TITLE 25.HEALTH SERVICES

Part 1. TEXAS DEPARTMENT OF HEALTH

Chapter 2. EMERGENCY PREPAREDNESS

25 TAC §2.1

The Texas Department of Health (department) proposes a new rule §2.1 concerning the establishment of the Preparedness Coordinating Council (council). Specifically, the rule covers the establishment, structure, and composition of a preparedness coordinating council. The purpose of the council is to provide advice and assistance to the Board of Health (board) and the department in coordinating effort to prepare the State of Texas for bioterrorism attacks, other infectious disease outbreaks, and additional public health threats and emergencies. This rule is necessary in order to comply with the requirements of Title 42 United States Code, §247d-3a(b) and Cooperative Agreement U90/CCU617001-03-3 (Public Health Preparedness and Response for Bioterrorism).

The council is established under the Health and Safety Code, §11.016, which allows the board to establish advisory committees, and Title 42 United States Code, §247d-3a(b), which requires an advisory committee to provide the department with advice on public health preparedness. The council is governed by the Government Code, Chapter 2110, concerning state agency advisory committees.

In 1993, the Texas Legislature passed Senate Bill 383 (now codified in the Government Code, Chapter 2110) which requires that each state agency adopt rules on advisory committees. The rules must state the purpose of the committee, describe the tasks of the committee, describe the manner in which the committee will report to the agency, and establish a date on which the committee will be automatically abolished unless the governing body of the agency affirmatively votes to continue the committee's existence.

Lisa Schultz, Staff Services Officer, Office of the State Epidemiologist, has determined that for each year of the first five years the section is in effect, there will be no fiscal implications for state and local government as a result of enforcing the section as proposed.

Lisa Schultz has also determined that for each year of the first five years the section is in effect, the public benefit anticipated as a result of enforcing the section will be to provide advice to the department on this important issue. There will be no costs to small business or micro-business resulting from compliance with this section, as this section addresses only the establishment, composition and structure of the council. There are no anticipated economic costs to persons who are required to comply with the section as proposed. There is no anticipated impact on local employment.

Comments may be submitted to Trish Taylor, Office of the State Epidemiologist, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756, Telephone 512-458-7219, Fax 512-458-7472, or Email address at trish.taylor@tdh.state.tx.us. Comments on the proposal will be accepted for 30 days following publication in the Texas Register .

The new rule is proposed under Health and Safety Code, §12.001 which provides the board with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner; and Government Code, §2110.005 which requires the department to adopt rules stating the purpose and tasks of its advisory committees.

The new rule affects the Health and Safety Code, Chapter 11, and the Government Code, Chapter 2110.

§2.1.Preparedness Coordinating Council.

(a) The council.

(1) The Preparedness Coordinating Council (council) shall be appointed under and governed by this section.

(2) The council is established under the Health and Safety Code, §11.016, which authorizes the board to establish advisory councils and Title 42 United States Code §247d-3a(b) which requires an advisory committee (or similar mechanism) to obtain input on preparedness planning.

(b) Applicable law. The council is subject to the Government Code, Chapter 2110, concerning state agency advisory councils.

(c) Purpose. The purpose of the council is to provide advice and assistance to the Board of Health (board) and the Department of Health (department) in coordinating efforts to prepare the state of Texas for bioterrorism attacks, other infectious disease outbreaks, and additional public health threats and emergencies.

(d) Tasks.

(1) The council shall advise the board concerning rules relating to major public health preparedness issues.

(2) The council will assist the department and the board in coordinating preparedness and response planning, improving disease surveillance and detection, developing epidemic response capabilities, and addressing other public health emergency activities related to the department.

(3) The council shall carry out any other tasks assigned by the board.

(e) Council abolished. By January 1, 2007, the board will initiate and complete a review of the council to determine whether the council should be continued, consolidated with another council, or abolished. If the council is not continued or consolidated, the council shall be abolished on that date.

(f) Composition. The council shall be composed of 17 members.

(1) The composition of the council shall include five consumer representatives, and 12 non-consumer representatives.

(2) The members of the council shall be appointed by the commissioner of health (commissioner) as follows:

(A) five consumers representing the interests of the general public;

(B) 12 non-consumer members, including the following:

(i) three representatives of local health departments or local governments;

(ii) three representatives from emergency management entities;

(iii) three representatives from community hospitals or other community health providers; and

(iv) three representatives from universities or health science centers.

(g) Terms of office. The term of office of each member shall be six years.

(1) Members shall be appointed for staggered terms so that the terms of six members will expire on December 31 of each even-numbered year.

(2) If a vacancy occurs, a person shall be appointed to serve the unexpired portion of that term.

(h) Officers. The council shall select from its members the presiding officer and an assistant presiding officer.

(1) The presiding officer shall serve until December 31 of each even-numbered year. The assistant presiding officer shall serve until December 31 of each odd-numbered year. Both the presiding officer and the assistant presiding officer may holdover until his or her replacement is elected by the council.

(2) The presiding officer shall preside at all council meetings which he or she attends, call meetings in accordance with this section, appoint subcommittees of the council as necessary, and cause proper reports to be made to the board. The presiding officer may serve as an ex-officio member of any subcommittee of the council.

(3) If the office of assistant presiding officer becomes vacant, it may be filled by vote of the council.

(4) A member shall serve no more than two consecutive terms as assistant presiding officer.

(5) The council may reference its officers by other terms, such as chairperson and vice-chairperson.

(i) Meetings. The council shall meet only as necessary to conduct council business.

(1) A meeting may be called by agreement of department staff and either the presiding officer or at least three members of the council.

(2) Meeting arrangements shall be made by department staff. Department staff shall contact council members to determine availability for a meeting date and place.

(3) The council is not a "governmental body" as defined in the Open Meetings Act. However, in order to promote public participation, each meeting of the council shall be announced and conducted in accordance with the Open Meetings Act, Texas Government Code, Chapter 551, with the exception that the provisions allowing executive sessions shall not apply.

(4) Each member of the council shall be informed of a council meeting at least five working days before the meeting.

(5) A simple majority of the members of the council shall constitute a quorum for the purpose of transacting official business.

(6) The council is authorized to transact official business only when in a legally constituted meeting with a quorum present.

(7) The agenda for each council meeting shall include an opportunity for any person to address the council on matters relating to council business. The presiding officer may establish procedures for such public comment, including a time limit on each comment.

(j) Attendance. Members shall attend council meetings as scheduled. Members shall attend meetings of subcommittees to which the members are assigned.

(1) A member shall notify the presiding officer or appropriate department staff if he or she is unable to attend a scheduled meeting.

(2) It shall be grounds for removal from the council if a member cannot discharge the member's duties for a substantial part of the term for which the member is appointed because of illness or disability, absence from more than half of the council and subcommittees meetings during a calendar year, or absence from at least three consecutive council meetings.

(3) The validity of an action of the council is not affected by the fact that it is taken when a ground for removal of a member exists.

(k) Staff. Staff support for the council shall be provided by the department.

(l) Procedures. Roberts Rules of Order, Newly Revised, shall be the basis of parliamentary decisions except where otherwise provided by law or rule.

(1) Any action taken by the council must be approved by a majority vote of the members present once a quorum is established.

(2) Each member shall have one vote.

(3) A member may not authorize another individual to represent the member by proxy.

(4) The council shall make decisions in the discharge of its duties without discrimination based on any person's race, creed, gender, religion, national origin, age, physical condition, or economic status.

(5) Minutes of each council meeting shall be taken by department staff.

(A) A draft of the minutes approved by the presiding officer shall be provided to the board and each member of the council within 30 days of each meeting.

(B) After approval by the council, the minutes shall be signed by the presiding officer.

(m) Subcommittee. The council may establish subcommittees as necessary to assist the council in carrying out its duties.

(1) The presiding officer shall appoint members of the council to serve on subcommittees and to act as subcommittee chairpersons. The presiding officer also may appoint nonmembers of the council to serve on subcommittees.

(2) Subcommittees shall meet when called by the subcommittee chairperson or when so directed by the council.

(3) A subcommittee chairperson shall make regular reports to the advisory council at each council meeting or in interim written reports as needed. The reports shall include an executive summary or minutes of each subcommittee meeting.

(n) Statement by members.

(1) The board, the department, and the council shall not be bound in any way by any statement or action on the part of any council member except when a statement or action is in pursuit of specific instructions from the board, department, or council.

(2) The council and its members may not participate in legislative activity in the name of the board, the department, or the council except with approval through the department's legislative process. Council members are not prohibited from representing themselves or other entities in the legislative process.

(3) A committee member should not accept or solicit any benefit that might reasonably tend to influence the member in the discharge of the member's official duties.

(4) A committee member should not disclose confidential information acquired through his or her committee membership.

(5) A committee member should not knowingly solicit, accept, or agree to accept any benefit for having exercised the member's official powers or duties in favor of another person.

(6) A committee member who has a personal or private interest in a matter pending before the committee shall publicly disclose the fact in a committee meeting and may not vote or otherwise participate in the matter. The phrase "personal or private interest" means the committee member has a direct pecuniary interest in the matter but does not include the committee member's engagement in a profession, trade, or occupation when the member's interest is the same as all others similarly engaged in the profession, trade, or occupation.

(o) Reports to board. The council shall file an annual written report with the board.

(1) The report shall list the meeting dates of the council and any subcommittees, the attendance records of its members, a brief description of actions taken by the council, a description of how the council has accomplished the tasks given to the council by the board, the status of any rules which were recommended by the council to the board, and anticipated activities of the council for the next year.

(2) The report shall identify the costs related to the council's existence, including the cost of agency staff time spent in support of the council's activities and the source of funds used to support the council's activities.

(3) The report shall cover the meetings and activities in the immediately preceding fiscal year and shall be filed with the board each January. The report shall be signed by the commissioner.

(p) Reimbursement for expenses. In accordance with the requirements set forth in the Government Code, Chapter 2110, a council member may receive reimbursement for the member's expenses incurred for each day the member engages in official council business if authorized by the General Appropriations Act or the budget execution process.

(1) No compensatory per diem shall be paid to council members unless required by law.

(2) A council member who is an employee of a state agency, other than the department, may not receive reimbursement for expenses from the department.

(3) Each member who is to be reimbursed for expenses shall submit to staff the member's receipts for expenses and any required official forms no later than 14 days after each council meeting.

(4) Requests for reimbursement of expenses shall be made on official state travel vouchers prepared by department staff.

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 October 18, 2002.

TRD-200206845

Susan Steeg

General Counsel

Texas Department of Health

Earliest possible date of adoption: December 1, 2002

For further information, please call: (512) 458-7236


Chapter 37. MATERNAL AND INFANT HEALTH SERVICES

Subchapter P. SURVEILLANCE AND CONTROL OF BIRTH DEFECTS

25 TAC §37.307

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

The Texas Department of Health (department) proposes the repeal of §37.307 concerning the Scientific Advisory Committee on Birth Defects in Texas (committee). The committee has provided advice to the Texas Board of Health (board) and the department in the area of implementing an effective birth defects registry and related research, referral, and educational activities.

In 1993, the Texas Legislature passed Senate Bill 383 (now codified in the Government Code, Chapter 2110) which requires that each state agency adopt rules on advisory committees. The rules must state the purpose of the committee, describe the tasks of the committee, describe the manner in which the committee will report to the agency, and establish a date on which the committee will be automatically abolished unless the governing body of the agency affirmatively votes to continue the committee's existence.

In 1995, the board established a rule relating to the Scientific Advisory Committee on Birth Defects in Texas. The rule states that the committee will automatically be abolished on March 1, 2003, and the board has determined that the committee should be abolished on that date. Issues relating to the type of advice previously provided by the committee have been implemented and future related issues are better addressed through the establishment of ad hoc workgroups.

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). The department has reviewed §37.307 and has determined that reasons for adopting the rule no longer continue to exist.

The department published a Notice of Intention to Review §37.307 in the Texas Register on April 28, 2000 (25 TexReg 3799). No comments were received due to publication of this notice.

Jacquelyn McDonald, Director, Office of the Board of Health, has determined that for each year of the first five years the repeal is in effect, there will be no fiscal implications for state or local governments as a result of enforcing or administering this section since the section will no longer exist.

Ms. McDonald has also determined that for each year of the first five years the repeal is in effect, the public benefit anticipated as a result of repealing the section will be increased flexibility and breadth in obtaining specific input on issues related to birth defect research and education. There will be no effect on micro businesses or small businesses. This was determined by interpretation of the rule that small businesses and micro-businesses will not be required to alter their business practices in order to comply with the repeal of the rule as proposed. There is no economic costs to persons as a result of this repeal. There will be no effect on local employment.

Comments may be submitted to Jacquelyn McDonald, Director, Office of the Board of Health, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756, (512) 458-7484. Comments on the proposed section will be accepted for 30 days following publication in the Texas Register .

The repeal is proposed under the Health and Safety Code, §11.016, which allows the board to establish advisory committees; the Government Code, Chapter 2110, which sets standards for the evaluation of advisory committees by the agencies for which they function, and the Health and Safety Code, §12.001, which provides the board with authority to adopt rules for the performance of every duty imposed by law upon the board, the department, and the commissioner of health.

The repeal affects the Health and Safety Code, Chapters 11 and 91, and the Government Code, Chapter 2110; and implements Government Code §2001.039.

§37.307.Scientific Advisory Committee on Birth Defects in Texas.

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 October 18, 2002.

TRD-200206850

Susan Steeg

General Counsel

Texas Department of Health

Earliest possible date of adoption: December 1, 2002

For further information, please call: (512) 458-7236


Chapter 61. CHRONIC DISEASES

Subchapter A. KIDNEY HEALTH CARE PROGRAM

25 TAC §61.12

The Texas Department of Health (department) proposes an amendment to §61.12 concerning the Kidney Health Care Advisory Committee (committee). The committee has provided advice to the Texas Board of Health (board) and the department in the area of end-stage renal disease (ESRD) and on current state-of-the-art treatment modalities, medication therapies, and prioritization of the needs of ESRD patients in Texas. The committee is established under the Health and Safety Code, §11.016, which allows the board to establish advisory committees and Health and Safety Code, §85.066, which allows the board to appoint an advisory committee to assist in the development of procedures and guidelines required by the Kidney Health Care Program. The committee is governed by the Government Code, Chapter 2110, concerning state agency advisory committees.

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). The department has reviewed §61.12 and has determined that reasons for adopting the section continue to exist; however, changes were necessary as described in this preamble.

The department published a Notice of Intention to Review §61.12 in the Texas Register on January 7, 2000 (25 TexReg 218). No comments were received due to publication of this notice.

In 1993, the Texas Legislature passed Senate Bill 383 (now codified in the Government Code, Chapter 2110) which requires that each state agency adopt rules on advisory committees. The rules must state the purpose of the committee, describe the tasks of the committee, describe the manner in which the committee will report to the agency, and establish a date on which the committee will be automatically abolished unless the governing body of the agency affirmatively votes to continue the committee's existence.

In 1997, the board established a rule relating to the Kidney Health Care Advisory Committee. The rule states that the committee will automatically be abolished on March 1, 2003. The board has now reviewed and evaluated the committee and has determined that the committee should continue in existence until March 1, 2008.

This section amends provisions relating to the operation of the committee. Specifically, language is revised to: continue the committee until March 1, 2008; include additional requirements regarding statements by members; and clarify the components that the committee must include in an annual report to the board.

Jacquelyn McDonald, Director of the Office of the Board of Health, has determined that for each year of the first five years the section is in effect, there will be no fiscal implications for state and local government as a result of amending the section as proposed.

Ms. McDonald has also determined that for each year of the first five years the section is in effect, the public benefit anticipated as a result of amending the section will be to provide a continuance of the committee and continued advice to the department on this important issue. There will be no costs to small business or micro-business resulting from compliance with this section, as this section addresses only continuance of the committee and terms of office. There are no anticipated economic costs to persons who are required to comply with the section proposed. There is no anticipated impact on local employment.

Comments may be submitted to Jacquelyn McDonald, Director, Office of the Board of Health, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756, (512) 458-7484. Comments on the proposed section will be accepted for 30 days following publication in the Texas Register .

The amendment is proposed under Health and Safety Code, §12.001 which provides the board with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner; §85.066 which allows the board to appoint the committee; and Government Code, §2110.005 which requires the department to adopt rules stating the purpose and tasks of its advisory committees.

The amendment affects the Health and Safety Code, Chapters 11 and 85, and the Government Code, Chapter 2110, and implements Government Code, §2001.039.

§61.12.Kidney Health Care Advisory Committee.

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

(e) Committee abolished. By March 1, 2008 [ 2003 ], the board will initiate and complete a review of the committee to determine whether the committee should be continued, consolidated with another committee, or abolished. If the committee is not continued or consolidated, the committee shall be abolished on that date.

(f) Composition. The committee shall be composed of nine members appointed by the board. The composition of the committee shall include three consumer representatives and six nonconsumer representatives.

[ (1) ] The six nonconsumer representatives shall be as follows:

(1) [ (A) ] three physicians who are nephrologists or renal transplant surgeons; and

(2) [ (B) ] three persons who are renal social workers, renal nurses, renal dietitians, dialysis technicians, renal administrators or pharmacists.

[(2) Since the composition of the committee as it existed on December 31, 1998, is changed under this section, existing members shall continue to serve until the board appoints members under the new composition.]

(g) (No change.)

(h) Officers. The committee [ chairman of the board ] shall select from its members the [ appoint a ] presiding officer and an assistant presiding officer to begin serving on March 1 of each odd-numbered year.

(1) Each officer shall serve until February 27th of each odd-numbered year. Each officer may holdover until his or her replacement is elected [ appointed by the chairman of the board ].

(2) (No change.)

(3) The assistant presiding officer shall perform the duties of the presiding officer in case of the absence or disability of the presiding officer. In case the office of presiding officer becomes vacant, the assistant presiding officer will [ serve until a successor is appointed to ] complete the unexpired portion of the term of the office of presiding officer.

(4) If the office of assistant presiding officer becomes vacant, it may be filled [ temporarily ] by vote of the committee [ until a successor is appointed by the chairman of the board ].

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

[(7) The presiding officer and assistant presiding officer serving on January 1, 1999, will continue to serve until the chairman of the board appoints their successors.]

(i) Meetings. The committee shall meet only as necessary to conduct committee business.

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

(5) A [ simple majority of the members of the committee shall constitute a ] quorum for the purpose of transacting official business is five members .

(6) - (7) (No change.)

(j) - (m) (No change.)

(n) Statement by members.

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

(3) A committee member should not accept or solicit any benefit that might reasonably tend to influence the member in the discharge of the member's official duties.

(4) A committee member should not disclose confidential information acquired through his or her committee membership.

(5) A committee member should not knowingly solicit, accept, or agree to accept any benefit for having exercised the member's official powers or duties in favor of another person.

(6) A committee member who has a personal or private interest in a matter pending before the committee shall publicly disclose the fact in a committee meeting and may not vote or otherwise participate in the matter. The phrase "personal or private interest" means the committee member has a direct pecuniary interest in the matter but does not include the committee member's engagement in a profession, trade, or occupation when the member's interest is the same as all others similarly engaged in the profession, trade, or occupation.

(o) Reports to board. The committee shall file an annual written report with the board.

(1) (No change.)

(2) The report shall identify the costs related to the committee's existence, including the cost of agency staff time spent in support of the committee's activities and the source of funds used to support the committee's activities .

(3) (No change.)

(p) (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 October 18, 2002.

TRD-200206846

Susan Steeg

General Counsel

Texas Department of Health

Earliest possible date of adoption: December 1, 2002

For further information, please call: (512) 458-7236


Chapter 98. HIV AND STD PREVENTION

Subchapter C. TEXAS HIV MEDICATION PROGRAM

1. GENERAL PROVISIONS

25 TAC §98.107, §98.114

The Texas Department of Health (department) proposes amendments to §§98.107 and 98.114 concerning client financial eligibility criteria for the Texas HIV Medication Program. Specifically, the proposed amendments are necessary to conform to budget constraints and to ensure the department is able to continue delivering program services to individuals infected with the human immunodeficiency virus (HIV).

The proposed amendments to §98.107 changes the formula for financial eligibility from 200 percent to 140 percent of the federal poverty income guidelines, eliminates the requirement to adjust the client's annual gross income, and establishes the program's priority to serve eligible pregnant women and eligible individuals younger than 18 years of age.

The proposed amendments to §98.114 require that currently enrolled clients submit a new application within six months of the effective date of this rule. The department will determine continued eligibility in the program based upon the client's new application.

I. Celine Hanson, M.D., Chief, Bureau of HIV and STD Prevention, has determined that for each year of the first five-years the sections are in effect, there will be no fiscal implication to state or local government as a result of enforcing or administering the sections as proposed.

I. Celine Hanson, M.D., Chief, Bureau of HIV and STD Prevention, has determined that for each year of the first five years the sections are in effect, the public benefits anticipated as a result of enforcing or administering the amendments will maintain the delivery of the program to eligible persons with HIV disease. There will be no effect on micro businesses or small businesses. There are no anticipated economic costs to persons who are required to comply with the sections as proposed. There is no anticipated impact on local employment.

Comments on the proposal may be submitted to I. Celine Hanson, M.D., Chief, Bureau of HIV and STD Prevention, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756-3199, (512) 490-2505. Comments will be accepted for 30 days following publication of this proposal in the Texas Register .

The amendments are proposed under the Health and Safety Code, §85.063, which provides the board authority to adopt rules necessary to establish eligibility guidelines to ensure the most appropriate distribution of funds; and §12.001, which provides the Texas Board of Health (board) with the authority to adopt rules for the performance of each duty imposed by law on the board, the department, and the commissioner of health.

The amendments affect the Health and Safety Code, Chapters 12 and 85.

§98.107.Criteria for Financial Eligibility.

(a) A person is financially eligible for the program if he or she:

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

(4) based on available funding has an [ adjusted ] annual gross income that does not exceed 140% [ 200% ] of the most recently published federal poverty income guidelines.

(b) Annual [ Adjusted annual ] gross income.

(1) An applicant's annual gross income (if single), or the combined annual gross income of the applicant and his or her spouse [ , minus the program's cost of the medication(s) that is (are) being prescribed ].

(2) For a minor, the child's annual gross income plus the annual gross income of the parent(s) [ if the child is an emancipated minor or meets the criteria established in Family Code, Chapter 32, §32.003, or the (combined) annual gross income of the parent(s), minus the program's cost of the medication(s) that is (are) being prescribed ]. The parent(s) [ spouse or the parent ] must be living in the same household as the child at the time of application.

(3) For an emancipated minor, the applicant's annual gross income (if single), or the combined annual gross income of the applicant and his or her spouse.

(c) (No change.)

(d) The department shall give priority to eligible individuals younger than 18 years of age and eligible pregnant women.

§98.114.Denial of Application or Termination of Client Benefits.

(a) Individuals applying for services or clients already receiving services will have their application denied or services terminated for any of the following reasons.

(1) Services will be denied or terminated if:

(A) (No change.)

(B) the [ adjusted ] annual gross income does not meet the criteria set in §98.107 of this title (relating to Criteria for Financial Eligibility);

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

(2) (No change.)

(b) (No change.)

(c) Clients currently enrolled in the program will be required to submit a new application within six months after this rule is effective and will be subject to the eligibility requirements defined by §98.107 of this title.

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 October 21, 2002.

TRD-200206881

Susan Steeg

General Counsel

Texas Department of Health

Earliest possible date of adoption: December 1, 2002

For further information, please call: (512) 458-7236


2. ADVISORY COMMITTEE

25 TAC §98.121

The Texas Department of Health (department) proposes an amendment to §98.121, concerning the Texas HIV Medication Advisory Committee (committee). The committee has provided advice to the Texas Board of Health (board) and the department on strategies in the development of procedures and guidelines for the HIV Medication Program. The committee was established under the Health and Safety Code, §11.016, which allows the board to establish advisory committees and Health and Safety Code, §85.066, which allows the board to appoint an advisory committee to assist in the development of procedures and guidelines required by the HIV Medication Program. The committee is governed by the Government Code, Chapter 2110, concerning state agency advisory committees.

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). The department has reviewed §98.121 and has determined that reasons for adopting the section continue to exist; however, changes were necessary as described in this preamble.

The department published a Notice of Intention to Review §98.121 in the Texas Register on April 28, 2000 (25 TexReg 3801). No comments were received due to publication of this notice.

In 1993, the Texas Legislature passed Senate Bill 383 (now codified in the Government Code, Chapter 2110) which requires that each state agency adopt rules on advisory committees. The rules must state the purpose of the committee, describe the tasks of the committee, describe the manner in which the committee will report to the agency, and establish a date on which the committee will be automatically abolished unless the governing body of the agency affirmatively votes to continue the committee's existence.

In 1994, the board established a rule relating to the Texas HIV Medication Advisory Committee. The rule states that the committee will automatically be abolished on March 1, 2003. The board has now reviewed and evaluated the committee and has determined that the committee should continue in existence until March 1, 2008.

This section amends provisions relating to the operation of the committee. Specifically, language is revised to: continue the committee until March 1, 2008; define committee tasks; include additional requirements regarding statements by members; and clarify the components that the committee must include in an annual report to the board.

Jacquelyn McDonald, Director of the Office of the Board of Health, has determined that for each year of the first five years the section is in effect, there will be no fiscal implications for state and local government as a result of amending the section as proposed.

Ms. McDonald has also determined that for each year of the first five years the section is in effect, the public benefit anticipated as a result of amending the section will be to provide a continuance of the committee and continued advice to the department on this important issue. There will be no costs to small business or micro-business resulting from compliance with this section, as this section addresses only continuance of the committee and terms of office. There are no anticipated economic costs to persons who are required to comply with the section as proposed. There is no anticipated impact on local employment.

Comments may be submitted to Jacquelyn McDonald, Director, Office of the Board of Health, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756, (512) 458-7484. Comments on the proposed section will be accepted for 30 days following publication in the Texas Register .

The amendment is proposed under Health and Safety Code, §12.001 which provides the board with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner; §85.066 which allows the board to appoint the committee; and Government Code, §2110.005 which requires the department to adopt rules stating the purpose and tasks of its advisory committees.

The amendment affects the Health and Safety Code, Chapters 11 and 85, and the Government Code, Chapter 2110, and implements Government Code, §2001.039.

§98.121.Texas HIV Medication Advisory Committee.

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

(d) Tasks. The committee shall:

[(1) evaluate the existing program and unmet needs;]

(1) [ (2) ] review the goals and targets of the program;

(2) [ (3) ] evaluate ongoing program efforts;

(3) [ (4) ] recommend [ define ] both short-range and long-range goals and objectives for medication needs; and

[(5) develop criteria and standards for the program; and]

(4) [ (6) ] carry out any other tasks given to the committee by the board.

(e) Committee abolished. By March 1, 2008 [ 2003 ], the board will initiate and complete a review of the committee to determine whether the committee should be continued, consolidated with another committee, or abolished. If the committee is not continued or consolidated, the committee shall be abolished on that date.

(f) Composition.

[ (1) ] The committee shall be composed of 11 members appointed as follows:

(1) [ (A) ] three physicians actively engaged in the treatment of adults with HIV infection;

(2) [ (B) ] one pediatrician actively engaged in the treatment of infants and children with HIV infection;

(3) [ (C) ] four persons who must be diagnosed as HIV positive;

(4) [ (D) ] one member who is an administrator of a public, nonprofit hospital involved in the delivery of services to persons with HIV infection;

(5) [ (E) ] one social worker currently working with persons with HIV infection; and

(6) [ (F) ] one pharmacist who participates in the HIV Medication Program.

[(2) Since the composition of the committee as it existed on December 31, 1998, is changed under this section, existing members shall continue to serve until the board appoints members under the new composition.]

(g) (No change.)

(h) Officers. The committee [ chairman of the board ] shall select from its members the [ appoint a ] presiding officer and an assistant presiding officer to begin serving on March 1 of each odd-numbered year.

(1) Each officer shall serve until February 27th of each odd-numbered year. Each officer may holdover until his or her replacement is elected [ appointed by the chairman of the board ].

(2) (No change.)

(3) The assistant presiding officer shall perform the duties of the presiding officer in case of the absence or disability of the presiding officer. In case the office of presiding officer becomes vacant, the assistant presiding officer will [ serve until a successor is appointed to ] complete the unexpired portion of the term of the office of presiding officer.

(4) If the office of assistant presiding officer becomes vacant, it may be filled [ temporarily ] by vote of the committee [ until a successor is appointed by the chairman of the board ].

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

[(7) The presiding officer and assistant presiding officer serving on January 1, 1999, will continue to serve until the chairman of the board appoints their successors.]

(i) Meetings. The committee shall meet only as necessary to conduct committee business.

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

(5) A [ simple majority of the members of the committee shall constitute a ] quorum for the purpose of transacting official business is six members .

(6) - (7) (No change.)

(j) - (m) (No change.)

(n) Statements by members.

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

(3) A committee member should not accept or solicit any benefit that might reasonably tend to influence the member in the discharge of the member's official duties.

(4) A committee member should not disclose confidential information acquired through his or her committee membership.

(5) A committee member should not knowingly solicit, accept, or agree to accept any benefit for having exercised the member's official powers or duties in favor of another person.

(6) A committee member who has a personal or private interest in a matter pending before the committee shall publicly disclose the fact in a committee meeting and may not vote or otherwise participate in the matter. The phrase "personal or private interest" means the committee member has a direct pecuniary interest in the matter but does not include the committee member's engagement in a profession, trade, or occupation when the member's interest is the same as all others similarly engaged in the profession, trade, or occupation.

(o) Reports to board. The committee shall file an annual written report with the board.

(1) (No change.)

(2) The report shall identify the costs related to the committee's existence, including the cost of agency staff time spent in support of the committee's activities and the source of funds used to support the committee's activities .

(3) (No change.)

(p) (No change.)

[(q) Effective date. This section shall become effective on January 1, 1995.]

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 October 18, 2002.

TRD-200206861

Susan Steeg

General Counsel

Texas Department of Health

Earliest possible date of adoption: December 1, 2002

For further information, please call: (512) 458-7236


Chapter 102. DISTRIBUTION OF TOBACCO SETTLEMENT PROCEEDS TO POLITICAL SUBDIVISIONS

25 TAC §102.3

The Texas Department of Health (department) proposes an amendment to §102.3, concerning the distribution of tobacco settlement proceeds to political subdivisions.

This rule implements a portion of the Government Code, Chapter 12, Subchapter J, which designates the department's responsibilities under the Agreement Regarding Disposition of Tobacco Settlement Proceeds (agreement) filed on July 24, 1998, in United States District Court, Eastern District of Texas, in the case styled The State of Texas v. The American Tobacco Co., et al., No. 5-96CV-91. The department collects information and certifies amounts of the tobacco settlement proceeds for annual distribution to political subdivisions. The term "political subdivision" means a hospital district, another local political subdivision owning or maintaining a public hospital, or a county of the State of Texas responsible for providing indigent health care to the general public. The Health and Safety Code, Chapter 61, defines which entities are responsible for providing indigent health care to the general public.

The amendment is needed to clarify the definition of unreimbursed expenditures that may be claimed by a political subdivision that owns a non-hospital district public hospital, as well as the manner in which the political subdivision funds are paid to the hospital and the source of the payment. The amendment is also needed to improve the procedures for submission of the annual expenditure statement by political subdivisions.

Peggy Belcher, Office of Health Information and Analysis, has determined that for each year of the first five years the proposed amendment is in effect, there will be positive fiscal implications to state and local governments as a result of administering the amended section as proposed. Clarification of unreimbursed expenditures and the methods and sources of payment between a political subdivision and a non-hospital district public hospital should aid in the filing of accurate expenditure statements by these entities. In addition, by not requiring original signatures on expenditure statements and identifying only one due date, the proposed amendment should help local governments in filing annual expenditure statements. Political subdivisions that do not meet the deadline are ineligible to receive any portion of the distribution of tobacco settlement proceeds in that year.

Ms. Belcher has also determined that for each year of the first five years the proposed amendment is in effect, the public benefit anticipated is the assurance that expenditure statements identifying unreimbursed health care expenditures are accurately filed by political subdivisions which, in turn, results in the appropriate amount of funds being distributed for expenditure by local governments for health care services to the general public. There will be no effect on small businesses or micro-businesses since such businesses do not receive tobacco settlement proceeds under this rule, no anticipated economic costs to persons who are required to comply with the section as proposed, and no anticipated impact on local employment.

Comments may be submitted to Peggy Belcher, Office of Health Information and Analysis, Texas Department of Health, 1100 West 49th Street, Austin, Texas, 78756-3199, (512) 458-7261 (phone), (512) 458-7344 (fax), or peggy.belcher@tdh.state.tx.us. Comments on the proposed section will be accepted for 30 days following publication in the Texas Register .

The amendment is proposed under Health and Safety Code, Chapter 12, Subchapter J, §§12.138 - 12.139, which requires the department to adopt rules governing the distribution of tobacco settlement proceeds to political subdivisions; and Health and Safety Code, §12.001, which provides the board with authority to adopt rules to implement every duty imposed by law on the Texas Board of Health, the department, and the commissioner of health.

The amendment affects the Health and Safety Code, Chapter 12, Subchapter J.

§102.3.Annual Claims.

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

(d) Non-hospital district public hospitals. For a non-hospital district public hospital owned by a political subdivision, the agreement further states that unreimbursed expenditures are to be calculated as "the total unreimbursed amount of political subdivision funds paid to such public hospital by any political subdivision during that year."

(1) As stated in subsection (a) of this section, unreimbursed expenditures are defined in the agreement as "those actual expenditures made by a Political Subdivision which are directly attributable to the provision of health care services to the general public, either directly or by contract or agreement with a third party provider, and for which no reimbursement is made by or expected from any third party source or fund. (Lump Sum Trust Account or Permanent Trust Account payments shall not count as reimbursement)".

(2) Under this subsection, a political subdivision may claim political subdivision funds actually paid to the hospital owned by the political subdivision or transferred from a general revenue account of a political subdivision into the hospital's account(s) in order to provide funds for health care services to the general public.

(3) A political subdivision may not claim political subdivision funds paid under paragraph (2) of this subsection when reimbursement is received by the hospital or political subdivision from any third party source or fund. Reimbursed funds are not "unreimbursed expenditures" under this subsection.

(4) The term "unreimbursed expenditures" does not include contractual allowances or discounts for health care services under a third party payor agreement.

(5) [ (1) ] The annual distribution paid to a political subdivision under this subsection [ A payment for unreimbursed expenditures of a non-hospital district public hospital ] shall be made to the political subdivision(s) which owns the hospital, not to the hospital itself.

(6) [ (2) ] A county eligible for a pro rata share of the annual distribution under both subsection (b) and this subsection shall file an expenditure statement for each. Such a county may receive a single warrant from the comptroller.

(7) [ (3) ] If a county or city handles the financial transactions of its public hospital, rather than the public hospital handling those transactions directly, the county or city may count the unreimbursed expenditures it makes on behalf of the public hospital as funds paid to that hospital.

(e) (No change.)

(f) Procedures.

(1) A political subdivision must submit a signed annual expenditure statement to the department, documenting its eligible expenditures for the preceding calendar year:

(A) by delivery, fax, or electronic mail received by the department no later than 5:00 p.m. on March 31 of each year; or

(B) by U.S. Postal Service mail or commercial mail carrier with a postmark reflecting a date no later than midnight on March 31 of each year. Private metered postmarks shall not be acceptable as proof of timely mailing.

[(1) A political subdivision must deliver an annual expenditure statement to the department by or on March 31 of each year, documenting its eligible expenditures for the preceding calendar year. A political subdivision may deliver a copy of the statement by fax or electronic mail by or on March 31; however, the original must be delivered to the department by or on April 7. An expenditure statement that is delivered by fax or electronic mail by or on March 31 in lieu of the original statement must be an exact facsimile of the original.]

(2) If a statement is not received by the department in accordance with the date and methods outlined in paragraph (1) of this subsection [ delivered to the department by March 31 ], the political subdivision shall not receive a pro rata share of the annual distribution.

(3) - (5) (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 October 18, 2002.

TRD-200206862

Susan Steeg

General Counsel

Texas Department of Health

Earliest possible date of adoption: December 1, 2002

For further information, please call: (512) 458-7236


Chapter 241. SHELLFISH SANITATION

The Texas Department of Health (department) proposes the repeal of existing §§241.1 - 241.7, and adoption of new §§241.1 - 241.9 concerning Texas crabmeat. The proposed rules will incorporate language concerning licensing, inspection and enforcement consistent with those in other Bureau of Food and Drug Safety programs; remove the requirements for written standard sanitation operating procedures; correct grammatical errors; and clarify the intent of these rules.

New §§241.3 - 241.5 are taken from existing §241.3 concerning licensing requirements. The one section is now three separate sections. Section 241.3 clarifies the licensing requirements, §241.4 clarifies the inspection requirements, and §241.5 clarifies the enforcement process, including the assessment of administrative penalties. These changes are also proposed to promote conformity among programs within the Bureau of Food and Drug Safety.

Title 21, Code of Federal Regulations (CFR), Part 123 contains the federal Seafood Hazard Analysis Critical Control Point (HACCP) Regulation as administered by the Food and Drug Administration (FDA). Proposed new §241.6 conforms to the federal HACCP Regulation.

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 241.1 - 241.7 have been reviewed and the department has determined that reasons for adopting the sections continue to exist; however, the rules needed revisions as described in this preamble.

The department published a Notice of Intention to Review §§241.1 - 241.7 in the Texas Register (26 TexReg 7582) on September 28, 2001. The department received no comments on these sections following publication of the notice.

Kirk Wiles, Director, Seafood Safety Division, has determined that for each year of the first five- year period these sections are in effect, there will be no fiscal implications to state or local government as a result of administering the sections as proposed.

Mr. Wiles has also determined that for each year of the first five years the sections are in effect, the public benefit will be clarification of the intent of these rules, the requirements to be in compliance to these rules, and provide conformity with the federal HACCP regulations. There are no anticipated economic costs to micro-businesses and/or small businesses and persons who are required to comply with the sections as proposed because the proposed changes in these rules are administrative and grammatical in nature; therefore, no additional expenditures are foreseen. There is no anticipated impact on local employment.

Comments on the proposal may be submitted to Mr. Kirk Wiles, Director, Seafood Safety Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas, 78756, 512/719-0215. Comments will be accepted for 30 days following publication of this proposal in the Texas Register .

Subchapter A. TEXAS CRAB MEAT

25 TAC §§241.1- 241.7

(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 Texas Department of Health or in the Texas Register office, Room 245, James Earl Rudder Building, 1019 Brazos Street, Austin.)

The repeals are proposed under the Health and Safety Code, §436.112, which provides the department with the authority to adopt necessary regulations pursuant to the enforcement of Chapter 436; and §12.001, which provides the Texas Board of Health (board) with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health.

The proposed repeals affect the Health and Safety Code, Chapters 436 and Chapter 12.

§241.1.Definitions.

§241.2.Sources of Crab Meat.

§241.3.Licensing Requirements.

§241.4.General HACCP Requirements.

§241.5.General Sanitation Requirements.

§241.6.Crab Meat Identification.

§241.7.Crab Meat Records.

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 October 18, 2002.

TRD-200206847

Susan Steeg

General Counsel

Texas Department of Health

Earliest possible date of adoption: December 1, 2002

For further information, please call: (512) 458-7236


Subchapter A. TEXAS CRABMEAT

25 TAC §§241.1 - 241.9

The new sections are proposed under the Health and Safety Code, §436.112, which provides the department with the authority to adopt necessary regulations pursuant to the enforcement of Chapter 436; and §12.001, which provides the Texas Board of Health (board) with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health.

The proposed new sections affect the Health and Safety Code, Chapters 436 and Chapter 12.

§241.1.Definitions.

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

(1) Authorized agent -- An employee of the Texas Department of Health who is designated by the commissioner of health to enforce the provisions of these sections.

(2) Act -- The Texas Health and Safety Code, Chapter 436, Aquatic Life.

(3) Commissioner -- The commissioner of health for the State of Texas.

(4) Compliance schedule -- A written schedule that provides a time period to correct critical, key and other deficiencies.

(5) Container -- The physical material in contact with or immediately surrounding the crabmeat that confines it into a single unit.

(6) Cook lot -- All of the crabmeat product cooked in one day at one location.

(7) Crabmeat -- The edible meat of steamed or cooked crabs that has not been processed other than by picking, packing, and chilling.

(8) Critical Control Point (CCP) -- A point, step or procedure in a food process at which control can be applied, and as a result a food safety hazard can be prevented, eliminated or reduced to acceptable levels.

(9) Critical deficiency -- A condition or practice which:

(A) results in the production of a product that is adulterated, decomposed, misbranded or unwholesome; or

(B) presents a threat to the health or safety of the consumer.

(10) Critical limit -- The maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.

(11) Dealer -- A person to whom a license is issued for the activities of crabmeat picking and packing or crabmeat picking, packing, and pasteurization.

(12) Department -- The Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756, or its successor state agency, having the responsibility for the enforcement of laws concerning the safety of the food supply including regulating the processing, picking, packing, pasteurization, and/or shipping of crabmeat.

(13) Food safety hazard -- Any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.

(14) HACCP -- Hazard Analysis Critical Control Point, a systematic, science-based approach used in food production as a means to assure food safety. The concept is built upon the seven principles identified by the National Advisory Committee on Microbiological Criteria for Foods (1992).

(15) HACCP Plan -- A written document that delineates the formal procedures that a dealer follows to implement the HACCP requirements set forth in Title 21, Code of Federal Regulations (CFR), §123.6.

(16) Key deficiency -- A condition or practice that may result in adulterated, decomposed, misbranded or unwholesome product.

(17) Label -- Any written, printed or graphic matter affixed to or appearing upon any package containing crabmeat.

(18) License -- A numbered document issued by the department that authorizes a dealer to process crabmeat for sale.

(19) License number -- The unique identification number issued by the department to each dealer for each location. Each license number shall consist of a one to five-digit Arabic number preceded by the two-letter state abbreviation and followed by a one or two-letter abbreviation for the type of activity or activities the dealer is qualified to perform in accordance with the following terms:

(A) crabmeat picking and packing (C); or

(B) crabmeat picking, packing, and pasteurization (CP).

(20) Licensed location -- A plant or place of business that has been inspected by the Seafood Safety Division of the department and for which a crabmeat processing license has been issued.

(21) Other deficiency -- A condition or practice that is not defined as critical or key, but is of a public health significance and, if left uncorrected, could result in a key or critical violation.

(22) Packing -- The placing of crabmeat into containers for off-premise consumption.

(23) Pasteurization plant -- A place where crabmeat is heat-treated, without complete sterilization, to improve keeping qualities of the meat.

(24) Pasteurized crabmeat -- The meat of crabs cooked, picked, and packed for off-premise consumption which has been heat treated, without complete sterilization, to improve keeping qualities of the meat.

(25) Person -- Any individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind, government, or governmental subdivision or agency, partnership, association, corporation or other legal entity.

(26) Pick(ing) -- The removal of crabmeat from the crab shell.

(27) Picking plant -- A place where crabs are cooked and edible meat is picked therefrom.

(28) Principal display panel -- The part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of retail sale.

(29) Sanitation control record -- Records that document the monitoring of sanitation practices and conditions.

(30) Sewer -- An artificial, usually subterranean, conduit to carry off sewage and/or surface water.

(31) SSD -- The Seafood Safety Division of the Texas Department of Health, to which responsibility for regulating the processing, picking, packing, pasteurization, and/or shipping of crabmeat is delegated.

§241.2.Sources of Crabmeat.

(a) No crabmeat may be offered for sale for food in the State of Texas unless the crabmeat has been processed and packaged in compliance with §§241.1 - 241.9 of this title (relating to Texas Crabmeat). If obtained from sources outside of the state, the crabmeat shall originate from a source acceptable to the department. These sources must be licensed and inspected by the appropriate state or other government authority.

(b) For sources outside the United States to be approved, documentation must be provided by a foreign governmental authority(s) that verifies the licensing and inspection and states that the processes involved comply with §§241.1 - 241.9 of this title, including the HACCP requirements described in §241.6 of this title (relating to General HACCP Requirements).

(c) Crabmeat from sources other than those outlined in this section shall not be sold, offered for sale, or held for sale in the State of Texas.

§241.3.Licensing Requirements.

(a) No person shall engage in any activity requiring a license under §§241.1 - 241.9 of this title (relating to Texas Crabmeat) without having applied for and obtained an annual numbered license pertaining to the particular activity from the commissioner. No license will be issued without a HACCP plan, in accordance with §241.6 of this title (relating to General HACCP Requirements), that is acceptable to the SSD.

(b) Dealer Licensing.

(1) Picker-Packer. Any person who cooks crabs and picks and packs the crabmeat shall be licensed as a picker-packer.

(2) Pasteurizer. Any person who cooks crabs, picks, packs, and pasteurizes the crabmeat, or pasteurizes crabmeat picked and packed in another location shall be licensed as a pasteurizer.

(c) Time Period for Processing and Issuing a License.

(1) The date a license application is received is the date the original application reaches the department.

(2) The period for processing an application begins on the date the SSD receives a compliance memo from an authorized agent of the state, which states the facility is in compliance with all applicable rules, including the HACCP requirements described in §241.6 of this title.

(3) An application for a license is complete when:

(A) the SSD has received, reviewed, and found acceptable the application information required by §§241.1 - 241.9 of this title.

(B) the SSD receives a compliance memo from an authorized agent of the state, which states the facility is in compliance with all applicable rules, including the HACCP requirements described in §241.6 of this title.

(4) A license is valid from March 1 through the last day of February each year, or part thereof.

(d) Prior to beginning construction of a new crabmeat plant or major remodeling of an existing crabmeat plant (which includes, but is not limited to: any process new to that particular plant; any change of product flow; or any enlarging of the plant structure), complete, legible plans showing the floor plan of the building with dimensions drawn to scale, location of equipment, doors, floor drains, etc., and written, complete operational procedures for all phases of the activity, including flow of the product, shall be submitted to SSD for review and written approval. Additional plans of the entire premises may be required showing all structures, as well as all water wells and septic systems, with related distances and a statement of specifications as to type, sizes, design, date installed, etc. Plans shall be submitted to the SSD no less than 30 days prior to initiating a new process or beginning construction. No operations shall be conducted while any construction or related activity, that has the potential to contaminate the product, is occurring inside the plant.

(e) A legibly written or typed application on forms provided by the department must be filed with the SSD each year.

(f) If the applicant proposes to use a date other than an open date, the application for a license must be accompanied by a written statement of the procedure the applicant will use to determine the date to be included on the label for crabmeat packed or pasteurized and shipped from the location listed in the application.

(g) A license and unique number shall be issued by the commissioner only after an inspection of the plant by an authorized agent has revealed that the plant and practices are in compliance with these sections. A license and unique number shall be issued to a dealer for each location at which crabmeat operations are to be conducted and a license is required.

(h) The inspection of a previously licensed plant which has exhibited operational problems, violations of operational requirements of these sections, or has had a license revoked shall not be conducted until written, complete operational procedures for all phases of the activity, including flow of the product, are submitted to the SSD for review and approval. An application may be refused and a license denied based on a history of failure to comply with the requirements of these sections in accordance with §241.5 of this title (relating to Enforcement).

(i) Crabmeat operations by the dealer shall not begin until the commissioner has issued the crabmeat processing license for that location. Each license shall expire automatically at 11:59 p.m. the last day of February following the date of issue. Licenses shall not be transferable.

§241.4.Inspections.

(a) After a license is issued, unannounced inspections may be conducted at any time the SSD has reasonable belief that the business may be in operation or that crabmeat may be stored on the premises. Inspections may be made at such frequency as may be necessary to assure that adequate operational and sanitary conditions are maintained, and the license holder is in compliance with these rules.

(b) All crabmeat at a licensed location shall be the responsibility of the dealer at that location for the purposes of these sections.

(c) A copy of the completed inspection form listing written descriptions of the violations observed, along with any necessary explanation, shall be provided by an authorized agent of the department to the most responsible individual present at the firm at the conclusion of the inspection. If a responsible individual is not present, the form will be mailed.

(d) Any violations of the same rule or regulation found on any two consecutive inspections may result in license suspension in accordance with §241.5(a) of this title (relating to Enforcement).

(1) When an inspection detects a critical deficiency, the violation shall be immediately corrected during that inspection or the plant must immediately cease production affected by the violation. If production affected by the violation does not voluntarily cease, all crabmeat handled or processed while the violation exists or existed shall be detained. Further enforcement action may be taken as authorized under this chapter.

(2) When an inspection detects four or more key deficiencies, the dealer shall establish a correction schedule acceptable to the SSD. The follow-up inspection shall determine if the violations have been corrected or are being corrected in accordance with the scheduled correction dates noted on the previous inspection report.

(3) When a routine inspection detects other deficiencies or three or fewer key deficiencies, the deficiencies shall be corrected prior to the next routine inspection.

§241.5.Enforcement.

(a) The department may refuse to license, suspend or revoke a license if the applicant or licensee:

(1) fails to comply with any provision of the statute;

(2) fails to comply with any provision of this chapter;

(3) commits fraud, misrepresentation, or concealment of a material fact on any documents required to be submitted to the department or required to be maintained by the facility pursuant to this chapter;

(4) aids, abets, or permits the commission of an illegal act;

(5) fails to comply with an order of the commissioner of health or another enforcement procedure under the statute;

(6) the license holder or representative refuses to allow an inspection or otherwise interferes with the authorized department agent in the performance of his or her duties;

(7) fails to have a HACCP plan, has a HACCP plan unacceptable to the SSD, or fails to comply with a HACCP plan that is acceptable to the SSD;

(8) fails to provide the required application;

(9) has any critical violations identified during the license inspection; or

(10) has more than two key deficiencies and three other deficiencies identified during the license inspection.

(b) If the department proposes to refuse to license, proposes to suspend, or proposes to revoke a license, the department shall notify the applicant or license holder of the reasons for the proposed action and offer the person an opportunity for a hearing. Notice may be sent by certified mail or first class mail.

(1) If the facility chooses to request a hearing, it shall do so within 20 calendar days of receipt of the notice. Receipt of the notice is presumed to occur on the fifth calendar day after the notice is mailed to the last address known to the department unless another receipt date is reflected on a United States Postal Service return receipt.

(2) The request for a hearing shall be in writing and submitted to the Director, SSD, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756-3199.

(3) A hearing shall be conducted pursuant to the Administrative Procedure Act, Texas Government Code, Chapter 2001, and the department's formal hearing procedures in Chapter 1 of this title (relating to Texas Board of Health).

(4) If the facility does not request a hearing in writing within 20 calendar days of receipt of the notice, the facility is deemed to have waived the opportunity for a hearing and the proposed action shall be taken.

(5) If the person fails to appear or be represented at the scheduled hearing, the person has waived the right to a hearing and the proposed action shall be taken.

(c) If the department suspends a license, the suspension shall remain in effect until the department determines that the reason for suspension no longer exists. An authorized representative of the department shall investigate prior to making a determination. During the time of suspension, the suspended license holder shall return the license to the department and shall not process crabmeat.

(d) If the department revokes a license, a person may reapply for a license 180 days after the date of signing of the final order of revocation. The department may refuse to issue a license if the reason for revocation or non-renewal continues to exist, or the applicant does not meet the requirements for a license.

(e) Upon revocation a license holder shall return the license to the department. A dealer whose license has been revoked may not be issued a new license for 180 days or before the next licensing period, whichever is longer, after the date of signing of the final order of revocation.

(f) Pursuant to Health and Safety Code, §§436.034 - 436.037, the department may assess an administrative penalty against a person who violates §436.011 of the statute or an order issued under this chapter.

(1) The penalty may not exceed $25,000 for each violation. Each day of a continuing violation constitutes a separate violation.

(2) In determining the amount of an administrative penalty assessed under this section, the department shall consider:

(A) the seriousness of the violation;

(B) the person's previous violations;

(C) the hazard to the health and safety of the public;

(D) the person's demonstrated good faith; and

(E) any other matters that justice may require.

(3) All proceedings for the assessment of an administrative penalty are subject to the Administrative Procedure Act, Government Code, Chapter 2001.

(4) If, after investigation of an alleged violation and the facts surrounding that alleged violation, the department determines that a violation has occurred, the department shall give written notice of the violation to the person alleged to have committed the violation. The notice shall include:

(A) a brief summary of the alleged violation including the statute and/or rules violated;

(B) a statement of the amount of the proposed penalty, based on the factors listed in paragraph (2) of this subsection; and

(C) a statement of the person's right to a hearing on the occurrence of the violation, the amount of the penalty, or both the occurrence of the violation and the amount of the penalty.

(5) The seriousness of violations for which administrative penalties are assessed may be categorized by one of the following severity levels.

(A) Severity Level I covers violations that are most significant and may have a significant negative impact on public health and safety.

(B) Severity Level II covers violations that are very significant and may have a negative impact on the public health and safety.

(C) Severity Level III covers violations that are significant, and if not corrected, could threaten public health and safety.

(D) Severity Level IV covers violations that are of more than minor public health and safety significance, but if left uncorrected could lead to more serious circumstances.

(E) Severity Level V covers violations that are of minor public health and safety significance.

(6) Not later than the 20th calendar day after the date the notice is received, the person notified may accept the determination of the department made under this section, including the recommended penalty, or make a written request for a hearing on that determination.

(7) If the person notified of the violation accepts the determination of the department, or fails to request a hearing, the department shall issue an order approving the determination that a violation occurred and ordering that person to pay the recommended penalty.

(8) If a hearing is requested, the department shall refer the matter to the State Office of Administrative Hearings for a hearing.

(9) The provisions of §§436.035 and 436.036 of the Act shall be followed in assessing and paying an administrative penalty.

§241.6.General HACCP Requirements.

(a) The department hereby adopts by reference Title 21, Code of Federal Regulations (CFR), §123.6 (Hazard Analysis and Hazard Analysis Critical Point (HACCP Plan), as amended. If the requirements of this chapter are more stringent than the requirements of other adopted requirements, then this chapter's requirements prevail and must be complied with.

(b) Those dealers required to be licensed under this subchapter shall comply with all the requirements of this section, the Texas Aquatic Life Act, Health and Safety Code, Chapter 436, and the requirements of Title 21, CFR, §123.6, as amended.

(c) Every dealer shall conduct a hazard analysis to determine the food safety hazards that are reasonably likely to occur for each kind of crabmeat product processed by that dealer and to identify the preventive measures that the dealer can apply to control those hazards. Such food safety hazards can be introduced both within and outside the processing plant environment and can occur before, during, and after harvest. A food safety hazard that is reasonably likely to occur is one for which a prudent dealer would establish controls because experience, illness data, scientific reports, or other information provide a basis to conclude that there is a reasonable possibility that the hazard will occur in the particular type of crabmeat product being processed in the absence of those controls.

(d) Every dealer shall have, implement, and comply with a written HACCP plan that is acceptable to the SSD. A copy of the plan shall be provided to the SSD upon request. A HACCP plan shall be specific to:

(1) each location where crabmeat products are processed by that dealer; and

(2) each kind of crabmeat product processed by the dealer. The plan may group kinds of crabmeat products together, or group kinds of production methods together if the food safety hazards, critical control points, critical limits, and procedures required to be identified and performed in this section are identical for all crabmeat products so grouped or for all production methods so grouped.

(e) The HACCP plan shall, at a minimum:

(1) list the food safety hazards that are reasonably likely to occur, as identified in accordance with subsection (c) of this section and that must be controlled for each crabmeat product. Consideration should be given to whether any food safety hazards are reasonably likely to occur as a result of the following:

(A) natural toxins;

(B) microbiological contamination;

(C) chemical contamination;

(D) pesticides;

(E) drug residues;

(F) unapproved use of direct or indirect food or color additives; and

(G) physical hazards;

(2) list the critical control points for each of the identified food safety hazards, including as appropriate:

(A) critical control points designed to control food safety hazards introduced outside the processing plant environment, including food safety hazards that occur before, during, and after harvest; and

(B) critical control points designed to control food safety hazards that could be introduced in the processing plant environment;

(3) list the critical limits that must be met at each of the critical control points;

(4) list the procedures, and frequency thereof, that will be used to monitor each of the critical control points to ensure compliance with the critical limits;

(5) include any written corrective action plans that have been developed in accordance with this section to be followed in response to deviations from critical limits at critical control points;

(6) list the verification procedures, and frequency thereof, that the dealer will use in accordance with this section; and

(7) provide for a record keeping system that documents the monitoring of critical control points. The records shall contain the actual values and observations obtained during monitoring.

(f) The HACCP plan shall be signed and dated by the most responsible individual on site at the processing facility or by a higher level official of the dealer:

(1) upon initial acceptance;

(2) upon any modification; and

(3) upon verification of the plan in accordance with subsection (i)(1)(A) of this section.

(g) Sanitation controls may be included in the HACCP plan, however they must be monitored in accordance with §241.7 of this title (relating to General Sanitation Requirements).

(h) Corrective actions.

(1) Whenever a deviation from a critical limit occurs, a dealer shall take corrective action either by:

(A) following a corrective action plan that is appropriate for the particular deviation; or

(B) following the procedures in paragraph (2) of this subsection.

(2) Dealers may develop written corrective action plans, which become part of their HACCP plans in accordance with subsection (e)(5) of this section, by which they predetermine the corrective actions that they will take whenever there is a deviation from a critical limit. A corrective action plan that is appropriate for a particular deviation is one that describes the steps to be taken and assigns responsibility for taking those steps to ensure that:

(A) no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation; and

(B) the cause of the deviation is corrected.

(3) When a deviation from a critical limit occurs and the dealer does not have a corrective action plan that is appropriate for that deviation, the dealer shall:

(A) segregate and hold the affected product, at least until the requirements of subparagraphs (B) and (C) of this paragraph are met;

(B) perform or obtain a review to determine the acceptability of the affected product for distribution. The review shall be performed by an individual or individuals who have adequate training or experience to perform such a review;

(C) take corrective action, when necessary, with respect to the affected product to ensure that no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation;

(D) take corrective action, when necessary, to correct the cause of the deviation; and

(E) perform or obtain timely reassessment by an individual or individuals who have been trained in accordance with this section to determine whether the HACCP plan needs to be modified to reduce the risk of recurrence of the deviation, and modify the HACCP plan as necessary.

(4) All corrective actions taken in accordance with this section shall be fully documented in records that are subject to verification in accordance with subsection (i) of this section and the record keeping requirements of subsection (j) of this section.

(i) Verification.

(1) Every dealer shall verify that the HACCP plan is adequate to control food safety hazards that are reasonably likely to occur and that the plan is being effectively implemented. Verification shall include, at a minimum:

(A) a reassessment of the adequacy of the HACCP plan at least annually or whenever any changes occur that could affect the hazard analysis or alter the HACCP plan in any way. The reassessment shall be performed by an individual or individuals who have been trained in accordance with subsection (k) of this section. The HACCP plan shall be modified immediately whenever a reassessment reveals that the plan is no longer adequate to fully meet the requirements of subsection (e) of this section. These changes may include:

(i) raw materials or source of raw materials;

(ii) product formulation;

(iii) processing methods or systems;

(iv) finished product distribution systems; or

(v) the intended use or consumers of the finished product;

(B) ongoing verification activities including:

(i) a review of any consumer complaints that have been received by the dealer to determine whether they relate to the performance of critical control points or reveal the existence of unidentified critical control points;

(ii) the calibration of process-monitoring instruments; and

(iii) at the option of the dealer, the performing of periodic end-product or in-process testing; and

(C) a review, including signing and dating, by an individual who has been trained in accordance with subsection (k) of this section, of the records that document:

(i) the monitoring of critical control points. The purpose of this review shall be, at a minimum, to ensure that the records are complete and to verify that they document values that are within the critical limits. This review shall occur within one week of the day that the records are made;

(ii) the taking of corrective actions. The purpose of this review shall be, at a minimum, to ensure that the records are complete and to verify that appropriate corrective actions were taken in accordance with subsection (h) of this section. This review shall occur within one week of the day that the records are made; and

(iii) the calibrating of any process monitoring instruments used at critical control points and the performing of any periodic end-product or in-process testing that is part of the dealer's verification activities. The purpose of these reviews shall be, at a minimum, to ensure that the records are complete and that these activities occurred in accordance with the dealer's written procedures as specified in the HACCP plan. These reviews shall occur within a reasonable time period after the records are made.

(2) Dealers shall immediately follow the procedures in subsection (h) of this section whenever any verification procedure, including the review of a consumer complaint, reveals the need to take a corrective action.

(3) The calibration of process-monitoring instruments and the performing of any periodic end-product and in-process testing, in accordance with paragraph (1)(B)(ii) and (iii) of this subsection shall be documented in records that are subject to the record keeping requirements of subsection (j) of this section.

(j) Records.

(1) All records required shall include:

(A) the name and location of the dealer;

(B) the date and time of the activity that the record reflects;

(C) the signature or initials of the person performing the operation; and

(D) where appropriate, the identity of the product and the production code, if any. Processing and other information shall be entered on records at the time that it is observed.

(2) All records required shall be retained at the processing facility for at least one year after the date they were prepared in the case of refrigerated products and for at least two years after the date they were prepared in the case of frozen products.

(3) Records that relate to the general adequacy of equipment or processes being used by a dealer, including the results of scientific studies and evaluations, shall be retained at the processing facility for at least two years from the date that product is first produced using the applicable equipment or processes.

(4) If the processing facility is closed for a prolonged period between seasonal operations or if record storage capacity is limited on a processing vessel or at a remote processing site, the records may be transferred to some other reasonably accessible location at the end of the seasonal operations, but shall be immediately producible for official review upon request by the department.

(5) All records required by subsection (j) of this section and HACCP plans required by subsections (d) and (e) of this section shall be available for official review and copying upon request by the department.

(6) The maintenance of records on computers is acceptable, provided that appropriate controls are implemented to ensure the integrity of the electronic data and electronic signatures.

(k) Training.

(1) At a minimum, the following functions shall be performed by an individual who has successfully completed training in the application of HACCP principles to crabmeat processing at least equivalent to that received under standardized curriculum recognized as adequate by the Food and Drug Administration (FDA) or who is otherwise qualified through job experience to perform these functions:

(A) developing a HACCP plan, which could include adopting a model or generic-type HACCP plan that is appropriate for a specific processor, in order to meet the requirements of subsection (e) of this section;

(B) reassessing and modifying the HACCP plan in accordance with the corrective action procedures specified in subsection (h)(3)(E) of this section, and the HACCP plan in accordance with the verification activities specified in subsection (i)(1)(B) of this section; and

(C) performing the record review required by subsection (i)(1)(C) of this section.

(2) Job experience will qualify an individual to perform these functions if it has provided knowledge at least equivalent to that provided through the standardized curriculum as determined by the SSD.

(3) The trained individual need not be an employee of the dealer.

§241.7.General Sanitation Requirements.

(a) Each dealer shall monitor conditions and practices that are both appropriate to the plant and the food being processed with sufficient frequency to ensure, at a minimum, conformance with the requirements specified in §§229.211 - 229.219 of this title (relating to Current Good Manufacturing Practice and Good Warehousing Practice in Manufacturing, Packing, or Holding Human Food). The requirements specified in §§229.211 - 229.219 of this title relate to the following sanitation items:

(1) safety of water for processing and ice production;

(2) condition and cleanliness of food contact surfaces;

(3) prevention of cross contamination;

(4) maintenance of hand washing, hand sanitizing and toilet facilities;

(5) protection from adulterants;

(6) proper labeling, storage, or use of toxic compounds;

(7) control of employees with adverse health conditions; and

(8) exclusion of pests.

(b) Each dealer shall maintain sanitation control records that, at a minimum, document the monitoring and corrections prescribed by subsection (a) of this section. These records are subject to the requirements of §241.6(j) of this title (relating to General HACCP Requirements).

(c) Sanitation controls may be included in the HACCP plan, as required by §241.6(d) of this title. However, to the extent that they are monitored in accordance with subsection (a) of this section, they need not be included in the HACCP plan.

§241.8.Crabmeat Identification.

(a) All containers of fresh or fresh frozen crabmeat shall have permanently recorded on the principal display panel, so as to be easily visible, the following information:

(1) the dealer or distributor's name;

(2) the dealer's or distributor's address, including at least the city and state;

(3) the license number for the licensed location where the crabmeat was packed or pasteurized; and

(4) where the name and address of a distributor is used, it shall be preceded by the words "PACKED FOR" or "DISTRIBUTED BY", or followed by the word "DISTRIBUTOR."

(b) The principal display panel on each container of fresh or fresh frozen crabmeat shall contain a date. The date shall be the date of packing unless a "SELL BY" date is established and used in accordance with subsection (c) of this section.

(c) The date shall be as follows:

(1) if it is an open date, it shall be the calendar date as follows: the abbreviation for the month, the numerical day of the month, and the year;

(2) if it is a code date, the proposed method must be submitted in writing to the SSD and approved by the SSD before it is used; and

(3) if it is a "SELL BY" date, it shall be based on the date the crabmeat was packed and the proposed method must be submitted in writing to the SSD and approved by the SSD before it is used.

(d) The presence of any chemical, if any is allowed, and the net weight of the contents shall be permanently recorded on the container. The proper designation of the contents of the container (lump, special, claw, finger, etc.) is required and shall be recorded either on the container sidewall or the lid.

(e) Frozen crabmeat shall be labeled as "FROZEN", "INDIVIDUALLY QUICK FROZEN", or "IQF", in print of similar prominence adjacent to the words "CRABMEAT." Containers shall be marked as frozen prior to freezing.

(f) All required information shall be provided in a legible and indelible form and shall be either:

(1) on the sidewall of the container unless the cover becomes an integral part of the container during a sealing process; or

(2) sealed into an area where it remains legible and visible as the principal display panel until all product from the container has been used or disposed of.

(g) Adhesive labels shall be durable and waterproof and shall not be used without prior approval from the SSD. The request for use of adhesive labels must be submitted in writing to the SSD.

(h) Use of rubber stamps is not allowed except for dating.

(i) All labeling is subject to review and approval by the SSD.

(j) Reusable containers for in-plant use during picking and packing are exempt from labeling requirements. These containers may be used only for temporary holding of crabmeat during picking and packing activities. Crabmeat may not be stored in unlabeled containers.

(k) The label on pasteurized crabmeat shall meet all of the requirements established for fresh or fresh frozen crabmeat in this section.

(l) The label on pasteurized crabmeat shall clearly identify the contents of the container as pasteurized crabmeat. Where the term "CRABMEAT" (or its equivalent) appears on the label of pasteurized crabmeat, the word "PASTEURIZED" shall be used in conjunction with it and in print of similar prominence.

(m) Each container of pasteurized crabmeat shall be permanently and legibly identified with a code indicating the batch and the day of processing.

(n) The words "PERISHABLE--KEEP UNDER REFRIGERATION" or their equivalent shall be prominently displayed on the label of pasteurized crabmeat.

(o) When packing and pasteurization of crabmeat by one dealer for another is practiced, the label shall clearly state the license number of the packer/pasteurizer.

(p) When crabmeat is packed in one licensed crabmeat picking plant and pasteurized in another licensed crabmeat pasteurization plant, the label shall clearly state the name and license number of both dealers.

§241.9.Crabmeat Records.

(a) Complete, accurate, and legible records in a form approved by the SSD shall be maintained by each dealer. The records shall be sufficient to document the dates of purchases of live crabs and the dates of purchases or shipments of crabmeat so that a container of crabmeat can be traced to the specific cook lot in which it was processed.

(b) Records covering purchases of live crabs and shipments of fresh crabmeat, pasteurized crabmeat, or frozen crabmeat shall be retained for a minimum of two years, or for a period of time that exceeds the shelf life of the product if that is longer than two years.

(c) Records shall be made available for inspection, review, or copying upon request of any authorized agent of the department at any reasonable time.

(d) All brand names or trade names used on packages or containers holding crabmeat shall be registered with the SSD prior to being used.

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 October 18, 2002.

TRD-200206848

Susan Steeg

General Counsel

Texas Department of Health

Earliest possible date of adoption: December 1, 2002

For further information, please call: (512) 458-7236


Subchapter B. MOLLUSCAN SHELLFISH

The Texas Department of Health (department) proposes the repeal of §§241.50 - 241.67, and new §§241.50 - 241.71 concerning molluscan shellfish. The rules include a change in the definition of the word "repacker"; a change in the language concerning certification, inspection and enforcement for clarity and to be consistent with those in other Bureau of Food and Drug Safety programs; the removal of the requirements for written Standard Sanitation Operating Procedures; changes to make these rules conform with the National Shellfish Sanitation Program's Model Ordinance; correction of grammatical errors; and clarification of the intent of these rules.

Proposed new §241.50 changes the definition of a "repacker." Changing the definition makes the rules consistent throughout the sections.

New §§241.58 - 241.60 are taken from existing §241.7, which is proposed for repeal concerning certification requirements. The one section is now three separate sections. Section 241.58 clarifies the certification requirements; §241.59 clarifies the inspection requirements; and §241.60 clarifies the enforcement process including the assessment of administrative penalties. These changes are also proposed to promote conformity among programs within the Bureau of Food and Drug Safety.

Title 21, Code of Federal Regulations (CFR), Part 123 contains the federal Seafood Hazard Analysis Critical Control Point (HACCP) Regulation administered by the Food and Drug Administration (FDA). Proposed changes in §241.62 are necessary to conform to the federal HACCP Regulation.

New §241.67 is a complete rewrite of current §241.64 proposed for repeal. These changes are necessary to be in conformance with Issue 01-224 at the 2001 Interstate Shellfish Sanitation Conference.

The addition of new §241.68 is necessary for the department to be in compliance with the National Shellfish Sanitation Program's Model Ordinance. The State of Texas is required to institute and maintain a Vibrio vulnificus Management Plan for oysters.

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 241.50 - 241.67 have been reviewed and the department has determined that reasons for adopting the sections continue to exist; however, the rules needed revisions as described in this preamble.

The department published a Notice of Intention to Review §§241.50 - 241.67 in the Texas Register (26 TexReg 7582) on September 28, 2001. The department received no comments on these sections as a result of the publication of the notice.

Kirk Wiles, Director, Seafood Safety Division, has determined that for each year of the first five- year period these sections are in effect, there will be no fiscal implications to state or local government as a result of administering the sections as proposed.

Mr. Wiles has also determined that for each year of the first five years the sections are in effect, the public benefit will be clarification of the intent of these rules and the requirements to be in compliance with these rules, and the implementation of a Vibrio vulnificus Management Plan to reduce illness and deaths associated with raw oyster consumption. There are no anticipated economic costs to micro-businesses and/or small businesses and persons who are required to comply with the sections as proposed because the proposed changes in these rules are administrative and grammatical in nature; therefore, no additional expenditures are foreseen. There is no anticipated impact on local employment.

Comments on the proposal may be submitted to Mr. Kirk Wiles, Director, Seafood Safety Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas, 78756, (512) 719-0215. Comments will be accepted for 30 days following publication of the proposal in the Texas Register .

25 TAC §§241.50 - 241.67

(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 Texas Department of Health or in the Texas Register office, Room 245, James Earl Rudder Building, 1019 Brazos Street, Austin.)

The repeals are proposed under the Health and Safety Code, §436.112, which provides the department with the authority to adopt necessary regulations pursuant to the enforcement of Chapter 436; and §12.001, which provides the Texas Board of Health (board) with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health.

The repeals affect the Health and Safety Code, Chapters 436 and Chapter 12.

§241.50.Definitions.

§241.51.Growing Area Classification.

§241.52.Shell Stock Transplanting and Gathering for Depuration.

§241.53.Molluscan Shellfish Aquaculture.

§241.54.Land Based Aquaculture.

§241.55.Polyculture Systems.

§241.56.Molluscan Shell Stock Harvesting and Handling.

§241.57.Certification Requirements.

§241.58.Molluscan Shell Stock Temperature Control.

§241.59.Trucks or Other Vehicles Used To Transport Molluscan Shell Stock to the Original Dealer.

§241.60.General HACCP Requirements.

§241.61.General Sanitation Requirements.

§241.62.Dealer Molluscan Shell Stock Identification.

§241.63.Shucked Molluscan Shellfish Labeling.

§241.64.Labeling of Molluscan Shellfish Post-Harvest Processed To Reduce Vibrio vulnificus.

§241.65.Shipping Documents and Records.

§241.66.Tagging of Depurated Molluscan Shellfish.

§241.67.Depuration Records.

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 October 18, 2002.

TRD-200206844

Susan Steeg

General Counsel

Texas Department of Health

Earliest possible date of adoption: December 1, 2002

For further information, please call: (512) 458-7236


25 TAC §§241.50 - 241.71

The new sections are proposed under the Health and Safety Code, §436.112, which provides the department with the authority to adopt necessary regulations pursuant to the enforcement of Chapter 436; and §12.001, which provides the Texas Board of Health (board) with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health.

The new sections affect the Health and Safety Code, Chapters 436 and Chapter 12.

§241.50.Definitions.

The following words and terms, when used in this subchapter of this title, relating to molluscan shellfish, shall have the following meanings unless the context clearly indicates otherwise.

(1) Act -- The Texas Health and Safety Code, Chapter 436, Aquatic Life.

(2) Air gap -- The unobstructed vertical distance through the free atmosphere between the lowest opening from any pipe or faucet supplying water to a tank, plumbing fixture or other device, and the flood level rim of that receptacle.

(3) Application process -- The filing of an application for certification with the Texas Department of Health followed by an inspection by an authorized agent confirming compliance with the rules.

(4) Approved area -- A classification used to identify a harvest area where harvest for direct marketing is allowed.

(5) Approved source -- A source of molluscan shellfish acceptable to the director (commissioner of health).

(6) Aquaculture -- The cultivation of seed in natural or artificial growing or harvest areas, or the cultivation of molluscan shellstock other than seed in harvest areas.

(7) Assure -- To make certain.

(8) Authorized agent -- An employee of the Texas Department of Health who is designated by the commissioner to enforce provisions of these sections.

(9) Backflow -- The flow of water or other liquids, mixtures or substances into the distribution pipes of a potable water supply from any source or sources other than the intended source.

(10) Back siphonage -- The flowing back of used, contaminated or polluted water from a plumbing fixture, vessel or other source into potable water supply pipes because of negative pressure in the water supply pipes.

(11) Blower -- A receptacle for washing shucked molluscan shellfish that uses forced air as a means of agitation.

(12) Certificate (molluscan shellfish certificate of compliance) -- A numbered document issued by the commissioner which authorizes a dealer to process molluscan shellfish for sale.

(13) Certification or certify -- The issuance of a numbered certificate to a person for a particular activity or group of activities that indicates:

(A) permission from the department to conduct the activity; and

(B) initial compliance with the requirements of §§241.50 - 241.71 of this title (relating to Molluscan Shellfish).

(14) Certification number -- The unique identification number issued by the commissioner to each dealer for each location. Each certification number shall consist of a one to five-digit Arabic number preceded by the two-letter state abbreviation and followed by a two-letter abbreviation for the type of activity or activities the dealer is qualified to perform in accordance with the following terms:

(A) shellstock shipper (SS);

(B) shucker/packer (SP);

(C) repacker (RP); and

(D) depuration processor (DP).

(15) Certified location -- A plant or place of business that has been inspected by the Seafood Safety Division of the department and for which a molluscan shellfish certificate of compliance has been issued.

(16) Coliform group -- All of the aerobic and facultative anaerobic, gram negative, non spore-forming, rod-shaped bacilli which ferment lactose broth with gas formation within 48 hours at 95 degrees Fahrenheit (35 degrees plus or minus 0.5 degrees Centigrade).

(17) Commingle or commingling -- The act of combining different lots of molluscan shell stock or shucked molluscan shellfish.

(18) Commissioner -- The commissioner of health for the State of Texas and the executive head of the department.

(19) Compliance schedule - A written schedule that provides a specific time period to correct critical, key and other deficiencies.

(20) Conditionally approved area -- A classification used to identify a harvest area which meets the criteria for the approved classification except under certain conditions described in a management plan established by the SSD.

(21) Conditionally restricted area -- A classification used to identify a harvest area which meets the criteria for the restricted classification except under certain conditions described in a management plan established by the SSD.

(22) Container -- The physical material in contact with or immediately surrounding molluscan shellfish that confines it into a single unit.

(23) Corrosion resistant materials -- Materials that maintain their original surface characteristics under normal exposure to the foods being contacted, normal use of cleaning compounds and bactericidal solutions, and other conditions of use.

(24) Critical Control Point (CCP) -- A point, step or procedure in a food process at which control can be applied, and a food safety hazard can as a result be prevented, eliminated or reduced to acceptable levels.

(25) Critical deficiency -- A condition or practice which:

(A) results in the production of a product that is adulterated, decomposed, misbranded or unwholesome; or

(B) presents a threat to the health or safety of the consumer.

(26) Critical limit -- The maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate or reduce to an acceptable level the occurrence of the identified food safety hazard.

(27) Cross connection -- An unprotected actual or potential connection between a potable water system and any source or system containing unapproved water or a substance that is not or cannot be approved as safe and potable. Examples include bypass arrangements, jumper connection, removable sections, swivel or change over devices, or other devices through which backflow could occur.

(28) Cull -- To remove dead or unsafe molluscan shell stock from a lot of molluscan shell stock.

(29) Dealer -- A person to whom certification is issued for the activities of molluscan shell stock shipper, shucker-packer, repacker, or depuration processor.

(30) Deficiency -- A condition or practice that is a violation of the Act or rules.

(31) Department -- The Texas Department of Health (TDH), 1100 West 49th Street, Austin, Texas 78756, or its successor state agency, having the responsibility for the enforcement of laws concerning the safety of the food supply, including molluscan shellfish growing area classification and certification of molluscan shellfish dealers.

(32) Depletion -- The removal, under the direct control of the Texas Parks and Wildlife Department, of all existing commercial quantities of market-size molluscan shellfish from a harvest area classified as prohibited.

(33) Depuration or depurate -- The process of reducing the level of bacteria and viruses that may be present in molluscan shellfish by using a controlled aquatic environment as the treatment process.

(34) Depuration plant -- A place where depuration of molluscan shellfish occurs.

(35) Depuration Processor (DP) -- A person who harvests or receives molluscan shell stock from harvest areas in the approved or conditionally approved, restricted, or conditionally restricted classification and submits such molluscan shell stock to an approved depuration process.

(36) Direct marketing -- The sale for human consumption of molluscan shellfish which:

(A) does not require depuration or relaying prior to sale; or

(B) have been subjected to depuration or relaying activities.

(37) Director -- The executive head (commissioner of health) of the Texas Department of Health.

(38) Dry storage -- The storage of molluscan shell stock out of water.

(39) Durable material -- Material with the ability to exist for several years without significant deterioration and able to withstand normal daily use associated with molluscan shellfish operations.

(40) Easily cleanable -- A surface which is:

(A) readily accessible; and

(B) is made of such materials, has a finish, and is so fabricated that residues may be effectively removed by normal cleaning methods.

(41) Facility -- A structure.

(42) FDA -- The United States Food and Drug Administration or its successor agency, the federal agency in which regulation of foods, including the Cooperative Shellfish Program, is vested.

(43) Food contact surface -- An equipment surface or utensil that normally comes into direct or indirect contact with shucked molluscan shellfish.

(44) Food safety hazard -- Any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.

(45) Gatherer -- Person who takes molluscan shellfish by any means from a growing area designated by the commissioner for delivery to a depuration plant.

(46) GLO -- The Texas General Land Office, 1700 North Congress, Austin, Texas 78701, or its successor agency, the state agency having the responsibility for the enforcement of laws concerning all state lands, including leasing of wetland bottom for private oyster leases.

(47) Growing area -- Any site that supports or could support the propagation of molluscan shell stock by natural or artificial means.

(48) HACCP -- Hazard Analysis Critical Control Point, a systematic, science-based approach used in food production as a means to assure food safety. The concept is built upon the seven principles identified by the National Advisory Committee on Microbiological Criteria for Foods (1992).

(49) HACCP Plan -- A written document that delineates the formal procedures that a dealer follows to implement the HACCP requirements set forth in Title 21, Code of Federal Regulations (CFR), §123.6.

(50) Harvest -- The act of removing molluscan shell stock from growing or harvest areas and its placement on or in a manmade conveyance or other means of transport.

(51) Harvest area -- An area that contains commercial quantities of molluscan shell stock and may include aquaculture sites and facilities.

(52) Harvester -- A person who takes molluscan shell stock by any means from a harvest area.

(53) Heat shock -- The process of subjecting molluscan shell stock to any form of heat treatment prior to shucking, including steam, hot water or dry heat, to facilitate removal of the meat from the shell without substantially altering the physical or organoleptic characteristics of the molluscan shellfish.

(54) ISSC -- The Interstate Shellfish Sanitation Conference. The ISSC consists of agencies from molluscan shellfish producing and receiving states, FDA, the molluscan shellfish industry, and the National Marine Fisheries Service of the U.S. Department of Commerce.

(55) Key deficiency -- A condition or practice that may result in adulterated, decomposed, misbranded or unwholesome product.

(56) Label -- Any written, printed or graphic matter affixed to or appearing upon any package containing molluscan shellfish.

(57) License -- The document issued by the Texas Parks and Wildlife Department, under the Texas Parks and Wildlife Code, Chapter 47 or Chapter 76, which authorizes a person to harvest or transport molluscan shell stock for commercial sale.

(58) Lot of molluscan shell stock -- A single type of bulk molluscan shell stock or containers of molluscan shell stock of no more than one day's harvest from a single defined harvest area gathered by one or more harvesters.

(59) Lot of molluscan shell stock for depuration -- Molluscan shell stock harvested from a particular area during a single day's harvest and delivered to one depuration plant.

(60) Lot of shucked molluscan shellfish -- A collection of containers of no more than one day's shucked molluscan shellfish product produced under conditions as uniform as possible, and designated by a common container code or marking.

(61) Marina -- Any water area with a structure (docks, basin, floating docks, etc.) which is:

(A) used for docking or otherwise mooring vessels; and

(B) constructed to provide temporary or permanent docking space for more than ten boats.

(62) Marine biotoxin -- Any poisonous compound produced by marine microorganisms and accumulated by molluscan shell stock. Examples of toxin producing marine microorganisms include Alexandrium spp. (Proto gonyaulax species) and Karenia breves.

(63) Market shellfish -- Molluscan shellfish which are, may be, or have been harvested and/or prepared for sale for human consumption as a fresh or frozen product.

(64) Molluscan shellfish -- All species of:

(A) oysters, clams or mussels, whether:

(i) shucked or in the shell;

(ii) fresh or frozen; and

(iii) whole or in part.

(B) scallops in any form, except when the final product form is the adductor muscle only.

(65) Monoculture -- The culture of a single molluscan shellfish species.

(66) MPN -- Most probable number.

(67) Nursery products -- Molluscan shellfish which do not exceed 10% of the market weight or that are six months or more growing time from market size.

(68) Open area -- A molluscan shellfish growing area where the harvesting for sale, harvesting for transplant, or gathering for depuration of molluscan shellfish is allowed. An open area status may be placed on any one of the classified area designations except for a prohibited area.

(69) Open water aquaculture -- The cultivation of molluscan shellfish in natural molluscan shellfish harvest areas.

(70) Other deficiency -- A condition or practice that is not defined as critical or key, but is of a public health significance and, if left uncorrected, could result in a key or critical deficiency.

(71) Pack (packing) -- All activities involved in placing molluscan shellfish in containers.

(72) Person -- Any individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind, government or governmental subdivision or agency, partnership, association, corporation or other legal entity.

(73) Poisonous or deleterious substance -- A toxic substance occurring naturally or added to the environment for which a regulatory tolerance limit or action level has been established in molluscan shellfish to protect public health.

(74) Polyculture -- The cultivation of:

(A) two or more species of molluscan shellfish; or

(B) molluscan shellfish with other species in a common environment.

(75) Potable water -- A water supply that is suitable for human consumption.

(76) Principal display panel -- The part of a label that is most likely to be displayed, presented, shown or examined under customary conditions of retail sale.

(77) Process batch -- A quantity of molluscan shell stock used to fill each separate tank or a series of tanks supplied by a single process water system for a specified depuration cycle in a depuration activity.

(78) Process water -- The water used in the scheduled depuration process.

(79) Prohibited area -- A classification used to identify a harvest area where the harvest of molluscan shell stock for any purpose, except depletion or gathering of seed for aquaculture, is not permitted.

(80) Records -- Written documents required to be maintained under this chapter.

(81) Relaying -- Transferring of shellstock from a growing area classified as restricted or conditionally restricted to a growing area classified as approved or conditionally approved for the purpose of reducing pathogens, as measured by the coliform indicator group or poisonous or deleterious substances that may be present in the shellstock, by using the ambient environment as the treatment process.

(82) Repacker (RP) -- A dealer who buys, repacks and sells molluscan shellfish. Repackers are not authorized to shuck shellfish.

(83) Repacking molluscan shellstock -- The practice of removing molluscan shell stock from containers and placing it into other containers.

(84) Restricted area -- A classification used to identify a harvest area where harvesting shall be by special license and the molluscan shell stock, following harvest, is subjected to a suitable and effective treatment process through transplanting or gathering for depuration.

(85) Safe materials -- Articles manufactured from or composed of materials that may not reasonably be expected to, directly or indirectly, become a component of or otherwise adversely affect the characteristics of any food.

(86) Sanitation control record -- Records that document the monitoring of sanitation practices and conditions.

(87) Sanitize -- To adequately treat food contact surfaces by a process that is effective in:

(A) destroying vegetative cells of microorganisms of public health significance;

(B) substantially reducing the numbers of other undesirable microorganisms; and

(C) not adversely affecti