Compliance and Enforcement
§229.171 Compliance and Enforcement.
(a) Use for intended purpose, public health protection.
(1) Safeguarding public health. The regulatory authority shall apply these rules to promote its underlying purpose, as specified in §229.161 of this title (relating to Purpose), of safeguarding public health and ensuring that food is safe, unadulterated, and honestly presented when offered to the consumer.
(2) Assessment of existing facilities. In enforcing the provisions of these rules, the regulatory authority shall assess existing facilities or equipment that were in use before the effective date of these rules based on the following considerations:
(A) whether the facilities or equipment are in good repair and capable of being maintained in a sanitary condition;
(B) whether food-contact surfaces comply with §229.165(a) of this title (relating to Equipment, Utensils, and Linens); and
(C) whether the capacities of cooling, heating, and holding equipment are sufficient to comply with §229.165(g)(1) of this title.
(b) Additional requirements, preventing health hazards, provision for conditions not addressed.
(1) Option to impose additional requirements. If necessary to protect against public health hazards or nuisances, the department may impose specific requirements in addition to the requirements contained in these rules if authorized by law.
(2) Required documentation. The regulatory authority shall document the conditions that necessitate the imposition of additional requirements and the underlying public health rationale. A copy of the documentation shall be provided to the food establishment and the original shall be maintained in the regulatory authority?s file for the food establishment.
(c) Variances.
(1) Modifications and waivers. The department?s Retail Foods Division may grant a variance by modifying or waiving the requirements of these rules if in its opinion a health hazard or nuisance will not result from the variance. If a variance is granted, the department shall retain the information specified in paragraph (2) of this subsection in its records for the food establishment.
(2) Documentation of proposed variance and justification. Before a variance from a requirement of these rules is approved, the information that shall be provided by the person requesting the variance shall include:
(A) a statement of the proposed variance of the rule requirement citing relevant
rule section numbers;
(B) an analysis of the rationale for how the potential public health hazards and nuisances addressed by the relevant rule sections will be alternatively addressed by the proposal; and
(C) a Hazard Analysis Critical Control Point (HACCP) plan if required as specified in subsection (d)(1)(A) of this section that includes the information specified in subsection (d)(2)(A) of this section as it is relevant to the variance requested.
(3) Conformance with Approved Procedures. If a variance is granted as specified in paragraph (1) of this subsection, or a HACCP plan is otherwise required as specified in subsection (d)(1) of this section, the food establishment shall:
(A) comply with the HACCP plans and procedures that are submitted and approved as specified in subsection (d)(2) of this section as a basis for the modification or waiver; and
(B) maintain and provide upon request, records specified in subsection (d)(2)(D) and (E) of this section that demonstrate that the following are routinely employed:
(i) procedures for monitoring critical control points;
(ii) monitoring of the critical control points;
(iii) verification of the effectiveness of an operation or process; and
(iv) necessary corrective actions if there is failure at a critical control point.
(d) HACCP plan requirements.
(1) When a HACCP plan is required.
(A) Before engaging in an activity that requires a HACCP plan, a food establishment shall submit to the regulatory authority for approval a properly prepared HACCP plan as specified under paragraph (2) of this subsection and the relevant provisions of these rules if a variance is required as specified under §229.164(o)(1) of this title (relating to Food) or §229.165(f)(10)(B) of this title.
(B) A food establishment shall have a properly prepared HACCP plan as specified under §229.164(o)(2) of this title.
(2) Contents of a HACCP plan. For a food establishment that is required under paragraph (1) of this subsection to have a HACCP plan, the plan and specifications shall indicate:
(A) a categorization of the types of potentially hazardous foods that are specified in the menu such as soups and sauces, salads, and bulk, solid foods such as meat roasts, or of other foods that are specified by the regulatory authority;
(B) a flow diagram by specific food or category type identifying critical control points and providing information on the following:
(i) ingredients, materials, and equipment used in the preparation of that food; and
(ii) formulations or recipes that delineate methods and procedural control measures that address the food safety concerns involved;
(C) food employee and supervisory training plan for the person(s) in charge and food employee(s) pertaining to public health and the safety and integrity of food;
(D) a statement of standard operating procedures for the plan under consideration including and clearly identifying:
(i) each critical control point;
(ii) the critical limits for each critical control point;
(iii) the method and frequency for monitoring and controlling each critical control point by the food employee designated by the person in charge;
(iv) the method and frequency for the person in charge to routinely verify that the food employee is following standard operating procedures and monitoring critical control points;
(v) action to be taken by the person in charge if the critical limits for each critical control point are not met; and
(vi) records to be maintained by the person in charge to demonstrate that the HACCP plan is properly operated and managed; and
(E) additional scientific data or other information, as required by the regulatory authority, supporting the determination that food safety is not compromised by the proposal.
(e) Confidentiality, trade secrets.
The regulatory authority shall treat as confidential in accordance with the requirements of the Public Information Act, Texas Government Code, Chapter 552, information that meets the criteria for a trade secret and is contained on inspection report forms and in the plans and specifications submitted as specified in subsection (d)(2) of this section.
(f) Permit requirement, prerequisite for operation.
A person may not operate a food establishment without a valid permit or license to operate issued by the regulatory authority.
(g) Conditions of permit retention, responsibilities of the permit holder.
Upon acceptance of the permit issued by the regulatory authority, the permit holder in order to retain the permit shall:
(1) post the permit in a location in the food establishment that is conspicuous to consumers;
(2) comply with the provisions of these rules including the conditions of a granted variance as specified under subsection (c)(3) of this section;
(3) if a food establishment is required under subsection (d)(1) of this section to operate under a HACCP plan, comply with the plan as specified under subsection (c)(3) of this section;
(4) immediately discontinue operations and notify the regulatory authority if an imminent health hazard exists as specified in subsection (k) of this section;
(5) allow representatives of the regulatory authority access to the food establishment as specified under subsection (i)(1) of this section;
(6) except as specified in paragraph (7) of this subsection, replace existing facilities and equipment allowed in subsection (a) of this section with facilities and equipment that comply with these rules if:
(A) the regulatory authority directs the replacement because the facilities and equipment constitute a public health hazard or nuisance or no longer comply with the criteria upon which the facilities and equipment were accepted;
(B) there is a change of ownership in the establishment; or
(C) the facilities and equipment are replaced in the normal course of operation.
(7) except for in-use food preparation line equipment, upgrade or replace refrigeration equipment as specified under §229.164(n)(6)(C) of this title if the circumstances specified under paragraph (6)(A)-(C) of this subsection do not occur first;
(8) comply with directives of the regulatory authority including time frames for corrective actions specified in inspection reports, notices, orders, warnings, and other directives issued by the regulatory authority in regard to the permit holder?s food establishment or in response to community emergencies;
(9) accept notices issued and served by the regulatory authority according to law; and
(10) be subject to the administrative, civil, injunctive, and criminal remedies authorized under law for failure to comply with these rules or a directive of the regulatory authority, including time frames for corrective actions specified in inspection reports, notices, orders, warnings, and other directives.
(h) Inspection frequency, performance-based and risk-based.
The regulatory authority should inspect each food establishment at least once every six months. If the regulatory authority cannot meet this frequency, inspection frequency shall be prioritized based upon assessment of a food establishment?s history of compliance with these rules and the potential for causing foodborne illness by evaluating:
(1) past performance for noncompliance with these rules, including HACCP plan requirements, that are critical;
(2) past performance for numerous or repeat violations of these rules, including HACCP plan requirements, that are noncritical;
(3) the hazards associated with the particular foods that are prepared, stored, or served;
(4) the type of operation including the methods and extent of food storage, preparation, and service;
(5) the number of people served;
(6) whether the population served is a highly susceptible population; and
(7) any other risk factor deemed relevant to the operation by the regulatory authority.
(i) Access.
(1) Allowed at reasonable times after due notice. After the regulatory authority presents official credentials, the person in charge shall allow the regulatory authority to determine if a food establishment is in compliance with these rules by allowing access to the establishment, allowing inspection, and providing information pertaining to food and supplies purchased, received or used, or to persons employed and records specified in these rules during the food establishment?s hours of operation and other reasonable times.
(2) Refusal, notification of right to access, and final request for access. If a person denies access to the regulatory authority, the regulatory authority shall:
(A) inform the person that:
(i) the food establishment is required to allow access to the regulatory authority as specified under this subsection;
(ii) access is a condition of the acceptance and retention of a food establishment permit to operate as specified under subsection (g)(5) of this section; and
(iii) if access is denied, an order issued by the appropriate authority allowing access, hereinafter referred to as an inspection warrant, may be obtained according to law; and
(B) make a final request for access.
(3) Refusal, reporting. If after the regulatory authority presents credentials and provides notice as specified under paragraph (1) of this subsection, explains the authority upon which access is requested, and makes a final request for access as specified in paragraph (2) of this subsection, the person in charge continues to refuse access, the regulatory authority shall provide details of the denial of access on an inspection report form.
(4) Inspection warrant to gain access. If denied access to a food establishment for an authorized purpose and after complying with paragraph (2) of this subsection, the regulatory authority may issue, or apply for the issuance of, an inspection warrant to gain access as provided under law.
(j) Report of findings.
(1) Documenting information and observations. The regulatory authority shall document administrative information about the establishment?s legal identity and all other findings and observations on the inspection report form. A copy of the inspection report form shall be furnished to the owner or person in charge which constitutes a written notice. The inspection report form shall summarize the inspectional findings, and shall set forth a weighted point value for each classification of inspection items. The total demerits of the establishment shall be the cumulative total of the demerit values of the inspection items.
(2) Specifying time frame for corrections. The regulatory authority shall specify on the inspection report form the time frame for correction of the violations as specified under subsections (k)(1), (l)(1), and (m) of this section.
(3) Issuing report and obtaining acknowledgment of receipt. At the conclusion of the inspection and according to law, the regulatory authority shall provide a copy of the completed inspection report and the notice to correct violations to the permit holder or to the person in charge, and request that the person in charge during the inspection sign the completed inspection report.
(4) Refusal to sign acknowledgment. The regulatory authority shall:
(A) inform a person who declines to sign an acknowledgment of receipt of inspectional findings as specified in paragraph (3) of this subsection that:
(i) an acknowledgment of receipt is not an agreement with findings;
(ii) refusal to sign an acknowledgment of receipt will not affect the permit holder?s obligation to correct the violations noted in the inspection report within the time frames specified;
(iii) a refusal to sign an acknowledgment of receipt is noted in the inspection report and conveyed to the regulatory authority?s historical record for the food establishment; and
(B) make a final request that the person in charge sign an acknowledgment of receipt of inspectional findings.
(5) Public information. Unless prohibited by law and except as specified in subsection (e) of this section, the regulatory authority shall treat the inspection report as a public document and shall make it available for disclosure upon request.
(6) Inspection report form. For the purposes of Chapter 437, Texas Health and Safety Code, the department adopts the Retail Food Establishment Inspection Report form as specified in the following figure: Figure 1: 25 TAC §229.171(j)(6)
(k) Imminent health hazards.
(1) Ceasing operations and reporting.
(A) Except as specified in subparagraph (B) of this paragraph, a food establishment shall immediately discontinue operations and notify the regulatory authority if an imminent health hazard may exist because of an emergency such as a fire, flood, extended interruption of electrical or water service, sewage backup, misuse of poisonous or toxic materials, onset of an apparent foodborne illness outbreak, gross insanitary occurrence or condition, or other circumstance that may endanger public health.
(B) A permit holder need not discontinue operations in an area of an establishment that is unaffected by the imminent health hazard.
(2) Resumption of operations. If operations are discontinued as specified under paragraph (1) of this subsection or otherwise according to law, the permit holder shall obtain approval from the regulatory authority before resuming operations.
(l) Critical violations, time frame for corrections.
(1) Timely correction.
(A) Except as specified in subparagraph (B) of this paragraph, the food establishment shall at the time of inspection implement immediate corrective actions of all food (PHF) temperature violations; personnel/handling/source requirement violations; facility and equipment requirement violations; any HACCP plan provision that is not in compliance with its critical limit; and
all other critical violations noted.
(B) Considering the nature of the potential hazard involved and the complexity of the corrective action needed, the regulatory authority may agree to or specify a longer time frame, not to exceed 10 calendar days after the inspection, for the food establishment to correct facility and equipment requirement violations.
(2) Verification and documentation of correction.
(A) After observing at the time of inspection a correction of a violation, the regulatory authority shall document the violation and note the corrective action on the inspection report.
(B) As specified under paragraph (1)(B) of this subsection, if immediate correction is not achieved, the regulatory authority shall verify correction of the violation made at the time of the next inspection, document the information on the inspection report, and enter the report in the regulatory authority?s records.
(C) When the total cumulative demerit value of an establishment exceeds 30 demerits, the establishment shall initiate immediate corrective action on all identified critical violations and shall initiate corrective action on all other violations within 48 hours. One or more reinspections shall be conducted at reasonable time intervals to assure correction.
(D) In the case of temporary food establishments, all critical violations must be corrected immediately and other violations must be corrected within 24 hours or sooner if required by the regulatory authority. If violations are not corrected, the establishment shall immediately cease food operations until authorized to resume by the regulatory authority.
(m) Other violations, time frame for corrections.
(1) Time frame. Except as specified in paragraph (2) of this subsection, the food establishment shall correct all other violations as soon as possible, and in any event, by the time of the next routine inspection, but no later than 90 calendar days after the inspection.
(2) Extension of compliance schedule. The regulatory authority may approve a compliance schedule that extends beyond the time limits specified under paragraph (1) of this subsection if a written schedule of compliance is submitted by the food establishment and no health hazard exists or will result from allowing an extended schedule for compliance.
(n) Examination and detention of food.
The regulatory authority may examine and collect samples of food as often as necessary for the enforcement of these rules. A receipt for samples shall be issued by the regulatory authority. The department shall, upon written notice to the owner or person in charge specifying the reason therefor, place under detention any food which it has probable cause to believe is adulterated or misbranded in accordance with the provisions of the Texas Food, Drug, and Cosmetic Act, Texas Health and Safety Code, Chapter 431.
(o) Investigation and control.
(1) Obtaining information: personal history of illness, medical examination, and specimen analysis. The regulatory authority shall act when it has reasonable cause to believe that a food employee has possibly transmitted disease; may be infected with a disease in a communicable form that is transmissible through food; may be a carrier of infectious agents that cause a disease that is transmissible through food; or is affected with a boil, an infected wound, or acute respiratory infection by requiring appropriate medical examinations, including collection of specimens for laboratory analysis, of a suspected employee and other employees.
(2) Restriction or exclusion of food employee, establishment closure. Based on the findings of an investigation related to an employee who is suspected of being infected or diseased, the regulatory authority may require any or all of the following:
(A) immediately restricting the employee?s services to specific areas and tasks in a food establishment that present no risk of transmitting the disease;
(B) immediately excluding the employee from all food establishments; or
(C) immediately closing the food establishment until, in the opinion of the regulatory authority, no further danger of disease outbreak exists.
(3) Restriction or exclusion order: warning or hearing not required, information required in order. Based on the findings of the investigation as specified in paragraph (1) of this subsection and to control disease transmission, the regulatory authority may issue an order of restriction or exclusion to a suspected employee or the permit holder without prior warning, notice of a hearing, or a hearing if the order:
(A) states the reasons for the restriction or exclusion that is ordered;
(B) states the evidence that the employee or permit holder shall provide in order to demonstrate that the reasons for the restriction or exclusion are eliminated;
(C) states that the suspected employee or the permit holder may request an appeal hearing by submitting a timely request as provided under law; and
(D) provides the name and address of the regulatory authority representative to whom a request for an appeal hearing may be made.
(4) Release of employee from restriction or exclusion. The regulatory authority shall release an employee from restriction or exclusion according to Texas Health and Safety Code, Chapter 438, §438.033 and the following conditions:
(A) an employee who was infected with Salmonella typhi if the employee?s stools are negative for S. typhi based on testing of at least three consecutive stool specimen cultures that are taken:
(i) not earlier than one month after onset;
(ii) at least 48 hours after discontinuance of antibiotics; and
(iii) at least 24 hours apart;
(B) if one of the cultures taken as specified in subparagraph (A) of this paragraph is positive, repeat cultures are taken at intervals of one month until at least three consecutive negative stool specimen cultures are obtained;
(C) an employee who was infected with Shigella spp. or Escherichia coli O157:H7 if the employee?s stools are negative for Shigella spp. or E. coli O157:H7 based on testing of two consecutive stool specimen cultures that are taken:
(i) not earlier than 48 hours after discontinuance of antibiotics; and
(ii) at least 24 hours apart; and
(D) an employee who was infected with hepatitis A virus if:
(i) symptoms cease; or
(ii) at least two blood tests show falling liver enzymes.
(p) Reporting of communicable diseases.
(1) Who shall report. Certain persons, as required in 25 Texas Administrative Code
(TAC), Chapter 97, §97.2, shall report certain confirmed and suspected foodborne diseases.
(2) What to report. Confirmed and suspected cases of the following diseases, including, but not limited to the following, are reportable: botulism; campylobacteriosis; cryptosporidiosis; Escherichia coli 0157:H7; hepatitis A, acute viral; listeriosis; salmonellosis; shigellosis; trichinosis; and Vibrio infection.
(3) When to report. Reporting of communicable diseases shall be done in accordance with 25 TAC, Chapter 97, §97.4.
(4) Where to report. Persons required to report communicable diseases shall report to the local health authority, or in the case where there is no local health authority, the report shall be made to the department?s Regional Director as required in 25 TAC, Chapter 97, §97.5.
(5) Reporting and other duties of local health authorities and regional directors. Local health authorities and regional directors shall report communicable diseases to the department as provided for in 25 TAC, Chapter 97, §97.6.
(q) Food establishment inspector qualifications.
An individual conducting inspections of retail food establishments should be a Registered Professional Sanitarian in Texas, as defined in 25 TAC, Chapter 337, §337.181, or meet the equivalent educational requirements in order to:
(1) assure application of basic scientific principles, including HACCP principles of food safety, during inspections;
(2) properly conduct foodborne illness investigations;
(3) assure uniformity in the interpretations of these rules; and
(4) assure fair and uniform enforcement of these rules.