A.R.S. tit. 36 ch. 4.3 — Arizona Revised Statutes Title 36 Chapter 4.3 — Environmental Laboratories

36-495. Definitions In this chapter, unless the context otherwise requires: 1. "Compliance testing" means laboratory analysis of any matter, pollutant, contaminant, hazardous substance or other substance subject to regulation pursuant to: (a) Title 49 or rules adopted or enforced by the department of environmental quality for the purpose of determining compliance with title 49. (b) Federal environmental statutes or regulations administered or enforced by the United States environmental protection agency relating to the safe drinking water act (42 United States Code sections 300f through 300j), the clean air act (42 United States Code sections 7401 through 7642), the clean water act (33 United States Code sections 1251 through 1376), the resource conservation and recovery act (42 United States Code sections 6921 through 6939B), the comprehensive environmental response, compensation, and liability act (42 United States Code sections 9601 through 9657) and the toxic substance control act (42 United States Code sections 2601 through 2654) as they relate only to the regulation of polychlorinated biphenyls and asbestos. (c) Federal or state statutes and rules relating to the safety, contamination and sanitation of drinking water sold in bottles, or ice or water sold by machine or hauled and enforced by the department of health services or the United States food and drug administration. 2. "Department" means the department of health services. 3. "Director" means the director of the department of health services. 4. "Environmental laboratory" or "laboratory" means a facility where compliance testing is performed. 5. "Facility" means a place, building, installation, structure or vehicle. 6. "Government agency" means an agency of the United States government, this state or a political subdivision of this state. 7. "Laboratory director" means an individual who administers the technical and scientific operation of an environmental laboratory and who is responsible for reporting laboratory test results as specified in this chapter or rules adopted pursuant to this chapter. 8. "License" means a regular license, renewal license or provisional license issued by the department pursuant to this chapter. 9. "Person" means an individual, employee, officer, managing body, trust, firm, joint stock company, consortium, corporation, partnership, association, state or political subdivision of a state or the United States government. 36-495.01. Licensure program; rules A. On or before July 1, 1991, the department shall license environmental laboratories engaged in compliance testing. Upon application for an environmental laboratory license, the department shall issue the license if, after investigation, the department determines that the application conforms with the standards established by the department. B. The director shall prescribe rules providing for minimum standards of proficiency, methodology, quality assurance, operation and safety for environmental laboratories and may prescribe standards for personnel education, training and experience to meet federal environmental statutes or regulations, or enabling reciprocity with other states and the manner and form in which compliance testing results are reported. The rules shall be developed in cooperation with the director of the department of environmental quality and shall be consistent with title 49 and rules administered or enforced by the director of environmental quality. C. The director shall prescribe rules providing minimum standards for third party accreditation. D. Unless exempted by section 36-495.02, no person may operate or maintain an environmental laboratory without a license issued by the department pursuant to this chapter. 36-495.02. Exemptions A. This chapter does not apply to an environmental laboratory in this state that is: 1. Certified or designated by the United States environmental protection agency as the laboratory that provides analytical services to this state required for the delegation of primary enforcement responsibility under a federal law or regulation administered by that agency. 2. Operated by the Arizona department of agriculture or the department of health services. 3. Performing only compliance testing of parameters that require analysis at the time of sample collection as long as the testing methodologies employed are approved by the director of the department of health services or the department of environmental quality. 4. Licensed to perform those analyses for which it is licensed or certified by another agency of this state. 5. Accredited by a national voluntary laboratory accreditation program administered by the national institute of standards and technology and approved by the department. B. In addition to the exemptions established in subsection A of this section, the director of the department of health services may also exempt by rule certain classes of environmental laboratories and types of compliance testing, parameters and methods, if the director determines that the exemptions will not adversely affect the public health or the environment. The rules shall be developed in cooperation with the director of the department of environmental quality and the director of the Arizona department of agriculture. 36-495.03. License application; issuance; expiration A. Unless exempted pursuant to section 36-495.02, a person who operates or maintains an environmental laboratory located in this state shall file an application with the department at least thirty days before the anticipated operation of a new laboratory for an environmental laboratory license accompanied by the license application fee established by this chapter. A person shall obtain a license for each laboratory, except that only one license is required for contiguous or coterminous laboratories under the same ownership. The director, by rule, shall prescribe when noncontiguous laboratories with the same owners may be operated under a single license. B. The application shall be on a form prescribed and furnished by the department. The application shall be under oath and shall contain: 1. The name and location of the environmental laboratory. 2. The name of the person owning the facility and the name of the individual directing the laboratory. 3. A description of the services and tests provided by the environmental laboratory. 4. Other information the department deems necessary to carry out its powers and duties under this chapter. C. The department shall issue a regular license to an applicant to operate an environmental laboratory to provide the services and tests described in the application if the department determines that the applicant is in compliance with the provisions of this chapter and rules adopted pursuant to this chapter. D. If the owner is not the laboratory director, the director shall issue a license jointly to the owner and the laboratory director who are jointly responsible for the maintenance and operation of the laboratory and for violations of this chapter or rules adopted pursuant to this chapter. E. A license issued by the department is valid only in the name of the persons to whom it is issued and cannot be sold, assigned or transferred. A license is valid only for the facility or facilities for which it is issued. If there is a change in the laboratory name, directorship or ownership or an appointment of an acting laboratory director, the license automatically expires, unless within twenty business days after the change the department is notified in writing of the change and an application for a new license is submitted to the department. A fee shall not be charged for this application. The director shall issue a new license reflecting the change if the laboratory is still in compliance with the provisions of this chapter and rules adopted pursuant to this chapter. F. A regular license expires one year after the date of issuance and shall be renewed on submission of a renewal application and payment of the renewal application fee prescribed in section 36-495.06, at least thirty days before expiration of the license, unless the director determines pursuant to section 36-495.09 that grounds exist to deny the application. 36-495.04. Laboratory director; duties The director of an environmental laboratory shall: 1. Ensure that all services and tests provided by the laboratory are performed in compliance with this chapter or rules adopted pursuant to this chapter. 2. Direct and supervise services and tests provided by the laboratory and be responsible for the work of all personnel in the laboratory. 3. Be responsible for safety and hazardous substance control in the laboratory. 36-495.05. Provisional licenses A. The department may issue a provisional license for a period of not more than twelve months at the time it issues a notice of suspension of a regular license. The department may suspend a regular license if an inspection or investigation of a laboratory reveals a violation of the rules adopted by the director pursuant to this chapter and the director believes that the immediate interests of the public are best served by affording the laboratory the opportunity to correct the deficiencies. The director shall issue a provisional license only if the licensee agrees to carry out a plan acceptable to the department to eliminate the deficiencies within the term of the provisional license or period of time specified by the department. B. A licensee's agreement to carry out a plan of correction does not constitute a waiver of its right to have a hearing on the notice of suspension. A hearing on the notice of suspension may include review of the appropriateness of the laboratory's plan of correction. C. An application for a regular license may be submitted thirty days before the expiration of a provisional license issued pursuant to this section. The department shall condition its issuance of a regular license at the expiration of the term of the provisional license on the licensee being in full compliance with the correction plan and this chapter or rules adopted pursuant to this chapter. 36-495.06. Fees A. The department shall charge and collect a nonrefundable fee for a regular or a renewal license. B. The director shall establish by rule a fee schedule that does not exceed the cost to the department to conduct an on-site inspection, approve third party accreditation, verify information submitted with the application and other activities related to licensure of environmental laboratories pursuant to this chapter or rules adopted pursuant to this chapter. The fee schedule for application for a regular or renewal license shall be based on the types of compliance testing that the laboratory is licensed to provide. 36-495.07. Inspection; investigations A. The department may make an initial inspection, and thereafter an annual inspection, of each laboratory to determine compliance with this chapter or rules adopted pursuant to this chapter. B. An application for licensure pursuant to this chapter constitutes permission for the department's entry or inspection of the laboratory during the pendency of the application and, if licensed, during the term of the license for the purpose of determining compliance with this chapter or rules adopted pursuant to this chapter. C. The department may require, as part of its inspections, that the laboratory demonstrate proficiency in performing tests that it offers by examining specimens submitted by the department, the United States environmental protection agency or other proficiency testing services approved by the department. D. In addition to the inspections provided for in subsection A of this section, the department, on its own initiative or on the receipt of a written complaint from a person setting forth facts which, if proven, constitute a violation of this chapter or rules adopted pursuant to this chapter, may make an investigation of the laboratory's operations, techniques and procedures. If the investigation or an inspection conducted pursuant to this section discloses past or current noncompliance with statutes and rules, the director, in accordance with section 36-495.09, may deny, suspend or revoke a license issued by the department pursuant to this chapter. E. At any time the department may conduct an investigation of the operation of an unlicensed laboratory performing compliance testing and may conduct on-site inspections of the laboratory, records, procedures and methods to determine whether the laboratory must be licensed pursuant to this chapter. F. The director by rule shall establish standards and procedures for third party accreditation and exempting inspections and inspection fees for a laboratory that is accredited by a third party. 36-495.08. Reports by laboratories A laboratory shall make available to the department on written request information and data concerning its operation, techniques and procedures. The department may require that the information be submitted under oath and signed by the owner or director of the laboratory. The department may require the laboratory director or owner to submit other reports or information that it deems necessary to administer this chapter. 36-495.09. Suspension, revocation or denial of license; hearing A. Pursuant to title 41, chapter 6, article 10, the director may deny, revoke or suspend the license of a laboratory if its owners, officers, agents or employees do any of the following: 1. Violate this chapter or rules adopted pursuant to this chapter. 2. Issue or cause to be issued a report on environmental laboratory work performed in another laboratory without designating the name and address of the laboratory that performed the work. 3. Commit a felony under the laws of any state or of the United States arising out of or in connection with the operation of a laboratory. The record of conviction or a certified copy is conclusive evidence of conviction. 4. Knowingly aid, permit or abet the submission of false or inaccurate information required by this chapter or rules adopted pursuant to this chapter. 5. Violate the requirements for licensure of the laboratory pursuant to this chapter. B. If the director reasonably believes that a violation of subsection A, paragraph 5 of this section has occurred and that the life or safety of the public is immediately affected, on written notice to the owner or director of the laboratory, the director may order the immediate termination of specific testing services, procedures or practices. C. Except as provided in subsection B of this section and section 41-1092.11, subsection B, the director shall not suspend, revoke or deny a license without affording the licensee notice and an opportunity for a hearing as provided in title 41, chapter 6, article 10. D. A person whose application for a license is denied by the director or who has been ordered pursuant to subsection B of this section to immediately terminate specific services, procedures or practices, at any time within thirty days after notice of the denial or order, may request in writing a hearing before the director or a person designated by the director to review the director's action. The hearing shall be held within thirty days after the written request. E. All hearings shall be held in accordance with title 41, chapter 6, article 10. 36-495.10. Operation of unlicensed laboratory; cease and desist order; injunction; letter A. The operation or maintenance of an environmental laboratory that does not hold a current or valid license or that exceeds the range of the services or tests authorized by a license issued pursuant to this chapter is a public nuisance. The director, in addition to other remedies provided in this chapter, may issue a cease and desist order pursuant to section 36-601 or, in the name of the people of this state, through the attorney general, may bring an action for an injunction to restrain the violation or to enjoin the future operation or maintenance of the environmental laboratory until the laboratory complies with the provisions of this chapter. B. Before issuing a cease and desist order or bringing an action for injunction pursuant to this section, the department may issue a certified letter to a licensed or unlicensed facility in which it states the factual basis for the department's belief that the laboratory is operating in violation of this chapter or rules adopted pursuant to this chapter. The department may include within the letter the enforcement options available to the department if the violations continue. 36-495.11. Violation; classification A. A person is guilty of a class 3 misdemeanor if he: 1. Operates, maintains, directs or engages in the business of operating an environmental laboratory without a license issued by the department. 2. Knowingly violates a provision of this chapter or a rule adopted pursuant to this chapter. B. Each day that a violation continues constitutes a separate offense. 36-495.12. Violations; civil penalties A. The department may assess a civil penalty in an amount of not more than three hundred dollars for each violation of this chapter after a hearing is conducted pursuant to title 41, chapter 6, article 10. Each day that a violation continues constitutes a separate violation. B. The attorney general or the county attorney shall bring actions to enforce the collection of penalties assessed pursuant to subsection A in the name of this state in the justice court or the superior court in the county in which the violation occurs. C. Penalties assessed under this section are in addition to other penalties imposed pursuant to this chapter. D. The director shall deposit, pursuant to sections 35-146 and 35-147, penalties collected pursuant to this section in the state general fund. 36-495.13. Powers of the director A. In addition to the rules required by section 36-495.01, the director may adopt other rules and prescribe forms that are necessary for the administration and enforcement of this chapter. B. The director may issue interpretive guidelines on subjects relating to the rules adopted under this chapter. C. The director may enter into intergovernmental agreements with other agencies of this state for the purpose of licensing environmental laboratories performing compliance testing. 36-495.14. Out-of-state laboratories; licensure; reciprocity A. Except as provided in this section, a laboratory located outside of this state that performs compliance testing shall be licensed pursuant to this chapter. The laboratory shall pay all applicable fees and is subject to the same investigatory and disciplinary powers of the department. In addition, the department, by rule, may require that the laboratory post a bond with the department to cover the travel costs of prelicensure and postlicensure inspections and evaluations. B. A laboratory which is located outside of this state and is licensed by this state shall renew the license by submitting an application and fee at least sixty days before the expiration of the license. The department, by rule, may also prescribe that an out-of-state application be accompanied by an additional fee to cover the costs of prerelicensure on-site evaluation and inspection. C. The director shall designate the location of hearings held in relation to disciplinary matters or the issuance of a license. D. The director may enter into a reciprocity agreement with the licensing agency of another state if the director determines that the licensing requirements of that state are substantially equal to those of this state. The agreement shall provide that the licensing agencies of both states shall recognize a current license issued by the other state for the purpose of meeting the licensure requirements of either state. The agreement shall also provide that both states, on the request of either state, shall conduct necessary investigations to determine compliance and shall allow on-site inspections by investigators from either state. E. If a reciprocal state revokes, suspends or refuses to renew the license of a laboratory located in that state, this state shall recognize that action unless the laboratory notifies the department within five business days of the action that it wishes this state to undertake an independent review and investigation and posts a bond as prescribed by the department to conduct the review. If, at the conclusion of that review, this state determines that the laboratory meets the licensure requirements of this state, it shall issue a license to that laboratory on payment of all fees required by this chapter. Notwithstanding the terms of a reciprocity agreement, if either state takes action contrary to the action of the other, neither state has to recognize the license issued by the other. 36-495.15. Environmental laboratory licensure revolving fund; use A. The environmental laboratory licensure revolving fund is established in the department which consists of monies from gifts, grants, donations, fees derived from department sponsored workshops, conferences and seminars and fees collected pursuant to this chapter. B. Subject to legislative appropriation, monies in the fund shall be used to support the administration of this chapter and for the costs incurred in administering this chapter and rules adopted for the implementation of this chapter. C. Monies in the fund are exempt from section 35-190. Interest earned on monies in the fund shall be credited to the fund. 36-495.16. Environmental laboratory advisory committee; membership; duties; compensation A. The environmental laboratory advisory committee is established consisting of members selected by the director. The director shall select members who represent a variety of persons affected by this article. Committee members serve at the pleasure of the director. B. The committee shall advise the director regarding the adoption of rules and other issues affecting environmental testing laboratories and shall make recommendations regarding interpretive guidelines necessary to properly administer the provisions of this article. C. Committee members are not eligible to receive compensation but are eligible for reimbursement of expenses pursuant to title 38, chapter 4, article 2.