Adopted Sections An agency may take final action on a section 30 days after a proposal has been published in the Texas Register. The section becomes effective 20 days after the agency files the correct document with the Texas Register, unless a later date is specified or unless a federal statute or regulation requires implementation of the action on shorter notice. If an agency adopts the section without any changes to the proposed text, only the preamble of the notice and statement of legal authority will be published. If an agency adopts the section with changes to the proposed text, the proposal will be republished with the changes. TITLE 1. ADMINISTRATION Part XII. Advisory Commission on State Emergency Communications Chapter 251. Regional Plans-Standards 1 TAC sec.251.3 The Advisory Commission on State Emergency Communications adopts an amendment to sec.251.3, concerning guidelines for addressing funds, without changes to the proposed text as published in the December 22, 1992, issue of the Texas Register (17 TexReg 8999). The amendment clarifies the procedures for the utilization of funds toward the completion of rural address assignments, which allow for the Automatic Location Identifier (ALI) feature to display the location of 9-1-1 callers. It will enable improved effectiveness of 9-1-1 call delivery. The section will serve as a guide for the distribution of addressing funds to local governments for the purpose of establishing addresses, essential to E9-1-1 system utilizing ALI. Comments were received from the following entities regarding reimbursement of addressing expenditures prior to January 1, 1991. Comments received were from the City of Rockport, Aransas County, and the West Central Texas Council of Governments. These comments did not support the rule change which would allow no costs prior to January 1, 1991, to be considered for state reimbursement. The amendment is adopted under the Health and Safety Code, sec.sec.771.055-771. 057, and 771.072, which provides the Advisory Commission on State Emergency Communications with the authority to develop and amend a regional plan for the establishment and operation of 9-1-1 emergency service throughout a 9-1-1 region that meets Commission standards and procedures. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on March 22, 1993. TRD-9320725 Mary A. Boyd Executive Director Advisory Commission on State Emergency Communications Effective date: April 13, 1993 Proposal publication date: December 22, 1992 For further information, please call: (512) 327-1911 TITLE 4. AGRICULTURE Part I. Texas Department of Agriculture Chapter 28. Texas Agricultural Finance Authority: Loan Guaranty Program 4 TAC sec.28.14 The Texas Department of Agriculture adopts new sec.28.14, concerning the collection, settlement, and enforcement of guaranteed loans, without changes to the proposed text as published in the December 25, 1992, issue of the Texas Register (17 TexReg 9073). The section is adopted to allow for expeditious action in the event of a default by a borrower. The section provides that the staff of the TDA Loan Guaranty Program may act with the approval of the commissioner, or his designee, on behalf of the TAFA Board in the collection, settlement, and enforcement of loans guaranteed by TAFA under the program. No comments were received regarding adoption of the new section. The new section is adopted under the Texas Agriculture Code, sec.58.022, which provides the board of the Texas Agricultural Finance Authority (TAFA), with the authority to adopt rules to establish procedures for administration of the TAFA Loan Guaranty Program. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on March 26, 1993. TRD-9320876 Dolores Alvarado Hibbs Chief Administrative Law Judge Texas Department of Agriculture Effective date: April 16, 1993 Proposal publication date: December 25, 1992 For further information, please call: (512) 463-7583 TITLE 22. EXAMINING BOARDS Part XXII. Texas State Board of Public Accountancy Chapter 501. Professional Conduct Other Responsibilities and Practices 22 TAC sec.501.46 The Texas State Board of Public Accountancy adopts an amendment to sec.501. 46 concerning form of practice, without changes to the proposed text as published in the February 9, 1993, issue of the Texas Register (18 TexReg 800). As a result of enforcing the section, the rule will be made clear and unambiguous regarding the forms of entities which practice public accountancy. The amendment to the rule tracks the language of the Public Accountancy Act regarding the definition of "corporation." No comments were received regarding adoption of the amendment. The amendment is adopted under Texas Civil Statutes, Article 41a-1, sec.6(a), which provide the Texas State Board of Public Accountancy with the authority to promulgate rules relating to form of practice. sec.501.46. Form of Practice. A certificate or registration holder may practice public accountancy only in a proprietorship, a partnership, a limited liability company, a registered limited liability partnership, a professional public accounting corporation organized under the Texas Professional Corporation Act, as amended (Texas Civil Statutes, Article 1528e), or other corporation authorized by applicable statutes, or an equivalent law of another state, territory, or foreign country, or as an employee of one of these entities. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on March 18, 1993. TRD-9320791 William Treacy Executive Director Texas State Board of Public Accountancy Effective date: April 14, 1993 Proposal publication date: February 9, 1993 For further information, please call: (512) 450-7066 TITLE 25. HEALTH SERVICES Part I. Texas Department of Health Chapter 37. Maternal and Child Health Services Midwives 25 TAC sec.37.180 The Texas Department of Health (department) adopts the repeal of existing sec.37.180 and new sec.37.180, concerning basic midwifery education and continuing education. The new section is adopted with changes to the proposed text as published in December 4, 1992, issue of the Texas Register (17 TexReg 8395). The new section outlines the dates before which a midwife must meet certain voluntary and mandatory education, experience, and examination requirements. The existing rules for voluntary basic education courses and examinations, sponsored by the Midwifery Program since 1985, will expire September 1, 1993, when the new mandated requirements become effective. The department is adopting the new section for two purposes: to permit midwives the ample time to meet the new education and examination requirements for the purpose of seeking exemption from the mandatory basic education program requirement; and to afford both midwives and the public the chance to comment on the proposed rules after sufficient time to review and study their content. The new section covers "core curriculum;" clinical requirements; requirements for and frequency of continuing education offerings; responsibilities and qualifications of those who teach or oversee the education courses; and a system for approval, disapproval and revocation of approval of courses. The following is a summary of comments received concerning the proposed new section, along with the department's response. Comment: A commenter requests that the Midwifery Board not be required to include a Texas Midwifery Board Standards of Practice in the Texas Midwifery Basic Information Manual. See proposed sec.37.180(3)(B)(v)(III). Response: The department disagrees. The language of the statute requires that the manual include Standards of Practice and this requirement is included as adopted sec.37.180(e)(1)(D)(iii) with a minor change in the name of the document. Comment: One commenter requests that the student clinical requirements found in proposed sec.37.180(3)(C) be dropped from the approval criteria for a mandatory basic midwifery education course. The commenter also requests that the rules should require "adequate clinical experience," that would allow the education committee of the Midwifery Board to determine adequacy of the course to meet the individual student needs. Response: The department believes that to allow self-determined numbers of clinical experiences provides neither a proper criteria for approval nor encouragement for adequate clinical experiences and has retained the clinical criteria in adopted sec.37.180(e)(2)(A) and (B). Comment: A commenter requests that in proposed sec.37.180(3)(C) the student clinical experience under a preceptor should include "observational/participational" experience. The commenter also requests that the number of experiences in each category should be changed as follows: Increase from 10 to 15 the number of initial histories and physical exams; increase from 10 to 60 prenatal visits; increase from 10 to 15 newborn exams; decrease from 35 to 30 the number of labors, deliveries, and immediate postpartums. Response: The department disagrees. The clinical requirements have been categorized as numbers of observations and numbers to perform or manage. Procedural numbers reflect those suggested by six Midwifery Board members and are adopted unchanged at sec.37.180(e)(2)(A). Comment: One person commented that until the development of the Texas Midwifery Basic Information Manual and its approval by the Midwifery Board, the proposed rules do not address the distribution of material concerning the seven required manual topics. Some midwives may not have access to this information. The commenter requested that proposed sec.37.180(3)(B)(v)(I)-(VII) be amended to correct this oversight. Response: The department agrees and has added language to adopted sec.37. 180(e)(1)(D) to require a course supervisor to cover the information contained in the individual items listed in sec.37.180(e)(1)(i)-(vii) in her or his course. The new language also requires an individual who has taken an approved course outside of Texas to read and study the same materials. Comment: A commenter requests a change in the criteria for the approval of a mandatory basic midwifery education course to decrease from 25 to 10 in the numbers for student clinical experiences with labors, deliveries, and immediate postpartums that each student must perform or manage. See proposed sec.37.180(3)(C)(ii)(III), (IV), and (V). Response: The department disagrees and has adopted the language as proposed in sec.37.180(e)(2)(B)(iii)-(v). The department believes that actual labor, delivery, and postpartum is a very critical time during normal pregnancy and delivery, therefore the department must reject the comment and retain the higher numbers. Comment: A commenter requests that all the numbers for required student clinical experiences found in proposed sec.37.180(3)(C)(ii)(I)-(VII) be withdrawn. Response: The department disagrees and has retained the requirements as proposed in adopted sec.37.180(e)(2)(B). The department believes that unbiased, objective criteria are needed. Comment: A commenter requests a change in the criterium for course preceptor proposed in sec.37.180(3)(E)(i)(III). The commenter wishes to change the requirement from "have at least two years midwifery (obstetric) practice and have independently performed at least 100 births;" to "have at least two years in midwifery (obstetric) practice and have participated in at least 100 births;" Response: The department disagrees. The department believes that a course preceptor must have defined clinical experience. A course preceptor's having independently managed births is a very critical aspect in acquiring skill and experience. The proposed wording is adopted with the addition of "intrapartum" care in sec.37.180(e)(3)(B). Comment: A commenter asks the department to withdraw the requirement found in proposed sec.37.180(3)(E)(i)(V), that a course supervisor/coordinator have had 150 hours of experience as a preceptor. Response: The department agrees with the comment. As there are no defined mechanisms to receive such experience and as pertinent clinical experience is required, this requirement has been withdrawn. Comment: Concerning proposed sec.37.180(4)(A)(ii), (iii), a person observed that the proposed rules do not provide enough time for the Midwifery Board to review applications for approval of mandatory continuing midwifery education courses and provide notice of its decision to the course sponsor before the course is scheduled to begin. Response: The department agrees. The time sequence in the application, review, and sponsor notification process has been extended in adopted sec.37. 180(g)(1)(B) and (C) to correct this oversight. The new language also permits the Continuing Midwifery Education Subcommittee to review and make recommendations to the full Midwifery Board for the approval or rejection of the application. The repeal is adopted under Texas Civil Statutes, Article 4512i, sec.8A, that require the Midwifery Board to adopt rules prescribing minimum standards for approval and revocation of approval of basic midwifery education courses and midwifery continuing education courses and requires the Board to approve rules adopted by the Midwifery Board; and the Health and Safety Code, sec.12. 001, which provides for the Texas Board of Health to adopt rules for the performance of legal duties imposed on the Texas Board of Health, Texas Department of Health, and the Commissioner of Health. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on March 29, 1993. TRD-9320910 Robert A. MacLean, M.D. Deputy Commissioner Texas Department of Health Effective date: April 19, 1993 Proposal publication date: December 4, 1992 For further information, please call: (512) 458-7700 The new section is adopted under Texas Civil Statutes, Article 4512i, sec.8A, that require the Midwifery Board to adopt rules prescribing minimum standards for approval and revocation of approval of basic midwifery education courses and midwifery continuing education courses and requires the Board to approve rules adopted by the Midwifery Board; and the Health and Safety Code, sec.12.001, which provides for the Texas Board of Health to adopt rules for the performance of legal duties imposed on the Texas Board of Health, Texas Department of Health, and the Commissioner of Health. sec.37.180. Education. (a) Purpose. This section establishes standards for mandatory basic midwifery education and continuing midwifery education. (b) Provisions. This section covers standards for completion of a mandatory basic midwifery education course; qualification for exemptions from taking the mandatory basic midwifery education course; establishes an education subcommittee and a continuing education subcommittee of the Midwifery Board; mandatory continuing midwifery education; course approval and revocation of course approval; and informal hearing rules. (c) Applicability. (1) As of September 1, 1993, an individual must have satisfactorily completed a mandatory basic midwifery education course approved by the Midwifery Board, or have been exempted from this requirement, in order to legally practice midwifery. (2) The department shall exempt a midwife from taking a mandatory basic midwifery education course if he or she provides proof of one of the following by November 30, 1993: (A) satisfactory completion of a department approved voluntary basic midwifery education course taken between September 1, 1983, and August 31, 1993; or (B) passing the department's voluntary basic midwifery education course examination between September 1, 1983, and August 31, 1993; or (C) passing the voluntary examination of the mandatory basic midwifery education course between September 1, 1993, and November 30, 1993. (d) Subcommittees. (1) Education Subcommittee. An Education Subcommittee will be appointed by the chairperson of the Midwifery Board to review all the applications for approval of voluntary and mandatory basic midwifery education courses. The subcommittee will consist of three members: a midwife chairperson one other midwife and a physician or the certified nurse midwife. The deliberations, formulations, and recommendations of the subcommittee are subject to the provisions of the Texas Open Meetings Act. (2) Continuing Education Subcommittee. A Continuing Education Subcommittee will be appointed by the chairperson of the Midwifery Board to review all applications for approval of continuing education courses. The subcommittee will consist of three members: a midwife chairperson, one other midwife, and a physician or the certified nurse midwife. The deliberations, formulations, and recommendations of the subcommittee are subject to the provisions of the Texas Open Meetings Act. (e) Mandatory basic midwifery education. As of September 1st, 1993, an individual must have satisfactorily completed an approved mandatory basic midwifery education course before she/he can apply for documentation or redocumentation and practice midwifery, unless she or he has been exempted from this requirement under subsection (c)(2)(A)-(C) of this section. Proof of such satisfactory completion must be provided at the time of documentation or redocumentation. Mandatory basic midwifery education courses will, for the most part, not be provided by the department but rather will be developed and offered by competent individuals outside of the department. This subsection covers the requirements for and the process of approval of such courses. (1) The didactic curriculum. In order for a mandatory basic midwifery education course to be approved, it must fulfill the following requirements. (A) The didactic portion of the course must last for at least 75 hours, with exceptions considered for home study courses. A student must have been present during at least 65 of these hours to complete the course satisfactorily. (B) The course must be based upon and completely cover the Draft 1991 Midwives Alliance of North America Core Competencies and Standards of Practice. Courses given at community and other colleges on subjects which are applicable to the education of midwives can be taken for credit and may be considered as part of the required curriculum. Such courses may include anatomy and physiology, nutrition, microbiology, psychology, women's studies and others. Such courses must be passed in order to qualify as part of the midwifery curriculum. (C) The course must require pertinent reading and study to include a complete reading of at least one current comprehensive nurse-midwifery text, and/or obstetric text which must be approved by the Midwifery Board. Instructional materials used in education must be current. (D) The course, when offered in Texas, must completely cover the Texas Midwifery Basic Information Manual, once this manual is developed. The manual will be developed by the department and approved by the Midwifery Board and the Texas Board of Health. An individual who has taken an approved course outside of Texas will still be required to completely read and study this manual. The manual will address the following topics: (i) the Midwifery Law (Texas Civil Statutes, Article 4512i) and the rules; (ii) other Texas laws impacting midwifery practice; (iii) the Texas Midwifery Standards of Practice (to be developed); (iv) the Draft 1991 Midwives Alliance of North America (M.A.N.A.) Standards of Practice; (v) the Draft 1991 M.A. N.A. Core Competencies; (vi) Texas birthing center and vital statistics requirements; and (vii) the requirements for mandatory basic and continuing midwifery education. (E) Prior to the development of the formal manual, the course supervisor, of a Texas course, will be sent the materials relevant to subparagraph (D)(i)-(vii) of this paragraph and will be required to completely cover them in her/his course. An individual who has taken an approved course outside of Texas will be required to completely read and study the same materials. (2) Clinical requirements. In order for a mandatory basic midwifery education course to be approved, the course must provide adequate clinical experience under the supervision of a qualified preceptor, as defined in paragraph (3) of this subsection. (A) The course must provide an appropriate observational experience to include: (i) at least 25 labors, deliveries, newborn exams, and immediate postpartum periods; and (ii) at least 30 prenatal visits, 10 of which must be in each trimester, and 10 of which must be initial histories and physical examinations. (iii) at least 10, 12-36 hour postpartum/newborn visits; 10, 72-hour to two- week postpartum/newborn visits and; 10, four-six-week postpartum/newborn visits. (B) The course must require that each student midwife satisfactorily perform or manage: (i) 45 prenatal visits of which: (I) 15 must be in the first trimester; (II) 15 in the second trimester; (III) 15 in the third trimester; and (IV) 15 of these visits listed in subclauses (I)-(III) of the clause must be complete initial prenatal histories and physical exams; (ii) 25 labors; (iii) five deliveries; (iv) 25 newborn exams; (v) 25 immediate postpartum mothers; and (vi) 45 postpartum mothers and newborns: (I) 15 at 12-36 hours; (II) 15 between 72 hours and two weeks; and (III) 15 at four to six weeks. (3) Course and clinical supervision. In order for a mandatory basic midwifery education course to be approved, the didactic instruction and clinical experience must be personally supervised by a documented midwife (or equivalent from another state), a certified nurse-midwife, or a licensed physician, with the following qualifications: (A) a high-school graduate or equivalent (GED); and (B) at least two years in midwifery (obstetric) practice and have independently performed at least 100 births (to include prenatal, intrapartum, postpartum and newborn care). (4) Student midwife's academic background. In order for a mandatory basic midwifery education course to be approved, it must require that each student midwife be, at least, a high-school graduate or the equivalent (GED). (5) Course changes. If there are any administrative or instructional changes in the course, the Midwifery Board must be notified in writing within 30 days of the change. (6) Course approval. (A) Applications for course approval must be submitted to the Education Subcommittee. (B) The subcommittee will review all applications and present its recommendations to the Midwifery Board for final approval or rejection of each course. (C) Applications may be submitted at any time but will only be acted upon at the next regularly scheduled meeting of the Education Subcommittee. (D) Each course will be re-evaluated by the Education Subcommittee at least every three years, based upon the criteria as set forth in this subsection. (E) The Midwifery Board will consider all appeals for reconsideration of rejected course applications. The course supervisor, of a rejected course, should request, in writing, to appear at a regularly scheduled Midwifery Board meeting. (f) Exemptions from mandatory basic midwifery education. (1) Voluntary basic midwifery education courses. In order to qualify for exemption through completion of a Texas Department of Health approved voluntary basic midwifery education course, the midwife must have taken either the Texas Department of Health sponsored voluntary course or another course which has been approved based upon satisfactory evidence that it meets the following criteria: (A) The course must include at least 45 hours of didactic learning or equivalent self-study. The following topics must be part of the subject matter and must be completely covered: (i) prenatal care; (ii) management of labor and delivery; (iii) newborn care and postpartum care up to six weeks; (iv) high risk factors, both maternal and fetal/infant (to include consideration of those conditions which preclude midwifery care); (v) signs and symptoms of complications and appropriate management (to include referral to a physician); (vi) sterile technique and infection control measures; (vii) laboratory tests and screening; and (viii) state laws and regulations effecting midwifery practice. (B) The primary instructor for the course must be: (i) a midwife with at least four years of experience (including antepartum, intrapartum, postpartum, and newborn care) who has personally managed at least 100 complete pregnancies; (ii) a certified nurse-midwife; or (iii) a licensed physician specializing in obstetrics, pediatrics and/or family medicine. (C) The sponsor of a course which fulfills all of the requirements in subparagraphs (A) and (B) of this paragraph may apply to the Midwifery Board, in writing for approval of her/his voluntary basic midwifery education course. A midwife who has taken such a course may also apply on behalf of the course which she/he has completed between September 1, 1983, and August 31, 1993 for retroactive approval of the course by the Midwifery Board. (D) The Midwifery Board's Education Subcommittee will evaluate all such application(s) and recommend approval or rejection of each course to the full Midwifery Board for final approval or rejection. The deliberations, formulations, and recommendations of the Subcommittee and Midwifery Board are subject to the provisions of the Texas Open Meetings Act. (2) The Texas Department of Health Voluntary Examination of the Voluntary Basic Midwifery Education Course. In order to be approved for exemption through achieving a passing grade on the department's voluntary basic midwifery education course examination, the midwife must provide the department with a copy of her or his Texas Department of Health letter of completion regarding her or his examination. Examinations may be scheduled by contacting the Midwifery Program at the Texas Department of Health and paying a $25 examination fee. In order to take this examination, an individual must have: (A) completed the Texas Department of Health voluntary basic midwifery education course; or (B) been documented as a midwife for two consecutive years; or (C) petitioned and been granted permission by the Midwifery Board to take the examination based upon her or his individual training. (3) The voluntary examination of the mandatory basic midwifery education course. In order to be approved for exemption through achieving a passing grade on the voluntary examination of the mandatory basic midwifery education course, the midwife must provide the department with a copy of her or his certificate regarding passing the exam. This examination, which will be given only between September 1, 1993 and November 30, 1993 will be approved by the Midwifery Board, upon recommendations of the Education Subcommittee. In order to take this examination an individual must have: (A) completed a Texas Department of Health approved voluntary basic midwifery education course; or (B) petitioned and been granted permission by the Midwifery Board to take the examination based upon her/his individual training. Examinations may be scheduled by contacting the Midwifery Program at the Texas Department of Health and paying a $25 examination fee by August 30, 1993. (g) Mandatory continuing midwifery education. As of September 1, 1993, all documented midwives must provide proof of 30 contact hours of continuing midwifery education every three years. This proof must be provided at the time of annual redocumentation. The first time that proof will be required will be for the 1997 redocumentation period. As with the basic midwifery education courses these courses will usually be provided by non-departmental personnel. The Midwifery Board will give final approval or rejection of continuing midwifery education courses, and may also periodically require courses on specific subjects essential to the well-being of mothers and babies. (1) Application review. Applications for course approval may be submitted to the Continuing Education Subcommittee. (A) All courses will be reviewed concerning topic, relevance to midwifery, teaching methods, and the qualifications of the instructor(s). Courses must be designed around current subjects necessary for midwives' practice, such as newly emerging concepts, theories, and research or a review of established information relevant to midwifery. Research under appropriate supervision and correspondence courses will also be considered for approval. (B) To have a course reviewed, the course supervisor must complete and submit a continuing midwifery education application form to the Continuing Education Subcommittee at least 180 days prior to the offering. The Continuing Education Subcommittee will review the application and make a recommendation for approval or rejection to the Midwifery Board. The Midwifery Board's decision regarding approval or rejection will be given in writing, at least 80 days before the course is scheduled to begin. (C) A midwife who requests approval of a course not pre-approved by the Midwifery Board must submit the retroactive continuing midwifery education application form to the Continuing Education Subcommittee within 60 days of completing the course. A copy of the course brochure and proof of attendance must also be submitted, and there must be documentation showing relevancy of the topic for midwifery and the qualifications of the instructor(s). The Continuing Education Subcommittee will review the application and make a recommendation for approval or rejection to the Midwifery Board. The Midwifery Board's decision regarding approval or rejection will be given in writing to the midwife within 100 days. (D) Continuing education course approval granted by other organizations will not automatically guarantee approval by the Midwifery Board. (E) Course approval is granted for three years and may be renewed by re- application. Re-application is also necessary if there are changes in the course or instructor(s). (F) Appeals to decisions regarding continuing midwifery education course approval must be addressed, in writing, to the Chairperson of the Midwifery Board and a decision will be made by the full board. (2) Course listing. A listing of approved courses and dates, for continuing midwifery education will be maintained by the Midwifery Program. (3) Sources of continuing midwifery education. Possible sources for continuing midwifery education include: (A) Association of Texas Midwives; (B) Midwives Alliance of North America; (C) International Confederation of Midwives; (D) American College of Nurse Midwives; (E) Nursing associations; (F) Medical associations; (G) Texas Department of Health; (H) Childbirth education organizations; (I) Lactation organizations; (J) American Academy of Pediatrics; and (K) American College of Obstetricians and Gynecologists. (h) Revocation of course approval. After notice to the course supervisor and the opportunity for an appeal, the Midwifery Board may revoke the approval of an education course if the Midwifery Board determines that: (1) the course does not meet the standards set by this section; (2) the course supervisor(s) does not have the qualifications required by this section; (3) the approval of the course or course supervisor or supervisors was obtained by fraud or deceit; or (4) the course supervisor has falsified the course attendance records and reported this false information to the department. (i) Informal hearing rules. Notice and hearings required under this section will be conducted according to and will be governed by the Texas Department of Health's informal hearing rules in Chapter 1 of this title (relating to Board of Health). This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on March 29, 1993. TRD-9320911 Robert A. MacLean, M.D. Deputy Commissioner Texas Department of Health Effective date: April 19, 1993 Proposal publication date: December 4, 1992 For further information, please call: (512) 458-7700 Chapter 241. Shellfish Sanitation Molluscan Shellfish The Texas Department of Health (department) adopts the repeal of existing sec.sec.241.50-241.100, and adopts new sec. sec.241.50-241.52 and sec.sec.241.54-241.100, concerning molluscan shellfish. Sections 241.55-241.56, 241.62-241.64, 241.74-241.75, 241.77-241.78 and 241.80-241.81 are adopted with changes to the proposed text as published in the October 2, 1992, issue of the Texas Register (17 TexReg 6737). Sections 241.51-241.52, 241.54, 241. 57-241.61, 241.65-241.73, 241.76, 241.79, and 241.82-241.100, are adopted without changes and will not be republished. The new sections provide for continued uniform regulation of the molluscan shellfish industry consistent with Public Health, the 1992 National Shellfish Sanitation Program Manual of Operations, Parts I and II, and with current industry practices. The new sections establish updated standards for the harvesting of shellstock and the handling, processing, packaging, refrigeration, and distribution of molluscan shellfish. A summary of comments concerning the proposed new rules and the department's response is as follows. COMMENT: Concerning sec.241.55(a), one commenter wanted the sections clarified so that the harvester is the responsible party for his/her shellstock until the certified dealer accepts control. RESPONSE: The department agrees with this comment and has changed this section accordingly. COMMENT: Concerning sec.241.55(a), several commenters stated that all shellstock should be transported under mechanical refrigeration without exception. RESPONSE: The department agrees with this comment and has changed this section accordingly. COMMENT: Concerning sec.241.55(c), one commenter recommended that the certified dealer be responsible for all shellstock tags. The commenter also stated that if dealers keep proper records, there is no need for the harvester tag, but, if a harvester tag is required, dealers shouldn't have to duplicate information onto the dealer's tag. RESPONSE: The department recognizes this commenter's concern, but the National Shellfish Sanitation Program (NSSP) manual (with which the deparment must comply) requires two tags and certain information on each tag. COMMENT: Concerning sec.241.55(c) and sec.241.56(c), one commenter pointed out that "quantity" is not required on Texas tags, but is required by the NSSP manual. RESPONSE: The department agrees with this comment and has changed these sections accordingly. COMMENT: Concerning sec.241.55(c), one commenter wanted separate intra-state requirements for information which would allow dealers shipping only intra-state to not have to put a harvester's tag on the product, but to maintain accurate records with a code on the certified dealer tag identifying the harvester and related information. RESPONSE: The department disagrees as this would be inconsistent with the NSSP manual requirements. COMMENT: Concerning sec.241.55(c), one commenter suggested that space be left on the harvester's tag and that the certified dealer be allowed to "stamp" the dealer information onto the harvester tag. RESPONSE: The department disagrees because stamping the dealer information onto the tag is not allowed and separate dealer and harvester tags are required by the NSSP manual. COMMENT: Concerning sec.241.55(c), during department review, staff noted that the NSSP manual has been amended to include on the dealer's tag the original shipper's certification number. RESPONSE: The department has made the appropriate change to this section. COMMENT: Concerning sec.241.62(b), during department review, staff noted that an indicating thermometer should not be installed more than six feet off the floor, so it could be easily read. RESPONSE: The department made appropriate changes to the section. COMMENT: Concerning sec.241.63(d), one commenter wanted a clarification of the term "flooding" to include "under normal conditions" or similar qualifier. RESPONSE: The department agrees with the comment and has changed this section to add the words "under normal conditions". COMMENT: Concerning sec.241.63(j), one commenter stated that obtaining a sanitary control easement for existing wells would not be practical and therefore should only be required for wells completed after the effective date of these sections. RESPONSE: The department agrees with the comment and has made the appropriate change to this section. However, the department believes sanitary easement information for new plants or plants undergoing major remodeling should be provided even if water wells and septic systems are in place. In order to have this information for review for new plants or plants undergoing major remodeling, the Department has made the appropriate changes to sec.241. 53(b). COMMENT: Concerning sec.241.63(m), one commenter wanted a "grandfather" clause for the records requirement for existing wells which may not have all the stipulated records. RESPONSE: The department disagrees with the comment since the records are obtainable from the Texas Water Commission. COMMENT: Concerning sec.241.63(o), one commenter questioned the need for intruder proof fences around private water wells since fencing would be expensive, a nuisance to deal with, and vandalism is not claimed as a problem. RESPONSE: The department agrees with the comment and has changed this section to delete the requirement. COMMENT: Concerning sec.241.63(r), one commenter wanted to know why the State cannot pick up water samples like they used to? Dealers have to pay approximately nine dollars per sample now. RESPONSE: The department believes this should be considered a cost of doing business for the commenter since the commenter has chosen to have a private well. COMMENT: Concerning sec.241.64(a), during department review, staff determined that under the present plumbing code, liquid discharge from sinks or lavatories directly on to the floor is not allowed as this would provide potential contamination of the product by splash from the discharge and foot traffic splash. RESPONSE: The department made appropriate changes to the section. COMMENT: Concerning sec.241.64(d), during department review, staff noted that for clarity three-compartment sinks needed to be specifically required to have hot water provided to them, although this has been the accepted practice for years. RESPONSE: The department made appropriate changes to the section. COMMENT: Concerning sec.241.74(a), one commenter wanted to date containers on the bottom so dates can be read when the containers are stored upside down. RESPONSE: The department does not have a requirement against this, but the date must be shown on the principal display panel. COMMENT: Concerning sec.241.74(b), during review of the comment related to sec.241.74(a), the department became aware that if the container is one-half gallon or larger, the date must also be on the lid in order to comply with NSSP requirements. RESPONSE: The department has changed this section accordingly. COMMENT: Concerning sec.241.74(c), one commenter suggested that a "BEST IF USED BY" date should be used on containers of frozen product of 63 ounces or less rather than a 14-day "Sell By" date which is only appropriate for fresh product. RESPONSE: The department agrees and has changed this section accordingly. COMMENT: Concerning sec.241.74(e), one commenter wanted to add the generic term IQF, meaning Individually Quick Frozen, as acceptable for labeling frozen product without also requiring the word FROZEN. RESONSE: The department agrees with this comment and has changed this section accordingly. COMMENT: Concerning sec.241.75(a), one commenter questioned the need for mechanical refrigeration of shucked shellfish containers. He wanted to be able to ship them packed in ice in insulated coolers. RESONSE: The department disagrees with this comment based on potential time temperature abuse of the product. Mechanical refrigeration facilities must be required for the proper temperature maintenance of the packed product even though icing is also required because the ice does melt away from the container providing an air gap that must be filled with refrigerated air to protect the product until the ice can be replenished. COMMENT: Concerning sec.241.75(a), one commenter wanted to be able to store packed gallons of shellfish upside down in boxes to make it easier to ice the conical shaped containers. RESPONSE: The department agrees with the comment for flexible walled containers which are sealed against liquid flow in or out and has changed this section accordingly. COMMENT: Concerning sec.241.77(a), during department review, staff recommended that the statement relating to record retention be deleted since the rule is covered in sec.241.77(b). RESPONSE: The department agrees and changed the section accordingly. COMMENT: Concerning sec.241.79(a), one commenter wanted the owner or certified person held responsible for conditions in the plant, not the manager or supervisor. RESPONSE: The department agrees with the comment and points out that it is addressed in the section. COMMENT: Concerning sec.241.80(b), during department review, staff recommended that the statement relating to the hand washing lavatory be deleted since the rule is already covered in sec.241.64(c). REPONSE: The department agrees and changed the section accordingly. COMMENT: Concerning sec.241.81(c), one commenter wanted the training course requirement to contain a "grandfather" clause for people already in the industry, or that an equivalency for similar courses be allowed. RESPONSE: The department disagrees with the comment. After consultation with the Division of Food and Drug, the department changed the section for clarification purposes. COMMENT: One commenter wanted to require all certified dealers to have product liability insurance. RESPONSE: The department believes this comment is not relative to the sections. COMMENT: One commenter wanted all "new" people getting a certificate to post a large financial bond before receiving the certificate. RESPONSE: The department noted that this comment would require legislation. COMMENT: One commenter suggested that all tags should be sold by the State for control purposes. RESPONSE: The department believes this comment may have some validity, but it would require legislation. COMMENT: One commenter suggested that an Oyster Advisory Committee be established for the department. RESPONSE: The department believes this comment is not relative to the sections. COMMENT: One commenter suggested the effective date of the new sections be made coincident with obtaining new oyster licenses for the 1993-1994 season. RESPONSE: The department requests that the Texas Board of Health make the sections effective August 1, 1993. The board approves this request. COMMENT: One commenter requested that if the training course is required, that the Department provide a list of acceptable courses with locations, times and costs. RESPONSE: The department believes this is not relative to the sections, but will provide this information as it becomes available. COMMENT: The department discovered during review that the division had incorrectly sited the statutory authority for the proposed repeal and adoption of the new sections under Texas Codes Annotated, the Parks and Wildlife Code, sec.76.203. RESPONSE: The department has corrected the oversight and the correct statutory authority is sited in the adoption preamble. Minor changes were made throughout the rules for grammar or clarification. 25 TAC sec.sec.241.50-241.100 The repeals are adopted under the Texas Health and Safety Code, sec.436.013, which authorizes the Texas Board of Health to adopt rules concerning the regulation of Texas molluscan shellfish; and the Texas Health and Safety Code, sec.12.001, which provides the Texas Board of Health with the authority to adopt rules for the performance of every duty imposed by law on the Texas Board of Health, the Texas Department of Health, and the commissioner of health. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on March 26, 1993. TRD-9320912 Robert A. MacLean, M.D. Deputy Commissioner Texas Department of Health Effective date: April 19, 1993 Proposal publication date: October 2, 1992 For further information, please call: (512) 458-7510 25 TAC sec.sec.241.50-241.52, 241.54-241.100 The new sections are adopted under the Texas Health and Safety Code, sec.436.013, which authorizes the Texas Board of Health to adopt rules concerning the regulation of Texas molluscan shellfish; and the Texas Health and Safety Code, sec.12.001, which provides the Texas Board of Health with the authority to adopt rules for the performance of every duty imposed by law on the Texas Board of Health, the Texas Department of Health, and the commissioner of health. sec.241.50. Definitions. The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise. Adequate-That which, in the judgement of the department, is needed to implement these sections and to accomplish the intended purpose in keeping with good public health practice. 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 the receptacle. Approved-Acceptable to the Commissioner of Health and the Division of Shellfish Sanitation Control. Approved area-The classification of a shellfish growing area determined by the Division of Shellfish Sanitation Control to be acceptable for harvesting shellfish for direct marketing. Authorized agent -An employee of the Department of Health who is designated by the commissioner to enforce provisions of these sections. Backflow-The flow of water or other liquids, mixtures, or substances into the distributing pipes of a potable supply of water from any source or sources other than its intended source. Backsiphonage-The flowing back of used, contaminated, or polluted water from a plumbing fixture or vessel or other source into a potable water supply pipe due to negative pressure in such pipes. Blower-A container for washing shucked shellfish which uses forced air as a means of agitation. Certificate of compliance (Certificate)-A numbered document issued by the Division of Shellfish Sanitation Control which authorizes a person to process shellfish for sale. Certification-The issuing by the Division of Shellfish Sanitation Control of a numbered document to operate that indicates compliance with these sections. Certification number -The number assigned by the Division of Shellfish Sanitation Control to each certified shellfish dealer. It consists of a one to five digit number preceded by the two letter state abbreviation and followed by the two letter symbol designating the type of operation certified. Certified laboratory evaluation officer-A person employed by the Texas Department of Health who has met the requirements of the United States Food and Drug Administration and who has been issued a letter of certification to evaluate shellfish laboratories in the State of Texas. Classes of shippers -The classes of shippers are as follows: (A) Depuration processor (DP)-A person who receives shellstock from areas designated by the Texas Department of Health and submits such shellstock to an approved controlled purification process. A depuration processor may not conduct a shellfish purification operation in a building or facility in which shellfish are being stored or handled for other purposes, unless the purification operation, including receiving, storage, packing and distribution areas, is entirely separated from other operations by physical barriers with no connecting openings. (B) Repacker (RP)-A person other than the original certified shucker/packer who repacks shucked shellfish into other containers. A repacker may also repack and ship shellstock. A repacker shall not shuck shellfish. (C) Shellstock shipper (SS)-A person who grows, harvests, buys, or repacks and sells shellstock. A shellstock shipper is not authorized to shuck shellfish nor to repack shucked shellfish. A shellstock shipper may ship properly packed and labeled shucked shellfish. (D) Shucker/packer (SP)-A person who shucks and packs shellfish. A shucker/packer may act as a shellstock shipper or repack shellfish originating from other certified dealers. (E) Wet storage operator (WS)-A shipper who purchases or harvests shellstock from areas meeting approved growing area criteria and holds such shellfish in water from an approved source. Closed area-A shellfish growing area where the harvesting of shellfish is temporarily or permanently not permitted. A closed area status is or may be placed on any of the five classified area designations as established in the National Shellfish Sanitation Program Manual of Operations as follows: approved; conditionally approved; restricted; conditionally restricted; or prohibited. For the purposes of these sections a closed area status shall be established by declaring the area to be a polluted area. Commingling-The act of combining different lots of shellstock or shucked shellfish. Commissioner-The Commissioner of Health for the State of Texas. Conditionally approved area-The classification of a shellfish growing area determined by the Division of Shellfish Sanitation Control to meet approved area criteria for a predictable period. The period is conditional upon established performance standards specified in a management plan. A conditionally approved area is a closed area when the area does not meet the approved growing area criteria. For the purposes of these sections a closed area status shall be established by declaring the area to be a polluted area. Conditionally restricted area-The classification of a shellfish growing area determined by the Division of Shellfish Sanitation Control to meet restricted area criteria for a predictable period. The period is conditional upon established performance standards specified in a management plan. A conditionally restricted area shall be declared to be a polluted area. The conditionally restricted area shall be open for transplanting or gathering for depuration only during the times it meets restricted area criteria and is so specified by the Texas Department of Health. Container-The physical material which is in contact with and/or directly surrounds the shellfish confining them into a single unit. Controlled purification or depuration-The process of using any approved artificially controlled aquatic environment to reduce the level of bacteria and viruses in live shellstock. Corrosion resistant materials-Those 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. Cross connection -Any physical connection or arrangement between two otherwise separate piping systems, one of which contains potable water and the other containing water of unknown or questionable safety, or steam, gas or chemical whereby there may be a flow from one system to the other, the direction of flow depending on the pressure differential between the two systems. Dealer-A commercial shellstock shipper, repacker, shucker/packer, or depuration processor. Department (TDH) -The Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756 or its successor. Depuration-See definition for controlled purification. Depuration plant -A facility of one or more depuration units. Depuration unit -A tank or series of tanks supplied by a single process water system. Division of Shellfish Sanitation Control (DSSC) -The division of the Texas Department of Health to which responsibility to classify shellfish growing waters, to issue certificates for the interstate shipment of shellfish and to regulate harvesting, processing, and shipping of shellfish is delegated, in accordance with the National Shellfish Sanitation Program Manual of Operations, Parts I and II. Dry storage-The storage of shellstock out of water. Easily cleanable -A surface which is readily accessible; and is made of such materials, has such a finish and is so fabricated that residues may be effectively removed by normal cleaning methods. Food and Drug Administration (FDA)-The federal agency in which regulation of foods, including the Cooperative Shellfish Program, is vested. Food contact surfaces-Those surfaces with which shucked shellfish come in contact and those surfaces from which drainage onto surfaces that come in contact with shucked shellfish ordinarily occurs during the normal course of operations. Food contact surfaces includes utensils and food contact surfaces of equipment. Gatherer-A person who takes shellfish by any means from a growing area designated by the commissioner for delivery only to a depuration plant. Growing area-An area which supports or could support live shellfish. Harvester-A person who takes shellfish by any means from any growing area for delivery to a certified dealer or for transplanting purposes. Heat shock-The process of subjecting shellstock to any form of heat treatment, such as steam, hot water or dry heat for a short period of time prior to shucking to facilitate removal of the meat from the shell without substantially altering the physical or organoleptic characteristics of the shellfish. Internal temperature -The actual temperature of the shellfish meat, as opposed to the air temperature of the area where the shellfish are stored. Interstate Certified Shellfish Shippers List (ICSSL) -The listing, published by FDA, of dealers certified by the states to pack and ship shellfish. Label-Any written, printed, or graphic matter affixed to or appearing upon any container of shellfish. License-The document issued by the Texas Parks and Wildlife Department, under the Texas Parks and Wildlife Code, Texas Codes Annotated, Chapter 47 or Chapter 76, which authorizes a person to harvest and transport shellfish for commercial sale. Lot of shellstock -A collection of containers of shellstock of no more than one day's harvest from a single defined growing area by one or more harvesters. Lot of shellstock for depuration-Shellstock gathered from a particular area at a particular time and delivered to one depuration plant. Lot of shucked shellfish-A collection of containers of no more than one day's shucked shellfish product produced under conditions as nearly uniform as possible, and designated by a common container code or marking. Marine toxins-Poisonous compounds accumulated by shellfish feeding upon toxic microorganisms. The poisons may come from dinoflagellates, e.g. Gonyaulax catenella, G. tamarensis, and Ptychodicus brevis. Market shellfish -Shellfish which are, may be, or have been harvested and/or prepared for sale for human consumption as a fresh or frozen product. National Shellfish Sanitation Program (NSSP)-The cooperative State/Food and Drug Administration/Industry program enabling the classification of shellfish growing waters and the certification of interstate shellfish shippers as described in the NSSP Manual of Operations, Parts I and II, or its successor program. Pack-All activities involved in placing shellfish in containers. Person-An individual, partnership, corporation, association or other legal entity. Poisonous or deleterious substance-A toxic compound occurring naturally or added to the environment that may be found in shellfish and for which a regulatory tolerance limit has been or may be established to protect public health. Examples of naturally occurring substances would be paralytic shellfish toxins and trace elements geologically leached from the environment, such as mercury. Examples of added substances would be agricultural pesticides and polynuclear aromatics from oil spills. Polluted area-The declaration of an area determined by the DSSC to be unacceptable for harvesting of shellfish for direct marketing. Shellfish may not be harvested from a polluted area unless they are subjected to transplanting or controlled purification in accordance with these sections and the permitting requirements of the Texas Parks and Wildlife Department, Title 31, sec.57.231 (relating to Transplant Permits) and sec.57.232 (relating to Harvest Permits). Principal display panel-The part of a label that is most likely to be displayed, presented, shown or examined under customary conditions for sale. Process batch-A quantity of shellfish used to fill each separate depuration unit. Process water-The water in depuration tanks during the time that shellfish are being depurated. Processor-A person who depurates, shucks, packs, or repacks shellfish. Prohibited area -The classification of a shellfish growing area determined by the DSSC to be unacceptable for the transplanting, gathering for depuration, or harvesting of shellfish. The only shellfish removal from a prohibited area allowed is for the purposes of depletion. Restricted area -The classification of a shellfish growing area determined by the DSSC to be unacceptable for harvesting of shellfish for direct marketing, but which is acceptable for transplanting or gathering for depuration. A restricted area shall be declared to be a polluted area. A restricted area may be closed for transplanting or gathering for depuration when the DSSC determines that the area does not meet the restricted area criteria established in the NSSP. Safe materials -Articles manufactured from or composed of materials that may not reasonably be expected to result, directly or indirectly, in their becoming a component or otherwise affecting the characteristics of any food. Sanitary survey -The evaluation of all factors having an effect on the sanitary quality of a shellfish growing area, including sources of pollution, the effects of wind, tides and currents in the distribution and dilution of the polluting materials, and the bacteriological quality of the water. Sanitize-The adequate treatment of food contact surfaces by a process that is effective in destroying vegetative cells of microorganisms of public health significance, and in substantially reducing numbers of other undesirable microorganisms, but without adversely affecting the product or its safety for the consumer. Shall-The term used to state mandatory requirements. Shellfish-All edible species of oysters, clams, and mussels either shucked, in the shell, fresh or fresh frozen, whole or in part, as defined in the NSSP. Shellstock-Shellfish in the shell. Shucked shellfish -Shellfish, whole or in part, from which one or both shells have been removed. Texas business address-A permanent structure on land within the jurisdiction of the State of Texas where aquatic products or orders for aquatic products are received or where aquatic products are sold, but does not include a boat or any type of floating device, a public cold storage vault, the portion of a structure that is used as a residence, or a vehicle of any kind. Texas Parks and Wildlife Department (TPWD) -The Texas Parks and Wildlife Department, 4200 Smith School Road, Austin, Texas 78744, or its successor state agency, having the responsibility for the enforcement of laws concerning harvesting and depletion of the resource in accordance with the NSSP Manual of Operations, Part I. Transaction record -A form(s) used to document each purchase or sale of shellfish at the wholesale level. Transplanting-Moving of shellfish from one growing area to another for improving growth, stocking depleted areas and leases, natural cleansing or for other aquaculture purposes. Wet storage-The temporary storage of shellfish from approved sources, intended for marketing, in containers or floats in natural bodies of water or in tanks containing natural or synthetic seawater. sec.241.55. Harvesting and Handling Shellstock. (a) Boats and trucks. (1) All boats used for harvesting or transporting shellstock and all trucks used for dry storing or hauling shellstock shall be constructed, operated, and maintained so as to prevent contamination, deterioration, or decomposition of the shellstock and shall be kept clean. All shellfish boats or trucks shall be subject to approval by the commissioner or his duly authorized representative. (2) Decks and storage bins shall be constructed and located so as to prevent bilge water or polluted over board water from coming into contact with the shellstock. (3) Bilge pump discharges shall be located so that pumpage will not contaminate shellstock or the boat. (4) Body waste shall not be discharged overboard from any boat at any time. (5) Portable toilets shall be provided on each boat, shall be used only for the purpose intended, and shall be secured and located so as to prevent contamination of the shellfish by spillage or leakage. (6) An adequate supply of toilet paper and hand cleanser and/or sanitizer shall be provided on each boat. (7) The contents of portable toilets shall be emptied only into an approved sewage disposal system, and the portable toilets shall be cleaned before being returned to the boat. Facilities used for cleaning food processing equipment shall not be used for cleaning portable toilets. (8) Sacks or other containers used for storing shellstock shall be clean and fabricated from safe materials. Storage areas shall be constructed of nontoxic materials. (9) Boat decks, truck floors, and storage bins shall be kept clean with potable water or water from an approved growing area and shall have effective drainage. (10) Adequate coverings shall be provided on harvest boats to protect shellstock from exposure to sun, birds, and other adverse conditions. (11) Portions of boats or trucks (decks, storage bins, floorbeds, etc.) and all other equipment (shovels, wheelbarrows, rakes, etc.) coming in contact with shellstock during handling or transport from polluted areas to approved areas for relaying shall be thoroughly cleaned and sanitized immediately after unloading before they are used to transport or handle shellfish from approved areas. (12) Commercial harvesters shall be responsible for control of their shellstock until acceptance by a certified dealer. Commercial harvesters shall be required to deliver shellstock to a certified dealer within the day the shellstock is harvested. For this purpose a day shall be considered to be midnight to midnight. Delivery of shellstock is considered to be transfer of the shellstock from the boat to the dock and acceptance by the certified dealer. Commercial harvesters shall sell their shellstock only to a currently certified shellfish dealer. The certified dealer shall place a properly completed tag on each sack immediately upon accepting control from the harvester. (13) Shellstock shall be placed under mechanical refrigeration at air temperatures between 45 degrees fahrenheit and 35 degrees fahrenheit within two hours of unloading from the boat. Mechanical refrigeration facilities shall be adequate in size and cooling capacity to refrigerate all shellstock on the premises. Each facility shall be equipped with an automatic temperature regulating control (thermostat) and an indicating thermometer installed to accurately measure, within three degrees, the temperature in the warmest location in the storage compartment. (14) Refrigerated shellstock shall be maintained at internal temperatures between 45 degrees fahrenheit and 35 degrees fahrenheit. After initial refrigeration, shellstock removed from refrigeration shall not be permitted to remain in air temperatures above 45 degrees fahrenheit for more than two hours. The internal air temperature in trailers shall be at or below 45 degrees fahrenheit when shellstock loading begins. (15) Trucks used to transport shellstock shall have the storage area constructed of a nontoxic, smooth, impervious material so as to protect the shellfish from contamination and shall be kept clean. Shellstock shall be transported in mechanically refrigerated trucks that can maintain an air temperature between 45 degrees fahrenheit and 35 degrees fahrenheit, shall be pelletized, and shall be arranged to allow maximum air circulation. Shellstock storage areas shall be similarly constructed. (16) Dogs, cats, or other animals shall not be permitted on vessels, in vehicles, or in any other area where shellstock is held or transported. (b) Washing of shellstock. (1) Shellstock shall be washed reasonably free of bottom sediments and detritus at the time of harvest or as soon after harvesting as is feasible. Washing shellstock shall be the responsibility of the harvester. (2) Water used for washing shellstock shall be obtained from an approved growing area, or from other safe sources approved by the Texas Department of Health (TDH). (c) Shellstock packing and identification. (1) Sacks, boxes, and other shellstock packing containers shall be clean and fabricated from safe material. (2) A shellfish harvester shall sack all shellstock and securely affix an approved, durable, waterproof, harvester's tag to each container of shellstock prior to delivery to a certified dealer. This tag shall remain on the container during transport and storage until the shellstock is processed or reaches the consumer. (3) The harvester's tags shall contain the following information: (A) the Texas Parks and Wildlife Department commercial harvester's number and name of the captain and the boat name or the oyster boat license number and the captain's name; (B) the date of harvesting; (C) the most precise identification of the harvest location as is practicable including the two letter state abbreviation; (D) the type and quantity of shellstock; and (E) the following statement in bold capitalized type "THIS TAG IS REQUIRED TO BE ATTACHED UNTIL CONTAINER IS EMPTY OR RETAGGED AND THEREAFTER KEPT ON FILE FOR 90 DAYS." (4) The initial certified shellfish dealer shall securely affix an approved, durable, waterproof, tag or label to each container of shellstock immediately upon accepting control of the shellstock. This tag or label shall remain on the container during transport and storage until the shellstock is processed or reaches the consumer. (5) The certified dealer's tags or labels shall contain the following information: (A) the name of the certified business as it appears on the certificate issued by the Division of Shellfish Sanitation Control (DSSC); (B) the address of the business, including at least the city and state; (C) the complete certification number assigned by the DSSC; (D) the original shipper's certification number including the state abbreviation; (E) the date of harvesting; (F) the most precise identification of the harvest location as is practicable including the two letter state abbreviation; (G) the type and quantity of shellstock; (H) the name of the harvester or the harvest boat; and (I) the following statement in bold capitalized type "THIS TAG IS REQUIRED TO BE ATTACHED UNTIL CONTAINER IS EMPTY AND THEREAFTER KEPT ON FILE FOR 90 DAYS." (6) All information shall be permanently printed on the tags or labels by the printing company, except the date of harvest, harvest location, and the name of the harvester or harvest boat, which shall be added by the certified dealer, before the tags or labels are affixed to the container. All information either printed or added to the tag or label must be done using a permanent type ink, and shall not be altered or changed after being entered on the tag or label. The certification number shall only be complete and valid if it has a proper state two letter abbreviation, followed by a one to five digit number followed by a two letter abbreviation for the type of operation the dealer is certified to perform, (SP for shucker/packer, RP for repacker, SS for shellstock shipper, or DP for depuration plant). These tags shall be no smaller than the minimum size allowed as stated in the National Shellfish Sanitation Program (NSSP) Manual, Part II. (7) The certified dealer shall accept responsibility for the shellstock at the time the tag is attached to the sack. sec.241.56. Shellstock Shipping. (a) Source, identification, and records. (1) All incoming shellstock shall be inspected to assure compliance with requirements of sec.241.54 of this title (relating to Sources of Shellfish). (2) Dead, unwholesome, inadequately protected, or unidentified shellfish shall be destroyed. (3) Complete, accurate, and legible records in a form approved by the Division of Shellfish Sanitation Control (DSSC) shall be maintained by each certified dealer. These records shall be sufficient to document that the shellstock are from an approved source and to permit a container to be traced back to the harvest area, date of harvest, and the name of the harvester or harvest boat. Purchases and sales shall be recorded in a permanently bound ledger book and maintained for a minimum of one year. Transaction records indicating origin, date, and time of receipt of the product shall be maintained in a legible, orderly file. If computer records are maintained, they shall be approved by the DSSC. (b) Shellstock storage and shipping. (1) Trucks used to store or transport shellstock shall be constructed, maintained, cleaned, and refrigerated in accordance with sec.241.55 of this title (relating to Harvesting and Handling Shellstock). (2) Buildings in which shellstock are held shall comply with the construction requirements of the sections of this undesignated head. Shellstock shippers shall have sanitary toilet facilities acceptable to the DSSC and an approved water supply providing at least warm water suitable for hand washing. (3) Shellstock in storage shall be protected from contamination and maintained at temperatures necessary to minimize microbial growth pursuant to the requirements of sec.241.55 and sec.241.75 of this title (relating to Refrigeration and Shipping of Shucked Shellfish). (4) All equipment and conveyances which come into contact with shellstock shall be maintained and cleaned according to the requirements of sec.241.68 of this title (relating to General Maintenance and Cleanliness). (5) Animals and unauthorized persons shall not be allowed in any area where shellstock is being stored or handled. (6) Shellstock shall be identified in accordance with the requirements of sec.241.55, and records shall be maintained in accordance with the requirements of sec.241.77 of this title (relating to Records). Shippers whose physical facilities consist of trucks and/or organized docking facilities only, shall have a Texas business address at which records are maintained and inspections can be performed. (c) Repacking and relabeling shellstock. (1) Only shellstock that are clean, alive, and wholesome shall be repacked or relabeled. (2) Shellstock repacking facilities shall be in compliance with the construction requirements established in the sections of this undesignated head. (3) Shellstock shall be held, transported, and handled in accordance with the requirements of sec.241.55 of this title. Shellstock repacking and relabeling shall be conducted in facilities which comply with the construction and operational requirements of this undesignated head. (4) Shellstock from different lots shall not be commingled during repacking. (5) Sacks, boxes, and other shellstock packing containers shall be clean, fabricated from safe materials, and protected from contamination. (6) Animals or unauthorized persons shall not be allowed in any area where shellstock is being stored or repacked. (7) A durable, waterproof tag or label shall be securely affixed to each container. This tag or label shall remain on the container during transport and storage until the shellstock is processed or reaches the consumer. The tag or label shall contain the following information in a legible and indelible form: (A) the name of the business as it appears on the certificate of compliance; (B) the business address including at least the city and state; (C) the complete certification number of the dealer performing the repacking or relabeling; (D) the date of harvest; (E) the most precise description of the harvest area as is practicable including the two letter state abbreviation; (F) the type and quantity of shellstock; (G) the name of harvester or harvest boat, or the source from which the shellstock was purchased; and (H) the following statement in bold capitalized type "THIS TAG IS REQUIRED TO BE ATTACHED UNTIL CONTAINER IS EMPTY OR RETAGGED AND THEREAFTER KEPT ON FILE FOR 90 DAYS." (8) Records shall be maintained which will permit a container of shellstock to be traced back to the harvest area. Records shall also include the date of harvest and the name of the harvester or harvest boat, or the source from which the shellstock was purchased. Records shall be maintained for a period of at least one year. sec.241.62. Heating, Cooling, and Ventilation. (a) Working rooms shall be adequately ventilated and heated or cooled. Adequate ventilation shall be provided to minimize odors, noxious fumes, vapors, or condensation (including steam) in areas where shellfish may become contaminated. Operation of cooling, heating or ventilating equipment shall not create conditions that may cause shellfish to become contaminated. (b) Dealers who wish to process shellfish when the temperature inside the plant exceeds 80 degrees fahrenheit shall have their facilities cooled with mechanical refrigeration adequate to maintain the internal air temperature at or below 80 degrees fahrenheit at all times the shellfish are being processed. Each processing room or area shall be equipped with an indicating thermometer installed to accurately measure, within three degrees, the temperature in the warmest location not to be more than six feet off the floor. sec.241.63. Water Supply. (a) Potable water shall be from a safe source, protected from contamination, and the water supply system shall be constructed, maintained, and operated according to this undesignated head. All water distribution systems shall be designed and constructed so as to provide a minimum residual pressure of 20 pounds per square inch under peak demand conditions. Under normal operating conditions, minimum pressures should not be less than 35 pounds per square inch in the distribution system. (b) Running water shall be provided at an adequate temperature and pressure in all areas where needed to process food, clean equipment, utensils, or containers, and supply sanitary facilities. (c) Hot and cold water shall be provided through a mixing valve at each compartment of every three compartment sink and at each hand washing lavatory. (d) Water wells shall be so located that there will be no danger of pollution from flooding under normal conditions or from insanitary surroundings, such as, privies, sewage, sewage treatment plants, livestock and animal pens, solid waste disposal sites, or abandoned and improperly sealed wells. (e) Well sites shall not be within 50 feet of a tile or concrete sanitary sewer, septic tank, or storm sewer, or within 150 feet of a septic tank perforated drainfield, absorption bed, evapotranspiration bed or underground fuel storage tank. (f) No well site shall be located within 500 feet of a sewage treatment plant or within 300 feet of a sewage wet well, sewage pumping station or a drainage ditch which contains industrial waste discharges or the wastes from sewage treatment systems. (g) No water wells shall be located within 500 feet of animal feed lots, solid waste disposal sites or lands irrigated by sewerage plant effluent. (h) Livestock shall not be allowed within 50 feet of water supply wells. (i) Abandoned water wells in the area of a proposed source shall be plugged and sealed properly to prevent possible contamination of freshwater strata. (j) A sanitary control easement covering that portion of the lands within 150 feet of the well location shall be secured from all such property owners and recorded in the deed records at the county courthouse for all completed wells dug after the effective date of these sections. (k) A concrete sealing block extending at least three feet from the well casing in all directions, with a minimum thickness of six inches and sloped to drain away at not less than 0.25 inches per foot shall be provided around the well head. (l) Wellheads and pump bases shall be sealed by the use of gaskets or sealing compounds and, as applicable, properly vented to prevent the possibility of contamination of the well water. (m) Upon completion of a new well, or after an existing well has been reworked, the well shall be disinfected and unused for at least six hours. After the water containing chlorine is completely flushed from the well, prior to placing the well in service, samples of water shall be collected by the well owner or the certified dealer and submitted for bacteriological analysis until three successive samples collected on separate days shall be free of coliform organisms. Accurate records pertaining to the well, such as, the log of the ground formations, casing records, material settings, water levels, etc., shall be kept on file and made available to the Division of Shellfish Sanitation Control (DSSC) upon request. (n) A suitable raw water sampling cock shall be provided on the discharge pipe of each well pump. (o) Mechanical disinfection facilities capable of maintaining a free chlorine residual of 0.2-0.5 parts per million shall be provided with the point of injection prior to the hydropneumatic pressure tank or shall be ahead of the water storage reservoir(s), if a storage reservoir is provided. A test kit must be provided and available for testing the chlorine residual of the potable water. (p) The use of disinfectants other than hypochlorination with mechanical injection shall be considered on a case-by-case basis. Hypochlorination solution containers and pumps shall be housed and locked to protect them from adverse weather conditions and vandalism. (q) All hydropneumatic tanks shall be located wholly above grade and shall be of steel construction with welded seams. (1) Metal thickness for hydropneumatic tanks shall be sufficient to provide at least a minimum of 1/8 inch corrosion allowance and to withstand the highest expected working pressures with a four to one factor of safety. (2) All hydropneumatic tanks shall be provided with a pressure release device and an easily readable pressure gauge. (3) The tank size shall be large enough to maintain 35 pounds per square inch working pressure to the farthest end of the distribution system and large enough to provide adequate disinfection contact time as reflected by negative confluent and/or coliform monthly sample results. The tank size shall not be less than 82 gallons. (r) At least one sample of water taken from the distribution system shall be submitted to an approved laboratory each month for bacteriological analysis. Any coliform positive or confluent (TNTC) sample shall necessitate resampling the water within 24 hours of receiving the result. All shellfish operations associated with the well shall immediately cease upon notification of a coliform positive result. The DSSC shall be notified upon receipt of a coliform positive sample result. If the resample result is coliform positive, the DSSC shall be notified upon receipt of the result and the DSSC shall determine the appropriate steps for disinfection and/or resampling. Shellfish operations shall not resume until a coliform negative result is obtained and the DSSC is properly notified. sec.241.64. Plumbing, Sewage, and Related Facilities. (a) Plumbing shall be installed in compliance with applicable state laws, and shall be of adequate size and design to: (1) carry adequate quantities of water to required locations throughout the plant; (2) properly convey sewage and liquid disposable waste from the plant; (3) ensure that the water supplies and food contact surfaces are not contaminated as a result of an inadequate plumbing system; (4) provide adequate floor drainage in all areas; (5) properly dispose of all sink and lavatory liquid by direct discharge into drainage outlets. Drainage outlets shall be constructed and maintained so as to prevent the possible entrance of insects and rodents. Floor drainage shall not be allowed to drain from the plant on top of the ground. (b) There shall be no cross connections between the approved pressure water supply and water from an unapproved source, and there shall be no fixtures or connections through which the approved pressure supply might be contaminated by backsiphonage. Adequate devices approved by the appropriate regulatory agency shall be installed to protect against backflow and backsiphonage at all fixtures and equipment where the air gap between the water supply inlet and the fixture's flood level rim is less than twice the diameter of the water system inlet. All submerged inlets, including hoses attached to faucets, shall be equipped with a backflow prevention device. If booster pumps are connected directly to the potable water supply, the pumps shall be equipped with a low pressure cutoff device or equivalent method to prevent backsiphonage. (c) Hand washing facilities shall be adequate in number and size for the number of employees, convenient to the work areas, and so located that the person responsible for supervision can readily observe that employees wash their hands before beginning work and after each interruption. There shall be at least one hand washing lavatory located in the shucking room. There shall be at least one hand washing lavatory in the packing room for use by packing room workers. Three compartment sinks used for washing and sanitizing equipment and utensils shall not be used for hand washing. There shall be at least one three compartment sink located in the packing room. This sink shall be of adequate size to completely immerse and properly clean equipment and utensils. (d) Hand washing lavatories and three-compartment sinks shall be provided with hot water of at least 100 degrees fahrenheit from either a controlled temperature source with a maximum temperature of 115 degrees fahrenheit, or from a hot and cold mixing or combination faucet. Steam water mixing valves or steam water combination faucets shall not be acceptable. (e) A supply of hand cleansing soap or detergent shall be available at each hand washing facility. A supply of disposable towels or a suitable hand drying device that provides heated air shall be conveniently located near each hand washing facility. Common towels shall be prohibited. Where disposable towels are used, easily cleanable waste receptacles, with covers, shall be conveniently located near the hand washing facilities. Hand washing signs, in languages understood by the employees, shall be posted in toilet rooms and near hand washing facilities. Hand washing facilities, hand drying devices, and all related facilities shall be kept clean and in good repair. (f) Toilet facilities, in toilet rooms separate for each sex, shall be provided in all places of employment in accordance with the following table. The number of facilities to be provided for each sex shall be based on the number of employees of that sex for whom the facilities are furnished. Where toilet rooms will be occupied by no more than one person at a time, can be locked from the inside, and contain at least one water closet, separate toilet rooms for each sex need not be provided. Where such single-occupancy rooms have more than one toilet facility, only one such facility in each toilet room shall be counted for the purposes of the table. The sewage disposal method shall not endanger the health of employees. Each water closet shall occupy a separate compartment with a door and walls or partitions between fixtures adequately high to assure privacy. Toilet room doors shall be tight fitting, self-closing, and not open directly into a processing area. Toilet rooms shall be kept clean and in good repair. A supply of toilet paper in a suitable holder shall be available in the toilet rooms. Air vents shall be screened or have self-closing louvers. A covered waste receptacle shall be provided in each toilet room. [graphic] (g) No drainpipes or wastepipes shall be located over food processing or storage areas, or over areas in which containers are stored or washed. (h) Sewage shall be discharged into an adequate sewerage system or shall be disposed of through other effective means. Where private sewerage systems are utilized, they shall be constructed and maintained according to state and local laws. Privies are not acceptable. The sewerage system shall be constructed and maintained in order that sewage will be inaccessible to flies or other insects, rodents, or other vermin, and the sewage shall not provide a source of contamination. All sewerage lines and floor drainage lines shall be separate and shall be trapped to prevent entrance of sewage into any portion of the plant. sec.241.74. Labeling Shucked Shellfish. (a) Each individual container of fresh or fresh frozen shucked shellfish shall have permanently recorded on the container or principal display panel, so as to be easily visible, the following information: (1) the packer's, or repacker's, name as it appears on the certificate of compliance; (2) the packer's or repacker's address, including at least the city and state; and (3) the two letter state abbreviation followed by the one-to-five digit certificate number and followed by the two letter abbreviation for the type of operation the dealer is qualified to perform (shucker/packer (SP) or repacker (RP)). (b) The principal display panel on each container of fresh or fresh frozen shucked shellfish shall contain a date in compliance with the current National Shellfish Sanitation Program (NSSP) Manual of Operations, Part II. Containers of 64 ounces or more shall have a shucking date, and it shall be preceded by the word SHUCKED. Containers of 64 ounces or more shall also have the date on the lid. (c) For unfrozen product, if the date is a sell by date, the method of determining that date shall be based on the date the shellfish are shucked and shall be approved by the Division of Shellfish Sanitation Control (DSSC) before being used. The proposed method must be submitted in writing to the DSSC. The sell by date for unfrozen product is 14 days after the date of shuck unless otherwise approved in writing by the DSSC. The sell by date shall be preceded by the words SELL BY. A sell by date shall be required on containers of 63 ounces or less containing unfrozen product. For containers of 63 ounces or less containing frozen product, the words BEST IF USED BY shall precede the date. (d) The principal display panel on each container of fresh or fresh frozen shucked shellfish shall contain a lot identification adequate to permit the container to be traced back to the incoming lot of shellstock from which it was packed. (e) Frozen shellfish shall be labeled as FROZEN, Individually Quick frozen, or IQF in print of equal prominence immediately adjacent to the name of the shellfish. The word FROZEN, Individually Quick Frozen, or IQF shall be impressed, embossed, lithographed, or otherwise permanently recorded on the container. Stamping shall not be allowed. (f) Reusable containers used to temporarily store shucked shellfish shall have the following information permanently recorded on the container: (1) the packer's or repacker's name as it appears on the certificate of compliance; (2) the packer's or repacker's address, including at least the city and state; and (3) the complete certification number. (g) Reusable containers must have a tag or label attached to each container indicating the date shucked so that the date on the final container can be determined properly at repacking. Other information necessary to properly identify the lot and source of the shucked product shall also be on the tag or label. (h) All required information shall be provided in a legible and indelible form. All information, except the date and lot identification, shall be impressed, embossed, lithographed, or otherwise permanently recorded on the container by the container printing company, unless, an adhesive label which has been approved by the DSSC is used. Adhesive labels shall be durable and waterproof and shall not be used unless prior approval from the DSSC is obtained. The request must be submitted in writing. All labeling is subject to review and approval by the DSSC. sec.241.75. Refrigeration and Shipping of Shucked Shellfish. (a) Shucked shellfish shall be held and transported under mechanical refrigeration at air temperatures of 45 degrees fahrenheit or less. Storage and shipping of containers of shucked shellfish in wet ice is also required. Containers of shucked shellfish shall not be stored upside down unless they are constructed of flexible material and the lids are sealed to prevent liquid flow in or out. (b) Containerized shellfish to be frozen shall be arranged to insure rapid freezing, and shall be frozen at an ambient air temperature of 0 degrees fahrenheit or less, with the shellfish frozen solid within 12 hours after the start of freezing. Frozen shellfish shall be handled in such a manner as to remain frozen solid, and shall be held at 0 degrees fahrenheit or less. Previously frozen shellfish which have thawed shall be destroyed. (c) Refrigeration and frozen storage compartments shall be equipped in compliance with sec.241.55 of this title (relating to Harvesting and Handling Shellstock). Mechanical refrigeration facilities shall be adequate in size and cooling capacity to refrigerate all shucked shellfish on the premises. Each facility shall be equipped with an automatic temperature regulating control (thermostat) and an indicating thermometer installed to accurately measure, within three degrees, the temperature in the warmest location in the storage compartment. (d) After initial refrigeration, shucked shellfish removed from refrigeration shall not be permitted to remain in air temperatures above 45 degrees fahrenheit for more than two hours. (e) All containers holding shucked shellfish shall be kept covered during refrigeration. (f) Trucks used to transport shucked shellfish shall have the storage area constructed of a nontoxic, smooth, impervious material so as to protect the shellfish from contamination and shall be kept clean. Shucked shellfish shall be transported in mechanically refrigerated units that can maintain an air temperature between 45 degrees fahrenheit and 35 degrees fahrenheit, shall be pelletized, and shall be arranged to allow maximum air circulation. (g) Dogs, cats, or other animals shall not be permitted on vessels, in vehicles, or in any other area where shucked shellfish are held or transported. sec.241.77. Records. (a) Complete, accurate, and legible records in a form approved by the Division of Shellfish Sanitation Control (DSSC) shall be maintained by each certified dealer. These reports shall be sufficient to document that the shellfish are from an approved source and to permit a container of shellfish to be traced back to its specific incoming lot. Purchases and sales shall be recorded in a permanently bound ledger book. Transaction records indicating origin, date, and time of receipt of the product shall be maintained in a legible, orderly file. If computer records are maintained, they shall be approved by the DSSC. (b) Records covering purchases and sales of fresh shellfish shall be retained for a minimum of one year. Records covering purchases and sales of frozen shellfish shall be retained for at least two years or for a period of time that exceeds the shelf life of the product, if that period is longer than two years. (c) Records shall be made available for inspection upon verbal request by an agent of the DSSC during all normal working hours. (d) The following items pertaining to purchases shall be identified in the records: (1) seller's identification (harvester or other certified dealer); (2) harvest location for shellstock; (3) harvest date for shellstock; (4) shuck date for shucked product; (5) quantity purchased; and (6) date purchased. (e) The following items pertaining to processing or shipping shall be identified in the records: (1) processing or repacking date; (2) quantity processed or repacked; (3) quantity remaining; (4) quantity disposed of and method; (5) date shipped; (6) quantity shipped; and (7) consignee identification. sec.241.78. Employee Health. (a) Persons infected by disease in a communicable form, or while a carrier of such disease, or while infected with boils, sores, infected wounds, or acute respiratory infection shall not work in a shellfish processing establishment in any capacity in which there is a likelihood of such persons contaminating shellfish or shellfish contact surfaces with pathogenic organisms or transmitting diseases to other persons. (b) Daily observation of employees shall be made by the supervisor, with reasonable inquiries being made when signs of illness appear. Employees having diarrhea, sore throat, or any other symptoms of illness or disease shall promptly report this to their supervisor. (c) Upon an inquiry indicating the possibility of a communicable disease, the infected employee shall be excluded from the plant pending clearance by a licensed medical doctor. (d) Shuckers, packing room personnel, or any other employee who has a stab wound, puncture, or any other open wound or sore and may handle the product shall be excluded from the plant, unless appropriate steps are taken to cover the wound and properly protect the product. sec.241.80. Personal Cleanliness. (a) Employees handling shucked shellfish shall wear clean outer garments. These outer garments shall be rinsed or changed as necessary to be kept clean. Persons rinsing and packing shellfish shall wear an apron of approved material. (b) Employees shall wash their hands thoroughly with soap and water and shall sanitize their hands before starting work, after each absence from the work station, after each interruption, and at any other time when their hands may have become soiled or contaminated. Utensil sinks shall not be used for hand washing. (c) Finger cots, gloves, and shields, if worn by shuckers, shall be sanitized as often as necessary or at least twice daily; shall be properly stored until used; and shall be maintained in an intact, clean, and sanitary condition. Finger cots, gloves, and shields shall be made of an impermeable material except where use of such materials would be inappropriate or incompatible with the work involved. (d) Hands of employees handling shucked shellfish shall be either protected by sanitized finger cots or gloves, or shall be washed and disinfected immediately before any manual handling of the shucked shellfish. (e) Employees shall not store clothing or other personal belongings, eat food, chew gum, drink beverages, use tobacco in any form, spit, or conduct any other unsanitary acts in areas where shellfish are being stored, shucked, or packed or in areas that are being used for washing equipment or utensils. (f) Employees handling shucked shellfish shall wear effective hair restraints, remove all insecure jewelry and remove from hands any jewelry that cannot be adequately sanitized. If jewelry cannot be removed from hands, adequate finger cots or gloves shall be worn. (g) Employees shall take other necessary precautions to prevent contamination of shucked shellfish with microorganisms or foreign substances, including, but not limited to, perspiration, hair, cosmetics, chemicals, and medicants. sec.241.81. Education and Training. (a) Supervisors shall receive appropriate training in proper food handling techniques and food protection principles and shall be cognizant of personal hygiene, sanitary practices, and the requirements established in these sections. Failure of any person or persons to avail themselves of this information does not relieve them of a violation of these sections. (b) Employees shall receive instruction and training in proper food handling and personal hygiene and sanitary practices from supervisory personnel or from other sources acceptable to the Division of Shellfish Sanitation Control (DSSC). (c) Shellfish plant owners and/or managers and supervisors shall be required to attend a Food Protection Management Program, obtain a certificate of completion, and provide a copy to the DSSC prior to obtaining a Shellfish Certificate of Compliance. New supervisors shall be required to attend the course and obtain a certificate of completion before working as a supervisor in a plant and shall submit a copy of their certificate to the DSSC within two weeks of employment. Training shall be accomplished by means of a training program consisting of fifteen classroom hours and said program shall be accredited by the Texas Department of Health (TDH). Persons seeking certification may obtain said training from commercial or educational activities accredited by the TDH. Certification shall be accomplished after all course requirements have been met and the applicants have demonstrated by means of an examination that they possess the required essential knowledge as determined by the Health Authority. Certificates shall be valid only for a period of three years. Prior to expiration a person may attend a refresher course approved by the TDH and obtain a certificate of completion or obtain a passing score on a national examination for certification of food service managers that meets requirements of the United States Food and Drug Administration and the TDH. Copies of proof of either must be submitted to the DSSC prior to expiration. (d) Unsanitary practices of employees shall be brought to the attention of the employees by their supervisor and the employees shall be instructed on the proper sanitary practice that is to be used. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on March 29, 1993. TRD-9320880 Robert A. MacLean, M.D. Deputy Commissioner Texas Department of Health Effective date: August 1, 1993 Proposal publication date: October 2, 1992 For further information, please call: (512) 458-7236 Chapter 241. Shellfish Sanitation Molluscan Shellfish 25 TAC sec.241.53 The Texas Department of Health (department) adopts new sec.241.53, concerning molluscan shellfish. The section is adopted with changes to the proposed text as published in the October 6, 1992, issue of the Texas Register (17 TexReg 6880). The new section will update and clarify existing sec.241.53 and will implement the requirements and guidelines established in the 1990 National Shellfish Sanitation Program Manual of Operations, Parts I and II, published by the Interstate Shellfish Sanitation Conference and the United States Food and Drug Administration. The following is a summary of comments and the department's response. COMMENT: Concerning sec.241.53(a), one commenter wanted other states to have to meet the same requirements as Texas dealers. RESPONSE: The department agrees with the comment and states that this is already required by the rule. COMMENT: The department discovered during review that the division had incorrectly sited as the statutory authority for the proposed adoption of the new section under Texas Codes Annotated, the Parks and Wildlife Code, sec.76. 203. RESPONSE: The department has corrected the oversight and the correct statutory authority is sited in the adoption preamble. The new section is adopted under the Texas Health and Safety Code, sec.436. 013, which authorizes the Texas Board of Health to adopt rules concerning the regulation of Texas molluscan shellfish; and the Texas Health and Safety Code, sec.12.001, which provides the Texas Board of Health with the authority to adopt rules for the performance of every duty imposed by law on the Texas Board of Health, the Texas Department of Health, and the commissioner of health. sec.241.53. Certification and Enforcement Procedures. (a) No shellfish shall be offered for sale for food in the State of Texas unless taken from areas approved by the commissioner, or obtained from sources outside the State which are approved by the Texas Department of Health (TDH). If obtained from sources outside of the State, the shellfish must be from areas approved by the State authorities having jurisdiction and must be obtained from shellfish dealers currently certified by the appropriate state authority. Shellfish obtained from sources other than those outlined in this section shall be considered unfit for human consumption. No person shall engage in the gathering, harvesting, shucking, packing, or repacking of shellfish for sale without having complied with these sections. No person shall engage in any activity requiring a certificate under these sections without having applied for and obtained a numbered certificate of compliance pertaining to the particular activity from the commissioner. Any shellfish in the possession of a person holding a valid license issued by the Texas Parks and Wildlife Department (TPWD) under Texas Parks and Wildlife Code, Chapters 47 or 76, shall be considered to be offered for sale for food in Texas. (b) Prior to beginning construction of a new shellfish plant, or major remodeling of an existing shellfish 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 the TDH's Division of Shellfish Sanitation Control (DSSC) for review and 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 no less than 30 days prior to initiating a new process or beginning construction. No operations shall be conducted while any inside plant construction or any other construction which has the potential to contaminate the product is occurring. A legibly written or typed application on forms provided by TDH must be filed with the DSSC before gathering, harvesting for market, or operation of the plant begins each fiscal year. A certificate of compliance and 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. (c) The inspection of a previously certified plant which has exhibited operational problems or violations of operational requirements of these sections or had a certificate of compliance 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 DSSC for review and approval. An application may be rejected and a certificate of compliance denied based on a history of failure to comply with the requirements of these sections. (d) Shellfish operations at the plant shall not begin until the shellfish certificate issued by the commissioner has been received and posted at the plant. Each certificate of compliance shall expire automatically at 11:59 p.m. the 31st day of August following the date of issue. Certificates of compliance shall not be transferable. (e) After a certificate of compliance is issued, unannounced inspections shall be conducted at any time the DSSC has reason to believe the business may be in operation and at such frequency as may be necessary to assure that adequate operational and sanitary conditions are maintained and shall be conducted a minimum of three times each six months. 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 TDH to the most responsible individual present at the firm at the conclusion of the inspection. Any violations of the same requirement found on a consecutive inspection may result in certificate revocation in accordance with subsection (f) of this section. Shellfish inspections and the DSSC forms shall comply with the requirements established in the current National Shellfish Sanitation Program (NSSP) Manual of Operations. (f) The DSSC may initiate procedures to revoke a certificate of compliance as follows. (1) The procedures, including the opportunity for a hearing prior to revocation, shall be in accordance with the provisions of the Administrative Procedure and Texas Register Act, Texas Civil Statutes, Article 6252-13a, and TDH formal hearing procedures in Chapter 1 of this title (relating to the Board of Health). (2) The grounds for revocation shall be one or more of the following: (A) inspection results indicate unsatisfactory conditions in the plant or the existence of a public health hazard; or (B) the certificate holder or representative refuses to allow an inspection or otherwise interferes with the authorized TDH agent in the performance of his or her duties. (g) The commissioner of health or his designee may revoke a certificate of compliance prior to a hearing as follows. (1) The grounds for revocation shall be one or more of the following: (A) the shellfish create or appear to create an imminent hazard to public health; (B) the certificate holder or representative refuses to allow an authorized TDH agent to inspect the facilities and premises when the agent has reason to believe that an imminent hazard to public health may exist; (C) cooling temperatures violate the requirements of these sections; (D) pathogenic bacteria are isolated in any sample; (E) sewage becomes accessible to flies or other insects, rodents, or other vermin. (F) facility operating while flooded; (G) unsafe water supply, including evidence of bad samples; (H) unapproved wet storage; (I) packing into containers without a valid certificate number for that location; (J) unsanitary ice supply; or (K) incomplete, inaccurate, or illegible business records not sufficient to validate source of product or permit containers to be traced. (2) Immediately after a revocation, the commissioner or his designee shall give the certificate holder the opportunity for a hearing in accordance with TDH formal hearing procedures in Chapter 1 of this title. (h) A person whose certificate has been revoked may not process any shellfish until the DSSC is satisfied that all necessary corrections have been made. A new certificate will not be issued until an inspection establishes that the firm is in full compliance with all applicable criteria of these sections. A person whose certificate has been revoked shall not apply for a new certificate until 30 days after the date of signing of the final order of revocation. (i) Should the commissioner deem it reasonably necessary for the enforcement of these sections, he is empowered to require of each person holding a certificate to post and maintain with him a good and sufficient bond, with a corporate surety or two personal sureties approved by the commissioner, or to make a cash deposit in a form acceptable to the commissioner. The bond will be posted or the cash deposited on the condition that the certificate holder will faithfully comply with all legal requirements imposed by virtue of the law and that, failing such, the certificate holder or his surety will pay as forfeiture a sum of at least $1,000. (j) By acceptance of a certificate, the holder agrees to save, hold harmless, and indemnify the State of Texas, TDH, and its employees against any and all liability, claims or losses for property damage or personal injury which result in whole or in part from the certificate holder's activities. The State of Texas shall not be held liable for financial losses incurred by the shellfish transplanters, gatherers, harvesters, plant supervisors, or plant owners due to failure of shellfish activity, condemnation of shellfish, loss of shellfish, or other reasons. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on March 26, 1993. TRD-9320879 Robert A. MacLean, M.D. Deputy Commissioner Texas Department of Health Effective date: August 1, 1993 Proposal publication date: October 6, 1992 For further information, please call: (512) 458-7236 Chapter 265. General Sanitation Texas Youth Camps Safety and Health 25 TAC sec.265.25 The Texas Department of Health (department) adopts new sec.265.25, without changes to the text as published in the October 6, 1992, issue of the Texas Register (17 TexReg 6881). The new section concerns administrative penalties and covers the amount of an administrative penalty which the Commissioner of Health (commissioner) may assess when a person violates the Texas Youth Camp Safety and Health Act or an order or rule or license issued under the Act, the criteria for assessing the penalty, and the hearing procedures available when a penalty is being proposed for assessment. The new section will implement the provisions of the Health and Safety Code, sec.141.016, which became effective on September 1, 1991. No comments were received regarding adoption of the new section. The new section is adopted under the Health and Safety Code, sec.141.016, which provides the commissioner with authority to assess an administrative penalty for a violation of the Youth Camp Safety and Health Act; sec.141.017, which provides the department with authority to provide an opportunity for a hearing when a penalty is being proposed; and sec.12.001 which provides the Texas Board of Health (board) with authority to adopt rules to implement every duty imposed by law on the board, the department, and the commissioner. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on March 25, 1993. TRD-9320836 Robert A. MacLean, M.D. Deputy Commissioner Texas Department of Health Effective date: April 15, 1993 Proposal publication date: October 6, 1992 For further information, please call: (512) 458-7236 TITLE 34. PUBLIC FINANCE Part III. Teacher Retirement System of Texas Chapter 23. Administrative Procedures 34 TAC sec.23.6 The Teacher Retirement System of Texas (TRS) adopts new sec.23.6 concerning the trustee to trustee transfers, of eligible rollover distributions from TRS, without changes to the proposed text as published in the December 22, 1992, issue of the Texas Register (17 TexReg 8997). The new section is adopted in order to comply with the provisions of the Unemployment Compensation Amendments of 1992, Public Law 102-318 (UCA), which require qualified retirement plans to permit such transfers for distributions made after December 31, 1992. As a qualified plan, TRS is required by federal law to allow such transfers. This section is intended to provide authority for TRS to make trustee to trustee transfers of eligible rollover distributions. The new section will permit a distributee of an eligible rollover distribution to elect to have the distribution paid directly to another eligible retirement plan. By doing so, the distributee will avoid a mandatory withholding of federal income tax on the distribution in the amount of 20% of the eligible distribution. No Comments were received regarding adoption of the new section. The new section is adopted under the Texas Government Code, sec.825.102, which authorizes the Board of Trustees of the retirement system to adopt rules for the administration of the funds of the retirement system and for the transaction of business of the Board, and under the Texas Government Code, sec.825.506, which authorizes the Board of Trustees to adopt rules that modify the plan to the extent necessary for the retirement system to be a qualified plan. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on March 25, 1993. TRD-9320824 Wayne Blevins Executive Secretary Teacher Retirement System of Texas Effective date: April 15, 1993 Proposal publication date: December 22, 1992 For further information, please call: (512) 370-0524 TITLE 40. SOCIAL SERVICES AND ASSISTANCE Part II. Texas Rehabilitation Commission Chapter 115. Memoranda of Understanding with Other State Agencies 40 TAC sec.115.6 The Texas Rehabilitation Commission adopts an amendment to sec.115.6, concerning investigation of all reports it receives relating to abuse, neglect, or exploitation of a TRC client who is a disabled adult (age 18 and over) or an elderly person (age 65 and over), without changes to the proposed text as published in the February 23, 1993, issue of the Texas Register (18 TexReg 1158). The Texas Rehabilitation Commission is adopting this new section to give the public notice of the roles of the Texas Department of Protective and Regulatory Services and the Texas Rehabilitation Commission in the investigation of abuse, neglect, or exploitation of a Texas Rehabilitation Commission client who is a disabled adult or an elderly person. The new section will function to clarify for the public and the agencies involved the roles of the Texas Department of Protective and Regulatory Services and the Texas Rehabilitation Commission in the investigation of abuse, neglect, or exploitation of a Texas Rehabilitation Commission client who is a disabled adult or elderly person. No comments were received regarding adoption of the amendment. The amendment is adopted under the Texas Human Resources Code, Title 7, which provides the Texas Rehabilitation Commission with the authority to make regulations governing personnel standards, the protection of records and confidential information, the manner and form of filing applications, eligibility, investigation, and determination for rehabilitation and other services, procedures for hearings, and other regulations subject to this section as necessary to carry out the purposes of the chapter. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on March 26, 1993. TRD-9320868 Andrea Sargent-Fambles Legal Examiner Texas Rehabilitation Commission Effective date: April 16, 1993 Proposal publication date: February 23, 1993 For further information, please call: (512) 483-4055