j)(1)(L)(i)(II)]

(ii) - (iii) (No change.)

(M) - (N) (No change.)

(2) Reports.

(A) - (B) (No change.)

(C) Reports of exposures and radiation levels exceeding the limits.

(i) In addition to the notification required by subparagraph (B) of this paragraph, each registrant shall submit a written report within 30 days after learning of any of the following occurrences:

(I) (No change.)

(II) doses in excess of any of the following:

(-a-) - (-d-) (No change.)

(-e-) any applicable limit in the certificate of registration;

(III) (No change.)

(ii) (No change.)

(iii) Each report filed in accordance with subparagraph (C)(i) of this paragraph shall include for each individual exposed: the name, a unique identification number [social security number], and date of birth. With respect to the limit for the embryo/fetus in subsection (i)(4)(A)(i)(IV) and (V) of this section, the identifiers should be those of the declared pregnant woman. The report shall be prepared so that this information is stated in a separate and detachable portion of the report.

(iv) (No change.)

(D) (No change.)

(k) Compliance and hearing procedures.

(1) (No change.)

(2) Hearing and enforcement procedures.

(A) - (B) (No change.)

(C) Compliance procedures for registrants and other persons.

(i) A registrant or other person who commits a violation(s) will be issued a notice of violation. The person receiving the notice shall provide the agency with a written statement and supporting documentation by the date stated in the notice describing the following:

(I) steps taken by the person and the results achieved;

(II) corrective steps to be taken to prevent recurrence; and

(III) the date when full compliance was or is expected to be achieved. The agency may require responses to notices of violation to be under oath.

(ii) - (iv) (No change.)

(v) When the agency determines that the action provided for in clause (viii) of this subparagraph or subparagraph (D) of this paragraph is not to be taken immediately, the agency may offer the registrant an opportunity to attend an informal meeting to discuss the following with the agency: [enforcement conference.]

(I) methods and schedules for correcting the violation(s); or

(II) methods and schedules for showing compliance with applicable provisions of the Act, the rules, registration conditions, or any orders of the agency.

(vi) Notice of any informal meeting [enforcement conference] shall be delivered by personal service, or certified mail, addressed to the last known address. An informal meeting [enforcement conference ] is not a prerequisite for the action to be taken in accordance with [under] clause (viii) of this subparagraph or subparagraph (D) of this paragraph.

(vii) - (ix) (No change.)

(D) Assessment of Administrative Penalties.

(i) - (ii) (No change.)

(iii) Application of administrative penalties. The agency may impose differing levels of penalties for different severity level violations and different classes of users as follows.

(I) - (II) (No change.)

(III) Adjustments to the [severity levels and] percentages of base amounts in Table IIB may be made for the presence or absence of the following factors:

(-a-) - (-f-) (No change.)

(IV) The penalty for each violation may be in an amount not to exceed $10,000 a day for a person who violates the Texas Radiation Control Act or a rule, order, or certificate of registration issued in accordance with [under] the Texas Radiation Control Act. Each day a violation continues may be considered a separate violation for purposes of penalty assessment.

(iv) (No change.)

(E) Severity levels of violations for registrants or other persons.

(i) (No change.)

(ii) Criteria to elevate or reduce severity levels.

(I) Severity levels [Violations] may be elevated to a higher severity level for the following reasons:

(-a-) - (-c-) (No change.)

(-d-) a violation was willful or grossly negligent; [ . This means the violation was the result of careless regard for requirements, deception, or other indications of willfulness by the registrant or employees of the registrant; or]

(-e-) compliance history ; or [.]

(-f-) other mitigating factors.

(II) Severity levels [Violations] may be reduced to a lower level for the following reasons:

(-a-) the registrant identified and corrected the violation prior to the agency inspection; [or]

(-b-) the registrant's actions corrected the violation and prevented recurrence ; or [.]

(-c-) other mitigating factors.

(iii) (No change.)

(F) (No change.)

(G) Emergency orders.

(i) - (iii) (No change.)

(iv) The person receiving the order shall be afforded the opportunity for a hearing on an emergency order. Notice of the action, along with a complaint, shall be given to the person by personal service or certified mail, addressed to the last known address. A hearing shall be held on an emergency order if the person receiving the order submits a written request to the director within 30 days of the date of the order.

(I) - (III) (No change.)

(H) (No change.)

§289.233.Radiation Control Regulations for Radiation Machines Used in Veterinary Medicine.

(a) - (b) (No change.)

(c) Definitions. The following words and terms when used in this section shall have the following meaning, unless the context clearly indicates otherwise.

(1) - (6) (No change.)

(7) Agency--The Department of State Health Services [ Texas Department of Health] or its successor.

(8) - (16) (No change.)

[(17) Board--The Texas Board of Health or its successor.]

(17) [(18)] Certificate of registration--A form of permission given by the agency to an applicant who has met the requirements for registration set out in the Act and this chapter.

(18) [(19)] Coefficient of variation or C--The ratio of the standard deviation to the mean value of a population of observations. It is estimated using the following equation:

Figure: 25 TAC §289.233(c)(18)

[Figure: 25 TAC §289.233(c)(19)]

(19) [(20)] Collective dose--The sum of the individual doses received in a given period of time by a specified population from exposure to a specified source of radiation.

(20) Commissioner--The Commissioner of the Department of State Health Services.

(21) - (33) (No change.)

[(34) Enforcement conference--A meeting held by the agency with a person to discuss the following:]

[(A) safety, safeguards, or environmental problems; ]

[(B) compliance with regulatory or registration condition requirements;]

[(C) proposed corrective measures including, but not limited to, schedules for implementation; and]

[(D) enforcement options available to the agency.]

(34) [(35)] 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.

(35) [(36)] Exposure rate--The exposure per unit of time.

(36) [(37)] External dose--That portion of the DE received from any source of radiation outside the body.

(37) [(38)] 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.

(38) [(39)] Field emission equipment--Equipment that uses an x-ray tube in which electron emission from the cathode is due solely to the action of an electric field.

(39) [(40)] Field size--The dimensions along the major axes of an area in a plane perpendicular to the central axis of the beam at the normal treatment or examination source to image distance and defined by the intersection of the major axes and the 50% isodose line.

(40) [(41)] Filter--Material placed in the useful beam to preferentially absorb selected radiation.

(41) [(42)] Fluoroscopic imaging assembly--A subsystem in which x-ray photons produce a fluoroscopic image. It includes the image receptors such as the image intensifier and spot-film device, electrical interlocks, if any, and structural material providing linkage between the image receptor and diagnostic source assembly.

(42) [(43)] 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) [(44)] Half-value layer (HVL)--The thickness of a specified material that attenuates the beam of radiation to an extent such that the exposure rate is reduced to one-half of its original value.

(44) [(45)] Healing arts--Any system, treatment, operation, diagnosis, prescription, or practice for the ascertainment, cure, relief, palliation, adjustment, or correction of any human disease, ailment, deformity, injury, or unhealthy or abnormal physical or mental condition.

(45) [(46)] Hearing--A proceeding to examine an application or other matter before the agency in order to adjudicate rights, duties, or privileges.

(46) [(47)] High radiation area--An area, accessible to individuals, in which radiation levels from radiation machines external to the body could result in an individual receiving a DE 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.

(47) [(48)] Image intensifier--A device, installed in its housing, that instantaneously converts an x-ray pattern into a corresponding light image of higher energy density.

(48) [(49)] Image receptor--Any device, such as a fluorescent screen or radiographic film, that transforms incident x-ray photons either into a visible image or into another form that can be made into a visible image by further transformations.

(49) [(50)] Individual--Any human being.

(50) [(51)] Individual monitoring--The assessment of DE to an individual by the use of:

(A) individual monitoring devices; or

(B) survey data.

(51) [(52)] Individual monitoring devices--Devices designed to be worn by a single individual for the assessment of DE. 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), and electronic personal dosimeters.

(52) Informal conference--A meeting held by the agency with a person to discuss the following:

(A) safety, safeguards, or environmental problems;

(B) compliance with regulatory or registration condition requirements;

(C) proposed corrective measures including, but not limited to, schedules for implementation; and

(D) enforcement options available to the agency.

(53) - (67) (No change.)

(68) Notice of violation--A written statement prepared by the agency of one or more alleged infringements of a legally binding requirement. [The notice requires the person receiving the notice to provide a written statement describing the following:]

[(A) corrective steps taken by the registrant and the results achieved;]

[(B) corrective steps to be taken to prevent recurrence; and]

[(C) the projected date for achieving full compliance. The agency may require responses to notices of violation to be under oath.]

(69) - (136) (No change.)

(d) (No change.)

(e) Communications.

(1) Except where otherwise specified, all communications and reports concerning this chapter and applications filed under them should be addressed to [the Bureau of] Radiation Control, Department of State Health Services [Texas Department of Health], 1100 West 49th Street, Austin, Texas, 78756-3189. Communications, reports, and applications may be delivered in person to the agency's office located at 8407 Wall Street, Austin, Texas.

(2) (No change.)

(f) (No change.)

(g) Fees for certificates of registration for veterinary facilities.

(1) Payment of fees.

(A) Each application for a certificate of registration shall be accompanied by a nonrefundable fee of $264 [$240]. No application will be accepted for filing or processed prior to payment of the full amount specified.

(B) A nonrefundable fee of $264 shall be paid for each certificate of registration for radiation machines used in veterinary medicine. The fee shall be paid every two years based on the month listed as the expiration month on [for the two-year term of] the certificate of registration and [ . The fee] shall be paid in full on or before the last day of the expiration month [and year of the certificate of registration]. In the case of a single certificate of registration that authorizes more than one category of use, the category listed in §289.204(j) of this title (relating to Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services) and assigned the higher fee will be used. For each additional use location on a single certificate of registration, the registrant shall pay an additional $72.

(C) Each application for reciprocal recognition of an out-of-state registration in accordance with subsection (h)(10) [(h)(9) ] of this section shall be accompanied by the $264 [$240 ] fee, provided that no such fee has been submitted within 24 months of the date of commencement of the proposed activity.

(D) Fee payments shall be in cash or by check or money order made payable to the Department of State Health Services [ Texas Department of Health]. The payments may be made by personal delivery to the central office, [Bureau of] Radiation Control, Department of State Health Services [Texas Department of Health], 1100 West 49th Street, Austin, Texas, or mailed to [the Bureau of] Radiation Control, Department of State Health Services [ Texas Department of Health], 1100 West 49th Street, Austin, Texas, 78756-3189.

(2) Failure to pay prescribed fees.

(A) (No change.)

(B) In any case where the agency finds that a registrant has failed to pay a fee prescribed by this section by the due date, [the certificate of registration has expired and ] the agency may implement compliance procedures as provided in subsection (k)(2) of this section.

(3) (No change.)

(h) Registration of radiation machine use.

(1) - (5) (No change.)

(6) Expiration of certificates of registration.

(A) Except as provided by paragraph (8) of this subsection, each [Effective September 1, 2004, the term of the certificate of registration is two years. Each] certificate of registration expires at the end of the day, in the month and year stated in the certificate of registration. [ Upon payment of the fee required by subsection (g) of this section and if the agency does not deny the renewal in accordance with paragraph (4)(D) of this subsection, the certificate of registration will be renewed.]

[(B) If the fee is not paid and the certificate of registration is not renewed in accordance with subparagraph (A) of this paragraph, the certificate of registration expires, and the registrant is in violation of the requirements in this chapter and is subject to administrative penalties in accordance with subsection (k)(2)(D) of this section.]

[(i) If the registrant pays the fee required by subsection (g) of this section within 30 days after expiration of the certificate of registration, the certificate of registration will be reinstated and the registrant will not be required to file an application in accordance with subsection (h) of this section.]

[(ii) If the registrant fails to pay the fee within 30 days after expiration of the certificate of registration, the registrant shall file an application in accordance with subsection (h) of this section.]

(B) [(C)] If a registrant does not submit an application for renewal of the certificate of registration in accordance with paragraph (8) of this subsection, as applicable, the registrant shall on or before the expiration date specified in the certificate of registration [fails to pay the fee required by subsection (g) of this section and the certificate of registration is not renewed, the registrant shall]:

(i) terminate use of all radiation machines within 30 days following the expiration date; [and]

(ii) submit to the agency a record of the disposition of the radiation machines and if transferred, to whom transferred within 30 days following the expiration date ; and [.]

(iii) pay any outstanding fees in accordance with subsection (g) of this section.

(C) [(D)] Expiration of the certificate of registration does not relieve the registrant of the requirements of this chapter.

(7) (No change.)

(8) Renewal of certificate of registration.

(A) An application for renewal of registration shall be filed in accordance with paragraph (1) or (2) of this subsection, as applicable.

(B) If a registrant files an application in proper form before the existing certificate of registration expires, such existing certificate of registration shall not expire until the application status has been determined by the agency.

(9) [(8)] Modification, suspension, and revocation of certificates of registration.

(A) The terms and conditions of all certificates of registration shall be subject to revision or modification. A certificate of registration may be suspended or revoked by reason of amendments to the Act, by reason of requirements of this chapter or orders issued by the agency.

(B) Any certificate of registration may be revoked, suspended, or modified, in whole or in part, for any of the following:

(i) any material false statement in the application or any statement of fact required under provisions of the Act;

(ii) conditions revealed by such application or statement of fact or any report, record, or inspection, or other means that would warrant the agency to refuse to grant a certificate of registration on an original application;

(iii) violation of, or failure to observe any of the terms and conditions of the Act, this chapter, the certificate of registration, or order of the agency; or

(iv) existing conditions that constitute a substantial threat to the public health or safety or the environment.

(C) Each certificate of registration revoked by the agency ends at the end of the day on the date of the agency's final determination to revoke the certificate of registration, or on the revocation date stated in the determination, or as otherwise provided by the agency order.

(D) Except in cases in which the occupational and public health or safety requires otherwise, no certificate of registration shall be suspended or revoked unless, prior to the institution of proceedings therefore, facts or conduct that may warrant such action shall have been called to the attention of the registrant in writing and the registrant shall have been afforded an opportunity to demonstrate compliance with all lawful requirements.

(10) [(9)] Reciprocal recognition for out-of-state certificates of registration.

(A) Whenever any radiation machine is to be brought into the state for any temporary use, the person proposing to bring the machine into the state shall apply for and receive a notice from the agency granting reciprocal recognition prior to beginning operations. The request for reciprocity shall include the following:

(i) completed BRC Form 226-1 (Business Information Form);

(ii) completed BRC Form 252-3 (Notice of Intent to Work in Texas Under Reciprocity);

(iii) copy of the applicant's current state certificate of registration or equivalent document;

(iv) copy of the applicant's current operating and safety procedures pertinent to the proposed use; and

(v) fee as specified in subsection (g) of this section.

(B) Upon a determination that the request for reciprocity meets the requirements of the agency, the agency may issue a notice granting reciprocal recognition authorizing the proposed use.

(C) Once reciprocity is granted, the out-of-state registrant shall file a BRC Form 252-3 with the agency prior to each entry into the state. This form shall be filed at least three working days before the radiation machine is to be used in the state. If, for a specific case, the three-day period would impose an undue hardship, the out-of-state registrant may, at the determination of the agency, obtain permission to proceed sooner.

(D) When radiation machines are used as authorized under reciprocity, the out-of-state registrant shall have the following in its possession at all times for inspection by the agency:

(i) completed BRC Form 252-3;

(ii) copy of the notice from the agency granting reciprocity;

(iii) copy of the out-of-state registrant's operating and safety procedures; and

(iv) copy of the applicable rules as specified in the notice granting reciprocity.

(E) If the state from which the radiation machine is proposed to be brought does not issue certificates of registration or equivalent documents, a certificate of registration shall be obtained from the agency in accordance with the requirements of this section.

(F) The agency may withdraw, limit, or qualify its acceptance of any certificate of registration or equivalent document issued by another agency upon determining that such action is necessary in order to prevent undue hazard to occupational and public health and safety or property.

(G) Reciprocal recognition will expire one year from the date it is granted. A new request for reciprocity shall be submitted to the agency each year. Reciprocity requests made after the initial request shall include only the following:

(i) a completed BRC Form 226-1;

(ii) a completed BRC Form 252-3;

(iii) the fee as specified in subsection (g) of this section; and

(iv) copy of the applicant's current state certificate of registration or equivalent document; and

(v) copy of the applicant's current operating and safety procedures pertinent to the proposed use.

(i) Use of radiation machines for veterinary medicine.

(1) - (2) (No change.)

(3) Personnel requirements.

(A) - (E) (No change.)

(F) Determination of occupational dose for the current year.

(i) - (vi) (No change.)

(vii) Occupational exposure form. The following BRC Form 233-1 (Occupational Exposure Record for a Monitoring Period), is to be used to document occupational exposures for a monitoring period.

Figure: 25 TAC §289.233(i)(3)(F)(vii) (.pdf)

[Figure: 25 TAC §289.233(i)(3)(F)(vii)]

(G) - (L) (No change.)

(4) Facility requirements.

(A) (No change.)

(B) Posting of notices to workers.

(i) - (ii) (No change.)

(iii) The following form, BRC [Bureau of Radiation Control (BRC)] Form 233-2, "Notice to Employees," which is found at the end of the section, or an equivalent document containing at least the same wording as BRC Form 233-2.

Figure: 25 TAC §289.233(i)(4)(B)(iii) (.pdf)

[Figure: 25 TAC §289.233(i)(4)(B)(iii)]

(iv) (No change.)

(C) - (H) (No change.)

(5) Radiation Machine Requirements.

(A) - (G) (No change.)

(H) Beam limiting devices. Beam limiting devices shall do the following:

(i) - (iii) (No change.)

(iv) limit the x-ray field such that the x-ray field shall not exceed:

(I) (No change.)

(II) 2.0% of the SID for the diagonal of the image receptor [for circular image receptors]; and

(v) (No change.)

(I) - (M) (No change.)

(N) Equipment performance evaluations.

(i) - (iv) (No change.)

(v) Fluoroscopic x-ray systems shall comply with the additional requirements specified in paragraph (6) of this subsection.

(6) - (11) (No change.)

(j) Records and reports.

(1) General provisions for records and reports.

(A) - (J) (No change.)

(K) Any person who submits written information or data to the agency and requests that the information be considered confidential, privileged, or otherwise not available to the public under the Texas Public Information Act, shall justify such request in writing, including statutes and cases where applicable, addressed to the agency.

(i) Documents containing information that is claimed to fall within an exception to the Texas Public Information Act shall be marked to indicate that fact. Markings shall be placed on the document on origination or submission.

(I) (No change.)

(II) The following wording shall be placed at the bottom of the front cover and title page, or first page of text if there is no front cover or title page:

Figure: 25 TAC §289.233(j)(1)(K)(i)(II)

[Figure: 25 TAC §289.233(j)(1)(K)(i)(II)]

(ii) - (iii) (No change.)

(L) - (P) (No change.)

(2) (No change.)

(3) Reports.

(A) - (B) (No change.)

(C) Reports of exposures and radiation levels exceeding the limits.

(i) In addition to the notification required by subparagraph (B) of this paragraph, each registrant shall submit a written report within 30 days after learning of any of the following occurrences:

(I) (No change.)

(II) doses in excess of any of the following:

(-a-) - (-d-) (No change.)

(-e-) any applicable limit in the certificate of registration;

(III) (No change.)

(ii) (No change.)

(iii) Each report filed in accordance with clause (i) of this subparagraph shall include for each individual exposed: the name, a unique identification number [social security number ], and date of birth. With respect to the limit for the embryo/fetus in subsection (i)(3)(A)(i)(IV) of this section, the identifiers should be those of the declared pregnant woman. The report shall be prepared so that this information is stated in a separate and detachable portion of the report.

(iv) (No change.)

(D) (No change.)

(k) Compliance and hearing procedures.

(1) (No change.)

(2) Hearing and enforcement procedures.

(A) - (B) (No change.)

(C) Compliance procedures for registrants and other persons.

(i) A registrant or other person who commits a violation(s) will be issued a notice of violation. The person receiving the notice shall provide the agency with a written statement and supporting documentation by the date stated in the notice describing the following:

(I) steps taken by the person and the results achieved;

(II) corrective steps to be taken to prevent recurrence; and

(III) the date when full compliance was or is expected to be achieved. The agency may require responses to notices of violation to be under oath.

(ii) - (iv) (No change.)

(v) When the agency determines that the action provided for in clause (viii) of this subparagraph or subparagraph (D) of this paragraph is not to be taken immediately, the agency may offer the registrant an opportunity to attend an informal meeting [ enforcement conference] to discuss the following with the agency:

(I) - (II) (No change.)

(vi) Notice of any informal meeting [ enforcement conference] shall be delivered by personal service, or certified mail, addressed to the last known address. An informal meeting [enforcement conference ] is not a prerequisite for the action to be taken in accordance with [under] clause (viii) of this subparagraph or subparagraph (D) of this paragraph.

(vii) Except in cases in which the occupational and public health, or safety requires otherwise, no certificate of registration shall be suspended or revoked unless, prior to the institution of proceedings therefore, facts or conduct that may warrant such action shall have been called to the attention of the registrant in writing, and the registrant shall have been afforded [accorded] an opportunity to demonstrate compliance with all lawful requirements.

(viii) - (ix) (No change.)

(D) Assessment of administrative penalties.

(i) - (ii) (No change.)

(iii) Application of administrative penalties. The agency may impose differing levels of penalties for different severity level violations and different classes of users as follows.

(I) - (II) (No change.)

(III) Adjustments to the [severity levels and] percentages of base amounts in Table IIB may be made for the presence or absence of the following factors:

(-a-) - (-f-) (No change.)

(IV) The penalty for each violation may be in an amount not to exceed $10,000 a day for a person who violates the Act or requirements of this chapter, order, certificate of registration issued in accordance with [under] the Act. Each day a violation continues may be considered a separate violation for purposes of penalty assessment.

(iv) (No change.)

(E) Severity levels of violations for registrants or other persons.

(i) (No change.)

(ii) Criteria to elevate or reduce severity levels.

(I) Severity levels [Violations] may be elevated to a higher severity level for the following reasons:

(-a-) - (-c-) (No change.)

(-d-) a violation was willful or grossly negligent; [ . This means the violation was the result of careless regard for requirements, deception, or other indications of willfulness by the registrant or employees of the registrant; or]

(-e-) compliance history ; or [.]

(-f-) other mitigating factors.

(II) Severity levels [Violations] may be reduced to a lower level for the following reasons:

(-a-) the registrant identified and corrected the violation prior to the agency inspection; [or]

(-b-) the registrant's actions corrected the violation and prevented recurrence ; or [.]

(-c-) other mitigating factors.

(iii) (No change.)

(F) - (H) (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 March 6, 2008.

TRD-200801332

Lisa Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: April 20, 2008

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

25 TAC §289.301

STATUTORY AUTHORITY

The proposed amendments are authorized by Health and Safety Code, §12.0111, which requires the department to charge fees for issuing or renewing a license; Health and Safety Code, §401.301, which allows the department to collect fees for radiation control licenses and registrations that it issues; 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 proposed amendments affect the Health and Safety Code, Chapters 12, 401, and 1001; and Government Code, Chapters 531 and 2001.

§289.301.Registration and Radiation Safety Requirements for Lasers and Intense-Pulsed Light Devices.

(a) Purpose.

(1) (No change.)

(2) This section establishes requirements for the registration of persons who receive, possess, acquire, transfer, or use Class 3b (IIIb), International Electrotechnical Commission (IEC) Class 3B and Class 4 (IV), IEC Class 4 lasers in the healing arts, veterinary medicine, industry, academic, research and development institutions, and of persons who are in the business of providing laser services. No person shall use Class 3b (IIIb), IEC Class 3B or 4 (IV), IEC Class 4 lasers or perform laser services except as authorized in a certificate of laser registration issued by the agency in accordance with the requirements of this section. Class 1 (I) lasers [laser], IEC Class 1 and 1M, Class 2 (II) lasers [laser], IEC Class 2 and 2M, and Class 3a (IIIa) lasers [laser], IEC Class 3R and IPL devices are not required to be registered. However, use of Class 1 (I) lasers [laser], IEC Class 1 and 1M, Class 2 (II) lasers [laser], IEC Class 2 and 2M, and Class 3a (IIIa) lasers [laser], IEC Class 3R and IPL devices are subject to other applicable requirements in this section.

(b) Scope.

(1) - (4) (No change.)

(5) In addition to the requirements of this section, all registrants authorized to use Class 3b and Class 4 lasers are subject to the following requirements:

(A) (No change.)

(B) §289.204 of this title (relating to Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services);

(C) - (D) (No change.)

(c) (No change.)

(d) Definitions. The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise.

(1) - (13) (No change.)

(14) Continuous wave--The output of a laser that is operated in a continuous rather than a pulsed mode. In this section, a laser operating with a continuous output for a period of ≥ [>=]0.25 seconds is regarded as a continuous wave laser.

(15) - (35) (No change.)

(36) Practitioner of the healing arts (practitioner)--For the purposes of this section, a person licensed to practice the healing arts by either the Texas Medical Board [ Texas State Board of Medical Examiners ] as a physician; the Texas State Board of Dental Examiners; the Texas Board of Chiropractic Examiners; or the Texas State Board of Pediatric Medicine [Texas State Board of Podiatry Examiners]. A practitioner's use of a laser is limited to his/her scope of professional practice as determined by the appropriate licensing agency.

(37) - (47) (No change.)

(e) - (i) (No change.)

(j) Responsibilities of registrant.

(1) - (2) (No change.)

(3) Each registrant shall inventory all Class 3B and 4 lasers in their possession at an interval not to exceed one year. The inventory record shall be maintained for inspection by the agency in accordance with subsection (ee) of this section and shall include:

(A) - (D) (No change.)

(E) if using a provider of lasers as defined in subsection (d)(38) [in accordance with subsection (d)(35)] of this section, a statement with the inventory that the registrant is using lasers provided by a provider of lasers.

(4) Notification to the agency is required within 30 days of the following:

(A) (No change.)

(B) if the registrant begins or terminates the use of a provider of lasers as defined in subsection (d)(38) [ in accordance with subsection (d)(35)] of this section.

(5) - (8) (No change.)

(k) Expiration of certificates of laser registration [ and administrative renewal].

(1) [Effective September 1, 2004, the term of the certificate of registration is two years. ] Except as provided by subsection (m) of this section, each certificate of laser registration expires at the end of the day, in the month and year stated in the certificate of laser registration. [Except for subsection (m)(5) of this section, upon payment of the fee required by §289.204 of this title and if the agency does not deny the renewal in accordance with subsection (i)(4) of this section, the certificate of laser registration will be administratively renewed. The requirements in this subsection are subject to the provisions of Government Code, §2001.054.]

[(2) If the fee is not paid and the certificate of laser registration is not renewed in accordance with paragraph (1) of this subsection, the certificate of laser registration expires, and the registrant is in violation of the requirements of this chapter and is subject to administrative penalties in accordance with §289.205 of this title.]

[(A) If the registrant pays the fee required by §289.204 of this title within 30 days after expiration of the certificate of laser registration, the certificate of laser registration will be reinstated and the registrant will not be required to file an application in accordance with subsection (g) of this section. ]

[(B) If the registrant fails to pay the fee within 30 days after expiration of the certificate of laser registration, the registrant shall file an application in accordance with subsection (g) of this section.]

(2) [(3)] If a registrant does not submit an application for renewal of the certificate of laser registration in accordance with subsection (m) of this section, as applicable, the registrant shall on or before the expiration date specified in the certificate of laser registration [ fails to pay the fee required by §289.204 of this title and the certificate of laser registration is not renewed, the registrant shall]:

(A) terminate use of all lasers and/or terminate laser servicing or laser services authorized under the certificate of laser registration;

(B) submit to the agency a record of the disposition of the lasers, if applicable, and if transferred, to whom it was transferred within 30 days following the expiration date ; and [.]

(C) pay any outstanding fees in accordance with §289.204 of this title.

(3) [(4)] Expiration of the certificate of laser registration does not relieve the registrant of the requirements of this chapter.

(l) (No change.)

(m) Renewal [Technical renewal] of certificate of laser registration.

(1) An [If required by the certificate of laser registration, an] application for [ technical] renewal of a certificate of laser registration shall be filed in accordance with subsection (g)(1)(A) - (B), and (E) - (G) of this section and applicable paragraphs of subsections (g)(2),(4), and (7) of this section. [An application for a technical renewal of a certificate of laser registration shall be submitted to the agency by the date specified in the certificate of laser registration. If the registrant fails to apply and pay the fee required by §289.204 of this title, or the agency does not approve the application in accordance with subsection (h)(1) of this section, the certificate of laser registration expires and the registrant is in violation of the requirements of this chapter and is subject to administrative penalties in accordance with §289.205 of this title. The registrant shall comply with the requirements of subsection (k)(3) of this section.]

[(2) Expiration of the certificate of registration does not relieve the registrant of the requirements of this chapter.]

(2) [(3)] If a registrant files an application for a [technical ] renewal in proper form before the existing certificate of laser registration expires [ and pays the fee required by §289.204 of this title], such existing certificate of laser registration shall not expire until the application status has been determined by the agency.

[(4) An application for technical renewal of a certificate of laser registration will be approved if the agency determines that the requirements of subsection (g)(1) of this section and the applicable paragraphs of subsection (g)(2) - (8) of this section have been satisfied.]

[(5) When the date for administrative renewal in accordance with subsection (k)(1) of this section and the date for the technical renewal in accordance with paragraph (1) of this subsection occur at the same time, the certificate of laser registration will be renewed if the fee required by §289.204 of this title is paid, the technical renewal is approved by the agency in accordance with paragraph (4) of this subsection, and the agency does not deny the renewal in accordance with subsection (i)(4) of this section.]

[(6) When the date for the administrative renewal in accordance with subsection (k)(1) of this section and the date for the technical renewal in accordance with paragraph (1) of this subsection occur at the same time, the certificate of laser registration renewal may be denied by the agency if any one of the following conditions apply:]

[(A) the fee required by §289.204 of this title is not paid;]

[(B) the agency denies the renewal in accordance with subsection (i)(4) of this section; or]

[(C) the agency does not approve the technical renewal in accordance with paragraph (4) of this subsection.]

[ (7) The requirements in this subsection are subject to the provisions of Government Code, §2001.054.]

(n) - (q) (No change.)

(r) Requirements for protection against Class 3b or 4 lasers and IPL device radiation. These requirements are for Class 3b or 4 lasers and IPL devices in their intended mode of operation and include special requirements for service, testing, maintenance, and modification. During some operations, certain engineering controls may be inappropriate. In situations where an engineering control may be inappropriate, for example, during medical procedures or surgery, the LSO shall specify alternate controls to obtain equivalent safety protection.

(1) MPE. Each registrant or user of any laser shall not permit any individual to be exposed to levels of laser or collateral radiation higher than are specified in ANSI Z136.1-2000, Safe Use of Lasers and Title 21, CFR, §1040.10 [Part 1040.10] respectively.

(2) Instructions to personnel. Personnel operating each laser presently being used or listed on the registrant's current inventory, shall be provided with written instructions for safe use, including clear warnings and precautions to avoid possible exposure to laser and collateral radiation in excess of the MPE, as delineated in ANSI Z136.1-2000, Safe Use of Lasers and the collateral limits listed in Title 21, CFR, §1040.10 [Part 1040.10]. The instructions to personnel shall be maintained in accordance with subsection (ee) of this section for inspection by the agency.

(3) Engineering controls.

(A) - (B) (No change.)

(C) Viewing optics and windows.

(i) All viewing ports, viewing optics, or display screens included as an integral part of an enclosed laser or laser product shall incorporate suitable means, (such as interlocks, filters, or attenuators, to maintain the laser radiation at the viewing position at or below the applicable MPE as delineated in ANSI Z136.1-2000, Safe Use of Lasers and the collateral limits listed in Title 21, CFR, §1040.10 [Part 1040.10 ], under any conditions of operation of the laser.

(ii) (No change.)

(D) (No change.)

(E) Controlled area. With a Class 3b laser, except those that allow access only to less than 5 mW visible peak power, or Class 4 laser, a controlled area shall be established when exposure to the laser radiation in excess of the MPE, as delineated in ANSI Z136.1-2000, Safe Use of Lasers or the collateral limits listed in Title 21, CFR, §1040.10 [Part 1040.10] is possible. The controlled area shall meet the following requirements, as applicable.

(i) - (iv) (No change.)

(v) For Class 4 indoor controlled areas, optical paths (for example, windows) from an indoor facility shall be controlled in such a manner as to reduce the transmitted values of the laser radiation to levels at or below the appropriate ocular MPE, as delineated in ANSI Z136.1-2000, Safe Use of Lasers and the collateral limits listed in Title 21, CFR, §1040.10 [Part 1040.10]. [(]When the laser beam must exit the indoor controlled area (as in the case of exterior atmospheric beam paths), the operator shall be responsible for ensuring that air traffic is protected from any laser projecting into navigable air space (contact Federal Aviation Administration (FAA) or other appropriate agencies, as necessary) or controlled ground space when the beam irradiance or radiant exposure is above the appropriate MPE, as delineated in ANSI Z136.1-2000, Safe Use of Lasers.

(vi) When the removal of panels or protective covers and/or overriding of interlocks becomes necessary, such as for servicing, testing, or maintenance, and accessible laser radiation exceeds the MPE, as delineated in ANSI Z136.1-2000, Safe Use of Lasers and the collateral limits listed in Title 21, CFR, §1040.10 [Part 1040.10 ], a temporary controlled area shall be established and posted.

(4) (No change.)

(s) Additional requirements for special lasers and applications.

(1) (No change.)

(2) Laser optical fiber transmission system.

(A) (No change.)

(B) Disconnection of a connector resulting in access to radiation in excess of the applicable MPE limits, as delineated in ANSI Z136.1-2000, Safe Use of Lasers and the collateral limits listed in Title 21, CFR, §1040.10 [Part 1040.10], shall take place in a controlled area. Except for medical lasers whose manufacture has been approved by the FDA, the use of a tool shall be required for the disconnection of a connector for service and maintenance purposes when the connector is not within a secured enclosure. All connectors shall bear the appropriate label or tag specified in subsection (v)(3) of this section.

(t) Additional requirements for safe operation.

(1) Eye protection. Protective eyewear shall be worn by all individuals with access to Class 3b and/or Class 4 levels of laser radiation. Protective eyewear devices shall meet the following requirements:

(A) - (D) (No change.)

(E) be examined, at intervals not to exceed 12 months, to ensure the reliability of the protective filters and integrity of the protective filter frames. Unreliable eyewear shall be discarded. Documentation of the examination shall be made and maintained in accordance with subsection (ee) of this section for inspection by the agency.

(2) (No change.)

(u) (No change.)

(v) Caution signs, labels, and posting for lasers and IPL devices.

(1) - (2) (No change.)

(3) Labeling lasers and posting laser facilities. All signs and labels associated with Class 2, 3a, 3b, and 4 lasers shall contain the following wording.

(A) - (D) (No change.)

(E) Lasers, except lasers used in the practice of medicine, shall have a label(s) in close proximity to each aperture through which is emitted accessible laser or collateral radiation in excess of the limits specified in ANSI Z136.1-2000, Safe Use of Lasers and the collateral limits listed in Title 21, CFR, §1040.10 [ Part 1040.10], with the following wording as applicable.

(i) - (iii) (No change.)

(F) Each noninterlocked or defeatably interlocked portion of the protective housing or enclosure that is designed to be displaced or removed during normal operation or servicing, and that would permit human access to laser or collateral radiation, shall have labels as follows:

(i) - (ii) (No change.)

(iii) for collateral radiation in excess of the emission limits as described in Title 21, CFR, §1040.10 [Part 1040.10], "CAUTION - HAZARDOUS ELECTROMAGNETIC RADIATION WHEN OPEN" and "CAUTION - HAZARDOUS X-RAY RADIATION" as applicable.

(G) - (I) (No change.)

(4) In lieu of the requirements in paragraphs (1) - (3) of this subsection and subsection (dd) of this section, the agency will accept labeling and signage designated by the following:

(A) Title 21, CFR, §1040.10 [Part 1040.10];

(B) - (C) (No change.)

(w) Surveys. Each registrant shall make or cause to be made such surveys as may be necessary to comply with this section and maintain records of the surveys in accordance with subsection (ee) of this section for inspection by the agency. Surveys shall be performed at intervals not to exceed 12 months, to include but not be limited to the following:

(1) - (5) (No change.)

(x) Records/documents. Each registrant shall maintain current records/documents required by this subsection in accordance with subsection (ee) of this section for inspection by the agency.

(y) - (dd) (No change.)

(ee) Keeping records/documents. The following chart contains time requirements for keeping records/documents:

Figure: 25 TAC §289.301(ee)

[Figure: 25 TAC §289.301(ee)]

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 March 6, 2008.

TRD-200801333

Lisa Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: April 20, 2008

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