Proposed Rules Title 25

TITLE 25. HEALTH SERVICES

PART 1. DEPARTMENT OF STATE HEALTH SERVICES

CHAPTER 37. MATERNAL AND INFANT HEALTH SERVICES

The Executive Commissioner of the Health and Human Services Commission, on behalf of the Department of State Health Services (department), proposes the repeal of existing §§37.111 - 37.119 and proposes new §§37.111 - 37.119 concerning the Hemophilia Assistance Program (HAP).

BACKGROUND AND PURPOSE

The proposed repeal and new rules will reorganize and update information, delete and revise language, and make grammatical corrections to improve flow, accuracy, and clarity.

Government Code, §2001.039, requires that each state agency review and consider for re-adoption each rule adopted by that agency pursuant to the Government Code, Chapter 2001 (Administrative Procedure Act). Sections 37.111 - 37.119 have been reviewed, and the department has determined that reasons for adopting the sections continue to exist because rules on this subject are needed.

SECTION-BY-SECTION SUMMARY

The following changes to names and addresses have been made throughout §§37.111 - 37.119. References to legacy agencies, now part of the Health and Human Services Commission, have been amended to reflect the department's name change from "Texas Department of Health" to "Department of State Health Services," and references to the "Board of Health" have been deleted.

The proposed new §37.111 groups the terms "purpose," "confidentiality of information," and "forms" together.

The proposed new §37.112 includes new definitions for terms used with the rules.

The proposed new §37.113 clarifies the eligibility requirements, the application and eligibility dates, financial criteria, and residency requirements.

The proposed new §37.114 clarifies existing language, updates new language, and sets out conditions for benefits and limitations of the HAP.

The proposed new §37.115 clarifies provider enrollment criteria for the HAP, change of provider ownership requirements, the consequences for not continuing to meet the requirements, and provider limitations.

The proposed new §37.116 includes language for authorizations and claims processing, including filing deadlines.

The proposed new §37.117 includes language concerning rights and responsibilities for applicants, clients, providers, and participating providers.

The proposed new §37.118 includes language concerning modifications, suspensions, denials, and terminations for applicants, clients, providers, and participating providers.

The proposed new §37.119 clarifies the appeal process, describes the procedures for informal disposition of a complaint, and describes the procedures for an administrative review and fair hearing request.

FISCAL NOTE

Jann Melton-Kissel, RN, MBA, Director, Specialized Health Services Section, has determined that for each year of the first five-year period that the sections will be in effect, there will be no fiscal impact to state or local governments as a result of enforcing and administering the sections as proposed. The repeals and new sections are intended to clarify, update, and strengthen the subchapter, and are not anticipated to be controversial or have significant fiscal impact to the department or local government.

MICRO-BUSINESS AND SMALL BUSINESS IMPACT ANALYSIS

Ms. Melton-Kissel has also determined that there will be no effect on small businesses or micro-businesses required to comply with the sections as proposed, because neither small businesses nor micro-businesses that are providers of HAP will 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.

ECONOMIC IMPACT STATEMENT AND REGULATORY FLEXIBILITY ANALYSIS

Ms. Melton-Kissel has determined that the proposed changes have no adverse economic impact on small businesses. Therefore, an economic impact statement and regulatory flexibility analysis for small businesses are not required.

PUBLIC BENEFIT

Ms. Melton-Kissel has determined that for each year of the first five years the sections are in effect, the public will benefit from adoption of the sections. The public benefit anticipated as a result of enforcing or administering the sections is improved accuracy and consistency in the rules, and more accurate interpretation of their intent. In addition, the new rules will allow the program to function more efficiently and effectively.

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 proposal does not restrict or limit an owner's right to his or her property that would otherwise exist in the absence of government action and, therefore, does not constitute a taking under Government Code, §2007.043.

PUBLIC COMMENT

Comments on the proposal may be submitted by mail to Alesia Brown, Purchased Health Services Unit, MC 1938, Department of State Health Services, P.O. Box 149347, Austin, Texas 78714-9347, by telephone at (512) 458-7111, extension 3664, or by email to alesia.brown@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.

SUBCHAPTER F. HEMOPHILIA ASSISTANCE PROGRAM

25 TAC §§37.111 - 37.119

(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 Government Code, §531.0055(e), and the 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 proposed repeals affect Government Code, Chapter 531; and Health and Safety Code, Chapter 1001.

§37.111.General.

§37.112.Recipient Requirements.

§37.113.Residency and Residency Documentation Requirements.

§37.114.Applications and Eligibility Date.

§37.115.Financial Criteria.

§37.116.Limitations and Benefits Provided.

§37.117.Participating Providers.

§37.118.Forms.

§37.119.Confidentiality of 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 August 18, 2008.

TRD-200804425

Lisa Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: September 28, 2008

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

25 TAC §§37.111 - 37.119

STATUTORY AUTHORITY

The proposed new sections are authorized by Government Code, §531.0055(e), and the 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 proposed new sections affect Government Code, Chapter 531; and Health and Safety Code, Chapter 1001.

§37.111.General Information.

(a) Purpose. The purpose of this chapter is to establish rules for the Hemophilia Assistance Program (HAP). The authority for these rules is granted in the Health and Safety Code, Chapter 41.

(b) Confidentiality of Information.

(1) All information submitted, as required by this chapter, may be verified at the discretion of the Department of State Health Services (department) with or without notice to the applicant or client of benefits of the HAP, or to the providers of HAP services. Information required by this chapter and received by the department is kept confidential to the extent authorized by law.

(2) Information may be disclosed in summary, statistical, or other forms that do not identify particular individuals.

(c) Forms that have been developed by the department for use in the HAP will be provided to applicants, clients, and providers.

§37.112.Definitions.

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

(1) Administrative review--A process that allows applicants or clients the opportunity to request an informal review of any intended HAP action that would suspend, modify, deny, or terminate their eligibility for benefits participation in the HAP or reimbursement for allowable products.

(2) Allowable products--Blood derivatives, blood concentrates, and manufactured pharmaceutical products indicated for the treatment of hemophilia and approved for payment by the HAP.

(3) Applicant--An individual whose application has been submitted, but HAP has not made a final determination of eligibility. This includes an individual whose application is submitted by a representative or person with legal authority to act for the individual.

(4) Client--A person who has applied for program services and who meets all HAP eligibility requirements and is determined to be eligible for program services.

(5) Commission--The Health and Human Services Commission (HHSC).

(6) Date of service (DOS)--The date the allowable products are dispensed.

(7) Department--Department of State Health Services.

(8) Effective date--The initial date of eligibility for a HAP client.

(9) Fair hearing--The informal hearing process the department follows under 25 Texas Administrative Code (TAC), §§1.51 - 1.55 (relating to Fair Hearing Procedures).

(10) Federal Poverty Level guidelines (FPL)--The minimum income needed by a family for food, clothing, transportation, shelter, and other necessities in the United States, according to the United States Department of Health and Human Services, or its successor agency/agencies. FPL vary according to family size, and after adjustment for inflation, are published annually in the Federal Register.

(11) Filing deadline--The last date that a claim may be received by the HAP and still be considered for benefits eligibility.

(12) Hemophilia Assistance Program (HAP)--A program funded by the State of Texas that provides limited financial assistance to persons age 21 and older who have been diagnosed with hemophilia and meet other program eligibility requirements for blood derivates, blood concentrates, and manufactured pharmaceutical products that are administered or dispensed by program-approved providers.

(13) Hemophilia--A human physical condition characterized by bleeding, resulting from a genetically determined deficiency of a blood coagulation factor or an abnormal or deficient plasma procoagulant that prevents the blood from clotting properly. The diagnoses covered by the HAP include:

(A) congenital factor VIII disorder (Hemophilia A);

(B) congenital factor IX disorder (Hemophilia B); and

(14) Inhibitor--A type of antibody that requires the use of higher doses of blood factor to contain a bleeding episode.

(15) Provider--Any individual or entity approved by the HAP to provide allowable products to HAP clients.

(16) Physician--An individual licensed by the Texas Medical Board to practice medicine in the State of Texas.

(17) Reimbursement--Payment of a claim for allowable products administered or dispensed to a HAP client submitted by a provider.

(18) Reimbursement rate--The HAP payment rate for allowable products, determined annually for the following fiscal year based on the current year's Texas Medicaid Program reimbursement rate.

§37.113.Eligibility.

(a) Client Requirements. A person shall meet all of the following requirements to be eligible for benefits from the HAP:

(1) have a diagnosis of hemophilia certified by a physician;

(2) be 21 years of age or older;

(3) be a resident of Texas as specified in subsection (d) of this section and not be:

(A) incarcerated in a city, county, state, or federal jail, or prison; or

(B) a ward of the state.

(4) submit a complete application for benefits to the HAP;

(5) satisfy the financial criteria as specified in subsection (c) of this section, including any person or persons who have a legal obligation to support the client; and

(6) the applicant must not be eligible for Children with Special Needs Services Program, the Texas Medicaid Program, or Medicare.

(b) Applications and Eligibility Dates.

(1) Persons meeting the eligibility requirements set forth in subsection (a) of this section must submit a complete application in order to receive benefits through the HAP.

(2) An eligibility determination will be made upon receipt of a complete application, which shall consist of all of the following:

(A) a complete Application for Assistance Form, with the applicant's, or the applicant's representative's, and physician's original signatures or "mark";

(B) documentation of Texas residency as specified in subsection (d) of this section; and

(3) Any application which does not meet all of the requirements of paragraph (2) of this subsection is incomplete and shall be returned to the submitting person for correction or completion if the missing information is not otherwise provided.

(4) The HAP eligibility date for HAP benefits will be either:

(A) the date the HAP receives a completed application; or

(B) the date of conditional authorization for allowable products, if all written information to establish eligibility is received within 30 calendar days following the date of conditional authorization.

(5) If HAP benefits are terminated, the eligibility date for any subsequent benefit period will be the date on which the HAP receives a subsequent completed application for HAP benefits or the date of conditional authorization for allowable products, if all written information to establish eligibility is received within 30 calendar days following the date of conditional authorization.

(6) All HAP clients are required to submit valid residency and income verification information as outlined in subsections (c) and (d) of this section upon request and at least annually, in order for the HAP to determine continuing program eligibility.

(7) The denial of any application submitted to the HAP shall be in writing and shall include the reason(s) for such denial. The applicant has the right of appeal as outlined in §37.119 of this title (relating to Right of Appeal).

(1) Income must be at or below 200% of the FPL.

(2) Acceptable income verification documentation as described in paragraph (3)(C) of this subsection shall be submitted with the application. Changes in income or financial qualifications that would affect the applicant's eligibility shall be reported to the HAP.

(3) Financial need is established on the basis of income available to the applicant and the person(s) who have a legal obligation to support the applicant. If the applicant and person(s) who have a legal obligation to support the applicant are unemployed, a statement(s) of termination from the employer(s), or other documentation acceptable to the HAP, is required.

(A) The income used to determine eligibility is the combined gross income of the applicant and of all persons who have a legal obligation to support the applicant.

(B) Income includes, but is not limited to:

(i) earned wages;

(ii) pensions;

(iii) allotments;

(iv) alimony; and

(v) any other monies received on a regular basis for support purposes.

(i) employer's written verification of gross monthly income;

(ii) the most recent pay check stub/monthly employee earnings statement;

(iii) Internal Revenue Service Income Tax Return forms for the most recently completed year;

(iv) pension/allotment award letters; or

(v) any other documents considered valid by the HAP.

(d) Residency Requirements.

(1) The following conditions shall be met by an applicant and maintained by a client to satisfy the residency requirements in this section:

(A) physically reside within the state; and

(B) maintain a home or abode within the state.

(2) If the applicant is a legal dependent of, and residing with, a person establishing residency on behalf of the applicant (such as a parent, a sibling, an adult child, or spouse), or if the applicant is a person under legal guardianship, then the person providing support or the legal guardian of the applicant must meet the requirements of paragraph (1) of this subsection.

(3) If the applicant is a parent residing with an adult child who meets the requirements of paragraph (1) of this subsection, residency may be established through the adult child.

(4) If the applicant is a parent being supported by an adult child, whether or not the child meets the requirements of paragraph (1) of this subsection, the parent applicant's residency may be established by the adult child's providing the required documents that establish the Texas residency of the parent applicant.

(5) The provisions of paragraphs (3) and (4) of this subsection apply, even if no legal guardianship has been established.

(6) An applicant who is currently a Texas resident and currently approved to receive benefits from Temporary Assistance for Needy Families (TANF) or Food Stamps is not required to provide additional residency verification.

(7) A person establishing residency on behalf of the applicant, who is currently a Texas resident and currently approved to receive benefits from Temporary Assistance for Needy Families (TANF) or Food Stamps, is not required to provide additional residency verification.

(8) An applicant or person establishing residency on behalf of the applicant, may submit a copy of any one of the following documents as evidence of residency. All documents shall be in the applicant's name or in the name of the person establishing residency for the applicant, and provide verification of a Texas address or domicile:

(A) a valid Texas driver license, or an identification card issued by the Texas Department of Public Safety;

(B) a valid Texas voter's registration card, or a copy of a validated (by a Texas county clerk's office) application for a voter's registration card;

(D) a statement reflecting that the applicant is currently receiving rent-free housing. The statement must be signed by an individual responsible for providing the rent-free housing and must include the address and phone number of the individual or the organization providing the rent-free housing;

(E) a Texas property tax receipt for the most recently completed tax year; or

(F) any of the following documents, which must not be older than three months immediately preceding the applicant's signature date on the HAP application not including the application month:

(i) a mortgage payment receipt;

(ii) a rent payment receipt;

(iii) a utility payment receipt;

(iv) a dated payroll or retirement check;

(v) prepared employment/unemployment records;

(vi) an account statement from a financial institution;

(vii) Social Security supplemental income or disability income records, or Social Security retirement benefit records; or

(viii) any other documents deemed appropriate by the HAP.

(e) Legal Relationship. If the applicant's residency is established through the residency of another person, the following conditions must be met.

(1) The applicant must include documentation of the legal relationship between the applicant and the resident or person providing financial support, such as:

(A) a marriage license or declaration of non-ceremonial marriage to document the marriage of the applicant and spouse;

(B) a birth certificate establishing the parent-child relationship between the applicant and the resident; or

(2) Any difference between the name of the applicant and the name on any document must be explained by additional documentation (example: marriage license, divorce decree, or adoption decree).

§37.114.Benefits and Limitations.

(a) The HAP provides limited reimbursement to providers for blood derivatives, blood concentrates, and manufactured pharmaceutical products indicated for the treatment of hemophilia and prescribed to eligible clients for use in medical or dental facilities, or in the home.

(b) All HAP benefits are limited to those allowable products prescribed by a physician and received in Texas from a provider.

(1) available funds;

(2) established limits for allowable products by type or category of product; and

(3) the reimbursement rates established by the department.

(d) Eligible clients with a private or group health insurance must exhaust all benefits prior to receiving benefits from the HAP.

(e) The HAP is payer of last resort. Applicants and currently eligible HAP clients are no longer eligible when they become eligible for the Children with Special Heath Care Needs (CSHCN) Services Program, the Texas Medicaid Program, or Medicare.

(f) To meet budgetary limitations, the department may:

(1) adjust the reimbursement rates established by the department;

(2) restrict the allowable products paid for under the HAP;

(3) adjust the established limits for allowable products;

(4) adjust the limits established based on the inhibitor status of the client or applicant;

(5) limit the number of providers approved to participate in the HAP; or

(6) establish a waiting list of persons eligible for the HAP. Appropriate information will be collected from each applicant who is placed on a waiting list. The information will be used to facilitate contacting the applicant and to allow efficient enrollment of the applicant when benefits become available. Eligibility must be maintained while on the waiting list.

§37.115.Providers.

(a) Applicable provider types for the HAP include, but are not limited to:

(1) pharmacies;

(2) hospitals; or

(3) blood blanks.

(b) In order for a provider to qualify for participation and to enroll in the HAP, the provider shall meet the following criteria:

(1) enter into an agreement to participate in the HAP;

(2) submit a completed HAP provider enrollment form to the HAP;

(3) submit a completed department Child Support Certification form to the HAP;

(4) be a current Texas Medicaid Program provider;

(5) reimburse the HAP for any overpayments made to the provider by the HAP upon request;

(6) not currently be on suspension as a HAP provider or as a Texas Medicaid Program provider;

(7) accept the payment amount authorized by the HAP as payment in full; and

(8) comply with provisions of the most current HAP Provider Manual.

(c) Changes in provider ownership require termination of the agreement to participate. A new agreement must be executed under the new ownership.

(d) The HAP may establish provider enrollment limitations in order to conserve funds, assure quality, and effectively administer the program.

(e) The HAP may modify, suspend, deny, or terminate a provider's approval to participate for the following reasons:

(1) submission of false or fraudulent claims;

(2) failure to provide and maintain quality services;

(3) failure to adhere to medically acceptable standards;

(4) breach of the provider agreement;

(5) disenrollment as a Texas Medicaid Program provider; or

(6) violation of the requirements of this chapter.

§37.116.Payment.

(a) Prior Authorization.

(1) Prior authorization is required for all allowable products.

(2) The HAP will grant conditional prior authorization for applicants who begin or are in the process of acquiring eligibility for the HAP. Providers must notify the HAP within five working days from the date of service.

(b) The HAP reimburses providers for allowable product(s) for eligible clients. Payment may be made only after the allowable product(s) has been dispensed and submission of a valid claim. Claims must meet the following criteria:

(1) be submitted on the claim form accepted by the HAP;

(2) be submitted by a HAP provider; and

(3) be filed directly with the HAP.

(1) Complete claims must be received by the HAP within 95 calendar days following the date of service.

(2) Incomplete and rejected claims will be denied.

(3) Denied claims may be considered for payment if the claim is corrected and resubmitted within 30 calendar days following the date of the HAP notice of denial or within the initial 95 calendar day filing deadline, whichever is later.

(d) Claims for products or services not allowed or covered by this chapter or for products provided to ineligible clients will not be reimbursed.

(e) The HAP is the payer of last resort. Applicants and currently eligible HAP clients are not eligible when they become eligible for CSHCN Services Program, Texas Medicaid Program or Medicare.

(f) The HAP reimbursement provides for only those products determined allowable by the HAP.

(g) Claims received by the HAP will be paid, rejected, or denied within 30 calendar days of receipt by the HAP.

§37.117.Rights and Responsibilities.

(a) Rights.

(1) The applicant and client shall have the right to:

(A) apply for eligibility determination;

(B) choose providers subject to the HAP limitations;

(D) appeal the HAP decision and receive a response within the deadline as described in §37.119 of this title (relating to Right of Appeal); and

(E) have confidentiality of information in the manner and to the extent authorized by law.

(2) The provider shall have the right to:

(A) apply and enroll as a provider;

(B) be notified of the HAP decision relating to modifications, suspensions, denials, or terminations; and

(b) Responsibilities.

(1) The applicant and client shall have the responsibility to:

(A) provide accurate medical information to providers and notify providers of HAP eligibility prior to delivery of services;

(B) provide the HAP with accurate information regarding any change of circumstance which might affect eligibility within 30 calendar days following such change; and

(C) notify the HAP of any lawsuit(s) contemplated or filed concerning the cause of the medical condition for which the HAP has made payment.

(2) The provider shall have the responsibility to:

(A) enroll as a HAP provider and submit a completed application to the HAP, including all documents requested;

(B) abide by the HAP rules and regulations;

(D) notify the HAP of any lawsuit(s) contemplated or filed concerning the cause of the medical condition for which the HAP has made payment.

§37.118.Modifications, Suspensions, Denials and Terminations.

(a) Any applicant or client shall be notified in writing of the action, the reason(s) for the action, and the right of appeal in accordance with §37.119 of this title (relating to Right of Appeal), if the HAP proposes to modify, suspend, deny, or terminate eligibility or benefits for reasons, which include but are not limited to the following:

(1) the application or other requested information is erroneous or falsified;

(2) financial eligibility requirements are not met;

(3) failure to establish or maintain Texas residency;

(4) financial and/or residency documentation is not provided as required or requested;

(5) failure to provide information when requested;

(6) client is or becomes incarcerated in a city, county, state, or federal jail, or prison;

(7) client is or becomes a ward of the state;

(8) failure to receive allowable products through a provider; or

(9) failure to continue premium payments on individual or group insurance or prepaid medical plans, where such plans provide benefits for the care and treatment of persons who have hemophilia and eligibility for benefits under the plan(s) was effective prior to eligibility for the HAP, and failure to provide a statement on the application form outlining the reason(s) why such insurance cannot be maintained.

(b) When eligibility for HAP benefits is terminated, an applicant or client may reapply for the HAP benefit.

(c) Any provider shall be notified in writing, if the HAP modifies, suspends, denies, or terminates a client's benefits or provider's enrollment. The written notification shall include the reason(s) for the action. The reasons for modifying, suspending, denying, or terminating a provider's enrollment include but are not limited to:

(1) failure to maintain required current licensures or certifications in the State of Texas;

(2) failure to maintain status as a Texas Medicaid Program provider;

(3) failure to have a current HAP provider agreement on file;

(4) failure to submit a completed department Child Support Certification form on file;

(5) failure to notify the HAP of change of ownership;

(6) failure to comply with all the provisions of the HAP provider agreement and the Provider Manual; or

(7) reduction or curtailment in funds available for the HAP.

§37.119.Right of Appeal.

(a) Appeal procedures for applicants, and clients.

(1) Administrative Review.

(A) If the HAP intends to modify, suspend, deny, or terminate benefits, the HAP shall give written notice of the reason and the right to request an administrative review of the denial within 30 calendar days following the date of the denial notice.

(B) If a written request for administrative review is not received by the HAP within the 30 calendar days following the date of the denial notice, the HAP will presume the administrative review process has been waived, and the HAP proposed action shall be final.

(C) If a written request for administrative review is received within 30 calendar days following the date of the denial notice, the HAP will conduct an administrative review of the circumstances on which the proposed modification, suspension, denial, or termination is based and give written notice of the HAP decision including the supporting reasons within 10 calendar days of receipt of the request for an administrative review.

(2) The Commission establishes the Texas Medicaid Program reimbursement rate upon which the HAP bases its reimbursement rate(s). Clients may not request an administrative review and may not appeal prior authorization decisions and reimbursement amounts for claims that are paid in accordance with the reimbursement rate as defined in §37.112(18) of this title (relating to Definitions).

(b) Fair Hearing.

(1) Applicants, and clients who are dissatisfied with a HAP administrative review decision and/or supporting reasons may request a fair hearing in writing addressed to the Hemophilia Assistance Program, Purchased Health Services Unit MC 1938, Department of State Health Services, P.O. Box 149347, Austin, Texas 78714-9347, within 20 calendar days following the date of receipt of the administrative review decision notice.

(2) If the request for a fair hearing is not received within 20 calendar days following the date of the receipt of the administrative review decision notice, the HAP will presume the fair hearing process has been waived, and the HAP may take final action.

(3) A fair hearing shall be conducted in accordance with §§1.51 - 1.55 of this title (relating to Fair Hearing Procedures).

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 August 18, 2008.

TRD-200804426

Lisa Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: September 28, 2008

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

CHAPTER 289. RADIATION CONTROL

SUBCHAPTER D. GENERAL

25 TAC §289.201, §289.202

(Editor's note: In accordance with Texas Government Code, §2002.014, which permits the omission of material which is "cumbersome, expensive, or otherwise inexpedient," the figure in 25 TAC §289.202(ggg)(2)(F) is not included in the print version of the Texas Register. The figure is available in the on-line edition of the August 29, 2008, issue of the Texas Register.)

The Executive Commissioner of the Health and Human Services Commission, on behalf of the Department of State Health Services (department), proposes an amendment to §289.201, concerning general provisions for radioactive material, and an amendment to §289.202, concerning standards for protection against radiation from radioactive materials.

BACKGROUND AND PURPOSE

The amendment to §289.201 corrects references, revises the definition of byproduct material, clarifies the definition of radiation safety officer, and adds definitions for discrete source and waste as required for compatibility with the U.S. Nuclear Regulatory Commission (NRC). Clarification is made in the rule for records of receipt, transfer, and disposal of sources of radiation, and a time frame is added for action to be taken for a radioactive sealed source that has been determined to be leaking. The address included for communications, reports, and applications has been updated.

The amendment to §289.202 is necessary for compatibility with the NRC. Texas, as an agreement state, must maintain rules that are compatible with NRC rules. These changes include clarification for the use of deep-dose equivalent and effective dose equivalent in determining occupational dose limits, and a requirement that portable gauge licensees use a minimum of two independent physical controls to secure gauges whenever they are not under the control and constant surveillance of the licensee. Clarification is added for waste disposal at approved facilities to be consistent with the new definition of byproduct material being proposed in §289.201 of this title. References to uranium rules are being deleted as a result of Senate Bill (SB) 1604, 80th Legislature, 2007, amending Health and Safety Code, §401.011, which transferred the regulatory authority for licensing and inspection of low-level waste processing and uranium recovery and disposal from the department to the Texas Commission on Environmental Quality (TCEQ). The elements, nitrogen and oxygen, are added to the list of elements and the table of values for annual intake for reasons of NRC compatibility. The date for submission to the NRC of the initial inventory for the National Source Tracking System is being changed based on compatibility with the NRC.

Government Code, §2001.039, requires that each state agency review and consider for readoption each rule adopted by that agency pursuant to the Government Code, Chapter 2001 (Administrative Procedure Act). Sections 289.201 and 289.202 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

The reference to the table listed in §289.201(b)(9)(A) has been revised. The definition of byproduct material in §289.201(b)(15) has been revised in order to maintain compatibility with the NRC. The definition of discrete source in §289.201(b)(28) is added in order to maintain compatibility with the NRC. Section 289.201(b)(71) corrects the reference to the Texas Medical Board. Section 289.201(b)(80) has information added to the definition of radiation safety officer in order to clarify citations specific to training and responsibilities for radiation safety officers. A typographical correction is made in §289.201(b)(99). The definition of total effective dose equivalent in §289.201(b)(109) has been changed in order to maintain compatibility with the NRC. Rule reference corrections have been made in §289.201(b)(112). The definition of waste has been added in §289.201(b)(118) in order to maintain compatibility with the NRC. In §289.201(d)(1)(A)(iii) and (iv), references to "person" have been changed to "licensee" for clarification purposes. Section 289.201(g)(6) adds clarification that a leaking sealed source must be repaired or transferred within two years, and equipment associated with a leaking source must also be checked for contamination. Both clarifications are made in order to maintain compatibility with the NRC. Section 289.201(k)(1) corrects the agency address.

Section 289.202(f)(3) clarifies that the deep-dose equivalent must be used in place of the effective dose equivalent if external exposure is determined by measurement with an external personal monitoring device, in order to maintain compatibility with the NRC. Section 289.202(p)(2)(E) clarifies details associated with the determination of the accuracy of instruments and equipment used for quantitative radiation measurements. Section 289.202(y)(3) adds security requirements for portable gauges in order to maintain compatibility with the NRC.

References to rules regarding uranium and licensing of radioactive waste processing and storage facilities are removed in §289.202(ff)(1)(A), §289.202(ccc)(2), §289.202(ddd)(1)(A), and §289.202(fff)(4) as a result of SB 1604, 80th Legislature, 2007, amending Health and Safety Code, §401.011, which transferred the regulatory authority for licensing and inspection of low-level waste processing and uranium recovery and disposal from the department to the TCEQ. Waste shipping requirements are added in §289.202(ff)(4), (5) and (6), in order to maintain compatibility with the NRC. References are corrected in §289.202(j)(4), §289.202(ll)(4), §289.202(eee)(2)(A), and §289.202(fff)(9). The elements, nitrogen and oxygen, are added to §289.202(ggg)(2)(E) in order to maintain compatibility with the NRC. A date correction is made in §289.202(hhh)(1)(H) in order to maintain compatibility with the NRC.

FISCAL NOTE

Susan E. Tennyson, Section Director, Environmental and Consumer Safety Section, has determined that for each year of the first five-year period that these sections are in effect, there will be no fiscal implications to the state or local government as a result of enforcing and administering the sections as proposed.

SMALL AND MICRO-BUSINESS IMPACT ANALYSIS

Ms. Tennyson has also determined that there could not be an adverse economic effect on small businesses or micro-businesses required to comply with §289.201 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 §289.201 as proposed. Regarding §289.202, there will be anticipated economic costs to persons required to comply with this proposed section, including small businesses. The only small businesses impacted by the amendment are those that are licensed to possess portable gauges and must leave them without the licensee's control and constant surveillance. A maximum of 234 licensees out of a total of approximately 1,600 are small businesses that could be affected financially from the amendment of §289.202. Of these 234 licensees, approximately over half are micro-businesses. The rule is not prescriptive and, therefore, each licensee has choices on how to meet the requirements of the rule. These choices range in cost from using simple chains and locks for a total of approximately $40 per gauge to the purchase of a very large double locking tool box at a cost of approximately $800 per gauge. Additionally the licensee can choose to employ a second person to maintain constant surveillance of the gauge at an approximate cost of $25 per hour rate. The number of hours that the additional employee would be required to maintain constant surveillance of the gauge would vary depending on the circumstances of the assigned job and the required use of the portable gauge. There is no anticipated negative impact on local employment from either proposed rule.

REGULATORY FLEXIBILITY ANALYSIS

Prior to the development of the amendment of §289.202, ideas were reviewed to determine if there were alternative ways to ensure the security of the radioactive sources housed in portable gauges. Texas as an agreement state, must maintain rules that are compatible with NRC rules. Because this requirement is an item of compatibility with the NRC, alternatives were limited. The compatibility requirement of this rule provides that Texas may be the same as or more restrictive than the federal government, but not less restrictive. Based on this, the department has determined that the rule would have to be required of all portable gauge licensees including small and micro-businesses. The rule is flexible in that it is not prescriptive, and each licensee is able to determine the method of security that best suits their operations.

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 §289.201 and §289.202 is to ensure the security of radioactive material, and to prevent it from falling into the hands of unlicensed and potentially terrorist individuals.

REGULATORY ANALYSIS

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, Environmental and Consumer Safety Section, Division for Regulatory Services, Department of State Health Services, 1100 West 49th Street, MC 1987, P.O. Box 149347, Austin, TX 78717-9347, (512) 834-6770, extension 2239, or by email to Cindy.Cardwell@dshs.state.tx.us. Comments will be accepted for 30 days following publication of the proposal in the Texas Register.

PUBLIC HEARING

A public hearing to receive comments on the proposal will be scheduled after publication in the Texas Register, and will be held at the Department of State Health Services, Exchange Building, 8407 Wall Street, Austin, Texas 78754. The meeting date will be posted on the Radiation Group 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

STATUTORY AUTHORITY

The proposed amendments are authorized by Health and Safety Code, §401.051, which provides the Executive Commissioner of the Health and Human Services Commission with authority to adopt rules and guidelines relating to the control of radiation; and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter 1001. The review of the rules implements Government Code, §2001.039.

The proposed amendments affect the Health and Safety Code, Chapters 401 and 1001; and Government Code, Chapter 531.

§289.201.General Provisions for Radioactive Material.

(a) (No change.)

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

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

(6) Agency--The Department of State Health Services [ ~~Texas Department of Health~~].

(7) - (8) (No change.)

(9) Airborne radioactivity area--A room, enclosure, or area in which airborne radioactive materials exist in concentrations:

(A) in excess of the derived air concentrations (DACs) specified in Table I, Column 3 [~~Column 1~~ ] of §289.202(ggg)(2)(F) of this title (relating to Standards for Protection Against Radiation from Radioactive Materials); or

(B) (No change.)

(10) - (14) (No change.)

(15) Byproduct material--Byproduct material is defined as:

(A) any radioactive material (except special nuclear material) yielded in or made radioactive by exposure to the radiation incident to the process of producing or utilizing special nuclear material; [~~and~~]

(B) the tailings or wastes produced by or resulting from the extraction or concentration of uranium or thorium from any ore processed primarily for its source material content, including discrete surface wastes resulting from uranium solution extraction processes. Underground ore bodies depleted by these solution extraction operations do not constitute "byproduct material" within this definition;

(C) any discrete source of radium-226 that is produced, extracted, or converted after extraction, for use for a commercial, medical, or research activity;

(D) any material that has been made radioactive by use of a particle accelerator; and is produced, extracted, or converted for use for a commercial, medical, or research activity; and

(E) any discrete source of naturally occurring radioactive material, other than source material, that is extracted or converted after extraction for use in a commercial, medical, or research activity and that the United States NRC, in consultation with the Administrator of the United States Environmental Protection Agency (EPA), the United States Secretary of Energy, the United States Secretary of Homeland Security, and the head of any other appropriate Federal agency, determines would pose a threat similar to the threat posed by a discrete source of radium-226 to the public health and safety or the common defense and security.

(16) - (27) (No change.)

(28) Discrete source--A radionuclide that has been processed so that its concentration within a material has been purposely increased for use for commercial, medical, or research activities.

(29) [~~(28)~~] Distinguishable from background--The detectable concentration of a radionuclide is statistically different from the background concentration of that radionuclide in the vicinity of the site, or, in the case of structures or equipment, in similar materials using adequate measurement technology, survey, and statistical techniques.

(30) [~~(29)~~] Distribution--The physical conveyance and authorized transfer of commodities from producers to consumers and any intermediate persons involved in that conveyance.

(31) [~~(30)~~] Dose--A generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed effective dose equivalent, total organ dose equivalent, or total effective dose equivalent. For purposes of this chapter, "radiation dose" is an equivalent term.

(32) [~~(31)~~] Dose equivalent (H_T )--The product of the absorbed dose in tissue, quality factor, and all other necessary modifying factors at the location of interest. The units of dose equivalent are the sievert (Sv) and rem.

(33) [~~(32)~~] Dose limits--The permissible upper bounds of radiation doses established in accordance with this chapter. For purposes of this chapter, "limits" is an equivalent term.

(34) [~~(33)~~] Effective dose equivalent (H_E)--The sum of the products of the dose equivalent to each organ or tissue (H_T) [ ~~(HT)~~] and the weighting factor (w_T ) applicable to each of the body organs or tissues that are irradiated (H_E = &Sgr;w_TH_T) [ ~~(H_E = &sgr;w_TH_T)~~].

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

(36) [~~(35)~~] Entrance or access point--Any opening through which an individual or extremity of an individual could gain access to radiation areas or to licensed sources of radiation. This includes portals of sufficient size to permit human access, irrespective of their intended use.

(37) [~~(36)~~] Exposure--The quotient of dQ by dm where "dQ" is the absolute value of the total charge of the ions of one sign produced in air when all the electrons (negatrons and positrons) liberated by photons in a volume element of air having mass "dm" are completely stopped in air. The SI unit of exposure is the coulomb per kilogram (C/kg). The roentgen is the special unit of exposure. For purposes of this chapter, this term is used as a noun.

(38) [~~(37)~~] Exposure rate--The exposure per unit of time.

(39) [~~(38)~~] External dose--That portion of the dose equivalent received from any source of radiation outside the body.

(40) [~~(39)~~] Extremity--Hand, elbow, arm below the elbow, foot, knee, and leg below the knee. The arm above the elbow and the leg above the knee are considered part of the whole body.

(41) [~~(40)~~] Generally applicable environmental radiation standards--Standards issued by the United States Environmental Protection Agency (EPA) under the authority of the Atomic Energy [~~energy~~] Act of 1954, as amended, that impose limits on radiation exposures or levels, or concentrations or quantities of radioactive material, in the general environment outside the boundaries of locations under the control of persons possessing or using radioactive material.

(42) [~~(41)~~] 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) [~~(42)~~] High radiation area--An area, accessible to individuals, in which radiation levels from sources of radiation external to the body could result in an individual receiving a dose equivalent in excess of 0.1 rem (1 millisievert (mSv)) in one hour at 30 cm from any source of radiation or from any surface that the radiation penetrates.

(44) [~~(43)~~] Human use--The internal or external administration of radiation or radioactive material to human beings for healing arts purposes or research and/or development specifically authorized by the agency.

(45) [~~(44)~~] Individual--Any human being.

(46) [~~(45)~~] Individual monitoring--The assessment of:

(A) dose equivalent to an individual by the use of individual monitoring devices; or

(B) committed effective dose equivalent to an individual by bioassay or by determination of the time-weighted air concentrations to which an individual has been exposed, that is, DAC-hours. (See the definition for DAC-hours in §289.202(c) of this title); or

(47) [~~(46)~~] Individual monitoring devices--Devices designed to be worn by a single individual for the assessment of dose equivalent. For purposes of this chapter, "personnel dosimeter" and "dosimeter" are equivalent terms. Examples of individual monitoring devices include, but are not limited to, film badges, thermoluminescence dosimeters (TLDs), optically stimulated luminescence dosimeters (OSLs), pocket ionization chambers (pocket dosimeters), electronic personal dosimeters, and personal air sampling devices.

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

(49) [~~(48)~~] Internal dose--That portion of the dose equivalent received from radioactive material taken into the body.

(50) [~~(49)~~] Ionizing radiation--Any electromagnetic or particulate radiation capable of producing ions, directly or indirectly, in its passage through matter. Ionizing radiation includes gamma rays and x rays, alpha and beta particles, high-speed electrons, neutrons, and other nuclear particles.

(51) [~~(50)~~] Land disposal facility--The land, buildings, and equipment that are intended to be used for the disposal of low-level radioactive waste (LLRW) into the subsurface of the land.

(52) [~~(51)~~] Lens dose equivalent--The external dose equivalent to the lens of the eye at a tissue depth of 0.3 cm (300 mg/cm²).

(53) [~~(52)~~] License--A form of permission given by the agency to an applicant who has met the requirements for licensing set out in the Act and this chapter.

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

(55) [~~(54)~~] Licensee--Any person who is licensed by the agency in accordance with the Act and this chapter.

(56) [~~(55)~~] Licensing state--Any state with rules equivalent to the Suggested State Regulations for Control of Radiation relating to, and having an effective program for, the regulatory control of naturally occurring or accelerator-produced radioactive material (NARM) and has been designated as such by the Conference of Radiation Control Program Directors, Inc. For the purposes of evaluation and/or distribution of sealed sources, this includes Licensing State Status: Product Review Only.

(57) [~~(56)~~] Lost or missing radioactive material--Radioactive material whose location is unknown. This definition includes licensed material that has been shipped but has not reached its planned destination and whose location cannot be readily traced in the transportation system.

(58) [~~(57)~~] Low-level radioactive waste (LLRW)--Radioactive material that meets the following criteria:

(A) LLRW is radioactive material that is:

(i) discarded or unwanted and is not exempt by rule adopted under the Texas Radiation Control Act (Act), Health and Safety Code, §401.106;

(ii) waste, as that term is defined in Title 10, CFR, §61.2 [~~Part 61.2~~]; and

(iii) subject to:

(I) concentration limits established in Title 10, CFR, §61.55 [~~Part 61.55~~ ], or compatible rules adopted by the agency or the Texas Commission on Environmental Quality (TCEQ), as applicable; and

(II) disposal criteria established in Title 10, CFR, or established by the agency or TCEQ, as applicable.

(B) LLRW does not include:

(i) high-level radioactive waste as defined by Title 10, CFR, §60.2 [~~Part 60.2~~];

(ii) spent nuclear fuel as defined by Title 10, CFR, §72.3 [~~Part 72.3~~];

(iii) byproduct material defined in the Act, Health and Safety Code, §401.003(3)(B);

(iv) naturally occurring radioactive material (NORM) waste that is not oil and gas NORM waste;

(v) oil and gas NORM waste; or

(vi) transuranics greater than 100 nanocuries per gram.

(59) [~~(58)~~] Manufacture--To fabricate or mechanically produce.

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

(61) [~~(60)~~] Minor--An individual less than 18 years of age.

(62) [~~(61)~~] Monitoring--The measurement of radiation, radioactive material concentrations, surface area activities, or quantities of radioactive material and the use of the results of these measurements to evaluate potential exposures and doses. For purposes of this chapter, "radiation monitoring" and "radiation protection monitoring" are equivalent terms.

(63) [~~(62)~~] NARM--Any naturally occurring or accelerator-produced radioactive material except source material or special nuclear material.

(64) [~~(63)~~] Natural radioactivity--Radioactivity of naturally occurring nuclides whose location and chemical and physical form have not been altered by man.

(65) [~~(64)~~] NRC--The United States Nuclear Regulatory Commission [~~(NRC)~~ ] or its duly authorized representatives.

(66) [~~(65)~~] Occupational dose--The dose received by an individual in the course of employment in which the individual's assigned duties involve exposure to sources of radiation from licensed/registered and unlicensed/unregistered sources of radiation, whether in the possession of the licensee/registrant or other person. Occupational dose does not include dose received from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with this chapter, from voluntary participation in medical research programs, or as a member of the public.

(67) [~~(66)~~] Particle accelerator--Any machine capable of accelerating electrons, protons, deuterons, or other charged particles in a vacuum and designed to discharge the resultant particulate or other associated radiation at energies usually in excess of 1 MeV.

(68) [~~(67)~~] Person--Any individual, corporation, partnership, firm, association, trust, estate, public or private institution, group, agency, local government, any other state or political subdivision or agency thereof, or any other legal entity, and any legal successor, representative, agent, or agency of the foregoing, other than NRC, and other than federal government agencies licensed or exempted by NRC.

(69) [~~(68)~~] Personnel monitoring equipment (See definition for individual monitoring devices.)

(70) [~~(69)~~] Pharmacist--An individual licensed by the Texas State Board of Pharmacy to compound and dispense drugs, prescriptions, and poisons.

(71) [~~(70)~~] Physician--An individual licensed by the Texas Medical Board [ ~~Texas State Board of Medical Examiners~~].

(72) [~~(71)~~] Principal activities--Activities authorized by the license that are essential to achieving the purpose(s) for which the license was issued or amended. Storage during which no licensed material is accessed for use or disposal and activities incidental to decontamination or decommissioning are not principal activities.

(73) [~~(72)~~] Public dose--The dose received by a member of the public from exposure to sources of radiation released by a licensee, or to any other source of radiation under the control of a licensee/registrant. It does not include occupational dose or doses received from background radiation, from any medical administration the individual has received, from exposure to individuals administered radioactive material and released in accordance with this chapter, or from voluntary participation in medical research programs.

(74) [~~(73)~~] Quality factor (Q)--The modifying factor listed in subsection (n)(1) and (2) of this section that is used to derive dose equivalent from absorbed dose.

(75) [~~(74)~~] Quarter (calendar quarter)--A period of time equal to one-fourth of the year observed by the licensee, approximately 13 consecutive weeks, providing that the beginning of the first quarter in a year coincides with the starting date of the year and that no day is omitted or duplicated in consecutive quarters.

(76) [~~(75)~~] Rad--The special unit of absorbed dose. One rad is equal to an absorbed dose of 100 ergs per gram (erg/g) or 0.01 J/kg (0.01 gray).

(77) [~~(76)~~] 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) emission of radiation from any electronic device to such energy density levels as to reasonably cause bodily harm; or

(C) sonic, ultrasonic, or infrasonic waves from any electronic device or resulting from the operation of an electronic circuit in an electronic device in the energy range to reasonably cause detectable bodily harm.

(78) [~~(77)~~] Radiation area--Any area, accessible to individuals, in which radiation levels could result in an individual receiving a dose equivalent in excess of 0.005 rem (0.05 mSv) in one hour at 30 cm from the source of radiation or from any surface that the radiation penetrates.

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

(80) [~~(79)~~] Radiation safety officer (RSO)--An individual who has a knowledge of and the authority and responsibility to apply appropriate radiation protection rules, standards, and practices, who must be specifically authorized on a radioactive material license, and who is the primary contact with the agency. Specific training and responsibilities for an RSO are listed in §289.252 of this title (relating to Licensing of Radioactive Material), §289.253 of this title (relating to Radiation Safety Requirements for Well Logging Service Operations and Tracer Studies), §289.255 of this title (relating to Radiation Safety Requirements and Licensing and Registration Procedures for Industrial Radiography), and §289.256 of this title (relating to Medical and Veterinary Use of Radioactive Material).

(81) [~~(80)~~] Radioactive material--Any material (solid, liquid, or gas) that emits radiation spontaneously.

(82) [~~(81)~~] Radioactive waste--As used in §289.254 of this title (relating to Licensing of Radioactive Waste Processing and Storage Facilities), this term is equivalent to LLRW.

(83) [~~(82)~~] Radioactivity--The disintegration of unstable atomic nuclei with the emission of radiation.

(84) [~~(83)~~] Radiobioassay (See definition for bioassay.)

(85) [~~(84)~~] Registrant--Any person issued a certificate of registration by the agency in accordance with the Act and this chapter.

(86) [~~(85)~~] Regulation (See definition for rule.)

(87) [~~(86)~~] Regulations of the United States Department of Transportation (DOT)--The requirements in Title 49, CFR, Parts 100-189.

(88) [~~(87)~~] Rem--The special unit of any of the quantities expressed as dose equivalent. The dose equivalent in rem is equal to the absorbed dose in rad multiplied by the quality factor (1 rem = 0.01 sievert (Sv)).

(89) [~~(88)~~] 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.

(90) [~~(89)~~] Residual radioactivity--The radioactivity in structures, materials, soils, groundwater, and other media at a site resulting from activities under the licensee's control. This includes radioactivity from all licensed and unlicensed sources used by the licensee, but excludes background radiation. It also includes radioactive materials remaining at the site as a result of routine or accidental releases of radioactive material at the site and previous burials at the site, even if those burials were made in accordance with the provisions of Title 30, Texas Administrative Code, §336.334.

(91) [~~(90)~~] Restricted area--An area, access to which is limited by the licensee for the purpose of protecting individuals against undue risks from exposure to sources of radiation. Restricted area does not include areas used as residential quarters, but separate rooms in a residential building may be set apart as a restricted area.

(92) [~~(91)~~] Roentgen (R)--The special unit of exposure. One roentgen (R) equals 2.58 x 10^-4 C/kg of air. (See definition for exposure.)

(93) [~~(92)~~] Rule (as defined in the Government Code, Chapters 2001 and 2002, as amended)--Any agency statement of general applicability that implements, interprets, or prescribes law or policy, or describes the procedure or practice requirements of an agency. The term includes the amendment or repeal of a prior section but does not include statements concerning only the internal management or organization of any agency and not affecting private rights or procedures. The word "rule" was formerly referred to as "regulation."

(94) [~~(93)~~] Sealed source--Radioactive material that is permanently bonded or fixed in a capsule or matrix designed to prevent release and dispersal of the radioactive material under the most severe conditions that are likely to be encountered in normal use and handling.

(95) [~~(94)~~] Shallow dose equivalent (H_s) (that applies to the external exposure of the skin or the skin of an extremity)--The dose equivalent at a tissue depth of 0.007 cm (7 mg/cm²) averaged over an area of 1 square centimeter (cm²).

(96) [~~(95)~~] SI--The abbreviation for the International System of Units.

(97) [~~(96)~~] Sievert--The SI unit of any of the quantities expressed as dose equivalent. The dose equivalent in sievert is equal to the absorbed dose in gray multiplied by the quality factor (1 Sv [~~S_V~~] = 100 rem).

(98) [~~(97)~~] Site boundary--That line beyond which the land or property is not owned, leased, or otherwise controlled by the licensee.

(99) [~~(98)~~] Source material--Source material is defined as:

(A) uranium or thorium, or any combination thereof, in any physical or chemical form; or

(B) ores that contain by weight [~~right~~] 0.05% or more of uranium, thorium, or any combination thereof; and

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

(101) [~~(100)~~] Special form radioactive material--Radioactive material that satisfies the following conditions.

(A) It is either a single solid piece or is contained in a sealed capsule that can be opened only by destroying the capsule;

(B) The piece or capsule has at least one dimension not less than 5 millimeters (mm) (0.2 inch); and

(C) It satisfies the requirements specified by NRC. A special form encapsulation designed in accordance with NRC requirements in effect on June 30, 1983, and constructed prior to July 1, 1985, may continue to be used. A special form encapsulation designed in accordance with NRC requirements in effect on March 31, 1996, and constructed prior to April 1, 1998, may continue to be used. A special form encapsulation either designed or constructed after April 1, 1998, must meet the requirements of this definition applicable at the time of its design or construction.

(102) [~~(101)~~] Special nuclear material--Special nuclear material is defined as:

(A) plutonium, uranium-233, uranium enriched in the isotope 233 or in the isotope 235, and any other material that NRC, in accordance with the provisions of the Atomic Energy Act of 1954, §51 as amended, determines to be special nuclear material, but does not include source material; or

(B) any material artificially enriched by any of the foregoing, but does not include source material.

(103) [~~(102)~~] Special nuclear material in quantities not sufficient to form a critical mass--Uranium enriched in the isotope 235 in quantities not exceeding 350 grams (g) of contained uranium-235; uranium-233 in quantities not exceeding 200 g; plutonium in quantities not exceeding 200 g; or any combination of them in accordance with the following formula.

(A) For each kind of special nuclear material, determine the ratio between the quantity of that special nuclear material and the quantity specified above for the same kind of special nuclear material. The sum of such ratios for all of the kinds of special nuclear material in combination shall not exceed "1" (i.e., unity).

(B) For example, the following quantities in combination would not exceed the limitation and are within the formula:

Figure: 25 TAC §289.201(b)(103)(B)

[~~Figure: 25 TAC §289.201(b)(102)(B)~~]

(104) [~~(103)~~] Special units--The conventional units historically used by licensees, for example, curie (activity), rad (absorbed dose), and rem (dose equivalent).

(105) [~~(104)~~] Survey--An evaluation of the radiological conditions and potential hazards incident to the production, use, transfer, release, disposal, and/or presence of sources of radiation. When appropriate, such survey includes, but is not limited to, tests, physical examination of location of materials and equipment, measurements of levels of radiation or concentration of radioactive material present, and evaluation of administrative and/or engineered controls.

(106) [~~(105)~~] Termination--A release by the agency of the obligations and authorizations of the licensee under the terms of the license. It does not relieve a person of duties and responsibilities imposed by law.

(107) [~~(106)~~] Test--A method of determining the characteristics or condition of sources of radiation or components thereof.

(108) [~~(107)~~] Texas Regulations for Control of Radiation (TRCR)--All sections of Title 25 Texas Administrative Code (TAC), Chapter 289.

(109) [~~(108)~~] Total effective dose equivalent (TEDE)--The sum of the effective dose [ ~~deep dose~~] equivalent for external exposures and the committed effective dose equivalent for internal exposures.

(110) [~~(109)~~] Total organ dose equivalent (TODE)--The sum of the deep dose equivalent and the committed dose equivalent to the organ receiving the highest dose as described in §289.202(rr)(1)(F) of this title.

(111) [~~(110)~~] Transport index--The dimensionless number (rounded up to the next tenth) placed on the label of a package, to designate the degree of control to be exercised by the carrier during transportation. The transport index is determined as follows:

(A) For non-fissile material packages, the number determined by multiplying the maximum radiation level in millisievert per hour (mSv/hr) at 1 meter (m) (3.3 feet) from the external surface of the package by 100 (equivalent to the maximum radiation level in millirem per hour (mrem/hr) at 1 m (3.3 feet); or

(B) For fissile material packages, the number determined by multiplying the maximum radiation level in mSv/hr at 1 m (3.3 feet) from the external surface of the package by 100 (equivalent to the maximum radiation level in mrem/hr at 1 m (3.3 feet), or, for criticality control purposes, the number obtained as described in 10 CFR 71.59, whichever is larger.

(112) [~~(111)~~] Type A quantity--A quantity of radioactive material, the aggregate radioactivity of which does not exceed A₁ for special form radioactive material or A₂ for normal form radioactive material, where A₁ and A₂ are given in §289.257(ff) [~~§289.257(s)(2)~~ ] of this title (relating to Packaging and Transportation of Radioactive Material) or may be determined by procedures described in §289.257(ff) [~~§289.257(s)(1)-(4)~~] of this title.

(113) [~~(112)~~] Type B quantity--A quantity of radioactive material greater than a type A quantity.

(114) [~~(113)~~] Unrefined and unprocessed ore--Ore in its natural form prior to any processing, such as grinding, roasting, beneficiating, or refining.

(115) [~~(114)~~] Unrestricted area (uncontrolled area)--An area, or access to, which is neither limited nor controlled by the licensee. For purposes of this chapter, "uncontrolled area" is an equivalent term.

(116) [~~(115)~~] Very high radiation area--An area, accessible to individuals, in which radiation levels from sources of radiation external to the body could result in an individual receiving an absorbed dose in excess of 500 rads (5 grays) in one hour at 1 meter (m) from a source of radiation or from any surface that the radiation penetrates. At very high doses received at high dose rates, units of absorbed dose, gray and rad, are appropriate, rather than units of dose equivalent, Sv and rem.

(117) [~~(116)~~] Veterinarian--An individual licensed by the Texas State Board of Veterinary Medical Examiners.

(118) Waste--Low-level radioactive wastes containing source, special nuclear, or byproduct material that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level radioactive waste means radioactive waste not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel, or byproduct material as defined in paragraph (15)(B) - (E) of this subsection.

(119) [~~(117)~~] Week--Seven consecutive days starting on Sunday.

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

(121) [~~(119)~~] Worker--An individual engaged in work under a license or certificate of registration issued by the agency and controlled by a licensee or registrant, but does not include the licensee or registrant.

(122) [~~(120)~~] Working level (WL) [ ~~W_L~~]--Any combination of short-lived radon daughters in 1 liter of air that will result in the ultimate emission of 1.3 x 10⁵ million electron volts (MeV) of potential alpha particle energy. The short-lived radon daughters are--for radon-222: polonium-218, lead-214, bismuth-214, and polonium-214; and for radon-220: polonium-216, lead-212, bismuth-212, and polonium-212.

(123) [~~(121)~~] Working level month (WLM)--An exposure to one working level for 170 hours - 2,000 working hours per year divided by 12 months per year is approximately equal to 170 hours per month.

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

(d) Records.

(1) Each licensee shall maintain records showing the receipt, transfer, and disposal of all non-exempt sources of radiation.

(A) Records of receipt, transfer, and disposal of sources of radiation shall include as a minimum, the following information:

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

(iii) for the licensee [~~person~~] transferring the source of radiation, the name of the transferee, the number of the transferee's radioactive material license authorizing possession of the material, and the regulatory agency issuing the license to the transferee; and

(iv) for the licensee [~~person~~] receiving the source of radiation, the name of the transferor, the number of the transferor's radioactive material license authorizing possession of the material, and the regulatory agency issuing the license to the transferor.

(B) (No change.)

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

(e) - (f) (No change.)

(g) Tests for leakage and/or contamination of sealed sources.

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

(6) The licensee shall immediately withdraw a leaking sealed source from use and shall take action to prevent the spread of contamination. Within two years of the determination that a sealed source is leaking, the [~~The~~] leaking sealed source shall be repaired or transferred for disposal in accordance with §289.202 of this title. The licensee shall check the equipment associated with the leaking source for radioactive contamination and, if contaminated, have it decontaminated or disposed of in accordance with §289.202 of this title.

(7) (No change.)

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

(k) Communications.

(1) Except where otherwise specified, all communications and reports concerning this chapter and applications filed under them should be addressed to Radiation Control, Department of State Health Services [~~the Bureau of Radiation Control, Texas Department of Health~~], 1100 West 49th Street, P.O. Box 149347, Austin, Texas, 78714-9347 [ ~~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.)

(l) Interpretations. Except as specifically authorized by the agency in writing, no interpretation of the meaning of this chapter by any officer or employee of the agency other than a written interpretation by the Office of General Counsel, Department of State Health Services [~~Texas Department of Health~~], will be considered binding upon the agency.

(m) Open records.

(1) (No change.)

(2) 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.

(A) 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 §289.201(m)(2)(A)(ii)

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

(3) - (4) (No change.)

(n) - (o) (No change.)

§289.202.Standards for Protection Against Radiation from Radioactive Materials.

(a) - (e) (No change.)

(f) Occupational dose limits for adults.

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

(3) When the external exposure is determined by measurement with an external personal monitoring device, the deep-dose equivalent shall be used in place of the effective dose equivalent, unless the effective dose equivalent is determined by a dosimetry method approved by the agency. The assigned deep dose equivalent shall be for the portion of the body receiving the highest exposure. The assigned shallow-dose equivalent shall be the dose averaged over the contiguous 10 square centimeters (cm²) of skin receiving the highest exposure.

(4) - (7) (No change.)

(g) - (i) (No change.)

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

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

(4) If the licensee is unable to obtain a complete record of an individual's current occupational dose while employed by any other licensee, the licensee shall assume in establishing administrative controls in accordance with subsection (f)(7) [~~(f)(8)~~] of this section for the current year, that the allowable dose limit for the individual is reduced by 1.25 rems (12.5 millisieverts (mSv)) for each quarter; or 416 mrem (4.16 mSv) for each month for which records were unavailable and the individual was engaged in activities that could have resulted in occupational radiation exposure.

(5) - (6) (No change.)

(k) - (o) (No change.)

(p) General surveys and monitoring.

(1) (No change.)

(2) The licensee shall ensure that instruments and equipment used for quantitative radiation measurements, for example, dose rate and effluent monitoring, are operable and calibrated:

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

(E) at an accuracy within 20% of the true radiation level , or inclusive of an appropriate efficiency associated with quantitative counting equipment.

(3) - (4) (No change.)

(q) - (x) (No change.)

(y) Security and control of licensed sources of radiation.

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

(3) Each portable gauge licensee shall use a minimum of two independent physical controls that form tangible barriers to secure portable gauges from unauthorized removal, whenever portable gauges are not under the control and constant surveillance of the licensee.

(z) - (ee) (No change.)

(ff) General requirements for waste management.

(1) Unless otherwise exempted, a licensee shall discharge, treat, or decay licensed material or transfer waste for disposal only:

(A) by transfer to an authorized recipient as provided in subsection (jj) of this section, §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),~~] §289.257 of this title, §289.259 of this title, or to the United States Department of Energy (DOE);

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

(D) as authorized in accordance with paragraph (2) of this subsection, and subsections (gg), [~~and~~] (hh), and (fff) of this section.

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

(4) Licensed material as defined in §289.201(b)(15)(C) - (E) of this title may be disposed of in accordance with Title 10, CFR, Part 61, even though it is not defined as low level radioactive waste. Therefore, any licensed byproduct material being disposed of at a facility, or transferred for ultimate disposal at a facility licensed under Title 10, CFR, Part 61, shall meet the requirements of this chapter.

(5) A licensee may dispose of byproduct material, as defined in §289.201(b)(15)(C) - (E) of this title, at a disposal facility authorized to dispose of such material in accordance with any Federal or State solid or hazardous waste law.

(6) Any licensee shipping byproduct material as defined in §289.201(b)(15)(C) - (E) of this title intended for ultimate disposal at a land disposal facility licensed under Title 10, CFR, Part 61, shall document the information required on the NRC's Uniform Low-Level Radioactive Waste Manifest and transfer this recorded manifest information to the intended consignee in accordance with §289.257(gg) of this title.

(gg) - (kk) (No change.)

(ll) General provisions for records.

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

(4) Records required in accordance with §289.201(d) of this title, and subsections (mm) - (oo) and (ss) - (uu) [ ~~, (tt), and (uu)~~] of this section shall include the date and the identification of individual(s) making the record, and, as applicable, a unique identification of survey instrument(s) used, and an exact description of the location of the survey. Records of receipt, transfer, and disposal of sources of radiation shall uniquely identify the source of radiation.

(5) (No change.)

(mm) - (bbb) (No change.)

(ccc) Vacating premises.

(1) (No change.)

(2) The licensee or person possessing non-exempt radioactive material shall decommission the premises to a degree consistent with subsequent use as an unrestricted area and in accordance with the requirements of subsection (ddd) of this section [~~or, for uranium recovery and byproduct material disposal facilities licensed in accordance with §289.260 of this title, subsection (eee) of this section~~].

(ddd) Radiological requirements for license termination.

(1) General provisions and scope.

(A) The requirements in this section apply to the decommissioning of facilities licensed 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)~~], §289.255 of this title [~~(relating to Radiation Safety Requirements and Licensing and Registration Procedures for Industrial Radiography)~~], and §289.258 of this title (relating to Licensing and Radiation Safety Requirements for Irradiators). [The requirements do not apply to uranium recovery and byproduct material disposal facilities already subject to the requirements of §289.260 of this title (relating to Licensing of Uranium Recovery and Byproduct Material Disposal Facilities).]

(B) - (D) (No change.)

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

(eee) Limits for contamination of soil, surfaces of facilities and equipment, and vegetation.

(1) (No change.)

(2) No licensee shall possess, receive, use, or transfer radioactive material in such a manner as to cause contamination of soil in unrestricted areas, to the extent that the contamination exceeds, on a dry weight basis, the concentration limits specified in:

(A) subsection (ddd) [~~(ggg)(8)~~] of this section; or

(B) the effluent concentrations in Table II, Column 2 of subsection (ggg)(2)(F) of this section, with the units changed from microcuries per milliliter to microcuries per gram, for radionuclides not specified in [~~subsection (ggg)(8) of this section or~~] paragraph (4) of this subsection.

(3) - (6) (No change.)

(fff) Exemption of specific wastes.

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

(4) Any licensee[~~, except those licensed in accordance with §289.254 of this title,~~] may, upon agency approval of procedures required in paragraph (6) of this subsection, discard licensed material included in subsection (ggg)(7) of this section, provided that it does not exceed the concentration and total curie limits contained therein, in a Type I municipal solid waste site as defined in the Municipal Solid Waste Regulations of the authorized regulatory agency (30 Texas Administrative Code Chapter 330), unless such licensed material also contains hazardous waste, as defined in §3(15) of the Solid Waste Disposal Act, Health and Safety Code, Chapter 361. Any licensed material included in subsection (ggg)(7) of this section and which is a hazardous waste as defined in the Solid Waste Disposal Act may be discarded at a facility authorized to manage hazardous waste by the authorized regulatory agency.

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

(9) Licensed material discarded under this section is exempt from the requirements of §289.252(ff) [ ~~§289.252(t)~~] of this title.

(ggg) Appendices.

(1) (No change.)

(2) Annual limits on intake (ALI) and derived air concentrations (DAC) of radionuclides for occupational exposure; effluent concentrations; concentrations for release to sanitary sewerage.

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

(E) List of elements.

Figure: 25 TAC §289.202(ggg)(2)(E)

[~~Figure: 25 TAC §289.202(ggg)(2)(E)~~]

(F) Tables--Values for annual limits. The following tables contain values for annual limits on intake (ALI) and derived air concentrations (DAC) of radionuclides for occupational exposure; effluent concentrations; concentrations for release to sanitary sewerage:

Figure: 25 TAC §289.202(ggg)(2)(F) (.pdf)

[~~Figure: 25 TAC §289.202(ggg)(2)(F)~~]

(3) - (7) (No change.)

~~[(8) Soil contamination limits for selected radionuclides (for use in subsection (eee) of this section).]~~

~~[~~Figure: 25 TAC §289.202(ggg)(8)~~]~~

(8) [~~(9)~~] Cumulative occupational exposure form. The following, BRC Form 202-2, is to be used to document cumulative occupational exposure history: (Please find BRC Form 202-2 at the end of this section.)

Figure: 25 TAC §289.202(ggg)(8) (.pdf)

[~~Figure: 25 TAC §289.202(ggg)(9)~~]

(9) [~~(10)~~] Occupational exposure form. The following, BRC Form 202-3, is to be used to document occupational exposure record for a monitoring period: (Please find BRC Form 202-3 at the end of this section.)

Figure: 25 TAC §289.202(ggg)(9) (.pdf)

[~~Figure: 25 TAC §289.202(ggg)(10)~~]

(hhh) Requirements for nationally tracked sources.

(1) Reports of transactions involving nationally tracked sources. Each licensee who manufactures, transfers, receives, disassembles, or disposes of a nationally tracked source shall complete and submit to NRC a National Source Tracking Transaction Report as specified in the following subparagraphs for each type of transaction.

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

(H) Each licensee that possesses Category 1 nationally tracked sources listed in paragraph (2) of this subsection shall report its initial inventory of Category 1 nationally tracked sources to the National Source Tracking System by January 31, 2009 [ ~~November 15, 2007~~]. Each licensee that possesses Category 2 nationally tracked sources listed in paragraph (2) of this subsection shall report its initial inventory of Category 2 nationally tracked sources to the National Source Tracking System by January 31, 2009 [~~November 30, 2007~~]. The information may be submitted to NRC by using any of the methods identified by subparagraph (F)(i) through (iv) of this paragraph. The initial inventory report shall include the following information:

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

(2) - (3) (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 August 13, 2008.

TRD-200804370

Lisa Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: September 28, 2008

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