PROPOSED RULES 
 
 Before an agency may permanently adopt a new or amended section or repeal an 
existing section, a proposal detailing the action must be published in the  
Texas Register at least 30 days before action is taken. The 30-day time period 
gives interested persons an opportunity to review and make oral or written 
comments on the section. Also, in the case of substantive action, a public 
hearing must be granted if requested by at least 25 persons, a governmental 
subdivision or agency, or an association having at least 25 members. 
  Symbology in proposed amendments. New language added to an existing section is 
indicated by the use of  bold text. [Brackets] indicate deletion of existing 
material within a section. 
 
   
  TITLE 4. AGRICULTURE 
 Part I. Texas Department of Agriculture 
  Chapter 5. Quarantines 
  
  Citrus Seed, Citrus Budwood and Citrus Nursery Stock Quarantine 
 
  4 TAC sec.sec.5.151-5.153 
 
  The Texas Department of Agriculture (the department) proposes amendments to 
sec.sec.5.151-5.153, concerning restricted shipments of citrus seed, citrus 
budwood and citrus nursery stock to require citrus seed and budwood to be tested 
and certified free of viruses before entry into the state. Currently, citrus 
seeds, citrus budded nursery stock or seedlings and citrus budwood may enter the 
state of Texas under permit from the department. However, it is necessary to 
amend the restricted shipment section and the restrictions on the citrus seed 
shipment section to require testing and certification of citrus products in 
order to assure that only disease-free and virus-free citrus budwood and citrus 
seed are allowed into this state. 
 Shashank Nilakhe, director, Agri-systems, has determined that for the first 
five-year period the sections are in effect there will be no fiscal implications 
for state or local government as a result of enforcing or administering the 
sections. 
 Dr. Nilakhe also has determined that for each year of the first five years the 
sections are in effect, the public benefit anticipated as a result of enforcing 
the sections will be that Texas citrus growers will be importing only certified 
disease-free and virus-free products. There will be no effect on small 
businesses. There is no anticipated economic cost to persons who are required to 
comply with the sections as proposed. 
 Comments on this proposal may be submitted to Shashank Nilakhe, Director, Agri-
Systems, Texas Department of Agriculture, P.O. Box 12847, Austin, Texas 78711, 
and must be received no later than 30 days from the date of publication of the 
proposal in the Texas Register. 
 The amendments are proposed under the Texas Agriculture Code, sec.71.007, which 
provides the Texas Department of Agriculture with the authority to adopt rules 
necessary for the protection of agricultural and horticultural interests. 
 The code chapter affected by this proposal is the Texas Agriculture Code, 
Chapter 71. 
 
 
  sec.5.151. Plant Diseases. <ol> It <nl>has been <ol> [is] determined [fact] 
that [such] plant diseases <nl>such<ol> as citrus canker, quick[,] decline, 
psorosis, leprosis, slow decline, creeping decline, tristeza virus, and other 
virus diseases are present in <nl>severe forms<ol> [all areas] outside of Texas; 
and the introduction of such diseases <nl>could<ol> [may] result <nl>from 
shipments of<ol> [by shipping] citrus seed, budwood, and nursery stock into 
Texas. 
 
   
  sec.5.152. Restricted Shipments. <ol> Citrus budded nursery stock or 
seedlings, citrus budwood, or any part of any citrus tree or seedling may not be 
shipped <nl>,<ol> carried or in any way transported by any means into the State 
of Texas from outside of the State of Texas; provided, however, that budwood or 
varieties of citrus not existing in the State of Texas may be shipped to the 
commissioner of agriculture from the State of Florida or the State of California 
under the following conditions: 
 
  (1) That before such budwood enters the State of Texas, <nl>a special permit 
from <ol> the commissioner of agriculture <nl>must be issued<ol> [has given 
express permission] for the admittance of that particular budwood into the State 
of Texas, and it is consigned to the commissioner of agriculture. 
   
  (2)  That such shipping or mailing container is addressed to the Texas [State] 
Department of Agriculture, <nl>P.O. Box 12847<ol>, Austin, Texas <nl>78711. 
   
  (3) Before any citrus budwood which originated outside the continental United 
States will be allowed to enter Texas and received by the commissioner of 
agriculture, it must be cleared through the [Division of Plant Exportation and 
Introduction, Bureau of Plant Industries and Agricultural Engineering,] United 
States Department of Agriculture, <nl>Animal and Plant Health Inspection 
Service, Plant Protection and Quarantine, Hyattsville<ol> [Beltsville], 
Maryland, and such clearance must be certified to the commissioner of 
agriculture before he will issue his permit for entrance or before he will 
accept such budwood shipment. 
   
  (4) All citrus budwood that is allowed to enter into the State of Texas 
<nl>must have been tested using the enzyme-linked-immuno-sorbent-assay (ELISA) 
method or alternative method approved by the commissioner of agriculture, and 
such test must have negative results, and such budwood <ol> shall be assigned to 
either a federal or state agency for the purpose of growing for <nl>confirmation 
tests<ol> [not less than two years to test and] to determine if the budwood is 
free from all virus and infectious diseases before it is released to the 
applicant. The budwood must be grown on three rootstock varieties: the Mexican 
Lime, the Sour Orange, and the Cleopatra Mandarin. Such growing must be in a 
partition, screened, quarantine house [and such houses may be] located [only] in 
[the counties of] Willacy, Hidalgo, or Cameron <nl>counties<ol>. Such citrus 
budwood shall be deemed free of all virus and infectious diseases when, and only 
when, the federal or state agency, to which the same has been assigned, shall 
certify that it has not exhibited any symptoms of any virus or infectious 
disease during the <nl>test<ol> [two-year] period that such agency has had such 
budwood in its custody. 
 
     
  sec.5.153. Restrictions on Citrus Seed Shipments.  No citrus seed can be 
shipped, brought, or in any manner transported into the State of Texas from any 
area outside the state other than from the State of Florida or the State of 
California. Citrus seed from the State of Florida or State of California may be 
imported into the State of Texas under the following conditions: 
 
  (1) A certified statement from the originating state's department of 
agriculture stating that the seed <nl>is from registered stock and <ol> was 
harvested in territory that is free from [the] citrus canker, and that the 
plants have been treated in Florida or California according to a procedure 
approved by the Texas Commissioner of Agriculture, witnessed by officials of the 
originating state's department of agriculture. 
   
  (2) (No change.) 
 
  This agency hereby certifies that the proposal has been reviewed by legal 
counsel and found to be within the agency's authority to adopt. 
 Issued in Austin, Texas, on June 29, 1994. 
 TRD-9443247 
  Dolores Alvarado Hibbs 
 Chief Administrative Law Judge 
 Texas Department of Agriculture 
    Earliest possible date of adoption: August 8, 1994 
 For further information, please call: (512) 463-7583 
         
                   
  TITLE 22. EXAMINING BOARDS 
 Part IX. Texas State Board of Medical Examiners 
  Chapter 185. Physician Assistants 
  
  22 TAC sec.sec.185.1-185.29 
 
  The Texas State Board of Medical Examiners proposes new  ssec.185.1-185.29, 
concerning the practice of physician assistants. The proposed new sections set 
forth the requirements for licensure, annual registration, and discipline of 
those persons practicing as physician assistants. Extensive rewrite of the 
section was necessary due to new legislative mandates; therefore, simultaneous 
repeal of current sections is proposed. 
 Tim Weitz, General Counsel, has determined that there will be fiscal 
implications as a result of enforcing or administering the section. Estimated 
additional cost to implement the rules will be approximately $240,000 per year 
for the first five-year period the section will be in effect. Estimated increase 
in revenue is anticipated at $240,000 per year for the first five-year to offset 
the cost of implementation. 
 Mr. Weitz also has determined that the public benefits anticipated as a result 
of enforcing the section as proposed will be to establish an orderly system of 
licensing and disciplining those persons practicing as physician assistants in 
the state of Texas in a manner which protects the health, safety, and welfare of 
the public. The anticipated economic cost to persons who are required to comply 
with the section as proposed will be $200 licensure fee plus $150 annual 
renewal. 
 Comments on the proposal may be submitted to Pat Wood, P.O. Box 149134, Austin, 
Texas 78714-9134. A public hearing will be held at a later time. 
 The new sections are proposed under Texas Civil Statutes, Article 4495b, which 
provide the Texas State Board of Medical Examiners with the authority to make 
rules, regulations and bylaws not inconsistent with this act as may be necessary 
for the governing of its own proceedings, the performance of its duties, the 
regulation of the practice of medicine in this state, and the enforcement of 
this act. 
 Cross Index to Statute-Physician Assistant Licensing Act, House Bill 2498, 73rd 
Legislature. 
 
  This agency hereby certifies that the proposal has been reviewed by legal 
counsel and found to be within the agency's authority to adopt. 
 Issued in Austin, Texas, on June 28, 1994. 
 TRD-9443264 
  Bruce A. Levy, M.D., J.D. 
 Executive Director 
 Texas State Board of Medical Examiners 
    Earliest possible date of adoption: August 8, 1994 
 For further information, please call: (512) 834-7728, Ext. 422 
         
       
  22 TAC sec.sec.185.1-185.16 
 
  (Editor's Note: The Texas State Board of Medical Examiners proposes for 
permanent adoption the repeals it adopts on an emergency basis in this issue. 
The text of the repeals is in the Emergency Rules section of this issue. ) 
   
  The Texas State Board of Medical Examiners proposes the repeal of sec.sec.185. 
1-185.16, concerning the practice of physician assistants. Pursuant to House 
Bill 2498, 73rd Legislature, extensive rewrite of this section was necessary; 
therefore repeal, with simultaneous new section is proposed. 
 Timothy E. Weitz, general counsel, has determined that for the first five-year 
period the repeals are in effect there will be no fiscal implications for state 
or local government as a result of enforcing or administering the repeals. 
 Mr. Weitz also has determined that for each year of the first five years the 
repeals are in effect the public benefit anticipated as a result of enforcing 
the repeals will be clarification of the rules by omission. There will be no 
effect on small businesses. There is no anticipated economic cost to persons who 
are required to comply with the repeals as proposed. 
 Comments on the proposal may be submitted to Pat Wood, P.O. Box 149134, Austin, 
Texas 78714-9134. A public hearing will be held at a later time. 
 The repeals are proposed under Texas Civil Statutes, Article 4495b, which 
provide the Texas State Board of Medical Examiners with the authority to make 
rules, regulations, and bylaws not inconsistent with this act as may be 
necessary for the governing of its own proceedings, the performance of its 
duties, the regulation of the practice of medicine in this state, and the 
enforcement of this act. 
 Cross Index to Statute-Physician Assistant Licensing Act, House Bill 2498, 73rd 
Legislature. 
 
  This agency hereby certifies that the proposal has been reviewed by legal 
counsel and found to be within the agency's authority to adopt. 
 Issued in Austin, Texas, on June 30, 1994. 
 TRD-9443266 
  Bruce A. Levy, M.D., J.D. 
 Executive Director 
 Texas State Board of Medical Examiners 
    Earliest possible date of adoption: August 8, 1994 
 For further information, please call: (512) 834-7728, Ext. 422 
         
             
  TITLE 25. HEALTH SERVICES 
 Part I. Texas Department of Health 
  Chapter 1. Texas Board of Health 
  
  The Texas Department of Health (department) proposes amendments to sec.sec.1. 
131, 1.132, 1.136, and 1.137; the repeal of sec.sec.1.133, 1.134, and 1.135; and 
new sec.sec.1.133, 1.134, and 1.135 concerning definition, treatment and 
disposition of special waste from health care related facilities, which are more 
commonly known as medical waste rules. Revisions to the rules include minimal 
changes to the definitions of some of the waste categories; adding some new 
definitions significant to the waste approval process; deleting some of the 
outdated terminology; and rewording definitions relating to cemeteries and 
handling of bodies to make them more applicable to medical waste rules. In 
addition, there will be references to current solid waste rules now administered 
through the Texas Natural Resource Conservation Commission (TNRCC) to more 
accurately reflect the split in regulatory activities between the department and 
the TNRCC. The most significant revision to the rules is the provision for 
systematic procedures to review and approve alternative treatment technologies 
for treatment of medical waste and related fees, which is proposed as new 
sec.1.135. 
 Mr. Charles R. Maddox, P.E., Chief, Bureau of Environmental Health, has 
determined that for the first five-year period the proposed sections are in 
effect there will be fiscal implications as a result of administering these 
sections. The cost to state government is estimated to be $86,000 the first 
year, and $54,000 for each of the succeeding four years. There will be no cost 
to local government. 
 Mr. Maddox also has determined that for each of the first five years the 
sections are in effect, the public benefit anticipated as a result of enforcing 
the proposed sections will be additional protection of the public's health 
through proper treatment and disposition of medical waste. The cost to all 
persons and businesses to comply with the new sections will be the application 
fee of $4,000 per alternative treatment process and annual listing fee of 
$2,000. No impact on local employment is anticipated. 
 Comments on the proposed sections may be sent to Charles R. Maddox, P.E., 
Chief, Bureau of Environmental Health, Texas Department of Health, 1100 West 
49th Street, Austin, Texas 78756-3199, (512) 834-6640. Mr. Maddox will accept 
comments for 30 days after publication in the Texas Register. 
   
  Definition, Treatment, and Disposition of Special LWaste from Health Care-
Related Facilities 
 
  25 TAC sec.sec.1.131, 1.132, 1.136, 1.137 
 
  The amendments are proposed under the Health and Safety Code, sec.sec.81.081-
81. 092, which provides the Board of Health (board) the authority to prevent and 
control communicable disease; sec.142.012, which authorizes the board to adopt 
rules concerning home and community support services agencies; sec.241.026, 
which authorizes the board to adopt rules concerning hospital licensing; 
sec.243.009, which authorizes the board to adopt rules concerning ambulatory 
surgical centers; sec.244.009, which authorizes the board to adopt rules 
covering birthing centers; sec.sec.245.009-245.010, which authorize the board to 
adopt rules covering abortion facilities; sec.694.001, which authorizes the 
board to regulate the disposition of dead bodies; sec.773.050, concerning the 
department's authority to regulate emergency medical service providers; sec.12. 
032, which authorizes the board to charge fees for public health services; and 
sec.12.001, which provides the board with the authority to adopt rules for the 
performance of every duty imposed by law on the board, the Texas Department of 
Health, and the Commissioner of Health. The new sections affect Health and 
Safety Code, sec.sec.12.001, 12.032, 81.081- 81.092, 142.012, 241.026, 243.009, 
244.009, 245.009-245.010, 694.001, 773.050. 
 
 
  sec.1.131. Purpose.  The purpose of these sections is to provide a definition 
of the term "special waste from health care-related facilities (SWFHCRF)," 
approve methods for the treatment [and disposition] of the waste, identify the 
entities that are subject to the provisions of these sections, and provide for 
the orderly application of the sections to covered entities. 
 
   
  sec.1.132. Definitions.  The following words and terms, when used in this 
undesignated head, shall have the following meanings unless the context clearly 
indicates otherwise. 
   
  <nl>   Approved alternate treatment process-A process for waste treatment 
which has been approved by the Texas Department of Health in accordance with 
sec.1.135 of this title (relating to Performance Standards for Commercially-
Available Alternate Treatment Technologies for Special Waste from Health care-
related Facilities). 
   
  <nl>   Biological indicators -Commercially-available microorganisms 
(e.g.,United States Food and Drug Administration-approved strips or vials of 
Bacillus <ol> species endospores) which can be used to verify the performance of 
waste treatment equipment and/or processes. 
   
  <nl>   Body fluids-Those free-flowing body substances other than blood, 
plasma, or serum identified under universal precautions as recommended by the 
United States Centers for Disease Control and Prevention, and includes, but are 
not limited to: 
 
  <nl>(A) semen; 
   
  <nl>(B) vaginal secretions; 
   
  <nl>(C) any body fluid containing visible blood; 
   
  <nl>(D) saliva in dental settings; 
   
  <nl>(E) amniotic fluid; 
   
  <nl>(F) cerebrospinal fluid; 
   
  <nl>(G) peritoneal fluid; 
   
  <nl>(H) pleural fluid; 
   
  <nl>(I) pericardial fluid; and 
   
  <nl>(J) synovial fluid. 
     
   Bulk-<nl>A containerized, aggregate<ol> [Bulk blood or body fluids shall mean 
a] volume of 100 milliliters <nl>(mL) <ol> or more. 
   
  <nl>   Bulk blood,<ol> [Blood and] blood products, <nl>and body fluids  -All 
<nl>free-flowing<ol> waste<nl>:<ol> [bulk] human blood<nl>; <ol>[,] serum 
<nl>;<ol>[,] plasma<nl>; <ol>[, and] other blood components<nl>; and body 
fluids; including disposable items saturated with blood or body fluids<ol>. 
   
   Burial park-A tract of land <nl>that is<ol> [which has been dedicated to the 
purposes of, and] used <nl>or <ol> [and] intended to be used[,] for the 
interment of pathological waste in graves. 
   
   Cemetery-A tract of land <nl>that is <ol> [which has been dedicated to the 
purposes of, and] used <nl>or<ol> [and] intended to be used for[,] the permanent 
interment of pathological waste, and includes: 
 
  (A)-(B) (No change.) 
   
  (C) a [crematory or crematory and] columbarium for cinerary interments; 
<nl>or<ol> [and] 
   
  (D) (No change.) 
     
  <nl>   Challenge waste load-A surrogate waste load assembled for use during 
waste treatment protocols to evaluate the efficacy of microbial inactivation 
processes. The composition of the challenge waste load will vary depending on 
the technology being evaluated. 
   
   Chemical disinfection -The use of a chemical agent to reduce significantly 
<nl>the numbers of active microorganisms, but not necessarily their endospores, 
from the surfaces of inanimate objects. <ol> [microbial activity. The chemical 
agent used shall be registered with the United States Environmental Protection 
Agency as a disinfectant and shall be used in accordance with the manufacturer's 
instructions; or the waste shall be immersed for not less than three minutes 
in:] 
 
  [(A) a freshly prepared solution of household chlorine bleach diluted 1: 10 
with water; or 
   
  [(B) a solution of 70% by volume 2-propanol (isopropyl alcohol). Waste which 
has been immersed in a liquid disinfectant must be thoroughly drained before 
disposal.] 
     
   Chlorine disinfection/maceration -The process of shredding waste in the 
presence of a chlorine [disinfectant] solution under negative pressure. [The 
shredded waste must be unrecognizable as to source. The chlorine disinfectant 
must have a free available chlorine concentration of 1,100 ppm when applied to 
the waste. The disinfectant solution must be drained from the waste prior to 
disposal.] 
   
   Contagious-Capable of transmission from human <nl>or animal<ol> to human. 
   
  <nl>   Contaminated-The presence or the reasonably anticipated presence of 
blood or those body fluids as defined elsewhere in this section. 
   
  <nl>   Cremated remains -The bone fragments remaining after the cremation 
process, which may include the residue of any foreign materials that were 
cremated with the pathological waste. 
   
  <nl>   Department-The Texas Department of Health. 
   
   Deposition in a sanitary landfill-Deposition in a sanitary landfill in 
accordance with <nl>30 TAC Chapter 330.<ol> [Chapter 325 of this title (relating 
to Solid Waste Management).] 
   
   Discharge to sanitary sewer system-A discharge or flushing of waste into 
<nl>a<ol> sanitary sewer system which is done in accordance with provisions of 
local sewage discharge ordinances. 
   
  <nl>   Disinfection-A somewhat less lethal process compared to sterilization, 
which destroys or inactivates viruses, fungi, and bacteria (but not necessarily 
their endospores) on inanimate surfaces. 
   
   Grave-A space of ground in a burial park <nl>that is used, or<ol> intended to 
be used for the permanent interment in the ground of pathological waste. 
   
  <nl>   Grinding-That physical process which pulverizes materials, thereby 
rendering them as unrecognizable, and for sharps, reduces the potential for the 
material to cause injuries such as puncture wounds. 
   
  <nl>   Immersed-A process in which waste is submerged fully into a liquid 
chemical agent in a container, or that a sufficient volume of liquid chemical 
agent is poured over a containerized waste, such that the liquid completely 
surrounds and covers the waste item(s) in the container. 
   
   Incineration-<nl>That process as defined in 30 TAC Chapter 101, whereby 
special waste from health care-related facilities is consumed <ol> [To consume 
special waste from health care related facilities] by burning under conditions 
in conformance with standards prescribed  <nl>in 30 TAC Chapter 111<ol> by the 
Texas <nl>Natural Resource Conservation Commission<ol> [Air Control Board]. 
   
   Interment-The disposition of pathological waste by cremation<nl>, 
entombment,<ol> [or] burial<nl>, or placement in a niche. 
   
   <nl>Log  point=4.52p  [sub]10-<ol>Logarithm to the base ten (10). 
   
  <nl>   Log/   [sub]10 / <ol>reduction-A mathematically defined unit used in 
reference to level or degree of microbial inactivation. A 4 log  [sub]10<ol> 
reduction represents a 99.99% reduction in the numbers of active microorganisms, 
while a 6 log/   [sub]10<ol> reduction represents a 99. 9999% reduction in the 
numbers of active microorganisms. 
   
   Mausoleum-A structure or building of most durable and lasting fireproof 
construction used, or intended to be used, for the  <nl>entombment<ol> 
[permanent interment in crypts and vaults of the remains of] pathological waste. 
   
  <nl>   Microbial inactivation -Inactivation of vegetative bacteria, fungi, 
lipophilic/hydrophilic viruses, parasites, and mycobacteria at a 6 log10 
 <nl>reduction or greater; and inactivation of Bacillus subtilis<ol> endospores 
or Bacillus stearothermophilus<ol> endospores at a 4 log10 
 <ol>reduction or greater. 
   
   Microbiological waste -Microbiological waste includes: 
 
  (A) <nl>discarded<ol> cultures and stocks of infectious agents and associated 
biologicals; 
   
  (B) <nl>discarded<ol> cultures of specimens from medical, pathological, 
pharmaceutical, research, clinical, commercial, and industrial laboratories; 
   
  (C) discarded live and attenuated vaccines<nl>, but excluding the empty 
containers thereof<ol>; 
   
  (D) <nl>discarded, used<ol> disposable culture dishes; and 
   
  (E) <nl>discarded, used<ol> disposable devices used to transfer, inoculate 
<nl>or <ol> [and] mix cultures. 
     
   Moist heat disinfection -The subjection of: 
 
  (A) internally shredded waste to moist heat, assisted by microwave radiation 
<nl>under those conditions which effect disinfection; <ol> [to a temperature of 
at least 95 degrees Celsius under atmospheric pressure for at least 30 minutes 
causing adequate disinfection as verified by routine performance monitoring 
using Bacillus subtilis<ol> test indicators;] or 
   
  (B) unshredded waste in sealed containers to moist heat, assisted by low-
frequency radiowaves <nl>under those conditions which effect disinfection,<ol> 
[to a temperature of at least 90 degrees Celsius under atmospheric pressure for 
at least two hours,] followed by shredding of the waste to the extent that the 
identity of the waste is unrecognizable. 
     
   Niche-A recess <nl>or space<ol> in <nl>a<ol> columbarium[,] used, or intended 
to be used, for the permanent interment of the cremated remains of pathological 
waste. 
   
  <nl>   Parametric controls -Measurable standards of equipment operation 
appropriate to the treatment equipment including, but not limited to pressure, 
cycle time, temperature, irradiation dosage, pH, chemical concentrations, or 
feed rates. 
   
   Pathological waste -Pathological waste includes but is not limited to: 
 
  (A) human materials removed during surgery, labor and delivery, autopsy<nl>, 
embalming,<ol> or biopsy, including: 
 
  (i)-(iv) (No change.) 
     
  (B) products of spontaneous or induced human abortions, <nl>regardless of the 
period of gestation,<ol> including <nl>:<ol> [body parts, tissues, fetuses, 
organs, and bulk blood and body fluids; regardless of the period of gestation;] 
 
  <nl>(i) <nl>body parts; 
   
  <nl>(ii) <nl>tissues or fetuses; 
   
  <nl>(iii) <nl>organs; and 
   
  <nl>(iv) <nl>bulk blood and body fluids; 
     
  (C)-(D) (No change.) 
     
  <nl>   Saturated-Thoroughly wet such that liquid or fluid flows freely from an 
item or surface without compression. 
   
   Sharps-Sharps include <nl>, but are not limited to<ol> the following 
materials <nl>: 
 
  <nl>(A) when contaminated: 
 
  <nl>(i)<ol>[(A)] hypodermic needles; 
   
  <nl>(ii)<ol>[(B)] hypodermic syringes with attached needles; 
   
  <nl>(iii)<ol>[(C)] scalpel blades; 
   
  <nl>(iv)<ol>[(D)] razor blades <nl>,<ol> [and] disposable razors<nl>, and 
disposable scissors<ol> used in surgery, labor and delivery, or other medical 
procedures; 
   
  <nl>(v) <nl>intravenous stylets and rigid introducers (e.g., J wires); 
   
  <nl>(vi)<ol>[(E)] <nl>glass <ol> pasteur pipettes<nl>, glass pipettes, 
specimen tubes, blood culture bottles, and microscope slides<ol>; [and] 
   
  <nl>(vii)<ol>[(F)] broken glass from laboratories; <nl>and 
   
  <nl>(viii)<ol>[(G)] <nl>tattoo needles, acupuncture needles, and electrolysis 
needles; 
     
  <nl>(B) regardless of contamination: 
 
  <nl>(i)<nl> hypodermic needles; and 
   
  <nl>(ii)<nl> hypodermic syringes with attached needles. 
       
  <nl>   Shredding-That physical process which cuts, slices, or tears materials 
into small pieces. 
   
   Special waste from health care-related facilities -A solid waste which if 
improperly treated or handled may serve to transmit an infectious disease(s) and 
which is comprised of the following: 
 
  (A) (No change.) 
   
  (B) bulk blood<nl>,<ol> [and] blood products<nl>, and body fluids<ol>; 
   
  (C)-(E) (No change.) 
     
   Steam sterilization -<nl>The act of subjecting waste to steam under pressure 
under those conditions which effect disinfection.<ol> [The act of autoclaving at 
temperature of at least 121 degrees Celsius, and a pressure of at least 15 
pounds per square inch for at least 30 minutes.] 
   
  <nl>   Sterilization-The use of a physical or chemical process to destroy all 
microbial life, including bacterial endospores. 
   
   Thermal inactivation -The act of subjecting  <nl>waste<ol> to dry heat 
<nl>under those conditions which effect disinfection.<ol> [of at least 160 
degrees Celsius under atmospheric pressure for at least two hours.] 
   
  <nl>   Unrecognizable-The original appearance of the waste item has been 
altered such that neither the waste nor its source can be identified. 
 
   
  sec.1.136. Approved Methods of Treatment and Disposition. 
 
  (a) Introduction. The following treatment and disposition methods for special 
waste from health care-related facilities are approved by the <nl>Texas Board of 
Health (board)<ol> for the waste specified. Where a special waste from a health 
care-related facility is also subject to the sections in Chapter 289 of this 
title (relating to [Occupational Health and] Radiation Control), the sections in 
Chapter 289 shall prevail over the sections in this undesignated head. 
<nl>Disposal of special waste from health care-related facilities in sanitary 
landfills or otherwise is under the jurisdiction of the Texas Natural Resource 
Conservation Commission and is governed by its rules found in 30 TAC Chapter 
330. 
 
  (1) Animal waste. Animal waste shall be subjected to one of the following 
methods of treatment and disposal. 
 
  (A) Carcasses of animals intentionally exposed to pathogens shall be subjected 
to one of the following methods of treatment and disposal: 
 
  (i)-(ii) (No change.) 
   
  (iii) carcasses of animals intentionally exposed to pathogens which are not 
contagious may be buried on-site under the supervision of a veterinarian 
licensed to practice veterinary medicine in the State of Texas; [or] 
   
  (iv) carcasses of animals intentionally exposed to pathogens which are not 
contagious may be sent to a rendering plant<nl>;<ol>[.] 
   
  <nl>(v)<nl> moist heat disinfection followed by deposition in a sanitary 
landfill; 
   
  <nl>(vi)<nl> chlorine disinfection/maceration followed by deposition in a 
sanitary landfill; or 
   
  <nl>(vii)<nl>an approved alternate treatment process followed by deposition in 
a sanitary landfill. 
     
  (B) Body parts of animals intentionally exposed to pathogens shall be 
subjected to one of the following methods of treatment and disposal: 
 
  (i)-(ii) (No change.) 
   
  (iii) incineration followed by deposition of the residue in a sanitary 
landfill; [or] 
   
  (iv) body parts of animals intentionally exposed to pathogens which are not 
contagious may be buried on site under the supervision of a veterinarian 
licensed to practice veterinary medicine in the State of Texas <nl>;<ol>[.] 
   
  <nl>(v)<nl> moist heat disinfection followed by deposition in a sanitary 
landfill; 
   
  <nl>(vi)<nl> chlorine disinfection/maceration followed by deposition in a 
sanitary landfill; or 
   
  <nl>(vii)<nl> an approved alternate treatment process followed by deposition 
in a sanitary landfill. 
     
  (C) Bulk whole blood, serum, plasma, and/or other blood components from 
animals intentionally exposed to pathogens shall be subjected to one of the 
following methods of treatment and disposal: 
 
  (i)-(viii) (No change.) 
   
  (ix) moist heat disinfection followed by deposition in a sanitary landfill; 
[or] 
   
  (x) chlorine disinfection/maceration followed by deposition in a sanitary 
landfill<nl>; or<ol>[.] 
   
  <nl>(xi)<nl> an approved alternate treatment process followed by deposition in 
a sanitary landfill. 
     
  (D) Bedding of animals intentionally exposed to pathogens shall be subjected 
to one of the following methods of treatment and disposal: 
 
  (i)-(iii) (No change.) 
   
  (iv) moist heat disinfection followed by deposition in a sanitary landfill; 
[or] 
   
  (v) chlorine disinfection/maceration followed by deposition in a sanitary 
landfill<nl>; or<ol>[.] 
   
  <nl>(vi)<nl> an approved alternate treatment process followed by deposition in 
a sanitary landfill. 
       
  (2) Bulk human blood<nl>,<ol> [and] blood products<nl>, and body fluids<ol>. 
Bulk human blood<nl>,<ol> [and] blood products<nl>, and body fluids<ol> shall be 
subjected to one of the following methods of treatment and disposal: 
 
  (A)-(E) (No change.) 
   
  <nl>(F) thermal inactivation, followed by deposition in a sanitary landfill; 
   
  <nl>(G) thermal inactivation, followed by grinding and discharging into a 
sanitary sewer system; 
   
  <nl>(H)<ol>[F] moist heat disinfection followed by deposition in a sanitary 
landfill; [or] 
   
  <nl>(I)<ol>[G] chlorine disinfection/maceration followed by deposition in a 
sanitary landfill<nl>; or<ol>[.] 
   
  <nl>(J) an approved alternate treatment process followed by deposition in a 
sanitary landfill. 
     
  (3) Microbiological waste. Microbiological waste shall be subjected to one of 
the following methods of treatment and disposal. 
 
  (A) <nl>Discarded cultures<ol> [Cultures] and stocks of infectious agents and 
associated biologicals shall be subjected to one of the following methods of 
treatment and disposal: 
 
  (i)-(iv) (No change.) 
   
  (v) moist heat disinfection followed by deposition in a sanitary landfill; 
[or] 
   
  (vi) chlorine disinfection/maceration followed by deposition in a sanitary 
landfill<nl>; or 
   
  <nl>(vii) an approved alternate treatment process followed by deposition in a 
sanitary landfill. 
     
  (B) <nl>Discarded cultures<ol> [Cultures] of specimens from medical, 
pathological, pharmaceutical, research, clinical, commercial, industrial and 
veterinary laboratories shall be subjected to one of the following methods of 
treatment and disposal: 
 
  (i)-(iv) (No change.) 
   
  (v) moist heat disinfection followed by deposition in a sanitary landfill; 
[or] 
   
  (vi) chlorine disinfection/maceration followed by deposition in a sanitary 
landfill<nl>; or<ol>[.] 
   
  <nl>(vii)<nl> an approved alternate treatment process followed by deposition 
in a sanitary landfill. 
     
  (C) Discarded live and attenuated vaccines<nl>, but excluding the empty 
containers thereof,<ol> shall be subjected to one of the following methods of 
treatment and disposal: 
 
  (i)-(iv) (No change.) 
   
  (v) moist heat disinfection followed by deposition in a sanitary landfill; 
[or] 
   
  (vi) chlorine disinfection/maceration followed by deposition in a sanitary 
landfill<nl>; or<ol>[.] 
   
  <nl>(vii)<nl> an approved alternate treatment process followed by deposition 
in a sanitary landfill. 
     
  (D) <nl>Discarded disposable<ol> [Disposable] culture dishes shall be 
subjected to one of the following methods of treatment and disposal<nl>. <ol>[:] 
 
  <nl>(i)<nl> All discarded, unused disposable culture dishes shall be disposed 
of in accordance with 30 TAC Chapter 330. 
   
  <nl>(ii)<nl> Discarded, used disposable culture dishes shall be subjected to 
the following methods of treatment and disposal: 
 
  <nl>(I)<ol>[(i)] steam sterilization followed by deposition in a sanitary 
landfill; 
   
  <nl>(II)<ol>[(ii)] incineration followed by deposition of the residue in a 
sanitary landfill; 
   
  <nl>(III)<ol>[(iii)] thermal inactivation followed by deposition in a sanitary 
landfill; 
   
  <nl>(IV)<ol>[(iv)] chemical disinfection followed by deposition in a sanitary 
landfill; 
   
  <nl>(V)<ol>[(v)] moist heat disinfection followed by deposition in a sanitary 
landfill; [or] 
   
  <nl>(VI)<ol>[(vi)] chlorine disinfection/maceration followed by deposition in 
a sanitary landfill<nl>; or<ol>[.] 
   
  <nl>(VII) an approved alternate treatment process followed by deposition in a 
sanitary landfill. 
       
  (E) <nl>Discarded disposable<ol> [Disposable] devices used to transfer, 
inoculate <nl>or <ol> [and] mix cultures shall be subjected to one of the 
following methods of treatment and disposal: 
 
  (i)-(iv) (No change.) 
   
  (v) moist heat disinfection followed by deposition in a sanitary landfill; 
[or] 
   
  (vi) chlorine disinfection/maceration followed by deposition in a sanitary 
landfill<nl>; or<ol>[.] 
   
  <nl>(vii)<nl> an approved alternate treatment process followed by deposition 
in a sanitary landfill. 
       
  (4) Pathological waste. Pathological waste shall be subjected to one of the 
following methods of treatment and disposal. 
 
  (A) Human materials removed during surgery, labor and delivery, autopsy<nl>, 
embalming<ol>, or biopsy shall be subjected to one of the following methods of 
treatment and disposal: 
 
  (i) body parts: 
 
  (I) (No change.) 
   
  (II) incineration followed by deposition of the residue in a sanitary 
landfill; [or] 
   
  (III) (No change.) 
   
  <nl>(IV) moist heat disinfection, provided that the grinding/shredding renders 
the item as unrecognizable, followed by deposition in a sanitary landfill; 
   
  <nl>(V) chlorine disinfection/maceration, provided that the grinding/shredding 
renders the item as unrecognizable, followed by deposition in a sanitary 
landfill; or 
   
  <nl>(VI) an approved alternate treatment process, provided that the process 
renders the item as unrecognizable, followed by deposition in a sanitary 
landfill; 
     
  (ii) tissues or fetuses: 
 
  (I)-(IV) (No change.) 
   
  (V) moist heat disinfection followed by deposition in a sanitary landfill; 
[or] 
   
  (VI) chlorine disinfection/maceration followed by deposition in a sanitary 
landfill; <nl>or 
   
  <nl>(VII) an approved alternate treatment process, provided that the process 
renders the item as unrecognizable, followed by deposition in a sanitary 
landfill; 
     
  (iii) organs: 
 
  (I)-(IV) (No change.) 
   
  (V) moist heat disinfection followed by deposition in a sanitary landfill; 
[or] 
   
  (VI) chlorine disinfection/maceration followed by deposition in a sanitary 
landfill; <nl>or 
   
  <nl>(VII) an approved alternate treatment process, provided that the process 
renders the item as unrecognizable, followed by deposition in a sanitary 
landfill; 
     
  (iv) bulk human blood and body fluids removed during surgery, labor and 
delivery, autopsy<nl>, embalming <ol>, or biopsy: 
 
  (I)-(VII) (No change.) 
   
  (VIII) moist heat disinfection followed by deposition in a sanitary landfill; 
[or] 
   
  (IX) chlorine disinfection/maceration followed by deposition in a sanitary 
landfill; <nl>or 
   
  <nl>(X) an approved alternate treatment process, provided that the process 
renders the item as unrecognizable, followed by deposition in a sanitary 
landfill. 
       
  (B) The products of spontaneous or induced human abortion shall be subjected 
to one of the following methods of treatment and disposal: 
 
  (i) body parts, tissues, or organs regardless of the period of gestation: 
 
  (I)-(II) (No change.) 
   
  (III) steam sterilization followed by interment; [or] 
   
  (IV) (No change.) 
   
  <nl>(V) moist heat disinfection followed by deposition in a sanitary landfill; 
   
  <nl>(VI) chlorine disinfection/maceration followed by deposition in a sanitary 
landfill; or 
   
  <nl>(VII) an approved alternate treatment process, provided that the process 
renders the item as unrecognizable, followed by deposition in a sanitary 
landfill; 
     
  (ii) blood and body fluids: 
 
  (I)-(VII) (No change.) 
   
  (VIII) moist heat disinfection followed by deposition in a sanitary landfill; 
[or] 
   
  (IX) chlorine disinfection/maceration followed by deposition in a sanitary 
landfill<nl>; or<ol>[.] 
   
  <nl>(X) an approved alternate treatment process, provided that the process 
renders the item as unrecognizable, followed by deposition in a sanitary 
landfill. 
       
  (C) <nl>Discarded laboratory<ol> [Laboratory] specimens of blood and/or 
tissues shall be subjected to one of the following methods of treatment and 
disposal: 
 
  (i) <nl>grinding and discharging<ol> [discharging with grinding if needed] 
into a sanitary sewer system; 
   
  (ii)-(iv) (No change.) 
   
  (v) moist heat disinfection followed by deposition in a sanitary landfill; 
[or] 
   
  (vi) chlorine disinfection/maceration followed by deposition in a sanitary 
landfill<nl>; or<ol>[.] 
   
  <nl>(vii) an approved alternate treatment process, provided that the process 
renders the item as unrecognizable, followed by deposition in a sanitary 
landfill. 
     
  (D) (No change.) 
     
  (5) Sharps. 
 
  <nl>(A) All discarded unused sharps shall be disposed of in accordance with 30 
TAC Chapter 330. 
   
  <nl>(B) Contaminated sharps<ol> [Sharps] shall be subjected to one of the 
following methods of treatment and disposal. 
 
  <nl>(i)<nl>[(A)] Hypodermic needles; and hypodermic syringes with attached 
needles,<ol> shall be subjected to one of the following methods of treatment and 
disposal: 
 
  <nl>(I)<ol>[(i)] chemical disinfection, and if the item can cause puncture 
wounds, placement in a puncture-resistant, leak-proof container <nl>followed by 
<ol> [and] deposition in a sanitary landfill; 
   
  <nl>(II)<ol>[(ii)] steam sterilization, and if the item can cause puncture 
wounds, placement in a puncture-resistant container <nl>followed by<ol> [and] 
deposition in a sanitary landfill; 
   
  <nl>(III)<ol>[(iii)] incineration, and if the item can cause puncture wounds, 
placement in a puncture-resistant container <nl>followed by<ol> [and] deposition 
in a sanitary landfill; 
   
  <nl>(IV)<ol>[(iv)] encapsulation in a matrix which will solidify and 
significantly reduce the possibility of puncture wounds <nl>followed by <ol> 
[and] deposition in a sanitary landfill; 
   
  <nl>(V)<ol>[(v)] moist heat disinfection followed by deposition in a sanitary 
landfill; [or] 
   
  <nl>(VI)<ol>[(vi)] chlorine disinfection/maceration followed by deposition in 
a sanitary landfill<nl>; or<ol>[.] 
   
  <nl>(VII) an approved alternate treatment process, provided that the process 
renders the item as unrecognizable and no longer capable of causing puncture 
wounds, followed by deposition in a sanitary landfill. 
       
  [(B) Hypodermic syringes with attached needles shall be subjected to one of 
the following methods of treatment and disposal:] 
 
  [(i) chemical disinfection, and if the item can cause puncture wounds, 
placement in a puncture-resistant, leak-proof container and deposition in a 
sanitary landfill; 
   
  [(ii) steam sterilization, and if the item can cause puncture wounds, 
placement in a puncture-resistant container, and deposition in a sanitary 
landfill; 
   
  [(iii) incineration, and if item can cause puncture wounds, placement in a 
puncture-resistant container, and deposition in a sanitary landfill; 
   
  [(iv) encapsulation in a matrix which will solidify and significantly reduce 
the possibility of puncture wounds and deposition in a sanitary landfill; 
   
  [(v) moist heat disinfection followed by deposition in a sanitary landfill; or 
   
  [(vi) chlorine disinfection/maceration followed by deposition in a sanitary 
landfill;] 
   
  <nl>(ii)<ol>[(C)] Razor blades <nl>,<ol> [and] disposable razors<nl>, and 
disposable scissors<ol> used in surgery, labor and delivery, or other medical 
procedures; and scalpel blades shall be subjected to one of the following 
methods of treatment and disposal: 
 
  <nl>(I)<ol>[(i)] chemical disinfection, and if the item can cause puncture 
wounds, placement in a puncture-resistant, leak-proof container <nl>followed by 
<ol> [and] deposition in a sanitary landfill; 
   
  <nl>(II)<ol>[(ii)] steam sterilization, and if the item can cause puncture 
wounds, placement in a puncture-resistant container <nl>followed by<ol> [and] 
deposition in a sanitary landfill; 
   
  <nl>(III)<ol>[(iii)] incineration, and if item can cause puncture wounds, 
placement in a puncture-resistant container <nl>followed by<ol> [and] deposition 
in a sanitary landfill; 
   
  <nl>(IV)<ol>[(iv)] encapsulation in a matrix which will solidify and 
significantly reduce the possibility of puncture wounds <nl>followed by <ol> 
[and] deposition in a sanitary landfill; 
   
  <nl>(V)<ol>[(v)] moist heat disinfection followed by deposition in a sanitary 
landfill; [or] 
   
  <nl>(VI)<ol>[(vi)] chlorine disinfection/maceration followed by deposition in 
a sanitary landfill<nl>; or<ol>[.] 
   
  <nl>(VII) an approved alternate treatment process, provided that the process 
renders the item as unrecognizable and no longer capable of causing puncture 
wounds, followed by deposition in a sanitary landfill. 
     
  <nl>(iii) Intravenous stylets and rigid introducers (e.g., J wires) shall be 
subjected to one of the following methods of treatment and disposal: 
 
  <nl>(I) chemical disinfection, and if the item can cause puncture wounds, 
placement in a puncture-resistant, leak-proof container followed by deposition 
in a sanitary landfill; 
   
  <nl>(II) steam sterilization, and if the item can cause puncture wounds, 
placement in a puncture-resistant, leak-proof container followed by deposition 
in a sanitary landfill; 
   
  <nl>(III) incineration, and if the item can cause puncture wounds, placement 
in a puncture-resistant, leak-proof container followed by deposition in a 
sanitary landfill; 
   
  <nl>(IV) encapsulation in a matrix which will solidify and significantly 
reduce the possibility of puncture wounds, followed by deposition in a sanitary 
landfill; 
   
  <nl>(V) moist heat disinfection followed by deposition in a sanitary landfill; 
[or] 
   
  <nl>(VI) chlorine disinfection/maceration followed by deposition in a sanitary 
landfill; or 
   
  <nl>(VII) an approved alternate treatment process, provided that the process 
renders the item as unrecognizable and no longer capable of causing puncture 
wounds, followed by deposition in a sanitary landfill. 
     
  <nl>(iv)<ol>[(D)] <nl>glass pasteur<ol> [Pasteur] pipettes <nl>, glass 
pipettes, specimen tubes, blood culture bottles, and microscope slides; and 
broken glass from laboratories <ol> shall be subjected to one of the following 
methods of treatment and disposal: 
 
  <nl>(I)<ol>[(i)] chemical disinfection, and if the item can cause puncture 
wounds, placement in a puncture-resistant, leak-proof container <nl>followed by 
<ol> [and] deposition in a sanitary landfill; 
   
  <nl>(II)<ol>[(ii)] steam sterilization, and if the item can cause puncture 
wounds, placement in a puncture-resistant container <nl>followed by<ol> [and] 
deposition in a sanitary landfill; 
   
  <nl>(III)<ol>[(iii)] incineration, and if the item can cause puncture wounds, 
placement in a puncture-resistant container <nl>followed by<ol> [and] deposition 
in a sanitary landfill; 
   
  <nl>(IV)<ol>[(iv)] encapsulation in a matrix which will solidify and 
significantly reduce the possibility of puncture wounds <nl>followed by <ol> 
[and] deposition in a sanitary landfill; 
   
  <nl>(V)<ol>[(v)] moist heat disinfection followed by deposition in a sanitary 
landfill; [or] 
   
  <nl>(VI)<ol>[(vi)] chlorine disinfection/maceration followed by deposition in 
a sanitary landfill<nl>; or<ol>[.] 
   
  <nl>(VII) an approved alternate treatment process, provided that the process 
renders the item as unrecognizable and no longer capable of causing puncture 
wounds, followed by deposition in a sanitary landfill. 
       
  [(E) Broken glass from laboratories shall be subjected to one of the following 
methods of treatment and disposal:] 
 
  [(i) chemical disinfection, and if the item can cause puncture wounds, 
placement in a puncture-resistant, leak-proof container and deposition in a 
sanitary landfill; 
   
  [(ii) steam sterilization, and if the item can cause puncture wounds, 
placement in a puncture-resistant container and deposition sanitary landfill; 
   
  [(iii) incineration, and if item can cause puncture wounds, placement in a 
puncture-resistant container and deposition in a sanitary landfill; 
   
  [(iv) encapsulation in a matrix which will solidify and significantly reduce 
the possibility of puncture wounds and deposition in a sanitary landfill; 
   
  [(v) moist heat disinfection followed by deposition in a sanitary landfill; or 
   
  [(vi) chlorine disinfection/maceration followed by deposition in a sanitary 
landfill;] 
   
  <nl>(v)<nl> Tattoo needles, acupuncture needles, and electrolysis needles 
shall be subjected to one of the following methods of treatment and disposal: 
 
  <nl>(I) chemical disinfection, and if the item can cause puncture wounds, 
placement in a puncture-resistant, leak-proof container followed by deposition 
in a sanitary landfill; 
   
  <nl>(II) steam sterilization, and if the item can cause puncture wounds, 
placement in a puncture-resistant, leak-proof container followed by deposition 
in a sanitary landfill; 
   
  <nl>(III) incineration, and if the item can cause puncture wounds, placement 
in a puncture-resistant, leak-proof container followed by deposition in a 
sanitary landfill; 
   
  <nl>(IV) encapsulation in a matrix which will solidify and significantly 
reduce the possibility of puncture wounds, followed by deposition in a sanitary 
landfill; 
   
  <nl>(V) moist heat disinfection followed by deposition in a sanitary landfill; 
   
  <nl>(VI) chlorine disinfection/maceration followed by deposition in a sanitary 
landfill; or 
   
  <nl>(VII) an approved alternate treatment process, provided that the process 
renders the item as unrecognizable and no longer capable of causing puncture 
wounds, followed by deposition in a sanitary landfill. 
           
  (b) Records. The facility treating the wastes shall maintain records to 
document the treatment of the special waste from health care-related facilities 
processed at the facility as to method and conditions of treatment <nl>in 
accordance with 30 TAC Chapter 330 <ol>. 
   
  (c) Facility responsibility. The facility treating the wastes shall be 
responsible for establishing the conditions necessary for <nl>operation of<ol> 
[treatment by] each method used at the facility to insure the [significant] 
reduction of microbial activity of any waste treated <nl>according to the 
manufacturer's specifications and according to any approval granted by the 
department<ol>. 
 
     
  sec.1.137. Enforcement. 
 
  [(a) Within one year of the effective date of these sections, the] <nl>The<ol> 
appropriate regulatory programs of the department shall incorporate the 
definition and methodology contained in these provisions into their respective 
general program rules and shall formulate and present for the board's 
consideration such additional rules as are necessary for the internal 
collection, storage, handling, movement, <nl>and <ol> treatment [and 
disposition] of special waste from health care-related facilities generated 
within or by the following facilities or activities: 
 
  (1)-(5) (No change.) 
   
  (6) <nl>hospitals<ol> [special residential care facilities]; 
   
  (7) <nl>special residential care facilities<ol> [hospitals]; and 
   
  (8) <nl>tattoo studios<ol> [long term care facilities]. 
     
  [(b) Within one year of the effective date of these sections, the Solid Waste 
Management Division of the department shall incorporate the definition and 
methodology contained in these provisions into the general rules for the 
management of municipal solid waste and the division shall formulate and present 
for the board's consideration such additional rules for collection, storage, 
handling, transportation, treatment and disposition of special waste from health 
care related facilities as are necessary.] 
 
  This agency hereby certifies that the proposal has been reviewed by legal 
counsel and found to be within the agency's authority to adopt. 
 Issued in Austin, Texas, on June 30, 1994. 
 TRD-9443288 
  John T. Richards 
 Assistant General Counsel, Office of General Counsel 
 Texas Department of Health 
    Proposed date of adoption: September 23, 1994 
 For further information, please call: (512) 834-6640 
         
               
  
  
  25 TAC sec.sec.1.133, 1.134, 1.135 
 
  (Editor's note: The text of the following sections proposed for repeal will 
not be published. The sections may be examined in the offices of the Texas Board 
of Health or in the Texas Register office, Room 245, James Earl Rudder Building, 
1019 Brazos Street, Austin.) 
   
  The repeals are proposed under the Health and Safety Code, sec.sec.81. 081-
81.092, which provide the Board of Health (board) the authority to prevent and 
control communicable disease; sec.142.012, which authorizes the board to adopt 
rules concerning home and community support services agencies; sec.241. 026, 
which authorizes the board to adopt rules concerning hospital licensing; 
sec.243.009, which authorizes the board to adopt rules concerning ambulatory 
surgical centers; sec.244.009, which authorizes the board to adopt rules 
covering birthing centers; sec.sec.245.009-245.010, which authorize the board to 
adopt rules covering abortion facilities; sec.694.001, which authorizes the 
board to regulate the disposition of dead bodies; sec.773.050, concerning the 
department's authority to regulate emergency medical service providers; sec.12. 
032, which authorizes the board to charge fees for public health services; and 
sec.12.001, which provides the board with the authority to adopt rules for the 
performance of every duty imposed by law on the board, the Texas Department of 
Health, and the Commissioner of Health. 
 
 
  sec.1.133. Effect. 
 
   
  sec.1.134. Exemptions. 
 
   
  sec.1.135. Application. 
 
  This agency hereby certifies that the proposal has been reviewed by legal 
counsel and found to be within the agency's authority to adopt. 
 Issued in Austin, Texas, on June 30, 1994. 
 TRD-9443289 
  John T. Richards 
 Assistant General Counsel, Office of General Counsel 
 Texas Department of Health 
    Proposed date of adoption: September 23, 1994 
 For further information, please call: (512) 834-6640 
         
         
  25 TAC sec.sec.1.133, 1.134, 1.135 
 
  The new sections are proposed under the Health and Safety Code, sec.sec.81. 
081-81.092, which provide the Board of Health (board) the authority to prevent 
and control communicable disease; sec.142.012, which authorizes the board to 
adopt rules concerning home and community support services agencies; sec.241. 
026, which authorizes the board to adopt rules concerning hospital licensing; 
sec.243.009, which authorizes the board to adopt rules concerning ambulatory 
surgical centers; sec.244.009, which authorizes the board to adopt rules 
covering birthing centers; sec.sec.245.009-245.010, which authorize the board to 
adopt rules covering abortion facilities; sec.694.001, which authorizes the 
board to regulate the disposition of dead bodies; sec.773.050, concerning the 
department's authority to regulate emergency medical service providers; sec.12. 
032, which authorizes the board to charge fees for public health services; and 
sec.12.001, which provides the board with the authority to adopt rules for the 
performance of every duty imposed by law on the board, the Texas Department of 
Health, and the Commissioner of Health. 
 
 
  sec.1.133. Scope, Covering Exemptions and Minimum Parametric Standards for 
Waste Treatment Technologies Previously Approved by the Texas Department of 
Health. 
 
  (a) Exemptions. 
 
  (1) Unless an item is specifically exempted, all special waste from health 
care-related facilities must be treated as provided in these sections. 
   
  (2) These sections do not apply to: 
 
  (A) teeth; 
   
  (B) human tissue, including fetal tissue, donated for research or teaching 
purposes, with the consent of the person authorized to consent as otherwise 
provided by law, to an institution of higher learning, medical school, a 
teaching hospital affiliated with a medical school, or to a research institution 
or individual investigator subject to the jurisdiction of an institutional 
review board required by 42 United States Codes, sec.289; 
   
  (C) placentas designated for sale and obtained from a licensed hospital or a 
licensed birthing center; 
   
  (D) in vitro<ol> tissue cultures that have not been intentionally exposed to 
pathogens; 
   
  (E) any material included in the definition of special waste from health care-
related facilities which has been sold, donated, or in any way transferred from 
one health care-related facility to a subsequent facility(s) and other entities 
specified in subparagraph (B) of this paragraph for research or teaching 
purposes until it is discarded; and 
   
  (F) disposition of fetal remains of a single pregnancy, body parts, or tissue 
(including bulk blood), transferred for disposition to a licensed funeral 
director in accordance with the Health and Safety Code, Chapter 711, and Chapter 
181 of this title (relating to Vital Statistics) with the consent of the person 
or persons authorized to consent to the disposition of the fetal remains, body 
parts, or tissue (including bulk blood). All subcategories of pathological 
waste, unless otherwise exempted, must be treated and disposed of in accordance 
with sec.1.136 of this title (relating to Approved Methods of Treatment and 
Disposition). 
       
  (b) Minimum parametric standards for waste treatment technologies previously 
approved by the Texas Department of Health. 
 
  (1) Chemical disinfection. 
 
  (A) Waste treatment via direct contact with chemical agents only shall utilize 
a registered chemical agent or an approved unregistered chemical agent as 
follows. 
 
  (i) Registered chemical agents. 
 
  (I) The chemical agent used shall be registered with the United States 
Environmental Protection Agency and the Texas Department of Agriculture. 
   
  (II) The chemical agent shall be used according to the manufacturer's 
instructions. 
     
  (ii) Unregistered chemical agents. 
 
  (I) Those unregistered chemical agents previously approved are: 
 
  (-a-) a freshly prepared solution of household chlorine bleach diluted 1:10 
(volume/volume) with water; or 
   
  (-b-) a solution of 70% by volume 2-propanol (isopropyl alcohol). 
     
  (II) The containerized waste items shall be totally immersed in either 
solution for a period of time not less than three minutes. 
       
  (B) If a chemical agent has been included by a manufacturer of a commercially-
available waste treatment technology as the principle step in the treatment 
process, then: 
 
  (i) the chemical agent (or its precursor(s)) or the microbial inactivating 
process must be registered with the United States Environmental Protection 
Agency for the purpose of waste treatment; or 
   
  (ii) the manufacturer must provide evidence that the technology utilizing said 
chemical agent (or its precursor(s)) or the microbial inactivating process has 
been approved for use in another state; or 
   
  (iii) the manufacturer must obtain approval for the process in accordance with 
sec.1.135 of this title (relating to Performance Standards for Commercially-
Available Alternate Treatment Technologies for Special Waste from Health care-
related Facilities). 
     
  (C) Waste immersed in a liquid chemical agent must be thoroughly drained 
before disposal. 
     
  (2) Chlorine disinfection/maceration. 
 
  (A) The waste must be shredded prior to treatment and made unrecognizable as 
to source. 
   
  (B) The chlorine solution must have a free available chlorine concentration of 
at least 1,100 parts per million (ppm) when applied to the waste. 
   
  (C) The chlorine solution must be drained from the waste prior to disposal. 
     
  (3) Moist heat disinfection. Moist heat disinfection shall utilize either of 
the following processes. 
 
  (A) When subjecting internally shredded waste to moist heat assisted by 
microwave radiation, the temperature of the waste must reach at least 95 degrees 
Celsius under atmospheric pressure for at least 30 minutes. 
   
  (B) When subjecting unshredded waste in sealed containers to moist heat 
assisted by low-frequency radiowaves, the temperature of the waste must reach at 
least 90 degrees Celsius under atmospheric pressure for at least two hours, 
followed by shredding of the waste to the extent that the identity of the waste 
is unrecognizable. 
     
  (4) Steam sterilization. Steam sterilization shall meet all of the following 
requirements. 
 
  (A) To allow for sufficient steam access to or penetration of the waste, the 
waste shall be: 
 
  (i) packaged according to the recommendations provided by the manufacturer; 
and 
   
  (ii) loaded into the chamber so as to not exceed the capacity limits as set by 
the manufacturer. 
     
  (B) When subjecting waste to steam under pressure, the temperature in the 
chamber of the autoclave must reach at least 121 degrees Celsius and there must 
be at least 15 pounds per square inch gauge pressure for at least 30 minutes. 
   
  (C) The autoclave must be operated according to the manufacturer's 
instructions. 
     
  (5) Thermal inactivation. Thermal inactivation shall meet all of the following 
requirements. 
 
  (A) To allow for sufficient dry heat access to or penetration of the waste, 
the waste shall be: 
 
  (i) packaged according to the recommendations provided by the manufacturer; 
and 
   
  (ii) loaded into the chamber so as to not exceed the capacity limits as set by 
the manufacturer. 
     
  (B) Waste shall be subjected to dry heat of at least 160 degrees Celsius under 
atmospheric pressure for at least two hours. 
   
  (C) Waste shall be subjected to dry heat according to the manufacturer's 
instructions. 
 
         
  sec.1.134. Application.  These sections apply to special waste from health 
care-related facilities generated by the operation of the following publicly or 
privately owned or operated health care-related facilities, including but not 
limited to: 
 
  (1) ambulatory surgical centers; 
   
  (2) abortion clinics; 
   
  (3) birthing centers; 
   
  (4) blood banks and blood drawing centers; 
   
  (5) clinics, including but not limited to medical, dental, veterinary; 
   
  (6) clinical, diagnostic, pathological or biomedical research laboratories; 
   
  (7) educational institution health centers; 
   
  (8) educational institution research laboratories; 
   
  (9) electrolysis facilities; 
   
  (10) emergency medical services; 
   
  (11) end stage renal dialysis facilities; 
   
  (12) funeral establishments; 
   
  (13) home health agencies; 
   
  (14) hospitals; 
   
  (15) long term care facilities; 
   
  (16) mental health and mental retardation facilities, including but not 
limited to hospitals, schools, and community centers; 
   
  (17) minor emergency centers; 
   
  (18) occupational health clinics and clinical laboratories; 
   
  (19) pharmacies; 
   
  (20) pharmaceutical manufacturing plants and research laboratories; 
   
  (21) professional offices, including but not limited to the offices of 
physicians, and dentists, and acupuncturists; 
   
  (22) special residential care facilities; 
   
  (23) tattoo studios; and 
   
  (24) veterinary clinical and research laboratories. 
 
     
  sec.1.135. Performance Standards for Commercially-Available Alternate 
Treatment Technologies for Special Waste from Health Care-Related Facilities. 
<ol>All manufacturers of commercially-available alternate technologies, 
equipment, or processes designed or intended for the treatment of special waste 
from health care-related facilities, except those meeting the standards of 
sec.1.133 (b) of this title (relating to Scope, Covering Exemptions and Minimum 
Parametric Standards for Waste Treatment Technologies Previously Approved by the 
Texas Department of Health), shall apply to the Texas Department of Health 
(department) on forms prescribed by the department for approval of said 
technologies, equipment, or processes to ensure that established performance 
standards are met. 
 
  (1) Levels of microbial inactivation. 
 
  (A) All laboratory evidence submitted to the department for review shall be 
provided by a laboratory that meets the standards of either the NSF 
International, the American Association for Laboratory Accreditation, or other 
accrediting agencies or organizations as approved by the department. 
   
  (B) All manufacturers of commercially-available alternate technologies, 
equipment, or processes designed and intended for the treatment of special waste 
from health care-related facilities shall provide specific laboratory evidence 
that demonstrates: 
 
  (i) inactivation of representative samples of vegetative bacteria, 
mycobacteria, lipophilic/hydrophilic viruses, fungi, and parasites at a level of 
6 log10 
 <ol>reduction or greater, as determined by the department; and 
   
  (ii) inactivation of  Bacillus stearothermophilus<ol> endospores or Bacillus 
subtilis<ol> endospores at a level of 4 log10 
 <ol>reduction or greater, as determined by the department. 
     
  (C) One or more representative surrogate microorganisms from each microbial 
group shall be used in treatment efficacy evaluation. The department shall 
determine the appropriate microorganisms to serve as representative surrogate 
microorganisms. 
   
  (D) The department shall prescribe those categories (types) and percent 
composition of special waste from health care-related facilities that present 
the most challenge to said treatment effectiveness under normal operating 
conditions of the equipment or process. 
   
  (E) Protocols developed for efficacy testing shall incorporate, as applicable, 
recognized, standard procedures. The protocols shall be congruent with the 
treatment method under review. The department shall determine the specific 
pieces of information to be provided by the manufacturer to assure a thorough 
evaluation of the alternate treatment technology. 
     
  (2) Documentation requirements. 
 
  (A) The manufacturer of the alternate treatment technology, equipment, or 
process shall provide to the department the following information: 
 
  (i) a detailed description of the treatment equipment, equipment 
specifications, operating instructions, and parameters of normal operation, and 
information detailing the intended use and typical site for which the equipment 
is designed; 
   
  (ii) complete documentation that the alternate treatment technology, 
equipment, or process meets microbial inactivation criteria for all required 
representative microorganisms for all department-specified challenge waste load 
compositions, including a description of the test methods used, and, upon 
request, the original data from test procedures conducted by the manufacturer; 
   
  (iii) documentation on available parametric controls, and, where technically 
feasible, evidence that demonstrates the efficacy relationship between 
biological indicator data and data derived from real-time parametric monitoring 
equipment; 
   
  (iv) details relating to waste residues including their potential 
hazards/toxicities and their specific mode of disposal or recycling; 
   
  (v) documentation providing occupational health assurance, and the means of 
providing required training in equipment operations; 
   
  (vi) evidence of United States Environmental Protection Agency registration 
and Texas Department of Agriculture registration for those treatment processes 
that employ a chemical agent to inactivate microorganisms, or evidence of 
approval of the treatment process by a state other than Texas; 
   
  (vii) documentation that user verification testing protocols are workable and 
valid; and 
   
  (viii) documentation of approval of the alternate treatment process or 
technology in other state(s) utilizing performance standard review, if 
applicable. 
     
  (B) Documentation must be submitted to the Texas Department of Health, Bureau 
of Environmental Health on those forms provided by the department. 
     
  (3) Alternate treatment technology approval conditions. 
 
  (A) Alternate treatment technology approval is granted only for the conditions 
specified in the manufacturer's instructions and equipment specifications, 
operating procedures and conditions, including but not limited to treatment 
times, temperatures, pressure, chemical concentrations, irradiation doses, feed 
rates, and waste load composition. Any significant revision to equipment and 
operating conditions will require re-application for approval to the department. 
   
  (B) Prior approval granted by a state other than Texas that utilizes a 
performance standards approach to review alternate treatment technologies shall 
be considered during the review process by the department. 
   
  (C) Facilities may keep whatever previously approved waste treatment 
technology they have on site. As this equipment is replaced, regardless of 
reason, with new or different technology with different parameters of 
operations, then the equipment or technology must be approved in accordance with 
the performance standards as outlined in this section. 
     
  (4) Fees. 
 
  (A) Initial application fee. 
 
  (i) The department shall charge an initial application fee for the evaluation 
of an alternate treatment technology pursuant to this section in the amount of 
$4,000. 
   
  (ii) The initial application fee must be paid in full before the department 
undertakes its evaluation of the manufacturer's alternate treatment technology. 
     
  (B) Annual listing fee. 
 
  (i) Each manufacturer shall be assessed an annual listing fee of $2,000 for 
each individual unit, process, or model listed. 
   
  (ii) Alternate treatment technologies must be listed at the time of purchase 
by a health care-related facility or any other person. 
   
  (iii) Failure by the manufacturer to maintain the listing after purchase does 
not preclude use of the alternate treatment technology, its transfer or re-sale, 
so long as compliance with sec.1.136(c) of this title (relating to Approved 
Methods of Treatment and Disposition) is achieved. 
   
  (iv) The department shall maintain a list of those approved alternate 
treatment technologies, including manufacturer, product name, model number, or 
other appropriate identifying information. The list shall be made available and 
distributed upon request by contacting the department. 
 
  This agency hereby certifies that the proposal has been reviewed by legal 
counsel and found to be within the agency's authority to adopt. 
 Issued in Austin, Texas, on June 30, 1994. 
 TRD-9443290 
  John T. Richards 
 Assistant General Counsel, Office of General Counsel 
 Texas Department of Health 
    Proposed date of adoption: September 23, 1994 
 For further information, please call: (512) 834-6640 
         
                   Chapter 37. Maternal and Child Health Services 
  
  Special Senses and Communication Disorders 
 
  25 TAC sec.37.48 
 
  (Editor's note: The text of the following section proposed for repeal will not 
be published. The section may be examined in the offices of the Texas Department 
of Health or in the Texas Register office, Room 245, James Earl Rudder Building, 
1019 Brazos Street, Austin.) 
   
  The Texas Department of Health (department) proposes the repeal of sec.37. 48, 
concerning operating procedures for the Children's Vision Screening Advisory 
Committee. The section covers the committee name and place of business, its 
purpose, membership and participation, meeting and voting, responsibilities of 
members, officers, public participation, and compensation. 
 In accordance with Texas Civil Statutes, Article 6252-33, the department must 
evaluate each of its advisory committees to determine whether the committee 
should be continued, modified, consolidated with other committees, or abolished. 
The Children's Vision Screening Advisory Committee was established in 1983. 
However, no formal committee meetings have been held in the last two years, and 
two of the six committee positions are currently vacant. Upon review, the 
department has determined that the committee no longer serves a useful purpose, 
that its functions can be more efficiently accomplished by department personnel 
and other professionals, and that it should be abolished. 
 Linda G. Prentice, M.D., Director of Clinical Operations, Division of Women's 
Health, Bureau of Women and Children, has determined that for the first five-
year period the repeal will be in effect, there will be no fiscal implications 
for state or local government. 
 Dr. Prentice also has determined that for each of the first five years the 
repeal is in effect, the public benefits anticipated are continuing compliance 
by the department with Texas Civil Statutes, Article 6252-33, concerning state 
agency advisory committees, and more efficient and economical operation of the 
department's Vision, Hearing, and Speech Services programs. There are no 
anticipated economic costs to small or large businesses or to persons who will 
be affected by the repeal, and no effect on local employment is anticipated. 
 Written comments on the proposed repeal may be submitted to Martha McGlothlin, 
Speech-Language Services, Bureau of Women and Children, Texas Department of 
Health, 1100 West 49th Street, Austin, Texas 78756. Telephone inquiries also may 
be made to Martha McGlothlin at (512) 458-7700. Comments will be accepted for 30 
days following the date of publication of this proposal in the Texas Register. 
 The repeal is proposed under Texas Civil Statutes, Article 6252-33, which sets 
standards for the evaluation of advisory committees by the agencies for which 
they function, and under the Health and Safety Code; sec.12.001, which provides 
the board with authority to adopt rules for the performance of every duty 
imposed by law upon the board, the department, and the commissioner of health. 
The repeal of sec.37.48 will affect Health and Safety Code, Chapter 36. 
 
 
  sec.37.48. Procedures of the Children's Vision Screening Advisory Committee. 
 
  This agency hereby certifies that the proposal has been reviewed by legal 
counsel and found to be within the agency's authority to adopt. 
 Issued in Austin, Texas, on June 30, 1994. 
 TRD-9443292 
  John T. Richards 
 Assistant General Counsel, Office of General Counsel 
 Texas Department of Health 
    Proposed date of adoption: September 23, 1994 
 For further information, please call: (512) 458-7700 
         
           
  Midwives 
 
  25 TAC sec.37.185 
 
  The Texas Department of Health (department) proposes new  s37.185, concerning 
standards of practice of midwifery by documented midwives in this state. 
 The new section is necessary to comply with the Texas Midwifery Act (Act), 
Texas Civil Statutes, Article 4512i, as amended by Chapter 337, Acts of the 73rd 
Legislature, Regular Session, 1993, which requires the Midwifery Board to adopt 
standards for the practice of midwifery by documented midwives in this state. 
 J. Scott Simpson, M.D., Division Director for Women's Health, Bureau of Women 
and Children, has determined that for the first five-year period the proposed 
amendment is in effect, there will be no fiscal implications for state or local 
government. 
 Dr. Simpson also has determined that for each of the first five-years the 
amendment is in effect, the public benefit anticipated is an improvement in the 
quality of midwifery practice and the continued efficient administration of the 
Act. The standards of practice will help midwives make the most appropriate 
decisions when questions or problems arise in their care of women and their 
infants. The standards of practice will also enhance the ability of the board, a 
midwife's peers, and the public to evaluate a midwife's care. No additional 
costs to small or large businesses to comply with the proposed new section are 
anticipated. There will be no cost to persons. There will be no effect on local 
employment. 
 Written comments on the proposal may be submitted to Cecilia P. Nobles, 
Midwifery Program Coordinator, Texas Department of Health, 1100 West 49th 
Street, Austin, Texas 78756-3199. Telephone inquiries may also be made to Ms. 
Nobles at (512) 458-7700. Comments will be accepted for 60 days following the 
date of publication in the Texas Register. An open forum will be held at 10:00 
a.m. on Monday, August 22, 1994, in Room T-607, Texas Department of Health, 1100 
West 49th Street, Austin to discuss the proposed standards. 
 This new section is proposed under Texas Civil Statutes, Article 4512i, 
sec.8A(a) and sec.9(a)(4), which requires the Midwifery Board to adopt standards 
for the practice of midwifery by documented midwives in this state; and the 
Health and Safety Code, sec.12.001(b), which provides the Texas Board of Health 
with authority to adopt rules for the performance of each duty imposed upon it 
by law. The proposed new section affects Texas Civil Statutes, Article 4512i. 
 
 
  sec.37.185. Standards for the Practice of Midwifery in Texas. <ol>Midwifery 
practice is based upon the acquisition of clinical skills necessary for the 
management and care of essentially normal pregnant women and newborns. These 
skills may be obtained through apprenticeship or within an institution. 
Management and care as defined by the Midwifery Board of the Texas Department of 
Health (department) includes antepartum, intrapartum, postpartum, and newborn 
services. The midwife is committed to maintaining a high standard of 
professional care, to participate in continuing education and to promote the 
concepts of high quality and safe practice among all Texas midwives. 
 
  (1) Standard I. Midwifery care shall be provided by qualified midwifes as 
defined by the Texas Midwifery Act, Texas Civil Statutes, Article 4512i. The 
midwife: 
 
  (A) shall be documented through the Texas Department of Health, Midwifery 
Program; 
   
  (B) must have attended an approved mandatory basic midwifery education course 
or has been exempted from this requirement prior to January 1, 1994; 
   
  (C) must show evidence of continuing competency through an ongoing process of 
continuing education; and 
   
  (D) must be in compliance with the legal requirements of Texas while 
practicing in the state. 
     
  (2) Standard II. Midwifery care shall support individual rights and self-
determination within the boundaries of safety. The midwife shall: 
 
  (A) provide clients with a description of the scope of midwifery practice, 
both in written and oral form, which includes but is not limited to her/his: 
 
  (i)  midwifery experience; 
   
  (ii) limitations of practice; 
   
  (iii) date of expiration of documentation; 
   
  (iv) date of expiration of CPR certification; 
   
  (v)  compliance with continuing education; 
   
  (vi)  compliance with this section; 
   
  (vii) compliance with the client's individual rights relative to this 
paragraph; 
   
  (viii) medical consultation arrangements; 
   
  (ix)  procedures regarding newborn blood screening; 
   
  (x)  practice for ophthalmia neonatorum prevention; and (xi) the prohibited 
acts as detailed by the Midwifery Act of 1993; and 
     
  (B)  provide information regarding the client's rights as follows. The client 
has the right: 
 
  (i) prior to the administration of any drug or natural remedy to herself or 
her infant, to be informed by the midwife caring for her of the reason for such 
administration, all potential direct or indirect effects, and all risks or 
hazards to herself or her unborn or newborn infant which may result from the use 
of the drug or remedy; 
   
  (ii) to be accompanied during the stress of labor and birth by someone she 
cares for, and to whom she looks for emotional comfort and encouragement; 
   
  (iii) to be informed of any known or suspected condition which may cause her 
or her baby difficulty or problems. She has the right to care by a physician or 
other licensed health care professional operating under physician supervision 
for conditions or problems which are outside the scope of practice of the 
midwife. The client has the right to timely referral in such situations; 
   
  (iv) to be informed of the name and qualifications of all individuals 
participating in her care; 
   
  (v) to have access to and receive copies upon request of her and her baby's 
midwifery records which must be complete, accurate and legible; and 
   
  (vi) of self-determination to decline care upon the midwife's recommendation. 
The client's decision to exercise this right must be made in writing. The 
midwife must retain a copy of this document to demonstrate compliance with this 
section. 
       
  (3)  Standard III. Midwifery care shall be based upon the knowledge, skill, 
intuition and judgment that foster the delivery of safe and competent care to 
mother and newborn, giving the newborn the opportunity for a good beginning. The 
midwife shall: 
 
  (A) provide care only to clients determined to be at low or normal risk of 
developing complications during pregnancy, childbirth, and the postpartum and 
neonatal periods; 
   
  (B) provide clients with information on other providers and services when 
requested or when care required is not within the scope of midwifery practice; 
   
  (C) practice in accordance with this section; 
   
  (D) not knowingly accept or thereafter maintain responsibility for the 
prenatal, intrapartum or postpartum care of a woman or neonatal care of an 
infant who has or develops a high risk condition or complication, except as 
detailed in clauses (i) and (viii) this subparagraph. 
 
  (i) If on the initial assessment or subsequent assessments, the midwife 
determines or suspects that the client has any of the conditions or symptoms 
listed in clauses (ii) and (iii) of this subparagraph, a consult by a licensed 
physician who has current obstetric knowledge or another licensed health care 
provider with current obstetric knowledge operating under such a physician's 
supervision must be obtained in a timely manner. "Consultation" refers to a 
particular client, not generalized advice affecting more than one woman. 
 
  (I) The consultant shall be requested to evaluate the client and then advise 
the midwife that she/he may continue to manage the client, may co-manage the 
client with specified medical supervision or must transfer the care of the 
client to an appropriate physician or licensed health care provider operating 
under a physician's supervision. 
   
  (II)  The midwife must and the consultant shall be requested to document the 
consultation in writing. 
   
  (III) If reasonable and documented attempts have been made to consult with a 
licensed physician or other licensed health care provider operating under 
physician supervision and the physician or other provider refuses to see the 
client, then the midwife may continue to manage the client after obtaining 
written informed consent that the client agrees to such care and is aware that 
she has or may have a high risk condition which should be evaluated by a 
physician. 
   
  (IV) If the client refuses to be referred, the care may be continued by a 
midwife only after the client has signed an informed consent refusing referral. 
     
  (ii) The midwife must recommend consultation if the client's history 
concerning prior pregnancies includes any of the following: 
 
  (I) preterm ( 146>36 weeks) labor during two or more previous pregnancies; 
   
  (II) preterm ( 146>36 weeks) rupture of membranes; 
   
  (III) prior delivery of an infant weighing  146>5 1/2 pounds or 2,500 grams; 
   
  (IV)  delivery of a large infant (weighing  524>10 pounds or 4,500 grams) that 
resulted in trauma to the infant; 
   
  (V) previous neonatal (first month of life) death; 
   
  (VI) severe postpartum hemorrhage (non-traumatic) requiring transfusion; 
   
  (VII)  three or more spontaneous abortions; 
   
  (VIII) suspicious for an incompetent cervix; 
   
  (IX)  mother or current conception's father having had a previous infant or 
fetus with a known or suspected genetic or familial disorder. Maternal, paternal 
or family history of a known or suspected genetic or familial disorder. (Refer 
to subsection 9 of this section for sample questions of prenatal genetic 
screening which is American College of Gynecologists (ACOG) Technical Bulletin 
108); 
   
  (X) mother or current conception's father having had a previous infant or 
fetus with a significant congenital anomaly; 
   
  (XI) pregnancy induced hypertension, pre-eclampsia, or eclampsia; 
   
  (XII) gestational diabetes (diet controlled); 
   
  (XIII) multiple gestation; 
   
  (XIV) intrauterine fetal demise; 
   
  (XV) shoulder dystocia that resulted in trauma to the infant; 
   
  (XVI) placenta previa at time of labor; 
   
  (XVII) placental abruptio; 
   
  (XVIII) Rh or other blood group isoimmunization; 
   
  (XIX) inverted uterus; 
   
  (XX) pelvic or genital tract anomaly; 
   
  (XXI) cardiac disease; 
   
  (XXII) rheumatic fever; 
   
  (XXIII) renal disease, pyelonephritis, recurrent urinary tract infection, 
urinary calculi, or urinary tract anomaly; 
   
  (XXIV) cancer; 
   
  (XXV) vascular disease; 
   
  (XXVI) any previous non A-Hepatitis; 
   
  (XXVII) hepatic insufficiency; 
   
  (XXVIII) thyroid disease; 
   
  (XXIX) syphilis; 
   
  (XXX) thrombophlebitis or thromboembolism; 
   
  (XXXI) HIV positivity; and 
   
  (XXXII) any other history which poses a risk to the mother or fetus. 
     
  (iii) The midwife must recommend a consultation if the client's history or 
examination concerning her current pregnancy includes any of the following: 
 
  (I) age 15 or under; 
   
  (II) exposure to a teratogen during current pregnancy or six weeks prior to 
conception; 
   
  (III) drug, tobacco and/or alcohol abuse; 
   
  (IV) significant psychological dysfunction; 
   
  (V) vaginal bleeding; 
   
  (VI) significant abdominal pain; 
   
  (VII) decreased fetal movement; 
   
  (VIII) possible rupture of membranes prior to 36 weeks; 
   
  (IX) urinary tract infection or signs or symptoms of urinary tract infection 
unresponsive to natural remedies or in association with temperature  524> 100.4 
degrees Fahrenheit ; 
   
  (X) elevated temperature ( 524>100.4 degrees Fahrenheit) for more than 48 
hours; 
   
  (XI) chest pain and/or difficulty breathing; 
   
  (XII) signs or symptoms of thrombophlebitis or thromboembolism; 
   
  (XIII) persistent, severe headaches; 
   
  (XIV) visual disturbances; 
   
  (XV) seizure disorder requiring treatment; 
   
  (XVI) asthma requiring treatment ; 
   
  (XVII) pulmonary disease; 
   
  (XVIII) gastrointestinal or colon disease requiring treatment; 
   
  (XIX) contracted pelvis; 
   
  (XX) hypertension, a diastolic blood pressure of at least 90 mm Hg or systolic 
pressure of at least 140 mm Hg or a rise in the former of at least 15 mm Hg or 
in the latter of 30 mm Hg. The blood pressures cited should be manifested on at 
least two occasions 6 hours or more apart; 
   
  (XXI) severe edema of hands, face or lower extremities; 
   
  (XXII) severe varicosities of vulva or lower extremities; 
   
  (XXIII) intrauterine fetal demise; 
   
  (XXIV) non-vertex presentation after 36 weeks; 
   
  (XXV) anemia (hemoglobin  146>10 g/dl or hematocrit  146>30%) not corrected by 
iron therapy; 
   
  (XXVI) active genital herpes; 
   
  (XXVII) gonorrhea, chlamydia, HIV, or pelvic inflammatory disease; 
   
  (XXVIII) syphilis; 
   
  (XXIX) HIV positivity; 
   
  (XXX) proteinuria,  524>+1 on two visits or  524>+2 on one visit; 
   
  (XXXI) ketonuria,  524>+1 on two visits; 
   
  (XXXII) hematuria,  524>+1 on two visits or  524>+2 on one visit; 
   
  (XXXIII) glycosuria,  524>+1 on two visits (if unable to perform blood glucose 
screening for this finding); 
   
  (XXXIV) abnormal pap smear; 
   
  (XXXV) abnormal fetal growth pattern: 
 
  (-a-) initial assessment size/date discrepancy  524>four weeks; 
   
  (-b-) growth in fundal height less than expected by two weeks or more over two 
visits; and 
   
  (-c-) growth of fundal height more than expected by two weeks or more over two 
visits; 
     
  (XXXVI) intrauterine growth retardation; 
   
  (XXXVII) post-term pregnancy,  524>42 and 0/7 weeks; 
   
  (XXXVIII) possible preterm ( 146>36 weeks) labor; 
   
  (XXXIX) significant maternal trauma; 
   
  (XL) hyperemesis gravidarum; 
   
  (XLI) polyhydramnios or ogliohydramnios; 
   
  (XLII) vaginitis other than simple, non-recurrent monilia; 
   
  (XLIII) hepatitis, chronic hepatic dysfunction, or positive Hepatitis B 
surface antigen; 
   
  (XLIV) thyroid disease; and 
   
  (XLV) any other medical or obstetric condition or symptom which could 
adversely affect the mother or fetus, as assessed by a midwife exercising 
ordinary skill and training. 
     
  (iv) If on any assessment the midwife determines that the client has one or 
more of the following conditions, her care must be immediately transferred to a 
licensed physician with current obstetric knowledge or another licensed health 
care provider with current obstetric knowledge operating under such a 
physician's supervision: 
 
  (I) history of incompetent cervix; 
   
  (II)  history of gestational diabetes in a prior pregnancy requiring insulin 
therapy; 
   
  (III) history of autoimmune disease; e.g. systemic lupus erythematosus; 
   
  (IV) diabetes mellitus or gestational diabetes during current pregnancy; 
   
  (V) history of prior C-section or uterine surgery; As an example, a vaginal 
birth after C-section (VBAC) may be conducted by an experienced midwife if all 
the following conditions are met: 
 
  (-a-) the client is made aware of her increased risk of uterine rupture (1-2% 
vs .05%), a potentially catastrophic condition, during such labor and the 
national obstetric standards which recommend that such labors be carried out in 
a hospital so that immediate treatment can be initiated in the event that 
rupture occurs. The client has given written informed consent for the procedure 
to include acknowledgment of this subclause; 
   
  (-b-) the labor is conducted in an appropriate setting no more than 15 minutes 
from a licensed hospital which provides obstetric services and has: 
 
 </vsh> (-1-) an obstetrician on site on a continuous 24-hour basis; 
 </vsb> </vsec> 
 </vsh> (-2-) an obstetric operating room personnel on site on a continuous 24-
hour basis; 
 </vsb> </vsec> 
 </vsh> (-3-) an anesthesiologist on site on a continuous 24- hour basis; 
 </vsb> </vsec>   
  (-4-) a pediatrician on site on a continuous 24-hour basis; 
 
 </vsh> (-5-) blood bank personnel on site on a continuous 24-hour basis; and 
 </vsb> </vsec> 
 </vsh> (-6-) the capacity to perform an emergency C- section on a continuous 
24-hour basis; 
 </vsb> </vsec>   
  (-c-) a car is available during the entire labor for immediate transport of 
the client to the hospital; 
   
  (-d-) the client has had only one prior low cervical transverse C-section, 
without extension, as verified by review of the operative note; 
   
  (-e-) the prior C-section did not involve a classical or low vertical 
incision; 
   
  (-f-) the pregnancy is otherwise not high risk; 
   
  (-g-) the pregnancy is singleton; 
   
  (-h-) the labor occurs between 36 and 42 weeks of gestation; 
   
  (-i-) the presentation during labor is vertex; 
   
  (-j-) he estimated fetal weight is  146>4,000 grams; and 
   
  (-k-) expanded fetal heart rate monitoring is employed i.e. auscultation every 
15 minutes during the first stage of labor and every 5 minutes during the second 
stage; 
     
  (VI) chronic hypertension; 
   
  (VII) hemoglobinopathy; 
   
  (VIII) preterm labor ( 146>36 weeks); 
   
  (IX)  preterm rupture of membranes ( 146>36 weeks); 
   
  (X)  multiple gestation; 
   
  (XI) Rh or other blood group isoimmunization; 
   
  (XII) seizure activity; 
   
  (XIII) pyelonephritis; 
   
  (XIV) AIDS or HIV positivity with immune compromise; and 
   
  (XV) cancer. 
     
  (v) If any of the following conditions or symptoms are noted during labor, 
delivery, or immediately postpartum (the first 24 hours), the midwife must 
transfer the client immediately to a physician: 
 
  (I) multiple gestation; 
   
  (II) preterm ( 146>36 weeks) labor; 
   
  (III) estimated fetal weight  146>5 1/2 pounds or 2500 grams; 
   
  (IV) non-vertex presentation; e.g. breech or transverse lie or face with 
position other than mentum anterior; 
   
  (V) vaginal bleeding more than bloody show (prior to delivery); 
   
  (VI) herpetic lesions; 
   
  (VII) active phase dilatation  146>1cm/3-4 hours; 
   
  (VIII) second stage  147>1-2 hours in a multiparous woman or  147>2-3 hours in 
a primiparous woman and delivery not imminent; 
   
  (IX) rupture of membranes for >>24 hours and not anticipated to deliver within 
four hours or delivery not imminent after an additional four hours; 
   
  (X)  premature rupture of membranes longer than 24 hours and not in the active 
phase of labor; 
   
  (XI) moderate to severe meconium staining of amniotic fluid unless birth is 
imminent; 
   
  (XII) foul smelling amniotic fluid; 
   
  (XIII) non-reassuring fetal heart rate-Persistent baseline rate  146>120 beats 
per minute or  147>160 beats per minute. Persistent decelerations ( 147> 10 
minutes without variability or  147>30 minutes with good variability) or 
recurring decelerations from baseline. A shorter observation interval prior to 
transfer may be indicated in the presence of large decreases in rate; 
   
  (XIV) umbilical cord or extremity prolapse; 
   
  (XV) hypertension, a diastolic blood pressure >>90 mm Hg or systolic pressure 
blood pressure >>140 mm Hg or a rise in the former of at least 15 mm Hg or in 
the latter of 30 mm Hg; 
   
  (XVI) persistent fall in blood pressure to  514>80/50; 
   
  (XVII) pulse persistently  147>120 or  146>50; 
   
  (XVIII) respiratory rate persistently  147>30 or  146>10; 
   
  (XIX) elevated temperature,  524>100.4 degrees Fahrenheit; 
   
  (XX) faintness, pallor, or other signs/symptoms consistent with shock; 
   
  (XXI) severe abdominal pain inconsistent with normal labor or involution; 
   
  (XXII) loss of consciousness; 
   
  (XXIII) persistent severe headache; 
   
  (XXIV) visual disturbance; 
   
  (XXV) seizure; 
   
  (XXVI) chest pain and/or difficulty breathing; 
   
  (XXVII) significant decrease in urine output; 
   
  (XXVIII) persistent vomiting or diarrhea; 
   
  (XXIX) client's desire for hospital birth; 
   
  (XXX) foul smell to the placenta or infant; 
   
  (XXXI) retained placenta or fragment, i.e. lack of spontaneous placental 
expulsion within 45 minutes or evidence of incomplete placenta on post expulsion 
exam; 
   
  (XXXII) uterine inversion; 
   
  (XXXIII) perineal laceration of three degrees or four degrees, or significant 
vulvar, vaginal, or cervical laceration; 
   
  (XXXIV) uterine atony; 
   
  (XXXV) inappropriate uterine involution; 
   
  (XXXVI) significant postpartum bleeding, i.e. >>1,000cc during the first 
twelve hours following delivery of the infant; 
   
  (XXXVII) inability to void within six hours of delivery; and 
   
  (XXXVIII) any other medical or obstetric condition which could adversely 
affect the mother or fetus, as assessed by a midwife exercising ordinary skill 
and training. 
     
  (vi) If any of the following conditions or symptoms are noted during the 
postpartum period, the midwife must refer the client in a timely manner to a 
licensed physician who has current obstetric knowledge or another licensed 
health care provider with current obstetric knowledge operating under such a 
physician's supervision: 
 
  (I) significant vaginal bleeding; 
   
  (II) persistent severe headache; 
   
  (III)  visual disturbance; 
   
  (IV) seizure; 
   
  (V) significant abdominal pain inconsistent with involution; 
   
  (VI) chest pain and/or difficulty breathing; 
   
  (VII) signs or symptoms of thrombophlebitis; 
   
  (VIII) absence of breast milk; 
   
  (IX) urinary problems, e.g. difficulty with initiation or emptying, pain, 
blood or frequency; 
   
  (X) blood pressure  524>140 mm Hg systolic or 90 mm Hg diastolic; 
   
  (XI) temperature  524>100.4 degrees Fahrenheit; 
   
  (XII) improper healing or infection of delivery site lacerations; 
   
  (XIII)  inappropriate uterine involution; 
   
  (XIV) foul smelling lochia; 
   
  (XV) significant edema of hands, legs or face; 
   
  (XVI) signs or symptoms of mastitis; 
   
  (XVII) hemoglobin  514>10 g/dl and/or hematocrit  514>30%; and 
   
  (XVIII) any other medical or obstetric condition which could adversely affect 
the mother, as assessed by a midwife exercising ordinary skill and training. 
     
  (vii) If any of the following conditions or symptoms are noted in the neonate 
at birth or during the immediate postpartum period (the first 24 hours), the 
infant must be immediately transferred to a physician: 
 
  (I) vital signs that indicate the following: 
 
  (-a-) APGAR score less than seven at five minutes and/or less than eight at 20 
minutes; 
   
  (-b-) pulse rate at rest persistently  146>120 beats per minute or >>160 beats 
per minute during the first hour of life and then  146>100 beats per minute or  
147>160 beats per minute; 
   
  (-c-) respiratory rate persistently  146>30 breaths per minute or >>60 breaths 
per minute and/or difficulty breathing, and/or grunting, and/or nasal flaring, 
and/or sternal retraction; 
   
  (-d-) persistent temperature  524>100.4 degrees Fahrenheit or  146>97.7 
degrees Fahrenheit rectally; and 
   
  (-e-) neonate requires full CPR resuscitation; 
     
  (II) physical exam within 1-2 hours that indicate the following: 
 
  (-a-)foul smelling infant; 
   
  (-b-) birth injury; 
   
  (-c-) head/length ratio discrepancy; (moved to consult) 
   
  (-d-) flaccidity and/or lethargy and/or irritability; 
   
  (-e-) asymmetrical movements of extremities; 
 
 </vsh> (-1-) spasticity; 
 </vsb> </vsec> 
 </vsh> (-2-) seizure and/or twitching and/or tremor; 
 </vsb> </vsec> 
 </vsh> (-3-) abnormal tone; and 
 </vsb> </vsec> 
 </vsh> (-4-) persistent jitterness; 
 </vsb> </vsec>   
  (-f-) shrill or abnormal cry; 
   
  (-g-) vomiting or choking; 
   
  (-h-) persistent poor suck or swallow; 
   
  (-i-) cyanotic; 
   
  (-j-) pale; 
   
  (-k-) persistent "beefy" red skin; 
   
  (-l-) mottling of skin; 
   
  (-m-) jaundice; 
   
  (-n-) presence of rash or vesicles; 
   
  (-o-) loss of consciousness; and 
   
  (-p-) delivered with any meconium staining on infant's skin or vernix; and 
     
  (III) any other condition or symptom which could adversely affect the infant, 
as assessed by a midwife exercising ordinary skill and training. 
     
  (viii) If any of the following conditions or symptoms are noted in the neonate 
within the first 24 to 36 hours after birth, then a consult by a licensed 
physician who has current pediatric knowledge or another licensed health care 
provider with current pediatric knowledge operating under such a physician's 
supervision must be obtained within 24 hours or the time specified: 
 
  (I) birth weight  146>5 1/2 pounds or >>10 pounds; 
   
  (II) congenital anomaly: 
 
  (-a-) cleft lip and/or palate; 
   
  (-b-) possible Down's Syndrome; 
   
  (-c-) umbilical abnormalities, e.g. umbilical cord with more or less than 
three vessels; 
   
  (-d-) abnormal abdominal wall; and 
   
  (-e-) spinal dimple; 
     
  (III) any non-vertex delivery; 
   
  (IV) absence of urination within 12-24 hours; 
   
  (V) absence of meconium passage within 24-36 hours; 
   
  (VI) absence of feeding within four hours; and 
   
  (VII) any other condition or symptom which could adversely affect the infant, 
as assessed by a midwife exercising ordinary skill and training. 
     
  (ix) If any of the following conditions or symptoms are noted in the infant 
during the first four-six weeks of life, she/he must be immediately referred to 
a licensed physician who has current pediatric knowledge or another licensed 
health care provider with current pediatric knowledge operating under such a 
physician's supervision: 
 
  (I) vital signs that indicate the following: 
 
  (-a-) pulse rate persistently  146>110 beats per minute or  147>160 beats per 
minute; 
   
  (-b-) respiratory rate persistently  146>30 breaths per minute or  147>60 
breaths per minute and/or difficulty breathing and/or grunting and/or nasal 
flaring and/or sternal retraction; and 
   
  (-c-) temperature  524>98.5 degrees Fahrenheit or  146>96.5 degrees Fahrenheit 
axillary; 
     
  (II) physical exam that indicate the following: 
 
  (-a-) flaccidity and/or lethargy and/or irritability general health; 
   
  (-b-)asymmetrical movements of extremities: 
 
 </vsh> (-1-) spasticity; 
 </vsb> </vsec> 
 </vsh> (-2-) seizure and/or twitching and/or tremor; 
 </vsb> </vsec> 
 </vsh> (-3-) abnormal tone; and 
 </vsb> </vsec> 
 </vsh> (-4-) jittery; 
 </vsb> </vsec>   
  (-c-) vomiting and/or choking; 
   
  (-d-) poor suck and/or poor swallow; 
   
  (-e-) cyanotic; 
   
  (-f-) pale; 
   
  (-g-) "beefy" red skin; 
   
  (-h-) mottling of skin; 
   
  (-i-) jaundice; 
   
  (-j-) ppresence of rash or vesicles; 
   
  (-k-) loss of consciousness; 
   
  (-l-) failure to appropriately wet eight to ten diapers per day; 
   
  (-m-) failure to pass a stool in a normal pattern; 
   
  (-n-) bloody stool and/or abdominal distention; 
   
  (-o-) poor feeding,  146>8 feedings daily; and 
   
  (-p-) failure to gain weight; 
     
  (III) abnormal lab: 
 
  (-a-) newborn screening; and 
   
  (-b-) positive syphilis serology; and 
     
  (IV)  any other condition or symptom which could adversely affect the infant, 
as assessed by a midwife exercising ordinary skill and training. 
         
  (4)  Standard IV. Midwifery care shall be is provided in accordance with 
established minimal standards which promote safe and competent care. 
 
  (A) The midwife shall collect and assess client care data through a detailed 
obstetric, gynecologic, medical, social, and family history; a complete prenatal 
physical exam and appropriate laboratory testing. The midwife shall then develop 
and implement a plan of care and thereafter evaluate the client's condition on 
an ongoing basis and modify the plan of care as necessary. 
 
  (i) Initial antepartum evaluation. The following components must be included 
in the initial antepartum evaluation. 
 
  (I) History. The initial history must include an inquiry regarding all of the 
following historical categories: 
 
  (-a-) client identification; 
   
  (-b-) age; 
   
  (-c-) race, ethnicity; 
   
  
   
  
   
  (-f-) medications; 
   
  (-g-) allergies; 
   
  (-h-) gynecologic; 
   
  (-i-) menstrual; 
   
  (-j-) contraceptive; 
   
  (-k-) sexual; 
   
  (-l-) HIV risk; 
   
  (-m-) obstetric; 
   
  (-n-) current pregnancy; 
   
  (-o-) perinatal risk; 
   
  (-p-) current problems; 
   
  (-q-) medical; 
   
  (-r-) surgical; 
   
  (-s-) anesthesia problems; 
   
  
   
  (-u-) transfusions; 
   
  
   
  (-w-) immunization status (Td, rubella, etc.); 
   
  (-x-) nutrition; and 
   
  (-y-) abuse/trauma. 
     
  (II) Physical exam. The initial physical exam must include at least the 
following: 
 
  (-a-) weight and height; 
   
  (-b-) blood pressure; 
   
  (-c-) pulse; 
   
  (-d-) breast exam, to include teaching on self exam; 
   
  (-e-) abdominal exam to include fundal height, estimated fetal weight and 
fetal heart tones; 
   
  (-f-) pelvic exam to include external genitalia, vagina, cervix, uterus, 
adnexa and pelvimetry (unless contraindicated); 
   
  (-g-) fetal lie, presentation if  524>36 weeks; 
   
  (-h-) estimation of gestational age by physical exam findings; and 
   
  (-i-) extremity exam. 
     
  (III) Laboratory. The client must be encouraged to have the following 
laboratory tests performed: 
 
  (-a-) hemoglobin and/or hematocrit or CBC; 
   
  (-b-) urine dipstick for protein, glucose, nitrites, leukocytes, and ketones, 
or complete urinalysis; 
   
  (-c-) syphilis serology; 
   
  (-d-) blood group, Rh type, and antibody screen; 
   
  (-e-) hepatitis B surface antigen; 
   
  (-f-) rubella screen; 
   
  (-g-) pap smear; 
   
  (-h-) gonorrhea test, if at risk; 
   
  (-i-) chlamydia test, if at risk; 
   
  (-j-) HIV test, if at risk; and 
   
  (-k-) hemoglobin electrophoresis if Black or of Italian, Greek, Mediterranean, 
Philippine or Oriental ancestry and not previously tested. 
     
  (IV) Assessment. At the conclusion of the initial evaluation the antepartum 
client's overall health and risk status must be assessed. The assessment must 
include a consideration of at least the following: 
 
  (-a-) gestational age; 
   
  (-b-) maternal status; 
   
  (-c-) fetal status; 
   
  (-d-) nutritional/Women, Infants, and Children (WIC) status; 
   
  (-e-) psychosocial status; and 
   
  (-f-) educational needs. 
     
  (V) Plan. A plan of care must be developed based upon the assessment of the 
antepartum client. The plan must include a management plan and a referral plan 
for diagnosis and treatment if necessary. 
   
  (VI) Education and counseling. Health education/counseling must be provided 
and must include consideration of at least the following (depending upon 
gestational age, certain of these items may be covered during subsequent visits 
as appropriate): 
 
  (-a-) midwife services/routine; 
   
  (-b-) reproductive physiology/anatomy; 
   
  (-c-) roles of various members of the health care team; 
   
  (-d-) caution concerning medications, recreational drugs, alcohol, tobacco, x-
ray and chemical exposure, and sexual transmitted disease (STD) exposure; 
   
  (-e-) HIV infection, "safer sex"; 
   
  (-f-) toxoplasmosis risk; 
   
  
   
  (-h-) nutritional needs of pregnancy, weight gain, referral to WIC; 
   
  (-i-) danger signs of pregnancy appropriate to gestational age; 
   
  (-j-) when to seek medical care and where to obtain care in the case of an 
emergency; 
   
  (-k-) delivery arrangements; 
   
  (-l-) signs and symptoms of preterm labor; 
   
  (-m-) labor; 
   
  (-n-) rupture of membranes; 
   
  (-o-) fetal movement; 
   
  (-p-) minor discomforts/symptoms of pregnancy; 
   
  (-q-) comfort measures; 
   
  (-r-) physical changes of pregnancy, fetal growth; 
   
  (-s-) sexual activity; 
   
  (-t-) self breast exam; 
   
  (-u-) physical activity/exercise/posture; 
   
  (-v-) preparation for labor and delivery, childbirth classes; 
   
  (-w-) preparation for parenthood and arrangement for infant health care; 
   
  (-x-) infant feeding choices, breastfeeding should be promoted; and 
   
  (-y-) family planning/ postpartum care. 
       
  (ii)  Subsequent antepartum evaluation. The following components must be 
included in each subsequent antepartum visit. 
 
  (I)  History. Each follow-up history must include an inquiry regarding at 
least the following historical categories: 
 
  (-a-) current problems; 
   
  (-b-)mprogress of pregnancy to include an evaluation of fetal movement after 
20 weeks; 
   
  (-c-) perinatal risks; and 
   
  (-d-) follow-up of problems identified in previous visits. 
     
  (II) Physical exam. Each follow-up exam must include at least the following: 
 
  (-a-) weight; 
   
  (-b-) blood pressure; 
   
  (-c-) abdominal exam to include fundal height, estimated fetal weight and 
fetal heart tones; 
   
  (-d-) fetal lie, presentation if  524>36 weeks; 
   
  (-e-) estimation of gestational age by physical exam findings; and 
   
  (-f-) extremity exam. 
     
  (III) Laboratory. Each follow-up exam must include at least the following: 
 
  (-a-) urine dipstick for protein, glucose, nitrites, leukocytes, and ketones; 
and 
   
  (-b-) laboratory tests performed at the times indicated: 
 
 </vsh> (-1-) hemoglobin and/or hematocrit at 28 and 36 weeks; 
 </vsb> </vsec> 
 </vsh> (-2-) blood glucose screening one hour post oral 50 gram glucose load at 
24 to 28 weeks; 
 </vsb> </vsec> 
 </vsh> (-3-) if Rh negative, and initial antibody screen negative, repeat 
antibody screen at 28 weeks as precursor to Rh immune globulin administration. 
If the screen is still negative, the midwife must strongly recommend that the 
client receive Rh immune globulin. If antibody screen is positive refer to 
physician; and 
 </vsb> </vsec> 
 </vsh> (-4-) Maternal Serum Alpha-Fetoprotein (MSAFP) or triple screen, ideally 
at 16-18 weeks, may be done from 15 to 20 weeks. 
 </vsb> </vsec>     
  (IV) Assessment. Each follow-up visit must conclude with an assessment which 
includes a consideration of at least the following: 
 
  (-a-) gestational age; 
   
  (-b-) maternal status; 
   
  (-c-) fetal status; 
   
  
   
  (-e-) psychosocial status; and 
   
  (-f-) educational needs. 
     
  (V) Plan. The current plan of care must be continued or modified based upon 
the assessment of the client. The plan must include a management plan and a 
referral plan for diagnosis and treatment if necessary. 
   
  (VI) Education and counseling. The following health education and counseling 
components must be discussed or reviewed at subsequent visits as appropriate to 
the client's gestational age and needs: 
 
  (-a-) danger signs of pregnancy appropriate to gestational age; 
   
  (-b-) signs and symptoms of preterm labor, 24-36 weeks. 
   
  (-c-) true/false labor, if  524>36 weeks; 
   
  (-d-) rupture of membranes; 
   
  (-e-) fetal movement; 
   
  (-f-) comfort measures; 
   
  (-g-) weight gain; 
   
  (-h-) physical activity/exercise/posture; 
   
  (-i-) physical changes of pregnancy/fetal growth; 
   
  (-j-) delivery arrangements; 
   
  (-k-) preparation for labor and delivery, childbirth classes; 
   
  (-l-) preparation for parenthood and arrangement for infant health care; 
   
  (-m-) infant feeding choices, breastfeeding should be promoted; and 
   
  (-n-) family planning/postpartum care. 
       
  (iii) Routine antepartum visits. Routine antepartum visits must be scheduled 
according to the following intervals: 
 
  (I)  every four weeks for the first 28 weeks; 
   
  (II) every two-three weeks from 28-36 weeks; 
   
  (III) every week after 36 weeks; and 
   
  (IV) additional antepartum visits should be scheduled if the client requires 
more frequent follow-up. 
     
  (iv) Recommended vitamins. The midwife should recommend to all clients that 
they take one, over-the-counter, prenatal, multi-vitamin supplement with folic 
acid/iron each day (unless allergic or contraindicated). 
     
  (B) The midwife shall appropriately evaluates the client when she presents for 
delivery, by obtaining a history, performing a physical exam, and performing a 
laboratory evaluation. The following components must be included in the 
evaluation of the client when she presents for delivery. 
 
  (i) History. The history must include an inquiry regarding all of the 
following: 
 
  (I) contractions-onset, frequency, duration; 
   
  (II) other abdominal or pelvic pain; 
   
  (III) status of membranes-if ruptured, when, amount, clear vs meconium 
stained; 
   
  (IV) vaginal bleeding; 
   
  (V) fetal movement; and 
   
  (VI) other problems or concerns. 
     
  (ii) Physical exam. The physical exam must include at least the following: 
 
  (I) blood pressure; 
   
  (II) pulse; 
   
  (III) temperature; 
   
  (IV) abdominal exam to include, estimated fetal weight, fetal lie, 
presentation, and fetal heart tones; 
   
  (V) extremity exam; and 
   
  (VI) pelvic exam (unless contraindicated) which must include the following: 
 
  (-a-) external genitalia; 
   
  (-b-) cervix for dilatation, effacement, station, presentation, and position; 
and 
   
  (-c-) a sterile speculum exam may be necessary prior to or in lieu of the 
cervical exam to evaluate for possible rupture of membranes. 
       
  (iii) Laboratory. The laboratory exam must be a urine dipstick for protein, 
glucose, nitrites, leukocytes, and ketones. 
     
  (C) The midwife shall appropriately monitor the client after presentation for 
delivery and throughout labor. 
 
  (i) The following components must be included in the evaluation. 
 
  (I) Vital signs. The following vital signs must be obtained: 
 
  (-a-) blood pressure-to be measured at least every two hours, or more 
frequently if indicated; 
   
  (-b-) pulse-to be taken at least every four hours; 
   
  at least every four hours; and 
   
  (-d-)  temperature-to be measured at least every four hours unless  524>99 
degrees Fahrenheit , then measured at least every one-two hours. 
     
  (II) Contractions. Contractions must be monitored as follows: 
 
  (-a-) frequency, duration, and intensity at least every two hours in the 
latent phase of the first stage; 
   
  (-b-) frequency, duration, and intensity at least every 30 minutes in the 
active phase of the first stage; and 
   
  (-c-) frequency, duration, and intensity at least every 15 minutes in the 
second stage; 
     
  (III) Fetal heart tones. Fetal heart tones must be auscultated as follows: 
 
  (-a-) for routine monitoring, first establish a baseline by listening for 
several minutes before, during, and after a contraction then listen during and 
for at least 30 seconds following a contraction according to the following 
schedule: 
 
 </vsh> (-1-) at least every two hours in the latent phase of the first stage; 
 </vsb> </vsec> 
 </vsh> (-2-) at least every 30 minutes in the active phase of the first stage; 
 </vsb> </vsec> 
 </vsh> (-3-) at least every 15 minutes in the second stage; and 
 </vsb> </vsec> 
 </vsh> (-4-)  for at least 30 seconds immediately after rupture of the 
membranes and during and for at least 30 seconds following the next contraction; 
and 
 </vsb> </vsec>   
  (-b-) As indicated for bleeding or other signs of a possible problem. 
     
  (IV) Cervical and vertex status. Vaginal examinations are performed to assess 
the progress of labor. Although necessary, they must be kept to a minimum to 
reduce the risk of infection. Attention must be directed toward aseptic 
technique. Cervical dilatation and effacement, and vertex station and position 
must be evaluated during each exam. 
   
  (V) Membrane status. Membrane status must be monitored for rupture, relative 
fluid volume, and the presence of meconium once ruptured. 
   
  (VI) Intake/output status. The intake/output of the client must be monitored 
as follows: 
 
  (-a-) intake-all oral or other intake must be monitored on an ongoing basis; 
and 
   
  (-b-) urinary output-the client must be encouraged to void at least every two 
to three hours. Frequency and relative volume of voiding must be monitored on an 
ongoing basis. 
     
  (VII) Subjective status. The client must be monitored for complaints and 
concerns. 
     
  (ii) The following must not occur: 
 
  (I)  application of pressure on the abdomen or uterus at any stage in labor; 
and 
   
  (II) administration by any method (buccal, vaginal, IM, IV, intranasal, etc.) 
of oxytocin (Pitocin, Syntocinon, Uteracon), ergot or prostaglandins prior to or 
during labor. Oxytocin or ergot may be administered after delivery of the 
placenta only under delegated authority of a licensed physician with current 
obstetric knowledge. 
       
  (D)  The midwife shall appropriately assist in normal, spontaneous vaginal 
deliveries. 
 
  (i) When delivery is imminent the patient must not be left unattended, nor 
should any attempt be made to delay the birth of the infant by physical 
restraint. 
   
  (ii) Forceps or vacuum extraction must not be utilized. 
     
  (E) The midwife shall appropriately monitor and advise the mother during the 
immediate postpartum period for at least two hours and until her condition is 
stable. The following components must be evaluated or covered during this time 
period. 
 
  (i) Vital signs. The following vital signs must be obtained: 
 
  (I) blood pressure-to be measured at least every 15 minutes during the first 
hour and then every hour if stable; 
   
  (II)  pulse-to be taken at least every 15 minutes during the first hour and 
then every hour if stable; 
   
  (III) respirations-to be taken at least every 15 minutes during the first hour 
and then every hour if stable; and 
   
  (IV) temperature-to be taken at least every hour. 
     
  (ii) Intake/output status. Intake and output must be monitored. 
   
  (iii) Physical exam. The client must be examined frequently to assure that: 
 
  (I) the uterine fundus is well contracted; and 
   
  (II) bleeding is not excessive. 
     
  (iv) Subjective status. The client must be monitored for complaints and 
concerns. 
   
  (v)  Laboratory. If unsensitized and Rh negative, the client must be referred 
to a licensed physician with current obstetric knowledge or another licensed 
health care provider with current obstetric knowledge operating under such a 
physician's supervision within 72 hours of delivery for administration of Rh 
immune globulin or the midwife must administer Rh immune globulin under standing 
delegation order from a licensed physician with current obstetric knowledge 
within 72 hours of delivery. 
   
  (vi) Education and counseling. Health education and counseling must be 
provided and must include consideration of at least the following (reinforcement 
must occur during subsequent postpartum visits): 
 
  (I) diet/nutrition; 
   
  (II) bowel/bladder function; 
   
  (III)  postpartum bleeding; 
   
  (IV) perineal care; 
   
  (V) breastfeeding; 
   
  (VI) warning signs; 
   
  (VII) pain relief; 
   
  (VIII) physical activity/exercise; 
   
  (IX) sexual activity; 
   
  (X) contraception; and 
   
  (XI) infant care-located in subparagraph (F)(iii) and (J)(vi) of this 
paragraph. 
       
  (F) The midwife shall appropriately evaluate and manage the newborn by 
monitoring the vital signs, performing a physical exam, and obtaining the 
laboratory tests necessary for the infant during the immediate postpartum period 
and provide pertinent education and counseling to the mother. 
 
  (i) Evaluation and monitoring. The following components must be included in 
the evaluation and monitoring of the infant. 
 
  (I) Vital signs. APGAR scores must be obtained at one minute and five minutes. 
If the five minute score is  146>7, obtain additional scores every five minutes 
until twenty minutes has passed or two successive scores are  524>7. The 
following vital signs must be taken at 30 minute intervals for at least two 
hours or until the infant's temperature has stabilized, whichever is longer: 
 
  (-a-) pulse; 
   
  (-b-) respirations (rate and effort); and 
   
  (-c-) temperature. 
     
  (II) Physical exam. The physical exam must include at least the following: 
 
  (-a-) skin; 
   
  (-b-) head and neck; 
   
  (-c-) eyes, ears, nose, and throat; 
   
  (-d-) fontanel; 
   
  (-e-) heart/lungs; 
   
  (-f-) abdomen; 
   
  (-g-) umbilical cord; 
   
  (-h-) external genitalia; 
   
  (-i-) back; 
   
  (-j-) extremities (check for hip dislocation); 
   
  (-k-) neurological exam; and 
   
  (-l-) weight, length, head circumference. 
     
  (III)  Laboratory. 
 
  (-a-) Cord blood must be taken and submitted to a state-approved lab for 
testing for syphilis. 
   
  (-b-) The blood specimen for the first newborn screening must be obtained at 
approximately 36 hours of age. It should be obtained after the baby has been 
breast feeding or on protein (milk) feeding for at least 24 hours. The second 
screen must be done between one and two weeks of age. 
     
  (IV) Monitoring. The newborn must be observed for a minimum of two hours if 
stable with no signs of distress. 
     
  (ii) Management of the infant. The following components must be included in 
the management of the infant. 
 
  (I) Prophylaxis. Eye treatment must be provided within two hours after birth 
using one of the CDC approved ophthalmic preparations, i.e. silver nitrate, 
erythromycin, or tetracycline. 
   
  (II) Feeding. Feeding can begin in the immediate newborn period if the infant 
is stable with no signs of distress. 
     
  (iii) Education and counseling. The following components must be included in 
education and counseling of the mother. 
 
  (I) Signs and symptoms. Significance of the following if observed in the 
newborn must be discussed: 
 
  (-a-) poor suck; 
   
  (-b-) abnormal cry; 
   
  (-c-) irritability, lethargy; and 
   
  (-d-) elimination; 
 
 </vsh> (-1-) abnormalities with urine; and 
 </vsb> </vsec> 
 </vsh> (-2-) abnormalities with stool. 
 </vsb> </vsec>     
  (II) Health care and immunization. Information regarding health care and 
immunization must be provided: 
 
  (-a-) Routine pediatric care by a licensed physician with current pediatric 
knowledge or another licensed health care provider with current pediatric 
knowledge operating under such a physician's supervision must be strongly 
recommended to begin at approximately 12 hours of age. Arrangements with an 
appropriate physician or other health care provider should be made during the 
antepartum period. 
   
  (-b-) Hepatitis B vaccine must be recommended at 12 hours of life. 
   
  (-c-) Other vaccinations must be recommended according to Centers for Disease 
Control/ American Academy of Pediatrics (CDC/AAP) guidelines. 
         
  (G) The midwife shall appropriately evaluate the mother at one-two days 
postpartum, including the following components. 
 
  (i) History. The history must include consideration of at least the following: 
 
  (I) current problems; 
   
  (II) abdominal/uterine/perineal pain; 
   
  (III)  bleeding; 
   
  (IV) intake/output; and 
   
  (V)  breastfeeding. 
     
  (ii) Physical exam. The physical must include at least the following: 
 
  (I) blood pressure; 
   
  (II) pulse; 
   
  (III) respirations; 
   
  (IV) temperature; 
   
  (V) breast exam; 
   
  (VI) abdominal/fundal exam; 
   
  (VII) perineal observation; and 
   
  (VIII) extremity exam. 
     
  (iii) Laboratory. Hemoglobin and/or hematocrit or CBC must be done. 
   
  (iv)  Assessment. The assessment must include at least the following: 
 
  (I) physical status; 
   
  (II) nutritional/WIC status; and 
   
  (III) psychosocial status. 
     
  (v)  Plan. A plan of care must be developed based upon the assessment of the 
client. The plan must include a management plan and a referral plan for 
diagnosis and treatment if necessary. The client must be counseled regarding 
family planning, contraception, and routine health care provided by a licensed 
physician or another licensed health care provider supervised by a licensed 
physician. The client's prenatal multi-vitamin supplement with folic acid/iron 
should be continued during the postpartum period unless contraindicated. 
     
  (H) The midwife shall appropriately evaluate the mother at two-three weeks 
postpartum, including the following components. 
 
  (i)  History. The history must include consideration of at least the 
following: 
 
  (I) drugs/alcohol/tobacco; 
   
  (II)  medications; 
   
  (III) current problems; 
   
  (IV) nutrition; 
   
  (V) bowel/bladder function; 
   
  (VI) abdominal/uterine/perineal pain; 
   
  (VII)  bleeding; and 
   
  (VIII) breastfeeding. 
     
  (ii) Physical exam. The physical must include at least the following: 
 
  (I) blood pressure; 
   
  (II) pulse; 
   
  (III) weight; 
   
  (IV) abdominal/fundal exam; 
   
  (V) perineal observation; and 
   
  (VI) extremity exam. 
     
  (iii) Assessment. The assessment must include at least the following: 
 
  (I) physical status; 
   
  (II)  nutritional/WIC status; and 
   
  (III) psychosocial status. 
     
  (iv) Plan. The current plan of care must be continued or modified based upon 
the assessment of the client. Family planning, contraception and the client's 
medical postpartum follow up must be discussed. 
 
  (I) The midwife shall appropriately follow the mother at four-six weeks 
postpartum, including the following components. 
     
  (i) History. The history must include consideration of at least the following 
categories: 
 
  (I) drugs/alcohol/tobacco; 
   
  (II) medications; 
   
  (III) allergies; 
   
  (IV) current problems; 
   
  (V)  abdominal/uterine/perineal pain; 
   
  (VI) nutrition; 
   
  (VII) bowel/bladder function; 
   
  (VIII) bleeding; 
   
  (IX) menstruation; 
   
  (X) gynecologic; 
   
  (XI) sexual activity; 
   
  (XII) contraception; and 
   
  (XIII) abuse/trauma. 
     
  (ii) Physical exam. The physical must include at least the following: 
 
  (I) blood pressure; 
   
  (II) pulse; 
   
  (III) weight; 
   
  (IV) abdominal exam; 
   
  (V) pelvic exam to include external genitalia, vagina, cervix, uterus, and 
adnexa; and 
   
  (VI) extremity exam. 
     
  (iii) Laboratory. Hemoglobin and/or hematocrit or CBC must be done. 
   
  (iv)  Assessment. The assessment must include at least the following: 
 
  (I) physical status; 
   
  (II) nutritional/WIC status; and 
   
  (III) psychosocial status. 
     
  (v)  Plan of care. A plan of care must be developed based upon the assessment 
of the client. The plan must include a management plan and a referral plan for 
diagnosis and treatment if necessary. Family planning, contraception, and 
routine health care follow up provided by a licensed physician or other licensed 
health care provider operating under the supervision of a licensed physician 
should be reiterated. 
     
  (J)  The midwife shall appropriately follow the infant in concert with the 
mother for the first 4-6 weeks postpartum. The following components must be 
included in each evaluation of the newborn. 
 
  (i)  History. The history must include consideration of at least the following 
categories: 
 
  (I) feeding; 
   
  (II) elimination: 
 
  (-a-) urine; and 
   
  (-b-) stool; 
     
  (III) concerns of mother; 
   
  (IV) problems; 
   
  (V) illnesses; 
   
  (VI) allergies; and 
   
  (VII)  evaluations by other health care providers. 
     
  (ii)  Vital signs. The following vital signs must be taken: 
 
  (I) pulse; 
   
  (II) respiratory rate; and 
   
  (III) temperature. 
     
  (iii) Physical exam. The physical exam must include at least the following: 
 
  (I)  weight, length, head circumference; 
   
  (II)  skin; 
   
  (III) head and neck; 
   
  (IV)  eyes, ears, nose and throat; 
   
  (V) fontanel; 
   
  (VI) heart/lungs; 
   
  (VII) breasts; 
   
  (VIII) abdomen; 
   
  (IX) cord, umbilicus appearance; 
   
  (X) external genitalia; 
   
  (XI) extremities; 
   
  (XII) neurological exam; and 
   
  (XIII) pulses. 
     
  (iv) Assessment. The infant's overall health and risk status must be assessed. 
The assessment must include at least the following: 
 
  (I) physical exam; and 
   
  (II) assessment of feeding and weight gain. 
     
  (v)  Plan of care. A plan of care must be developed based upon the assessment 
of the infant. The plan must include a management plan and a referral plan for 
diagnosis and treatment if necessary. 
   
  (vi)  Education and counseling. Health education and counseling must be 
provided to the mother and reviewed as appropriate to the infant's age and 
needs. It must include consideration of at least the following: 
 
  (I) diet, nutrition; 
   
  (II) elimination: 
 
  (-a-) urine; and 
   
  (-b-) stool; 
     
  (III) growth, weight gain; 
   
  (IV) bathing; 
   
  (V) clothing; 
   
  (VI)  injury/poison prevention; 
   
  (VII) danger signs, illness; 
   
  (VIII) medical care and follow up; and 
   
  (IX)  immunizations. 
         
  (5) Standard V. Midwifery care is provided in a safe environment. The midwife 
shall: 
 
  (A) assess the practice setting for reasonable freedom from environmental 
hazards; 
   
  (B) arrange, with the cooperation of the woman and family, the intended birth 
place; 
   
  (C) bring her/his own equipment and supplies; 
   
  (D) not make arrangements for a home delivery if there is no phone or adequate 
emergency transport; 
   
  (E)  demonstrate accessibility to an emergency transport system; 
   
  (F) promote involvement of family and support persons in the practice setting; 
   
  (G) promote adequate personal support in the setting where the midwife 
practices; 
   
  (H) not leave the client unattended during established labor; 
   
  (I) be available and respond promptly to her client's needs; 
   
  (J) follow accepted infection control procedures regarding equipment, 
examinations, and procedures; and 
   
  (K) practice and follow universal precautions established by Occupational 
Safety and Health Administration (OSHA) guidelines. 
     
  (6) STANDARD VI. Midwifery care shall utilize the community health care and 
social system to meet medical, phychosocial, economic and cultural or family 
needs. The midwife shall; 
 
  (A) collaborate and consult with and refer to the available medical and health 
care community; 
   
  (B) utilize ancillary health and social community services; and 
   
  (C) demonstrate knowledge of psychosocial, economic, cultural and family 
factors that may affect care, appropriate collaboration, and referral. 
     
  (7) STANDARD VII. Midwifery care shall be documented in complete, legible 
health records. The midwife shall: 
 
  (A) completely and accurately document the client's history, physical exam, 
laboratory test results, antepartum visits, consultation reports, referrals, 
labor, delivery, postpartum visits, and neonatal evaluations at the time 
midwifery services are delivered and when reports are received; 
   
  (B) utilize a record format that facilitates communication of information to 
consultants or other appropriate providers of care; 
   
  (C) facilitate clients' access to their own records; 
   
  (D) maintain the confidentiality of client records; and 
   
  (E) retain records for a minimum of five years. 
     
  (8) Standard VIII. Midwifery care shall include an ongoing process of 
evaluation and quality assurance. The midwife shall: 
 
  (A) collect client care data systematically and shall be involved in analysis 
of that data for evaluation of the process and outcome of care; 
   
  (B) seek consultation to review problems identified by the midwife or by other 
professionals or consumers in the community; and 
   
  (C)  act to resolve problems that are identified. 
     
  (9) Sample Prenatal Genetic Screen. The following questions on this sample 
prenatal genetic screening form should be answered to determine possible risks. 
 
  
   
  
  [graphic] 
         
  This agency hereby certifies that the proposal has been reviewed by legal 
counsel and found to be within the agency's authority to adopt. 
 Issued in Austin, Texas, on June 30, 1994. 
 TRD-9443294 
  Susan K. Steeg 
 General Counsel 
 Texas Department of Health 
    Proposed date of adoption: September 8, 1994 
 For further information, please call: (512) 458-7700 
         
         Chapter 38. Chronically Ill and Disabled Children's Services Program 
  
  25 TAC sec.38.17, sec.38.18 
 
  The Texas Department of Health (department) proposes an amendment to sec.38.17 
and new sec.38.18. The amended section covers the department's authority to use 
task forces to obtain ad hoc advice and counsel in the Chronically Ill and 
Disabled Children's Services (CIDC) Program. The new section establishes the 
Children with Special Health Care Needs Advisory Committee to advise the Bureau 
of Women and Children and the board. Specifically, the proposed new section 
covers applicable law, purpose, tasks, abolishment, terms of office, officers, 
meetings, attendance, staff, procedures, subcommittees, statements by members, 
reports to the board, reimbursement of members' expenses, and the rule's 
effective date. 
 In accordance with Texas Civil Statutes, Article 6252-33, the department must 
evaluate each of its advisory committees to determine whether the committee 
should be continued, modified, consolidated with other committees, or abolished. 
The department has reviewed the structure, composition, and purpose of the 
Health Service Systems Advisory Committee and the Community Advisory Committee 
which advise the CIDC Program. Those committees have been consolidated to better 
balance gender, minority representation, regional representation, and consumer 
and professional membership, and the committee's size has been reduced. The 
consolidation will also enable association and state agency representatives, 
providers, and CIDC parents to meet together. 
 Susan Penfield, M.D., Director, Division of Children's Health, Bureau of Women 
and Children, has determined that for the first five-year period the section 
will be in effect, there will be no fiscal implications for state or local 
government as a result of administering the amended and new sections as 
proposed. 
 Dr. Penfield also has determined that for each of the first five years the 
section is in effect, the public benefits anticipated are the department's 
continued compliance with Texas Civil Statutes, Article 6252-33, concerning 
state agency advisory committees, and the department's continued access to an 
effective forum in which providers and consumer can offer advice to the Bureau 
of Women and Children and to the board. There are no anticipated economic costs 
to small or large businesses or individuals who are required to comply with the 
section as proposed, and no effect on local employment is anticipated. 
 Written comments on the proposed addition may be submitted to Robbie Davis, 
Ph.D., System Development/Strategic Planning Manager, Planning, Research, 
Information System Management Division, Bureau of Women and Children, Texas 
Department of Health, 1100 West 49th Street, Austin, Texas 78756-3179. Telephone 
inquiries also may be made to Robbie Davis, Ph.D., at (512) 458-7700. Comments 
will be accepted for 30 days following the date of publication of this proposal 
in the Texas Register . 
 The amendment and new section are proposed under Texas Civil Statutes, Article 
6252-33, which set standards for the evaluation of advisory committees by the 
agencies for which they function, and under Health and Safety Code, sec.12.001, 
which provides the board with authority to adopt rules for the performance of 
every duty imposed by law upon the board, the department, and the commissioner 
of health. The new section will affect Health and Safety Code, Chapter 35. 
 
 
  sec.38.17. Development and Improvement of Standards and Services.  To ensure 
that cost effective, quality, appropriate medical and related services are 
available and delivered to Chronically Ill and Disabled Children's Services 
(CIDC) Program clients, the CIDC Program may establish a system of program 
evaluation that provides management information about the CIDC Program's 
operation and effectiveness; establishes guidelines and standards for CIDC 
Program health care services upon Texas Board of Health (board) approval; 
monitors compliance with these established standards and guidelines; and 
identifies and analyzes patterns and trends in provider billing and services 
delivered. 
 
  (1)-(2) (No change.) 
   
  (3) <nl>Task Forces. The CIDC Program may establish task forces to advise the 
CIDC Program.<ol> [Advisory Committees. The board may establish advisory 
committees to advise the CIDC Program in areas of policy alternatives, medical 
criteria for CIDC Program coverage and standards for health care services. The 
composition of advisory committees includes representation by physicians, 
dentists, facilities, other providers, parents, and advocates.] 
   
  (4) (No change.) 
 
     
  sec.38.18. Children with Special Health Care Needs Advisory Committee. 
 
  (a) The committee. The Children with Special Health Care Needs Advisory 
Committee (committee) shall be appointed under and governed by this section. 
   
  (b) Applicable law. The committee is subject to Texas Civil Statutes, Article 
6252-33, relating to state agency advisory committees. 
   
  (c) Purpose. The purpose of the committee is to provide advice to the Texas 
Board of Health (board) in the area of developing comprehensive systems of 
health care for children with special health care needs and their families. 
   
  (d) Tasks. 
 
  (1) The committee shall advise the board concerning rules relating to the 
Chronically Ill and Disabled Children's Services (CIDC) Program and any other 
programs administered by the department that provide services to children with 
special health care needs. 
   
  (2) The committee shall promote the development of systems of care for all 
children with special health care needs consistent with the Social Security Act, 
Title V, by participating in long range planning activities including: 
 
  (A) discussion of contemporary health care issues affecting children with 
special health care needs, their families, and service providers; and 
   
  (B) as needed: 
 
  (i) development of recommendations for proposed legislation, appropriations, 
rules, policies, needs-assessment and grant project activities, as needed; 
   
  (ii) review of alternatives for and assistance in the development of program 
policies including service criteria for program coverage, as needed; 
   
  (iii) review of and comment on proposed service and quality assurance 
standards and guidelines for services and providers, as needed; 
   
  (iv) review of and comment on program quality assurance and utilization review 
reports, as needed; and 
   
  (v) review of and comment on program fiscal status reports and cost 
containment methodologies and advising the program about funding alternatives, 
as needed. 
       
  (3) The committee shall carry out any other tasks given to the committee by 
the board. 
     
  (e) Committee abolished. The committee shall be automatically abolished on 
January 1, 1999. 
   
  (f) Composition. The committee shall be composed of 18 members. 
 
  (1) The composition of the committee shall include nine consumer 
representatives and nine nonconsumer representatives. 
 
  (A) Consumer members include parents of children with special health care 
needs receiving CIDC, Medicaid or other publicly-funded services for children 
with special health care needs, adults with disabilities who have received 
services as children with special health care needs, and representatives of 
consumer advocacy organizations that represent children with special health care 
needs. 
   
  (B) Nonconsumer members include service providers for children with special 
health care needs who are enrolled as CIDC or Medicaid providers, 
representatives of professional associations whose members provide services to 
children with special health care needs and their families, representatives from 
institutions of higher education with expertise in public health and children 
with special health care needs, and other service providers who deliver services 
to children with special health care needs. 
     
  (2) The members of the committee shall be appointed by the board. 
     
  (g) Terms of office. The term of office of each member shall be 6 years. 
 
  (1) Members shall be appointed for staggered terms so that the terms of six 
members will expire on December 31st of each even-numbered year beginning in 
1996. 
   
  (2) If a vacancy occurs, a person shall be appointed to serve the unexpired 
portion of that term. 
     
  (h) Officers. The committee shall elect a presiding officer and an assistant 
presiding officer at its first meeting after August 31st of each year. 
 
  (1) Each officer shall serve until the next regular election of officers. 
   
  (2) The presiding officer shall preside at all committee meetings at which he 
or she is in attendance, call meetings in accordance with this section, appoint 
subcommittees of the committee as necessary, and cause proper reports to be made 
to the board. The presiding officer may serve as an ex-officio member of any 
subcommittee of the committee. 
   
  (3) The assistant presiding officer shall perform the duties of the presiding 
officer in case of the absence or disability of the presiding officer. In case 
the office of presiding officer becomes vacant, the assistant presiding officer 
will serve until a successor is elected to complete the unexpired portion of the 
term of the office of presiding officer. 
   
  (4) A vacancy which occurs in the offices of presiding officer or assistant 
presiding officer may be filled at the next committee meeting. 
   
  (5) A member shall serve no more than two consecutive terms as presiding 
officer and/or assistant presiding officer. 
   
  (6) The committee may reference its officers by other terms, such as 
chairperson and vice-chairperson. 
     
  (i) Meetings. The committee shall meet only as necessary to conduct committee 
business. 
 
  (1) A meeting may be called by agreement of department staff and either the 
presiding officer or at least three members of the committee. 
   
  (2) Meeting arrangements shall be made by department staff. Department staff 
shall contact committee members to determine availability for a meeting date and 
place. 
   
  (3) Each meeting of the committee shall be announced and conducted in 
accordance with the Open Meetings Act, Texas Government Code, Chapter 551. 
   
  (4) Each member of the committee shall be informed of a committee meeting at 
least five working days before the meeting. 
   
  (5) A simple majority of the members of the committee shall constitute a 
quorum for the purpose of transacting official business. 
   
  (6) The committee is authorized to transact official business only when in a 
legally constituted meeting with a quorum present. 
   
  (7) The agenda for each committee meeting shall include an opportunity for any 
person to address the committee on matters relating to committee business. The 
presiding officer may establish procedures for such public comment, including a 
time limit on each comment. 
     
  (j) Attendance. Members shall attend committee meetings as scheduled. Members 
shall attend meetings of subcommittees to which the members are assigned. 
 
  (1) A member shall notify the presiding officer or appropriate department 
staff if he or she is unable to attend a scheduled meeting. 
   
  (2) It is grounds for removal from the committee if a member cannot discharge 
the member's duties for a substantial part of the term for which the member is 
appointed because of illness or disability, absense from more than half of the 
committee and subcommittee meetings during a calendar year; or absense from at 
least three consecutive committee meetings. 
   
  (3) The validity of an action of the committee is not affected by the fact 
that it is taken when a ground for removal of a member exists. 
   
  (4) The attendance records of the members shall be reported to the board. The 
report shall include attendance at committee and subcommittee meetings. 
     
  (k) Staff. Staff support for the committee shall be provided by the 
department. 
   
  (l) Procedures. Roberts Rules of Order, Newly Revised, shall be the basis of 
parliamentary decisions except where otherwise provided by law or rule. 
 
  (1) Any action taken by the committee must be approved by a majority vote of 
the members present once a quorum is established. 
   
  (2) Each member shall have one vote. 
   
  (3) A member may not authorize another individual to represent the member by 
proxy. 
   
  (4) The committee shall make decisions in the discharge of its duties without 
discrimination based on any person's race, creed, sex, religion, national 
origin, age, physical condition, or economic status. 
   
  (5) Minutes of each committee meeting shall be taken by department staff. 
 
  (A) A draft of the minutes approved by the presiding officer shall be provided 
to the board and each member of the committee within 30 days of each meeting. 
   
  (B) After approval by the committee, the minutes shall be signed by the 
presiding officer. 
       
  (m) Subcommittees. The committee may establish subcommittees as necessary to 
assist the committee in carrying out its duties. 
 
  (1) The presiding officer shall appoint members of the committee to serve on 
subcommittees and to act as subcommittee chairpersons. The presiding officer may 
also appoint nonmembers of the committee to serve on subcommittees. 
   
  (2) Subcommittees shall meet when called by the subcommittee chairperson or 
when so directed by the committee. 
   
  (3) A subcommittee chairperson shall make regular reports to the advisory 
committee at each committee meeting or in interim written reports as needed. The 
reports shall include an executive summary or minutes of each subcommittee 
meeting. 
     
  (n) Statement by members. The board, the department, and the committee shall 
not be bound in any way by any statement or action on the part of any committee 
member except when a statement or action is in pursuit of specific instructions 
from the board, department, or committee. 
   
  (o) Reports to board. The committee shall file an annual written report with 
the board. 
 
  (1) The report shall list the meeting dates of the committee and any 
subcommittees, the attendance records of its members, a brief description of 
actions taken by the committee, a description of how the committee has 
accomplished the tasks given to the committee by the board, the status of any 
rules which were recommended by the committee to the board, anticipated 
activities of the committee for the next year, and any amendments to this 
section requested by the committee. 
   
  (2) The report shall identify the costs related to the committee's existence, 
including the cost of agency staff time spent in support of the committee's 
activities. 
   
  (3) The report shall cover the meetings and activities in the immediate 
proceeding 12 months and shall be filed with the board each January. It shall be 
signed by the presiding officer and appropriate department staff. 
     
  (p) Reimbursement for expenses. In accordance with the requirements set forth 
in Texas Civil Statutes, Article 6252-33, a committee member may receive 
reimbursement for the member's expenses incurred for each day the member engages 
in official committee business. 
 
  (1) No compensatory per diem shall be paid to committee members unless 
required by law. 
   
  (2) A committee member who is an employee of a state agency, other than the 
department, may not receive reimbursement for expenses from the department. 
   
  (3) A nonmember of the committee who is appointed to serve on a subcommittee 
may not receive reimbursement for expenses from the department. 
   
  (4) Each member who is to be reimbursed for expenses shall submit to staff the 
member's receipts for expenses and any required official forms no later than 14 
days after each committee meeting. 
   
  (5) Requests for reimbursement of expenses shall be made on official state 
travel vouchers prepared by department staff. 
     
  (q) Effective date. This section shall become effective on January 1, 1995. 
 
  This agency hereby certifies that the proposal has been reviewed by legal 
counsel and found to be within the agency's authority to adopt. 
 Issued in Austin, Texas on June 30, 1994. 
 TRD-9443293 
  John T. Richards 
 Assistant General Counsel, Office of General Counsel 
 Texas Department of Health 
    Proposed date of adoption: September 23, 1994 
 For further information, please call: (512) 458-7700 
         
             Chapter 229. Food and Drugs 
  
  Licensure of Wholesale Device Distributors 
 
  25 TAC sec.sec.229.291-229.303 
 
  The Texas Department of Health (department) proposes new  ssec.229.291-229. 
303 concerning the licensure of wholesale device distributors. Senate Bill 564, 
73rd Legislature, 1993, amended the Texas Health and Safety Code, Chapter 431, 
to require that the department establish a licensing system and minimum 
standards for wholesale device distributors. 
 These sections provide for the minimum licensure standards necessary to ensure 
the safety and efficacy of devices distributed by wholesale device distributors. 
 These new sections will enable the department to collect licensure fees to 
recover the costs of establishing an official establishment inventory, 
implementing surveillance activities, monitoring violative facilities, and 
removing adulterated and misbranded devices from commerce. 
 Dennis E. Baker, Deputy Chief, Bureau of Food and Drug Safety, Texas Department 
of Health, has determined that for the first five-year period the sections are 
in effect there will be fiscal implications as a result of enforcing or 
administering the sections as proposed. The effect on state government for the 
first five years will be an estimated increase in revenue of $250,115 based on 
the fee rates established in the sections. The additional cost of administering 
the program is expected to equal the revenue generated. There will be no effect 
on local government. 
 Mr. Baker also has determined that for each of the first five years the 
sections are in effect the public benefit anticipated as a result of enforcing 
the sections will be the protection of public health by establishing minimum 
standards for wholesale device distributors. The anticipated costs to small 
businesses and individuals who are required to comply with the proposed sections 
will be the cost of the required license fee. There will be no effect on local 
employment. 
 Comments on the proposed sections may be submitted to Dennis E. Baker, Acting 
Director, Division of Food and Drugs, Texas Department of Health, 1100 West 49th 
Street, Austin, Texas, 78756 (512) 719-0200. Comments will be accepted for 30 
days following the date of publication of the proposed sections in the  Texas 
Register. In addition, a public hearing on the proposed rule will be held in the 
Texas Department of Health Auditorium, 1100 West 49th Street, Austin, Texas on 
July 20, 1994, beginning at 9:00 a.m. 
 The sections are proposed under the Texas Health and Safety Code, sec.431. 241, 
which provides TDH with the authority to adopt necessary regulations pursuant to 
the enforcement of this Chapter; and 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.229.291. Purpose.  These sections provide for the minimum licensure 
standards necessary to ensure the safety and efficacy of devices distributed by 
wholesale device distributors. 
 
   
  sec.229.292. Applicable Laws and Regulations. 
 
  (a) The Texas Department of Health (department) adopts by reference the 
following laws and regulations: 
 
  (1) Federal Food, Drug, and Cosmetic Act, 21 United States Code, et seq 
(1994); 
   
  (2) 21 Code of Federal Regulations (CFR), Part 801, Labeling (1994); 
   
  (3) 21 CFR, Part 803, Medical Device Reporting (1994); 
   
  (4) 21 CFR, Part 804, Medical Device Distributor Reporting (1994); 
   
  (5) 21 CFR, Part 807, Establishment Registration and Device Listing for 
Manufacturers and Distributors of Devices (1994); 
   
  (6) 21 CFR, Part 820, Good Manufacturing Practice for Medical Devices: General 
(1994); 
   
  (7) 21 CFR, Part 814, Premarket Approval of Medical Devices (1994); and 
   
  (8) 21 CFR, Subchapter J-Radiological Health (1994). 
     
  (b) The effective date for all referenced federal regulations refers to the 
regulations on the date specified and does not include any additions or 
deletions subsequent to the date specified. 
   
  (c) Copies of these laws and regulations are indexed and filed in the office 
of the Division of Food and Drugs, Texas Department of Health, 1100 West 49th 
Street, Austin, Texas 78756, and are available for inspection during normal 
working hours. 
   
  (d) Nothing in these sections shall relieve any person of the responsibility 
for compliance with other applicable Texas and federal laws and regulations. 
 
     
  sec.229.293. Definitions.  The following words and terms, when used in these 
sections, shall have the following meanings, unless the context clearly 
indicates otherwise. 
   
   Act-The Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 
431. 
   
   Adulteration-Has the meaning given in the Texas Food, Drug, and Cosmetic Act, 
Health and Safety Code, Chapter 431, as interpreted in the rules of the Texas 
Board of Health (board) and judicial decision. 
   
   Advertising-All representations disseminated in any manner or by any means, 
other than by labeling, for the purpose of inducing, or that are likely to 
induce, directly or indirectly, the purchase of food, drugs, devices, or 
cosmetics. 
   
   Authorized agent -An employee of the department who is designated by the 
commissioner to enforce the provisions of this chapter. 
   
   Board-The Texas Board of Health. 
   
   Commissioner-The Commissioner of Health. 
   
   Department-The Texas Department of Health. 
   
   Device-An instrument, apparatus, implement, machine, contrivance, implant, in 
vitro reagent, or other similar or related article, including any component, 
part, or accessory, that is: 
 
  (A) recognized in the official United States Pharmacopoeia National Formulary 
or any supplement to it; 
   
  (B) intended for use in the diagnosis of disease or other conditions, or in 
the cure, mitigation, treatment, or prevention of disease in man or other 
animals; or 
   
  (C) intended to affect the structure or any function of the body of man or 
other animals and that does not achieve any of its principal intended purposes 
through chemical action within or on the body of man or other animals and is not 
dependent on metabolization for the achievement of any of its principal intended 
purposes. 
     
   Electronic product radiation-Any ionizing or nonionizing electromagnetic or 
particulate radiation, or any sonic, infrasonic, or ultrasonic wave, which is 
emitted from an electronic product as the result of the operation of an 
electronic circuit in such product. 
   
   Finished device -A device, or any accessory to a device, which is suitable 
for use, whether or not packaged or labeled for commercial distribution. 
   
   Health authority -A physician designated to administer state and local laws 
relating to public health. 
   
   Importer-Any person who initially distributes a device imported into the 
United States. 
   
   Ionizing radiation -Any electromagnetic or particulate radiation capable of 
producing ions, directly or indirectly, in its passage through matter. Ionizing 
radiation includes gamma rays and x-rays, alpha and beta particles, high speed 
electrons, neutrons, and other nuclear particles. 
   
   Labeling-All labels and other written, printed, or graphic matter: 
 
  (A) upon any article or any of its containers or wrappers; or 
   
  (B) accompanying such article. 
     
   Manufacturing-The making by chemical, physical, biological, or other 
procedures of any article that meets the definition of device. The term includes 
the following activities: 
 
  (A) repackaging or otherwise changing the container, wrapper, or labeling of 
any device package in furtherance of the distribution of the device from the 
original place of manufacture to the person who makes final delivery or sale to 
the ultimate consumer; 
   
  (B) initial distribution of imported devices; or 
   
  (C) initiation of specifications for devices that are manufactured by a second 
party for subsequent commercial distribution by the person initiating 
specifications. 
     
   Misbranding-Has the meaning given in the Texas Food, Drug, and Cosmetic Act, 
Health and Safety Code, Chapter 431, as interpreted in the rules of the board 
and judicial decision. 
   
   Person-Includes individual, partnership, corporation, and association. 
   
   Place of business -Each location at which a device for wholesale distribution 
is located. 
   
   Radiation machine -Any device capable of producing ionizing radiation except 
those devices with radioactive material as the only source of radiation. 
   
   Radioactive material -Any material (solid, liquid, or gas) that emits 
radiation spontaneously. 
   
   Reconditioning-Has the meaning given in the Texas Food, Drug, Device, and 
Cosmetic Salvage Act, Health and Safety Code, Chapter 432, as interpreted in the 
rules of the board in  s229.192 of this title (relating to Regulation of Food, 
Drug, Device and Cosmetic Salvage Establishments and Brokers) and judicial 
decision. 
   
   Restricted device -Has the meaning given in the Federal Food, Drug, and 
Cosmetic Act, as amended, sec.520(e)(1). 
   
   Wholesale distribution -Distribution to a person other than a consumer or 
patient, including, but not limited to, distribution to any person by a 
manufacturer, repacker, own label distributor, jobber, importer, or wholesaler. 
The term does not include: 
 
  (A) the manufacture of raw materials or components to be used in the 
manufacture or assembly of a device who would otherwise not be required to 
license under the provisions of these sections; 
   
  (B) the manufacture of general purpose articles such as chemical reagents or 
laboratory equipment whose uses are generally known by persons trained in their 
use and which are not labeled or promoted for medical uses; 
   
  (C) the manufacture or otherwise altering of devices by licensed 
practitioners, including physicians, dentists, and optometrists solely for use 
in their practice; 
   
  (D) the manufacture, preparation, propagation, compounding, or processing of 
devices used solely in research, teaching, or analysis and which are not 
introduced into commercial distribution; 
   
  (E) the purchase or acquisition by a hospital or other health care entity that 
is a member of a group purchasing organization of a device for its own use from 
the group purchasing organization or from other hospitals or health care 
entities that are members of such organizations; 
   
  (F) the sale, purchase, or trade of a device or an offer to sell, purchase, or 
trade a device among hospitals or other health care entities that are under 
common control. For the purpose of this subsection, "common control" means the 
power to direct or cause the direction of the management and policies of a 
person or an organization, whether by ownership of stock, voting rights, 
contract, or otherwise; 
   
  (G) the sale, purchase, or trade of a device or an offer to sell, purchase, or 
trade a device for emergency medical reasons. For purposes of this definition, 
"emergency medical reasons"includes transfers of prescription devices by a 
retail pharmacy to another retail pharmacy to alleviate a temporary shortage; 
   
  (H) the sale, purchase, or trade of a device, an offer to sell, purchase, or 
trade a device, or the dispensing of a device pursuant to a prescription; or 
   
  (I) the distribution of device samples by manufacturers' representatives or 
distributors' representatives. 
 
     
  sec.229.294. Exemptions. 
 
  (a) A person is exempt from licensing under these sections if the person 
engages only in the following types of wholesale device distribution: 
 
  (1) intracompany sales; or 
   
  (2) the sale, purchase, or trade of a distressed or reconditioned device by a 
salvage broker or a salvage operator licensed under sec.229.203 of this title 
(relating to Regulation of Food, Drug, Device, and Cosmetic Salvage 
Establishments and Brokers). 
     
  (b) An exemption from the licensing requirements under these sections does not 
constitute an exemption from other applicable provisions of the Texas Food, 
Drug, and Cosmetic Act (Act) or the rules adopted by the Texas Board of Health 
to administer and enforce the Act. 
 
     
  sec.229.295. Licensure Requirements. 
 
  (a) General. Except as provided by sec.229.294 of this title (relating to 
Exemptions), a person may not engage in the wholesale distribution of devices in 
Texas unless the person has a valid license from the Commissioner of Health 
(commissioner) for each place of business. 
   
  (b) Display of license. The license shall be displayed in an open public area 
at each place of business. 
   
  (c) Existing place of business. Each person involved in the wholesale 
distribution of devices in Texas on the effective date of these sections must 
apply for a wholesale device distributor license no later than 60 days following 
the effective date of these sections. 
   
  (d) New place of business. Each person acquiring or establishing a place of 
business for the purpose of wholesale device distribution after the effective 
date of these sections shall apply to the Texas Department of Health 
(department) for a license of such business prior to beginning operation. 
   
  (e) Two or more places of business. If the wholesale device distributor 
operates more than one place of business, the wholesale device distributor shall 
license each place of business separately. 
   
  (f) Issuance of license. The department may license a wholesale distributor of 
devices who meets the requirements of this section and sec.229. 301 of this 
title (relating to Minimum Standards for Licensure). 
   
  (g) Transfer of license. Licenses shall not be transferable from one person to 
another or from one place of business to another. 
   
  (h) License expiration. Unless the department revokes or suspends a license as 
provided in sec.229.300 of this title (relating to Refusal, Cancellation, 
Suspension, or Revocation of a License), the initial license shall be valid for 
one year from the date of issuance which becomes the anniversary date. 
   
  (i) Renewal of license. 
 
  (1) Each year prior to the anniversary date, the wholesale distributor of 
devices shall renew its license following the requirements of this section and 
sec.229.296 of this title (relating to Licensing Procedures). 
   
  (2) The renewal license shall be valid for one year from the anniversary date. 
   
  (3) The license renewal application and fee for each place of business shall 
be submitted to the department 30 days prior to the expiration date of the 
current license in accordance with department procedures in sec.229.296 of this 
title. A person who files a renewal application after the expiration date must 
pay an additional $100 as a delinquency fee. 
   
  (4)  Failure to submit the renewal application prior to the current licensure 
expiration date may subject the wholesale device distributor to the enforcement 
provisions under the Act and also to the provisions of sec.229.300 of this 
title. 
     
  (j) Amendment of license. A license that is amended, including a change of 
name, ownership, or a notification of a change in the location of a licensed 
place of business will require submission of fees as outlined in sec.229.299 of 
this title. 
   
  (k) Notification of change of location of place of business. Not fewer than 30 
days in advance of the change, the licensee shall notify the commissioner or the 
commissioner's designee in writing of the licensee's intent to change the 
location of a licensed place of business. The notice shall include the address 
of the new location, and the name and residence address of the individual in 
charge of the business at the new location. Not more than ten days after the 
completion of the change of location, the licensee shall notify the commissioner 
or the commissioner's designee in writing to verify the change of location, the 
specific date of change, the new location, the address of the new location, and 
the name and residence address of the individual in charge of the business at 
the new address. Notice will be deemed adequate if the licensee provides the 
intent and verification notices to the commissioner or the commissioner's 
designee by certified mail, return receipt requested, mailed to the Texas 
Department of Health, 1100 West 49th Street, Austin, Texas. 
 
     
  sec.229.296. Licensing Procedures. 
 
  (a) License application forms. License application forms may be obtained from 
the Texas Department of Health, Division of Food and Drugs, 1100 West 49th 
Street, Austin, Texas, 78756. 
   
  (b) License application. The wholesale device distributor license application 
shall be signed and verified, shall be made on a license application form 
furnished by the Texas Department of Health (department), and shall contain the 
following information: 
 
  (1) the legal name under which the business is conducted; 
   
  (2) the address of each place of business that is licensed; 
   
  (3) if a proprietorship, the name and residence address of the proprietor; if 
a partnership, the names and residence addresses of all partners; if a 
corporation, the date and place of incorporation and name and address of its 
registered agent in the state and a copy of the Articles of Incorporation; or if 
any other type of association, then the names of the principals of such 
association; 
   
  (4) the name, residence address, and valid driver license number for each 
individual in an actual administrative capacity which, in the case of 
proprietorship, shall be the managing proprietor; partnership, the managing 
partner; corporation, the officers and directors; or those in a managerial 
capacity in any other type of association; 
   
  (5) for each place of business, the residence address of the individual in 
charge thereof; 
   
  (6) a list of categories which must be marked and adhered to in the 
determination and payment of the fee; and 
   
  (7) a statement verified by the applicant's signature that acknowledges the 
applicant has read, understood, and agrees to abide by the provisions of these 
sections and those of the Texas Food, Drug, and Cosmetic Act, Health and Safety 
Code, Chapter 431. 
 
       
  sec.229.297. Report of Changes. The license holder shall notify the Texas 
Department of Health (department) in writing within 10 days of any change which 
would render the information contained in the application for the license, 
reported pursuant to sec.229.296 of this title (relating to Licensing 
Procedures), no longer accurate. Failure to inform the department no later than 
ten days of a change in the information required in the application for a 
license may result in a suspension or revocation of the license. 
 
   
  sec.229.298. Licensure Requirements for Wholesale Device Distributors Located 
in Other Jurisdictions. 
 
  (a) A person who engages in the wholesale distribution of devices outside 
Texas may engage in wholesale distribution of devices in Texas if the person 
holds a license issued by the Commissioner of Health (commissioner). 
   
  (b) The commissioner may accept reports from state and federal authorities in 
other jurisdictions to determine the extent of compliance with the minimum 
requirements specified in these sections and the Texas Food, Drug, and Cosmetic 
Act, Health and Safety Code, Chapter 431 (Act). On examination of those reports 
and the person's compliance history and current compliance record, the 
commissioner may issue a license to the person if the commissioner determines 
that the person is in compliance with these sections and the Act. 
   
  (c) The commissioner shall consider on an individual basis each license 
application filed by a person who wishes to engage in the wholesale distribution 
of devices in Texas. 
 
     
  sec.229.299. Licensure Fees. 
 
  (a) License fee. All wholesale device distributors who distribute devices in 
Texas shall obtain a license annually and must apply for a license no later than 
60 days following the effective date of these sections with the Texas Department 
of Health (department) and shall pay a licensure fee for each place of business 
operated as follows: 
 
  (1) $100 per wholesale distributor having gross annual sales of $0-$19,999.99; 
   
  (2) $400 per wholesale distributor having gross annual sales of $20, 000-
$199,999.99; 
   
  (3) $900 per wholesale distributor having gross annual sales of $200, 000-
$19,999,999.99; and 
   
  (4) $1500 per wholesale distributor having gross annual sales greater than or 
equal to $20,000,000. 
     
  (b) Exemption from licensure fees. A person is exempt from the licensure fees 
required by this section if the person is: 
 
  (1) licensed under sec.289.121 of this title (relating to Licensing of 
Radioactive Materials) or registered under  s289.122 of this title (relating to 
Registration of Radiation Machines and Services) and engages only in the 
following types of wholesale device distribution: 
 
  (A) the manufacture or distribution of radiation machines which are devices; 
or 
   
  (B) the manufacture or distribution of devices which contain radioactive 
materials; or 
     
  (2) a charitable organization, as described in the Internal Revenue Code of 
1986, sec.501(c)(3), or a nonprofit affiliate of the organization, to the extent 
otherwise permitted by law. 
 
       
  sec.229.300. Refusal, Cancellation, Suspension, or Revocation of License. 
 
  (a) The Commissioner of Health (commissioner) may refuse an application or may 
suspend or revoke a license if the applicant or licensee: 
 
  (1) has been convicted of a felony or misdemeanor that involves moral 
turpitude; 
   
  (2) is an association, partnership, or corporation and the managing officer 
has been convicted of a felony or misdemeanor that involves moral turpitude; 
   
  (3) has been convicted in a state or federal court of the illegal use, sale, 
or transportation of intoxicating liquors, narcotic drugs, barbiturates, 
amphetamines, desoxyephedrine, their compounds or derivatives, or any other 
dangerous or habit-forming drugs; 
   
  (4) is an association, partnership, or corporation and the managing officer 
has been convicted in state or federal court of the illegal use, sale, or 
transportation of intoxicating liquors, narcotic drugs, barbiturates, 
amphetamines, desoxyephedrine, their compounds or derivatives, or any other 
dangerous or habit-forming drugs; 
   
  (5) has violated any of the provisions of the Texas Food, Drug, and Cosmetic 
Act, Health and Safety Code, Chapter 431 (Act) or these sections; 
   
  (6) has failed to pay a license fee or an annual renewal fee for a license; or 
   
  (7) has obtained or attempted to obtain a license by fraud or deception. 
     
  (b) The commissioner may refuse an application for a license or may suspend or 
revoke a license if the commissioner determines from evidence presented during a 
hearing that the applicant or licensee: 
 
  (1) has violated the Health and Safety Code, sec.431.021(l)(3), relating to 
the counterfeiting of a drug or the sale or holding for sale of a counterfeit 
drug; 
   
  (2) has violated the Health and Safety Code, Chapter 481 (Texas Controlled 
Substance Act), or the Health and Safety Code, Chapter 483 (Dangerous Drugs 
Act); or 
   
  (3) has violated the rules of the director of the Department of Public Safety, 
including being responsible for a significant discrepancy in the records that 
state law requires the applicant or licensee to maintain. 
     
  (c) The Texas Department of Health (department) may, after providing 
opportunity for hearing, refuse to license a wholesale distributor of devices, 
or may suspend or revoke a license for violations of the requirements in these 
sections or for any of the reasons described in the Act. 
   
  (d) Any hearings for the refusal, revocation or suspension of a license are 
governed by the department's formal hearing procedures in Chapter 1 of this 
title (relating to the Board of Health) and the Administrative Procedure and 
Texas Register Act, Texas Civil Statutes, Chapter 2001. 
   
  (e) A license issued under these sections shall be returned to the department 
if the wholesale device distributor's place of business: 
 
  (1) ceases business or otherwise ceases operation on a permanent basis; 
   
  (2) relocates; or 
   
  (3) changes ownership. For a corporation, an ownership change is deemed to 
have occurred, resulting in the necessity to return the license to the 
department, when 5.0% or more of the share of stock of a corporation is 
transferred from one person to another. 
 
       
  sec.229.301. Minimum Standards for Licensure. 
 
  (a) Minimum requirements. All wholesale distributors of devices engaged in 
manufacturing, packing, storage, or installation of devices must comply with the 
minimum standards of this section in addition to the statutory requirements 
contained in the Texas Food, Drug, and Cosmetic Act, Health and Safety Code, 
Chapter 431 (Act). For the purpose of this section, the policies described in 
the United States Food and Drug Administration's (FDA's) Compliance Policy 
Guides as they apply to devices shall be the policies of the Texas Department of 
Health (department). 
   
  (b) Federal establishment registration and device listing. All persons who 
operate as wholesale device distributors in Texas shall meet the applicable 
requirements in 21 Code of Federal Regulations (CFR), Part 807, titled 
"Establishment Registration and Device Listing for Manufacturers and 
Distributors of Devices." Devices distributed by wholesale device distributors 
shall have met, if applicable, the premarket notification requirements of 21 
CFR, Part 807, or the premarket approval provisions of 21 CFR, Part 814, titled 
"Premarket Approval of Medical Devices." 
   
  (c) Good manufacturing practices. Wholesale device distributors engaged in the 
manufacturing, packing, storage, or installation of finished devices shall be in 
compliance with the applicable requirements of 21 CFR, Part 820, titled "Good 
Manufacturing Practice For Medical Devices: General." This regulation sets forth 
the current good manufacturing practices for methods used in, and the facilities 
and controls used for, the manufacture, packing, storage, and installation of 
all finished devices intended for human use. 
   
  (d) Buildings and facilities. All manufacturing, assembling, packaging, 
packing, holding, testing, or labeling of devices shall take place in buildings 
and facilities described in 21 CFR, Part 820, Subpart C, titled "Buildings." No 
manufacturing, assembling, packaging, packing, holding, testing, or labeling 
operations of devices shall be conducted in any personal residence. 
   
  (e) Device labeling. Devices distributed by wholesale device distributors 
shall meet the labeling requirements of the Act and 21 CFR, Part 801, titled 
"Labeling." 
   
  (f) Device labeling exemptions. Device labeling or packaging exemptions 
adopted under the Federal Food, Drug, and Cosmetic Act, as amended, shall apply 
to devices in Texas except insofar as modified or rejected by rules of the Texas 
Board of Health (board). 
   
  (g) Reconditioned devices. Reconditioned devices must comply with the 
provisions of the Act and these sections and are subject to the provisions of 
the Texas Food, Drug, Device and Cosmetic Salvage Act, Health and Safety Code, 
Chapter 432. 
   
  (h) Medical device reporting. Wholesale device distributors shall meet the 
medical device reporting requirements of 21 CFR, Part 803, titled "Medical 
Device Reporting" or 21 CFR, Part 804, titled "Medical Device Distributor 
Reporting". 
   
  (i) Radiation emitting devices. Devices which emit electronic product 
radiation and are distributed by wholesale device distributors shall meet the 
applicable requirements of the Act and 21 CFR, Subchapter J, titled 
"Radiological Health". 
 
     
  sec.229.302. Advertising. 
 
  (a) An advertisement of a device shall be deemed to be false if it is false or 
misleading in any particular. 
   
  (b) An advertisement of a device is false if the advertisement represents that 
the device affects: 
 
  (1) infectious and parasitic diseases; 
   
  (2) neoplasms; 
   
  (3) endocrine, nutritional, and metabolic diseases and immunity disorders; 
   
  (4) diseases of blood and blood-forming organs; 
   
  (5) mental disorders; 
   
  (6) diseases of the nervous system and sense organs; 
   
  (7) diseases of the circulatory system; 
   
  (8) diseases of the respiratory system; 
   
  (9) diseases of the digestive system; 
   
  (10) diseases of the genitourinary system; 
   
  (11) complications of pregnancy, childbirth, and the puerperium; 
   
  (12) diseases of the skin and subcutaneous tissue; 
   
  (13) diseases of the musculoskeletal system and connective tissue; 
   
  (14) congenital anomalies; 
   
  (15) certain conditions originating in the perinatal period; 
   
  (16) symptoms, signs, and ill-defined conditions; or 
   
  (17) injury and poisoning. 
     
  (c) Subsection (b) of this section does not apply to an advertisement of a 
device if the advertisement does not violate sec.431.182(a) of the Act and is 
disseminated: 
 
  (1) to the public for self-medication and is consistent with the labeling 
claims permitted by the United States Food and Drug Administration (FDA); 
   
  (2) only to members of the medical, dental, and veterinary professions and 
appears only in the scientific periodicals of those professions; or 
   
  (3) only for the purpose of public health education by a person not 
commercially interested, directly or indirectly, in the sale of the device. 
     
  (d) This section does not indicate that self-medication for a disease other 
than a disease listed under subsection (b) of this section is safe and 
effective. 
 
     
  sec.229.303. Enforcement and Penalties. 
 
  (a) Inspection. 
 
  (1) To enforce these sections or the Texas Food, Drug, and Cosmetic Act, 
Health and Safety Code, Chapter 431 (Act), the Commissioner of Health 
(commissioner), an authorized agent, or a health authority may, on presenting 
appropriate credentials to the owner, operator, or agent in charge of a place of 
business: 
 
  (A) enter at reasonable times a place of business, including a factory or 
warehouse, in which a device is manufactured, assembled, packed, or held for 
introduction into commerce or held after the introduction; 
   
  (B) enter a vehicle being used to transport or hold a device in commerce; or 
   
  (C) inspect at reasonable times, within reasonable limits, and in a reasonable 
manner, the place of business or vehicle and all equipment, finished and 
unfinished materials, containers, and labeling of any item and obtain samples 
necessary for the enforcement of these sections or the Act. 
     
  (2) The inspection of a place of business, including a factory, warehouse, or 
consulting laboratory, in which a restricted device is manufactured, assembled, 
packed, or held for introduction into commerce extends to any place or thing, 
including a record, file, paper, process, control, or facility, in order to 
determine whether the device: 
 
  (A) is adulterated or misbranded; 
   
  (B) may not be manufactured, introduced into commerce, sold, or offered for 
sale under the Act; or 
   
  (C) is otherwise in violation of these sections or the Act. 
     
  (3) An inspection under paragraph (2) of this subsection may not extend to: 
 
  (A) financial data; 
   
  (B) sales data other than shipment data; 
   
  (C) pricing data; 
   
  (D) personnel data other than data relating to the qualifications of technical 
and professional personnel performing functions under the Act; or 
   
  (E) research data other than data: 
 
  (i) relating to devices; and 
   
  (ii) subject to reporting and inspection under regulations issued under 
sec.519 or sec.520(g) of the Federal Food, Drug, and Cosmetic Act, as amended. 
       
  (4) An inspection under paragraph (2) of this subsection shall be started and 
completed with reasonable promptness. 
     
  (b) Receipt for samples. An authorized agent or health authority who makes an 
inspection of a place of business, including a factory or warehouse, and obtains 
a sample during or on completion of the inspection and before leaving the place 
of business, shall give to the owner, operator, or the owner's or operator's 
agent a receipt describing the sample. 
   
  (c) Access to records. A person who is required to maintain records under the 
Texas Food, Drug, and Cosmetic Act, Health and Safety Code, Chapter 431 (Act) or 
sec.519 or sec.520(g) of the Federal Food, Drug, and Cosmetic Act or a person 
who is in charge or custody of those records shall, at the request of an 
authorized agent or health authority, permit the authorized agent or health 
authority at all reasonable times access to and to copy and verify the records. 
   
  (d) Adulterated and misbranded device. If the Texas Department of Health 
(department) identifies an adulterated or misbranded device, the department may 
enforce the applicable provisions of Subchapter C of the Act including, but not 
limited to: detention, emergency order, recall, condemnation, destruction, civil 
penalties, criminal enforcement, and/or administrative penalties, using the 
Severity Levels set out in sec.229.261 of this title (relating to Assessment of 
Administrative or Civil Penalties). 
 
  This agency hereby certifies that the proposal has been reviewed by legal 
counsel and found to be within the agency's authority to adopt. 
 Issued in Austin, Texas, on July 1, 1994. 
 TRD-9443366 
  John T. Richards 
 Assistant General Counsel, Office of General Counsel 
 Texas Department of Health 
    Proposed date of adoption: September 23, 1994 
 For further information, please call: (512) 458-7236 
         
                   
  TITLE 30. ENVIRONMENTAL QUALITY 
 Part I. Texas Natural Resource Conservation Commission 
  Chapter 334. Underground and Aboveground Storage Tanks 
  
  The Texas Natural Resource Conservation Commission (TNRCC) proposes amendments 
to sec.sec.334.49, 334.51, 334.55, and 334.77, concerning the underground and 
aboveground storage tank program. The TNRCC is required by the U.S. 
Environmental Protection Agency (EPA) to amend these four regulations to satisfy 
criteria for EPA program approval of the TNRCC's storage tank program. The 
amendments proposed here are intended to satisfy the "no-less stringency" 
requirement for program approval as required by EPA Region 6 staff. 
 EPA has established requirements for approving state underground storage tank 
programs. These requirements, found in 40 CFR Part 281, include demonstration 
that state regulations are at least as stringent as the federal requirements for 
the design and installation of underground storage tanks (USTs), upgrading USTs, 
operating USTs, and reporting releases. EPA staff has identified four state 
regulations that need to be amended for clarification on meaning before state 
program approval can be considered. More specifically, these regulations pertain 
to alternative systems that will be allowed for corrosion protection of USTs, 
alternative systems that will be allowed for spill and overfill prevention 
equipment on USTs, and the reporting requirements of initial abatement measures 
for confirmed releases. The fourth regulation proposed for amendment involves 
correction of a cross-reference to another regulation previously renumbered by 
rule amendment. 
 Stephen Minick, Division of Budget and Planning, has determined that for the 
first five years these sections as proposed are in effect, there will be no 
fiscal implications for state or local governments as a result of enforcement 
and administration of the sections. 
 Mr. Minick also has determined that during the first five-year period the 
sections as proposed are in effect, the public benefit anticipated as a result 
of enforcing or administering the sections will be improvements in the 
consistency between federal and state programs related to the regulation of 
underground storage tanks. There will be no effect on small businesses. There is 
no anticipated economic cost to persons who are required to comply with the 
sections as proposed. 
 Comments on the proposal may be submitted to David Duncan, Senior Attorney, 
Legal Services Division, Texas Natural Resource Conservation Commission, P.O. 
Box 13087, Austin, Texas 78711-3087, (512) 239-0600. Comments will be accepted 
until 5:00 p.m., 30 days following publication of this proposal in the Texas 
Register. 
   
  Subchapter C. Technical Standards 
 
  30 TAC sec.sec.334.49, 334.51, 334.55 
 
  The amendments are proposed under the Texas Water Code,  s5.103, which 
authorizes the TNRCC to promulgate rules necessary to carry out the powers and 
duties under the Texas Water Code and other laws of this state. 
 
 
  sec.334.49. Corrosion Protection. 
 
  (a) General requirements. 
 
  (1)-(2) (No change.) 
   
  (3) Any alternative methods for corrosion protection or variances from the 
requirements of this section are prohibited, except when reviewed and approved 
by the executive director  <nl>pursuant to procedures for variances found in 
sec.334.43 <ol> [in accordance with sec.334.43] of this title (relating to 
Variances and Alternative Procedures). 
   
  (4)-(5) (No change.) 
     
  (b)-(e) (No change.) 
 
     
  sec.334.51. Spill and Overfill Prevention and Control. 
 
  (a)  (No change.) 
   
  (b) Spill and overfill prevention equipment. Except as provided in paragraph 
(4) of this subsection, all underground storage tanks systems shall be equipped 
with spill and overfill prevention equipment which shall be designed, installed, 
and maintained in a manner that will prevent any spilling or overfilling of 
regulated substances resulting from transfers to such systems, as provided in 
this subsection. 
 
  (1)-(3) (No change.) 
   
  (4) Exceptions. 
 
  (A) UST systems are not required to be equipped with the spill and overfill 
prevention equipment prescribed in this subsection if one or more of the 
following conditions are applicable to such system: 
 
  (i) (No change.) 
   
  (ii) the underground storage tank system is equipped with alternative 
equipment which has been reviewed and determined by the executive director to 
prevent spills and overfills of regulated substances in a manner that is no less 
protective of human health and the environment than the equipment prescribed in 
this subsection, <nl>pursuant to procedures for variances found in 
sec.334.43<ol> [as provided in sec.334.43] of this title (relating to Variances 
and Alternative Procedures); or 
   
  (iii) the installation of the spill and overfill prevention equipment 
prescribed in this subchapter has been reviewed and determined by the executive 
director to be impracticable or unreasonable due to the type, design, or use of 
the underground storage tank system, <nl>pursuant to procedures for variances 
found in sec.334.43<ol> [as provided in sec.334.43] of this title (relating to 
Variances and Alternative Procedures). 
     
  (B)-(C) (No change.) 
       
  (c) (No change.) 
 
     
  sec.334.55. Permanent Removal from Service. 
 
  (a) General provisions. 
 
  (1)-(5) (No change.) 
   
  (6) As part of the required procedure for the permanent removal of any 
underground storage tank system from service, the owner or operator shall 
determine whether or not any prior release of a stored regulated substance has 
occurred from the system. 
 
  (A) (No change.) 
   
  (B) This determination shall be made by visual inspection of the area in and 
immediately surrounding the excavation zone for any aboveground releases and for 
any exposed belowground releases, and by using one or both of the following 
methods or procedures: 
 
  (i) the continual operation (through the time that the stored regulated 
substances are removed from the underground storage tank system) of one or more 
of the external release monitoring and detection methods operating in accordance 
with <nl> s334.50(d) (5)-(d)(9)<ol> [ s334.50(d)(4)-(d)(8)] of this title 
(relating to Release Detection); or 
   
  (ii) (No change.) 
     
  (C)-(D) (No change.) 
     
  (7)-(9) (No change.) 
     
  (b)-(f) (No change.) 
 
  This agency hereby certifies that the proposal has been reviewed by legal 
counsel and found to be within the agency's authority to adopt. 
 Issued in Austin, Texas, on July 1, 1994. 
 TRD-9443365 
  Mary Ruth Holder 
 Director, Legal Services Division 
 Texas Natural Resource Conservation Commission 
    Earliest possible date of adoption: August 8, 1994 
 For further information, please call: (512) 239-6087 
         
             
  Subchapter D. Release Reporting and Corrective Action 
 
  30 TAC sec.334.77 
 
  The amendment is proposed under the Texas Water Code, sec.5.103, which 
authorizes the TNRCC to promulgate rules necessary to carry out the powers and 
duties under the Texas Water Code and other laws of this state. 
 
 
  sec.334.77. Initial Abatement Measures and Site Check. 
 
  (a)  (No change.) 
   
  (b) <nl>Within<ol> [Unless directed to do otherwise by the executive director, 
within] 20 days after release confirmation, owners and operators must submit a 
report to the executive director summarizing the initial abatement steps taken 
under subsection (a) of this section and any resulting information or data 
<nl>unless another reporting period is specified by the executive director. 
 
  This agency hereby certifies that the proposal has been reviewed by legal 
counsel and found to be within the agency's authority to adopt. 
 Issued in Austin, Texas, on July 1, 1994. 
 TRD-9443364 
  Mary Ruth Holder 
 Director, Legal Services Division 
 Texas Natural Resource Conservation Commission 
    Earliest possible date of adoption: August 8, 1994 
 For further information, please call: (512) 239-6087 
         
                   
  TITLE 34. PUBLIC FINANCE 
 Part I. Comptroller of Public Accounts 
  Chapter 5. Funds Management (Fiscal Affairs) 
  
  Claims Processing<nl>-<ol>[through] Electronic Funds Transfers 
 
  34 TAC sec.5.11, sec.5.13 
 
  The Comptroller of Public Accounts proposes amendments to sec.5.11 and 
sec.5.13, concerning claims processing-electronic funds transfers. The 
amendments will conform the sections with new sec.5.16, concerning the use of 
electronic funds transfers to reimburse state employees for travel expenses 
incurred while conducting official state business. 
 Mike Reissig, chief revenue estimator, has determined that for the first five-
year period the rules will be in effect there will be no significant revenue 
impact on the state or local government. 
 Mr. Reissig also has determined that for each year of the first five years the 
rules are in effect the public benefit anticipated as a result of enforcing the 
rules will be in providing new information regarding electronic funds transfers. 
There will be no significant fiscal implications for small businesses. There is 
no significant anticipated economic cost to individuals who are required to 
comply with the proposed rules. 
 Comments on the proposals may be submitted to Kenny McLeskey, Manager of Claims 
Division, P.O. Box 13528, Austin, Texas 78711. 
 The amendments are proposed under the Texas Government Code, sec.403.016, which 
provides the comptroller with the authority to prescribe, adopt, and enforce 
rules relating to the electronic funds transfer system. The amendments implement 
the Government Code, sec.403.016. 
 
 
  sec.5.11. Miscellaneous Provisions. (Government Code, sec.403.016). 
 
  (a) (No change.) 
   
  (b) References to payments by the comptroller. When a rule of this 
undesignated head refers to the comptroller paying <nl>or reimbursing<ol> an 
individual or entity, the reference means: 
 
  (1) (No change). 
   
  (2) the comptroller's payment <nl>or reimbursement <ol> of an individual or 
entity in satisfaction of obligations owed to the individual or entity by the 
comptroller as a result of the fulfillment of the comptroller's constitutional 
or statutory duties. 
     
  (c) (No change.) 
 
     
  sec.5.13. Paying State Employees Through Electronic Funds Transfers. 
(Government Code,  s403.016). 
 
  (a) Definitions. The following words and terms, when used in this section, 
shall have the following meanings, unless the context clearly indicates 
otherwise. 
 
  (1)-(14) (No change.) 
   
  <nl>(15) Travel expense-A transportation, meals, lodging, or incidental 
expense incurred by a state employee while traveling on official state business 
according to state law and the State of Texas Travel Allowance Guide. 
     
  (b) (No change.) 
   
  (c) Payments by the comptroller. 
 
  (1)-(5) (No change.) 
   
  (6) Claiming an exemption. 
 
  (A)-(B) (No change.) 
   
  <nl>(C) A state employee may claim an exemption for payments of compensation 
without claiming an exemption for travel reimbursements. When a state employee 
claims an exemption only for payments of compensation from a state agency, the 
agency is solely responsible for ensuring that the payments are not paid through 
the electronic funds transfer system. 
   
  <nl>(D)<ol>[(C)] A custodial state agency must retain the authorization forms 
on which state employees and participating state employees have claimed the 
exemptions provided by this subsection. The agency may not send the forms to the 
comptroller. The agency must make the forms available to the state auditor and 
the comptroller upon request. The agency may destroy a form no earlier than the 
second anniversary of the employee's termination of employment with the agency. 
       
  (d)-(i) (No change.) 
   
  (j) Compensatory per diem <nl>and<ol>[,] salary per diem[, travel expense and 
subsistence] payments. The comptroller intends to adopt rules at a later date 
concerning compensatory per diem <nl>and<ol> [,] salary per diem[, travel 
expense, and subsistence] payments to state employees through the electronic 
funds transfer system. Until then, the comptroller has determined that it would 
be impractical to make those payments through the electronic funds transfer 
system. 
   
  (k) Miscellaneous provisions. 
 
  (1) General effective date. Except as otherwise provided in this subsection, 
this section <nl>first took effect on June 10, 1992 <ol> [, takes effect on the 
earliest date it may take effect under the Texas Civil Statutes, Article 6252-
13a, Administrative Procedure and Texas Register Act]. 
   
  (2) (No change.) 
   
  (3) Applicability of section. This section applies to all state employees 
whose compensation is paid through the electronic funds transfer system, 
including employees whose compensation was first paid through the electronic 
funds transfer system before <nl>June 10, 1992<ol> [the effective date of this 
section]. 
   
  (4) Existing accounts. 
 
  (A) This subparagraph applies to each account of a state employee that 
received a payment of the employee's compensation through the electronic funds 
transfer system before <nl>June 10, 1992<ol> [the effective date of this 
section]. Each account is an EFT account for the purpose of this section unless: 
 
  (i) the employee properly notified the employer of the employee before 
<nl>June 10, 1992,<ol> [the effective date of this section] that the account 
would no longer be available to receive electronic funds transfers; and 
   
  (ii) the notification  <nl>was<ol> [is] still in effect on <nl>June 10, 
1992<ol> [the effective date of this section]. 
     
  (B) A state employee that has one or more EFT accounts under subparagraph (A) 
of this paragraph on <nl>June 10, 1992,<ol> [the effective date of this section] 
is a participating state employee <nl>on that date <ol> for the purpose of this 
section. 
   
  (C) An employer of a state employee that is the custodial state agency for 
more than one EFT account of the employee on <nl>June 10, 1992,<ol> [the 
effective date of this section] may terminate the designation of one or more of 
those accounts only if subsection (e)(4) of this section authorizes the 
termination. The requirement in subsection (e)(2) of this section to obtain the 
consent of an employer before designating a second or subsequent EFT account 
does not apply to the accounts that are EFT accounts under subparagraph (A) of 
this paragraph on <nl>June 10, 1992<ol> [the effective date of this section]. 
 
  This agency hereby certifies that the proposal has been reviewed by legal 
counsel and found to be within the agency's authority to adopt. 
 Issued in Austin, Texas on June 30, 1994. 
 TRD-9443222 
  Martin E. Cherry 
 Chief, General Law Section 
 Comptroller of Public Accounts 
    Earliest possible date of adoption: August 8, 1994 
 For further information, please call: (512) 463-4028 
         
               
  34 TAC sec.5.16 
 
  The Comptroller of Public Accounts proposes new sec.5.16, concerning claims 
processing-electronic funds transfers. The new section covers requirements and 
procedures for using the electronic funds transfer system to reimburse state 
employees for travel expenses incurred while conducting official state business. 
 Tom Plaut, chief revenue estimator, has determined that for the first five-year 
period the rule will be in effect there will be no significant revenue impact on 
the state or local government. 
 Dr. Plaut also has determined that for each year of the first five years the 
rule is in effect the public benefit anticipated as a result of enforcing the 
rule will be in providing new information regarding electronic funds transfers. 
There will be no significant fiscal implications for small businesses. There is 
no significant anticipated economic cost to persons who are required to comply 
with the proposed rule. 
 Comments on the new section may be submitted to Kenny McLeskey, Manager of 
Claims Division, P.O. Box 13528, Austin, Texas 78711. 
 The new section is proposed under the Texas Government Code, sec.403.016, which 
provides the comptroller with the authority to prescribe, adopt, and enforce 
rules relating to the electronic funds transfer system. The amendment implements 
the Government Code, sec.403.016. 
 
 
  sec.5.16. Reimbursing the Travel Expenses of State Employees Through 
Electronic Funds Transfers. 
 
  (a) Definitions. The following words and terms, when used in this section, 
shall have the following meanings, unless the context clearly indicates 
otherwise. 
 
  (1) Above group 7-Group 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, or 
21. 
   
  (2) Annuitant-An individual who receives substantially equal and periodic 
benefit payments from one or more retirement plans administered by a retirement 
system. 
   
  (3) Authorization form-The form designed by the comptroller and used in 
accordance with this section. 
   
  (4) Below group 8-Group 2, 3, 4, 5, 6, or 7. 
   
  (5) Classification salary schedule-The classification salary schedule and the 
detailed listing of all classified positions table in the General Appropriations 
Act. 
   
  (6) Compensation-The salary, wages, and other compensation that a state 
employee earns as consideration for providing services to a state agency. The 
term excludes a payment of compensatory or salary per diem; a lump sum payment 
of accrued vacation leave; a lump sum payment of accrued sick leave; a lump sum 
payment of accrued vacation and sick leave; a refund of amounts deducted under 
the Federal Insurance Contributions Act; a reimbursement of meal expenses 
incurred while conducting official state business; and any payment made pursuant 
to a supplemental payroll voucher submitted to the comptroller. 
   
  (7) Custodial state agency-The state agency to which a state employee or a 
participating state employee submitted a properly completed authorization form 
to designate an EFT account, claim an exemption from the requirement to 
reimburse travel expenses through the electronic funds transfer system, or 
transfer custodianship of an EFT account from one state agency to another. 
   
  (8) EFT account-An account that has been designated in accordance with this 
section to receive credit entries. 
   
  (9) Participating state employee-A state employee who receives credit entries 
initiated by the comptroller. 
   
  (10) Paying state agency-With respect to a particular credit or debit entry, 
the state agency that requested the comptroller to initiate the entry. 
   
  (11) Retirement system-The Employees Retirement System of Texas or the Teacher 
Retirement System of Texas. 
   
  (12) State agency-A governmental entity that employs one or more state 
employees. The term includes the comptroller. 
   
  (13) State employee-An individual whose compensation either is paid by warrant 
issued by the comptroller and made payable to the individual or is paid through 
the comptroller's electronic funds transfer system. The fact that an individual 
is a head of agency, a part 30>time employee, an hourly employee, a temporary 
employee, an employee who is not covered by the Position Classification Act of 
1961, a member of a governmental body, an appointed or elected officer or 
official of the state, a member of the legislature, or a combination of the 
preceding is irrelevant when determining whether the individual is a state 
employee. However, the term does not include an independent contractor, the 
employee of an independent contractor, or an annuitant. 
   
  (14) Travel expense-A transportation, meal, lodging, or incidental expense 
incurred by a state employee while traveling on official state business 
according to state law and the  State of Texas Travel Allowance Guide<ol>. 
     
  (b) Mandatory or voluntary participation. 
 
  (1) Mandatory participation. 
 
  (A) Except as provided in subparagraph (C) of this paragraph, a state employee 
who holds a position included in the classification salary schedule must be a 
participating state employee. 
   
  (B) Except as provided in subparagraph (C) of this paragraph, a state employee 
who does not hold a position included in the classification salary schedule must 
be a participating state employee. 
   
  (C) A state employee is not required to be a participating state employee if 
subsection (c)(2)-(5) of this section would prohibit the employee's travel 
expenses from being reimbursed through the electronic funds transfer system if 
the employee were a participating employee. An employee who is not required to 
be a participating state employee under this subparagraph must claim an 
exemption for each state agency that reimburses the employee's travel expenses 
in accordance with subsection (c)(6) of this section. 
     
  (2) Voluntary participation. 
 
  (A) A state employee who is not required by paragraph (1) of this subsection 
to be a participating state employee may be a participating state employee. 
   
  (B) This subparagraph applies only to reimbursements of travel expenses that 
are not required by this section to be made through the electronic funds 
transfer system. A state employee and a state agency may agree on which 
reimbursements of travel expenses from the agency will be made through the 
electronic funds transfer system. Unless the comptroller is a party to the 
agreement: 
 
  (i) the comptroller is not required to take any actions to facilitate or 
ensure the agency's compliance with the agreement; and 
   
  (ii) the comptroller is not liable for any damages that result from the 
agency's failure to comply with the agreement. 
       
  (3) Powers and responsibilities of the comptroller and state agencies. 
 
  (A) This paragraph applies only to a state employee who is required by 
paragraph (1) of this subsection to be a participating state employee. 
   
  (B) A state agency must ensure that each state employee to whom the agency 
reimburses travel expenses is a participating state employee. 
   
  (C) If a state employee is required but refuses or fails to become a 
participating state employee, then the employee's travel expense reimbursements 
may be retained by the paying state agency until the employee becomes a 
participating state employee. 
       
  (c) Payments by the comptroller. 
 
  (1) Payment methods. 
 
  (A) Except as otherwise provided in this subsection, the comptroller must 
reimburse a participating state employee's travel expenses through the 
electronic funds transfer system. 
   
  (B) The comptroller may not reimburse a non 30>participating state employee's 
travel expenses through the electronic funds transfer system. 
   
  (C) The state agency on whose behalf the comptroller reimburses travel 
expenses is responsible for determining whether the reimbursement must be made 
through the electronic funds transfer system. The comptroller may rely on that 
determination. 
     
  (2) Exemption based on classification. 
 
  (A) Notwithstanding paragraph (1)(A) of this subsection, the comptroller may 
not reimburse through the electronic funds transfer system the travel expenses 
of a participating state employee who holds a position classified below group 8 
of the classification salary schedule unless the employee has been approved to 
be paid in this way under subsection (b)(2) of this section. 
   
  (B) When a participating state employee holds a position classified below 
group 8 of the classification salary schedule, the employee holds that position 
for the purpose of this paragraph even if the compensation paid to the employee 
exceeds the compensation paid to certain state employees who hold positions 
classified above group 7. 
   
  (C) When a participating state employee holds a position classified above 
group 7 of the classification salary schedule, the employee holds that position 
for the purpose of this paragraph even if the compensation paid to the employee 
is less than the compensation paid to certain state employees who hold positions 
classified below group 8. 
     
  (3) Exemption based on cost. Notwithstanding paragraph (1)(A) of this 
subsection, the comptroller may not reimburse the travel expenses of a 
participating state employee through the electronic funds transfer system if: 
 
  (A) the comptroller determines that making the reimbursement by warrant would 
cost less to the state; 
   
  (B) the employee determines that making the reimbursement by warrant would 
cost less to the employee; or 
   
  (C) the paying state agency determines that making the reimbursement by 
warrant would cost less to the agency. 
     
  (4) Exemption based on impracticality. 
 
  (A) Notwithstanding paragraph (1)(A) of this subsection, the comptroller may 
not reimburse the travel expenses of a participating state employee through the 
electronic funds transfer system if: 
 
  (i) the comptroller determines that making the reimbursement through the 
electronic funds transfer system would be impractical to the state; 
   
  (ii) the employee determines that making the reimbursement through the 
electronic funds transfer system would be impractical to the employee; or 
   
  (iii) the paying state agency determines that making the reimbursement through 
the electronic funds transfer system would be impractical to the agency. 
     
  (B) Notwithstanding subparagraph (A)(iii) of this paragraph, a state agency 
must adopt a written policy before it may determine that reimbursing the travel 
expenses of any state employee through the electronic funds transfer system is 
impractical to the agency. The policy must clearly state the circumstances under 
which the agency will find impracticability. The policy must be made available 
to the comptroller, the state auditor, and state employees upon request. 
     
  (5) Exemption based on inability to obtain an account. Notwithstanding 
paragraph (1)(A) of this subsection, the comptroller may not reimburse the 
travel expenses of a participating state employee through the electronic funds 
transfer system if the employee is unable to obtain an account at a financial 
institution that may be used to receive credit entries. 
   
  (6) Claiming an exemption. 
 
  (A) The exemption provided in paragraph (2)(A), (3)(B), (4)(A)(ii), or (5) of 
this subsection does not apply until a state employee or participating state 
employee properly claims the exemption in accordance with this paragraph. 
   
  (B) A state employee or participating state employee may claim an exemption 
only by properly completing an authorization form and submitting the form to the 
paying state agency. An exemption applies only to travel reimbursements from the 
paying state agency to which the state employee or participating state employee 
submitted the authorization form. 
   
  (C) A state employee may claim an exemption for travel expense reimbursements 
without claiming an exemption for payments of compensation. When a state 
employee claims an exemption only for travel expense reimbursements from a state 
agency, the agency is solely responsible for ensuring that the reimbursements 
are not paid through the electronic funds transfer system. 
   
  (D) A custodial state agency must permanently retain the authorization forms 
on which state employees and participating state employees have claimed the 
exemptions provided by this subsection. The agency may not send the forms to the 
comptroller. The agency must make the forms available to the state auditor and 
the comptroller upon request. 
       
  (d) Commencement and termination of participation. 
 
  (1) Obtaining authorization forms. Except as provided in subsection (e) (3) 
and (5) of this section, a state employee or a participating state employee may 
obtain an authorization form from any state agency. 
   
  (2) Becoming a participating state employee. 
 
  (A) A state employee who is required or who wants to be a participating state 
employee must properly designate an EFT account in accordance with subsection 
(e)(1) of this section. 
   
  (B) A state employee is not a participating state employee until the employee 
has properly designated at least one EFT account and the designation has become 
effective. 
     
  (3) A participating state employee's termination of the employee's 
participation. 
 
  (A) A participating state employee may terminate the employee's participation 
if: 
 
  (i) the employee voluntarily became a participating state employee under 
subsection (b)(2) of this section; or 
   
  (ii) none of the employee's travel expense reimbursements are still required 
by law to be made through the electronic funds transfer system. 
     
  (B) A participating state employee may terminate the employee's participation 
only by terminating the designation of each of the employee's EFT accounts in 
accordance with subsection (e)(3) of this section. 
   
  (C) The comptroller may not initiate a credit entry to a state employee on or 
after the effective date of the termination of the designation of the employee's 
last EFT account. 
     
  (4) A custodial state agency's termination of a participating state employee's 
participation. 
 
  (A) A custodial state agency may terminate a participating state employee's 
participation only if the agency is the only custodial state agency for the 
employee. 
   
  (B) A custodial state agency may terminate the participation of a 
participating state employee if: 
 
  (i) the agency determines in accordance with subsection (c)(4) of this section 
that continued participation would be impractical to the agency; or 
   
  (ii) the agency no longer reimburses the travel expenses of the employee. 
     
  (C) If a custodial state agency is authorized under this paragraph to 
terminate the participation of a participating state employee, then the agency 
may do so only by terminating the designation of each of the employee's EFT 
accounts in accordance with subsection (e)(4) of this section. 
   
  (D) The comptroller may not initiate a credit entry to a state employee on or 
after the effective date of the termination of the designation of the employee's 
last EFT account. 
   
  (E) A participating state employee's participation may be terminated under 
this paragraph without prior notice to the employee. 
     
  (5) Inquiries. 
 
  (A) A participating state employee may contact only the paying state agency 
when the employee has a question about a particular credit entry or debit entry. 
   
  (B) If a participating state employee receives an unidentified credit entry or 
debit entry, the employee must first contact its financial institution to obtain 
necessary information about the entry. If the financial institution is unable to 
provide the information, then the employee may ask the comptroller for the 
information. 
   
  (C) A participating state employee may contact any state agency if the 
employee has a question about this section. 
     
  (6) Rules. A participating state employee shall comply with the rules as 
amended from time to time. 
     
  (e) EFT accounts. 
 
  (1) Designating an EFT account. 
 
  (A) A state employee or a participating state employee may designate an EFT 
account if: 
 
  (i) the employee properly completes an authorization form and submits the form 
to a state agency; 
   
  (ii) the account to be designated as an EFT account is a checking or savings 
account of the employee; and 
   
  (iii) the account to be designated as an EFT account is at a financial 
institution that allows credit entries to be made to the account. 
     
  (B) A custodial state agency shall promptly submit a properly completed 
authorization form or the information on the form to the comptroller in 
accordance with the comptroller's requirements. 
   
  (C) If a state employee or a participating state employee properly designates 
an EFT account, the effective date of the designation is the fourteenth calendar 
day after the comptroller processes the information on the authorization form. 
The comptroller may initiate credit entries to the EFT account on or after the 
effective date. 
     
  (2) Multiple EFT accounts. 
 
  (A) Notwithstanding anything else in this paragraph, a state employee may 
require each state agency that reimburses the employee's travel expenses to be 
the custodial state agency for one EFT account of the employee. The employee may 
impose this requirement without obtaining the consent of any state agency. 
   
  (B) This subparagraph applies when a state employee wants a state agency to be 
the custodial state agency for more than one of the employee's EFT accounts. The 
employee may not designate a second or subsequent EFT account unless the state 
agency consents to each account beyond the first account. 
   
  (C) Subject to the other requirements of this paragraph, a participating state 
employee may designate a second or subsequent EFT account by properly completing 
an authorization form and submitting the form to the appropriate state agency. 
   
  (D) A state agency may not submit a participating state employee's 
authorization form to the comptroller if: 
 
  (i) the form would designate an EFT account for the employee; and 
   
  (ii) the employee has already designated the same account as an EFT account. 
     
  (E) A participating state employee that has multiple EFT accounts and a state 
agency may agree that a certain type of travel expense reimbursement will be 
paid only to the account or accounts designated in the agreement. Unless the 
comptroller is a party to the agreement: 
 
  (i) the comptroller is not required to take any actions to facilitate or 
ensure the agency's compliance with the agreement; and 
   
  (ii) the comptroller is not liable for any damages that result from the 
agency's failure to comply with the agreement. 
       
  (3) A participating state employee's termination of the designation of an EFT 
account. 
 
  (A) A participating state employee may terminate the employee's designation of 
an EFT account if the termination would not result in a violation of subsection 
(b)(1) of this section. 
   
  (B) A participating state employee may terminate the designation of all the 
employee's EFT accounts if the employee is authorized by subsection (d)(3) of 
this section to terminate the employee's participation. 
   
  (C) A participating state employee may terminate the employee's designation of 
an EFT account only by: 
 
  (i) obtaining an authorization form from the custodial state agency for the 
account; 
   
  (ii) properly completing the form; and 
   
  (iii) submitting the form to the agency. 
     
  (D) A custodial state agency shall promptly submit a properly completed 
authorization form or the information on the form to the comptroller in 
accordance with the comptroller's requirements. 
   
  (E) The comptroller may not initiate a credit entry to an EFT account on or 
after the date on which the comptroller processes the information on the 
authorization form that terminates the designation of the account. 
     
  (4) A custodial state agency's termination of the designation of an EFT 
account. 
 
  (A) A state agency may terminate the designation of an EFT account if: 
 
  (i) the agency is the custodial state agency for the account; 
   
  (ii) the agency properly completes an authorization form and submits the form 
or the information on the form to the comptroller in accordance with the 
comptroller's requirements; and 
   
  (iii) the termination would not result in a violation of subsection (b)(1) of 
this section. 
     
  (B) The comptroller may not initiate a credit entry to an EFT account on or 
after the date on which the comptroller processes the information on the 
authorization form that terminates the designation of the account. 
   
  (C) The designation of an EFT account may be terminated under this paragraph 
without prior notice to the state employee or the participating state employee 
that owns the account. 
     
  (5) Modifying information about an EFT account. 
 
  (A) A participating state employee may modify information about an EFT account 
of the employee only by: 
 
  (i) obtaining an authorization form from the custodial state agency for the 
account; 
   
  (ii) properly completing the form; and 
   
  (iii) submitting the form to the agency. 
     
  (B) A custodial state agency shall promptly submit a properly completed 
authorization form or the information on the form to the comptroller in 
accordance with the comptroller's requirements. 
   
  (C) New information about an EFT account applies to credit entries that the 
comptroller initiates on or after the fourteenth calendar day after the 
comptroller processes the information on the authorization form that provides 
the new information. 
     
  (6) Number of custodial state agencies. An EFT account has only one custodial 
state agency at any given time. 
     
  (f) The comptroller's powers and responsibilities. 
 
  (1) Initiating debit entries. 
 
  (A) The comptroller may initiate a debit entry to an EFT account of a 
participating state employee if the appropriate paying state agency determines 
that an erroneous credit entry has been made to the account. 
   
  (B) The comptroller may initiate a debit entry to an account of a state 
employee if: 
 
  (i) the appropriate paying state agency determines that an erroneous credit 
entry has been made to the account; 
   
  (ii) the erroneous credit entry was made to the account when it was an EFT 
account; and 
   
  (iii) the erroneous credit entry was made when the state employee was a 
participating state employee. 
     
  (C) The comptroller may initiate a debit entry without prior notice to a state 
employee or a participating state employee. 
     
  (2) Compliance with the rules. The comptroller must comply with the rules when 
initiating credit entries and debit entries. 
   
  (3) Contacts. The comptroller may contact a state agency or a participating 
state employee if the comptroller has a question about a credit entry or debit 
entry. 
   
  (4) Termination of a participating state employee's participation. 
 
  (A) The comptroller may terminate the participation of a participating state 
employee at any time if the termination would not result in a violation of 
subsection (b)(1) of this section. 
   
  (B) The comptroller may terminate participation under this paragraph without 
providing prior notice to the participating state employee. 
     
  (5) Termination of the designation of an EFT account. 
 
  (A) The comptroller may terminate the designation of an EFT account at any 
time if the termination would not result in a violation of subsection (b) (1) or 
(c)(1)(A) of this section. 
   
  (B) The comptroller may terminate the designation of an EFT account without 
providing prior notice to the participating state employee that owns the 
account. 
     
  (6) Stop payments. The comptroller's authority to stop the payment of a credit 
entry is equivalent to the comptroller's authority to stop the payment of a 
warrant. 
     
  (g) Acceptance and return of credit entries. 
 
  (1) Voluntary acceptance of credit entries. Neither a participating state 
employee nor a participating state employee's financial institution is required 
to accept a credit entry. However, a rejected credit entry must be returned in 
accordance with the rules. 
   
  (2) Liability resulting from the rejection of credit entries. 
 
  (A) The comptroller, the state treasurer, and a state agency are not liable 
for the consequences of the rejection of a credit entry by a participating state 
employee or the employee's financial institution. 
   
  (B) When a credit entry is rejected, the State of Texas and its state 
agencies: 
 
  (i) are not in default on any obligation; and 
   
  (ii) shall not incur any penalty, interest, or late charge by reason of the 
rejection. 
       
  (3) Rejection of credit entries. Even if a participating state employee or the 
employee's financial institution does not reject a credit entry in accordance 
with the rules, the employee does not accept a credit entry as being in the 
correct amount if: 
 
  (A) the employee ensures that the paying state agency receives written notice 
by no later than the thirtieth calendar day after the employee's financial 
institution receives the credit entry; and 
   
  (B) the written notice clearly states that the amount of the credit entry is 
erroneous. 
       
  (h) Credit for paying state agencies. 
 
  (1) Applicability. This subsection applies unless a participating state 
employee returns a credit entry in accordance with subsection (g) of this 
section. 
   
  (2) When credit required. A participating state employee shall credit the 
paying state agency for the amount of a credit entry on the effective date of 
the credit entry, regardless of when the employee's financial institution posts 
the credit entry to the employee's account. 
   
  (3) Accrual of interest and other charges or fees. The accrual of interest or 
other charges or fees payable with respect to the amount of a credit entry shall 
cease when a participating state employee credits the paying state agency for 
the credit entry. 
     
  (i) Liability. 
 
  (1) Liability for actions of certain parties. A participating state employee, 
the State of Texas, a state agency, a paying state agency, the comptroller, the 
state treasurer, and a custodial state agency are not liable for the act or 
omission of any automated clearing house, financial institution, or other person 
or entity except as specified in the rules. 
   
  (2) Liability for actions of state agencies or paying state agencies. Neither 
the comptroller nor the state treasurer is liable for damages arising out of 
delays caused or errors committed by a state agency or a paying state agency. 
     
  (j) Miscellaneous provisions. 
 
  (1) General effective date. Except as otherwise provided in this subsection, 
this section takes effect on the earliest date it may take effect under the 
Administrative Procedure Act, Government Code, Chapter 2002. 
   
  (2) Applicability of section. This section applies to all state employees 
whose travel expense reimbursements are made through the electronic funds 
transfer system, including employees whose travel expense reimbursements were 
first made through the electronic funds transfer system before the effective 
date of this section. 
   
  (3) Existing accounts. 
 
  (A) This subparagraph applies to each account of a state employee that 
received a travel expense reimbursement through the electronic funds transfer 
system before the effective date of this section. Each account is an EFT account 
for the purpose of this section unless: 
 
  (i) the employee properly notified the custodial state agency of the account 
before the effective date of this section that the account would no longer be 
available to receive electronic funds transfers; and 
   
  (ii) the notification is still in effect on the effective date of this 
section. 
     
  (B) A state employee that has one or more EFT accounts under subparagraph (A) 
of this paragraph on the effective date of this section is a participating state 
employee for the purpose of this section. 
   
  (C) A custodial state agency for more than one EFT account of a state employee 
on the effective date of this section may terminate the designation of one or 
more of those accounts only if subsection (e)(4) of this section authorizes the 
termination. The requirement in subsection (e)(2) of this section to obtain the 
consent of a state agency before designating a second or subsequent EFT account 
does not apply to the accounts that are EFT accounts under subparagraph (A) of 
this paragraph on the effective date of this section. 
     
  (4) Existing exemptions relating to the payment of compensation. 
 
  (A) In this paragraph, "compensation exemption" means an exemption claimed 
under sec.5.13 of this undesignated head (relating to Claims Processing-
Electronic Funds Transfer) from the requirement to pay compensation through the 
electronic funds transfer system. 
   
  (B) A compensation exemption that is in effect on the effective date of this 
section is also an exemption from the requirement in this section to reimburse 
travel expenses through the electronic funds transfer system. The exemption 
remains in effect until properly rescinded or superceded. 
 
  This agency hereby certifies that the proposal has been reviewed by legal 
counsel and found to be within the agency's authority to adopt. 
 Issued in Austin, Texas, on June 30, 1994. 
 TRD-9443319 
  Martin E. Cherry 
 Chief, General Law Section 
 Comptroller of Public Accounts 
    Earliest possible date of adoption: August 8, 1994 
 For further information, please call: (512) 463-4028 
         
                       
  TITLE 40. SOCIAL SERVICES AND ASSISTANCE 
 Part I. Texas Department of Human Services 
  Chapter 3. Income Assistance Services 
  
  Subchapter OO. Electronic Benefit Transfer (EBT) Retailer Requirements 
 
  40 TAC sec.sec.3.5001-3.5010 
 
  The Texas Department of Human Services (DHS) proposes new sec.sec.3.5001-3. 
5010, concerning Electronic Benefit Transfer (EBT) retailer requirements in the 
Aid to Families with Dependent Children (AFDC) and Food Stamp Programs, in its 
Income Assistance Services rule chapter. In the June 10, 1994, issue of the  
Texas Register (19 TexReg 4515), DHS proposed rules which describe benefit 
issuance via EBT as it affects AFDC and Food Stamp clients. The purpose of this 
proposal is to establish rules regarding the relationship between retailers and 
the primary EBT contractor and between retailers and DHS. 
 The proposed new sections delineate the qualifications and general conditions 
for retailer participation, requirements for retailers operating point-of-sale 
(POS) terminals supplied by the EBT contractor, and provisions for POS terminal 
deployment. The rules will also govern off-line (manual) transactions, 
settlements and credits, and third-party processor requirements. In addition, 
the rules will outline appeal rights regarding disputes between a retailer, 
third-party processor, and the primary EBT contractor. 
 Burton F. Raiford, commissioner, has determined that for the first five-year 
period the proposed sections will be in effect there will be no fiscal 
implications for state or local government as a result of enforcing or 
administering the sections. 
 Mr. Raiford also has determined that for each year of the first five years the 
sections are in effect the public benefit anticipated as a result of enforcing 
the sections will be rules that govern EBT retailer participation. There will be 
no effect on small businesses. There is no anticipated economic cost to persons 
who are required to comply with the proposed sections. 
 Questions about the content of the proposal may be directed to Rita King at 
(512) 450-4148 in DHS's Client Self-Support Services. Comments on the proposal 
may be submitted to Nancy Murphy, Agency Liaison, Policy and Document Support-
201, Texas Department of Human Services W-402, P.O. Box 149030, Austin, Texas 
78714-9030, within 30 days of publication in the Texas Register. 
 The new sections are proposed under the Human Resources Code, Title 2, Chapters 
22 and 33, which provides the department with the authority to administer public 
and nutritional assistance programs. 
 The proposal implements the Human Resources Code, sec.22.001 and sec.33.002. 
 
 
  sec.3.5001. Definitions.  <ol>The following words and terms, when used in this 
subchapter, shall have the following meanings unless the context clearly 
indicates otherwise: 
   
   ACF-The Administration for Children and Families Office of Family Assistance, 
of the United States Department of Health and Human Services. 
   
   ACH-Automated Clearing House Network. The ACH network is operated by the 
Federal Reserve and financial institutions to electronically process funds 
transfers between financial institutions. 
   
   AFDC-Aid to Families with Dependent Children. AFDC program benefits are 
administered federally by ACF. 
   
   Advice-Message that notifies a party of an action that has already been taken 
and that requires no approval, but requires acknowledgement of receipt. An 
Advice may be declined if the transaction data does not match the corresponding 
voice authorization. 
   
   Banking Business Day-A calendar day (beginning at 12:00 midnight and ending 
the following 12:00 midnight) other than a calendar day that is a Saturday, 
Sunday, or day on which banks and federal institutions are closed. 
   
   CFR-The United States Code of Federal Regulations. 
   
   Cash back-The disbursement of funds from a cash benefit account transacted 
through a point-of-sale (POS) terminal. 
   
   Client-A household member and/or his authorized representative eligible to 
receive AFDC and/or Food Stamp program benefits and to perform transactions 
using an EBT card. 
   
   DHS-The Texas Department of Human Services. 
   
   EBT-Electronic Benefit Transfer. The delivery of government benefits through 
electronic means and media. 
   
   EBT system-A computer-based system in which the benefit authorization is 
received from a central computer through a POS terminal. 
   
   EBT program transactions-Transactions involving the authorization, issuance, 
redemption, accounting, settlement, and/or reconciliation of, and/or query with 
respect to, EBT program benefits, and/or EBT program benefit accounts. 
   
   Equipment-The hardware and equipment, if any, to be provided to a retailer by 
the primary EBT contractor on behalf of the Texas Department of Human Services 
(DHS). 
   
   Food and Nutrition Service (FNS)-Division of the United States Department of 
Agriculture responsible for administering the Food Stamp Program. 
   
   Food stamps-The federal food assistance program administered by FNS. 
   
   Primary Account Number (PAN)-The client's EBT number embossed and encoded on 
the EBT card. The number identifies the issuer and specifies an individual 
account or hierarchy of accounts. 
   
   POS terminal-Point-of-sale terminal used in connection with the authorization 
and redemption of EBT program benefits, whether or not the terminal is used for 
other purposes. 
   
   Primary EBT contractor-The vendor who has been awarded the contract by DHS to 
provide EBT services in Texas. 
   
   Software-The software operating on and/or in connection with the equipment. 
   
   Third-party processor -Financial institution; cardholder authorization 
processor, other than the primary EBT contractor; and a retailer, in the event 
the retailer drives POS terminals for itself and/or other retailers that are 
capable of relaying EBT program transactions to the EBT system central-database 
computer for authorization through its own systems. 
 
   
  sec.3.5002. Qualifications for Retailers and Third-Party Processors. 
 
  (a) Participation in the Electronic Benefit Transfer (EBT) program is limited 
to retailers and third-party processors who do business in and along the state 
borders of the state of Texas. 
   
  (b) A retailer must be either: 
 
  (1) currently authorized by the Food and Nutrition Service (FNS) to 
participate in the Food Stamp program; or 
   
  (2) a non-FNS-certified retailer that has executed a written agreement with 
the primary EBT contractor to provide Aid to Families with Dependent Children 
(AFDC) cash back. 
     
  (c) A retailer or third-party processor must represent and warrant that it 
validly exists and is in good standing under the laws of the jurisdiction of its 
organization. 
   
  (d) A retailer must represent and warrant that the facility in which a point-
of-sale (POS) terminal(s) is or will be located complies with all applicable 
building and zoning codes and ordinances. 
   
  (e) A retailer or third-party processor must not have been debarred from 
contracting by any unit of the federal government or any unit of a state 
government. 
   
  (f) A retailer or third-party processor that is a for-profit corporation must 
not be delinquent in making state franchise tax payments. 
 
     
  sec.3.5003. General Conditions for Retailer and Third-Party Processor 
Participation. 
 
  (a) Compliance with program regulations. Retailer participation is governed by 
federal regulations set forth in 7 Code of Federal Regulations (CFR), 
sec.274.12(g). A retailer must also comply with all program regulations 
governing retailer participation in the Food Stamp program as codified in 7 CFR, 
sec.sec.274 and 278 and this title of the Texas Administrative Code. 
   
  (b) Written agreement. A retailer or third-party processor and the primary 
Electronic Benefit Transfer (EBT) contractor must execute a written agreement 
adopted in compliance with 7 CFR sec.274.12(g)(6). 
   
  (c) Voluntary participation. 
 
  (1) Participation in the EBT program by a retailer is voluntary. A Food and 
Nutrition Service-certified retailer must notify the primary EBT contractor in 
writing that it wishes to decline participation in the EBT program. 
   
  (2) If a retailer is suspended or terminated as a redeemer of Food Stamp 
program benefits, for any reason, the retailer must immediately notify the 
primary EBT contractor and cease utilization of the EBT system to redeem Food 
Stamp benefits. 
     
  (d) Training. Retail store employees must be trained in EBT system operation 
prior to implementation. 
 
  (1) The primary EBT contractor must provide a retailer with training in the 
processing of EBT program transactions, including the operation of the equipment 
(if supplied by the primary EBT contractor). The primary EBT contractor must 
notify the retailer in advance of the retailer's scheduled time for in-person 
training. 
   
  (2) In lieu of in-person training, retailers may receive training by mail. 
These retailers must certify that they have undertaken the course of written 
instruction with their staff. 
     
  (e) Systems testing. After training has been completed, the primary EBT 
contractor visits the site to determine whether a retailer's equipment, whether 
supplied by the primary EBT contractor, a third-party processor, or the retailer 
has passed system testing. When system testing has been approved, access to the 
EBT system is granted. 
   
  (f) Nondiscrimination. A retailer must not, on the grounds of race, color, 
national origin, age, sex, disability, religious belief, or political belief, 
refuse to process a client's EBT program transaction, or otherwise subject any 
client, employee, or applicant to actions which are discriminatory in nature. 
   
  (g) No charge. A retailer may not charge a fee to a client to access the EBT 
system. 
   
  (h) Sufficient cash. A retailer redeeming Aid to Families with Dependent 
Children (AFDC) program benefits by providing cash back on a no-purchase-
required basis must maintain a sufficient amount of cash on hand to accommodate 
cash-back transaction volumes. 
   
  (i) Certifications. A retailer must complete and agree to comply with the 
terms of: 
 
  (1) Certification Regarding Debarment, Suspension, Ineligibility and Voluntary 
Exclusion for Covered Contracts; and 
   
  (2) Texas Corporate Franchise Tax Certification (if applicable). 
     
  (j) Compliance Audits. A retailer and third-party processor must conduct 
audits of itself and its processing agents at least annually to ensure 
compliance with the terms of the Retailer or Third-Party Processor Agreement and 
the processor interface specifications. These audits may be conducted by either 
the retailer's or third-party processor's internal auditing staff or by their 
external auditors, at their option. The resulting letter of compliance must be 
filed annually with the primary EBT contractor. 
 
     
  sec.3.5004. Requirements for Retailers Operating Point-of-Sale (POS) Terminals 
Supplied by the Primary EBT Contractor. 
 
  (a) Site survey. A retailer must permit the primary Electronic Benefit 
Transfer (EBT) contractor to conduct all necessary site surveys at all locations 
of a retailer participating in the EBT program. During the course of this 
survey, the primary EBT contractor must determine the equipment needs for each 
qualified location to comply with the applicable POS terminal deployment 
provisions stated in sec.3.5005 of this title (relating to Deployment of Point-
of-Sale (POS) Terminals (Food Stamp Redeemers Only)). 
   
  (b) Equipment. A retailer may, but is not required to, obtain equipment from 
the primary EBT contractor which is needed to allow the retailer to participate 
in the EBT program. The primary EBT contractor must supply equipment necessary 
to participate in the Food Stamp program at no charge to Food and Nutrition 
Service-certified retailers who choose to receive this equipment. The equipment 
must be the sole property of the primary EBT contractor. 
   
  (c) Terminal software license. Software provided to retailers is provided by 
the primary EBT contractor under license. The terms and conditions of the 
license must be contained in the terms and conditions of the Retailer Agreement. 
 
     
  sec.3.5005. Deployment of Point-of-Sale (POS) Terminals (Food Stamp Redeemers 
Only). 
 
  (a) General. POS terminals, whether provided by the primary Electronic Benefit 
Transfer (EBT) contractor or a third-party processor, must be deployed in 
accordance with 7 CFR sec.272.12(g)(4)(ii). 
   
  (b) Optional terminals. A retailer has the option to deploy a POS terminal(s) 
within their respective store office, customer service area, or other location, 
to enable clients not making a purchase to complete account balance inquiries, 
credit transactions, and cash back transactions. 
   
  (c) Minimum redemptions. The primary EBT contractor must supply equipment at 
no cost to the retailer only if a retailer's Food Stamp program redemptions 
average more than $100 per month over any six-month period. A retailer whose 
Food Stamp program redemptions average less than $100 per month over any six-
month period may participate in the EBT program using the manual voucher 
transaction process. These retailers may participate in the electronic system, 
if they choose; however, these retailers must acquire the hardware and equipment 
necessary to interface with the primary EBT contractor's system at their own 
expense. 
   
  (d) Special checkout lanes. A retailer may not establish special checkout 
lanes that are only for EBT program transactions. If special lanes are 
designated for the purpose of accepting other electronic debit or credit cards 
and/or other methods of payment, such as by checks, clients with EBT system 
cards may also be assigned to these lanes as long as other commercial customers 
are assigned there as well. 
 
     
  sec.3.5006. Off-Line (Manual) Transactions. 
 
  (a) Maximum authorization. The maximum authorized off-line (manual) 
transaction and benefit account encumbrance is $50 per purchase. The primary 
Electronic Benefit Transfer (EBT) contractor, and not the Texas Department of 
Human Services (DHS), is liable to a retailer in the amount of the difference 
between the $50 maximum and the actual authorized transaction amount when the 
authorized amount is higher. 
   
  (b) Manual vouchers with delayed telephone verification. The following 
procedures apply when a retailer uses manual vouchers with delayed telephone 
verification: 
 
  (1) A retailer who does not have immediate access to telephones at the time of 
purchase must use a manual voucher system with delayed telephone verification 
when selling food to eligible Food Stamp customers. These retailers include 
stationary food stores which make home deliveries to Food Stamp households, 
house-to-house trade routes which operate on standing orders from customers 
(such as milk and bread delivery routes), food-buying cooperatives, and other 
food retailers authorized under 7 CFR sec.278.1. 
   
  (2) The retailer must telephone the primary EBT contractor before redeeming 
the manual voucher in order to log the transaction and obtain an authorization 
number. 
     
  (c) Manual vouchers with preliminary telephone verification. The following 
procedures apply when a retailer uses manual vouchers with preliminary telephone 
verification: 
 
  (1) A retailer must process off-line (manual) Food Stamp program redemptions 
accounts when he is able to contact the primary EBT contractor by telephone. A 
retailer may, at his option, process off-line (manual) Aid to Families with 
Dependent Children (AFDC) program cash back redemptions when he is able to 
contact the primary EBT contractor by telephone. 
   
  (2) An authorization number for the amount of purchase must be received by the 
retailer from the primary EBT contractor via telephone before completing the 
sale. 
     
  (d) Manual voucher submission and processing. This subsection applies to 
manual vouchers with delayed telephone verification and preliminary telephone 
verification. 
 
  (1) The following information must be entered properly and legibly on the 
manual voucher form: 
 
  (A) full names of the client and the sales clerk; 
   
  (B) client's primary account number (PAN) (this is the embossed number on the 
client's EBT debit card); 
   
  (C) total purchase amount; 
   
  (D) date of purchase; and 
   
  (E) telephone authorization number. 
     
  (2) The manual voucher must be submitted to the primary EBT contractor for 
processing within seven calendar days following the date of purchase. 
   
  (3) The primary EBT contractor must process submitted manual vouchers within 
two banking business days of receipt. 
   
  (4) A manual voucher found to be incomplete or otherwise improperly prepared 
and submitted must be returned to the retailer for correction and/or completion 
within four banking business days of the date the primary EBT contractor 
received it. 
     
  (e) Electronic voucher transaction (store-and-forward). When the link to the 
EBT System is down, a retailer may use off-line processing of EBT transactions 
if the retailer's system, or that of its designated third-party processor, has 
the capability to electronically store-and-forward an EBT program transaction. 
Store-and-forward transactions cannot be completed if the point-of-sale (POS) 
terminal system malfunctions. The following procedures apply to electronic 
voucher transactions: 
 
  (1) A retailer must complete a manual voucher as specified in subsection 
(d)(1) of this section. 
   
  (2) A retailer must obtain voice authorization from the primary EBT contractor 
prior to completing the manual voucher transaction. The authorization code must 
be entered on the manual voucher and in the advice. 
   
  (3) The period within which a retailer or third-party processor may submit the 
electronic voucher (advice) transaction to the primary EBT contractor shall not 
exceed seven calendar days from the date of the original EBT program 
transaction. 
     
  (f) Liability for off-line transactions. Liability is assessed as follows: 
 
  (1) DHS may be held liable only for those off-line (manual) transactions 
performed in accordance with the provisions set forth in the federal EBT 
regulations under 7 CFR sec.274.12(g)(6)(iv) and the processing standards 
specified under 7 CFR sec.274.12(h). 
   
  (2) The primary EBT contractor, and not DHS, is liable to the retailer for 
off-line (manual) transactions that are conducted in accordance with terms and 
conditions of the Retailer Agreement but for which an insufficient amount of 
benefits remain in the client's account at the time the manual voucher is 
presented for processing and payment. 
   
  (3) A retailer is not required to process off-line (manual) transactions 
except when he is able to contact the primary EBT contractor by telephone for 
authorization. If authorization cannot be obtained before or at the time of 
purchase, a retailer assumes the risk of insufficient benefits being available 
in the client's account. 
   
  (4) A retailer is liable for EBT program transactions completed using voice 
authorization and electronic voucher store-and-forward capabilities of a 
retailer's or third-party processor's system which are rejected by the primary 
EBT contractor upon electronic submission because the retailer and/or third-
party processor failed to follow the procedures in subsection (e) of this 
section. 
     
  (g) Re-presentation of manual voucher. Neither the primary EBT contractor nor 
the retailer may "re-present" a manual voucher for payment if insufficient funds 
exist when the voucher is submitted for processing and payment. 
 
     
  sec.3.5007. Third-Party Processors. <ol>Retailers may choose to use a third-
party processor. A third-party processor must comply with performance and 
technical standards set forth in 7 CFR,  s274.12(h)(1) and (2). In order to 
participate, a third-party processor must: 
 
  (1) be able to meet all third-party interface specifications and certification 
standards associated with 7 CFR, sec.274.12 (h)(5); 
   
  (2) execute a written agreement adopted in accordance with 7 CFR, 
sec.274.12(g)(6) with the primary EBT contractor; 
   
  (3) meet the qualifications established in sec.3.5002(a), (c), (e), and (f) of 
this title (relating to Qualifications for Retailers and Third-Party 
Processors); and 
   
  (4) comply with applicable general conditions established in sec.3.5003 of 
this title (relating to General Conditions for Retailer and Third-Party 
Processor Participation). 
 
     
  sec.3.5008. Settlements and Credits. 
 
  (a) Settlement account. A retailer or third-party processor must maintain a 
settlement account with a federally insured financial institution capable of 
accepting credits and debits in the Automated Clearinghouse Network (ACH) 
format. A retailer or third-party processor must give the primary Electronic 
Benefit Transfer (EBT) contractor at least 30 days' advance notice of any 
changes in settlement account information. 
   
  (b) Retailer/processor cutoff time. A retailer or third-party processor must 
establish the daily time at which their banking business day ends for purposes 
of EBT program transactions. 
   
  (c) Primary EBT contractor cutoff time. The Texas Department of Human Services 
(DHS) establishes the daily time at which the primary EBT contractor's 
settlement day ends for purposes of EBT program transactions. The primary EBT 
contractor gives retailers and third-party processors a minimum of 15 days 
advance written notice of changes to the daily cutoff time. 
   
  (d) Discrepancies and adjustments. Any discrepancy between the primary EBT 
contractor's and a retailer's or third-party processor's total must be 
communicated by the retailer or third-party processor within ten banking 
business days of discovery. Adjustment requests must be reported in writing and 
include the applicable documentation. Discrepancies or adjustments reported 
after 90 days from the settlement date are rejected by the primary EBT 
contractor. 
 
     
  sec.3.5009. Resolution Procedures for Primary Electronic Benefit Transfer 
(EBT) Contractor, Retailer, and/or Third Party Processor Disputes. 
 
  (a) Definitions. The following words and terms, when used in this section, 
have the following meanings, unless the context clearly indicates otherwise: 
 
  (1) Initiator-The party initiating the process to resolve a dispute with the 
respondent. 
   
  (2) Respondent-The second party to the dispute identified by the initiator. 
   
  (3) Chargeback-A food account adjustment entry, against the respondent's 
settlement account, made as a result of the resolution of the dispute in favor 
of the Initiator. 
     
  (b) Subject matter of disputes. A dispute may be initiated for any reason 
deemed valid by the initiator, including, but not limited to, the reasons 
specified in paragraphs (1)-(3) of this subsection. However, client-related 
disputes are resolved in accordance with sec.3.2406 of this title (relating to 
Right to Appeal). 
 
  (1) processing errors, including duplicate processing; 
   
  (2) incorrect manual voucher; and 
   
  (3) delayed benefit draft recovery, if requested. 
     
  (c) Maximum time to initiate dispute. All disputes must be initiated with the 
respondent no later than 90 calendar days from the date the initiator knows or 
has reason to know of the dispute. 
   
  (d) Maximum time to complete the investigation and respond. The primary 
Electronic Benefit Transfer (EBT) contractor must respond in writing to all 
disputes within 20 banking business days of initiation. 
   
  (e) Funds flow. Funds flow only on resolution of the disputed EBT program 
transaction and is affected by use of the chargeback transaction. A chargeback 
may be issued against the primary EBT contractor, the retailer, or the third-
party processor's settlement account. 
 
     
  sec.3.5010. Administrative Remedies Regarding Disputes. The following 
procedures concern contract-related complaints between a retailer or third-party 
processor and the primary Electronic Benefit Transfer (EBT) contractor: 
 
  (1) All complaints must be referred to the primary EBT contractor for 
investigation and resolution. 
   
  (2) A retailer or third-party processor has the right to request an informal 
review of any decision of the primary EBT contractor. A written request for an 
informal review must be filed with the Texas Department of Human Services (DHS) 
so that DHS receives it within 15 days after the retailer or third-party 
processor receives the official notice of action from the primary EBT 
contractor. The request for a hearing must be addressed to the Texas Department 
of Human Services; Electronic Benefit Transfer Contract Management Unit, Mail 
Code E-304; P. O. Box 149030; Austin, Texas 78714-9030. 
   
  (3) Any retailer, third-party processor, or the primary EBT contractor who is 
dissatisfied with the results of an informal review may obtain an administrative 
hearing by written request submitted to the Texas Department of Human Services, 
Hearings Department (Mail Code W-613), P.O. Box 149030, Austin, Texas, 78714-
9030. 
 
  This agency hereby certifies that the proposal has been reviewed by legal 
counsel and found to be within the agency's authority to adopt. 
 Issued in Austin, Texas on July 1, 1994. 
 TRD-9443371 
  Nancy Murphy 
 Section Manager, Policy and Document Support 
 Texas Department of Human Services 
    Proposed date of adoption: October 1, 1994 
 For further information, please call: (512) 450-3765 
         
               Chapter 10. Self-support Services [Family Self-Support Services] 
  
  Employment Services 
 
  40 TAC sec.sec.10.2312, 10.2313, 10.2314 
 
  The Texas Department of Human Services (DHS) proposes new sec.sec.10.2312, 10. 
2313, and 10.2314, concerning employment services in its Self-support Services 
chapter, formerly titled Family Self-support Services. The purpose of the new 
sections is to establish rules regarding employment services contracting to 
include administrative requirements, audits, and basis of payment. 
 Burton F. Raiford, commissioner, has determined that for the first five-year 
period the proposed new sections will be in effect there will be no fiscal 
implications for state or local government as a result of enforcing or 
administering the new sections. 
 Mr. Raiford also has determined that for each year of the first five years the 
new sections are in effect the public benefit anticipated as a result of 
enforcing the new sections will be that employment services contracting will be 
conducted based on federal and state regulations and policies. There will be no 
effect on small businesses. There is no anticipated economic cost to persons who 
are required to comply with the proposed sections. 
 Questions about the content of the proposal may be directed to Carol Barron at 
(512) 450-4242 in DHS's Self-support Services Section. Comments on the proposal 
may be submitted to Nancy Murphy, Agency Liaison, Media and Policy Services-173, 
Texas Department of Human Services W-402, P.O. Box 149030, Austin, Texas 78714-
9030, within 30 days of publication in the Texas Register. 
 The new sections are proposed under the Human Resources Code, Title 2, Chapter 
22, which provides the department with the authority to administer public 
assistance programs. 
 The new sections implements the Human Resources Code sec.22.001-22.024. 
Employment Services sec.10.2312. Administrative Requirements for the Employment 
Services Programs. <ol>The Texas Department of Human Services (DHS) and the 
Employment Services contractor must comply with Office of Management and Budget 
Circulars A-102 or A-110 as clarified by federal regulations and DHS guidelines. 
These circulars contain administrative requirements, such as property management 
and procurement, applicable to entities receiving federal funds. 
 
 
  sec.10.2313. Audits of Employment Services Contractors. 
 
  (a)  All Employment Services contractors are subject to audit or review by the 
Texas Department of Human Services (DHS). DHS may audit all relevant records or 
statistically sample records and project findings, including overpayments, based 
on that sample. DHS may also audit cost or rate study data submitted by the 
contractor. 
   
  (b) Employment Services contractors subject to the Single Audit Act must have 
an independent audit performed in compliance with either the Office of 
Management and Budget Circulars A-128 or A-133. The audit must be approved by 
the cognizant agency for the contractor, with a copy provided by the contractor 
to DHS for review by DHS. The contractor may be reimbursed by DHS for the DHS's 
share of audit expenses if prior approval by DHS is obtained, funding is 
available, the audit is found to be acceptable upon review by DHS, and the audit 
and reimbursement request are acceptable. 
 
     
  sec.10.2314. Basis of Payment for Employment Services Program. 
 
  (a)  The Texas Department of Human Services (DHS) uses cost reimbursement or 
fixed fee methodologies as the basis of payment for Employment Services 
contractors. Cost reimbursement is used for program services and a fixed-fee 
unit rate is used for supportive services. 
   
  (b) Under cost reimbursement, the contractor is paid based on periodic actual, 
reasonable, allowable, properly allocated cost, up to the allocation of funds 
available. Budget and expenditure shifts are allowed subject to the terms of the 
contract. 
   
  (c) Costs are determined to be reasonable, allowable, and properly allocated 
in accordance with Office of Management and Budget Circulars A-21, A-87, and A-
122; other applicable federal statutes and regulations; and DHS guidelines in 
the contract. There is no provision for profit in budgeting, payment, or 
reimbursement of Employment Services program services expense. 
   
  (d) Under fixed-fee, the supportive services contractor is paid a set unit 
rate for services delivered. Periodically, the contractor bills DHS a set 
rate(s) based on the actual units of service provided during the period. If the 
rate is cost-based, it is subject to reconciliation after the end of the 
contractor's fiscal year. At the end of the contractor's fiscal year, the 
contractor reconciles actual, reasonable, allowable, properly allocated rate per 
unit of service to the billed rate. If the rate paid by DHS was less than the 
actual, reasonable, allowable, properly allocated rate, the contractor is 
entitled to payment for the difference. If the actual, reasonable, allowable, 
properly allocated rate is less than the rate paid by DHS, the contractor must 
refund the difference. 
 
  This agency hereby certifies that the proposal has been reviewed by legal 
counsel and found to be within the agency's authority to adopt. 
 Issued in Austin, Texas, on June 30, 1994. 
 TRD-9443326 
  Nancy Murphy 
 Section Manager, Media and Policy Services 
 Texas Department of Human Services 
    Proposed date of adoption: September 1, 1994 
 For further information, please call: (512) 450-3765 
         
               Chapter 90. Nursing Facilities and Related Institutions 
  
  Subchapter G. Abuse, Neglect, and Exploitation; Complaint and Incident Reports 
and Investigations 
 
  40 TAC sec.90.215 
 
  The Texas Department of Human Services (DHS) proposes an amendment to 
sec.90.215, concerning investigations of incidents and complaints, in its 
Nursing Facilities and Related Institutions rule chapter. The purpose of the 
amendment is to incorporate into sec.90.215 recent changes in the Health and 
Safety Code, sec.242.126. The amendment clarifies that complaint investigations 
may include a visit to the resident's facility if DHS determines this is 
appropriate. The amendment makes this rule consistent with DHS's Personal Care 
Facility rules. 
 Burton F. Raiford, commissioner, has determined that for the first five-year 
period the proposed amendment will be in effect there will be no fiscal 
implications for state or local government as a result of enforcing or 
administering the amendment. 
 Mr. Raiford also has determined that for each year of the first five years the 
amendment is in effect the public benefit anticipated as a result of enforcing 
the section will be elimination of a mandatory facility visit to investigate 
complaints. There will be no effect on small businesses. There is no anticipated 
economic cost to persons who are required to comply with the proposed amendment. 
 Questions about the content of the proposal may be directed to Susan Syler at 
(512) 450-3111 in DHS's Institutional Policy Section. Comments on the proposal 
may be submitted to Nancy Murphy, Agency Liaison, Policy and Document Support-
002, Texas Department of Human Services W-402, P.O. Box 149030, Austin, Texas 
78714-9030, within 30 days of publication in the Texas Register. 
 The amendment is proposed under the Health and Safety Code, Chapter 242, which 
provides the department with the authority to regulate long-term care nursing 
facilities and under Texas Civil Statutes, Article 4413 (502), which transferred 
all functions, programs, and activities related to long-term care licensing, 
certification, and surveys from the Texas Department of Health to the Texas 
Department of Human Services. 
 The amendment implements the Health and Safety Code, sec. s242.001-242.186. 
 
 
  sec.90.215. Investigations of Incidents and Complaints. 
 
  (a)-(c)  (No change.) 
   
  (d) Complaint investigations <nl>may<ol> [shall] include a visit [or visits] 
to the  <nl>resident's facility<ol> [resident and the facility] and an interview 
with the resident<nl>, if DHS determines that these actions are appropriate<ol>. 
If the facility fails to admit <nl>DHS<ol> [department] staff for <nl>complaint 
<ol> [such] investigations,  <nl>DHS<ol> [the department] will seek a probate or 
county court order for admission. 
   
  (e)-(g) (No change.) 
 
  This agency hereby certifies that the proposal has been reviewed by legal 
counsel and found to be within the agency's authority to adopt. 
 Issued in Austin, Texas, on June 30, 1994. 
 TRD-9443325 
  Nancy Murphy 
 Section Manager, Media and Policy Services 
 Texas Department of Human Services 
    Proposed date of adoption: September 1, 1994 
 For further information, please call: (512) 450-3765