Emergency Sections 
 An agency may adopt a new or amended section or repeal an existing section on 
an emergency basis if it determines that such action is necessary for the public 
health, safety, or welfare of this state. The section may become effective 
immediately upon filing with the Texas Register, or on a stated date less than 
20 days after filing, for no more than 120 days. The emergency action is 
renewable once for no more than 60 days. 
 Symbology in amended emergency sections. 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 25. HEALTH SERVICES 
 Part I. Texas Department of Health 
  Chapter 229. Food and Drug 
  
  Licensure Registration of Manufacturers of Food and Wholsale Distributors of 
Food-Including Good Manufacturing Practices 
 
  25 TAC sec.sec.229.181-229.184 
 
  The Texas Department of Health (department) adopts on an emergency basis 
amendments to sec.sec.229.181-229.184 concerning licensure of manufacturers of 
food and wholesale distributors of food-including good manufacturing practices. 
These amendments will enable the department to collect licensure fees from food 
wholesalers in Texas. The amendments establish fees which are to be collected, 
amend the sections to include food wholesalers, and establish standards for 
licensure. The sections currently address only food manufacturers. 
 The sections are adopted on an emergency basis to implement Senate Bill 565, 
73rd Legislature, 1993, which requires the department to license food 
wholesalers in addition to food manufacturers, effective September 1, 1993. The 
amendments are simultaneously proposed for adoption in this issue. 
 The amendments are adopted on an emergency basis to implement the provisions of 
Senate Bill 565 which require the department to adopt rules effecitve September 
1, 1993, for the licensure of food wholesalers; the Health and Safety Code, 
sec.431.241, which provides the department with the authority to adopt necessary 
regulations pursuant to the enforcement of this Chapter; sec.431.241, which 
provides the department with the authority to adopt necessary regulations 
pursuant to the enforcement of this chapter; 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; and Texas Civil Statutes, Article 6252-
13a, sec.5, which provide the board with authority to adopt emergency rules. 
 
 
  sec.229.181. Definitions. 
   
   Establishment-Each location where food is manufactured as defined in the 
<nl>Health and Safety Code, Chapter 431<ol> [Texas Civil Statutes, Article 4476-
5, sec.23a.3]; however, a food service establishment or a commissary supplying 
food service establishments is not a manufacturer unless it regularly engages in 
the labeling, combining, and purifying of food which is either sold for resale 
or packaged for sale in other than individual portions. 
   
   <nl>Food manufacturer -A person who combines, purifies, processes, or 
packages food for sale through a wholesale outlet. The term also includes a 
retail outlet that packages or labels food before sale and a person that 
represents itself as responsible for the purity and proper labeling of an 
article of food by labeling the food with the person's name and address. 
   
   <nl>Food wholesaler -A person who distributes food for resale, either through 
a retail outlet owned by that person or through sales to another person. The 
term "food wholesaler" shall not include a commissary which distributes food 
primarily intended for immediate consumption on the premises of a retail outlet 
under common ownership. 
   
   Manufacture-The process of combining or purifying [Articles of] food and 
packaging <nl>food<ol> [same] for sale to  <nl>a<ol> [the] consumer <nl>at<ol> 
[, either by] wholesale or retail. [Any person, firm, or corporation who 
represents itself as responsible for the purity and the proper labeling of any 
article of food by placing or having placed its name and address upon the label 
of any food shall be deemed a manufacturer and shall be included with the 
meaning of these sections.] 
   
  <nl>   >>Place of business -Each location where a person manufactures food or 
where food for wholesale is distributed. 
   
  <nl>   Public food warehouse (terminal)-A food storage facility from which 
foods owned by others are stored and distributed, and for which services the 
operator of the facility is paid for the storage and/or distribution of the 
foods. 
 
   
  sec.229.182. <nl>Licensing  [Registration] Fee and Procedures. 
 
  (a) <nl>Licensing<ol> [Registration] fee and exemptions. 
 
  (1)  All manufacturers of food in Texas shall <nl>obtain a license<ol> 
[register] annually with the Texas Department of Health and shall pay <nl>a 
license fee<ol> [registration fees] as follows: 
 
  (A)-(G) (No change.) 
     
  (2) A manufacturer of food operating an establishment wherein all 
manufacturing operations are regulated under statutes administered by the Texas 
Department of Health other than the <nl>Health and Safety Code, Chapter 431,<ol> 
[Texas Food, Drug and Cosmetic Act] shall be exempt from the payment of the 
licensing [registration] fee. 
   
  <nl>(3) All wholesale food distributors in Texas shall obtain a license 
annually with the Texas Department of Health and shall pay a license fee as 
follows: 
 
  <nl>(A) $100 per establishment having a gross annual volume of $0. 00-
$499,999.99 for food products distributed from that establishment; 
   
  <nl>(B) $300 per establishment having a gross annual volume of $500, 000.00-
$9,999,999.99 for food products distributed from that establishment; 
   
  <nl>(C) $500 per establishment having a gross annual volume of $10,000,000 or 
more for food products distributed from that establishment; 
   
  <nl>(D) $250 per public food warehouse (terminal) which may have no gross 
annual volume of sales of food, but which is used for storage from which foods 
are distributed by one or more wholesale distributors of foods; and 
   
  <nl>(E) $100 per drop ship location, operated by a food manufacturer for 
temporary storage of foods for the purpose of further distribution. 
     
  <nl>(4) For the purpose of collecting licensing fees under this section, a 
person that distributes both its own manufactured food and food it does not 
manufacture must obtain only a food manufacture's license. However, when 
calculating the amount of the licensing fee, the manufacturer must include the 
total for both the foods manufactured and the foods warehoused. In addition, 
food warehousing locations operated by a manufacturer of foods, including 
locations from which foods are held for limited periods of time for 
distribution, and which are totally separate from any manufacturing location, 
must be individually licensed as food wholesalers. 
   
  <nl>(5) For the purpose of collecting licensing fees under this section, a 
food broker which engages in the storage of food, even for limited periods of 
time, must license as a food wholesaler. 
     
  (b) <nl>License<ol> [Registration] forms. <nl>License<ol> [Registration] forms 
may be obtained from the Division of Food and Drugs, Texas Department of Health, 
1100 West 49th Street, Austin, Texas, 78756-3182. 
   
  (c) <nl>License application<ol> [Registration statement]. <nl>All <ol> [the] 
manufacturers[']  <nl>of food and wholesale food distributors<ol> [registration 
statement] shall <nl>file a license application<ol> [be signed and verified, 
shall be made] on a [registration] form furnished by the department<nl>. The 
application form shall be signed and verified<ol>, and shall contain the 
following information: 
 
  (1)  (No change.) 
   
  (2) the address of each place of business in the state <nl>that is<ol> [being] 
<nl>licensed<ol> [registered]; 
   
  (3)  (No change.) 
   
  (4) the names <nl>and residences <ol> of those individuals in an actual 
administrative capacity which, in the case of a sole proprietorship shall be the 
managing proprietor; in a partnership, the managing partner; in a corporation, 
the officers and directors; in any other association, those in a managerial 
capacity<nl>; and the residence address of a person in charge of each place of 
business <ol>; and 
   
  (5) a list of categories of gross annual volume which must be marked and 
adhered to by the <nl>licensee <ol> [registrant] in the determination and paying 
of the fee. 
     
  (d) Two or more establishments. If the manufacturer  <nl>or food 
wholesaler<ol> operates more than one establishment, <nl>each establishment <ol> 
[the manufacturer] shall <nl>be licensed<ol> [register each establishment] 
separately by listing the name and address of each establishment on the 
<nl>license application <ol> [registration statement]. 
   
  (e) <nl>Prelicense<ol> [Preregistration] inspection. The applicant shall 
cooperate with any <nl>prelicense <ol> [preregistration] inspection by the 
department of the manufacturer's <nl>or food wholesaler's<ol> facilities. 
   
  (f) Issuance of <nl>license<ol> [certificate of registration]. The department 
may <nl>license <ol> [register and issue a certificate of registration to] a 
manufacturer <nl>or wholesaler<ol> of foods who meets the requirements of this 
section and  s229.183 of this title (relating to Minimum Standards for 
<nl>Licensure<ol> [Registration]). 
 
  (1) The initial <nl>license<ol> [certificate of registration] shall be valid 
for one year from the date of issuance, which becomes the anniversary date. 
   
  (2)  The renewal <nl>license<ol> [certificate of registration] shall be valid 
for one year from the anniversary date. 
     
  (g) Renewal of <nl>license<ol> [registration]. 
 
  (1) Each year, the food manufacturer <nl>or wholesaler<ol> shall renew its 
<nl>license<ol> [registration] following the requirements of this section and 
sec.229.183 of this title [(relating to Minimum Standards for <nl>Licensure<ol> 
[Registration])]. 
   
  (2) A person who holds a <nl>license<ol> [certificate of registration] issued 
by the department under the Health and Safety Code shall renew the 
<nl>license<ol> [certificate of registration] by filing an application for 
renewal on a form prescribed by the department, accompanied by the appropriate 
<nl>licensing <ol> [registration] fee. A <nl>licensee<ol> [registrant] must file 
for renewal before the expiration date of the current <nl>license <ol> 
[certificate of registration]. A person who files a renewal application after 
the expiration date must pay an additional $100 as a delinquency fee. 
   
  (3)  Failure to submit the renewal annually may subject the food manufacturer 
<nl>or food wholesaler <ol> to the offense provisions under the Health and 
Safety Code, Chapter 431, and also to the provision of sec.229.184 of this title 
(relating to the Refusal, Revocation, or Suspension of <nl>License<ol> 
[Registration]). 
     
  <nl>(h) Amendment of license. 
 
  <nl>(1) Fees. 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 required under the Health and Safety Code, sec.431.2251, will require 
submission of fees as outlined in subsection (a) of this section. 
   
  <nl>(2)  Change in location of place of business. Not later than the 31st day 
before the date of the change, the license holder shall notify in writing the 
commissioner or the commissioner's designee of the license holder'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 place of business. Not later than the 10th day after 
the completion of the change of location, the license holder shall forward to 
the commissioner or the commissioner's designee the name and residence address 
of the individual in charge of the new place of business. Notice is considered 
adequate if the license holder 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, Division of Food 
and Drugs, 1100 West 49th Street, Austin, Texas, 78756-3182. 
 
       
  sec.229.183. Minimum Standards for <nl>Licensure [Registration]. 
 
  <nl>(a) Manufacturers of foods. 
 
  <nl>(1)<ol>[(a)] Minimum Standards] All manufacturers of food in Texas shall 
comply with the minimum standards specified in <nl>paragraph (2) [subsection 
(b)] of this subsection<ol> [section] in addition to the existing standards 
contained in the following statutes<nl>:<ol> [,] the Health and Safety Code, 
<nl>Chapters<ol> [Chapter] 431, [Health and Safety Code Chapter] 434, and 
[Health and Safety Code Chapter] 438. 
   
  <nl>(2)<ol>[(b)] Current good manufacturing practice in manufacturing, 
processing, packing, or holding human food. The department adopts by reference 
the Current Good Manufacturing Practice in Manufacturing, Processing, Packing, 
or Holding Human Food, Code of Federal Regulations, Title 21, Part 110,  
ssec.110.3-110.110, [as amended, 1987]. Copies are indexed and filed in the 
office of the Division of Food and Drugs, Texas Department of Health, 1100 West 
49th Street, Austin, Texas, 78756-3182, and are available for inspection during 
normal working hours. 
   
  <nl>(3)<ol>[(c)] Living areas. No manufacturing of foods shall be conducted in 
any room used as living or sleeping quarters. All manufacturing operations shall 
be separated from any living or sleeping quarters by complete partitioning. 
   
  <nl>(4)<ol>[(d)] Potentially hazardous foods. The internal product temperature 
of potentially hazardous food shall be 45 degrees F (7 degrees C) or below or at 
an internal temperature of 140 degrees Fahrenheit (60 degrees Centigrade) or 
above at all times, except during periods of necessary preparation. Potentially 
hazardous food means any food that consists in whole or in part of milk or milk 
products, eggs, meat, poultry, fish, shellfish, edible crustacea, or other 
ingredients including synthetic ingredients, in a form capable of supporting 
rapid and progressive growth of infectious or toxigenic microorganisms. The term 
does not include clean, whole, uncracked, odorfree shell eggs or foods which 
have a ph level of 4.5 or below or a water activity (Aw) value of 0.85 or less. 
Frozen foods shall be kept frozen and shall be stored at a temperature of 0 
degrees Fahrenheit (-18 degrees Centigrade) or below. 
   
  <nl>(5)<ol>[(e)] Food labeling. If a person, firm, or corporation labels an 
article of food, the label shall meet the requirements of the Health and Safety 
Code, Chapter 431. 
     
  <nl>(b) Food wholesalers. 
 
  <nl>(1) Food storage facilities shall be properly constructed and maintained. 
All walls, ceilings, and floors shall be intact to preclude entry of vermin and 
environmental contaminants. 
   
  <nl>(2)  Doors and loading docks shall be tight-fitting and kept closed at all 
times when not in use, or adequately screened during normal operating hours to 
prevent entry of rodents, birds, or other pests. 
   
  <nl>(3) Outer premises, including trash receptacles, shall be kept clean and 
free of odors, debris, high weeds, or standing water which could harbor or 
attract vermin. 
   
  <nl>(4) Handwashing and toilet facilities shall be provided and maintained, 
including hot and cold running water, hand soap, and single-service towels as 
deemed appropriate by the regulatory authority for the types of foods handled by 
the licensee. 
   
  <nl>(5) Adequate lighting shall be provided to facilitate cleaning and 
inspection of stored goods. 
   
  <nl>(6) Wastewater shall be disposed of in a manner approved by the regulatory 
authority. 
   
  <nl>(7) All foods, including refrigerated and frozen foods, shall be stored 
off the floor and away from walls to help prevent contamination by vermin 
(rodents and insects for example) and moisture, and to facilitate cleaning and 
inspection. 
   
  <nl>(8)  Food storage facilities and transportation vehicles shall be kept 
free of rodents, insects, birds, and other pests which may contaminate food. 
   
  <nl>(9) Damaged, distressed, and infested foods shall be stored in a "morgue 
area," adequately separated from undamaged foods and shall be disposed of in a 
timely manner to preclude further contamination. 
   
  <nl>(10)  The internal temperature of potentially hazardous foods shall be 
maintained at 45 degrees Fahrenheit (7 degrees Centigrade) or below at all times 
to preclude temperature abuse during staging, loading, and transporting. Frozen 
foods shall be kept frozen at all times. 
   
  <nl>(11) During warehousing and transporting, all chemicals shall be properly 
stored and physically separated from foods to preclude contamination. 
   
  <nl>(12)  Foods being warehoused shall be rotated on a "first in, first out" 
basis. 
   
  <nl>(13) Packaged foods, including imported foods, shall comply with all 
applicable food labeling regulations. 
   
  <nl>(14) Food storage facilities and transportation vehicles operated under 
the control of the licensee shall be kept clean and free of excessive dust, 
dirt, spillage, and other debris, including excess moisture. 
   
  <nl>(15) Food transport vehicles shall be operated in compliance with federal 
regulations pertaining to back-hauling. 
   
  <nl>(16) Each incoming lot shall be examined at the time of receipt to 
preclude acceptance of contaminated or adulterated foods. 
   
  <nl>(17) Swollen, leaking, and/or severely dented containers of food shall be 
segregated and promptly placed in the "morgue area" to preclude further 
contamination, attraction of vermin, or sale prior to reconditioning. 
   
  <nl>(18) Distressed foods salvaged by the licensee shall be salvaged in 
accordance with sec.sec.229.191-229.202 of this title (relating to Regulation of 
Food, Drug, Device, and Cosmetic Salvage Establishments and Brokers). 
   
  <nl>(19) Only pesticides approved by the Environmental Protection Agency (EPA) 
for use in a food warehouse and/or food processing facility may be used. 
Pesticides shall be used only according to label directions. Rodenticides shall 
be placed inside enclosed bait boxes or other approved receptacles. Only a 
licensed pesticide applicator may apply restricted use pesticides. 
   
  <nl>(20) Food wholesalers engaged in the receipt and distribution of over-the-
counter or prescription drugs shall comply with sec.229.253 of this title 
(relating to Minimum Standards for Licensure). 
   
  <nl>(21) The licensee shall keep accurate distribution records to facilitate 
the recall of any foods found to be unfit for human consumption. 
 
       
  sec.229.184. Refusal, Revocation, or Suspension of <nl>Licensure  
[Registration]. 
 
  (a) Basis. The department may, after providing <nl>an <ol> opportunity for 
<nl>a <ol> hearing, refuse <nl>an application for a<ol> [to] <nl>license<ol> 
[register] <nl>from<ol> a food manufacturer <nl>or food wholesaler<ol>, or may 
revoke or suspend <nl>a <ol> [the] <nl>license<ol> [registration] for violations 
of the requirements in sec.229.182 of this title (relating to <nl>Licensing<ol> 
[Registration] Fee and Procedures) and sec.229.183 of this title (relating to 
Minimum Standards for <nl>Licensure<ol> [Registration]) or for interference with 
the department in the performance of its duty under these rules. 
   
  (b) Hearings. Any hearings for the refusal, revocation, or suspension of a 
license [registration] are governed by  ssec.1.21-<nl>1.34<ol> [1.32] of this 
title (relating to Formal Hearing Procedures). 
       
  Issued in Austin, Texas on September 1, 1993. 
 TRD-9328184 
  Susan K. Steeg 
 General Counsel 
 Texas Department of Health 
    Effective date: September 1, 1993 
 Expiration date: December 31, 1993 
 For further information, please call: (512) 458-7236