TITLE 9. HEALTH SERVICES
CHAPTER 14. DEPARTMENT OF HEALTH SERVICES
LABORATORIES
ARTICLE 1. DIRECT ACCESS TESTS AND LABORATORY STANDING ORDERS
Article 1, consisting of Sections R9-14-101 through R9-14-103, made by exempt rulemaking at 11 A.A.R. 2734, effective July 1, 2005 (Supp. 05-3).
Article 1, consisting of Sections R9-14-101 through R9-14-115, expired under A.R.S. § 41-1056(E) at 7 A.A.R. 1382, effective February 28, 2001 (Supp. 01-1).
R9-14-102. Direct Access Test List
R9-14-103. Laboratory Standing Orders
Article 2, consisting of Sections R9-14-211 through R9-14-215, expired under A.R.S. § 41-1056(E) at 7 A.A.R. 1382, effective February 28, 2001 (Supp. 01-1).
Article 3, consisting of Sections R9-14-301 through R9-14-302, expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Article 5, consisting of Sections R9-14-501 through R9-14-505, recodified to R9-13-201 through R9-13-205, effective August 31, 2005 (Supp. 05-3).
ARTICLE 6. LICENSING OF ENVIRONMENTAL LABORATORIES
Article 6, consisting of Sections R9-14-601 through R9-14-617 adopted effective December 20, 1991 (Supp. 91-4).
Article 6, consisting of Sections R9-14-601 through R9-14-607 repealed effective December 20, 1991 (Supp. 91-4).
Article 6 consisting of Sections R9-14-601 through R9-14-607 adopted effective August 16, 1985.
R9-14-602. Exemptions from Applicability
R9-14-603. License Application and Process; Transferability
R9-14-604. Third Party Accreditation
R9-14-605. Compliance Monitoring
R9-14-606. Provisional Licensing
R9-14-608. Installment Payment of Fees by Small Businesses
R9-14-609. Proficiency Evaluation Testing
R9-14-610. Approved Methods and References
R9-14-611. Drinking Water Compliance Testing
R9-14-612. Wastewater Compliance Testing
R9-14-613. Solid Waste Compliance Testing
R9-14-614. Air and Stack Compliance Testing
R9-14-617. Laboratory Records and Reports
R9-14-618. Mobile Laboratories
R9-14-619. Out-of-State Environmental Laboratory Licensing
R9-14-620. Changes to a License
Table 1. Time-frames (in days)
Exhibit I. Approved Methods; Method Fees; Instrumentation Fees
Exhibit II. Alternate Default Limits
ARTICLE 7. HEALTH SCREENING SERVICES
Article 7, consisting of Sections R9-14-701 through R9-14-709, adopted effective December 2, 1993 (Supp. 93-4).
R9-14-701. Health Screening Laboratory Services
ARTICLE 1. DIRECT ACCESS TESTS AND LABORATORY STANDING ORDERS
In this Article, unless otherwise specified:
1. "ALT" means alanine amino transferase.
2. "AST" means aspartate amino transferase.
3. "BUN" means blood urea nitrogen.
4. "CBC" means complete blood count.
5. "Clinical laboratory" means the same as in A.R.S. § 36-451.
6. "CMP" means comprehensive metabolic panel.
7. "Component" means a test included in a panel or profile.
8. "Direct access test" means the same as in A.R.S. § 36-466.
10. "HDL" means high-density lipoprotein.
12. "Hgb A1c" means glycosylated hemoglobin.
13. "Laboratory standing order" means a written directive by a licensed practitioner to a clinical laboratory to perform a test.
14. "LDL" means low-density lipoprotein.
15. "Licensed practitioner" means:
a. A podiatrist licensed under A.R.S. Title 32, Chapter 7;
b. A doctor of chiropractic licensed under A.R.S. Title 32, Chapter 8;
c. A doctor of medicine licensed under A.R.S. Title 32, Chapter 13 or licensed in another state;
d. A doctor of naturopathic medicine licensed under A.R.S. Title 32, Chapter 14;
e. A doctor of osteopathic medicine licensed under A.R.S. Title 32, Chapter 17 or licensed in another state;
f. A homeopathic physician licensed under A.R.S. Title 32, Chapter 29;
g. A dentist licensed under A.R.S. Title 32, Chapter 11, Article 2;
h. A physician assistant who is licensed under Title 32, Chapter 25 and who has the supervising physician's delegation required in A.R.S. § 32-2531; or
i. A registered nurse practitioner licensed under A.R.S. Title 32, Chapter 15 and certified under A.A.C. R4-19-504.
16. "MCH" means mean corpuscular hemoglobin.
17. "MCHC" means mean corpuscular hemoglobin concentration.
18. "MCV" means mean corpuscular volume.
19. "MPV" means mean platelet volume.
20. "Panel" means a group of clinical laboratory tests associated with specific organs or diseases.
21. "Patient" means an individual receiving services from a licensed practitioner.
22. "pH" means acidity-alkalinity status.
23. "Profile" means a group of clinical laboratory tests frequently done together or in combinations.
24. "PSA" means prostatic specific antigen.
25. "RBC" means red blood cells.
26. "RDW" means red cell distribution width.
27. "Reflex testing" means a follow-up test automatically initiated by a clinical laboratory after an abnormal test result.
28. "State" means the same as in A.R.S. § 36-841.
29. "Supervising physician" means the same as in A.R.S. § 32-2501.
30. "Test" means a clinical laboratory's examination or analysis of material from an individual's body.
32. "TSH" means thyroid stimulating hormone.
33. "WBC" means white blood cells.
Historical Note
Section expired under A.R.S. § 41-1056(E) at 7 A.A.R. 1382, effective February 28, 2001 (Supp. 01-1). New Section made by exempt rulemaking at 11 A.A.R. 2734, effective July 1, 2005 (Supp. 05-3).
R9-14-102. Direct Access Test List
A. Unless expressly excluded in subsection (B), a component is a direct access test.
B. The direct access test list includes:
1. Lipid profile, including the following components:
3. Dipstick urinalysis, including the following components:
4. TSH with T4 reflex testing;
7. CBC, including the following components:
Historical Note
Section expired under A.R.S. § 41-1056(E) at 7 A.A.R. 1382, effective February 28, 2001 (Supp. 01-1). New Section made by exempt rulemaking at 11 A.A.R. 2734, effective July 1, 2005 (Supp. 05-3).
R9-14-103. Laboratory Standing Orders
a. The licensed practitioner's name, type of license, and licensing state;
Historical Note
Section expired under A.R.S. § 41-1056(E) at 7 A.A.R. 1382, effective February 28, 2001 (Supp. 01-1). New Section made by exempt rulemaking at 11 A.A.R. 2734, effective July 1, 2005 (Supp. 05-3).
Historical Note
Amended effective August 7, 1975 (Supp. 75-1). Section expired under A.R.S. § 41-1056(E) at 7 A.A.R. 1382, effective February 28, 2001 (Supp. 01-1).
Historical Note
Section expired under A.R.S. § 41-1056(E) at 7 A.A.R. 1382, effective February 28, 2001 (Supp. 01-1).
Historical Note
Section expired under A.R.S. § 41-1056(E) at 7 A.A.R. 1382, effective February 28, 2001 (Supp. 01-1).
Historical Note
Section expired under A.R.S. § 41-1056(E) at 7 A.A.R. 1382, effective February 28, 2001 (Supp. 01-1).
Historical Note
Section expired under A.R.S. § 41-1056(E) at 7 A.A.R. 1382, effective February 28, 2001 (Supp. 01-1).
Historical Note
Section expired under A.R.S. § 41-1056(E) at 7 A.A.R. 1382, effective February 28, 2001 (Supp. 01-1).
Historical Note
Section expired under A.R.S. § 41-1056(E) at 7 A.A.R. 1382, effective February 28, 2001 (Supp. 01-1).
Historical Note
Section expired under A.R.S. § 41-1056(E) at 7 A.A.R. 1382, effective February 28, 2001 (Supp. 01-1).
Historical Note
Section expired under A.R.S. § 41-1056(E) at 7 A.A.R. 1382, effective February 28, 2001 (Supp. 01-1).
Historical Note
Section expired under A.R.S. § 41-1056(E) at 7 A.A.R. 1382, effective February 28, 2001 (Supp. 01-1).
Historical Note
Section expired under A.R.S. § 41-1056(E) at 7 A.A.R. 1382, effective February 28, 2001 (Supp. 01-1).
Historical Note
Section expired under A.R.S. § 41-1056(E) at 7 A.A.R. 1382, effective February 28, 2001 (Supp. 01-1).
Historical Note
Adopted effective May 24, 1976 (Supp. 76-3). Repealed effective August 15, 1989 (Supp. 89-3).
Historical Note
Section expired under A.R.S. § 41-1056(E) at 7 A.A.R. 1382, effective February 28, 2001 (Supp. 01-1).
Historical Note
Section expired under A.R.S. § 41-1056(E) at 7 A.A.R. 1382, effective February 28, 2001 (Supp. 01-1).
Historical Note
Section expired under A.R.S. § 41-1056(E) at 7 A.A.R. 1382, effective February 28, 2001 (Supp. 01-1).
Historical Note
Section expired under A.R.S. § 41-1056(E) at 7 A.A.R. 1382, effective February 28, 2001 (Supp. 01-1).
Historical Note
Section expired under A.R.S. § 41-1056(E) at 7 A.A.R. 1382, effective February 28, 2001 (Supp. 01-1).
Historical Note
Adopted effective September 29, 1976 (Supp. 76-4). Section expired under A.R.S. § 41-1056(E) at 7 A.A.R. 1382, effective February 28, 2001 (Supp. 01-1).
Historical Note
Adopted effective September 29, 1976 (Supp. 76-4). Section expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Adopted prior to codification November 1974. Amended as an emergency effective July 19, 1982, pursuant to A.R.S. § 41-1003, valid for only 90 days (Supp. 82-4). Amended as a permanent rule effective October 25, 1982; text of the amended rule identical to the emergency (Supp. 82-5). Former Section R9-14-411 renumbered without change as Section R9-14-401 effective March 3, 1987 (Supp. 87-1). Former Section R9-14-401 repealed, new Section R9-14-401 renumbered from R9-14-402 and amended effective August 27, 1992 (Supp. 92-3). Amended effective February 28, 1994 (Supp. 94-1). Section expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Adopted prior to codification November 1974. Amended as an emergency effective July 19, 1982, pursuant to A.R.S. § 41-1003, valid for only 90 days (Supp. 82-4). Amended as a permanent rule effective October 25, 1982; text of the amended rule similar to the emergency (Supp. 82-5). Amended Paragraph (11) as an emergency effective 12:00 midnight, May 29, 1984, pursuant to A.R.S. § 41-1003, valid for only 90 days (Supp. 84-3). Amended Paragraph (11) as a permanent rule effective August 27, 1984 (Supp. 84-4). Former Section R9-14-412 renumbered without change as Section R9-14-402 effective March 3, 1987 (Supp. 87-1). Former Section R9-14-402 renumbered to R9-14-401, new Section R9-14-402 renumbered from R9-14-403 and amended effective August 27, 1992 (Supp. 92-3). Amended effective February 28, 1994 (Supp. 94-1). Section expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Adopted prior to codification November 1974. Amended as an emergency effective July 19, 1982, pursuant to A.R.S. § 41-1003, valid for only 90 days (Supp. 82-4). Amended as a permanent rule effective October 25, 1982; text of the amended rule similar to the emergency (Supp. 82-5). Former Section R9-14-413 renumbered without change as Section R9-14-403 effective March 3, 1987 (Supp. 87-1). Former Section R9-14-403 renumbered to R9-14-402, new Section R9-14-403 renumbered from R9-14-404 and amended effective August 27, 1992 (Supp. 92-3). Amended by emergency action effective June 1, 1993, pursuant to A.R.S. § 41-1026, valid for only 90 days (Supp. 93-2). Amended again by emergency action effective September 16, 1993, pursuant to A.R.S. § 41-1026, valid for only 90 days (Supp. 93-3). Amended again by emergency action effective December 13, 1993, pursuant to A.R.S. § 41-1026, valid for only 90 days (Supp. 93-4). Emergency amendments permanently adopted effective February 28, 1994 (Supp. 94-1). Amended effective February 12, 1996 (Supp. 96-1). Amended by emergency rulemaking at 7 A.A.R. 2509, effective May 24, 2001 (Supp. 01-2). Amended by final rulemaking at 7 A.A.R. 5364, effective November 9, 2001 (Supp. 01-4). Amended by emergency rulemaking at 11 A.A.R. 2224, effective May 31, 2005 for 180 days (Supp. 05-2). Amended by emergency rulemaking at 11 A.A.R. 3568, effective September 1, 2005 for 180 days (Supp. 05-3). Emergency renewed at 11 A.A.R. 5323, effective November 22, 2005 for 180 days (Supp. 05-4). Emergency renewed at 12 A.A.R. 827, effective February 23, 2006 for 180 days (Supp. 06-1). Section expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Adopted prior to codification November 1974. Amended as an emergency effective July 19, 1982, pursuant to A.R.S. § 41-1003, valid for only 90 days (Supp. 82-4). Amended as a permanent rule effective October 25, 1982; text of the amended rule similar to the emergency (Supp. 82-5). Amended as an emergency effective 12:00 midnight, May 29, 1984, pursuant to A.R.S. § 41-1003, valid for only 90 days (Supp. 84-3). Amended as a permanent rule effective August 27, 1984 (Supp. 84-4). Former Section R9-14-414 renumbered and amended as Section R9-14-404 effective March 3, 1987 (Supp. 87-1). Former Section R9-14-404 renumbered to R9-14-403, new Section R9-14-404 renumbered from R9-14-405 and amended effective August 27, 1992 (Supp. 92-3). Amended effective February 28, 1994 (Supp. 94-1). Amended effective February 12, 1996 (Supp. 96-1). Amended by emergency rulemaking at 7 A.A.R. 2509, effective May 24, 2001 (Supp. 01-2). Amended by final rulemaking at 7 A.A.R. 5364, effective November 9, 2001 (Supp. 01-4). Amended by emergency rulemaking at 11 A.A.R. 2224, effective May 31, 2005 for 180 days (Supp. 05-2). Amended by emergency rulemaking at 11 A.A.R. 3568, effective September 1, 2005 for 180 days (Supp. 05-3). Emergency renewed at 11 A.A.R. 5323, effective November 22, 2005 for 180 days (Supp. 05-4). Emergency renewed at 12 A.A.R. 827, effective February 23, 2006 for 180 days (Supp. 06-1). Section expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Adopted prior to codification November 1974. Amended as an emergency effective July 19, 1982, pursuant to A.R.S. § 41-1003, valid for only 90 days (Supp. 82-4). Amended as a permanent rule effective October 25, 1982; text of the amended rule similar to the emergency (Supp. 82-5). Amended as an emergency effective 12:00 midnight, May 29, 1984, pursuant to A.R.S. § 41-1003, valid for only 90 days (Supp. 84-3). Amended as a permanent rule effective August 27, 1984 (Supp. 84-4). Former Section R9-14-415 renumbered and amended as Section R9-14-405, Exhibits E through U amended, and Exhibits V through X adopted effective March 3, 1987 (Supp. 87-1). Former Section R9-14-405 renumbered to R9-14-404 and Exhibits E through X moved to end of Article, new Section R9-14-405 renumbered from R9-14-406 and amended effective August 27, 1992 (Supp. 92-3). Amended effective February 28, 1994 (Supp. 94-1). Section expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Adopted prior to codification November 1974. Amended as an emergency effective July 19, 1982, pursuant to A.R.S. § 41-1003, valid for only 90 days (Supp. 82-4). Amended as a permanent rule effective October 25, 1982; text of the amended rule similar to the emergency (Supp. 82-5). Former Section R9-14-416 renumbered and amended as R9-14-406 effective March 3, 1987 (Supp. 87-1). Former Section R9-14-406 renumbered to R9-14-405, new Section R9-14-406 renumbered from R9-14-407 and amended effective August 27, 1992 (Supp. 92-3). Amended effective February 28, 1994 (Supp. 94-1). Section expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Adopted prior to codification November 1974. Amended as an emergency effective July 19, 1982, pursuant to A.R.S. § 41-1003, valid for only 90 days (Supp. 82-4). Correction to emergency adoption, subsection (C) should include Paragraph (4) as follows: "Receive a score of 70% or better on an examination administered by the Department." Amended as a permanent rule effective October 25, 1982; text of the amended rule similar to the emergency (Supp. 82-5). Former Section R9-14-417 renumbered and amended as Section R9-14-407 effective March 3, 1987 (Supp. 87-1). Former Section R9-14-407 renumbered to R9-14-406, new Section R9-14-407 renumbered from R9-14-408 and amended effective August 27, 1992 (Supp. 92-3). Amended effective February 28, 1994 (Supp. 94-1). Section expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Adopted prior to codification November 1974. Amended as an emergency effective July 19, 1982, pursuant to A.R.S. § 41-1003, valid for only 90 days (Supp. 82-4). Amended as a permanent rule effective October 25, 1982; text of the amended rule similar to the emergency. Exhibits A and B initially adopted as part of the emergency amendment now adopted as part of the permanent rule (Supp. 82-5). Amended as an emergency effective 12:00 midnight, May 20, 1984, pursuant to A.R.S. § 41-1003, valid for only 90 days (Supp. 84-3). Amended as a permanent rule effective August 27, 1984. Exhibits C and D initially adopted as part of the emergency (Supp. 84-4). Editorial correction, Supp. 84-3, should read Amended as an emergency effective 12:00 midnight, May 29, 1984, pursuant to A.R.S. § 41-1003, valid for only 90 days (Supp. 84-6). Former Section R9-14-418 renumbered without change as R9-14-408, Exhibits A through D amended effective March 3, 1987 (Supp. 87-1). Former Section R9-14-408 renumbered to R9-14-407 and Exhibits A through D moved to end of Article, new Section R9-14-408 renumbered from R9-14-409 and amended effective August 27, 1992 (Supp. 92-3). Amended effective February 28, 1994 (Supp. 94-1). Section expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Adopted prior to codification November 1974. Amended as an emergency effective July 19, 1982, pursuant to A.R.S. § 41-1003, valid for only 90 days (Supp. 82-4). Amended as a permanent rule effective October 25, 1982; text of the amended rule similar to the emergency (Supp. 82-5). Section R9-14-419 renumbered without change as Section R9-14-409 effective March 3, 1987 (Supp. 87-1). Former Section R9-14-409 renumbered to R9-14-408, new Section R9-14-409 renumbered from R9-14-411 and amended effective August 27, 1992 (Supp. 92-3). Section expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Adopted prior to codification November 1974. Amended as an emergency effective July 19, 1982, pursuant to A.R.S. § 41-1003, valid for only 90 days (Supp. 82-4). Amended as a permanent rule effective October 25, 1982; text of the amended rule identical to the emergency (Supp. 82-5). Former Section R9-14-420 renumbered without change as Section R9-14-410 effective March 3, 1987 (Supp. 87-1). Section R9-14-410 repealed effective August 27, 1992 (Supp. 92-3).
Historical Note
Adopted prior to codification November 1974. Amended as an emergency effective July 19, 1982, pursuant to A.R.S. § 41-1003, valid for only 90 days (Supp. 82-4). Amended as a permanent rule effective October 25, 1982; text of the amended rule similar to the emergency (Supp. 82-5). Former Section R9-14-421 renumbered and amended as Section R9-14-411 effective March 3, 1987 (Supp. 87-1). Former Section R9-14-411 renumbered to R9-14-409 effective August 27, 1992 (Supp. 92-3).
Historical Note
Adopted as an emergency effective 12:00 midnight, May 20, 1984, pursuant to A.R.S. § 41-1003, valid for only 90 days (Supp. 84-3). Adopted as a permanent rule effective August 27, 1984 (Supp. 84-4). Editorial correction, Supp. 84-3, should read Amended as an emergency effective 12:00 midnight, May 29, 1984, pursuant to A.R.S. § 41-1003, valid for only 90 days (Supp. 84-6). Former Section R9-14-422 renumbered and amended as Section R9-14-412 effective March 3, 1987 (Supp. 87-1). Section R9-14-412 repealed effective August 27, 1992 (Supp. 92-3).
Historical Note
Exhibit 1 made by emergency rulemaking at 11 A.A.R. 2224, effective May 31, 2005 (Supp. 05-2). Emergency renewed at 11 A.A.R. 5323, effective November 22, 2005 (Supp. 05-4). Exhibit 1 expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit 2 made by emergency rulemaking at 11 A.A.R. 2224, effective May 31, 2005 (Supp. 05-2). Emergency renewed at 11 A.A.R. 5323, effective November 22, 2005 (Supp. 05-4). Exhibit 2 expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit 2A made by emergency rulemaking at 11 A.A.R. 2224, effective May 31, 2005 (Supp. 05-2). Emergency renewed at 11 A.A.R. 5323, effective November 22, 2005 (Supp. 05-4). Exhibit 2A expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit 3 made by emergency rulemaking at 11 A.A.R. 2224, effective May 31, 2005 (Supp. 05-2). Emergency renewed at 11 A.A.R. 5323, effective November 22, 2005 (Supp. 05-4). Exhibit 3 expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit 3A made by emergency rulemaking at 11 A.A.R. 2224, effective May 31, 2005 (Supp. 05-2). Emergency renewed at 11 A.A.R. 5323, effective November 22, 2005 (Supp. 05-4). Exhibit 3A expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit 4 made by emergency rulemaking at 11 A.A.R. 3568, effective September 1, 2005 (Supp. 05-3). Emergency renewed at 12 A.A.R. 827, effective February 23, 2006 (Supp. 06-1). Exhibit 4 expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit 5 made by emergency rulemaking at 11 A.A.R. 3568, effective September 1, 2005 (Supp. 05-3). Emergency renewed at 12 A.A.R. 827, effective February 23, 2006 (Supp. 06-1). Exhibit 5 expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit 6 made by emergency rulemaking at 11 A.A.R. 3568, effective September 1, 2005 (Supp. 05-3). Emergency renewed at 12 A.A.R. 827, effective February 23, 2006 (Supp. 06-1). Exhibit 6 expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit 6A made by emergency rulemaking at 11 A.A.R. 3568, effective September 1, 2005 (Supp. 05-3). Emergency renewed at 12 A.A.R. 827, effective February 23, 2006 (Supp. 06-1). Exhibit 6A expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit A moved from Section R9-14-408 and amended effective August 27, 1992 (Supp. 92-3). Exhibit A expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit B moved from Section R9-14-408 and amended effective August 27, 1992 (Supp. 92-3). Exhibit B expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit C moved from Section R9-14-408 and amended effective August 27, 1992 (Supp. 92-3). Exhibit C expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit D moved from Section R9-14-408 and amended effective August 27, 1992 (Supp. 92-3). Exhibit D expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit E moved from Section R9-14-405 and amended effective August 27, 1992 (Supp. 92-3). Exhibit E expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit EE adopted effective August 27, 1992 (Supp. 92-3). Exhibit EE expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit F moved from Section R9-14-405 and amended effective August 27, 1992 (Supp. 92-3). Exhibit F expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit G moved from Section R9-14-405 and amended effective August 27, 1992 (Supp. 92-3). Exhibit G expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit H moved from Section R9-14-405 and amended effective August 27, 1992 (Supp. 92-3). Exhibit H expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit I moved from Section R9-14-405 and amended effective August 27, 1992 (Supp. 92-3). Exhibit I expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit II adopted effective August 27, 1992 (Supp. 92-3). Amended effective February 28, 1994 (Supp. 94-1). Exhibit II expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit J moved from Section R9-14-405 and amended effective August 27, 1992 (Supp. 92-3). Exhibit J expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit K moved from Section R9-14-405 and repealed, new Exhibit K renumbered from Exhibit M and amended effective August 27, 1992 (Supp. 92-3). Exhibit K expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit KK adopted effective August 27, 1992 (Supp. 92-3). Exhibit KK expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit L moved from Section R9-14-405 and repealed, new Exhibit L renumbered from Exhibit N and amended effective August 27, 1992 (Supp. 92-3). Exhibit L expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit M moved from Section R9-14-405 and renumbered to Exhibit K; new Exhibit M renumbered from Exhibit O and amended effective August 27, 1992 (Supp. 92-3). Exhibit M expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit N moved from Section R9-14-405 and renumbered to Exhibit L, new Exhibit N renumbered from Exhibit R and amended effective August 27, 1992 (Supp. 92-3). Exhibit N expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit NN adopted effective August 27, 1992 (Supp. 92-3). Exhibit NN expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit O moved from Section R9-14-405 and renumbered to Exhibit M, new Exhibit O renumbered from Exhibit S and amended effective August 27, 1992 (Supp. 92-3). Exhibit O expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit OO adopted effective August 27, 1992 (Supp. 92-3). Amended effective February 28, 1994 (Supp. 94-1). Exhibit OO expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit OOO adopted effective February 28, 1994 (Supp. 94-1). Exhibit OOO expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit P moved from Section R9-14-405 and repealed, new Exhibit P renumbered from Exhibit T and amended effective August 27, 1992 (Supp. 92-3). Exhibit P expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
New Exhibit P-EN made by emergency rulemaking at 7 A.A.R. 2509, effective May 24, 2001 (Supp. 01-2). Amended by final rulemaking at 7 A.A.R. 5364, effective November 9, 2001 (Supp. 01-4). Exhibit P-EN expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit PP adopted effective February 28, 1994 (Supp. 94-1). Exhibit PP expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
New Exhibit PP-EN made by emergency rulemaking at 7 A.A.R. 2509, effective May 24, 2001 (Supp. 01-2). Amended by final rulemaking at 7 A.A.R. 5364, effective November 9, 2001 (Supp. 01-4). Exhibit PP-EN expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit Q moved from Section R9-14-405 and repealed, new Exhibit Q renumbered from Exhibit U and amended effective August 27, 1992 (Supp. 92-3). Amended effective February 28, 1994 (Supp. 94-1). Exhibit Q expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
New Exhibit Q-EN made by emergency rulemaking at 7 A.A.R. 2509, effective May 24, 2001 (Supp. 01-2). Amended by final rulemaking at 7 A.A.R. 5364, effective November 9, 2001 (Supp. 01-4). Exhibit Q-EN expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit QQ adopted effective February 28, 1994 (Supp. 94-1). Exhibit QQ expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
New Exhibit QQ-EN made by emergency rulemaking at 7 A.A.R. 2509, effective May 24, 2001 (Supp. 01-2). Amended by final rulemaking at 7 A.A.R. 5364, effective November 9, 2001 (Supp. 01-4). Exhibit QQ-EN expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit R moved from Section R9-14-405 and renumbered to Exhibit N, New Exhibit R renumbered from Exhibit V and amended effective August 27, 1992 (Supp. 92-3). Exhibit R expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit RR adopted effective August 27, 1992 (Supp. 92-3). Exhibit RR expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit S moved from Section R9-14-405 and renumbered to Exhibit O, new Exhibit S renumbered from Exhibit W and amended effective August 27, 1992 (Supp. 92-3). Exhibit S expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit T moved from Section R9-14-405 and renumbered to Exhibit P, new Exhibit T renumbered from Exhibit X and amended effective August 27, 1992 (Supp. 92-3). Exhibit T expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit U moved from Section R9-14-405 and renumbered to Exhibit Q, new Exhibit U adopted effective August 27, 1992 (Supp. 92-3). Exhibit U expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit UU adopted effective August 27, 1992 (Supp. 92-3). Exhibit UU expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit V moved from Section R9-14-405 and renumbered to Exhibit R, new Exhibit V adopted effective August 27, 1992 (Supp. 92-3). Exhibit V expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit W moved from Section R9-14-405 and renumbered to Exhibit S, new Exhibit W adopted effective August 27, 1992 (Supp. 92-3). Exhibit W expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit WW adopted effective August 27, 1992 (Supp. 92-3). Amended effective February 28, 1994 (Supp. 94-1). Exhibit WW expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit WWW adopted effective February 28, 1994 (Supp. 94-1). Exhibit WWW expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
New Exhibit WWW-EN made by emergency rulemaking at 7 A.A.R. 2509, effective May 24, 2001 (Supp. 01-2). Amended by final rulemaking at 7 A.A.R. 5364, effective November 9, 2001 (Supp. 01-4). Exhibit WWW-EN expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit X moved from Section R9-14-405 and renumbered to Exhibit T effective August 27, 1992 (Supp. 92-3). New Exhibit X adopted effective February 12, 1996 (Supp. 96-1). Exhibit X expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit Y adopted effective February 12, 1996 (Supp. 96-1). Exhibit Y expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Exhibit Y adopted effective February 12, 1996 (Supp. 96-1). Exhibit Z expired under A.R.S. § 41-1056(E) at 13 A.A.R. 689, effective July 31, 2006 (Supp. 06-3).
Historical Note
Adopted effective November 2, 1979 (Supp. 79-6). Section R9-14-501 renumbered from R9-14-512 and amended effective June 14, 1990 (Supp. 90-2). Amended by emergency action effective October 27, 1994, pursuant to A.R.S. § 41-1026, valid for 90 days (Supp. 94-4). Amended again by emergency action effective January 25, 1995, valid for 180 days (Supp. 95-1). Amended effective July 10, 1995 (Supp. 95-3). Amended by final rulemaking at 7 A.A.R. 4965, effective January 1, 2002 (Supp. 01-4). Section recodified to R9-13-201 at 11 A.A.R. 3577, effective August 31, 2005 (Supp. 05-3).
Historical Note
Adopted effective November 2, 1979 (Supp. 79-6). Section R9-14-502 renumbered from R9-14-513 and amended effective June 14, 1990 (Supp. 90-2). Amended by emergency action effective October 27, 1994, pursuant to A.R.S. § 41-1026, valid for 90 days (Supp. 94-4). Amended again by emergency action effective January 25, 1995, valid for 180 days (Supp. 95-1). Amended effective July 10, 1995 (Supp. 95-3). Amended by final rulemaking at 7 A.A.R. 4965, effective January 1, 2002 (Supp. 01-4). Section recodified to R9-13-202 at 11 A.A.R. 3577, effective August 31, 2005 (Supp. 05-3).
Historical Note
Adopted effective November 2, 1979 (Supp. 79-6). Section R9-14-503 renumbered from R9-14-514 and amended effective June 14, 1990 (Supp. 90-2). Amended effective July 10, 1995 (Supp. 95-3). Amended by final rulemaking at 7 A.A.R. 4965, effective January 1, 2002 (Supp. 01-4). Section recodified to R9-13-203 at 11 A.A.R. 3577, effective August 31, 2005 (Supp. 05-3).
Historical Note
Adopted effective November 2, 1979 (Supp. 79-6). Section R9-14-504 renumbered from R9-14-515 and amended effective June 14, 1990 (Supp. 90-2). Amended effective July 10, 1995 (Supp. 95-3). Amended by final rulemaking at 7 A.A.R. 4965, effective January 1, 2002 (Supp. 01-4). Section recodified to R9-13-204 at 11 A.A.R. 3577, effective August 31, 2005 (Supp. 05-3).
Historical Note
Adopted by emergency action effective October 27, 1994, pursuant to A.R.S. § 41-1026, valid for 90 days (Supp. 94-4). Adopted again by emergency action effective January 25, 1995, valid for 180 days (Supp. 95-1). Adopted effective July 10, 1995 (Supp. 95-3). Amended by final rulemaking at 7 A.A.R. 4965, effective January 1, 2002 (Supp. 01-4). Section recodified to R9-13-205 at 11 A.A.R. 3577, effective August 31, 2005 (Supp. 05-3).
Historical Note
Adopted effective November 2, 1979 (Supp. 79-6). Repealed effective June 14, 1990 (Supp. 90-2)
Historical Note
Adopted effective November 2, 1979 (Supp. 79-6). Section R9-14-512 renumbered to R9-14-501 effective June 14, 1990 (Supp. 90-2).
Historical Note
Adopted effective November 2, 1979 (Supp. 79-6). Section R9-14-512 renumbered to R9-14-502 effective June 14, 1990 (Supp. 90-2)
Historical Note
Adopted effective November 2, 1979 (Supp. 79-6). Section R9-14-514 renumbered to R9-14-503 effective June 14, 1990 (Supp. 90-2).
Historical Note
Adopted effective November 2, 1979 (Supp. 79-6). Section R9-14-515 renumbered to R9-14-504 effective June 14, 1990 (Supp. 90-2).
ARTICLE 6. LICENSING OF ENVIRONMENTAL LABORATORIES
In addition to the definitions in A.R.S. § 36-495, the following definitions apply in this Article, unless otherwise specified:
1. "Acceptance criteria" means the range of satisfactory test results for a parameter.
2. "ADEQ" means the Arizona Department of Environmental Quality.
3. "Affiliate" means a business organization that:
a. Controls or has the power to control the business organization that owns the laboratory,
b. Is controlled by or could be controlled by the business organization that owns the laboratory, or
c. Could be controlled by a third business organization that could also control the business organization that owns the laboratory.
4. "Alternate method" means an analytical test procedure or technique that is not an approved method and for which approval is requested under R9-14-610(C).
5. "Analyst" means an individual who performs compliance testing at a laboratory.
6. "Analyte" means the substance or chemical constituent being sought or measured in an analytical procedure.
7. "Applicant" means a person or persons requesting an initial or renewal license under R9-14-603, approval of an alternate method or method alteration under R9-14-610(C), or approval of an exemption under R9-14-615(D), and includes, as required under A.R.S. § 36-495.03(D), the owner and, if the owner is not the laboratory director, the laboratory director.
8. "Approved method" means an analytical test procedure or technique authorized by the Department to test for the presence of a particular contaminant or characteristic and includes an alternate method approved by the Department under R9-14-610(C) and an approved method used with a method alteration approved by the Department under R9-14-610(C).
9. "ASTM" means American Society for Testing and Materials.
10. "Blind proficiency testing" means the Department's determination of a laboratory analyst's ability to analyze samples correctly, accomplished by submitting samples for testing in such a manner that the laboratory analyst is not aware that the proficiency testing is occurring.
11. "Business organization" means an entity such as a sole proprietorship, an unincorporated association, a corporation, a limited liability company, a partnership, or a governmental entity.
12. "Calibration curve" means a graphical display of the functional relationship between the instrument or analytical device response and the analyte amount.
13. "Calibration model" means a mathematical form for a calibration curve.
14. "CCC" means calibration check compounds.
15. "CCV" means continuing calibration verification standard.
16. "Client" means a person that submits a sample to a laboratory for compliance testing.
17. "Contaminant" means a matter, pollutant, hazardous substance, or other substance for which a sample is being tested.
18. "Contiguous grounds" means real property that can be enclosed by a single unbroken boundary line that does not enclose property owned or leased by another.
19. "Critical step" means a task in the testing procedure that is required to be performed within a specified time period by regulation, method, standard operating procedure, or quality assurance plan.
20. "Current" means up-to-date and extending to the present time.
21. "Data outlier" means a test result that falls outside of acceptance criteria.
22. "Days" means calendar days, excluding the day of the act, event, or default from which a designated period of time begins to run and excluding the last day of the period if 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.
23. "DBCP" means 1,2-Dibromo-3-chloropropane.
24. "DDT" means dichloro-diphenyl-trichloroethane.
25. "DOC" means dissolved organic carbon.
26. "ECD" means electron capture detector.
27. "EDB" means 1,2-Dibromoethane.
28. "Effluent" means an outflow, as of a stream that flows out of a facility.
29. "EOX" means extractable organic halides.
30. "EP" means extraction procedure.
31. "EPA" means the United States Environmental Protection Agency.
32. "FID" means flame ionization detector.
34. "FT-IR" means Fourier transform infrared.
35. "GC" means gas chromatography.
36. "HEM" means n-Hexane extractable material.
37. "HPLC" means high performance liquid chromatography.
38. "HRGC" means high resolution gas chromatography.
39. "HRMS" means high resolution mass spectrometry.
40. "ICV" means initial calibration verification.
41. "IDOC" means initial demonstration of capability.
42. "Initial Demonstration of Capability" means a test performed by an analyst, as prescribed by a method, to document the analyst's ability to perform the method.
43. "Investigation" means an evaluation of a licensee's or applicant's compliance with A.R.S. Title 36, Chapter 4.3 and this Article conducted by the Department upon its own initiative or upon receipt of a written complaint and may include a laboratory inspection.
44. "IPC" means instrument performance check.
45. "Key reference" means a document incorporated by reference in R9-14-610(B).
46. "Laboratory inspection" means the Department's assessment of operations at a laboratory to determine a licensee's compliance with A.R.S. Title 36, Chapter 4.3 and this Article.
47. "LCS" means laboratory control sample.
48. "Level I license" means an approval issued by the Department authorizing compliance testing of one to nine total parameters at a laboratory.
49. "Level II license" means an approval issued by the Department authorizing compliance testing of 10 to 17 total parameters at a laboratory.
50. "Level III license" means an approval issued by the Department authorizing compliance testing of more than 17 total parameters at a laboratory.
51. "LFB" means laboratory fortified blank.
52. "LFM" means laboratory fortified sample matrix.
53. "Licensee" means a person or persons to whom the Department issues a license to operate a laboratory and includes, as required under A.R.S. § 36-495.03(D), the owner and, if the owner is not the laboratory director, the laboratory director.
54. "Limit of detection" means an analyte- and matrix-specific estimate of the minimum amount of a substance that an analytical process can reliably detect, which may be laboratory dependent and is developed according to R9-14-615(C)(7).
55. "Limit of quantitation" means the minimum levels, concentrations, or quantities of a target variable such as an analyte that can be reported with a specific degree of confidence.
56. "LOQ" means limit of quantitation.
57. "LRMS" means low resolution mass spectrometry.
58. "Method" means an analytical test procedure or technique.
59. "Method alteration" means a change to an established method.
60. "Method reporting limit" means the minimum concentration of a contaminant reported after analyzing a sample in a given parameter, determined after corrections have been made for sample dilution and sample weight.
61. "Mobile laboratory" means a non-stationary facility where compliance testing is performed.
62. "MPN" means most probable number.
63. "MRL" means minimum reporting level.
64. "MS" means mass spectrometry.
65. "MSE" means microscale solvent extraction.
66. "NPD" means nitrogen phosphorous detector.
67. "NPDES" means national pollutant discharge elimination system.
68. "NTU" means nephelometric turbidity units.
69. "ONPG-MUG" means ortho-nitrophenyl-ß-D-galactopyranoside-4-methylumbelliferyl-ß-D-glucuronide.
70. "Owner" means a person that has controlling legal or equitable interest in and authority over a laboratory's operations.
71. "PAH" means polynuclear aromatic hydrocarbon.
72. "Parameter" means the combination of a particular type of sample with a particular approved method by which the sample will be analyzed for a particular analyte or characteristic.
74. "PCB" means polychlorinated biphenyls.
75. "PCDD" means polychlorinated dibenzodioxins.
76. "PCDF" means polychlorinated dibenzofurans.
77. "PDA" means photodiode array.
78. "PID" means photoionization detection.
79. "POX" means purgeable organic halides.
80. "Precision" means repeatability of measurement data, specifically the similarity of successive independent measurements of a single magnitude generated by repeated applications of a process under specified conditions.
81. "Proficiency testing" means a proficiency testing service's determination of a laboratory analyst's ability to analyze samples correctly, accomplished by submitting samples to the laboratory for testing and then analyzing the acceptability of the results.
82. "Proficiency testing service" means an independent service acceptable to the EPA or, if the EPA has not indicated acceptance of a proficiency testing service for a parameter, acceptable to the Department based on recognition from a national organization such as the National Environmental Laboratory Accreditation Program.
83. "Qualified" means explained in documentation.
84. "Quality assurance plan" means documentation that meets the requirements of R9-14-615(B).
85. "Quality control checks" means the steps taken by laboratory analysts to monitor the accuracy and precision of sample analysis.
86. "QCS" means quality control sample.
87. "RDX" means Hexahydro-1,3,5-trinitro-1,3,5-triazine.
88. "Records" means all written, recorded, and electronic documentation necessary to reconstruct all laboratory activities that produce data and includes all information relating to the laboratory's equipment, analytical test methods, and related activities.
89. "RPD" means relative percent difference.
90. "Ruggedness" means the ability of a method to withstand changes in environmental factors and produce repeatable results.
91. "Sample" means a specimen that is a representative part of a whole or a single item from a group.
92. "Single laboratory" means an individual laboratory facility or multiple laboratory facilities located on contiguous grounds and having the same owner.
93. "Small business" means a business organization, including its affiliates, that is independently owned and operated, that is not dominant in its field, and that employs fewer than 100 full-time employees or had gross annual receipts of less than $4 million in its last fiscal year.
94. "SOUR" means specific oxygen uptake rate.
95. "SPE" means solid-phase extraction.
96. "SPLP" means synthetic precipitation leaching procedure.
97. "Standard operating procedure" means a documented process for carrying on business, analysis, or action, with instructions for performing routine or repetitive tasks.
98. "Statistical outlier" means an individual data point that has a value far from those of the other data points in a set and that has been determined through statistical analysis to have derived from a different population than the other data points.
99. "TCLP" means toxicity characteristics leaching procedure.
100. "TDS" means total dissolved solids.
101. "TE" means thermal extraction.
102. "TNT" means trinitrotoluene.
103. "TOC" means total organic carbon.
104. "TOX" means total organic halides.
105. "Traceability" means the establishment of an unbroken chain of comparisons to the reference of origin.
107. "TSS" means total suspended solids.
109. "Valid" means that a license, certificate, or other form of authorization is in full force and effect and not suspended.
Historical Note
Adopted effective August 16, 1985 (Supp. 85-4). Former Section R9-14-601 repealed, new Section R9-14-601 adopted effective December 20, 1991 (Supp. 91-4). Amended effective June 20, 1997 (Supp. 97-2). Amended by final rulemaking at 7 A.A.R. 184, effective December 15, 2000 (Supp. 00-4). Amended by final rulemaking at 12 A.A.R. 4798, effective December 5, 2006
(Supp. 06-4).
R9-14-602. Exemptions from Applicability
This Article does not apply to:
1. The laboratories exempted by A.R.S. § 36-495.02(A);
2. Compliance testing performed under the Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 136-136y; or
3. An out-of-state laboratory at which only microbiology testing of bottled water is performed and for which the owner holds a current and valid environmental laboratory license or certificate, issued by another state of the United States, that specifically authorizes drinking water testing.
Historical Note
Adopted effective August 16, 1985 (Supp. 85-4). Former Section R9-14-602 repealed, new Section R9-14-602 adopted effective December 20, 1991 (Supp. 91-4). Amended effective June 20, 1997 (Supp. 97-2). Amended by final rulemaking at 7 A.A.R. 184, effective December 15, 2000 (Supp. 00-4). Amended by final rulemaking at 12 A.A.R. 4798, effective December 5, 2006
(Supp. 06-4).
R9-14-603. License Application and Process; Transferability
A. To obtain an initial or renewal license to operate a laboratory, an applicant shall submit to the Department, within the time prescribed in subsection (C), an application completed using a Department-provided form and including:
1. The name of the laboratory;
2. The current Arizona license number for the laboratory, if any;
3. The current EPA certification number for the laboratory, if any;
4. The physical and mailing addresses for the laboratory;
5. The telephone number; fax number; and e-mail address for the laboratory;
6. The name and address of the owner and of each additional person that has an ownership interest in the laboratory;
7. For the owner and each additional business organization with an ownership interest in the laboratory, the name of each officer, principal, and statutory agent;
8. The name of the laboratory director;
b. Company, performing internal work only;
d. Other, with a description of the type of laboratory operation;
10. The license Level for which the applicant is applying;
11. Whether the applicant is applying to license a single laboratory or multiple laboratories;
12. If the applicant is applying to license a mobile laboratory, the vehicle make, vehicle identification number, and Arizona vehicle license number of the mobile laboratory;
13. If the applicant is applying to license a mobile laboratory that is affiliated with a non-mobile laboratory, the name of the non-mobile laboratory;
14. The name, title, and educational background of each individual authorized to sign final reports for the laboratory;
15. A list of the parameters for which the applicant is requesting to be licensed or, if an application for a renewal license, an indication that the applicant desires to be licensed for the same parameters as on the current license;
16. A list of the instruments and equipment to be used at the laboratory for compliance testing or, if an application for a renewal license, an indication that the applicant is using the same instruments and equipment as used under the current license;
17. A list of the software to be used at the laboratory for instrument control and data reduction interpretation or, if an application for a renewal license, an indication that the applicant is using the same software as used under the current license;
18. If the applicant is applying for an out-of-state laboratory, whether the applicant wants to receive technical updates at the laboratory by fax or through the Internet;
19. If an application for an initial license:
a. A copy of a proficiency testing report, for the current or most recently completed year, for the state in which the laboratory is located or, if that state does not require proficiency testing, for another state in which the laboratory is licensed or certified, for each of the parameters for which licensure is requested;
b. A list of the states in which the laboratory is licensed or certified and the corresponding license or certificate number for each state; and
c. A copy of a current quality assurance plan for the laboratory;
20. If an application for a renewal license:
a. A copy of a current standard operating procedure, limit of detection, and proficiency testing report, if available, for each parameter newly requested on the application; and
b. If the applicant desires to make payments in installments as permitted under R9-14-608, an indication of this and the monthly, bimonthly, or quarterly schedule for the payments;
21. Except as provided in subsection (J), the fees required under R9-14-607 and R9-14-608, payable to the Arizona Department of Health Services by credit card; certified check; business check; or money order; or, if the owner is an Arizona state agency, purchase order;
22. Attestation, made under oath, that the owner and the laboratory director are aware of all applicable requirements in A.R.S. Title 36, Chapter 4.3 and this Article and that the information provided in the application, including the information in the documents accompanying the application form, is accurate and complete; and
23. The dated and notarized signature of the laboratory director and:
a. If the owner is an individual, the individual;
b. If the owner is a corporation, an officer of the corporation;
c. If the owner is a partnership, one of the partners;
d. If the owner is a limited liability company, a manager or, if the limited liability company does not have a manager, a member of the limited liability company;
e. If the owner is an association or cooperative, a member of the governing board of the association or cooperative;
f. If the owner is a joint venture, one of the individuals signing the joint venture agreement;
g. If the owner is a governmental agency, the individual in the senior leadership position with the agency or an individual designated in writing by that individual; or
h. If the owner is a business organization type other than those described in subsections (A)(23)(b) through (f), an individual who is a member of the business organization.
B. An application may include an agreement between the applicant and the Department that the Department may submit supplemental requests for additional information.
C. An applicant shall submit an application:
1. For an initial license for an in-state laboratory, at least 30 days before the applicant intends to begin operating the in-state laboratory;
2. For an initial license for an out-of-state laboratory, at least 60 days before the applicant intends to begin performing Arizona compliance testing;
3. For a renewal license for an in-state laboratory, at least 30 days before the expiration date of the current license; and
4. For a renewal license for an out-of-state laboratory, at least 60 days before the expiration date of the current license.
D. The Department may issue a single laboratory license for:
2. Multiple laboratories that are located on contiguous grounds and have the same owner, if the applicant submits one application and combined fees for the laboratories; or
3. Multiple laboratories, including mobile laboratories, that have the same owner but are not located on contiguous grounds, if:
a. The applicant submits a separate application and fees for each laboratory,
b. Each non-mobile laboratory is located in Arizona, and
c. Each mobile laboratory has a current and valid Arizona vehicle registration.
E. The Department shall not issue a single laboratory license for multiple laboratories that do not meet the requirements of subsection (D)(2) or (3).
F. The Department shall not consider an applicant to be in compliance with the requirements for licensure, as provided under A.R.S. § 36-495.09(A)(5), if the applicant does not pay the appropriate fees required under R9-14-607 and R9-14-608.
G. The Department shall process an application as provided in R9-14-621.
H. A laboratory license is valid only for the facility or facilities for which the license is issued and cannot be transferred to another facility.
I. A laboratory license is valid only in the name of the persons to whom it is issued and expires upon a change in laboratory name, laboratory director, or ownership, unless within 20 business days after the change, the Department receives written notice of the change and an application for a new license.
J. The Department shall not charge a fee for a license application submitted under subsection (I) and shall issue a new license reflecting the change upon determining continued compliance with A.R.S. Title 36, Chapter 4.3 and this Article.
Historical Note
Adopted effective August 16, 1985 (Supp. 85-4). Former Section R9-14-603 repealed, new Section R9-14-603 adopted effective December 20, 1991 (Supp. 91-4). Section citation corrected in preceding historical note; Section amended effective June 20, 1997 (Supp. 97-2). Amended by final rulemaking at 7 A.A.R. 184, effective December 15, 2000 (Supp. 00-4). Amended by final rulemaking at 12 A.A.R. 4798, effective December 5, 2006 (Supp. 06-4).
R9-14-604. Third Party Accreditation
A. A laboratory that holds current and valid accreditation issued by the National Voluntary Laboratory Accreditation Program administered by the National Institute of Standards and Technology is exempt from licensure under this Article, as authorized under A.R.S. § 36-495.02, for the term of the accreditation.
B. If a laboratory's accreditation issued by the National Voluntary Laboratory Accreditation Program expires or is suspended, revoked, or voluntarily terminated, the laboratory is required to be licensed as provided under A.R.S. Title 36, Chapter 4.3 and this Article.
Historical Note
Adopted effective August 16, 1985 (Supp. 85-4). Former Section R9-14-604 repealed, new Section R9-14-604 adopted effective December 20, 1991 (Supp. 91-4). Section citation corrected in preceding historical note; former Section R9-14-604 renumbered to R9-14-605; new Section adopted effective June 20, 1997 (Supp. 97-2). Amended by final rulemaking at 7 A.A.R. 184, effective December 15, 2000 (Supp. 00-4). Section repealed; new Section made by final rulemaking at 12 A.A.R. 4798, effective December 5, 2006 (Supp. 06-4).
R9-14-605. Compliance Monitoring
A. The Department may conduct a laboratory inspection, investigation, or proficiency testing, or any combination of the three, at any time before or during a laboratory's license period.
B. The Department shall conduct at least two laboratory inspections before determining whether to conduct annual laboratory inspections as provided under subsection (C).
C. In determining whether to conduct an annual laboratory inspection, the Department shall consider:
1. The Department's findings at the last two laboratory inspections;
2. The licensee's adherence to any corrective action plans created as a result of the last two laboratory inspections;
3. Whether there has been a change in ownership or laboratory director since the last laboratory inspection;
4. The extent to which the compliance testing performed at the laboratory has changed since the last laboratory inspection or would change as a result of a renewal application; and
5. Performance on the most recent proficiency testing completed at the laboratory.
D. For a laboratory at which drinking water compliance testing is performed, the Department shall conduct a laboratory inspection at least every three years or as otherwise required by the EPA.
E. The Department shall comply with A.R.S. § 41-1009 in conducting laboratory inspections and investigations that occur at a laboratory.
F. If the Department determines based on a laboratory inspection, investigation, or proficiency testing, or any combination of the three, that a laboratory owner, officer, agent, or employee has engaged in conduct described under A.R.S. § 36-495.09(A) the Department shall request that the licensee or applicant submit to the Department a written corrective action plan, unless the Department determines one of the following, in which case the Department may take action under A.R.S. § 36-495.09:
1. That the deficiencies were committed intentionally;
2. That the deficiencies cannot be corrected within a reasonable period of time;
3. That the deficiencies are evidence of a pattern of noncompliance;
4. That the deficiencies are a risk to any person; the public health, safety, or welfare; or the environment; or
5. That there is a reasonable belief, as stated in A.R.S. § 36-495.09(B), that a violation of A.R.S. § 36-495.09(A)(5) has occurred and that the life or safety of the public is immediately affected.
G. Within 30 days after receiving a request for a written corrective action plan, a licensee or applicant shall submit to the Department a written corrective action plan that includes the following for each identified deficiency:
1. A description of how the deficiency will be corrected, and
2. A date of correction for the deficiency.
H. The Department shall accept a written corrective action plan if the plan:
1. Describes how each identified deficiency will be corrected, and
2. Includes a date for correcting each deficiency as soon as practicable based upon the actions necessary to correct the deficiency.
I. If the Department disapproves a corrective action plan, the Department shall send to the licensee or applicant a written notice of disapproval requesting that the licensee or applicant submit to the Department a revised corrective action plan for the items that the Department disapproves.
1. A licensee or applicant shall submit a revised corrective action plan to the Department within 21 days after the date of a written notice of disapproval.
2. If a licensee or applicant does not submit a revised corrective action plan within 21 days after the date of a written notice of disapproval, the Department may take action under A.R.S. § 36-495.09.
J. A licensee or applicant shall notify the Department when corrective action has been completed.
K. Within 30 days after receiving notice that corrective action has been completed, the Department shall determine whether each deficiency has been corrected and whether the corrective action brings the laboratory operations into substantial compliance with A.R.S. Title 36, Chapter 4.3 and this Article.
L. If the Department determines that a licensee or applicant has not corrected a deficiency or that the licensee or applicant has not corrected a deficiency within a reasonable period of time, the Department may take any enforcement action authorized by law as a result of the deficiency.
M. Under A.R.S. § 41-1009(G), the Department's decision regarding whether a licensee or applicant may submit a corrective action plan or whether a deficiency has been corrected or has been corrected within a reasonable period of time is not an appealable agency action as defined by A.R.S. § 41-1092.
Historical Note
Adopted effective August 16, 1985 (Supp. 85-4). Former Section R9-14-605 repealed, new Section R9-14-605 adopted effective December 20, 1991 (Supp. 91-4). Section citation corrected in preceding historical note; former Section R9-14-605 renumbered to R9-14-606; new Section R9-14-605 renumbered from R9-14-604 and amended effective June 20, 1997 (Supp. 97-2). Former Section R9-14-605 renumbered to R9-14-606; new Section R9-14-605 adopted by final rulemaking at 7 A.A.R. 184, effective December 15, 2000 (Supp. 00-4). Amended by final rulemaking at 12 A.A.R. 4798, effective December 5, 2006 (Supp. 06-4).
R9-14-606. Provisional Licensing
A. The Department may issue a provisional license to a licensee when the Department suspends the licensee's regular license because of deficiencies identified in an investigation, laboratory inspection, or proficiency testing, or any combination of the three, if the licensee agrees to carry out a plan acceptable to the Department to eliminate the deficiencies.
B. In determining whether to issue a provisional license, the Department shall consider:
1. The nature of the deficiencies upon which the suspension is based;
2. The licensee's history of compliance with A.R.S. Title 36, Chapter 4.3 and this Article;
3. The extent to which the public health and safety may be impacted by the continued operation of the laboratory with a provisional license; and
4. The extent to which the public's interests are served by allowing the licensee the opportunity to correct the deficiencies and continue operating with a provisional license.
C. The Department shall issue an amended list of parameters for a provisional license.
D. A licensee shall return its regular license to the Department within 14 days after receiving written notification of license suspension.
E. A provisional license is valid for a period established by the Department, not to exceed 12 months.
F. A licensee with a provisional license who desires to obtain a regular license shall apply for an initial license at least 30 days before the provisional license expires.
G. The Department shall issue a regular license as described in subsection (F) only upon determining that a licensee is in full compliance with the corrective action plan; A.R.S. Title 36, Chapter 4.3; and this Article.
H. The Department shall not issue a provisional license to an applicant for an initial license.
Historical Note
Adopted effective August 16, 1985 (Supp. 85-4). Former Section R9-14-606 repealed, new Section R9-14-606 adopted effective December 20, 1991 (Supp. 91-4). Section citation corrected in preceding historical note; former Section R9-14-606 renumbered to R9-14-607; new Section R9-14-606 renumbered from R9-14-605 and amended effective June 20, 1997 (Supp. 97-2). Former Section R9-14-606 renumbered to R9-14-607; new Section R9-14-606 renumbered from R9-14-605 and amended by final rulemaking at 7 A.A.R. 184, effective December 15, 2000 (Supp. 00-4). Amended by final rulemaking at 12 A.A.R. 4798, effective December 5, 2006 (Supp. 06-4).
A. Except as provided in R9-14-608, an applicant shall submit the following fees to the Department with each application for an initial or renewal license:
1. The cumulative method and instrumentation fees for each laboratory, as determined according to Tables 1 and 2 in Exhibit I;
2. The following application fees:
a. If applying for a single license for a single laboratory, which may include multiple laboratories located on contiguous grounds and having the same owner, the following fee:
i. For a Level I license, $1,677;
ii. For a Level II license, $2,130; or
iii. For a Level III license, $2,348; or
b. If applying for a single license for multiple laboratories not located on contiguous grounds, the following fee for each laboratory:
i. For a Level I license, $1,442;
ii. For a Level II license, $1,895; and
iii. For a Level III license, $2,130;
3. An administrative fee of $130 for the proficiency testing to occur during the license period; and
4. If applying for an out-of-state laboratory, an annual information update fee of $126.
B. The fees paid to the Department under this Article are nonrefundable, unless A.R.S. § 41-1077 applies.
Historical Note
Adopted effective August 16, 1985 (Supp. 85-4). Former Section R9-14-607 repealed, new Section R9-14-607 adopted effective December 20, 1991 (Supp. 91-4). Section citation corrected in preceding historical note; former Section R9-14-607 renumbered to R9-14-608; new Section R9-14-607 renumbered from R9-14-606 and amended effective June 20, 1997 (Supp. 97-2). Former Section R9-14-607 renumbered to R9-14-609; new Section R9-14-607 renumbered from R9-14-606 and amended by final rulemaking at 7 A.A.R. 184, effective December 15, 2000 (Supp. 00-4). Amended by final rulemaking at 12 A.A.R. 4798, effective December 5, 2006 (Supp. 06-4).
R9-14-608. Installment Payment of Fees by Small Businesses
A. A licensee may, for license renewal, pay the fees calculated under R9-14-607(A)(1), (3), and (4) to the Department in 12 or fewer installments if the laboratory owner is a small business.
B. A licensee who desires to make payments in installments as described in subsection (A) shall indicate this on the application for license renewal and shall indicate a monthly, bimonthly, or quarterly schedule for the payments, which shall result in full payment within 12 or fewer months.
C. A licensee making installment payments shall submit the first installment to the Department along with the application for license renewal and the application fee calculated under R9-14-607(A)(2), and each subsequent installment on a monthly, bimonthly, or quarterly basis, as indicated on the application, or until the fees are paid in full, whichever comes first.
D. A licensee shall ensure that each installment payment is:
1. Paid by the first day of the month in which it is due; and
2. At least equal to the amount calculated by dividing the total fees due under R9-14-607(A)(1), (3), and (4) by the number of payments indicated on the application for license renewal.
E. If a licensee fails to submit an installment within seven days after its due date, the Department shall charge a $50 fee for processing the late payment.
F. If a licensee fails to submit an installment within 30 days after its due date, the Department may initiate action under A.R.S. § 36-495.09.
Historical Note
Adopted effective August 16, 1985 (Supp. 85-4). Former Section R9-14-608 repealed, new Section R9-14-608 adopted effective December 20, 1991 (Supp. 91-4). Section citation corrected in preceding historical note; Section R9-14-608 renumbered to R9-14-609; new Section R9-14-608 renumbered from R9-14-607 and amended effective June 20, 1997 (Supp. 97-2). Former Section R9-14-608 renumbered to R9-14-610; new Section R9-14-608 adopted by final rulemaking at 7 A.A.R. 184, effective December 15, 2000 (Supp. 00-4). Amended by final rulemaking at 12 A.A.R. 4798, effective December 5, 2006 (Supp. 06-4).
R9-14-609. Proficiency Testing
A. At least once in each 12-month period, and more often if requested by the Department, each licensee or applicant that performs drinking water compliance testing shall have at least one laboratory analyst demonstrate proficiency in drinking water compliance testing by participating in proficiency testing provided by the Department, the EPA, or a proficiency testing service.
B. Each proficiency testing for drinking water compliance testing shall include at least one proficiency testing sample for each parameter for which an initial license or renewal license has been issued or requested. If more than one method is used to test for an analyte, a different lot shall be used for each method.
C. At least once in each 12-month period, and more often if requested by the Department, each licensee or applicant that performs non-drinking-water compliance testing shall have at least one laboratory analyst demonstrate proficiency in non-drinking-water compliance testing by participating in proficiency testing provided by the Department, the EPA, or a proficiency testing service, if proficiency testing is available.
D. Each proficiency testing for non-drinking-water compliance testing shall include at least one proficiency testing sample for each parameter for which an initial license or renewal license has been issued or requested and for which proficiency testing samples are available.
E. To demonstrate proficiency for a parameter, test results reported for the parameter shall be within acceptance limits established by:
1. For drinking water inorganic chemistry parameters, the EPA, as provided in 40 CFR 141.23;
2. For drinking water organic chemistry parameters, the EPA, as provided in 40 CFR 141.24;
3. For lead or copper in drinking water, the EPA, as provided in 40 CFR 141.89;
4. For disinfection byproducts in drinking water, the EPA, as provided in 40 CFR 141.131; and
5. For other parameters, the EPA or the proficiency testing service.
F. A licensee or applicant shall ensure that:
1. Each proficiency testing sample accepted at the licensee's or applicant's laboratory is analyzed at the licensee's or applicant's laboratory;
2. Each proficiency testing sample is tested within the holding times required for its parameter, using the same procedures and techniques employed for routine sample testing, and calculating the holding time from the time the sample seal is broken or as indicated in the instructions accompanying the sample;
3. A proficiency testing service provides proficiency testing results directly to the Department;
4. If proficiency testing is provided by the Department, the licensee or applicant submits to the Department payment for the actual costs of the proficiency testing materials; and
5. If proficiency testing is not provided by the Department or the EPA, the licensee or applicant selects a proficiency testing service and contracts with and pays the proficiency testing service directly for proficiency testing.
G. The Department may submit blind proficiency testing samples to a licensed laboratory at any time during the license period.
Historical Note
Adopted effective December 20, 1991 (Supp. 91-4). Former Section R9-14-609 renumbered to R9-14-610; new Section R9-14-609 renumbered from R9-14-608 and amended effective June 20, 1997 (Supp. 97-2). Former Section R9-14-609 renumbered to R9-14-611; new Section R9-14-609 renumbered from R9-14-607 and amended by final rulemaking at 7 A.A.R. 184, effective December 15, 2000 (Supp. 00-4). Amended by final rulemaking at 12 A.A.R. 4798, effective December 5, 2006 (Supp. 06-4).
R9-14-610. Approved Methods and References
A. A licensee or applicant shall ensure that compliance testing is performed according to an approved method and may use method alterations approved by the Department under subsection (C).
B. The approved methods listed by parameter in Exhibit I, Table 1 are found in the following references, which are incorporated by reference with the modifications described below; are on file with the Department; include no future editions or amendments, and are available as provided below.
A Environmental Monitoring and Support Laboratory-Cincinnati, EPA, Pub. No. EPA-600/4-79-020, Methods for Chemical Analysis of Water and Wastes (rev. March 1983), available at http://nepis.epa.gov/pubtitleord.htm.
A1 Environmental Monitoring and Support Laboratory-Cincinnati, EPA, Pub. No. EPA/600/R-94/111, Methods for the Determination of Metals in Environmental Samples: Supplement I (May 1994), available at http://nepis.epa.gov/pubtitleord.htm.
A2 Environmental Monitoring Systems Laboratory, EPA, Pub. No. EPA/600/R-93/100, Methods for the Determination of Inorganic Substances in Environmental Samples (August 1993), available at http://nepis.epa.gov/pubtitleord.htm, modified to increase the maximum holding time from 48 hours to 14 days at 4° C for chlorinated, unacidified drinking water samples collected for determination of nitrate.
A3 Technicon Industrial Systems, Industrial Method No. 380-75WE, Fluoride in Water and Wastewater (July 1977), available from Bran & Luebbe Analyzing Inc., 1025 Busch Parkway, Buffalo Grove, IL 60089.
A4 Office of Water, EPA, Pub. No. EPA-821-R-02-019, Method 1631, Revision E: Mercury in Water by Oxidation, Purge and Trap, and Cold Vapor Atomic Fluorescence Spectrometry (August 2002), available at http://www.epa.gov/waterscience/methods/1631.html.
A5 Technicon Industrial Systems, Industrial Method No. 129-71W, Fluoride in Water and Wastewater (December 1972), available from Bran & Luebbe Analyzing Inc., 1025 Busch Pkwy., Buffalo Grove, IL 60089.
A6 Herbert P. Wagner et al., EPA, Pub. No. EPA 815-B-01-001, Method 317.0: Determination of Inorganic Oxyhalide Disinfection By-Products in Drinking Water Using Ion Chromatography with the Addition of a Postcolumn Reagent for Trace Bromate Analysis (rev. 2.0 July 2001), available at www.epa.gov/safewater/methods/sourcalt.html.
A7 Herbert P. Wagner et al., EPA, Pub. No. EPA 815-R-05-007, Method 326.0: Determination of Inorganic Oxyhalide Disinfection By-Products in Drinking Water Using Ion Chromatography Incorporating the Addition of a Suppressor Acidified Postcolumn Reagent for Trace Bromate Analysis (rev. 1.0 June 2002), available at www.epa.gov/safewater/methods/sourcalt.html.
A8 Teri A. Dattilio et al., EPA, Pub. No. EPA 815-R-05-008, Method 327.0: Determination of Chlorine Dioxide and Chlorite Ion in Drinking Water Using Lissamine Green B and Horseradish Peroxidase with Detection by Visible Spectrophotometry (rev. 1.1 May 2005), available at www.epa.gov/safewater/methods/sourcalt.html.
A9 B.B. Potter and J.C. Wimsatt, EPA, Pub. No. EPA/600/R-05/055, Method 415.3: Determination of Total Organic Carbon and Specific UV Absorbance at 254 nm in Source and Drinking Water (rev. 1.1 February 2005), available at www.epa.gov/nerlcwww/ordmeth.htm.
B Herman L. Krieger, EPA, Pub. No. EPA-600/4-75-008, Interim Radiochemical Methodology for Drinking Water (March 1976), available from National Technical Information Service, 5285 Prt. Royal Rd., Springfield, VA 22161.
C American Public Health Association et al., Standard Methods for the Examination of Water and Wastewater (19th ed. 1995), available from American Public Health Association, 800 I Street, NW, Washington, DC 20001.
C1 Hach Company, Hach Water Analysis Handbook (3rd ed. 1997), available from Hach Company, P.O. Box 389, Loveland, CO 80539-0389.
C2 American Public Health Association et al., Standard Methods for the Examination of Water and Wastewater (20th ed. 1998), available from American Public Health Association, 800 I St., NW, Washington, DC 20001, modified to require:
a. For drinking water TOC testing:
i. That inorganic carbon be removed from each TOC sample before analysis,
ii. That each TOC sample not be filtered before analysis,
iii. That the pH of each TOC sample be checked and documented before analysis and that the test result be qualified in the final report if the sample pH was >2, and
iv. That each acidified TOC sample be analyzed within 28 days; and
b. For drinking water DOC testing:
i. That each DOC sample be filtered through a 0.45 um pore-diameter filter as soon as practical and no later than 48 hours after sampling,
ii. That each DOC sample be acidified after filtration to achieve a pH 2 with minimal addition of the acid specified in the method or by the instrument manufacturer,
iii. That each acidified DOC sample be analyzed within 28 days after sample collection,
iv. That inorganic carbon be removed from each DOC sample before analysis,
v. That water passed through the filter before filtration of the DOC sample serve as the filtered blank, and
vi. That the filtered blank be analyzed using procedures identical to those used for analysis of the DOC sample and have DOC < 0.5 mg/L;
c. For drinking water testing of UV-absorbing organic constituents:
i. That UV absorption be measured at 253.7 nm or 254 nm,
ii. That each UV sample be filtered through a 0.45 um pore-diameter filter before analysis,
iii. That the pH of UV samples not be adjusted, and
iv. That each UV sample be analyzed as soon as practical and no later than 48 hours after sampling; and
d. For drinking water disinfection byproducts testing by micro liquid-liquid extraction/GC-ECD using method 6251B, that each sample be extracted within 14 days after sample collection.
D Environmental Monitoring Systems Laboratory-Cincinnati, EPA, Pub. No. EPA/600/4-88/039, Methods for the Determination of Organic Compounds in Drinking Water (rev. July 1991), available at http://nepis.epa.gov/pubtitleord.htm.
D1 Environmental Monitoring Systems Laboratory-Cincinnati, EPA, Pub. No. EPA/600/4-90/020, Methods for the Determination of Organic Compounds in Drinking Water: Supplement I (July 1990), available at http://nepis.epa.gov/pubtitleord.htm.
D2 Environmental Monitoring Systems Laboratory-Cincinnati, EPA, Pub. No. EPA/600/R-92/129, Methods for the Determination of Organic Compounds in Drinking Water: Supplement II (August 1992), available at http://nepis.epa.gov/pubtitleord.htm.
D3 National Exposure Research Laboratory-Cincinnati, EPA, Pub. No. EPA/600/R-95/131, Methods for the Determination of Organic Compounds in Drinking Water: Supplement III (August 1995), available at http://nepis.epa.gov/pubtitleord.htm.
D4 Office of Ground Water and Drinking Water Technical Support Center, EPA, Pub. No. EPA 815-R-05-004, Manual for the Certification of Laboratories Analyzing Drinking Water: Criteria and Procedures Quality Assurance (5th ed. January 2005), available at http://www.epa.gov/ogwdw/labcert/labindex.html).
D5 J.W. Munch and W.J. Bashe, EPA, Method 549.2: Determination of Diquat and Paraquat in Drinking Water by Liquid-Solid Extraction and High Performance Liquid Chromatography with Ultraviolet Detection (rev. 1 June 1997), available at http://www.nemi.gov.
D6 Anne M. Pawlecki-Vonderheide and David J. Munch, EPA, Method 515.3: Determination of Chlorinated Acids in Drinking Water by Liquid-Liquid Extraction, Derivatization and Gas Chromatography with Electron Capture Detection (rev. 1 July 1996), available at http://www.nemi.gov.
D7 M.V. Bassett et al., EPA, Pub. No. EPA 815-B-01-002, Method 531.2: Measurement of N-Methylcarbamoyloximes and N-Methylcarbamates in Water by Direct Aqueous Injection HPLC with Postcolumn Derivatization (rev. 1.0 September 2001), available at http://www.nemi.gov.
D8 S.C. Wendelken et al., EPA, Method 515.4: Determination of Chlorinated Acids in Drinking Water by Liquid-Liquid Microextraction, Derivatization, and Fast Gas Chromatography with Electron Capture Detection (rev. 1.0 April 2000), available at http://www.nemi.gov.
D9 Ed K. Price et al., EPA, Pub. No. 815-R-05-005, Method 527: Determination of Selected Pesticides and Flame Retardants in Drinking Water by Solid Phase Extraction and Capillary Column Gas Chromatography/Mass Spectrometry (GC/MS) (rev. 1.0 April 2005), available at http://www.epa.gov/safewater/methods/sourcalt.html.
D10 J.W. Munch, EPA, Pub. No. 600/R-05/052, Method 529: Determination of Explosives and Related Compounds in Drinking Water by Solid Phase Extraction and Capillary Column Gas Chromatography/Mass Spectrometry (GC/MS) (rev. 1.0 September 2002), available at http://www.epa.gov/nerlcwww/ordmeth.htm.
D11 J.A. Shoemaker and M.V. Bassett, EPA, Pub. No. EPA/600/R-05/053, Method 535: Measurement of Chloroacetanilide and Other Acetamide Herbicide Degradates in Drinking Water by Solid Phase Extraction and Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS) (version 1.1 April 2005), available at http://www.epa.gov/nerlcwww/ordmeth.htm.
D12 J.W. Munch and M.V. Bassett, EPA, Pub. No. EPA/600/R-05/054, Method 521: Determination of Nitrosamines in Drinking Water by Solid Phase Extraction and Capillary Column Gas Chromatography with Large Volume Injection and Chemical Ionization Tandem Mass Spectrometry (MS/MS) (version 1.0 September 2004), available at http://www.epa.gov/nerlcwww/ordmeth.htm.
D13 M.M. Domino et al., EPA, Pub. No. EPA 815-B-03-002, Method 552.3: Determination of Haloacetic Acids and Dalapon in Drinking Water by Liquid-Liquid Extraction, Derivatization, and Gas Chromatography with Electron Capture Detection (rev. 1.0 July 2003), available at www.epa.gov/safewater/methods/sourcalt.html.
E 40 CFR Part 136 app. A (July 2005), available at http://www.access.gpo.gov/nara/cfr/cfr-table-search.html).
E1 Office of Water Engineering and Analysis Division, EPA, Pub. No. EPA-821-R-93-010-A, Methods for the Determination of Nonconventional Pesticides in Municipal and Industrial Wastewater: Volume I (rev. 1 August 1993), available from National Technical Information Service, 5285 Prt. Royal Rd., Springfield, VA 22161.
F Office of Solid Waste and Emergency Response, EPA, Pub. No. SW-846, Test Methods for Evaluating Solid Waste, Physical/Chemical Methods (3rd ed. 1986), as amended by Update I, July 1992; Update IIA, August 1993; Update II, September 1994; Update IIB, January 1995; Update III, December 1996; Update IIIA, June 1999; and Update IIIB, July 2005, available from National Technical Information Service, 5285 Prt. Royal Rd., Springfield, VA 22161, and at http://www.epa.gov/epaoswer/hazwaste/test/main.htm.
F1 Thomas A. Bellar and James J. Lichtenberg, EPA, Pub. No. EPA-600/4-81-045, The Determination of Polychlorinated Biphenyls in Transformer Fluid and Waste Oils (September 1982), available at http://nepis.epa.gov/pubtitleord.htm.
F2 EPA, Method 5035A: Closed-System Purge-and-Trap and Extraction for Volatile Organics in Soil and Waste Samples (draft rev. 1 July 2002), available at http://www.epa.gov/epaoswer/hazwaste/test/new-meth.htm.
F3 EPA, Method 4025: Screening for Polychlorinated Dibenzodioxins and Polychlorinated Dibenzofurans (PCDD/Fs) by Immunoassay (rev. 0 October 2002), available at http://www.epa.gov/epaoswer/hazwaste/test/new-meth.htm.
F4 EPA, Method 3570: Microscale Solvent Extraction (MSE) (rev. 0 November 2002), available at http://www.epa.gov/epaoswer/hazwaste/test/new-meth.htm.
F5 EPA, Method 3511: Organic Compounds in Water by Microextraction (rev. 0 November 2002), available at http://www.epa.gov/epaoswer/hazwaste/test/new-meth.htm.
F6 EPA, Method 5030C: Purge-and-Trap for Aqueous Samples (rev. 3 May 2003), available at http://www.epa.gov/epaoswer/hazwaste/test/new-meth.htm.
F7 EPA, Method 8015D: Nonhalogenated Organics Using GC/FID (rev. 4 June 2003), available at http://www.epa.gov/epaoswer/hazwaste/test/new-meth.htm.
F8 EPA, Method 5021A: Volatile Organic Compounds in Various Sample Matrices Using Equilibrium Headspace Analysis (rev. 1 June 2003), available at http://www.epa.gov/epaoswer/hazwaste/test/new-meth.htm.
F9 EPA, Method 9015: Metal Cyanide Complexes by Anion Exchange Chromatography and UV Detection (rev. 0 November 2004), available at http://www.epa.gov/epaoswer/hazwaste/test/new-meth.htm.
F10 EPA, Method 9013A: Cyanide Extraction Procedure for Solids and Oils (rev. 1 November 2004), available at http://www.epa.gov/epaoswer/hazwaste/test/new-meth.htm.
F11 EPA, Method 7000B: Flame Atomic Absorption Spectrophotometry (rev. 2 January 1998), available at http://www.epa.gov/epaoswer/hazwaste/test/up4a.htm#7_series.
F12 EPA, Method 7010: Graphite Furnace Atomic Absorption Spectrophotometry (rev. 0 January 1998), available at http://www.epa.gov/epaoswer/hazwaste/test/up4a.htm#7_series.
G National Institute for Occupational Safety and Health, U.S. Department of Health and Human Services, Pub. No. 84-100, NIOSH Manual of Analytical Methods: Volume 1, (3rd ed. February 1984), updated May 1985, August 1987, and May 1989, available from Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325.
H Environmental Monitoring Systems Laboratory-Research Triangle Park, EPA, Pub. No. EPA-600/M4-82-020, Interim Method for the Determination of Asbestos in Bulk Insulation Samples (December 1982), available at http://www.rti.org/pubs/test-method.pdf.
H1 Eric J. Chatfield and M. Jane Dillon, EPA, Pub. No. EPA-600/4-83-043, Method 100.1: Analytical Method for Determination of Asbestos Fibers in Water (September 1983), available at http://www.nemi.gov.
H2 Kim A. Brackett et al., EPA, Pub. No. EPA/600/R-94/134, Method 100.2: Determination of Asbestos Structures over 10 m in Length in Drinking Water (June 1994), available at http://www.nemi.gov.
I ASTM, Annual Book of ASTM Standards, Vols. 11.01 and 11.02 (1995), available from ASTM International, 100 Barr Harbor Dr., P.O. Box C700, W. Conshohocken, PA 19428-2959.
J U.S. Geological Survey, U.S. Department of the Interior, "Methods for Determination of Inorganic Substances in Water and Fluvial Sediments," published in Techniques of Water-Resources Investigations of the United States Geological Survey at bk. 5, ch. A1 (3rd ed. 1989), available from National Technical Information Service, 5285 Prt. Royal Rd., Springfield, VA 22161.
J1 L.L. Thatcher et al., U.S. Department of the Interior, "Methods for Determination of Radioactive Substances in Water and Fluvial Sediments," published in Techniques of Water-Resources Investigations of the United States Geological Survey at bk. 5, ch. A5 (3rd ed. 1989), available from National Technical Information Service, 5285 Prt. Royal Rd., Springfield, VA 22161.
K Division of State Laboratory Services, Arizona Department of Health Services, Method No. BLS-188, Ethylene Glycol in Waste Water (rev. April 1991); and Bureau of State Laboratory Services, Arizona Department of Health Services, C10 - C32 Hydrocarbons in Soil - 8015AZ (rev. 1.0 September 1998), available from the Bureau of State Laboratory Services, 250 N. 17th Ave., Phoenix, AZ 85007, and at www.azdhs.gov/lab/license/tech/bls188.pdf and www.azdhs.gov/lab/license/tech/8015azr1.pdf.
K1 Office of Water, EPA, Pub. No. EPA-821-R-98-002, Method 1664, Revision A: N-Hexane Extractable Material (HEM; Oil and Grease) and Silica Gel Treated N-Hexane Extractable Material (SGT-HEM; Non-polar Material) by Extraction and Gravimetry (February 1999), available at http://www.nemi.gov.
K2 Office of Water, EPA, Pub. No. EPA-821-B-98-016, Analytical Methods for the Determination of Pollutants in Pharmaceutical Manufacturing Industry Wastewater (July 1998), available at http://www.epa.gov/waterscience/guide/pharm/compend1.pdf.
L Herman L. Krieger and Earl L. Whittaker, EPA, Pub. No. EPA-600/4-80-032, Prescribed Procedures for Measurement of Radioactivity in Drinking Water (August 1980), available from National Technical Information Service, 5285 Prt. Royal Rd., Springfield, VA 22161.
M1 Environmental Monitoring Systems Laboratory-Cincinnati, EPA, Pub. No. EPA/600/4-90/027F, Methods for Measuring the Acute Toxicity of Effluents and Receiving Waters to Freshwater and Marine Organisms (4th ed. August 1993), available from National Technical Information Service, 5285 Prt. Royal Rd., Springfield, VA 22161.
N1 Environmental Monitoring Systems Laboratory-Cincinnati, EPA, Pub. No. EPA-600-4-91-002, Short-Term Methods for Estimating the Chronic Toxicity of Effluents and Receiving Water to Freshwater Organisms (3rd ed. July 1994), available at http://nepis.epa.gov/pubtitleord.htm.
O 40 CFR Part 50 (July 2006), available at http://www.access.gpo.gov/nara/cfr/cfr-table-search.html).
P EPA, Pub. No. EPA/600/4-84/013, USEPA Manual of Methods for Virology (rev. June 2001), Chapters 1-12 and 14-16 available at www.epa.gov/nerlcwww/about.htm and Chapter 13 available at http://nepis.epa.gov/pubtitleord.htm.
P1 Jay Vasconcelos and Stephanie Harris, EPA, Pub. No. EPA 910/9-92-029, Consensus Method for Determining Groundwaters Under the Direct Influence of Surface Water Using Microscopic Particulate Analysis (MPA) (October 1992), available from National Technical Information Service, 5285 Prt. Royal Rd., Springfield, VA 22161.
P2 G. Shay Fout et al., EPA, Pub. No. EPA/600/R-95/178, ICR Microbial Laboratory Manual (April 1996), available at http://nepis.epa.gov/pubtitleord.htm.
P3 Charles P. Gerba, University of Arizona, U of A 2000: Ascaris lumbricoides in Water (1999), available from the University of Arizona, Microbial Analytical Laboratory, Building No. 90, Rm. 406, Tucson, AZ 85721.
P4 EPA, Pub. No. EPA 815-R-05-001, Method 1622: Cryptosporidium in Water by Filtration/IMS/FA (December 2005), available at http://www.epa.gov/microbes/, modified to require flow cytometer-counted spiking suspensions for MS samples and ongoing precision and recovery samples.
P5 EPA, Pub. No. EPA 815-R-05-002, Method 1623: Cryptosporidium and Giardia in Water by Filtration/IMS/FA (December 2005), available at http://www.epa.gov/microbes/, modified to require flow cytometer-counted spiking suspensions for MS samples and ongoing precision and recovery samples.
Q 40 CFR Part 60 app. A (July 2006), available at http://www.access.gpo.gov/nara/cfr/cfr-table-search.html).
R Office of Air Quality, ADEQ, Arizona Testing Manual for Air Pollutant Emissions (rev. F March 1992), available from the Office of Air Quality, ADEQ, 1110 W. Washington St., Phoenix, AZ 85007, and at http://www.azdeq.gov/environ/air/compliance/download/manual.pdf.
S 40 CFR Part 61 apps. B and C (July 2006), available at http://www.access.gpo.gov/nara/cfr/cfr-table-search.html).
S1 EPA, Pub. No. EPA/625/R-96/010b, Compendium of Methods for the Determination of Toxic Organic Compounds in Ambient Air (2nd ed. January 1999), available at http://nepis.epa.gov/pubtitleord.htm.
U Environmental Measurements Laboratory, U.S. Department of Energy, Pub. No. HASL-300, EML Procedures Manual, Vol. I (28th ed. February 1997), available from National Technical Information Service, 5285 Prt. Royal Rd., Springfield, VA 22161.
V Eastern Environmental Radiation Facility, EPA, Pub. No. EPA 520/5-84-006, Eastern Environmental Radiation Facility Radiochemistry Procedures Manual (2nd prtg. 1988), available from National Technical Information Service, 5285 Prt. Royal Rd., Springfield, VA 22161.
W Environmental Monitoring and Support Laboratory Las Vegas, EPA, Pub. No. EMSL-LV-0539-17, Radiochemical Analytical Procedures for Analysis of Environmental Samples (March 1979), available from National Technical Information Service, 5285 Prt. Royal Rd., Springfield, VA 22161.
X Office of Ground Water and Drinking Water, EPA, Pub. No. EPA/600/4-91/016, Test Methods for Escherichia Coli in Drinking Water: EC Medium with Mug Tube Procedure, Nutrient Agar with Mug Membrane Filter Procedure (July 1991), available at http://nepis.epa.gov/pubtitleord.htm.
Y Office of Water, EPA, Pub. No. EPA-821-R-99-013, Method OIA-1677: Available Cyanide by Flow Injection, Ligand Exchange, and Amperometry (August 1999), available at http://www.epa.gov/waterscience/methods/cyanide/.
Z EPA, Pub. No. EPA 815-R-00-014, Volume 1, Methods for the Determination of Organic and Inorganic Compounds in Drinking Water (August 2000), available at http://nepis.epa.gov/pubtitleOW.htm, modified to require the following when testing for bromate using method 321.8:
a. That each sample be analyzed within 28 days after sampling, and
b. That the test result be qualified in the final report if the sample was not preserved with 50 mg of ethylenediamine per liter of sample at the time of sampling.
Z1 EPA, Pub. No. EPA 821/R/01/034, EPA Method 1605: Aeromonas in Finished Water by Membrane Filtration Using Ampicillin-Dextrin Agar with Vancomycin (ADA-V) (October 2001), available at http://www.epa.gov/safewater/methods/pdfs/met1605.pdf.
Z2 EPA, Pub. No. EPA 821/R-93-010-A, Methods for the Determination of Nonconventional Pesticides in Municipal and Industrial Wastewater, Volume I (rev. 1 August 1993), available from National Technical Information Service, 5285 Prt. Royal Rd., Springfield, VA 22161.
Z3 EPA, Pub. No. EPA-821-R-02-013, Short-term Methods for Estimating the Chronic Toxicity of Effluents and Receiving Waters to Freshwater Organisms (4th ed. October 2002), available at www.epa.gov/ost/wet/disk3/.
Z4 IDEXX Laboratories, Inc., IDEXX SimPlate TM HPC Method for Heterotrophs in Water (November 2000), available from IDEXX Laboratories, Inc., One IDEXX Dr., Westbrook, ME 04092.
Z5 William A. Yanko, EPA, Pub. No. EPA/600/1-87/014, Occurrence of Pathogens in Distribution and Marketing Municipal Sludges (1987), available from National Technical Information Service, 5285 Prt. Royal Rd., Springfield, VA 22161.
Z6 ASTM, Standard Test Methods for Determining Sediment Concentration in Water Samples (reapproved 2002), available from ASTM International, 100 Barr Harbor Dr., P.O. Box C700, W. Conshohocken, PA 19428-2959.
Z7 CEM Corporation, Closed Vessel Microwave Digestion of Wastewater Samples for Determination of Metals (April 1992), available from CEM Corporation, P.O. Box 200, Matthews, NC 28106-0200.
Z8 EPA, Pub. No. EPA-821-R-02-024, Method 1604: Total Coliforms and Escherichia coli in Water by Membrane Filtration Using a Simultaneous Detection Technique (MI Medium) (September 2002), available at http://www.epa.gov/safewater/methods/pdfs/met1604.pdf.
Z9 Lachat Instruments, QuikChem Method 10-204-00-1-X, Digestion and Distillation of Total Cyanide in Drinking and Wastewaters Using MICRO DIST and Determination of Cyanide by Flow Injection Analysis (rev. 2.1 November 30, 2000), available from Lachat Instruments, 6645 W. Mill Rd., Milwaukee, WI 53218.
Z10 OI Analytical/ALPKEM, Nitrogen, Total Kjeldahl, Method PAI-DK01 (Block Digestion, Steam Distillation, Titrimetric Detection) (rev. December 22, 1994), available from OI Analytical/ALPKEM, P.O. Box 9010, College Station, TX 77842.
Z11 OI Analytical/ALPKEM, Nitrogen, Total Kjeldahl, Method PAI-DK02 (Block Digestion, Steam Distillation, Colorimetric Detection) (rev. December 22, 1994), available from OI Analytical/ALPKEM, P.O. Box 9010, College Station, TX 77842.
Z12 OI Analytical/ALPKEM, Nitrogen, Total Kjeldahl, Method PAI-DK03 (Block Digestion, Automated FIA Gas Diffusion) (rev. December 22, 1994), available from OI Analytical/ALPKEM, P.O. Box 9010, College Station, TX 77842.
Z13 EPA, Pub. No. EPA-821-R-02-012, Methods for Measuring the Acute Toxicity of Effluents and Receiving Waters to Freshwater and Marine Organisms (5th ed. October 2002), available at www.epa.gov/waterscience/WET/disk2/.
C. If an approved method is not available for a particular parameter, or a different method or method alteration is required or authorized to be used for a particular parameter by the EPA, ADEQ, the U.S. Food and Drug Administration, or 9 A.A.C. 8, a licensee may request approval of an alternate method or method alteration.
1. For an alternate method or method alteration required or authorized by the EPA, ADEQ, the U.S. Food and Drug Administration, or 9 A.A.C. 8, the request shall include:
a. The name, address, and telephone number of the licensee submitting the request;
b. The name, address, and telephone number of the laboratory for which approval of the alternate method or method alteration is requested;
c. Identification of the parameter for which approval of the alternate method or method alteration is requested;
d. Reference to the EPA, ADEQ, U.S. Food and Drug Administration, or 9 A.A.C. 8 requirement or authorization for the use of the alternate method or method alteration for which approval is requested; and
e. An alternate method or method alteration approval fee of $50 payable to the Arizona Department of Health Services in the form of a certified check, business check, money order, or credit card payment.
2. For an alternate method or method alteration that is not required or authorized by the EPA, ADEQ, the U.S. Food and Drug Administration, or 9 A.A.C. 8, the request shall include:
a. The name, address, and telephone number of the licensee submitting the request;
b. The name, address, and telephone number of the laboratory for which approval of the alternate method or method alteration is requested;
c. Identification of the parameter for which approval of the alternate method or method alteration is requested; and
d. Written justification for using the alternate method or method alteration for which approval is requested, including the following:
i. A detailed description of the alternate method or method alteration;
ii. References to published or other studies confirming the general applicability of the alternate method or method alteration to the parameter for which its use is intended;
iii. Reference to the EPA, ADEQ, U.S. Food and Drug Administration, or 9 A.A.C. 8 requirement to test the parameter; and
iv. Data that demonstrate the performance of the alternate method or method alteration in terms of accuracy, precision, reliability, ruggedness, ease of use, and ability to achieve a detection limit appropriate for the proposed use of the alternate method or method alteration; and
e. An alternate method or method alteration approval fee of $50 payable to the Arizona Department of Health Services in the form of a certified check, business check, money order, or credit card payment.
3. Before approving an alternate method or method alteration that is not required or authorized by the EPA, ADEQ, the U.S. Food and Drug Administration, or 9 A.A.C. 8, the Department may require that the alternate method or method alteration be performed by a laboratory at a designated by the Department to verify that, using the parameter for which its use is intended, the alternate method or method alteration produces data that comply with subsection (C)(2)(d)(iv).
4. The Department may approve an alternate method or method alteration if the Department determines:
i. Use of the alternate method or method alteration is required or authorized by the EPA, ADEQ, the U.S. Food and Drug Administration, or 9 A.A.C. 8; or
ii. Use of the alternate method or method alteration is justified as described in subsection (C)(2)(d); and
b. If the alternate method or method alteration pertains to drinking water compliance testing, the EPA concurs that the alternate method or method alteration may be used.
Historical Note
Adopted effective December 20, 1991 (Supp. 91-4). Former Section R9-14-610 renumbered to R9-14-611; new Section R9-14-610 renumbered from R9-14-609 and amended effective June 20, 1997 (Supp. 97-2). Former Section R9-14-610 renumbered to R9-14-612; new Section R9-14-610 renumbered from R9-14-608 and amended by final rulemaking at 7 A.A.R. 184, effective December 15, 2000 (Supp. 00-4). Amended by final rulemaking at 10 A.A.R. 1687, effective April 6, 2004 (Supp. 04-2). Amended by final rulemaking at 12 A.A.R. 4798, effective December 5, 2006 (Supp. 06-4).
R9-14-611. Drinking Water Compliance Testing
A licensee for a laboratory at which drinking water compliance testing is performed shall ensure that:
1. The laboratory is operated in compliance with the guidelines in Key Reference D4, excluding the requirements for laboratory personnel education and experience;
2. Each drinking water sample for Arizona compliance testing is analyzed using an approved method:
a. Listed under Exhibit I, Table 1, Section A, Drinking Water Parameters; or
b. Approved for drinking water compliance testing under R9-14-610(C); and
3. If the licensee desires to be licensed to perform testing for vinyl chloride, the licensee also obtains licensure to perform testing for each of the analytes listed in 40 CFR 141.61(a)(2)-(21).
Historical Note
Adopted effective December 20, 1991 (Supp. 91-4). Former Section R9-14-611 renumbered to R9-14-612; new Section R9-14-611 renumbered from R9-14-610 and amended effective June 20, 1997 (Supp. 97-2). Former Section R9-14-611 renumbered to R9-14-613; new Section R9-14-611 renumbered from R9-14-609 and amended by final rulemaking at 7 A.A.R. 184, effective December 15, 2000 (Supp. 00-4). Amended by final rulemaking at 12 A.A.R. 4798, effective December 5, 2006 (Supp. 06-4).
R9-14-612. Wastewater Compliance Testing
A licensee for a laboratory at which wastewater compliance testing is performed shall ensure that each wastewater sample for Arizona compliance testing is analyzed using an approved method:
1. Listed under Exhibit I, Table 1, Section B, Wastewater Parameters; or
2. Approved for wastewater compliance testing under R9-14-610(C).
Historical Note
Adopted effective December 20, 1991 (Supp. 91-4). Former Section R9-14-612 renumbered to R9-14-613; new Section R9-14-612 renumbered from R9-14-611 and amended effective June 20, 1997 (Supp. 97-2). Former Section R9-14-612 renumbered to R9-14-614; new Section R9-14-612 renumbered from R9-14-610 and amended by final rulemaking at 7 A.A.R. 184, effective December 15, 2000 (Supp. 00-4). Amended by final rulemaking at 12 A.A.R. 4798, effective December 5, 2006 (Supp. 06-4).
R9-14-613. Solid Waste Compliance Testing
A. A licensee for a laboratory at which solid waste compliance testing is performed shall ensure that each solid waste sample for Arizona compliance testing is analyzed using an approved method:
1. Listed under Exhibit I, Table 1, Section C, Solid Waste Parameters; or
2. Approved by the Department for solid waste compliance testing under R9-14-610(C).
B. A licensee for a laboratory at which solid waste compliance testing is performed using an 8000 series method from Key Reference F shall:
1. If the method includes specific quality control requirements, follow the specific quality control requirements in the method;
2. If the method does not include specific quality control requirements, follow all requirements in EPA, Method 8000C: Determinative Chromatographic Separations (rev. 3 March 2003), incorporated by reference, on file with the Department, including no future editions or amendments, and available at http://www.epa.gov/epaoswer/hazwaste/test/new-meth.htm; and
3. If the method does not include specific sample extraction procedures, follow the procedures in the following from Key Reference F, as applicable:
C. A licensee for a laboratory at which solid waste compliance testing is performed using a non-8000 series method from Key Reference F shall comply with the following from Key Reference F, as applicable according to the requirements of the specific method:
D. A licensee for a laboratory at which solid waste compliance testing is performed using a method from Key Reference F shall comply with Chapters 1 through 8 of Key Reference F, as applicable according to the requirements of the specific method.
Historical Note
Adopted effective December 20, 1991 (Supp. 91-4). Former Section R9-14-613 renumbered to R9-14-614; new Section R9-14-613 renumbered from R9-14-612 and amended effective June 20, 1997 (Supp. 97-2). Former Section R9-14-613 renumbered to R9-14-615; new Section R9-14-613 renumbered from R9-14-611 and amended by final rulemaking at 7 A.A.R. 184, effective December 15, 2000 (Supp. 00-4). Amended by final rulemaking at 12 A.A.R. 4798, effective December 5, 2006 (Supp. 06-4).
R9-14-614. Air and Stack Compliance Testing
A licensee for a laboratory at which air or stack compliance testing is performed shall ensure that each air or stack sample for Arizona compliance testing is analyzed using an approved method:
1. Listed under Exhibit I, Table 1, Section D, Air and Stack Parameters; or
2. Approved by the Department for air or stack compliance testing under R9-14-610(C).
Historical Note
Adopted effective December 20, 1991 (Supp. 91-4). Former Section R9-14-614 renumbered to R9-14-615; new Section R9-14-614 renumbered from R9-14-613 and amended effective June 20, 1997 (Supp. 97-2). Former Section R9-14-614 renumbered to R9-14-616; new Section R9-14-614 renumbered from R9-14-612 and amended by final rulemaking at 7 A.A.R. 184, effective December 15, 2000 (Supp. 00-4). Amended by final rulemaking at 12 A.A.R. 4798, effective December 5, 2006 (Supp. 06-4).
A. A licensee or applicant shall ensure that the analytical data produced at the licensee's or applicant's laboratory are of known and acceptable precision and accuracy, as prescribed by the approved method for each analysis or as prescribed by the limits described under subsection (C)(9), and are scientifically valid and defensible.
B. A licensee or applicant shall have, implement, and comply with a written quality assurance plan that contains the following and is available at the laboratory for Department review:
1. A title page identifying the laboratory and date of review and including the laboratory director's signature of approval;
3. An organization chart or list of the laboratory personnel, including names, line of authority, and identification of principal quality assurance personnel;
4. A copy of the current laboratory license and a list of licensed parameters;
5. A statement of quality assurance objectives, including data quality objectives with precision and accuracy goals and the criteria for determining the acceptability of each testing;
b. Preparation of sample containers,
c. Preservation of samples, and
d. Maximum allowable holding times;
7. A procedure for documenting laboratory receipt of samples and tracking of samples during laboratory testing;
8. A procedure for analytical instrument calibration, including frequency of calibration and complying with the requirements for calibration in subsection (C);
9. A procedure for compliance testing data reduction and validation and reporting of final results, including the identification and treatment of data outliers, the determination of the accuracy of data transcription, and all calculations;
10. A statement of the frequency of all quality control checks;
11. A statement of the acceptance criteria for all quality control checks;
12. Preventive maintenance procedures and schedules;
13. Assessment procedures for data acceptability;
14. Corrective action procedures to be taken when results from analytical quality control checks are unacceptable, including steps to demonstrate the presence of any interference if the precision, accuracy, or limit of quantitation the reported compliance testing result is affected by the interference; and
15. Procedures for chain-of-custody documentation, including procedures for the documentation and reporting of any deviation from the sample handling or preservation requirements listed in this Section.
C. A licensee or applicant shall:
1. Have available at the laboratory all methods, equipment, reagents, and glassware necessary for the compliance testing for which the licensee or applicant is licensed or is requesting a license;
2. Use and document the use of only reagents of a grade equal to or greater than that required by the approved methods;
3. Maintain and require each analyst to comply with a complete and current standard operating procedure for each licensed method, which shall include at least:
a. A requirement that the method be performed in compliance with the requirements in the approved method;
b. A description of all procedures to be followed when the method is performed;
c. A list of the concentrations for calibration standards, check standards, and spikes;
d. Requirements for instrumental conditions and set up;
e. A requirement for frequency of calibration;
f. Calculations for the quantitation of the final concentration of samples, with the actual sample dilution factors and the calibration algorithm used, which reflect the procedures followed; and
g. Requirements for preventative maintenance;
4. Calibrate each instrument as required by each approved method for which the equipment is used, as follows:
a. If a calibration model is specified in the method, using the specified calibration model or, if another calibration model has been approved by the Department as a method alteration, using the calibration model approved as a method alteration;
b. If multiple calibration models are included as options in the method, using one of the included calibration models or, if another calibration model has been approved by the Department as a method alteration, using the calibration model approved as a method alteration; or
c. If the method does not include a calibration model, using the manufacturer's specifications for calibration;
5. Maintain calibration documentation, including documentation that demonstrates the calculations performed using each calibration model;
6. Develop, document, and maintain a current limit of detection and limit of quantitation for each compliance parameter for each instrument;
7. Develop each limit of detection using:
a. The protocol in the applicable test method;
b. The protocol in the applicable federal regulation; or
c. A process that complies with the guidelines in Section D.1.2 of Chapter 5, Appendix D--Essential Quality Control Requirements, in National Environmental Laboratory Accreditation Conference, EPA Pub. No. EPA/600/R-04/003, 2003 NELAC Standard (June 5, 2003), including no future editions or amendments, which is incorporated by reference, on file with the Department, and available from the National Environmental Laboratory Accreditation Conference, US EPA ORD/NERL, Mailcode E243-05, RTP, NC 27711, or at www.epa.gov/nelac/;
8. Maintain all compliance testing equipment in proper operating condition;
9. For each parameter tested at the laboratory for which quality control acceptance criteria are not specified in the approved method or by EPA or ADEQ:
a. Use default limits provided in Exhibit II; or
b. Statistically develop limits from historical data by:
i. Determining the mean and standard deviation for a minimum of 20 data points not invalidated for cause, excluding statistical outliers;
ii. Setting the limits no more than three standard deviations from the mean and in the detectable range, using as the lower end of the detectable range the limit of quantitation or the lowest standard value represented in the initial calibration; and
iii. Explaining the origin of the lower end of the detectable range in the laboratory's standard operating procedure;
10. Discard or segregate all expired standards or reagents;
11. Maintain a record showing the traceability of reagents; and
12. Ensure that a calibration model is not used or changed to avoid necessary instrument maintenance.
D. A licensee or applicant may submit a written request to the Department for an exemption from subsection (C)(1) for a specific parameter if the licensee or applicant:
1. Documents that the approved method has been performed at the laboratory and that the analytical data generated were scientifically valid and defensible and of known and acceptable precision and accuracy; and
2. Documents the licensee's or applicant's ability to obtain the equipment, reagent, or glassware necessary to perform the approved method.
E. The written request for an exemption under subsection (D) shall include:
1. The name, address, and main telephone number of the laboratory;
2. The name, address, and telephone number of the licensee or applicant submitting the request;
3. Identification of the parameter and the equipment, reagent, or glassware for which the licensee or applicant is requesting an exemption; and
4. The documentation described in subsections (D)(1) and (2).
F. The Department may approve a request for an exemption under subsection (D) if it determines:
1. That the approved method has been performed at the laboratory;
2. That the analytical data generated were scientifically valid and defensible and of known and acceptable precision and accuracy; and
3. That the license or applicant is able to obtain the equipment, reagent, or glassware necessary to perform the approved method.
G. A licensee or applicant shall ensure that a laboratory's written quality assurance plan is a separate document available at the laboratory and includes all of the components required in subsection (B), but a licensee or applicant may satisfy the components required in subsections (B)(3) through (15) through incorporating by reference provisions in separate documents such as standard operating procedures.
H. A licensee or applicant shall ensure that each laboratory standard operating procedure is a separate document available at the laboratory and includes all of the components required in subsection (C)(3), but a licensee or applicant may satisfy the components required in subsections (C)(3)(f) and (g) through incorporating by reference provisions in separate documents such as other standard operating procedures.
Historical Note
Adopted effective December 20, 1991 (Supp. 91-4). Former Section R9-14-615 renumbered to R9-14-616; new Section R9-14-615 renumbered from R9-14-614 and amended effective June 20, 1997 (Supp. 97-2). Former Section R9-14-615 renumbered to R9-14-617; new Section R9-14-615 renumbered from R9-14-613 and amended by final rulemaking at 7 A.A.R. 184, effective December 15, 2000 (Supp. 00-4). Amended by final rulemaking at 12 A.A.R. 4798, effective December 5, 2006 (Supp. 06-4).
1. A compliance testing sample accepted at the licensee's laboratory is analyzed:
a. At the licensee's laboratory,
b. At another laboratory licensed under this Article, or
c. At a laboratory exempted under A.R.S. § 36-495.02(A) or R9-14-602;
2. The facility and utilities required to operate equipment and perform compliance testing are maintained;
3. Environmental controls are maintained within the laboratory to ensure that laboratory environmental conditions do not affect analytical results beyond quality control limits established for the methods performed at the laboratory;
4. Storage, handling, and disposal of hazardous materials at the laboratory are in accordance with all state and federal regulations;
5. The following information is maintained for all supervisory, quality assurance, and analytical personnel:
a. A summary of each individual's education and professional experience;
b. Documentation of each individual's review of the quality assurance plan required under R9-14-615(B) and the approved methods and laboratory standard operating procedures for each area of testing performed by the individual or for which the individual has supervisory or quality assurance responsibility;
c. Documentation of each analyst's completion of training on the use of equipment and of proper laboratory technique, including the name of the analyst, the name of the instructor, the duration of the training, and the date of completion of the training;
d. Documentation of each analyst's completion of training classes, continuing education courses, seminars, and conferences that relate to the testing procedures used by the analyst for compliance testing;
e. Documentation of each analyst's completion of Initial Demonstration of Capability as required by each approved method performed by the analyst, as applicable;
f. Documentation of each analyst's performance of proficiency testing, as applicable;
g. Documentation of each analyst's completion of training related to instrument calibration that includes:
i. Instruction on each calibration model that the analyst will use or for which the analyst will review data;
ii. For each calibration model described in subsection (5)(g)(i), the specific aspects of the calibration model that might compromise the data quality, such as detector saturation, lack of detector sensitivity, the calibration model's not accurately reflecting the calibration points, inappropriate extension of the calibration range, weighting factors, and dropping of mid-level calibration points without justification; and
iii. Instruction that a calibration model shall not be used or changed to avoid necessary instrument maintenance; and
h. Documentation of each individual's applicable certifications and specialized training; and
6. The licensee complies with all applicable federal, state, and local occupational safety and health regulations.
Historical Note
Adopted effective December 20, 1991 (Supp. 91-4). Former Section R9-14-616 renumbered to R9-14-617; new Section R9-14-616 renumbered from R9-14-615 effective June 20, 1997 (Supp. 97-2). Former Section R9-14-616 repealed; new Section R9-14-616 renumbered from R9-14-614 and amended by final rulemaking at 7 A.A.R. 184, effective December 15, 2000 (Supp. 00-4). Amended by final rulemaking at 12 A.A.R. 4798, effective December 5, 2006 (Supp. 06-4).
R9-14-617. Laboratory Records and Reports
A licensee or applicant shall ensure that:
1. Each record and report required to be maintained by this Article is available for inspection and copying by the Department during normal business hours;
2. The Department is permitted to remove copied records and reports from a laboratory;
3. The licensee or applicant maintains records and reports of compliance testing for at least five years after the date of compliance testing, with:
a. All records and reports for at least the most current two years maintained onsite at the laboratory and the remaining records and reports stored in a secure storage facility;
b. Each hard copy document containing data either maintained as a hard copy document or scanned into a PDF file or another electronic file format that preserves an exact copy of the hard copy data; and
c. All instrument-generated electronic data maintained in a reproducible format from which reports can be produced and printed;
4. No portion of a record or report of compliance testing is altered or deleted to hide or misrepresent any part of the data;
5. The licensee or applicant produces all records and reports requested by the Department within 24 hours after the request or, if the licensee or applicant requests a period longer than 24 hours, a longer period of time agreed upon by the Department;
6. Upon Department request, the licensee or applicant makes available for inspection and copying the requested data from non-Arizona compliance samples;
7. A compliance testing record contains:
a. Sample information, including the following:
i. A unique sample identification assigned at the laboratory,
ii. The location or location code of sample collection,
iii. The sample collection date and time,
iv. The type of testing to be performed, and
v. The name of the individual who collected the sample;
b. The name and address of the client submitting the sample to the laboratory;
c. The name of the individual who submitted the sample to the laboratory;
d. The date and time of receipt of the sample at the laboratory;
e. The name of the individual who received the sample at the laboratory;
f. The dates and times of testing, including the date and time of each critical step;
g. The actual results of compliance testing, including all raw data, work sheets, and calculations performed;
h. The actual results of quality control data validating the test results, including the calibration and calculations performed;
i. The name of each analyst or who performed the testing; and
j. A copy of the final report;
8. A final report of compliance testing contains:
a. The name, address, and telephone number of the laboratory;
b. The license number assigned to the laboratory by the Department;
c. Actual scientifically valid and defensible results of compliance testing in appropriate units of measure, obtained in accordance with an approved method and quality assurance plan;
d. Qualified results of compliance testing not obtained in accordance with an approved method and quality assurance plan;
e. A list of each approved method used to obtain the reported results;
f. Sample information, including the following:
i. The unique sample identification assigned at the laboratory,
ii. The location or location code of sample collection,
iii. The sample collection date and time,
iv. The name of the individual who collected the sample,
v. The name of the client that submitted the sample to the laboratory, and
vi. The name of the individual who submitted the sample to the laboratory;
g. The date of analysis for each parameter reported;
Historical Note
Adopted effective December 20, 1991 (Supp. 91-4). Former Section R9-14-617 renumbered to R9-14-618; new Section R9-14-617 renumbered from R9-14-616 and amended effective June 20, 1997 (Supp. 97-2). Former Section R9-14-617 renumbered to R9-14-618; new Section R9-14-617 renumbered from R9-14-615 and amended by final rulemaking at 7 A.A.R. 184, effective December 15, 2000 (Supp. 00-4). Amended by final rulemaking at 12 A.A.R. 4798, effective December 5, 2006 (Supp. 06-4).
R9-14-618. Mobile Laboratories
A. An applicant shall obtain a license for each mobile laboratory, unless the applicant chooses the single license option for multiple laboratories as described in R9-14-603(D).
B. A licensee or applicant for a mobile laboratory shall ensure that the mobile laboratory is operated in compliance with all of the requirements of this Article.
C. Upon Department request, a licensee or applicant for a mobile laboratory shall provide to the Department the mobile laboratory's location and a list of the parameters for which testing is performed at the mobile laboratory.
Historical Note
R9-14-618 renumbered from R9-14-617 and amended effective June 20, 1997 (Supp. 97-2). Former Section R9-14-618 renumbered to R9-14-619; new Section R9-14-618 renumbered from R9-14-617 and amended by final rulemaking at 7 A.A.R. 184, effective December 15, 2000 (Supp. 00-4). Amended by final rulemaking at 12 A.A.R. 4798, effective December 5, 2006 (Supp. 06-4).
R9-14-619. Out-of-State Environmental Laboratory Licensing
A. A licensee or applicant for an out-of-state laboratory at which Arizona compliance testing is performed shall comply with the requirements of A.R.S. Title 36, Chapter 4.3 and this Article.
B. A licensee or applicant for an out-of-state laboratory shall pay all actual expenses incurred by the Department as a result of the laboratory's location, including:
1. The estimated costs of each laboratory inspection or investigation at the laboratory;
2. The amount by which the actual costs of each laboratory inspection or investigation at a laboratory exceed the estimated costs;
3. Additional expenses incurred by the Department for each investigation at the laboratory; and
4. A zone fee for each Department representative required to appear at the laboratory to perform the laboratory inspection or investigation, as follows:
a. For zone 1, including California, Nevada, Utah, Colorado, and New Mexico: $114;
b. For zone 2, including all states west of the Mississippi River not listed in subsection (B)(4)(a): $179;
c. For zone 3, including all states east of the Mississippi River and Alaska and Hawaii: $290; and
d. For zone 4, including all countries outside of the United States: $516.
1. Determine the estimated costs and zone fees for a laboratory inspection or investigation after making travel arrangements to visit an out-of-state laboratory;
2. Send the licensee or applicant for an out-of-state laboratory a bill for the estimated costs and zone fees, with instructions to submit the amount billed to the Department within 20 days after the date that the Department sends the bill; and
3. After a laboratory inspection or investigation is completed, determine the actual costs for the inspection or investigation and any additional expenses incurred for an investigation and:
a. If the actual costs and additional expenses exceed the estimated costs and zone fees already paid, send a bill to the licensee or applicant for the out-of-state laboratory for the amount by which the actual costs and expenses exceed the estimated costs and zone fees paid, with instructions to submit the amount billed to the Department within 20 days after the date that the Department sends the bill; or
b. If the actual costs and expenses are less than the estimated costs and zone fees already paid, notify the licensee or applicant, determine whether the licensee or applicant desires a refund or a credit, and send a refund or issue a credit within 45 days after the date that the licensee or applicant specifies the desired form of payment.
Historical Note
New Section R9-14-619 renumbered from R9-14-618 and amended by final rulemaking at 7 A.A.R. 184, effective December 15, 2000 (Supp. 00-4). Amended by final rulemaking at 12 A.A.R. 4798, effective December 5, 2006 (Supp. 06-4).
R9-14-620. Changes to a License
A. During the term of a license, a licensee may request to have one or more parameters added to the license.
B. To request to have one or more parameters added to a license, a licensee shall submit to the Department:
1. A written request that includes:
a. The name, address, and telephone number of the licensee submitting the request;
b. The name, address, and telephone number of the laboratory for which the addition is requested; and
c. Identification of each parameter requested to be added;
2. The applicable method and instrumentation fees, as determined according to Tables 1 and 2 in Exhibit I, payable to the Arizona Department of Health Services by credit card; certified check; business check; or money order; or, if the owner is an Arizona state agency, purchase order;
3. If the addition results in a different Level of license, the difference between the application fee paid with the most recent application and the application fee for the new Level of license required under R9-14-607(A)(2), payable to the Arizona Department of Health Services as provided in subsection (B)(2); and
4. The following for each parameter requested to be added:
a. The limit of detection, if applicable;
b. A copy of a proficiency testing report; and
c. A copy of the standard operating procedure.
C. The Department may conduct a laboratory inspection during the substantive review period for a request to have one or more parameters added to a license.
D. The Department shall process a request to have one or more parameters added to a license as provided in R9-14-621.
E. A licensee may request deletion of parameters at no charge three times during a license period, but shall pay $17 per parameter for the fourth and each subsequent deletion requested during a license period.
Historical Note
Former R9-14-620 renumbered to R9-14-621; new R9-14-620 made by final rulemaking at 12 A.A.R. 4798, effective December 5, 2006 (Supp. 06-4).
A. The overall time-frame described in A.R.S. § 41-1072 for each type of approval granted by the Department under this Article is set forth in Table 1.
1. An applicant and the Department may agree in writing to extend the substantive review time-frame and the overall time-frame.
2. An extension of the substantive review time-frame and the overall time-frame may not exceed 25% of the overall time-frame.
B. The administrative completeness review time-frame described in A.R.S. § 41-1072 for each type of approval granted by the Department under this Article is set forth in Table 1 and begins on the date that the Department receives an application or request for approval.
1. The Department shall send a notice of administrative completeness or deficiencies to an applicant within the administrative completeness review time-frame.
a. A notice of deficiencies shall list each deficiency and the information or items needed to complete the application or request for approval.
b. The administrative completeness review time-frame and the overall time-frame are suspended from the date that a notice of deficiencies is sent until the date that the Department receives all of the missing information or items from an applicant.
2. If an applicant fails to submit to the Department all of the information and items listed in a notice of deficiencies within 60 days after the date that the Department sent the notice of deficiencies, the Department shall consider the application or request for approval withdrawn and deny the license or other approval requested.
3. If the Department issues a license or other approval to an applicant during the administrative completeness review time-frame, the Department shall not issue a separate written notice of administrative completeness.
C. The substantive review time-frame described in A.R.S. § 41-1072 is set forth in Table 1 and begins on the date of a notice of administrative completeness.
1. As part of the substantive review for an initial license application, the Department may conduct a laboratory inspection, investigation, or proficiency testing, or a combination of the three, as described in R9-14-605.
a. The Department shall commence a laboratory inspection, investigation, or proficiency testing, or combination of the three, no more than 30 days after notice of administrative completeness has been mailed for an in-state laboratory or no more than 60 days after notice of administrative completeness has been mailed for an out-of-state laboratory.
b. The Department and an applicant may mutually agree in writing to schedule a laboratory inspection, proficiency testing, or investigation later than the date required under subsection (C)(1)(a).
2. The Department shall send written notification of approval or denial of a license or other approval to an applicant within the substantive review time-frame.
3. During the substantive review time-frame, the Department may make one comprehensive written request for additional information, unless the Department and applicant have agreed in writing to allow the Department to submit supplemental requests for information.
4. If the Department 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 Department issues the request until the date that the Department receives all of the information requested.
5. If an applicant fails to submit to the Department all of the information and items listed in a comprehensive written request or a supplemental request for information within 60 days after the date that the Department sent the comprehensive written request or supplemental request for information, the Department shall deny the license or other approval requested.
6. The Department shall grant a license or other approval unless:
a. An applicant fails to submit requested information or a requested item as described in subsection (B)(2) or (C)(5);
b. For an initial license application or a regular license renewal application where the regular license is not suspended, the Department determines that grounds to deny the license exist under A.R.S. § 36-495.09;
c. For a regular license renewal application where the regular license is suspended, the Department determines that the licensee is not in full compliance with the corrective action plan; A.R.S. Title 36, Chapter 4.3; or this Article;
d. For a request for approval of an alternate method or method alteration, the Department determines that the alternate method or method alteration does not meet the standard for approval under R9-14-610(C)(4); or
e. For a request for approval of an exemption under R9-14-615(D), the Department determines that the request does not meet the standard for approval under R9-14-615(F).
7. If the Department denies a license or other approval, the Department shall send to the applicant a written notice of denial setting forth the reasons for denial and all other information required by A.R.S. § 41-1076.
Historical Note
New Section adopted by final rulemaking at 7 A.A.R. 184, effective December 15, 2000 (Supp. 00-4). Section R9-14-621 renumbered from R9-14-620 and amended by final rulemaking at 12 A.A.R. 4798, effective December 5, 2006 (Supp. 06-4).
Table 1. Time-frames (in days)
Historical Note
New Table adopted by final rulemaking at 7 A.A.R. 184, effective December 15, 2000 (Supp. 00-4). Amended by final rulemaking at 12 A.A.R. 4798, effective December 5, 2006 (Supp. 06-4).
EXHIBIT I. APPROVED METHODS; METHOD FEES; INSTRUMENTATION FEES
Table 1. Approved Methods; Method Fees