DAR File No. 27234

Health, Epidemiology and Laboratory Services, Laboratory Improvement

R444-14

Rule for the Certification of Environmental Laboratories

NOTICE OF PROPOSED RULE

DAR File No.: 27234
Filed: 06/15/2004, 02:01
Received by: NL

RULE ANALYSIS

Purpose of the rule or reason for the change:

This amendment will incorporate the current major technical parts of the National Environmental Laboratory Accreditation Conference (NELAC) standards into the state rule.

Summary of the rule or change:

This amendment incorporates the 2002 standards for laboratory certification and the 2003 proficiency testing standards established by the NELAC. It also incorporates the latest federal regulations dealing with analytical methods for environmental testing.

State statutory or constitutional authorization for this rule:

Subsection 26-1-30(2)(9)

40 CFR 136, 141, 142, 261 (July 1992-2004); and National Environmental Laboratory Conference 2002 certification standard and 2003 proficiency testing standard

Anticipated cost or savings to:

the state budget:

There will be no impact on the state budget. This amendment does not change the state's responsibilities or workload in certifying environmental laboratories.

local governments:

Changes to the incorporated standards are technical in nature to clarify requirements and provide consistency to the standard. The Division does not anticipate any significant resources required or eliminated to make changes to the laboratory's quality system to stay inline with the proposed incorporated standards. Overall the costs and savings should balance out or be minimal.

other persons:

The changes to the incorporated standards are technical in nature to clarify requirements and provide consistency to the standard. The Division does not anticipate any significant resources required or eliminated to make changes to the laboratory's quality system to stay inline with the proposed incorporated standards. Overall the costs and savings should balance out or be minimal.

Compliance costs for affected persons:

Laboratories affected should already be complying with the previous revision of the national standards adopted in this rule. Additional compliance costs will be zero to negligible.

Comments by the department head on the fiscal impact the rule may have on businesses:

For Utah to maintain primacy under U.S. EPA (especially for drinking water) there must exist a laboratory certification program within the state. This rule is the foundation of the certification program. The certification program uses the standards from NELAC that are currently in effect. This rule incorporates the currently effective NELAC standards. Fiscal impact on businesses has been minimized to the extent possible. Scott D. Williams, MD

The full text of this rule may be inspected, during regular business hours, at the Division of Administrative Rules, or at:

Direct questions regarding this rule to:

David Mendenhall at the above address, by phone at 801-584-8470, by FAX at 801-584-8501, or by Internet E-mail at davidmendenhall@utah.gov

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

08/02/2004

This rule may become effective on:

08/03/2004

Authorized by:

Scott D. Williams, Executive Director

RULE TEXT

R444. Health, Epidemiology and Laboratory Services, 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.

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 Chapter 4, "Accreditation Process", of the National Environmental Laboratory Accreditation Conference Standards approved [May 2001]July 2002, 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 [2002]2004, 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 Chapter 2, "Proficiency Testing", of the National Environmental Laboratory Accreditation Conference Standards approved [May 2001]July 2003, which are incorporated by reference.

R444-14-6. Quality System.

(1) A certified laboratory must adhere to the requirements found in Chapter 5, Quality Systems, of the National Environmental Laboratory Accreditation Conference Standards approved [May 2001]July 2002, which are incorporated by reference.

R444-14-7. Recognition of NELAP Accreditation.

The department may certify a laboratory that is NELAP-accredited. A laboratory seeking certification because of its NELAP accreditation must provide evidence of its accreditation and apply for certification on that basis. A laboratory certified on the basis of NELAP 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 penalties of up to $5,000.00 for each offense, criminal sanctions of a class B misdemeanor on the first offense and a class A misdemeanor on the second offense, and criminal penalties of up to $5,000.00 for each offense 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

[June 12, 2003]2004

Notice of Continuation June 13, 2002

26-1-30(2)(m)

ADDITIONAL INFORMATION

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For questions regarding the content or application of this rule, please contact David Mendenhall at the above address, by phone at 801-584-8470, by FAX at 801-584-8501, or by Internet E-mail at davidmendenhall@utah.gov

For questions about the rulemaking process, please contact the Division of Administrative Rules (801-538-3764). Please Note: The Division of Administrative Rules is NOT able to answer questions about the content or application of these administrative rules.