PART 1. DEPARTMENT OF STATE HEALTH SERVICES

CHAPTER 221. MEAT SAFETY ASSURANCE

SUBCHAPTER B. MEAT AND POULTRY INSPECTION

25 TAC §§221.11 - 221.16

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), proposes amendments to §221.11, concerning Federal Regulations on Meat and Poultry Inspection; §221.12, concerning Meat and Poultry Inspection; §221.13, concerning Enforcement and Penalties; §221.14, concerning Custom Exempt Slaughter and Processing; Low-Volume Poultry or Rabbit Slaughter Operations; §221.15, concerning Inspection of Alternate Source Food Animals; and §221.16, concerning Fees.

BACKGROUND AND PURPOSE

The purpose of the proposal is to implement Senate Bill (S.B.) 691, 88th Legislature, Regular Session, 2023, that amended Subchapter A, Chapter 433, Texas Health and Safety Code by adding §433.0065, relating to an animal share exemption for certain meat and meat food products and providing for a civil penalty. The proposed amendments provide guidance regarding how producers may engage in the slaughtering, processing, labeling, and distribution of meat and meat food products produced for members of an animal share while remaining in compliance with state and federal laws and the regulatory requirements of 25 Texas Administrative Code (TAC) §221.14.

The proposed amendments also implement S.B. 664, 88th Legislature, Regular Session, 2023, that amended Subchapter D, Chapter 431, Texas Health and Safety Code, by adding §431.0805, that defines analogue and cell-cultured food products as distinguished from the definitions of "meat," "poultry," "meat food products," and "poultry food products." The proposed amendments update, correct, improve, and clarify the rule language and incorporate plain language where appropriate.

SECTION-BY-SECTION SUMMARY

The proposed amendment to §221.11 includes a revision to the exemption listed for 9 Code of Federal Regulations (CFR) §303 and the removal of 9 CFR §355, and revises the DSHS Meat Safety website address.

The proposed amendment to §221.12 adds the definitions for "animal share," "meat," and "meat food product" as required by S.B. 691, 88th Legislature, Regular Session, 2023, and S.B. 664, 88th Legislature, Regular Session, 2023. This proposal also revises the definitions for "custom exempt operation," "custom processor," "custom slaughterer," "department," "federal regulations," "feral swine," "game animals," "grant of custom exemption," "heat-treated," "meat safety assurance section," "poultry," "poultry or rabbit exemption," and "slaughter" for clarity. Definitions for the terms "humane slaughter," "livestock producer," "official slaughter establishments premises," "poultry product," and "ritual cut" have been added. Revisions also add to the basic requirements to receive a grant from DSHS. Rules covering the humane treatment of livestock were moved from §221.14 to §221.12. Other minor revisions were made for clarity.

The proposed amendment to §221.13 includes additional examples of violations for severity levels I-V.

The proposed amendment to §221.14 includes combining rules required by both custom slaughter and custom processing establishments into one section for better clarity; consolidating and moving rules for the humane treatment of livestock from §221.14 to §221.12; revising temperature charts for the cooking of custom prepared meat and poultry products and renumbering those related figures, §221.14(c)(10)(B)(i) and §221.14(c)(10)(B)(ii); and updating the requirements for the custom slaughter and processing of co-owned livestock. The rule title is updated to include animal share, "Custom Exempt Slaughter and Processing; Animal Share and Low-Volume Poultry or Rabbit Slaughter Operations."

The proposed amendment to §221.15 includes the removal of subsection (e), Rabbits, and its reference to 9 CFR §354; subsection (f), Migratory water fowl, game birds, squab, and its reference to 9 CFR §362; and subsection (g), Certified products for dogs, cats, and other carnivora, and its reference to 9 CFR §355. Other minor revisions were made for clarity.

The proposed amendment to §221.16 updates language surrounding fees for clarity and incorporates plain language.

FISCAL NOTE

Christy Havel Burton, Chief Financial Officer, has determined, for each year of the first five years 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 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 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 implement legislation that does not specifically state that §2001.0045 applies to the rules.

PUBLIC BENEFIT AND COSTS

Dr. Timothy Stevenson, Associate 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 the enhanced availability and safety of meat and meat food products.

Christy Havel Burton, Chief Financial Officer, 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 these rule amendments do not create any additional fees.

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 may be submitted to Rules Coordination Office, P.O. Box 13247, Mail Code 4102, Austin, Texas 78711-3247, or street address 701 W. 51st 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 23R055" in the subject line.

STATUTORY AUTHORITY

The amendments are authorized by Texas Health and Safety Code Chapters 431 and 433, which direct the Executive Commissioner of HHSC to adopt rules to implement legislation; Texas Government Code §531.0055 and Texas Health and Safety Code §1001.075, which authorize the Executive Commissioner of HHSC to adopt rules necessary 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 §531.0055 and Texas Health and Safety Code Chapters 431, 433 and 1001.

§221.11.Federal Regulations on Meat and Poultry Inspection.

(a) The department adopts by reference the following federal regulations in the Code of Federal Regulations (CFR), as amended.[:]

(1) 9 CFR[,] Part 301, Terminology; Adulteration and Misbranding Standards;

(2) 9 CFR[,] Part 303, Exemptions, except §303.1(a)(2)(i) [§303.1(a) and (b)];

(3) 9 CFR[,] Part 304, Application for Inspection; Grant of Inspection;

(4) 9 CFR[,] Part 305, Official Numbers; Inauguration of Inspection; Withdrawal of Inspection; Reports of Violation;

(5) 9 CFR[,] Part 306, Assignment and Authorities of Program Employees;

(6) 9 CFR[,] Part 307, Facilities for Inspection;

(7) 9 CFR[,] Part 309, Ante-Mortem Inspection;

(8) 9 CFR[,] Part 310, Post-Mortem Inspection;

(9) 9 CFR[,] Part 311, Disposal of Diseased or Otherwise Adulterated Carcasses and Parts;

(10) 9 CFR[,] Part 312, Official Marks, Devices and Certificates;

(11) 9 CFR[,] Part 313, Humane Slaughter of Livestock;

(12) 9 CFR[,] Part 314, Handling and Disposal of Condemned or Other Inedible Products at Official Establishments;

(13) 9 CFR[,] Part 315, Rendering or Other Disposal of Carcasses and Parts Passed for Cooking;

(14) 9 CFR[,] Part 316, Marking Products and Their Containers;

(15) 9 CFR[,] Part 317, Labeling, Marking Devices, and Containers;

(16) 9 CFR[,] Part 318, Entry into Official Establishments; Reinspection and Preparation of Products;

(17) 9 CFR[,] Part 319, Definitions and Standards of Identity or Composition, with the [. The] following requirements applying, [shall apply] except in the case of restaurant menus and signs:[.]

(A) the [The] label of products prepared from bison meat must contain the words "bison meat," "North American bison meat," or "Native American bison meat"; and[."]

(B) the [The] label of products prepared from buffalo meat must contain the words "water buffalo meat," or "Asian buffalo meat";[."]

(18) 9 CFR[,] Part 320, Records, Registration, and Reports;

(19) 9 CFR[,] Part 321, Cooperation with States and Territories;

(20) 9 CFR[,] Part 322, Exports;

(21) 9 CFR[,] Part 325, Transportation;

(22) 9 CFR[,] Part 327, Imported Products;

(23) 9 CFR[,] Part 329, Detention; Seizure and Condemnation; Criminal Offenses;

(24) 9 CFR[,] Part 331, Special Provisions for Designated States and Territories; and for Designation of Establishments Which Endanger Public Health and for Such Designated Establishments;

(25) 9 CFR[,] Part 335, Rules of Practice Governing Proceedings Under [under] the Federal Meat Inspection Act;

(26) 9 CFR[,] Part 350, Special Services Relating to Meat and Other Products;

(27) 9 CFR[,] Part 352, Exotic Animals and Horses; Voluntary Inspection, except 9 CFR §352, Subpart B;

(28) 9 CFR[,] Part 354, Voluntary Inspection of Rabbits and Edible Products Thereof;

[(29) 9 CFR, Part 355, Certified Products for Dogs, Cats, and Other Carnivora; Inspection, Certification, and Identification as to Class, Quality, Quantity, and Condition;]

(29) [(30)] 9 CFR[,] Part 362, Voluntary Poultry Inspection Regulations;

(30) [(31)] 9 CFR[,] Part 381, Poultry Products Inspection Regulations, except §381.10(a)(3) through §381.10(c);

(31) [(32)] 9 CFR[,] Part 416, Sanitation;

(32) [(33)] 9 CFR[,] Part 417, Hazard Analysis and Critical Control Point [(HACCP)] Systems;

(33) [(34)] 9 CFR[,] Part 418, Recalls;

(34) [(35)] 9 CFR[,] Part 424, Preparation and Processing Operations;

(35) [(36)] 9 CFR[,] Part 430, Requirements for Specific Classes of Product;

(36) [(37)] 9 CFR[,] Part 441, Consumer Protection Standards: Raw Products;

(37) [(38)] 9 CFR[,] Part 442, Quantity of Contents Labeling and Procedures and Requirements for Accurate Weights; and

(38) [(39)] 9 CFR[,] Part 500, Rules of Practice.

(b) Copies of these regulations are available via the Internet at www.dshs.texas.gov/meat-safety [https://www.dshs.texas.gov/meat/laws-rules.aspx].

§221.12.Meat and Poultry Inspection.

(a) Introduction. The purpose of this subchapter is to protect the public health by establishing uniform rules to assure that meat and poultry products are clean, wholesome, and truthfully labeled.

(b) Definitions. The following words and terms, when used in this subchapter, [shall] have the following meanings, unless the context clearly indicates otherwise.

(1) Act--The Texas Meat and Poultry Inspection Act, Texas Health and Safety Code[,] Chapter 433.

(2) Adulterated--A carcass, part of a carcass, or a meat food product where:

(A) any part of it is the product of an animal that has died in a manner other than by slaughter;

(B) any part of it consists of a filthy, putrid, or decomposed substance or is for another reason unsound, unhealthy, unwholesome, or otherwise unfit for human food; or

(C) it contains, because of administration of any substance to a live animal or otherwise, an added poison or harmful substance that makes the carcass, part of the carcass, or meat food unfit for human food.

(3) Alternate source food animals--Animals slaughtered and processed for food that are amenable to inspection under the Act but are not amenable to inspection under the Federal Meat Inspection Act (21 United States Code (USC) [U.S.C.] §601 et seq.) or Federal Poultry Products Inspection Act (21 USC [U.S.C.] §451 et seq.).

(4) Animal share--An ownership interest, conveyed and documented before slaughter, in one or more identified livestock animals created by a contract between a livestock producer, who owns the livestock, and a prospective co-owner of the livestock.

(A) Animal shares are defined portions of one or more specifically identified livestock and do not apply to groups of livestock or herds.

(B) Purchase, acquisition, or ownership of animal shares is limited to an individual co-owner. Animal shares may not be purchased, acquired, or owned by groups, businesses, or organizations.

(C) A livestock producer may, but is not required to, own a share of the individual livestock animal at the time of slaughter.

(5) [(4)] Bison--An animal known by the scientific name Bovidae bison bison, commonly known as the North American prairie bison; or an animal known by the scientific name Bovidae bison athabascae, commonly known as the Canadian wood bison.

(6) [(5)] Bison meat--The meat or flesh of a bison.

(7) [(6)] Buffalo--An animal known by the scientific name Bovidae bubalus bubalus, commonly known as the Asian Indian buffalo, water buffalo, or caraboa; an animal known by the scientific name Bovidae syncerus caffer, commonly known as the African buffalo or the Cape buffalo; an animal known by the scientific name Bovidae anoa depressicornis, commonly known as the Celebes buffalo; or an animal known by the scientific name Bovidae anoa mindorenis, commonly known as the Philippine buffalo or Mindoro buffalo.

(8) [(7)] Buffalo meat--The carcass, part of the carcass, or meat food product made in whole or part of a buffalo.

(9) [(8)] Change in ownership--

(A) A change in the business organization operating the business that [which] changes the legal entity responsible for operation of the business; or

(B) any change in control of the business.

(10) [(9)] Commissioner--Commissioner of the Department of State Health Services. For the purposes of this subchapter, the term "Secretary," [Secretary,] when used in 9 Code of Federal Regulations (CFR), means [CFR, shall mean] commissioner.

(11) [(10)] Custom exempt operation--

(A) The slaughtering of livestock or the processing of an uninspected carcass or parts thereof for the owner of that livestock animal, carcass, or parts;[,] a member of the owner's household;[,] or a nonpaying guest or employee of the owner in accordance with Texas Health and Safety Code[,] §433.006; or

(B) the selling of livestock to be slaughtered and processed by the purchaser on premises owned or operated by the seller for the exclusive use of the purchaser;[,] a member of the owner's household;[,] or a nonpaying guest or employee of the owner in accordance with Texas Health and Safety Code[,] §433.006.

(12) [(11)] Custom processor--A person who prepares meat food products from uninspected livestock carcasses or parts thereof for the owner of those carcasses or parts for the exclusive use of the owner, a member of the owner's household, or a nonpaying guest or employee of the owner in accordance with Texas Health and Safety Code[,] §433.006.

(13) [(12)] Custom slaughterer--A person who slaughters livestock for a custom exempt operation [the owner of the livestock animal for the exclusive use of the owner of the livestock or sells livestock to be slaughtered by the purchaser on premises owned or operated by the seller, for the exclusive use of the purchaser of the livestock, a member of the purchaser's (owner's) household, or a nonpaying guest of the purchaser (owner)] in accordance with Texas Health and Safety Code[,] §433.006. Custom slaughter includes all activities related to slaughter, including restraining [of] livestock, cleaning or preparing any equipment used for slaughter such as tools and knives, and cleaning and preparing the slaughter facility.

(14) [(13)] Department--The Department of State Health Services. For the purposes of this subchapter, when using the federal regulations adopted by reference in §221.11 of this subchapter (relating to Federal Regulations on Meat and Poultry Inspection), the terms "United States Department of Agriculture" or "department" mean the Department of State Health Services [the term United States Department of Agriculture, when used in federal regulations adopted by reference by the department in §221.11 of this title (relating to Federal Regulations on Meat and Poultry Inspection), shall mean the department].

(15) Disfavored--Having a negative impact upon the determination to award a Grant of Custom Exemption, Grant of Inspection, or Grant of Voluntary Inspection.

(16) [(14)] Exotic animal--A member of a species of game not indigenous to this state, including axis deer, nilgai antelope, or other cloven hoofed ruminant animal.

(17) [(15)] Federal regulations--Chapter 9 of the Code of Federal Regulations (CFR) as [The regulations] adopted by reference [by the department] in §221.11 of this subchapter [title].

(18) [(16)] Feral swine--Nondomestic descendants of domestic swine that have either escaped or were released and subsequently developed survival skills necessary to thrive in the wild. Some feral swine are outcrossed with "Russian boar." Live feral [Feral] swine delivered to an establishment are subject to the same regulations as domestic swine.

(19) [(17)] Game animals--Wild animals [that are indigenous to this state], not amenable to the Act, for which the hunter must obtain a hunting license from the Texas Parks and Wildlife Department before hunting animals, such as white-tailed deer, mule deer, pronghorn antelope, and big horn sheep.

(20) [(18)] Grant of Custom Exemption--An authorization from the department to engage in a business of custom slaughtering or processing livestock for the owner of the livestock. This exemption is limited to [includes] the exclusive use for [of] the owner, a member of the owner's household, or a nonpaying guest or employee of the owner, in accordance with Texas Health and Safety Code[,] §433.006, provided that the following conditions are met:

(A) the establishment slaughters only sound, healthy livestock and conducts all processing and handling under sanitary standards and procedures resulting in meat products that are not adulterated;

(B) the product meets the marking and labeling requirements as specified in §221.14 of this subchapter [title] (relating to Custom Exempt Slaughter and Processing; Animal Share and Low-Volume Poultry or Rabbit Slaughter Operations); and

(C) the establishment maintains records as specified in §221.14 of this subchapter [title].

(21) [(19)] Grant of Inspection--An authorization issued by the department to engage in a business subject to inspection under the Act.

(22) [(20)] Grant of Voluntary Inspection--An authorization from the department to engage in a business subject to inspection of alternate source food animals under the Act.

(23) [(21)] Granted establishment--Any establishment with a Grant of Inspection, Grant of Voluntary Inspection, or Grant of Custom Exemption.

(24) [(22)] Heat-treated--Meat or poultry products that are offered for human consumption following [ready-to-eat or have the appearance of being ready-to-eat because they received] heat processing.

(25) Humane Slaughter--In the case of cattle, calves, horses, mules, sheep, swine, and other livestock, all animals are rendered insensible to pain by a single blow or gunshot or electrical, chemical, or other means that is rapid and effective, before being shackled, hoisted, thrown, cast, or cut.

(26) [(23)] Livestock--Cattle, sheep, swine, goats, horses, mules, other equines, poultry, domestic rabbits, exotic animals, or domesticated game birds.

(27) Livestock producer--A person actively engaged in livestock production or husbandry.

(28) [(24)] Low-volume livestock operation--For purposes of this subchapter, a low-volume livestock operation includes an establishment that processes fewer than 10,000 domestic rabbits or more than 1,000 but fewer than 10,000 poultry in a calendar year. The term[, but] does not include an establishment that processes 1,000 or fewer poultry raised by the operator of the establishment in a calendar year[,] or processes fewer than 500 domestic rabbits in a calendar year.

(29) Meat--Has the meaning assigned by 9 CFR §301.2. The term does not include an analogue product, or a cell-cultured product as defined in Texas Health and Safety Code §431.0805.

(30) Meat food product--Has the meaning assigned by 9 CFR §301.2. The term does not include an analogue product, or a cell-cultured product as defined in Texas Health and Safety Code §431.0805.

(31) [(25)] Meat Safety Assurance Section--The organization overseen by the state director, within the Department of State Health Services, responsible for meat safety in granted establishments and associated in-commerce products in Texas. For the purposes of this subchapter, the term "Food Safety and Inspection Service (FSIS)," [Food Safety and Inspection Service (FSIS),] when used in federal regulations adopted by reference by the department in §221.11 of this subchapter, means the [title, shall mean] Meat Safety Assurance Section.

(32) Official slaughter establishments premises--Locations where animals are held, including lots, pens, cages, and facilities associated with the holding and movement of livestock or poultry intended for slaughter. These facilities specifically include antemortem pens, suspect pens, alleyways, driveways, unloading areas, and adjoining pens that contain livestock intended for slaughter.

(33) [(26)] Person--Any individual, partnership, association, corporation, or unincorporated business organization.

(34) [(27)] Poultry--Any domesticated bird (chickens, turkeys, ducks, geese, guineas, ratites, or squabs, also termed young pigeons from one to about 30 days of age), whether live or dead. The term does not include an analogue product, or a cell-cultured product as defined in Texas Health and Safety Code §431.0805 [A live or dead domesticated bird].

(35) [(28)] Poultry or Rabbit Exemption--Registration with the department for a person to engage in a low-volume livestock operation of slaughtering and processing poultry, rabbits, or both. The person must raise the animals [of their own raising] on their own property and personally distribute [distributing] the carcasses and parts to retail consumers, restaurants, or other retail establishments, provided [that ] the following conditions are met:

(A) the person slaughters [more than] 500 or more but fewer than 10,000 domestic rabbits or [and/or] more than 1,000 but fewer than 10,000 poultry in a calendar year[, January 1 through December 31 inclusive];

(B) the person does not buy or sell other poultry or rabbit products (except live chicks, baby rabbits, and [and/or ] breeding stock);

(C) the person slaughters only sound, healthy poultry or rabbits and conducts all processes and handling under sanitary standards and procedures resulting in poultry or rabbit products that are not adulterated;

(D) the product meets the marking and labeling requirements as specified in §221.14(e)(4) [§221.14(c)(4)] of this subchapter [title]; and

(E) the poultry is not a ratite.

(36) Poultry product--Has the meaning assigned by 9 CFR §381.1(b). The term does not include an analogue product, or a cell-cultured product as defined in Texas Health and Safety Code §431.0805.

(37) [(29)] Ratite--Poultry such as ostrich, emus, or rhea.

(38) Responsibly connected person--An officer, partner, director, managerial or executive employee, holder or owner of 10 percent or more of the business's voting stock.

(39) Ritual cut--The simultaneous and instantaneous severance of the carotid arteries with a sharp instrument in accordance with the ritual requirements of the Jewish faith or any other religious faith that prescribes a method of slaughter whereby the animal suffers loss of consciousness by anemia of the brain.

(40) [(30)] Slaughter--Methods of [humane] death, for the purpose of food, under sanitary conditions.

(41) [(31)] State director--For the purposes of this subchapter, the term "administrator," [administrator,] when used in federal regulations adopted by reference by the department in §221.11 of this subchapter, means [title, shall mean] state director.

(c) Grant of Inspection, Grant of Voluntary Inspection, or Grant of Custom Exemption.

(1) Basic requirements.

(A) A person must [shall] not engage in a business subject to the Act unless that person has met the standards established by the Act, the federal regulations as adopted by the department, and this subchapter, and has obtained the appropriate Grant of Inspection, Grant of Voluntary Inspection, or Grant of Custom Exemption issued by the department.

(B) A person must [shall] not engage in custom operations unless that person has met the standards established by the Act, the federal regulations, and this subchapter, and has obtained a Grant of Custom Exemption issued by the department.

(C) A person must [shall] not engage in exempted poultry or rabbit slaughter and processing operations unless that person has met the standards established by the Act, the federal regulations, and this subchapter, and has registered with the department, if required.

(D) A person must [shall] not engage in alternate food source livestock slaughter and processing operations unless that person has met the standards established by the Act, the federal regulations, and this subchapter, and has obtained a Grant of Voluntary Inspection issued by the department. Hunter-killed exotic game animals processed exclusively for donation to a non-profit food bank, as defined by Texas Government Code §418.026(a), do not require inspection.

(E) The establishment must [shall] display the Grant of Inspection, Grant of Voluntary Inspection, and Grant of Custom Exemption in a prominent place at the physical business location, easily visible to the public.

(F) All regulated establishments operating as a livestock or animal dealer, by conducting on-premises livestock or poultry sales, must also comply with all regulatory requirements required as an animal or livestock seller, dealer, broker, or market.

(2) Application.

(A) To apply for a Grant of Inspection, Grant of Voluntary Inspection, or Grant of Custom Exemption, a person must [shall] complete department application forms, which can be obtained from the department's [Department of State Health Services,] Meat Safety Assurance Section.

(B) Upon submission of an application for a Grant of Inspection, Grant of Voluntary Inspection, or Grant of Custom Exemption, the applicant must prove that the establishment meets all regulatory requirements for the grant.

(C) The department must [shall] conduct an inspection to verify whether the establishment meets all regulatory requirements for the grant. Additionally, the department must ensure that the grant application contains all necessary information to issue a grant and determine if any responsibly connected persons are unfit to engage in any business requiring inspection or whose compliance history is subject to the application being disfavored as defined by this section. The department must [and shall] notify the applicant of the results in accordance with policy, after [of the inspection within 45 working days of] receiving a complete and accurate application and making the required determinations.

(i) If the establishment meets all regulatory requirements and no responsibly connected persons associated with the establishment are subject to the application being disfavored as defined by this section [on the date of inspection], the department will provide the applicant with the appropriate grant.

(ii) If the establishment does not meet all regulatory requirements [on the date of inspection], the department will provide the applicant with a listing of the regulatory requirements that the establishment failed to meet. In this case, the applicant may reapply when the applicant can [is ready to] support that the establishment meets all regulatory requirements for the grant.

(iii) If the establishment meets all regulatory requirements, the department may deny the application if one or more responsibly connected person(s) associated with the establishment is subject to the application being disfavored as defined by this section.

(3) Duration. The applicant who has complied with the standards in the Act, the federal regulations, and this subchapter will receive a Grant of Inspection, Grant of Voluntary Inspection, or Grant of Custom Exemption for an indefinite period subject to the denial, suspension, and revocation provisions in paragraph (6) of this subsection.

(4) Non-transferable. A Grant of Inspection, Grant of Voluntary Inspection, and Grant of Custom Exemption is not transferable to another person.

(5) Change of ownership. Any person operating a business under a Grant of Inspection, Grant of Voluntary Inspection, or Grant of Custom Exemption from the department must [shall] notify the department of any change in ownership of that business and[, in such event, shall] relinquish the current grant to the department. The new owner must apply [shall make application] for a new grant on forms provided by the department. This notification and new application must [shall ] be approved [made] before the new ownership begins operations [ownership change].

(6) Denial, suspension, and revocation.

(A) The department may deny a Grant of Inspection, Grant of Voluntary Inspection, or Grant of Custom Exemption to any applicant who does not comply with the standards of the Act, the federal regulations, and this subchapter.

(B) The department will consider the compliance history of the establishment and any responsibly connected person(s) to determine whether to deny, revoke, or suspend a Grant of Inspection, Grant of Voluntary Inspection, or Grant of Custom Exemption. The department will review all compliance history records maintained according to the department's Records Retention Policy. A disfavored application may lead to denial, revocation, or suspension. An application indicating the following will be disfavored:

(i) an establishment or responsibly connected person(s) is unfit to engage in any business requiring inspection according to 9 CFR §500.6(a)(9); or

(ii) a connection with an establishment or responsibly connected person(s) whose compliance history includes revocation, surrendered grant while enforcement actions are pending, or default on a previous enforcement action or agreement with the department.

(C) [(B)] The department may suspend or revoke a Grant of Inspection, Grant of Voluntary Inspection, or Grant of Custom Exemption of any person who violates the standards of the Act, the federal regulations, [and] this subchapter, and engages in conduct described in §221.12(c)(6)(B) of this subsection.

(D) [(C)] The department may suspend a Grant of Inspection, Grant of Voluntary Inspection, or Grant of Custom Exemption if an establishment is inactive for a period in excess of 30 calendar days.

(E) [(D)] An establishment, where a grant has been suspended, must [shall] undergo reinspection before reinstatement of the grant.

(F) [(E)] A person whose grant has been denied, suspended, or revoked is entitled to an opportunity for a formal hearing in accordance with §§1.21, 1.23, 1.25, and 1.27 of this title (relating to Formal Hearing Procedures).[)]

(7) Meat and poultry establishments and related industries.

(A) For the purpose of conducting an inspection or performing any other inspection program duty, the department representatives must have access to the premises and to every part of an establishment that slaughters livestock or otherwise prepares or processes meat or poultry products subject to inspection[, at all times, day or night, whether the establishment is being operated]. The [numbered] official badge of a department representative is sufficient identification to allow [entitle] the representative [to] admittance to all parts of such an establishment and its premises at all times, day or night.

(B) At all reasonable hours, any person subject to record keeping requirements under the Act or this chapter (whether holding or not holding a Grant of Inspection or exemption therefrom) must permit access to a department representative upon presentation of credentials. The department representative may[, to enter the place of business to] examine the facilities and inventory. The department representative may also [and to] examine and copy [the] records specified in this chapter.

(C) All inspected establishments must enter into a work schedule agreement with the department. Work schedule agreements may be made for a maximum of 40 hours per week and do not include operations on weekends or official holidays. Work schedule agreements may be altered by the department due to inspector availability, other conditions inhibiting the ability of the department to provide inspection services, or to conserve resources, as necessary. Custom exempt establishments must communicate the intended hours of operation to the department at least five (5) business days before commencing operations to facilitate inspection. Mobile slaughter and mobile processing establishments, whether inspected or custom exempt, must communicate the intended location to the department at least five (5) business days before commencing operations to facilitate inspection. Deviation from these requirements, or the requirements set forth in 9 CFR §307.4, require prior written approval from the department.

(8) Disposition of livestock not eligible for entry into commerce.

(A) Livestock deemed ineligible for entry into commerce by the department may be slaughtered and processed under all applicable custom exemption rules and regulations if the department veterinarian determines such actions to be appropriate and that the livestock appear to be in such a condition that the resulting meat or meat food product may be fit for human consumption.

(B) All abnormal livestock, including livestock intended for slaughter and processing under custom exemption, must be presented for inspection at an establishment with a Grant of Inspection during hours of inspected operation.

(9) Requirements for the humane treatment of livestock, excluding poultry and domesticated game birds, at granted establishments.

(A) Livestock pens, driveways, ramps, gates, restraining devices, and all other facilities must be maintained in good repair and free from sharp or protruding objects that may cause injury or pain to the animals. Floors of livestock pens, driveways, ramps, restraining devices, and all other facilities must be constructed and maintained so as to provide good footing for livestock.

(B) A pen sufficient to protect livestock from the adverse climatic conditions of the locale is required at granted establishments that hold animals overnight or through the day.

(C) Animals must have access to water in all holding pens and, if held longer than 24 hours, access to feed. There must be sufficient room in the holding pen for animals held overnight to lie down. Disabled livestock must be separated from non-disabled livestock while being held in the establishments holding pens.

(D) Livestock must be humanely slaughtered in accordance with this section and 9 CFR §313, adopted by reference in §221.11 of this subchapter.

(i) Stunning instruments must be maintained in good repair and available for inspection by a department representative.

(ii) Inhumane treatment of animals is prohibited, and any observed inhumane treatment of animals is subject to regulatory control actions and enforcement actions.

(E) Establishments conducting ritual slaughter in accordance with 7 USC §1902(b).

(i) Establishments conducting ritual slaughter must have a completed document signed and dated by an appropriate religious authority, including the name, title, address, and other contact information of the appropriate religious authority. The document must describe and attest to the conduct of ritual slaughter at that establishment. This document must list, by name, the individuals authorized to perform ritual slaughter at that establishment. Individuals not specifically listed on the current document are not authorized to perform the ritual cut at the establishment unless an effective stunning procedure is utilized before the ritual cut. Any modification of the procedures, individuals authorized to perform ritual slaughter, or religious authority information requires completing an updated document. An individual listed on the current document may be assisted in the ritual slaughter by other establishment employees not listed on the document.

(ii) Establishments conducting ritual slaughter in accordance with 7 USC §1902(b) are exempt from the stunning requirements of this section and the requirements of 9 CFR §§313.2(f), 313.5, 313.15, 313.16, 313.30, and 313.50(c) pertaining to stunning methods provided the following.

(I) Animals are humanely restrained and adequately restrained to prevent harm to the animal throughout the slaughter process.

(II) The ritual cut severs both carotid arteries immediately and simultaneously in a single cut unless an effective stunning procedure is utilized before the ritual cut.

(III) Animals are fully unconscious before being shackled, hoisted, thrown, cast, or cut except for the ritual cut.

(10) Good Commercial Practices for Poultry. Poultry and domesticated game birds are to be slaughtered in a manner that ensures breathing has stopped before scalding, so birds do not drown. Slaughter must result in thorough bleeding of the poultry carcass. The slaughtering of poultry and domesticated game birds must comply with 9 CFR §381.90. Poultry and domesticated game bird carcasses showing evidence of having died from causes other than slaughter are considered adulterated and must be condemned. As required in 9 CFR §381.65(b), the department requires poultry and domesticated game birds be slaughtered in accordance with good commercial practices.

§221.13.Enforcement and Penalties.

(a) Administrative Penalties. The purpose of this section is to establish the criteria and procedures by which the commissioner will assess administrative penalties for violations relating to [the ] provisions of the Act, these rules, [and] licenses, and orders issued pursuant to the Act or the rules.

(1) Determining the amount of the penalty. In determining the amount of the penalty, the commissioner must [shall] consider the criteria described in paragraphs (2) - (6) of this subsection.

(2) The seriousness of the violation.

(A) Violations must [shall] be categorized by one of the following severity levels.

(i) Severity Level I covers violations that are most significant and have a direct negative impact on, or represent a threat to, [the] public health and safety. Violations include: [and including, but not limited to, adulteration, misbranding, false representation, or false advertising that results in fraud.]

(I) adulteration;

(II) intentional and egregious inhumane treatment of animals;

(III) failure to remove known adulterated product from commerce; and

(IV) misbranding, false representation, or false advertising resulting in a danger to the public or improper monetary gain of over $25,000 by the violator.

(ii) Severity Level II covers violations that are very significant and [have] impact [on the] public health and safety. Violations include: [including, but not limited to, adulteration, misbranding, false representation, or false advertising, that results in fraud.]

(I) adulteration;

(II) repetitive egregious inhumane treatment of animals;

(III) slaughter of animals without a Grant of Inspection or Grant of Custom Exemption (when required by the department);

(IV) violation of a regulatory control action;

(V) bribery, coercion, or interference with inspection or attempted bribery, coercion, or interference with inspection; and

(VI) misbranding, false representation, or false advertising resulting in the entry of potentially harmful products into commerce or improper monetary gain of over $10,000 by the violator.

(iii) Severity Level III covers violations that are significant and which, if not corrected, could adversely impact public health and safety. Violations include: [threaten the public and have an adverse impact on the public health and safety, including, but not limited to, adulteration, misbranding, false representation, or false advertising that results in fraud.]

(I) adulteration;

(II) egregious or repetitive non-egregious inhumane treatment of animals;

(III) failure to remove known misbranded product from commerce;

(IV) misbranding, false representation, or false advertising resulting in public health risk or improper monetary gain of over $1,000 by the violator;

(V) producing product without a Grant of Inspection or Grant of Custom Exemption (when required by the department);

(VI) failing to correct significant deficiencies in Hazard Analysis and Critical Control Point plans, Sanitation Standard Operating Procedures; and

(VII) problems involving food contact surfaces.

(iv) Severity Level IV covers violations that are of more than minor significance, and if left uncorrected, would lead to more serious circumstances. Violations include:

(I) non-egregious inhumane treatment of animals;

(II) misbranding, false representation, or false advertising resulting in monetary gain of under $1,000 by the violator;

(III) failure to correct minor deficiencies in Hazard Analysis and Critical Control Point plans or Sanitation Standard Operating Procedures; and

(IV) problems involving non-food-contact surfaces.

(v) Severity Level V covers violations where minor noncompliant practices by a violator create some risk for production of adulterated product in the production environment. Violations include: [that are of minor safety or fraudulent significance.]

(I) failure by the establishment to correct minor noncompliant deficiencies in the production environment that do not involve product handling or product contact surfaces;

(II) failing to correct incidental noncompliance;

(III) general disrepair;

(IV) conditions that could potentially cause inhumane treatment of animals; and

(V) misbranding, false representation, or false advertising that does not result in public health risk or monetary gain by the violator.

(B) The severity of a violation must [shall ] be increased if the violation involves deception or other indications of willfulness. In determining the severity of a violation, the department must take [there shall be taken] into account the economic benefit gained by a person through noncompliance.

(3) History of previous violations. The department may consider previous violations. Repetitive violations may be considered when determining the severity of a violation and may result in increased penalties within a severity level or elevation to a higher severity level. [The base penalty may be reduced or increased for past performance. Past performance involves the consideration of the following factors:]

[(A) how similar the previous violation was;]

[(B) how recent the previous violation was; and]

[(C) the number of previous violation(s) in regard to correction of the problem.]

(4) Demonstrated good faith. The department may consider demonstrated good faith. The base penalty may be reduced if good faith efforts to correct a violation have been made[,] or are being made. Good faith effort must [shall] be determined on a case-by-case [case by case] basis and be fully documented.

(5) Hazard to public [the] health and safety [of the public]. The department may consider the hazard to public [the] health and safety [of the public]. The base penalty must [shall] be increased when a direct hazard to public [the] health or [and/or to the] safety [of the public] is involved, with consideration to [. It shall be taken into account, but need not be limited to, the following factors]:

(A) whether any disease or injuries have occurred from the violation;

(B) whether any existing conditions contributed to a situation that could expose humans to a health hazard; or

(C) whether the consequences would be of an immediate or long-range [long range] hazard.

(6) Other matters. The commissioner may consider other matters as justice may require.

(7) Levels of penalties.

(A) The department [Department] will impose different levels of penalties for different severity level violations as follows:

Figure: 25 TAC §221.13(a)(7)(A) (No change.)

(B) Each day a violation continues may be considered a separate violation.

(8) Assessment, payment, and refund procedures.

(A) The commissioner may assess an administrative penalty only after a person charged with a violation is given an opportunity for an administrative hearing under Texas [. The hearing shall be in accordance with the] Health and Safety Code[,] §433.095; Texas [the] Government Code[,] Chapter 2001; and the department's formal hearing procedures in Chapter 1 of this title (relating to Miscellaneous Provisions [Texas Board of Health]).

(B) Payment of an administrative penalty must [shall] be made under [in accordance with] the provision of Texas [the] Health and Safety Code[,] §433.096.

(C) Refund of an administrative penalty must be made under [shall be in accordance with] the provisions of Texas [the] Health and Safety Code[,] §433.097.

(b) Criminal Penalties.

(1) Interference with inspection.

(A) A person commits an offense if the person with criminal negligence interrupts, disrupts, impedes, or otherwise interferes with a livestock inspector while the inspector is performing a duty under the Act.

(B) An offense under this section is a Class B misdemeanor.

(C) It is a defense to prosecution under this section that the interruption, disruption, impediment, or interference alleged consisted of speech only.

(2) General.

(A) A person commits an offense if the person violates a provision of the Act or these rules for which these rules do not provide another criminal penalty.

(B) Except as provided by paragraph (2)(C) of this subsection, an offense under this section is punishable by a fine of not more than $1,000, imprisonment for not more than one year, or both.

(C) If an offense under this section involves intent to defraud, or [a] distribution or attempted distribution of an adulterated article[,] except adulteration described by Texas Health and Safety Code [(HSC),] §433.004(11), (12), or (13), the offense is punishable by a fine of not more than $10,000, imprisonment for not more than three years, or both.

(D) A person does not commit an offense under this section by receiving for transportation an article in violation of the Act if the receipt is in good faith and if the person furnishes, on request of a representative of the commissioner:

(i) the name and address of the person from whom the article is received; and

(ii) any document pertaining to the delivery of the article.

(E) This section does not require the commissioner to report for prosecution, or for institution of complaint or injunction proceedings, a minor violation of this chapter if the commissioner believes [that] the public interest will be adequately served by a suitable written warning notice.

(3) Injunction.

(A) If it appears [that] a person has violated or is violating the Act or a rule adopted under the Act, the commissioner may request the attorney general or the district attorney or county attorney in the jurisdiction where the violation is alleged to have occurred, is occurring, or may occur to institute a civil suit for:

(i) an order enjoining [injoining] the violation; or

(ii) a permanent or temporary injunction, a temporary restraining order, or other appropriate remedy, if the commissioner shows [that] the person has engaged in or is engaging in a violation.

(B) Venue for a suit brought under this section is in the county in which the violation occurred or in Travis County.

(C) The commissioner or the attorney general may recover reasonable expenses incurred in obtaining injunctive relief under this section, including investigation and court costs, reasonable attorney's fees, witness fees, and other expenses. The expenses recovered by the commissioner under this section may be used for the administration and enforcement of Texas Health and Safety Code [HSC,] Chapter 433. The expenses recovered by the attorney general may be used by the attorney general for any purpose.

(4) Emergency withdrawal of mark or suspension of inspection services [Withdrawal of Mark or Suspension of Inspection Services].

(A) The commissioner or the commissioner's designee may immediately withhold the mark of inspection or suspend or withdraw inspection services if:

(i) the commissioner or the commissioner's designee determines [that] a violation of the Act or these rules presents an imminent threat to public health and safety; or

(ii) a person affiliated with the processing establishment impedes an inspection under this chapter, including[, but not limited to,] assaulting, threatening to assault, intimidating, or interfering with a department employee.

(B) An affected person is entitled to a review of an action of the commissioner or the commissioner's designee under subparagraph (A) of this paragraph [subsection (a)] in the same manner that a refusal or withdrawal of inspection services may be reviewed under Texas Health and Safe Code [HSC,] §433.028.

(C) For purposes of this section only, the definition of "imminent threat" [imminent threat] to public health and safety includes[, but is not limited to]:

(i) the establishment produced and shipped adulterated or misbranded product as defined under Texas Health and Safety Code [HSC,] §433.004 and §433.005;

(ii) the establishment does not have or has an inadequate Hazard Analysis and Critical Control Point [a HACCP] plan as specified in 9 Code of Federal Regulations (CFR) §417.6 [CFR, §417.2];

(iii) the establishment does not have Sanitation Standard Operating Procedures as specified in 9 CFR §§416.11 - 416.16[, §416.11 and §416.12];

(iv) sanitary conditions are such that products in the establishment are or would be rendered adulterated under Texas Health and Safety Code [HSC,] §433.004; or

(v) the establishment violated the terms of a regulatory control action as specified in Texas Health and Safety Code [HSC,] §433.030, 9 CFR[,] §310.4, or 9 CFR[,] §416.6.

(D) This section in no way restricts or prohibits the department from taking action under Texas Health and Safety Code [HSC,] Chapter 431, Texas Health and Safety Code [HSC, ] §433.008, the Federal Meat Inspection Act (21 United States Code (USC) [USC] 12), and the Poultry Products Inspection Act (21 USC 10) and the regulations adopted [thereunder] in §221.11 of this subchapter [title] (relating to Federal Regulations on Meat and Poultry Inspection).

§221.14.Custom Exempt Slaughter and Processing; Animal Share and Low-Volume Poultry or Rabbit Slaughter Operations.

(a) Custom Exempt Slaughter and Processing Operation Requirements. The requirements of this section apply to the custom exempt slaughter and custom exempt processing of uninspected livestock.

(1) Record keeping.

(A) Operators of facilities conducting custom exempt operations must keep records for a period of two years from the date of slaughter or processing.

(B) The records must be available to department representatives on request.

(C) Additional records that must be kept include records such as bills of sale, invoices, bills of lading, and receiving and shipping papers for transactions in which any livestock or carcass, meat, or meat food product is purchased, sold, shipped, received, transported, or otherwise handled by the custom slaughter establishment.

(D) If the custom exempt establishment also maintains a retail meat outlet, the records requirements in subparagraph (C) of this paragraph must be separately maintained.

(2) Containers used for meat food products, paper, or other materials in contact with meat food products.

(A) To avoid adulteration of product, containers must be lined with suitable material of good quality before packing.

(B) Containers and trucks or other means of conveyance in which any carcass or part is transported to the owner must be kept in a clean and sanitary condition.

(C) Paper or other materials used for covering or lining containers and the cargo space of trucks or other means of conveyance must be of a kind that does not tear during use but remains intact and does not disintegrate when moistened by the product.

(D) Boxes and any containers used as tote boxes must be clean and stored off the floor in a manner sufficient to prevent the creation of insanitary conditions and to ensure product is not adulterated.

(3) Tagging insanitary equipment, utensils, rooms, and carcasses.

(A) A department representative may attach a "Texas Rejected" tag to any equipment, utensil, room, or compartment at a custom exempt establishment that a department representative determines is insanitary and a health hazard. No equipment, utensil, room, or compartment, so tagged, may be used until untagged or released by a department representative. Such tags may not be removed by anyone other than a department representative.

(B) A department representative who determines a carcass or parts are adulterated, unfit for human food, is from an unhealthy or unsound animal, or could result in a health hazard, may attach a "Texas Retained" tag to the carcass and parts, document the reason for attaching the tag on a form specified by the department, and deliver the form to the operator of the custom exempt establishment. The owner of the carcass and parts must be notified by the plant operator and advised of the potential health risk. The custom exempt establishment must ensure the owner of the carcass and parts either authorizes the voluntary destruction and denaturing of the carcass and all parts or agrees to remove the carcass and parts from the custom exempt establishment. Under no circumstances may the carcass and parts be further processed at the establishment.

(4) Denaturing procedures. Carcasses, parts thereof, meat, and meat food products that are adulterated or not returned to the owner must be adequately denatured or decharacterized to preclude use as human food. Before the denaturing agents are applied, carcasses and carcass parts must be freely slashed or sectioned. The denaturing agent must be mixed with all of the carcasses or carcass parts to be denatured and must be applied in such quantity and manner that it cannot be removed by washing or soaking. A sufficient amount of the appropriate agent must be used to give the material a distinctive color, odor, or taste so that such material cannot be confused with an article of human food.

(b) [(a)] Custom Slaughter Requirements [slaughter requirements]. The requirements of this section [shall] apply to the custom slaughter of livestock by any person [of livestock], as defined in §221.12(b) of this subchapter [title] (relating to Meat and Poultry Inspection), delivered by or for the owner [thereof] for such slaughter, not for sale to the public, and for the exclusive use of the owner, a member of the owner's household, or a nonpaying guest or employee of the owner. The requirements of this section do not apply to hunter-killed [hunter killed] game animals, hunter-killed exotic animals, or hunter-killed feral swine. [as defined in §221.12(b) of this title. The requirements of this section do not apply to processing of hunter killed exotic animals, or hunter killed feral swine, as defined in §221.12(b) of this title, provided persons engaged in such processing do not utilize the same facilities to engage in the receipt, storage, processing, or distribution of other meat and/or poultry food products.]

(1) Animals for slaughter. Only healthy animals, exhibiting no abnormalities, may be accepted for custom slaughter at custom slaughter establishments. Unhealthy or unsound animals are those that exhibit any condition [that is] not normally expected [to be exhibited] in a healthy and sound member of that species.

(A) Examples of abnormal or unsound animals include animals that are not able to get up, or animals that have a missing or abnormal eye, swellings, rectal or vaginal prolapse, ocular or nasal discharge, a cough, or a limp.

(B) Animals that have an obviously recent break of the lower leg (below the stifle or elbow) and are able to walk and stand are not considered to be unsound or unhealthy if no other abnormal conditions are noted.

(2) Record keeping.

[(A) Operators of facilities conducting custom slaughter shall keep records for a period of two years, beginning on January 1 of the previous year plus the current year to date.]

[(B) The records shall be available to department representatives on request.]

[(C)] Custom slaughter records must [shall] contain the name, address, and telephone number of the owner of each animal presented, the date the animal was slaughtered, the species, and brief description of the livestock. If a custom processor accepts farm-slaughtered [farm slaughtered] animals for custom processing, records must [shall] contain a signed statement from the animal owner that the animal was healthy and exhibited no abnormalities, other than an obviously recent break to the lower leg (below the stifle or elbow), and was able to walk and stand at the time of slaughter.

[(D) Additional records that must be kept include records such as bills of sale, invoices, bills of lading, and receiving and shipping papers for transactions in which any livestock or carcass, meat or meat food product is purchased, sold, shipped, received, transported or otherwise handled by the custom slaughter establishment.]

[(E) If the custom slaughter establishment also maintains a retail meat outlet, separate records as listed in subparagraph (D) of this paragraph, shall be maintained for each type of business conducted at the establishment.]

(3) Sanitary methods. Custom slaughter establishments, including mobile operations, must [operations shall] be maintained in sanitary condition. Each custom slaughter establishment must [shall] comply with the requirements of 9 Code of Federal Regulations (CFR) [CFR,] Part 416, adopted under §221.11 of this subchapter [title] (relating to Federal Regulations on Meat and Poultry Inspection). Establishments that accept farm-slaughtered [farm slaughtered] livestock must complete and document cleaning and sanitization of all surfaces and equipment used in the processing of the farm-slaughtered [farm slaughtered] livestock before those surfaces and equipment may be used to process other products.

(4) Specified risk materials from cattle; handling and disposition. Each custom slaughter establishment must comply with the requirements of 9 CFR §310.22, adopted under §221.11 of this subchapter [Humane treatment of animals].

[(A) Livestock pens, driveways, and ramps shall be maintained in good repair and free from sharp or protruding objects which may cause injury or pain to the animals. Floors of livestock pens, ramps, and driveways shall be constructed and maintained so as to provide good footing for livestock.]

[(B) A pen sufficient to protect livestock from the adverse climatic conditions of the locale shall be required at those custom slaughter establishments that hold animals overnight or through the day.]

[(C) Animals shall have access to water in all holding pens and, if held longer than 24 hours, access to feed. There shall be sufficient room in the holding pen for animals held overnight to lie down.]

[(D) Livestock must be humanely slaughtered in accordance with this section and 9 CFR §313, Humane Slaughter of Livestock, adopted by reference in §221.11 of this title. The slaughtering of livestock by using captive bolt stunners, electrical stunners, and shooting with firearms, are designated as humane methods of stunning.]

[(i) The captive bolt stunners, electrical stunners, or delivery of a bullet or projectile shall be applied to the livestock in a manner so as to produce immediate unconsciousness in the animal before they are shackled, hoisted, thrown, cast, or cut. The animal shall be stunned in such a manner that they will be rendered unconscious with a minimum of excitement and discomfort.]

[(ii) The driving of animals to the stunning area shall be done with a minimum of excitement and discomfort to the animals. Delivery of calm animals to the stunning area is essential since accurate placement of stunning equipment is difficult on nervous or injured animals. Electrical equipment shall be minimally used with the lowest effective voltage to drive the animal to the stunning area. Pipes, sharp or pointed objects, and other items which would cause injury or unnecessary pain to the animal shall not be used to drive livestock.]

[(iii) Immediately after the stunning blow is delivered, the animals shall be in a state of complete unconsciousness and remain in this condition throughout shackling, sticking, and rapid exsanguination.]

[(iv) Stunning instruments must be maintained in good repair and available for inspection by a department representative.]

[(v) Inhumane treatment of animals is prohibited and any observed inhumane treatment of animals shall be subject to the tagging provisions of paragraph (6)(C) of this subsection in addition to possible enforcement action.]

[(E) Establishments conducting ritual slaughter in accordance with 7 U.S.C. §1902(b).]

[(i) Establishments conducting ritual slaughter must have a completed document, that is signed and dated by an appropriate authority attesting to the conduct of ritual slaughter at that establishment. This document must list, by name, the individuals authorized to perform ritual slaughter at that establishment.]

[(ii) Establishments conducting ritual slaughter in accordance with 7 U.S.C. §1902(b) are exempt from the stunning requirements of this section and the requirements of 9 CFR §313.2(f), §313.5, §313.15, §313.16, §313.30, and §313.50(c) pertaining to stunning methods provided animals are humanely restrained and adequately restrained to prevent harm to the animal throughout the slaughter process.]

(5) Custom exempt slaughter operators must adhere to the humane treatment of livestock as outlined in §221.12(c)(9) of this subchapter [Containers used for meat food products, paper, or other materials in contact with meat food products].

[(A) To avoid contamination of product, containers shall be lined with suitable material of good quality before packing.]

[(B) Containers and trucks, or other means of conveyance in which any carcass or part is transported to the owner shall be kept in a clean and sanitary condition.]

[(C) Paper or other materials used for covering or lining containers and the cargo space of trucks, or other means of conveyance shall be of a kind which does not tear during use but remains intact and does not disintegrate when moistened by the product.]

(6) Custom exempt slaughter operators must adhere to the humane treatment of poultry and domesticated game birds as outlined in §221.12(c)(10) of this subchapter [Tagging insanitary equipment, utensils, rooms, and carcasses].

[(A) A department representative may attach a "Texas Rejected" tag to any equipment, utensil, room, or compartment at a custom slaughter establishment that a department representative determines is insanitary and is a health hazard. No equipment, utensil, room, or compartment so tagged shall again be used until untagged or released by a department representative. Such tag shall not be removed by anyone other than a department representative.]

[(B) A department representative that determines a carcass is adulterated, unfit for human food, is from an unhealthy or unsound animal, or could result in a health hazard, may attach a "Texas Retained" tag to the carcass and document the reason for attaching the tag on a form specified by the department and deliver the form to the operator of the custom slaughter establishment. The owner of the carcass shall be notified by the plant operator and advised of the potential health risk. The custom slaughter establishment shall ensure that the owner of the carcass either authorizes the voluntary destruction and denaturing of the carcass and all parts or agrees to remove the carcass from the custom slaughter establishment.]

(7) [(C)] Inhumane treatment of animals [that is] observed by a department representative will [shall] result in the attaching of a "Texas Rejected" tag to the deficient equipment, facility structure, or the stunning area causing the inhumane treatment. No equipment, area, or facility so tagged may [shall] be used until untagged or released by the department representative.

(8) [(7)] Marking and labeling of custom prepared products. Carcasses and parts therefrom that are prepared on a custom basis must [shall] be marked at the time of preparation with the term "Not for Sale" in letters at least 3/8 [three-eighths] inch in height, and must [shall] also be identified with the owner's name or a code that allows identification of the carcass or carcass part to its owner. Ink used for marking such products must be labeled for such purpose. Ink containing FD&C Violet No. 1 must [shall] not be used.

(9) [(8)] Requirements concerning procedures.

(A) Heads from animals slaughtered by gunshot to the head must [shall] not be used for food purposes. Such heads must [shall] be denatured in accordance with this section [paragraph (10) of this subsection] and placed into containers marked "INEDIBLE." Heads with gunshot wounds may be returned to the owner only after they have been freely slashed and adequately denatured to preclude [their] use for human food.

(B) Cattle paunches and hog stomachs intended for use in preparing [the preparation of] meat food products must [shall] be emptied of [their] contents immediately upon removal from the carcass and thoroughly cleaned on all surfaces and parts.

(C) Carcasses must [shall] not be adulterated, as defined in §221.12(b)(2) of this subchapter [title], when placed in coolers.

(10) [(9)] Requirements concerning ingredients. All ingredients and other articles used in the preparation of any carcass must [shall] be clean, sound, healthful, wholesome, and [will] not result in the adulteration of the carcass. A letter of guaranty from the manufacturer stating [that] the ingredient or article is safe when used in contact with food must [shall] be obtained by the custom slaughter establishment and made available upon request to the department representative.

[(10) Denaturing procedures. Carcasses, parts thereof, meat and meat food products that are adulterated or not returned to the owner shall be adequately denatured or decharacterized to preclude their use as human food. Before the denaturing agents are applied, carcasses and carcass parts shall be freely slashed or sectioned. The denaturing agent must be mixed with all of the carcasses or carcass parts to be denatured, and must be applied in such quantity and manner that it cannot be removed by washing or soaking. A sufficient amount of the appropriate agent shall be used to give the material a distinctive color, odor, or taste so that such material cannot be confused with an article of human food.]

(c) [(b)] Custom processing requirements. The requirements of this section [shall] apply to the custom processing by any person of uninspected livestock carcasses or parts, delivered by or for the owner thereof for such processing. These products are[,] not for sale to the public and are for the exclusive use of the owner, a member of the owner's household, or a nonpaying guest or employee of the owner. The requirements of this section do [shall] not apply to hunter-killed game animals, hunter-killed exotic animals, or hunter-killed feral swine. [processing hunter killed game animals, as defined in §221.12(b) of this title. The requirements of this section do not apply to processing of hunter killed exotic animals, or hunter killed feral swine, as defined in §221.12(b) of this title, provided persons engaged in such processing do not utilize the same facilities to engage in the receipt, storage, processing, or distribution of other meat and/or poultry food products.]

(1) Carcasses and parts for processing. No adulterated carcasses or parts as defined in §221.12(b)(2) of this subchapter may [title shall] be accepted for custom processing.

(2) Record keeping. Temperature monitoring records must be maintained by the custom processor for heat-treated or ready-to-eat products. These records must include the temperature attained and time held during heating and the time and temperatures during the cool down process.

[(A) Operators of facilities conducting custom processing shall keep records for a period of two years, beginning on January 1 of the previous year plus the current year to date.]

[(B) The records shall be available to the department representative on request.]

[(C) Custom processing records shall contain the name, address, and telephone number of the owner of each carcass or parts presented, the date the carcass or parts were delivered, the species and amount.]

[(D) Additional records such as bills of sale, invoices, bills of lading, and receiving and shipping papers for transactions in which any carcass, meat or meat food product is purchased, sold, shipped, received, transported or otherwise handled by the custom processor shall also be kept by the custom processor.]

[(E) If the custom processing establishment also maintains a retail meat outlet, separate records, as listed in subparagraph (D) of this paragraph, shall be maintained for each type of business conducted at the establishment.]

[(F) Temperature monitoring records shall be maintained by the custom processor, for heat treated or ready-to-eat products. These records shall include the temperature attained and time held during heating and the time and temperatures during the cool down process.]

(3) Sanitary methods. Custom processing establishments, including mobile operations, must [shall] be maintained in sanitary condition. Each custom processing establishment must [shall] comply with the requirements of 9 CFR[,] Part 416, adopted under §221.11 of this subchapter [title].

(4) Specified risk materials from cattle; handling and disposition. Each custom slaughter establishment must comply with the requirements of 9 CFR §310.22, adopted under §221.11 of this subchapter [Containers used for product; paper or other materials in contact with product].

[(A) To avoid contamination of product, containers shall be lined with suitable material of good quality before packing.]

[(B) Containers and trucks, or other means of conveyance in which any product is transported to the owner shall be kept in a clean and sanitary condition.]

[(C) Boxes and any containers used as tote boxes shall be clean and stored off the floor in a manner that does not interfere with good sanitation.]

[(5) Tagging insanitary equipment, utensils, rooms, and carcasses.]

[(A) A department representative may attach a "Texas Rejected" tag to any equipment, utensil, room, or compartment at a custom processing establishment that a department representative determines is insanitary and is a health hazard. No equipment, utensil, room, or compartment so tagged shall again be used until untagged or released by a department representative. Such tag so attached shall not be removed by anyone other than a department representative.]

[(B) A department representative that determines a carcass is adulterated, unfit for human food, is from an unhealthy or unsound animal, or may be a health hazard, may attach a "Texas Retained" tag to the carcass and document the reason for attaching the tag on a form specified by the department and deliver the form to the operator of the establishment. The owner of the carcass shall be notified by the plant operator and advised of the potential health risk. The custom processor shall ensure that the owner of the carcass or parts either authorizes the voluntary destruction and denaturing of the carcass and all parts or agrees to remove the carcass from the custom processing establishment. Under no circumstances may the carcass be further processed at the establishment.]

(5) [(6)] Death by other means than slaughter. Carcasses, or parts thereof, derived from animals that have died through circumstances other than [otherwise than by] slaughter. This includes animals[,] such as roadkill or animals that have died by disease, trauma, or other accident. Such animals[,] may not enter[,] or be processed by a granted establishment.

(6) [(7)] Marking and labeling of custom prepared products.

(A) Products that are custom prepared must be packaged immediately after preparation and must be labeled with the term "Not For Sale" in lettering not less than 3/8 [three-eighths] inch in height. Such custom prepared products or [their] containers must [shall] also bear the owner's name and any additional labeling, such as product cut or description.

(B) Safe handling instructions must [shall ] accompany every customer's raw or not fully cooked products. The information must [shall] be in lettering no smaller than 1/16 [one-sixteenth] of an inch in size and may be placed on each product package, placed on each tote box or bag containing packaged product, or given as a flyer to the customer with the product. The safe handling instructions must [shall] be placed immediately after the heading in subparagraph (A) of this paragraph and must [shall] include the following or similar statements.

(i) "Some food [meat and meat] products may contain bacteria that could cause illness if the product is mishandled or cooked improperly. For your protection, follow these safe handling instructions."

(ii) "Keep [Meat and poultry must be kept] refrigerated or frozen. Thaw in refrigerator or microwave." However, any portion of this statement [that is] in conflict with the product's specific handling instructions may be omitted ([,]e.g., some products may have instructions to cook without thawing). A graphic illustration of a refrigerator must [may] be displayed next to this statement.

(iii) "Keep raw [Raw] meat and poultry [must be kept] separate from other foods. Wash working surfaces (including cutting boards), utensils, and hands after touching raw meat or poultry." A graphic illustration of soapy hands under a faucet must [may] be displayed next to this statement.

(iv) "Cook thoroughly." ["Meat and poultry must be cooked thoroughly. Ground meat products should be cooked to an internal temperature of 160 degrees Fahrenheit or until the juices run clear. Other meat products should be cooked so that the external temperature reaches 160 degrees Fahrenheit."] A graphic illustration of a skillet must [may] be displayed next to this statement.

(v) "Keep hot foods hot [Hot foods must be kept hot]. Refrigerate leftovers immediately or discard." A graphic illustration of a thermometer must [may] be displayed next to the statement.

(7) [(8)] Requirements concerning procedures.

(A) Uninspected heads from custom slaughtered animals may not be sold or used in the preparation of meat food products unless prepared specifically for the owner of the animal for [his] personal use.

(B) Heads for use in the preparation of meat food products must [shall] be split and the bodies of the teeth, the turbinates and ethmoid bones, ear tubes, and horn butts removed, and the heads then thoroughly cleaned.

(C) Bones and parts of bones must [shall] be removed from product [which is] intended for chopping or grinding.

(D) Kidneys for use in the preparation of meat food products must [shall] first be freely sectioned and then thoroughly soaked and washed.

(E) Clotted blood must [shall] be removed from livestock hearts before they are used in the preparation of meat food products.

(F) Product must [shall] not be adulterated, as defined in §221.12(b)(2) of this subchapter, [title] when placed in coolers or freezers.

(G) Frozen product may be defrosted in water or thawed [pickle] in a manner [that is] not conducive to promoting bacterial growth or resulting in adulteration of the product.

(8) [(9)] Requirements concerning ingredients.

(A) All ingredients and other articles used in the preparation of any product must [shall] be clean, sound, healthful, wholesome, and not [otherwise such as to not] result in the adulteration of product. A letter of guaranty from the manufacturer stating [that] the ingredient or article is safe when used as an ingredient or in contact with food must [shall] be obtained by the custom processor and made available upon request to the department representative.

(B) Ingredients for use in any product may not contain any pesticide chemical or other residues in excess of levels permitted under the federal [Federal] Food, Drug, and Cosmetic Act.

(9) [(10)] Approval of substances for use.

(A) No substance may be used in the preparation of any product unless it is a Food and Drug Administration-approved [Administration approved] food additive.

(B) No product may [shall] contain any substance that [which] would render it adulterated.

(C) Nitrates must [shall] not be used in curing bacon.

(i) Nitrites in the form of sodium nitrite may be used at 120 parts per million (ppm) ingoing (or in the form of potassium nitrite at 148 ppm ingoing) maximum for injected, massaged, or immersion cured bacon; and 550 ppm of sodium ascorbate or sodium erythorbate (isoascorbate) for injected, massaged, or immersion cured bacon must [shall] be used.

(ii) Sodium or potassium nitrite may be used at 2 pounds to 100 gallons pickle at 10% pump level; 1 ounce to 100 pounds meat (dry cure).

(iii) Sodium ascorbate or sodium erythorbate (isoascorbate) may be used at 87.5 ounces to 100 gallons pickle at 10% pump level; 7/8 ounces to 100 pounds meat; or 10% solution to surfaces of cut meat.

(iv) Sodium nitrite must [shall] not exceed 200 ppm ingoing or an equivalent amount of potassium nitrite (246 ppm ingoing) in dry cured bacon based on the actual or estimated skin-free green weight of the bacon belly.

(D) When curing products other than bacon, nitrites, nitrates, or combination must [shall] not result in more than 200 ppm of nitrite in the finished product.

(i) Sodium or potassium nitrite may be used at 2 pounds to 100 gallons pickle at 10% pump level; 1 ounce to 100 pounds meat (dry cure); or 1/4 ounce to 100 pounds chopped meat or [and/or ] meat byproduct.

(ii) Sodium or potassium nitrate may be used at 7 pounds to 100 gallons pickle; 3-1/2 ounces [3 1/2 ounce] to 100 pounds meat (dry cure); or 2-3/4 ounces [2 3/4 ounce] to 100 pounds chopped meat. (Nitrates may not be used in bacon.)

(10) [(11)] Prescribed treatment of heat-treated meat and poultry products.

(A) All forms of fresh meat and poultry, including fresh unsmoked sausage and pork such as bacon and jowls, are classified as products that are customarily well cooked in the home before being consumed. Therefore, the treatment of such products to destroy [for the destruction of] pathogens is not required.

(B) Meat and poultry products, which [that ] are not customarily cooked or may not be cooked before consumption because they have the appearance of being fully cooked, must not contain pathogens.

(i) Heat-treated, [products and] dry, semi-dry, and fermented meat products [sausages, that are less than three inches in diameter,] are required to be heated to an internal temperature according to the following chart:

Figure: 25 TAC §221.14(c)(10)(B)(i) (.pdf)

[Figure: 25 TAC §221.14(b)(11)(B)(i)]

(ii) Heat treated, [products and] dry, semi-dry, and fermented poultry products [sausages, that are more than three inches in diameter,] are required to be heated to an internal temperature according to the following chart:

Figure: 25 TAC §221.14(c)(10)(B)(ii) (.pdf)

[Figure 25 TAC §221.14 (b)(11)(B)(ii)]

(iii) Heat treated meat and poultry products that must be stored under refrigerated temperatures must be cooled quickly to prevent bacterial growth. During cooling, the product's maximum internal temperature must [should] not remain between 130 degrees Fahrenheit and 80 degrees Fahrenheit for more than 1-1/2 [1 1/2] hours nor between 80 degrees Fahrenheit and 40 degrees Fahrenheit for more than 5 hours. Custom processors may slowly cool cured products in accordance with Meat Safety Assurance (MSA) [Food Safety and Inspection Services (FSIS)] Directive 7111.1, Verification Procedures for Lethality and Stabilization [7110.3, Time/Temperature Guidelines for Cooling Heated Products], which may be viewed at www.dshs.texas.gov/meat-safety [www.fsis.usda.gov], or other substantiated support.

(iv) Custom processors not utilizing a heating step as described in clauses (i), (ii), and (iii) of this subparagraph must submit an alternate procedure, describing the method utilized in determining safety, to a department representative.

(v) Custom processors may produce heat-treated or ready-to-eat custom products, including chorizo, at temperatures other than those listed in clauses (i), (ii), and (iii) of this subparagraph when requested to do so by the owner of the product. The custom processor must obtain a signed statement from the owner of the product stating [that] the risks associated with eating under-cooked meat products are understood.

(C) When necessary to comply with the requirements of this section, [the] smokehouses, drying rooms, and other compartments used in the treatment of meat and poultry products to destroy pathogens must [shall] be suitably equipped with accurate automatic recording thermometers[,] by the operator of the custom processing establishment [with accurate automatic recording thermometers].

[(12) Denaturing procedures. Carcasses, parts thereof, meat and meat food products that are adulterated and/or not returned to the owner shall be adequately denatured or decharacterized to preclude their use as human food. Before the denaturing agents are applied, carcasses and carcass parts shall be freely slashed or sectioned. The denaturing agent must be mixed with all of the carcasses or carcass parts to be denatured, and must be applied in such quantity and manner that it cannot easily and readily be removed by washing or soaking. A sufficient amount of the appropriate agent shall be used to give the material a distinctive color, odor, or taste so that such material cannot be confused with an article of human food.]

(d) Animal Share Exemption Requirements. Livestock co-owned under an animal share program may be exempted from inspection under Texas Health and Safety Code §433.006 and are eligible to be custom slaughtered or custom processed under subsections (a) and (b) of this section. Livestock producers and custom exempt operators engaging in animal share programs must comply with the requirements of this subsection in addition to the requirements contained in subsections (a) and (b) of this section. Each animal share applies to one particular, identified livestock animal. A livestock producer may sell shares of more than one animal to a particular co-owner as long as those shares are collectively consistent with amounts for personal use. Each animal share is reflective of a defined percentage of the livestock animal on either a per animal basis or a percentage of portions, cuts, or products produced from the livestock animal. Livestock ownership must be documented and 100% of the animal must be designated before slaughter.

(1) Animals for slaughter.

(A) Animals presented for slaughter under an animal share must comply with all other requirements for animals slaughtered at the facility providing the slaughtering and processing services.

(B) Animals under an animal share must be slaughtered at the facility providing the slaughtering and processing services and may not be slaughtered on ungranted premises and be presented for custom processing only.

(C) The meat and meat food products are:

(i) prepared from livestock subject to an animal share and delivered to the establishment preparing the products by a co-owner of the livestock or the livestock producer boarding the livestock; and

(ii) following preparation, delivered directly to the co-owner or co-owners by either the custom exempt operator or the livestock producer.

(D) The custom operator or livestock producer that delivers the product to the co-owner or co-owners is responsible for maintaining the product in wholesome, sanitary conditions, including maintaining the product under proper storage temperature and conditions until the product is delivered. If the livestock producer holds the product on behalf of the co-owner, the livestock producer must comply with all other regulatory requirements pertaining to the storage of such products.

(2) Recordkeeping.

(A) Custom exempt operators must:

(i) maintain records and make them available as required by §221.14 of this subchapter;

(ii) document the name, address, and telephone number of each co-owner of the animal share livestock animal presented. These documents must also include the date the livestock animal was delivered, the species, and amount defined as a percentage, based on either the entire animal or particular portions, cuts, or products, delivered to each co-owner;

(iii) maintain additional records, including bills of sale, invoices, bills of lading, and receiving and shipping papers for transactions in which any carcass, meat, or meat food product is purchased, sold, shipped, received, transported, or otherwise handled by the custom processor; and

(iv) provide to the livestock producer or co-owner, upon delivery of the meat or meat food products, written notice that conspicuously displays the warning that the department has not inspected the meat or meat food products.

(B) Livestock producers must:

(i) provide a bill of sale to the co-owner conveying an ownership interest in the animal;

(ii) complete a written agreement, which, at a minimum, includes:

(I) a provision authorizing the livestock producer to board the livestock and arrange preparation of the livestock as meat and meat food products for the co-owner; and

(II) a provision entitling the co-owner to a share of meat and meat food products derived from the livestock;

(iii) provide to the co-owner information describing the standards the livestock producer followed in maintaining livestock health and preparing the meat and meat food products derived from the livestock; and

(iv) provide to the co-owner, upon delivery of the meat or meat food products, written notice that conspicuously displays the warning that the department has not inspected the meat or meat food products.

(3) Marking and labeling of custom prepared animal share products.

(A) Animal share meat and meat food products must be marked and labeled under the requirements in subsections (b)(8) and (c)(6) of this section.

(B) On delivery of the meat or meat food products to the co-owner, the custom exempt operator must provide to the co-owner notice that the department has not inspected the meat or meat food products in:

(i) a separate written statement that conspicuously displays the warning; or

(ii) a warning statement conspicuously displayed on a label affixed to the meat or meat food product packaging.

(4) Enforcement. A person may not sell, donate, or commercially redistribute meat or meat food products produced under this section. A person who violates this section is liable for a civil penalty in the amount of $10,000 for each violation as provided by §221.13(a)(2)(A)(ii) of this subchapter.

(e) [(c)] Low-Volume Poultry or Rabbit Slaughter Operations Requirements [Low-volume poultry or rabbit slaughter operations requirements].

(1) Animals for slaughter. Adulterated [No adulterated] poultry or rabbits, as defined in §221.12(b)(2) of this subchapter, may not [title shall] be slaughtered for the purpose of selling the [its] carcass or parts for food. Only healthy poultry and rabbits, exhibiting no abnormalities, may be slaughtered for sale as food. Unhealthy or unsound poultry and rabbits are those that exhibit any condition [that is] not normally expected to be exhibited in a healthy and sound member of that species. Examples of abnormal or unsound animals include animals that are not able to get up, or animals that have a missing or abnormal eye, [any] swellings, rectal or vaginal prolapse, ocular or nasal discharge, a cough, or a limp.

(2) Record keeping.

(A) Operators of facilities conducting slaughter under a Poultry or Rabbit Exemption must [shall] keep records such as bills of sale, invoices, bills of lading, and receiving and shipping papers for transactions in which any livestock or carcass, meat, or meat food product is purchased, sold, shipped, received, transported, or otherwise handled for a period of two years, beginning on January 1 of the previous year plus the current year to date.

(B) The records must [shall] be available to department representatives on request.

(3) Sanitary methods. Low-volume poultry or rabbit slaughter operations must [shall] be maintained in sanitary condition.

(4) Marking and labeling of products. Carcasses and parts therefrom that are prepared under the Poultry or Rabbit Exemption must [shall] be packaged and the container must [shall] be marked with each of the following in letters at least 1/4 [one-quarter] inch in height, unless otherwisestated:

(A) the slaughterer's name and address and the term "Exempted P.L. 90-492" and the statement "Not Produced Under Inspection";["]

(B) the common or usual name of the product, or [if any there be, and if there is none,] a truthful descriptive designation of the product;

(C) a special handling label such as, "Keep Refrigerated," "Keep Frozen," "Keep Refrigerated or Frozen," "Perishable - Keep Under Refrigeration," or any other similar statement that the establishment has received approval from the department to use; and

(D) safe handling instructions must [shall ] be in lettering no smaller than 1/16 [one-sixteenth ] of an inch in size and must [shall] be prominently placed with such conspicuousness (as compared with other words, statements, designs, or devices in the labeling) as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.[:]

(i) Safe handling information. The safe handling information must [shall] be presented on the label under the heading "Safe Handling Instructions," which must [shall] be set in type size larger than the print size of the rationale statement and safe handling statement. The safe handling information must [shall] be set off by a border and must [shall] be one color type printed on a single-color [single color] contrasting background whenever practical.

(ii) Rationale statement. The safe handling instructions must [shall] include the following rationale statement, "This product was prepared from meat or [and/or] poultry. Some food products may contain bacteria that could cause illness if the product is mishandled or cooked improperly. For your protection, follow these safe handling instructions." This statement must [shall] be placed immediately after the heading for safe handling instructions in clause (i) of this subparagraph and before the safe handling statement in clause (iii) of this subparagraph.

(iii) Safe handling statement. The safe handling instructions must [shall] include the following safe handling statements.[:]

(I) "Keep refrigerated or frozen. Thaw in refrigerator or microwave." [(]Any portion of this statement [that is] in conflict with the product's specific handling instructions may be omitted ([,]e.g., some products may have specific instructions to cook without thawing).[) (]A graphic illustration of a refrigerator must [shall] be displayed next to the statement.[);]

(II) "Keep raw meat and poultry separate from other foods. Wash working surfaces (including cutting boards), utensils, and hands after touching raw meat or poultry." [(]A graphic illustration of soapy hands under a faucet must [shall] be displayed next to the statement.[);]

(III) "Cook thoroughly." [(]A graphic illustration of a skillet must [shall] be displayed next to the statement.[); and]

(IV) "Keep hot foods hot. Refrigerate leftovers immediately or discard." [(]A graphic illustration of a thermometer must [shall] be displayed next to the statement.[)]

§221.15.Inspection of Alternate Source Food Animals.

(a) Requirements. Specific requirements of this section are [shall be] in addition to those required by the rules adopted for inspection of livestock, under the Texas Meat and Poultry Inspection Act, and federal regulations as listed in §221.11 of this subchapter [title] (relating to Federal Regulations on Meat and Poultry Inspection).

(b) Fees. Fees are [shall be] assessed in one-half hour increments for inspection services, provided by a department inspector to a facility holding a grant of inspection, as specified in §221.16 of this subchapter [title] (relating to Fees). Failure of a grant holder to promptly pay invoices will result in cessation of overtime inspection services. Inspection time includes:

(1) the inspector's time in the field during a hunt;

(2) the inspector's time spent completing inspection records;

(3) the inspector's time spent waiting for any purpose to facilitate the processor;

(4) the inspector's time for travel between hunt sites; and

(5) the inspector's time for travel from the inspector's official duty location to the field site and return.

(c) Sanitary Dressing Procedures [dressing procedures]. The following are general guidelines of sanitary dressing applicable to all species of livestock slaughtered.

(1) The person performing slaughter operations must not permit any contamination of edible portions of the carcass with materials such as feces, urine, hair, ingesta, milk, bile, pathological tissues and exudates, or [and] other filth. All controls of slaughter and dressing procedures must be aimed at accomplishing this purpose.

(2) Slaughter operations must be conducted in a manner that precludes contamination, i.e., adequate separation of carcasses, parts, and viscera during dressing; routine cleaning and disinfection of certain equipment and hand tools; design and arrangement of equipment to prevent the contact of successive carcasses and parts; and appropriately located, functional lavatories and disinfection units.

(3) In the event [that] contamination does occur, it must be handled promptly and in a manner that ensures adequate protection to the remaining product. Contamination with feces, milk, pus, or pathological tissue or exudate must be promptly removed by trimming. Removal must be complete. Enough tissue must be removed so only clean meat remains. Scraping with the edge or back of a knife, wiping with a cloth or towel, or the use of a water spray are unacceptable procedures for removal of this type of contamination.

(d) Exotic Animals [animal].

(1) Sanitation. All slaughter operations are to be conducted in a way that precludes contamination. The following conditions, at [as] a minimum, must [shall] be met.

(A) The slaughter facility unit must [shall ] be constructed of smooth and impervious material capable of being thoroughly cleaned and sanitized before commencing operations and must be so maintained.

(B) Potable [Only potable] water must [shall] be used in conjunction with exotic animal slaughter procedures. Water from private water wells must [shall] be tested for potability by an approved laboratory within six months before [prior to] use. Water from portable water tanks must [shall] be tested by an approved laboratory every six months to determine that potable water remains potable after being in the portable tanks. Results of such testing must [shall] be made available to the department inspector.

(C) Hot water at a temperature adequate to facilitate equipment and unit sanitization during pre-operational and operational sanitation procedures is required on the skinning and evisceration [skinning/evisceration] floor. A procedure utilizing chemical sanitization in lieu of hot water may be used.

(D) Mobile as well as fixed slaughter units must [shall] provide adequate measures to control flies, other insects, and dust.

(E) Inedible by-products must be handled in a manner that does not create an insanitary condition or adulteration and ensures inedibles are not diverted to human food. When containers are used to remove inedibles from the premises, such containers must [shall] be marked "INEDIBLE" in letters at least two inches high. An adequate amount of denaturant in accordance with 9 Code of Federal Regulations (CFR) [CFR] §314.3 must [will] be used on all products placed in the "INEDIBLE" containers.

(2) Ante-mortem procedures.

(A) The producer must certify by completing and signing form MSA-71, Microchip Certification and Drug Advisory For Alternate Food Animal Species, whether the animal or animals [animal(s) ] have been identified with a microchip device.

(B) For mobile and field slaughter, once an animal has been shot, the animal will be exsanguinated as soon as possible in the field with a properly sanitized knife. The assigned inspector will examine and inspect each animal before its entry into the processing facility to ensure [assure that] the animals being harvested appear to have been healthy and were killed by the harvester.

(C) For field slaughter, environmental temperature may affect the time that may lapse before it is necessary to return to the mobile slaughter unit or processing facility for skinning and eviscerating. High environmental temperature may shorten the time lapse before dressing, as dressing must begin before the carcass becomes distended due to gas formation in the interstitial tissues or in the small intestine. The department inspector has the final decision in determining the actual time allowed between exsanguination and skinning; however, a 2-1/2 [two and one-half] hour time lapse may [shall] not be exceeded.

(3) Post-mortem procedures.

(A) The vehicle used for transporting the slaughtered exotic animals must [shall] be clean before use and must [shall] be cleaned as needed, during the operation.

(B) Dressing procedures are to begin at the slaughter unit or facility as soon as practical after slaughter.

(C) Heads from animals slaughtered by gunshot to the head must [shall] not be used for food purposes. Such heads must [shall] be denatured and placed into inedible containers.

(D) In the event [that] an animal is shot in an area other than the head, the resulting wound area and bruised areas must be trimmed of all contamination.

(E) The dressing of any animal whether it be the removal of a foot, head, or any part is strictly forbidden in any area other than inside the slaughter unit, regardless of the size of the animal. However, the removal of the antlers only is permitted before entering the slaughter facility.

(4) Dressing procedures.

(A) Persons butchering an animal must keep [their] hands as clean as possible. Adequate hand washing facilities must be readily available.

(B) Skinning operations must be conducted in a sanitary manner.

(C) As the pelt is removed, care must be taken to prevent contamination of the carcass by dirty hands, knife, or pelt.

(D) If a pelt puller is used in such a manner [that] the carcass is raised to a horizontal position, the carcasses of the female animals must be checked closely for urine leakage.

(E) Heads must remain with the carcass until inspection is completed. Nasal and oral cavities should be flushed before heads are placed on inspection tables.

(F) Overall washing of carcasses must [should ] be accomplished before any openings are made for inspection or evisceration; however, any feces, ingesta, or milk must be trimmed before washing. The washer must [should] take care to prevent filling the rectum with water during washing operations.

(G) The knife or other instrument used to open the breast must be disinfected after each use.

(H) The bung is not to be dropped until washing is completed. After opening the pelvic area, the neck of the bladder and the dropped bung should be grasped firmly and held until they clear the body cavity.

(I) Evisceration must be accomplished in a manner that precludes contamination of the carcass with contents from the bladder or intestine; viscera are [is] to be placed in an inspection pan.

(J) If intestines are to be saved, contamination should be prevented by stripping or [and/or] tying between the large and small intestine before removing from the table and sending to the next station.

(5) Processing. Processing of carcasses must [shall] be conducted in a manner and location that complies with requirements for processing all livestock carcasses, including the provisions adopted under §221.11 of this subchapter [title].

[(e) Rabbits. See 9 CFR, Part 354, as adopted by §221.11 of this title.]

[(f) Migratory water fowl, game birds, squab. See 9 CFR, Part 362, as adopted by §221.11 of this title.]

[(g) Certified products for dogs, cats, and other carnivora. See 9 CFR, Part 355, as adopted by §221.11 of this title.]

§221.16.Fees.

Special fees for inspection services.

(1) Inspection time. Inspection time may include:

(A) the inspector's time for performing inspection services;

(B) the inspector's time for completing inspection records;

(C) the inspector's time for waiting for any purpose to facilitate the slaughterer or processor [slaughterer/processor ] to begin [their] regulated activity; and

(D) the inspector's time for traveling to perform inspection services.

(2) Fees. Fees are [shall be] assessed in one-half hour increments for inspection services. Invoices are due upon receipt and become delinquent 30 calendar days from the date [which is printed] on the invoice. Inspection services will not be performed for any establishment having a delinquent account.

(3) Overtime and holiday rate. The overtime and holiday rate for inspection services is [shall be] $60 per hour, per department [program] employee.

(4) Rate. Rate for inspections not required by state or federal meat and poultry inspection laws. The rate for special inspections is [shall be] $60 per hour, per program employee.

(5) Overtime and special inspection services. Overtime and special inspection services are subject to the availability of inspectors.

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 November 8, 2024.

TRD-202405415

Cynthia Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: December 22, 2024

For further information, please call: (512) 834-6760