DAR File No. 27850

Health, Epidemiology and Laboratory Services, Laboratory Improvement

R444-14

Rule for the Certification of Environmental Laboratories

NOTICE OF PROPOSED RULE

DAR File No.: 27850
Filed: 05/02/2005, 10:56
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 2003 NELAC 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, 40 CFR 136, 141, 142, 261 (July 1992-2005).

State statutory or constitutional authorization for this rule:

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

40 CFR 136, 141, 142, and 261 (July 1992-2005), and National Environmental Laboratory Accreditation Conference Standards (2003)

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:

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:

Labs 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 the EPA (especially for drinking water), there must exist a laboratory certification program within the state. The certification program uses the standards from NELAC that are currently in effect. This rule incorporates the currently effective NELAC standards. These largely technical changes should not have a significant fiscal impact on regulated businesses. David N. Sundwall, MD, Executive Director

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:

06/14/2005

This rule may become effective on:

07/01/2005

Authorized by:

David N. Sundwall, Executive Director

RULE TEXT

R444. Health, Epidemiology and Laboratory Services, Laboratory Improvement.

R444-14. Rule for the Certification of Environmental Laboratories.

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 [July 2002]June 2003, 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 [2004]2005, 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.

R444-14-6. 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 [July 2002]June 2003, which are incorporated by reference.

KEY: laboratories

[August 9, 2004]2005

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.