Historical Note

New Section made by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-102. Applicability

This Article does not apply to the following:

1. Beneficial use of wildlife meat authorized in A.R.S. § 17-240 and 12 A.A.C. 4, Article 1;

2. Group homes, as defined in A.R.S. Title 36, Chapter 5.1, Article 1;

3. Child care group homes, as defined in A.R.S. Title 36, Chapter 7.1, Article 4;

4. Residential group care facilities, as defined in 6 A.A.C. 5, Article 74, that have 20 or fewer clients;

5. Assisted living homes, as defined in 9 A.A.C. 10, Article 7;

6. Adult day health care services, as defined in 9 A.A.C. 10, Article 7, that have 15 or fewer clients;

7. Behavioral health service agencies, licensed under 9 A.A.C. 20, that provide residential or partial care services for 10 or fewer clients; and

8. Hospice inpatient facilities, licensed under 9 A.A.C. 10, Article 8, that have 20 or fewer patients.

Historical Note

New Section made by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2). Amended by final rulemaking at 9 A.A.R. 317, effective March 14, 2003 (Supp. 03-1). Amended by final rulemaking at 12 A.A.R. 2768, effective September 9, 2006 (Supp. 06-3).

R9-8-103. Food Establishment License Application

A. To obtain a FOOD ESTABLISHMENT LICENSE, an applicant shall complete and submit to the REGULATORY AUTHORITY a FOOD ESTABLISHMENT LICENSE application form supplied by the REGULATORY AUTHORITY that indicates all of the following:

1. The full name, telephone number, and mailing address of the applicant;

2. The name, telephone number, and street address of the FOOD ESTABLISHMENT;

3. Whether the FOOD ESTABLISHMENT is mobile or stationary;

4. Whether the FOOD ESTABLISHMENT is temporary or permanent;

5. Whether the FOOD ESTABLISHMENT facility is one of the following:

a. A new construction that is not yet completed,

b. An existing structure that is being converted for use as a FOOD ESTABLISHMENT, or

c. An existing FOOD ESTABLISHMENT facility that is being remodeled;

6. Whether the FOOD ESTABLISHMENT prepares, offers for sale, or serves POTENTIALLY HAZARDOUS FOOD;

7. Whether the FOOD ESTABLISHMENT does any of the following:

a. Prepares, offers for sale, or serves POTENTIALLY HAZARDOUS FOOD only to order upon CONSUMER request;

b. Prepares, offers for sale, or serves POTENTIALLY HAZARDOUS FOOD in advance, in quantities based on projected CONSUMER demand;

c. Prepares, offers for sale, or serves POTENTIALLY HAZARDOUS FOOD using time alone, rather than time and temperature, as the public health control as described in FC § 3-501.19;

d. Prepares POTENTIALLY HAZARDOUS FOOD in advance using a multiple stage FOOD preparation method that may include the following:

i. Combining POTENTIALLY HAZARDOUS FOOD ingredients,

ii. Cooking,

iii. Cooling,

iv. Reheating,

v. Hot or cold holding,

vi. Freezing, or

vii. Thawing;

e. Prepares FOOD as specified under subsection (A)(7)(d) for delivery to and consumption at a location off of the PREMISES where prepared;

f. Prepares FOOD as specified under subsection (A)(7)(d) for service to a HIGHLY SUSCEPTIBLE POPULATION; or

g. Does not prepare FOOD, but offers for sale only pre-PACKAGED FOOD that is not POTENTIALLY HAZARDOUS FOOD; and

8. The applicant's signature and the date signed.

B. An applicant who operates FOOD ESTABLISHMENTS at multiple locations shall submit a completed LICENSE application for each location.

Historical Note

New Section made by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-104. Time-frames

A. This Section applies to the Department and to a local health department or public health services district to which the duty to comply with A.R.S. Title 41, Chapter 6, Article 7.1 has been delegated by the Department.

B. The overall time-frame described in A.R.S. § 41-1072 for each type of approval granted by the REGULATORY AUTHORITY is provided in Table 1. The applicant, LICENSE HOLDER, or requester and the REGULATORY AUTHORITY may agree in writing to extend the substantive review time-frame and the overall time-frame. An extension of the substantive review time-frame and the overall time-frame may not exceed 25% of the overall time-frame.

C. The administrative completeness review time-frame described in A.R.S. § 41-1072 for each type of approval granted by the REGULATORY AUTHORITY is provided in Table 1 and begins on the date that the REGULATORY AUTHORITY receives an application or request for approval.

1. The REGULATORY AUTHORITY shall mail a notice of administrative completeness or deficiencies to the applicant, LICENSE HOLDER, or requester within the administrative completeness review time-frame.

a. A notice of deficiencies shall list each deficiency and the information and documentation needed to complete the application or request for approval.

b. If the REGULATORY AUTHORITY issues a notice of deficiencies within the administrative completeness review time-frame, the administrative completeness review time-frame and the overall time-frame are suspended from the date that the notice is issued until the date that the REGULATORY AUTHORITY receives the missing information from the applicant, LICENSE HOLDER, or requester.

c. If the applicant, LICENSE HOLDER, or requester fails to submit to the REGULATORY AUTHORITY all of the information and documents listed in the notice of deficiencies within 180 days from the date that the REGULATORY AUTHORITY mailed the notice of deficiencies, the REGULATORY AUTHORITY shall consider the application or request for approval withdrawn.

2. If the REGULATORY AUTHORITY issues a LICENSE or other approval to the applicant, LICENSE HOLDER, or requester during the administrative completeness review time-frame, the REGULATORY AUTHORITY shall not issue a separate written notice of administrative completeness.

D. The substantive review time-frame described in A.R.S. § 41-1072 is provided in Table 1 and begins as of the date on the notice of administrative completeness.

1. The REGULATORY AUTHORITY shall mail written notification of approval or denial of the application or other request for approval to the applicant, LICENSE HOLDER, or requester within the substantive review time-frame.

2. As part of the substantive review for a FOOD ESTABLISHMENT LICENSE, the REGULATORY AUTHORITY may complete an inspection that may require more than one visit to the FOOD ESTABLISHMENT.

3. During the substantive review time-frame, the REGULATORY AUTHORITY may make one comprehensive written request for additional information, unless the REGULATORY AUTHORITY and the applicant, LICENSE HOLDER, or requester have agreed in writing to allow the REGULATORY AUTHORITY to submit supplemental requests for information.

a. The comprehensive written request regarding a FOOD ESTABLISHMENT LICENSE application may include a request for submission of plans and specifications, as described in FC § 8-201.11.

b. The comprehensive written request regarding a request for a VARIANCE under FC § 8-103.10 may include a request for a HACCP PLAN, as described in FC § 8-201.13(A), if the REGULATORY AUTHORITY determines that a HACCP PLAN is required.

c. If the REGULATORY AUTHORITY issues a comprehensive written request or a supplemental request for information, the substantive review time-frame and the overall time-frame are suspended from the date that the REGULATORY AUTHORITY issues the request until the date that the REGULATORY AUTHORITY receives all of the information requested.

4. The REGULATORY AUTHORITY shall issue a license or an approval unless:

a. For a FOOD ESTABLISHMENT LICENSE application, the REGULATORY AUTHORITY determines that the application for a FOOD ESTABLISHMENT LICENSE or the FOOD ESTABLISHMENT does not satisfy all of the requirements of this Article;

b. For a VARIANCE, the REGULATORY AUTHORITY determines that the request for a VARIANCE fails to demonstrate that the VARIANCE will not result in a health HAZARD or nuisance;

c. For approval of plans and specifications, the REGULATORY AUTHORITY determines that the plans and specifications do not satisfy all of the requirements of this Article;

d. For approval of a HACCP PLAN, the REGULATORY AUTHORITY determines that the HACCP PLAN does not satisfy all of the requirements of this Article;

e. For approval of an inspection form, the Department determines that the inspection form does not satisfy all of the requirements of R9-8-108(B)-(C); or

f. For approval of a quality assurance program, the Department determines that the quality assurance program does not satisfy all of the requirements of R9-8-108(E)(1).

5. If the REGULATORY AUTHORITY denies an application or request for approval, the REGULATORY AUTHORITY shall send to the applicant, LICENSE HOLDER, or requester a written notice of denial setting forth the reasons for the denial and all other information required by A.R.S. § 41-1076.

E. For the purpose of computing time-frames in this Section, the day of the act, event, or default from which the designated period of time begins to run is not included. Intermediate Saturdays, Sundays, and legal holidays are included in the computation. The last day of the period so computed is included unless it is a Saturday, a Sunday, or a legal holiday, in which event the period runs until the end of the next day that is not a Saturday, a Sunday, or a legal holiday.

Historical Note

New Section made by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

Table 1. Time-frames (in days)

Historical Note

New Section made by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-106. License Suspension or Revocation

A. The REGULATORY AUTHORITY may suspend or revoke a FOOD ESTABLISHMENT LICENSE if the LICENSE HOLDER:

1. Violates this Article or A.R.S. § 36-601, or

2. Provides false information on a LICENSE application.

B. A LICENSE revocation or suspension hearing shall be conducted as follows:

1. If the REGULATORY AUTHORITY is the Department, the hearing shall be conducted in accordance with A.R.S. Title 41, Chapter 6, Article 10 and any rules promulgated by the Office of Administrative Hearings;

2. If the REGULATORY AUTHORITY is a local health department or public health services district to which the duty to comply with A.R.S. Title 41, Chapter 6, Article 10 has been delegated, the hearing shall be conducted in accordance with A.R.S. Title 41, Chapter 6, Article 10 and any rules promulgated by the Office of Administrative Hearings; and

3. For all other REGULATORY AUTHORITIES, a LICENSE revocation or suspension hearing shall be conducted in accordance with the procedures adopted by a county board of supervisors as required by A.R.S. § 36-183.04(E).

Historical Note

New Section made by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-107. Food Safety Requirements

A. A LICENSE HOLDER shall comply with the United States Food and Drug Administration publication, Food Code: 1999 Recommendations of the United States Public Health Service, Food and Drug Administration (1999), as modified, which is incorporated by reference. This incorporation by reference contains no future editions or amendments. The incorporated material is on file with the Department and is available for purchase from the United States Department of Commerce, Technology Administration, National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161, as report number PB99-115925, or from the United States Government Printing Office, Superintendent of Documents, Mail Stop: SSOP, Washington, D.C. 20402-9328, as ISBN 0-16-050028-1; and is available on the Internet at http://www.fda.gov.

B. The material incorporated by reference in subsection (A) is modified as follows:

1. Where the term "permit" appears, it is replaced with "license";

2. Subparagraph 1-201.10(B)(2)(a) is modified to read: "`Food additive' has the meaning stated in A.R.S. § 36-901(7).";

3. Subparagraph 1-201.10(B)(2)(b) is modified to read: "`Color additive' has the meaning stated in A.R.S. § 36-901(2).";

4. Subparagraph 1-201.10(B)(3) is modified to read: "`Adulterated' means possessing one or more of the conditions enumerated in A.R.S. § 36-904(A).";

5. Subparagraph 1-201.10(B)(4) is modified to read: "`Approved' means acceptable to the REGULATORY AUTHORITY or to the FOOD regulatory agency that has jurisdiction based on a determination of conformity with principles, practices, and generally recognized standards that protect public health.";

6. Subparagraph 1-201.10(B)(14) is modified by deleting "or FOOD PROCESSING PLANT";

7. Subparagraph 1-201.10(B)(31)(c)(iii) is deleted;

8. Subparagraph 1-201.10(B)(32) is modified to read: "`Food processing plant' means a FOOD ESTABLISHMENT that manufactures, packages, labels, or stores FOOD for human consumption and does not provide FOOD directly to a CONSUMER.";

9. Subparagraph 1-201.10(B)(50)(a) is modified to read: "`Packaged' means bottled, canned, cartoned, securely bagged, or securely wrapped.";

10. Subparagraph 1-201.10(B)(54) is modified to read: "`Person in charge' means the individual present at a FOOD ESTABLISHMENT who is responsible for the management of the operation at the time of inspection.";

11. Subparagraph 1-201.10(B)(69) is modified to read: "`Regulatory authority' means the Department or a local health department or public health services district operating under a delegation of authority from the Department.";

12. Paragraph 3-202.11(C) is modified to read: "POTENTIALLY HAZARDOUS FOOD that is cooked to a temperature and for a time specified under §§ 3-401.11 - 3-401.13 and received hot shall be at a temperature of 54° C (130° F) or above.";

13. Paragraph 3-202.14(B) is modified to read: "All milk and milk products sold at the retail level in Arizona shall comply with the requirements in A.A.C. Title 3, Chapter 2, Article 8.";

14. Paragraph 3-202.17(B) is deleted;

15. Paragraph 3-202.18(B) is deleted;

16. Paragraph 3-203.11(A) is modified to read: "Except as specified in ¶¶ (B) and (C) of this Section, MOLLUSCAN SHELLFISH may not be removed from the container in which they are received other than immediately before sale, preparation for service, or preparation in a FOOD PROCESSING PLANT licensed by the REGULATORY AUTHORITY.";

17. Paragraph 3-203.12(B) is modified to read:

"(B) The identity of the source of SHELLSTOCK that are prepared by a FOOD PROCESSING PLANT licensed by the REGULATORY AUTHORITY, sold, or served shall be maintained by retaining SHELLSTOCK tags or labels for 90 calendar days from the date the container is emptied by:

(1) Using an APPROVED record keeping system that keeps the tags or labels in chronological order correlated to the date when, or dates during which, the SHELLSTOCK are prepared by a FOOD PROCESSING PLANT licensed by the REGULATORY AUTHORITY, sold, or served; and

(2) If SHELLSTOCK are removed from their tagged or labeled container:

(a) Using only one tagged or labeled container at a time, or

(b) Using more than one tagged or labeled container at a time and obtaining a VARIANCE from the REGULATORY AUTHORITY as specified in § 8-103.10 based on a HACCP PLAN that:

(i) Is submitted by the LICENSE HOLDER and APPROVED as specified under § 8-103.11,

(ii) Preserves source identification by using a record keeping system as specified under Subparagraph (B)(1) of this Section, and

(iii) Ensures that SHELLSTOCK from one tagged or labeled container are not commingled with SHELLSTOCK from another container before being ordered by the CONSUMER or prepared by a FOOD PROCESSING PLANT licensed by the REGULATORY AUTHORITY.";

18. Paragraph 3-301.11(B) is modified by replacing "SINGLE-USE gloves" with "non-latex SINGLE-USE gloves";

19. Paragraph 3-304.12(F) is modified to read: "In a container of water if the water is maintained at a temperature of at least 54° C (130° F) and the container is cleaned at a frequency specified under Subparagraph 4-602.11(D)(7).";

20. Section 3-304.15 is modified by adding a new Paragraph (E):

"(E) Latex gloves may not be used in direct contact with FOOD.";

21. Section 3-401.13 is modified to read: "Fruits and vegetables that are cooked for hot holding shall be cooked to a temperature of 54° C (130° F).";

22. Paragraph 3-403.11(C) is modified to read: "READY-TO-EAT FOOD taken from a commercially processed, HERMETICALLY SEALED CONTAINER, or from an intact package from a FOOD PROCESSING PLANT that is inspected by the FOOD regulatory agency that has jurisdiction over the plant, shall be heated to a temperature of at least 54° C (130° F) for hot holding.";

23. Subparagraph 3-501.14(A)(1) is modified to read: "Within 2 hours, from 54° C (130° F) to 21° C (70° F); and";

24. Paragraph 3-501.16(A) is modified to read: "At 54° C (130° F) or above; or";

25. Subparagraph 3-501.16(C)(2) is modified to read: "Within 10 years of the adoption of this Code, the EQUIPMENT is upgraded or replaced to maintain FOOD at a temperature of 5° C (41° F) or less.";

26. Section 3-502.11 is modified by deleting "custom processing animals that are for personal use as FOOD and not for sale or service in a FOOD ESTABLISHMENT;";

27. Paragraph 3-701.11(C) is modified by replacing "who has been restricted or excluded as specified under § 2-201.12" with "who has any of the conditions that require reporting to the PERSON IN CHARGE under § 2-201.11 or who has been excluded by the REGULATORY AUTHORITY under the communicable disease rules at 9 A.A.C. 6";

28. Subparagraph 4-602.11(D)(7) is modified by replacing "60° C (140° F)" with "54° C (130° F)";

29. Section 5-101.13 is modified to read: "BOTTLED DRINKING WATER used or sold in a FOOD ESTABLISHMENT shall be obtained from APPROVED sources, in accordance with LAW.";

30. Paragraph 5-501.116(A) is modified by replacing "§ 5-402.14" with "§§ 5-402.13 and 5-403.11";

31. Section 6-501.116 is added to read:

"6-501.116 Vending Machine Signs.

The LICENSE HOLDER for a VENDING MACHINE shall affix to the VENDING MACHINE a permanent sign that includes:

1. A unique identifier for the VENDING MACHINE, and

2. A telephone number for CONSUMERS to contact the LICENSE HOLDER.";

32. Paragraph 8-101.10(A) is modified by deleting ", as specified in § 1-102.10,";

33. Paragraph 8-201.11(C) is modified by replacing "as specified under ¶ 8-302.14(C)" with "as described in R9-8-103(A)(6)-(7)";

34. Paragraph 8-304.11(D) is modified to read: "Require FOOD EMPLOYEE applicants to whom a conditional offer of employment is made and FOOD EMPLOYEES to report to the PERSON IN CHARGE the information required under § 2-201.11";

35. Paragraph 8-304.11(H) is modified by replacing "5 years" with "10 years";

36. Section 8-304.20 is modified by replacing "as specified under ¶ 8-302.14(C)" with "as described in R9-8-103(A)(6)-(7)";

37. Section 8-402.11 is modified by adding the following at the end of the Section: "The Department or a local health department or public health services district to which the duty to comply with A.R.S. § 41-1009 has been delegated by the Department shall comply with A.R.S. § 41-1009 when performing inspections.";

38. Section 8-403.50 is modified by deleting "Except as specified in § 8-202.10," and capitalizing "the";

39. Section 8-404.12 is modified by adding the following at the end of the Section: "The REGULATORY AUTHORITY shall approve or deny resumption of operations within five days after receipt of the LICENSE HOLDER'S request to resume operations.";

40. Section 8-405.11 is modified by adding the following at the end of the Section:

"(C) The Department or a local health department or public health services district to which the duty to comply with A.R.S. § 41-1009 has been delegated by the Department shall not provide the LICENSE HOLDER an opportunity to correct critical Code violations or HACCP PLAN deviations after the date of inspection if the Department or the local health department or public health services district determines that the deficiencies are:

(1) Committed intentionally;

(2) Not correctable within a reasonable period of time;

(3) Evidence of a pattern of noncompliance; or

(4) A risk to any PERSON; the public health, safety, or welfare; or the environment.

(D) If the Department or a local health department or public health services district to which the duty to comply with A.R.S. § 41-1009 has been delegated by the Department allows the LICENSE HOLDER an opportunity to correct violations or deviations after the date of inspection, the Department, local health department, or public health services district shall inspect the FOOD ESTABLISHMENT within 24 hours after the deadline for correction has expired. If the Department, local health department, or public health services district determines that the violations or deviations have not been corrected, the Department, local health department, or public health services district may take any enforcement action authorized by LAW, based upon those violations or deviations.

(E) A decision made under subparagraph 8-405.11(C) or subparagraph 8-405.11(D) by the Department or a local health department or public health services district to which the duty to comply with A.R.S. § 41-1009 has been delegated by the Department is not an appealable agency action, as defined by A.R.S. § 41-1092.";

41. The following FC Sections are deleted:

a. Section 1-102.10,

b. Section 1-103.10,

c. Section 2-201.12,

d. Section 2-201.13,

e. Section 2-201.14,

f. Section 2-201.15,

g. Section 8-102.10,

h. Section 8-202.10,

i. Section 8-302.11,

j. Section 8-302.12,

k. Section 8-302.13,

l. Section 8-302.14,

m. Section 8-303.10,

n. Section 8-303.20,

o. Section 8-303.30,

p. Section 8-402.20,

q. Section 8-402.30,

r. Section 8-402.40,

s. Section 8-403.10,

t. Section 8-501.10,

u. Section 8-501.20,

v. Section 8-501.30, and

w. Section 8-501.40; and

42. The annexes are excluded.

Historical Note

New Section made by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2). Amended by final rulemaking at 12 A.A.R. 2768, effective September 9, 2006 (Supp. 06-3).

R9-8-108. Inspection Standardization and Documentation

A. At each inspection, the REGULATORY AUTHORITY shall, at a minimum, inspect for compliance with each of the applicable CRITICAL ITEMS in the following categories:

1. Temperature control of POTENTIALLY HAZARDOUS FOODS, as required by FC §§ 3-401.11, 3-401.12, 3-403.11, 3-501.14, and 3-501.16;

2. EMPLOYEE health and hygienic practices, as required by FC §§ 2-201.11, 2-301.11, 2-301.12, 2-301.14, 2-401.11, 2-401.12, 2-403.11, 3-301.11, 3-301.12, and 5-203.11;

3. Time as a public health control, as required by FC § 3-501.19;

4. FOOD condition and source, as required by FC §§ 3-101.11, 3-201.11, 3-201.12, 3-201.14, 3-201.15, 3-201.16, 3-201.17, 3-202.11, 3-202.13, 3-202.14, 3-202.15, 3-202.16, 3-202.18, 3-203.12, 5-101.11, and 5-101.13;

5. CONSUMER advisories, as required by FC § 3-603.11;

6. Contamination prevention, as required by FC §§ 3-302.11, 3-302.13, 3-302.14, 3-304.11, 3-306.13, 3-306.14, 4-601.11, 4-602.11, 4-702.11, 4-703.11, 5-101.12, 5-201.11, and 5-202.11;

7. Date marking and disposal of READY-TO-EAT FOODS, as required by FC §§ 3-501.17 and 3-501.18;

8. Responsibility and knowledge of the PERSON IN CHARGE, as required by FC §§ 2-101.11 and 2-102.11; and

9. Compliance with a HACCP PLAN or VARIANCE, as required by FC § 8-103.12;

B. The REGULATORY AUTHORITY shall document its inspection results on an inspection report form provided or approved by the Department. The inspection report form shall include the following:

1. The name and address of the FOOD ESTABLISHMENT inspected;

2. The LICENSE number of the FOOD ESTABLISHMENT inspected;

3. The date of inspection;

4. The type of inspection;

5. A rating for each of the observed CRITICAL ITEMS listed in subsection (A), using a rating scheme that indicates whether the CRITICAL ITEM is met;

6. Space for comments, including observed violations of non-CRITICAL ITEMS;

7. Signature and date lines for the PERSON IN CHARGE of the FOOD ESTABLISHMENT; and

8. Signature and date lines for the inspector conducting the inspection.

C. The REGULATORY AUTHORITY shall also document on the inspection form the applicable CRITICAL ITEMS listed in subsection (A) that were not observed during the inspection, unless the REGULATORY AUTHORITY has a quality assurance program that has been approved by the Department under subsection (E).

D. If a REGULATORY AUTHORITY desires to create its own inspection form, the REGULATORY AUTHORITY may request approval of its inspection form by submitting a written request to the Department along with a copy of the inspection form for which approval is sought. The Department shall approve an inspection form if it determines that the inspection form satisfies all of the requirements of subsections (B) and (C).

E. A REGULATORY AUTHORITY may request approval of a quality assurance program by submitting a written request to the Department along with a description of the quality assurance program for which approval is sought.

1. The quality assurance program shall include the following:

a. A system for monitoring the inspection reports completed by each inspector every six months and comparing them to the reports of other inspectors and the REGULATORY AUTHORITY as a whole with respect to the number and types of violations documented during the same period;

b. Identification of each inspector whose inspection reports are incongruous;

c. Reinspection of a representative sample of an inspector's FOOD ESTABLISHMENTS for which inspection reports are incongruous by a quality assurance inspector within 30 days of identification of an inspector under subsection (E)(1)(b) to determine whether the incongruous reports indicate a misapplication of the rules by the inspector;

d. Follow-up with each inspector determined by a quality assurance inspector to have misapplied the rules:

i. If the inspector has not previously required follow-up, additional training by a quality assurance inspector regarding any misapplication of the rules by the inspector;

ii. If the inspector has previously received additional training under subsection (E)(1)(d)(i), formal counseling by the inspector's direct supervisor and a quality assurance inspector; or

iii. If the inspector has previously been formally counseled under subsection (E)(1)(d)(ii), disciplinary action; and

e. Consideration by the REGULATORY AUTHORITY of any misapplication of the rules by the inspector when completing the inspector's performance evaluations.

2. The Department shall approve a quality assurance program if it determines that the quality assurance program satisfies all of the requirements of subsection (E)(1).

Historical Note

New Section made by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-109. Cease and Desist and Abatement

A. Engaging in any practice in violation of this Article is a public nuisance.

B. If the REGULATORY AUTHORITY has reasonable cause to believe that any FOOD ESTABLISHMENT is creating or maintaining a nuisance, the REGULATORY AUTHORITY shall order the LICENSE HOLDER for the FOOD ESTABLISHMENT to cease and desist the activity and to abate the nuisance as follows:

1. The REGULATORY AUTHORITY shall serve upon the LICENSE HOLDER for the FOOD ESTABLISHMENT a written cease and desist and abatement order requiring the LICENSE HOLDER to cease and desist the activity and to remove the nuisance at the LICENSE HOLDER's expense within 24 hours after service of the order. The order shall contain the following:

a. A reference to the statute or rule that is alleged to have been violated or on which the order is based,

b. A description of the LICENSE HOLDER's right to request a hearing, and

c. A description of the LICENSE HOLDER's right to request an informal settlement conference.

2. The REGULATORY AUTHORITY shall serve the order and any subsequent notices by personal delivery or certified mail, return receipt requested, to the LICENSE HOLDER's or other party's last address of record with the REGULATORY AUTHORITY or by any other method reasonably calculated to effect actual notice on the LICENSE HOLDER or other party.

3. The LICENSE HOLDER or another party whose rights are determined by the order may obtain a hearing to appeal the order by filing a written notice of appeal with the REGULATORY AUTHORITY within 30 days after service of the order. The LICENSE HOLDER or other party appealing the order shall serve the notice of appeal upon the REGULATORY AUTHORITY by personal delivery or certified mail, return receipt requested, to the office of the REGULATORY AUTHORITY or by any other method reasonably calculated to effect actual notice on the REGULATORY AUTHORITY.

4. If a notice of appeal is timely filed, the REGULATORY AUTHORITY shall do one of the following:

a. If the REGULATORY AUTHORITY is the Department or a local health department or public health services district to which the duty to comply with A.R.S. Title 41, Chapter 6, Article 10 has been delegated, the notification and hearing shall comply with A.R.S. Title 41, Chapter 6, Article 10 and any rules promulgated by the Office of Administrative Hearings.

b. For all other regulatory authorities, the notification and hearing shall comply with the procedures adopted by a county board of supervisors as required by A.R.S. § 36-183.04(E).

5. If no written notice of appeal is timely filed, the order shall become final without further proceedings.

C. The REGULATORY AUTHORITY shall inspect the FOOD ESTABLISHMENT 24 hours after service of the order to determine whether the LICENSE HOLDER has complied with the order. If the REGULATORY AUTHORITY determines upon inspection that the LICENSE HOLDER has not ceased the activity and abated the nuisance, the REGULATORY AUTHORITY shall cause the nuisance to be removed, regardless of whether the LICENSE HOLDER is appealing the order.

D. If the LICENSE HOLDER fails or refuses to comply with the order after a hearing has upheld the order or after the time to appeal the order has expired, the REGULATORY AUTHORITY may file an action against the LICENSE HOLDER in the superior court of the county in which the violation occurred, requesting that a permanent injunction be issued to restrain the LICENSE HOLDER from engaging in further violations as described in the order.

Historical Note

New Section made by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-110. Reserved

R9-8-111. Repealed

Historical Note

Amended effective July 10, 1979 (Supp. 79-4). Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-112. Repealed

Historical Note

Former Section R9-8-112 repealed, new Section R9-8-112 adopted effective July 10, 1979 (Supp. 79-4). Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-113. Repealed

Historical Note

Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-114. Repealed

Historical Note

Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-115. Repealed

Historical Note

Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-116. Repealed

Historical Note

Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-117. Repealed

Historical Note

Corrected Article reference (Supp. 77-3). Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-118. Repealed

Historical Note

Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-119. Repealed

Historical Note

Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-120. Reserved

R9-8-121. Repealed

Historical Note

Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-122. Repealed

Historical Note

Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-123. Repealed

Historical Note

Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-124. Repealed

Historical Note

Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-125. Repealed

Historical Note

Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-126. Repealed

Historical Note

Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-127. Repealed

Historical Note

Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-128. Reserved

R9-8-129. Reserved

R9-8-130. Reserved

R9-8-131. Repealed

Historical Note

Former Section R9-8-131 repealed, new Section R9-8-131 adopted effective July 10, 1979 (Supp. 79-4). Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-132. Repealed

Historical Note

Adopted effective July 10, 1979 (Supp. 79-4). Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-133. Repealed

Historical Note

Adopted effective July 10, 1979 (Supp. 79-4). Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-134. Repealed

Historical Note

Adopted effective July 10, 1979 (Supp. 79-4). Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-135. Repealed

Historical Note

Adopted effective July 10, 1979 (Supp. 79-4). Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-136. Repealed

Historical Note

Adopted effective July 10, 1979 (Supp. 79-4). Amended effective August 6, 1990 (Supp. 90-3). Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-137. Repealed

Historical Note

Adopted effective July 10, 1979 (Supp. 79-4). Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-138. Repealed

Historical Note

Adopted effective July 10, 1979 (Supp. 79-4). Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-139. Repealed

Historical Note

Adopted effective July 10, 1979 (Supp. 79-4). Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-140. Repealed

Historical Note

Adopted effective July 10, 1979 (Supp. 79-4). Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-141. Reserved

R9-8-142. Reserved

R9-8-143. Reserved

R9-8-144. Reserved

R9-8-145. Reserved

R9-8-146. Reserved

R9-8-147. Reserved

R9-8-148. Reserved

R9-8-149. Reserved

R9-8-150. Reserved

R9-8-151. Repealed

Historical Note

Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-152. Reserved

R9-8-153. Reserved

R9-8-154. Reserved

R9-8-155. Reserved

R9-8-156. Repealed

Historical Note

Correction of reference from R9-1-415(B) to R9-1-415(A) (Supp. 83-3). Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-157. Reserved

R9-8-158. Reserved

R9-8-159. Reserved

R9-8-160. Repealed

Historical Note

Adopted effective January 18, 1977 (Supp. 77-1). Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-161. Repealed

Historical Note

Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-162. Repealed

Historical Note

Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-163. Repealed

Historical Note

Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-164. Repealed

Historical Note

Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-165. Repealed

Historical Note

Adopted effective January 18, 1977 (Supp. 77-1). Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-166. Reserved

R9-8-167. Reserved

R9-8-168. Reserved

R9-8-169. Reserved

R9-8-170. Reserved

R9-8-171. Repealed

Historical Note

Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-172. Repealed

Historical Note

Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-173. Repealed

Historical Note

Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-174. Repealed

Historical Note

Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-175. Repealed

Historical Note

Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-176. Repealed

Historical Note

Correction, subsection (A), reference R9-1-412(D) should read R9-1-415(B) (Supp. 83-3). Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-177. Repealed

Historical Note

Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-178. Repealed

Historical Note

Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-179. Reserved

R9-8-180. Reserved

R9-8-181. Repealed

Historical Note

Legislative enactment transferred function of meat inspection to the Livestock Sanitary Board by Laws 1973, Ch. 158. Responsibility for meat inspection returned to Department of Health Services by Laws 1977, Ch. 92, effective May 26, 1977. Amended as an emergency effective June 6, 1977 (Supp. 77-3). Emergency filings valid for 90 days pursuant to A.R.S. § 41-1003. New Section R9-8-181 adopted effective March 29, 1978 (Supp. 78-2). Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-182. Repealed

Historical Note

Legislative enactment transferred function of meat inspection to the Livestock Sanitary Board by Laws 1973, Ch. 158. Responsibility for meat inspection returned to Department of Health Services by Laws 1977, Ch. 92, effective May 26, 1977. Amended as an emergency effective June 6, 1977 (Supp. 77-3). Emergency filings valid for 90 days pursuant to A.R.S. § 41-1003. New Section R9-8-182 adopted effective March 29, 1978 (Supp. 78-2). Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-183. Repealed

Historical Note

Legislative enactment transferred function of meat inspection to the Livestock Sanitary Board by Laws 1973, Ch. 158. Responsibility for meat inspection returned to Department of Health Services by Laws 1977, Ch. 92, effective May 26, 1977. Amended as an emergency effective June 6, 1977 (Supp. 77-3). Emergency filings valid for 90 days pursuant to A.R.S. § 41-1003. New Section R9-8-183 adopted effective March 29, 1978 (Supp. 78-2). Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-184. Repealed

Historical Note

Legislative enactment transferred function of meat inspection to the Livestock Sanitary Board by Laws 1973, Ch. 158. Responsibility for meat inspection returned to Department of Health Services by Laws 1977, Ch. 92, effective May 26, 1977. Amended as an emergency effective June 6, 1977 (Supp. 77-3). Emergency filings valid for 90 days pursuant to A.R.S. § 41-1003. New Section R9-8-184 adopted effective March 29, 1978 (Supp. 78-2). Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-185. Repealed

Historical Note

Legislative enactment transferred function of meat inspection to the Livestock Sanitary Board by Laws 1973, Ch. 158. Responsibility for meat inspection returned to Department of Health Services by Laws 1977, Ch. 92, effective May 26, 1977. Amended as an emergency effective June 6, 1977 (Supp. 77-3). Emergency filings valid for 90 days pursuant to A.R.S. § 41-1003. New Section R9-8-185 adopted effective March 29, 1978 (Supp. 78-2). Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-186. Repealed

Historical Note

Legislative enactment transferred function of meat inspection to the Livestock Sanitary Board by Laws 1973, Ch. 158. Responsibility for meat inspection returned to Department of Health Services by Laws 1977, Ch. 92, effective May 26, 1977. Amended as an emergency effective June 6, 1977 (Supp. 77-3). Emergency filings valid for 90 days pursuant to A.R.S. § 41-1003. New Section R9-8-186 adopted effective March 29, 1978 (Supp. 78-2). Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-187. Repealed

Historical Note

Legislative enactment transferred function of meat inspection to the Livestock Sanitary Board by Laws 1973, Ch. 158. Responsibility for meat inspection returned to Department of Health Services by Laws 1977, Ch. 92, effective May 26, 1977. Amended as an emergency effective June 6, 1977 (Supp. 77-3). Emergency filings valid for 90 days pursuant to A.R.S. § 41-1003. New Section R9-8-187 adopted effective March 29, 1978 (Supp. 78-2). Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-188. Repealed

Historical Note

Legislative enactment transferred function of meat inspection to the Livestock Sanitary Board by Laws 1973, Ch. 158. Responsibility for meat inspection returned to Department of Health Services by Laws 1977, Ch. 92, effective May 26, 1977. Amended as an emergency effective June 6, 1977 (Supp. 77-3). Emergency filings valid for 90 days pursuant to A.R.S. § 41-1003. New Section R9-8-188 adopted effective March 29, 1978 (Supp. 78-2). Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-189. Repealed

Historical Note

Adopted effective March 29, 1978 (Supp. 78-2). Section repealed by final rulemaking at 7 A.A.R. 1719, effective October 3, 2001 (Supp. 01-2).

R9-8-190. Reserved

R9-8-191. Repealed

Historical Note

Repealed effective August 6, 1990 (Supp. 90-3).

ARTICLE 2. BOTTLED WATER

R9-8-201. Definitions

In this Article, unless the context otherwise requires:

1. "Applicant" has the same meaning as in R9-8-101.

2. "Aquifer" means a layer of underground sand, gravel or porous rock where water collects.

3. "Artesian well" means a drilled well that accesses an aquifer with a water level that stands above the bottom of the confining bed of the aquifer.

4. "Bottled water" has the same meaning as in 21 CFR 165.110(a)(1) (2003), incorporated by reference, on file with the Department, including no future editions or amendments, and available at http://www.gpoaccess.gov/cfr/index.html and from U.S. Government Printing Office, 732 N. Capitol Street, N.W. Washington, D.C. 20401.

5. "Bottled water plant" means a food establishment that processes and sells bottled water.

6. "CFR" means the Code of Federal Regulations.

7. "Confining bed" means a layer of ground that resists water penetration.

8. "Department" means the Arizona Department of Health Services.

9. "Drilled well" means a hole bored into the ground to reach underground water.

10. "Food establishment" has the same meaning as in A.A.C. Title 9, Chapter 8, Article 1.

11. "Licensed laboratory" means a laboratory licensed by the Department under A.R.S. Title 36, Chapter 4.3, Article 1.

12. "Plant operator" means an individual designated by the applicant to operate a specific bottled water plant.

13. "Processes" means the steps taken to ensure source water meets the quality standards for bottled water in 21 CFR 165.110(b) (2003), incorporated by reference, on file with the Department, including no future editions or amendments, and available at http://www.gpoaccess.gov/cfr/index.html and from U.S. Government Printing Office, 732 N. Capitol Street, N.W. Washington, D.C. 20401.

14. "Public water system" has the same meaning as in A.A.C. R18-4-101 .

15. "Source" means an artesian well, drilled well, public water system, or spring.

16. "Source water" means water from an artesian well, drilled well, public water system, or spring.

17. "Spring" has the same meaning as "spring water" in 21 CFR 165.110(a)(2)(vi) (2003), incorporated by reference, on file with the Department, including no future editions or amendments, and available at http://www.gpoaccess.gov/cfr/index.html and from U.S. Government Printing Office, 732 N. Capitol Street, N.W. Washington, D.C. 20401.

Historical Note

Adopted effective August 6, 1990 (Supp. 90-3). Amended by final rulemaking at 10 A.A.R. 4178, effective November 23, 2004 (Supp. 04-3). Section R9-8-201(4), (13) and (17) corrected to include the incorporated by reference material date (Supp. 07-2).

R9-8-202. General Requirements

A food establishment that processes and sells bottled water in Arizona shall use a source approved by the Department.

Historical Note

Adopted effective August 6, 1990 (Supp. 90-3). Section repealed; new Section made by final rulemaking at 10 A.A.R. 4178, effective November 23, 2004 (Supp. 04-3).

R9-8-203. Application for an Approval of a Source

A. An applicant shall complete and submit to the Department, an application for an approval of a source on a form provided by the Department that includes:

1. The name, mailing address, and telephone number of the applicant;

2. The name, street address, and telephone number of the bottled water plant;

3. The location of the source used at the bottled water plant;

4. The applicant's signature; and

5. The date the application is signed.

B. With the completed application, an applicant shall include test results from a licensed laboratory that has tested the bottled water according to the quality requirements for bottled water in 21 CFR 165.110(b) (2003), incorporated by reference, on file with the Department, including no future editions or amendments, and available at http://www.gpoaccess.gov/cfr/index.html and from U.S. Government Printing Office, 732 N. Capitol Street, N.W. Washington, D.C. 20401.

C. An applicant shall comply with subsections (A) and (B) for each source used at the bottled water plant.

Historical Note

Adopted effective August 6, 1990 (Supp. 90-3). Section repealed; new Section made by final rulemaking at 10 A.A.R. 4178, effective November 23, 2004 (Supp. 04-3). Section R9-8-203(B) corrected to include the incorporated by reference material date (Supp. 07-2).

R9-8-204. Time-frames

A. The overall time-frame described in A.R.S. § 41-1072 for the Department to act on an application for an approval of a source is 60 days. The applicant and the Department may agree in writing to extend the substantive review time-frame and the overall time-frame by no more than 25% of the overall time-frame.

B. The administrative completeness review time-frame described in A.R.S. § 41-1072 for an application for an approval of a source is 30 days and begins on the date the application is received.

1. The Department shall mail notice of administrative completeness or deficiencies to the applicant within the administrative completeness review time-frame.

a. A notice of deficiencies shall list each deficiency and the information and documentation needed to complete the application.

b. If the Department issues a notice of deficiencies within the administrative completeness review time-frame, the administrative completeness review time-frame and the overall time-frame are suspended from the date that the notice is issued until the date the Department receives the missing information from the applicant.

c. If the applicant fails to submit to the Department all the information and documents listed in the notice of deficiencies within 60 days of the date the Department mailed the notice of deficiencies, the Department deems the application for approval of a source withdrawn.

2. If the Department issues an approval of a source to the applicant during the administrative completeness review time-frame, the Department does not issue a separate written notice of administrative completeness.

C. The substantive review time-frame described in A.R.S. § 41-1072 is 30 days and begins on the date the notice of administrative completeness is mailed to the applicant.

1. The Department shall mail an approval of a source or a written notification of denial of approval to the applicant within the substantive review time-frame.

2. If the Department issues a comprehensive written request or supplemental request for information, the substantive review time-frame and the overall time-frame are suspended from the date the Department issues the request until the date the Department receives all of the information.

3. If the Department denies approval of a source, the Department shall send the applicant a written notice of disapproval that lists the reasons for disapproval and all other information required in A.R.S. § 41-1076.

D. If a time-frame's last day is on a Saturday, Sunday, or legal holiday, the Department considers the next business day as the time-frame's last day.

Historical Note

Adopted effective August 6, 1990 (Supp. 90-3). Section repealed; new Section made by final rulemaking at 10 A.A.R. 4178, effective November 23, 2004 (Supp. 04-3).

R9-8-205. Quality Testing Requirements

A. To maintain approval of its source, a plant operator shall have a licensed laboratory test the quality of the bottled water at the times stated in 21 CFR 129.80(g) (2003), incorporated by reference, on file with the Department, including no future editions or amendments, and available at http://www.gpoaccess.gov/cfr/index.html and from U.S. Government Printing Office, 732 N. Capitol Street, N.W. Washington, D.C. 20401.

B. A plant operator shall maintain records of the quality testing of the bottled water on the bottled water plant premises for two years from the date the bottled water is tested and ensure that the records are readily available for inspection by the Department.

Historical Note

Adopted effective August 6, 1990 (Supp. 90-3). Section repealed; new Section made by final rulemaking at 10 A.A.R. 4178, effective November 23, 2004 (Supp. 04-3). Sect