TITLE 25. HEALTH SERVICES

PART 1. DEPARTMENT OF STATE HEALTH SERVICES

CHAPTER 217. MILK AND DAIRY

SUBCHAPTER D. BULK MILK REGULATIONS

The executive commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Texas Department of State Health Services (DSHS), proposes amendments to §217.61, concerning Bulk Milk Hauler/Sampler Qualifications and Requirements; §217.62, concerning Bulk Milk Holding Tanks; §217.63, concerning Milk Tank Trucks; §217.64, concerning Unloading Stations and Milk Tank Truck Cleaning Facilities; and §217.65, concerning Responsibilities of the Bulk Milk Hauler/Sampler.

BACKGROUND AND PURPOSE

The purpose of the proposal is to update and clarify regulations related to bulk milk operations to ensure consistency with current industry practices and federal requirements in the Grade "A" Pasteurized Milk Ordinance (PMO). The proposed amendments to Chapter 217, Subchapter D, are necessary to align rule language with current federal standards governing the production, transportation, and handling of milk and dairy products in interstate commerce and to reflect current program practices.

The proposed amendments remove references to the PMO because it is adopted by reference in §217.2, relating to Adopted Regulations and Standards for milk. The proposal updates terminology, improves clarity, and incorporates plain language revisions to enhance readability and understanding. The proposed amendments also remove duplicative or unnecessary provisions and clarify existing requirements without creating new regulatory obligations.

SECTION-BY-SECTION SUMMARY

The proposed amendment to §217.61 requires bulk milk haulers and samplers to collect a temperature control at the first stop and label it appropriately and updates a reference.

The proposed amendment to §271.62 updates a reference.

The proposed amendment to §217.63 allows DSHS to honor the milk tank truck permits of the regulatory agencies of other states and modifies the requirement that milk tank trucks be inspected every 12 months to every 24 months.

The proposed amendment to §217.64 removes the requirement for unloading stations to provide agitation equipment and a minimum agitation time of milk prior to sampling; uses the department issued certification number instead of the sample collector's driver's license number; removes outdated or unnecessary requirements, including limitations on the distance between unloading and wash stations, and duplicative provisions to improve clarity and consistency; revises cleaning requirements to align with manufacturer specifications for cleaning solutions; allows milk tank trucks to deliver to only one facility without a wash tag if the facility can demonstrate that cleaning and sanitizing occurred; and updates a reference.

The proposed amendment to §217.65 requires bulk milk haulers and samplers to request certification renewal before certification expires and updates a reference.

FISCAL NOTE

Christy Havel Burton, Chief Financial Officer, has determined that for each year of the first five years that the rules will be in effect, enforcing or administering the rules does not have foreseeable implications relating to costs or revenues of state or local governments.

GOVERNMENT GROWTH IMPACT STATEMENT

DSHS has determined that during the first five years that the rules will be in effect:

(1) the proposed rules will not create or eliminate a government program;

(2) implementation of the proposed rules will not affect the number of DSHS employee positions;

(3) implementation of the proposed rules will result in no assumed change in future legislative appropriations;

(4) the proposed rules will not affect fees paid to DSHS;

(5) the proposed rules will not create a new regulation;

(6) the proposed rule will expand existing regulations;

(7) the proposed rules will not change the number of individuals subject to the rules; and

(8) the proposed rules will not affect the state's economy.

SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS

Christy Havel Burton has also determined that there will be no adverse economic effect on small businesses, micro-businesses, or rural communities. The rules do not impose any additional costs on small businesses, micro-businesses, or rural communities that are required to comply with the rules.

LOCAL EMPLOYMENT IMPACT

The proposed rules will not affect a local economy.

COSTS TO REGULATED PERSONS

Texas Government Code §2001.0045 does not apply to these rules because the rules are necessary to protect the health, safety, and welfare of the residents of Texas, do not impose a cost on regulated persons, and are necessary to comply with federal law.

PUBLIC BENEFIT AND COSTS

Dr. Timothy Stevenson, Deputy Commissioner, Consumer Protection Division, has determined that for each year of the first five years the rules are in effect, the public will benefit from improved clarity and consistency in bulk milk regulations and alignment with federal standards that support safe milk production and transport.

Christy Havel Burton has also determined that for the first five years the rules are in effect, there are no anticipated economic costs to persons who are required to comply with the proposed rules because the regulated entities are already in compliance with the federal regulations and program practices.

TAKINGS IMPACT ASSESSMENT

DSHS has determined that the proposal does not restrict or limit an owner's right to the owner's property that otherwise exists in the absence of government action and, therefore, does not constitute a taking under Texas Government Code §2007.043.

PUBLIC COMMENT

Written comments on the proposal, including information related to the cost, benefit, or effect of the proposed rule, as well as any applicable data, research, or analysis, may be submitted to Rules Coordination Office, P.O. Box 13247, Mail Code 4102, Austin, Texas 78711-3247, or street address 4601 West Guadalupe Street, Austin, Texas 78751; or emailed to HSRulesCoordinationOffice@hhs.texas.gov.

To be considered, comments must be submitted no later than 31 days after the date of this issue of the Texas Register. Comments must be (1) postmarked or shipped before the last day of the comment period; (2) hand-delivered before 5:00 p.m. on the last working day of the comment period; or (3) emailed before midnight on the last day of the comment period. If the last day to submit comments falls on a holiday, comments must be postmarked, shipped, or emailed before midnight on the following business day to be accepted. When emailing comments, please indicate "Comments on Proposed Rule 26R066" in the subject line.

STATUTORY AUTHORITY

The amendments are authorized by Texas Government Code §524.0151, which provides that the executive commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services system, Texas Health and Safety Code §1001.075, which authorizes the executive commissioner of HHSC to adopt rules and policies for the operation and provision of health and human services by DSHS and for the administration of Texas Health and Safety Code Chapter 1001.

The amendments implement Texas Government Code §524.0151 and Texas Health and Safety Code Chapter 1001 and §435.003.

§217.61. Bulk Milk Hauler/Sampler Qualifications and Requirements.

(a) Requirements for Bulk Milk Hauler/Sampler Certifications [bulk milk hauler/sampler certifications].

(1) Each bulk milk hauler/sampler candidate must [shall] complete a [comprehensive] training program provided or approved by the department. The program must teach how [, which shall include a course teaching specific procedures necessary] to transport [properly handle] milk from the dairy farm to the unloading [plant, receiving station, or transfer] station. This program must [shall further] include [practical] field training and evaluation in handling [sufficient to develop a proficient working knowledge of proper] bulk milk [handling procedures].

(2) Each [After training has been completed, each] hauler/sampler candidate must [shall] pass a written test [qualifying examination] administered by the department. The department denies certification to candidates who score below 70 percent. Retesting is necessary until a candidate receives a passing score. [Candidates failing the exam with a score of less than 70%, shall be denied permits or licenses until they can achieve a passing score of 70%. The examination should be adequate enough to determine if a bulk milk hauler/sampler is competent.] The test must include at least [exam shall be composed of a minimum of] 20 total questions broken down into the following areas:

(A) six questions about [relating to] sanitation and personal cleanliness;

(B) six questions about [relating to] sampling and weighing procedures;

(C) four questions about [relating to] equipment, including proper use, care, cleaning[, etc.]; and

(D) four questions about [relating to] proper record keeping requirements.

(3) A candidate may use an [An] industry sponsored training program instead [may be used in lieu] of this program, if [provided that]:

(A) such training program meets or exceeds the [minimum standards and] requirements [set forth] in these rules [regulations];

(B) the department has issued written [a letter indicating the] acceptance of the training program; and

(C) the department administers the written test [qualifying examination is administered by the department].

(4) The department certifies individuals who pass the written test and field evaluation. [Bulk milk haulers/samplers successfully qualifying by examination and who have been satisfactorily evaluated in the field will be certified by the department to perform milk hauler/sampler duties.] Only certified [those milk] haulers/samplers having certification issued by the department or by the authorized Regulatory Agency of another state will be allowed to remove milk from a farm bulk milk tank. Only certified samplers may [and] collect milk samples for laboratory testing [examination].

(5) The department must reevaluate certified individuals [All official milk samplers, including bulk milk haulers/samplers, shall be evaluated] at least once every 24 months. Certification will expire on the last day of the same month on which it was issued. The [by the] department or [by] the authorized Regulatory Agency of another state will conduct this evaluation [of another state].

(6) The department may issue temporary hauler/sampler certifications in emergency situations. The department may waive the training, test, and evaluation if the employer proves the individual's competence. This is a [without the prescribed examinations, evaluation and training program, provided acceptable certification of competence is made by the employer of the individual. A] temporary permit that is only valid for 30 days.

(7) The department may suspend a [hauler/sampler] certification if an investigation determines a violation of [when, upon investigation, the department finds a violation of any of the following]:

(A) this subchapter; or

(B) §217.2 of this chapter (relating to Adopted Regulations and Standards) [title (relating to Grade A Pasteurized Milk Ordinance)].

(b) Procedure and Handling Requirements.

(1) Each bulk milk [pickup] tanker must have [shall be supplied with sanitized sample bottles or bags, other] sampling equipment[, and supplies necessary], as required in §217.2 of this chapter, [title] to collect samples [clean and sanitize multi-use equipment used in sampling and pickup operations].

(3) [(2)] All [bulk milk] haulers must provide [operating bulk milk pickup tankers shall make available to the department upon request] a copy of the load manifest and a current list of producers for each route pickup load. These documents must include [with] the following information:

(A) the producer name and number in the order of milk pickup;

(B) the time of arrival at each dairy;

(C) the time of arrival at the unloading station;

(D) the name and address of the unloading station; and

(E) the hauler/sampler name and certification [driver's license] number.

§217.62. Bulk Milk Holding Tanks.

(a) Farm bulk milk tanks must be large enough to hold the milk produced [shall have a capacity adequate for production] between routine pickups. Pickups must occur at least every other day. There must be enough milk in the tank after [The time between pickups shall not exceed every other day. Milk must be of sufficient quantity for adequate mechanical agitation at the completion of] the first milking to allow proper mechanical agitation to achieve a representative sample.

(b) Farm bulk milk tanks must have [shall be equipped with] an indicating thermometer. The thermometer's[, the] sensor must be able to read [of which shall be located to permit the registering of] the temperature of the milk [contents] when the tank contains no more than 20 percent [20%] of its calibrated capacity.

(c) Farm bulk milk tanks must have a [will be equipped with easily accessible] sampling port [ports] or a sample cock.

(d) Farm bulk milk tanks must meet [shall comply with] the requirements of the "Grade A Pasteurized Milk Ordinance" [which is adopted by reference] in §217.2 of this chapter (relating to Adopted Regulations and Standards) [title (relating to Grade A Pasteurized Milk Ordinance)].

§217.63. Milk Tank Trucks.

(a) Each milk tank truck used to transport milk or milk products must have a permit from [to or from a dairy farm, milk plant, or receiving station, shall be permitted by] the department. The department may honor permits issued [or] by the authorized Regulatory Agency of another state. Failure to obtain a permit may result in the department removing the milk tank truck and its contents [being immediately removed] from Grade A milk or food use.

(b) All vehicles and milk tank trucks containing milk or milk products must display [shall be legibly marked with] the name and address of the milk plant or hauler in possession of the contents. The department issued permit sticker must [issued by the department shall] be placed near the outlet valve of the tanker truck or trailer.

(c) The department must inspect [All] milk tank trucks before issuing [must be inspected prior to the issuance of] a permit. Milk tank trucks must be inspected at least [and a minimum of] once each 24 [12] months plus the remaining days of the month. This requirement [thereafter. The requirement for this annual inspection] does not replace [eliminate or supersede] other required regulatory licenses or permits [required by any other official regulatory agency]. The transport [owner or manager of the milk transportation] company must [will] report [verbally or in writing to the department, within ten days, any milk transport tanks taken out of service or] severely damaged or out-of-service tankers to the department within 10 days of the occurrence. This report may be verbal or written.

(d) Milk tank trucks must be [operated] in compliance with the following provisions.

(1) Permanently installed milk tank truck washing equipment must be approved by the department. The equipment must meet 3-A Sanitary Standards and Accepted Practice standards [be in compliance with the current edition of the 3-A Sanitary Standards and Accepted Practices at the time of installation and be approved by the department]. This equipment must [shall be so designed that it will properly] clean and sanitize all milk-contact surfaces when using [connected to] a cleaning system. Cleaning and sanitizing must occur at an approved milk tank truck cleaning facility.

(2) Each milk tank truck must provide [bulk milk pickup tanker shall be provided with adequate] space for sanitary storage[,] without overcrowding of the equipment and supplies. Storage items may include:[, of] fittings, valves, milk pumps, racks for milk conducting equipment, wrenches, sample bottles, dippers, solutions for washing and sanitizing milk contact equipment, and all other equipment used for milk handling and sampling purposes.

(3) Compartment [When compartment] milk tank trucks must not transport [are used,] Grade A milk [shall not be permitted to be hauled] in one compartment and [while] ungraded milk or another product [is being hauled] in another compartment [on the same tanker].

(4) Certified samplers must protect the milk from contamination during agitation and sampling. These [Agitating and sampling milk in a milk tank truck shall be accomplished in such a manner as to provide maximum protection against product contamination. In no instance shall these] activities must occur [be performed] at a department approved [place other than a] location [approved by the department].

(5) Milk tank trucks must [may] not [be used to] transport poisonous or toxic substances.

(6) Pasteurized product tankers must not transport microbiological products, including raw milk, raw milk products, and raw egg products, that could cause contamination. The department determines what a microbiological product is. Pasteurized milk transported in a potentially microbiological contaminated tanker must be re-pasteurized. Pasteurized product tankers must not transport chemical products that could cause contamination [Milk tank trucks transporting pasteurized milk or milk products that will not be re-pasteurized at the receiving milk processing plant shall not be used to transport raw milk, raw egg products, or any other product determined by the department to be a source of microbiological or chemical contamination].

§217.64. Unloading Stations and Milk Tank Truck Cleaning Facilities.

(a) Milk tank truck unloading stations.

(1) An [When the milk tank truck] unloading station operating as [is] a receiving station or a milk processing plant must follow [, it shall comply with the following] sanitation rules. The requirements for equipment are located in §217.2 of this chapter (relating to Adopted Regulations and Standards). These requirements cover areas, including [requirements for Grade A pasteurized milk as specified in the "Grade A Pasteurized Milk Ordinance" which is adopted by reference in §217.2 of this title (relating to Grade A Pasteurized Milk Ordinance)]:

(A) floors;

(B) walls and ceilings;

(C) doors and windows;

(D) lighting and ventilation;

(E) toilet-sewage disposal facilities;

(F) water supply;

(G) hand-washing facilities;

(H) milk plant cleanliness;

(I) sanitary piping;

(J) construction and repair of containers and equipment;

(K) cleaning and sanitizing of containers and equipment;

(L) storage of cleaned containers and equipment;

(M) storage of single service containers, utensils, and materials;

(N) protection from contamination;

(O) cooling of milk;

(P) personnel cleanliness; and

(Q) surroundings.

(2) Unloading stations operating as transfer stations must follow [When the unloading station is a transfer station, it shall comply with] all receiving station [the] requirements . The rules [of a receiving station except that the provisions] for walls, ceilings, doors, and windows do not apply [are not required] unless climatic and operation conditions interfere with safe handling of the milk. Unloading stations must provide overhead [Overhead] protection [shall be provided] in all cases.

(3) The unloading [pump-out] of the tanker must take place [milk tank truck shall be done] in an area where a cover extends over the entire milk tank truck. Unloading must occur in an enclosed space when the environment prevents safe handling of the milk. Unloading stations must [complete transport tank or, when climatic and operating conditions require, in a completely enclosed area. Pump-out operations must be protected in such a manner as to] prevent product contamination during the unloading process. Manhole or air inlet vents must have a suitable filter if the unloading area is not enclosed. Suitable filters are also required if the station doors are open during unloading. [If the area is not completely enclosed or doors of the unloading area are open during unloading, a suitable filter is required for the manhole or the air inlet vent.]

(4) Unloading stations must protect the milk from contamination during milk tank truck agitation and sampling. Only certified milk samplers may collect official representative "universal" samples [The agitating and sampling of the transport tank milk shall be accomplished in such a manner as to provide maximum protection against product contamination. The unloading station shall provide the necessary equipment to adequately agitate the milk in the transport tank. The milk shall be agitated for a minimum of 15 minutes prior to obtaining samples. The department may approve alternative procedures to achieve adequate agitation. Samples shall be collected only by certified milk samplers. In no instance shall agitation and sampling be done at a place other than a location approved by the department].

(5) The unloading station must keep a [shall] record of [the following information on] each load of milk received for at least[, and maintain these records for a period of not less than] 90 days. The information recorded must include:

(A) the date the load was received;

(B) the time received;

(C) the number of pounds in the load;

(D) the temperature of the milk when received [upon receipt];

(E) the permit number of the milk tank truck delivering the milk;

(F) the name of the station operator receiving the milk; and

(G) the manifest with the [driver's license number of the] sample collector's certification number [collector].

(6) Unloading stations must not receive milk [In no case shall milk be received] from a milk tank truck that appears [to be] damaged or [,] dirty. Unloading stations must not receive milk from a milk tank truck that[, or] does not have a current wash [cleaning] tag, except as provided in subsection (b)(7) of this section, without the permission of the department.

(b) Milk Tank Truck Cleaning Facilities.

(1) Each [It shall be the responsibility of each] unloading station must [to] provide a milk tank truck cleaning facility. This [The milk tank truck cleaning] facility may be [an integral] part of the unloading station or a separate facility. Only permitted facilities may wash and sanitize milk tank trucks. [When the milk tank truck cleaning facility is a separate facility, it shall be located convenient to and in the proximity of the unloading station. All milk tank trucks that transport milk and milk products as permitted by the department, shall be washed and sanitized at a permitted milk plant, receiving station, transfer station, or milk tank truck cleaning facility.]

(2) The milk tank truck cleaning facilities must follow [facility shall comply with] the same [following] sanitation rules as [requirements for Grade A pasteurized milk] unloading stations. The requirements for cleaning and sanitizing are located in §217.2 of this chapter. These requirements cover areas listed in (a)(1)(A)-(Q) of this rule. [of the "Grade A Pasteurized Milk Ordinance:" floors; walls and ceilings; doors and windows; lighting and ventilation; toilet-sewage disposal facilities; water supply; hand-washing facilities; milk plant cleanliness; sanitary piping; construction and repair of containers and equipment; cleaning and sanitizing of containers and equipment; storage of cleaned containers and equipment; storage of single service containers, utensils, and materials; protection from contamination; cooling of milk; personnel cleanliness; and surroundings.]

(3) Unloading stations may receive [An unloading station which receives milk in] milk tank trucks [equipped] with permanently installed tank washers. These stations must [will] provide a milk tank truck cleaning facility [equipped] with the following:

(A) [adequate] water heating facilities or equipment capable of providing a supply of hot water to complete all cleaning and sanitization processes without interruption;

(B) tanks [of an adequate size] to hold the rinsing, washing, [rinse, wash,] and sanitizing solutions to complete all cleaning and sanitization processes without interruption [solution];

(C) a wash pump to [which will] deliver [the] cleaning and sanitizing solutions [solution] to the inside [milk-contact surface] of the milk tank truck and the delivery to the milk-contact surfaces must be at a [an adequate] rate and velocity to clean and sanitize all milk-contact surfaces;

(D) a removal pump to [which will] remove rinsing [rinse] and cleaning solutions from the tanker [milk tank truck] as fast as such solutions are pumped into the milk tank truck;

(E) a cleaned and sanitized screen to [a screening device shall be provided which will] prevent [the passage of any] foreign material from entering [into] the system [that would adversely affect the performance of the spray device(s), and located so as to be easily cleaned and sanitized];

(F) a temperature recorder and pressure indicator, which meets current equipment [the applicable] requirements located in §217.2 of this chapter and: [of the most current revision of the "Grade A Pasteurized Milk Ordinance" shall be provided. In addition, a pressure indicator should be provided. These may be an integral unit or separate units.]

(i) the [The] temperature sensor must [should] be located in the return solution line;[.]

(ii) the [The] pressure sensor must [shall] be located in the solution-rinse line downstream from the pressure supply pump;[.]

(iii) recording [Recording] charts must show the [shall be properly identified (showing] date, permit number of milk tank truck, and [transportation tank cleaned,] operator's initials; and[, etc.)]

(iv) the unloading station must keep temperature recording charts [and kept] on file for at least [not less than] 90 days;

(G) cleaning [the necessary] equipment: [shall be provided]

(i) for [the] cleaning [of transport] tank pumps, gaskets, hoses, and other parts or equipment [etc.], which do not clean in place (CIP);

(ii) for cleaning [. Equipment shall be provided to clean the] hoses by circulating [circulation of] cleaning solution [in conjunction] with a [the] clean-out-of-place (COP) vat [that is equipped] with a temperature recorder that [which] meets the [applicable] requirements of §217.2 of this chapter; and

(iii) if a built-in CIP system and equipment are used for circulation to clean equipment, it must [of the most current revision of the "Grade A Pasteurized Milk Ordinance;" however, if an integrated CIP system designed to clean transport tanker, milk pumps, gaskets, hoses and appurtenances, by circulation is provided, the following criteria must be met]:

(I) [(i)] include a temperature recorder and a pressure indicator that meet [complies with the applicable] requirements of §217.2 of this chapter [the most current revision of the "Grade A Pasteurized Milk Ordinance" and a pressure recorder shall be provided];

(II) [(ii)] provide an [the] extended tube holder for cleaning [milk] hoses long enough [and receiving hoses shall be of adequate length] to accommodate up to 35 feet in length of hoses [of 35 feet maximum length];

(III) [(iii)] provide cleaning programs for the CIP system that must include [shall provide a cleaning regimen for a] pre-rinse, wash, post-rinse, and sanitize cycles; the system must clean and sanitize milk tank trucks, [sanitizing of the transport tanker,] milk pumps, gaskets, hoses, receiving hose, and related parts [appurtenances]; and

(IV) [(iv)] ensure [the CIP system shall be capable of a minimum] wash temperature that meets the requirements of the approved cleaning solution [of 135 degrees Fahrenheit] and minimum circulation flow rate of five feet per second; [and]

(H) [all] equipment and utensils must meet [be in compliance with the current edition of the] 3-A Sanitary Standards and Accepted Practices standards at the time of installation; and

(I) the milk tank truck cleaning facility must establish and post a cleaning procedure [regimen shall be established and posted in the milk tank truck cleaning facility]. This procedure must [regimen shall] provide for pre-rinsing [a pre-rinse] and sanitizing of the milk tank truck. The wash solution must meet [have a minimum] temperature requirements of the approved cleaning solution. The facility must measure the temperature in the return line [of 135 degrees Fahrenheit].

(4) An [The department may permit an] unloading station may use a [to utilize a milk tank truck] cleaning facility [equipped only] with portable [tank] washing equipment. Portable washing equipment can include drop-in washers. The unloading station must get department approval if it only has portable washing equipment. The station must have [(drop in washers) or with] the equipment and personnel necessary to manually clean tankers. The department may approve the use of portable washing equipment only if the station demonstrates it can effectively clean and sanitize milk tank trucks. A station approved under this paragraph may unload a milk tank truck equipped with an installed tank washer only with department permission, which the department grants [for manual tank cleaning, providing the station can demonstrate the capability of effectively cleaning and sanitizing the milk tank trucks. In no case will milk tank trucks equipped with installed tank washers be unloaded into said unloading stations without the permission of the department. This permission will be granted] only in emergency situations.

(5) All milk tank trucks, equipment, and related parts must be cleaned on the same day they are used. A milk tank truck and its related parts must be cleaned after each use, unless the truck is used continuously to pick up multiple loads during a 24-hour period. In that case, the truck and its related parts must be washed at the end of the 24-hour period. [The milk tank truck and appurtenances shall be thoroughly cleaned after each use and all equipment shall be thoroughly cleaned at least once each day used. It is allowable to pick up multiple loads continuously within a 24-hour period, provided the milk tank truck is washed after each day's use.]

(6) The milk tank truck and its related parts must [appurtenances shall] be sanitized with an approved sanitizer immediately after being washed [washing with an approved sanitizer]. The wash-rinse system must pump [milk tank truck shall be sanitized by pumping] the sanitizing solution through the tanker. Cleaned and sanitized milk tank trucks not used within 96 hours of being cleaned and sanitized [the wash-rinse system. When the time elapsed after cleaning and sanitizing, and before its first use, exceeds 96 hours, the tank] must be re-sanitized.

(7) The cleaning facility must attach a [A] cleaning and sanitizing tag [shall be affixed] to the outlet valve of the tanker. This cleaning and sanitizing tag must remain attached [milk tank truck] until the milk tank truck is unloaded. When unloading the milk, unloading stations must remove the wash tag and keep it for at least 15 days. Haulers and unloading stations must verify cleaning and sanitizing occurred before loading or unloading a milk tank truck missing a wash tag. Milk tank trucks delivering to only one facility do not need a cleaning and sanitizing tag if the facility can prove cleaning and sanitizing occurred. [next washed and sanitized. When the milk tank truck is washed and sanitized, the previous cleaning and sanitizing tag shall be removed and stored at the location where the milk tank truck was washed for a period of not less than 15 days.] The cleaning and sanitizing tag must include [shall bear] the following information:

(A) the milk tank truck permit number;

(B) the date and time cleaning and sanitizing occurred [it was cleaned and sanitized];

(C) the name and location of the cleaning facility [station]; and

(D) the name of the person who cleaned and sanitized the milk tank truck.

§217.65. Responsibilities of the Bulk Milk Hauler/Sampler.

Duties and responsibilities of the Bulk Milk Hauler/Sampler must comply [shall be in compliance] with §217.2 of this chapter (relating to Adopted Regulations and Standards) [title (relating to Grade A Pasteurized Milk Ordinance)]. In addition, the Bulk Milk Hauler/Sampler must [shall]:

(1) agitate the farm bulk milk tank for a minimum of 10 [ten] minutes, or longer, if necessary to obtain a representative sample;[. Larger tanks may require more time; and]

(2) deliver producer samples to a department approved [designated] place and personnel; and [as approved by the department.]

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on September 24, 2026.

TRD-202604128

Cynthia Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: November 8, 2026

For further information, please call: (512) 289-1704

CHAPTER 229. FOOD AND DRUG

The executive commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Texas Department of State Health Services (DSHS), proposes an amendment to Subchapter P §229.261, concerning Assessment of Administrative Penalties; and new Subchapter JJ, Shrimp Labeling, consisting of §229.1101, concerning Purpose and Scope; §229.1102, concerning Definitions; §229.1103, concerning Exemptions; §229.1104, concerning Shrimp Labeling; §229.1105, concerning Records; and §229.1106, concerning Enforcement.

BACKGROUND AND PURPOSE

The proposal is necessary to comply with Senate Bill (SB) 823, 89th Legislature, Regular Session, 2025, which amended Texas Health and Safety Code (HSC) Chapter 436, Subchapter F, by adding §436.083. HSC §436.083 requires wholesalers to label shrimp as imported if the shrimp does not satisfy the United States country of origin requirements for wild or farm-raised shellfish established by Title 7 Code of Federal Regulations §60.128, or successor regulations. SB 823 allows DSHS to assess administrative penalties for violators that are required to license with DSHS according to HSC Chapter 431. The proposal amends §229.261 by adding HSC Chapter 436 for penalty assessment and adds new Subchapter JJ to implement labeling requirements.

SECTION-BY-SECTION SUMMARY

The proposed amendment to §229.261 adds a reference to HSC Chapter 436 for the assessment of administrative penalties, updates rule citation for formal hearing rules, and makes plain language revisions to improve clarity, readability, and consistency with current drafting standards.

Proposed new Subchapter JJ, Shrimp Labeling, adds a new subchapter in Chapter 229 to implement state legislation as listed below.

Proposed new §229.1101 describes the purpose and scope of the rule. Statutory authority and the applicability of the rule to shrimp wholesaled into and within Texas are described in this section.

Proposed new §229.1102 establishes the definitions used throughout the subchapter.

Proposed new §229.1103 establishes exemptions to the rule.

Proposed new §229.1104 establishes the labeling requirements for shrimp.

Proposed new §229.1105 establishes the records wholesalers must retain to substantiate the labeling.

Proposed new §229.1106 establishes DSHS' authority to assess administrative penalties for rule violations.

FISCAL NOTE

Christy Havel Burton, Chief Financial Officer, has determined that for each year of the first five years that the rules will be in effect, enforcing or administering the rules does not have foreseeable implications relating to costs or revenues of state or local governments.

GOVERNMENT GROWTH IMPACT STATEMENT

DSHS has determined that during the first five years that the rules will be in effect:

(1) the proposed rules will not create or eliminate a government program;

(2) implementation of the proposed rules will not affect the number of DSHS employee positions;

(3) implementation of the proposed rules will result in no assumed change in future legislative appropriations;

(4) the proposed rules will not affect fees paid to DSHS;

(5) the proposed rules will create a new regulation;

(6) the proposed rules will expand existing regulations;

(7) the proposed rules will not change the number of individuals subject to the rules; and

(8) the proposed rules will not affect the state's economy.

SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS

Christy Havel Burton has also determined that there will be an adverse economic effect on small businesses or micro-businesses, or rural communities.

DSHS estimates that the number of small businesses and micro-businesses subject to the proposed rules is approximately 8,200. DSHS cannot estimate the projected economic impact for a small business and micro-business due to insufficient data.

DSHS determined that alternative methods to achieve the purpose of the proposed rules for small businesses, micro-businesses, or rural communities would not be consistent with ensuring the health and safety of consumers of shrimp.

LOCAL EMPLOYMENT IMPACT

The proposed rules will not affect a local economy.

COSTS TO REGULATED PERSONS

Texas Government Code §2001.0045 does not apply to these rules because the rules are necessary to protect the health, safety, and welfare of the residents of Texas and are necessary to implement legislation that does not specifically state that §2001.0045 applies to the rules.

PUBLIC BENEFIT AND COSTS

Timothy Stevenson, DVM, Ph.D., Deputy Commissioner, Consumer Protection Division, has determined that for each year of the first five years the rules are in effect, the public benefit will be increased consumer awareness and greater transparency for customers and seafood markets about the shrimp's origin.

Christy Havel Burton has also determined that for the first five years the rules are in effect, persons who are required to comply with the proposed rules may incur economic costs because the new requirements may cause shrimp wholesalers to update labels or labeling, procedures, provide additional training, and maintain records to substantiate the label. Shrimp wholesalers may incur costs to come into compliance with the requirements.

TAKINGS IMPACT ASSESSMENT

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

PUBLIC COMMENT

Written comments on the proposal, including information related to the cost, benefit, or effect of the proposed rule, as well as any applicable data, research, or analysis, may be submitted to Rules Coordination Office, P.O. Box 13247, Mail Code 4102, Austin, Texas 78711-3247, or street address 4601 West Guadalupe Street, Austin, Texas 78751; or emailed to HHSRulesCoordinationOffice@hhs.texas.gov.

To be considered, comments must be submitted no later than 31 days after the date of this issue of the Texas Register. Comments must be (1) postmarked or shipped before the last day of the comment period; (2) hand-delivered before 5:00 p.m. on the last working day of the comment period; or (3) emailed before midnight on the last day of the comment period. If the last day to submit comments falls on a holiday, comments must be postmarked, shipped, or emailed before midnight on the following business day to be accepted. When emailing comments, please indicate "Comments on Proposed Rule 26R051" in the subject line.

SUBCHAPTER P. ASSESSMENT OF ADMINISTRATIVE PENALTIES

STATUTORY AUTHORITY

The amendment is authorized by Texas Government Code §524.0151, and Texas Health and Safety Code (HSC) §1001.075, which authorize the executive commissioner of HHSC to adopt rules and policies for the operation and provision of health and human services by DSHS and for the administration of HSC Chapter 1001.

The amendment implements Texas Government Code §524.0151, HSC Chapter 1001, and HSC §436.083.

§229.261. Assessment of Administrative Penalties.

(a) Proposals for assessment of administrative penalties. The Texas Department of State Health Services (department) proposes [department shall propose to assess] administrative penalties in accordance with [the requirements of the] Texas Health and Safety Code (HSC)[,] Chapter 146, concerning Tattoo and Certain Body Piercing Studios; Chapter 431, concerning Texas Food, Drug, and Cosmetic Act; Chapter 432, concerning Texas Food, Drug, Device, and Cosmetic Salvage Act; Chapter 436, concerning Aquatic Life; and Chapter 437, concerning Regulation of Food Service Establishments, Retail Food Stores, Mobile Food Units, and Roadside Food Vendors.

(b) Assessment of administrative penalties and conduct of hearings. The department must [shall] assess administrative penalties and conduct hearings pursuant to those administrative penalties according to [in accordance with] the appropriate statute in subsection (a) of this section and rules adopted under it; the Administrative Procedure Act, Texas Government Code[,] Chapter 2001; and the department's formal hearing rules under Chapter 1 of this title (relating to Miscellaneous Provisions) [procedures in §§1.21, 1.23, 1.25, and 1.27 of this title (relating to Formal Hearing Procedures)].

(c) Criteria for the assessment of administrative penalties. The department must [shall] assess administrative penalties based on [upon] one or more of the following criteria:

(1) history of previous violations;

(2) seriousness of the violation;

(3) danger [hazard] to the health and safety of the public;

(4) demonstrated good faith efforts to correct;

(5) economic harm to property or the environment;

(6) amounts necessary to deter future violations;

(7) enforcement costs relating to the violation; and

(8) any other matter justice may require.

(d) Severity levels. The violations must [shall] be categorized by one of the following severity levels.

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

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

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

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

(5) Severity Level V covers violations that are of minor health or safety significance.

(e) Levels of penalties. Except [as provided] for [in] subsection (f) of this section [relating to retail food establishments] and subsection (g) of this section [relating to tattoo studios], the department will impose different levels of penalties per day, per violation, for the following severity level violations:

(1) Level I--Up to $25,000;

(2) Level II--Up to $15,000;

(3) Level III--Up to $10,000;

(4) Level IV--Up to $5,000; and

(5) Level V--Up to $2,500.

(f) Levels of penalties for retail food establishments. For [As to] retail food establishments permitted under HSC [Texas Health and Safety Code,] Chapter 437, the department will impose different levels of penalties per day, per violation, for the following severity level violations:

(1) Level I--Up to $10,000;

(2) Level II--Up to $7,500;

(3) Level III--Up to $5,000;

(4) Level IV--Up to $2,500; and

(5) Level V--Up to $1,250.

(g) Levels of penalties for tattoo and body-piercing studios. For [As to certain] tattoo and body-piercing studios licensed under HSC [Texas Health and Safety Code,] Chapter 146, the department will impose different levels of penalties per day, per violation, for the following severity level violations:

(1) Level I--Up to $5,000;

(2) Level II--Up to $4,000;

(3) Level III--Up to $3,000;

(4) Level IV--Up to $2,000; and

(5) Level V--Up to $1,000.

(h) Adjustments to penalties. The department may adjust the penalties listed in subsections (e), (f), or (g) of this section for any one of the following factors.

(1) Previous violations. The department may consider previous violations. The penalty may be reduced or increased for past performance. Past performance involves the consideration of the following factors:

(A) whether the previous violation was identical or similar to the current violation;

(B) how recent was the previous violation;

(C) the number of previous violations; and

(D) the violator's response to previous violations in regard to correction of the problem.

(2) Demonstrated good faith. The department may consider good faith efforts of the violator to correct the violations and demonstrate compliance with the department's rules and regulations as a basis to reduce the proposed penalty. The penalty may be reduced if good faith efforts to correct a violation have been, or are being made. Good faith effort is determined by the department on a case-by-case basis. All good faith efforts to comply with the department's rules and regulations must be fully documented by the violator to merit consideration from the department [as to whether] to reduce the proposed penalty.

(3) Danger [Hazard] to the health and safety of the public. The department may consider the danger [hazard] to the health and safety of the public. The penalty may be increased when a direct danger [hazard] to the health and safety of the public is involved. The department will consider [shall take into account], but is [need] not [be] limited to, the following factors:

(A) whether any deaths, diseases, or injuries have occurred from the violation;

(B) whether any existing conditions contribute to a situation that could expose humans to a danger to health [hazard];

(C) the impact that the danger [hazard] has on various segments of the population such as children, surgical patients, and the elderly; and

(D) whether the consequences would be of an immediate or long-range danger to health [hazard].

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on September 24, 2026.

TRD-202604126

Cynthia Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: November 8, 2026

For further information, please call: (512) 834-6670

SUBCHAPTER JJ. SHRIMP LABELING

STATUTORY AUTHORITY

The new sections are authorized by Texas Government Code §524.0151, and Texas Health and Safety Code (HSC) §1001.075, which authorize the executive commissioner of HHSC to adopt rules and policies for the operation and provision of health and human services by DSHS and for the administration of HSC Chapter 1001.

The new sections implement Texas Government Code §524.0151, HSC Chapter 1001, and HSC §436.083.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on September 24, 2026.

TRD-202604127

Cynthia Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: November 8, 2026

For further information, please call: (512) 834-6670