R444.  Health, Disease Control and Prevention, Laboratory Improvement.
R444-14.  Rule for the Certification of Environmental Laboratories.
R444-14-1.  Introduction.
	(1)  This rule is authorized by Utah Code Section 26-1-30(2)(m).
	(2)  This rule applies to laboratories that analyze samples for compliance with Federal Safe Drinking Water Act, Federal Clean Water Act, and the Federal Resource Conservation and Recovery Act.
	(3)  A laboratory that analyzes samples for compliance with rules established by the Utah Department of Environmental Quality that require that the analysis be conducted by a certified laboratory, must become certified under this rule and comply with its provisions.
	(4)  A laboratory that, under subcontract with another laboratory, analyzes samples for compliance with rules established by the Utah Department of Environmental Quality that require that the analysis be conducted by a certified laboratory, must become certified under this rule and comply with its provisions.
	(5)  A laboratory certified under this rule to analyze samples for compliance with rules established by the Utah Department of Environmental Quality that require that the analysis be conducted by a certified laboratory must also obtain approval under this rule for each analyte analyzed by a specific method.

R444-14-2.  Definitions.
	(1)  "Analyte" means the substance or thing for which a sample is analyzed to determine its presence or quantity.
	(2)  "Approved" means the determination by the department that a certified laboratory may analyze for an analyte under this rule.
	(3)  "Clean Water Act" means U.S.  Public Law 92-500, as amended, governing water pollution control programs.
	(4)  "Department" means the Utah Department of Health.
	(5) "Revoke" means to withdraw a certified laboratory's certification or the approval for a certified laboratory to perform one or more specified methods.
	(6)  "Resource Conservation and Recovery Act" means U.S.  Public Law 94-580, as amended, governing solid and hazardous waste programs.
	(7)  "Safe Drinking Water Act" means U.S.  Public Law 93-523 94-580, as amended, governing drinking water programs.
	(8)  "TNI" means The NELAC Institute.

R444-14-3.  Laboratory Certification.
	(1)  A laboratory is the organization and facilities established for testing samples.
	(2)  A laboratory that conducts tests that are required by Department of Environmental Quality rules to be conducted by a certified laboratory must be certified under this rule.
	(3)  To become certified, to renew certification, or to become recertified under this rule, a laboratory must adhere to the requirements found in Volume 1 "Management and Technical Requirements for Laboratories Performing Environmental Analysis" of the TNI Standard adopted September 8, 2009, which are incorporated by reference.

R444-14-4.  Analytical Methods.
	(1)  The department may only approve a certified laboratory to analyze an analyte by specific method.  The department may approve a certified laboratory for an analyte using methods described in the July 1, 1992 through 2010, editions of 40 CFR Parts 141, 142, and 143 (Safe Drinking Water Act); 40 CFR Parts 136 and 503.8 (Clean Water Act); 40 CFR Parts 260 and 261 (Resource Conservation and Recovery Act).
	(2)  In analyzing a sample for compliance with the Safe Drinking Water Act, the Clean Water Act, or the Resource Conservation and Recovery Act, a certified laboratory must follow the method that it reports on its final report to have used.

R444-14-5.  Proficiency Testing.
	For a certified laboratory to become approved and to maintain approval for an analyte by a specific method, the certified laboratory must, at its own expense, meet the proficiency testing requirements of this rule.  A certified laboratory must adhere to the requirements found in Volume 1 Module 1 "Proficiency Testing" of the TNI Standard adopted September 8, 2009, which are incorporated by reference.

R444-14-6.  Quality System.
	(1)  A certified laboratory must adhere to the requirements found in Volume 1 Modules 2, 3, 4, 5, 6, 7 "Quality systems" of the TNI Standard adopted September 8, 2009, which are incorporated by reference.

R444-14-7.  Recognition of TNI Accreditation.
	The department may certify a laboratory that is TNI accredited.  A laboratory seeking certification because of its TNI accreditation must provide evidence of its accreditation and apply for certification on that basis.  A laboratory certified on the basis of TNI accreditation must obtain approval from the department for each analyte and meet the approval requirements of this rule.

R444-14-8.  Penalties.
	A laboratory violates this rule and is subject to the penalties provided in Title 26, Chapter 23, including administrative and civil if it:
	(1)  without being certified under this rule, holds itself out as one capable of testing samples for compliance with Federal Safe Drinking Water Act, Federal Clean Water Act, Federal Resource Conservation and Recovery Act; or
	(2)  without being approved to analyze for the analyte , analyzes samples for the analyte for compliance with rules established by the Utah Department of Environmental Quality that require that the analysis be conducted by a certified laboratory.

KEY:  laboratories
Date of Enactment or Last Substantive Amendment:  October 12, 2011
Notice of Continuation:  July 26, 2016
Authorizing, and Implemented or Interpreted Law:  26-1-30(2)(m)