Health, Disease Control and Prevention, Laboratory Improvement

Rule R444-14

Rule for the Certification of Environmental Laboratories

Notice of Proposed Rule

(Amendment)

DAR File No.: 35110
Filed: 08/04/2011 01:02:59 PM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The purpose of this amendment is to update the citation for the National Environmental Laboratory Accreditation Conference (NELAC) Institute standard currently in force.

Summary of the rule or change:

The NELAC 2003 Standard was revised and reformatted to become The NELAC Institute(TNI) 2009 Standard. The revised standard removes nonessential requirements and clarifies the language of the standard. This amendment will incorporate the revised standard by reference into this rule.

State statutory or constitutional authorization for this rule:

• Subsection 26-1-30(2)(m)

Anticipated cost or savings to:

the state budget:

It is not likely the revised standard will have any impact on state budgets, but any impact would be minimal. The transition to the new standard will require training of the regulating staff but the program is funded by fees.

local governments:

It is not likely the revised standard will have any impact on local budgets, but any impact would be minimal. For those local governments with a regulated laboratory, there will be minor changes in requirements that could reduce compliance costs.

small businesses:

It is not likely the revised standard will have any impact. No significant change to current enforcement practices is predicted. There will be minor changes in requirements that could reduce compliance costs for the regulated laboratory but the savings would be minimal and are not expected to be passed to the client.

persons other than small businesses, businesses, or local governmental entities:

It is not likely the revised standard will have any impact. No significant change to current enforcement practices is predicted. There will be minor changes in requirements that could reduce compliance costs for the regulated laboratory but the savings would be minimal and are not expected to be passed to the client.

Compliance costs for affected persons:

It is not likely the revised standard will have any impact. No significant change to current enforcement practices is predicted. There may be minor changes in requirements that could reduce compliance costs. For example: 1) The regulated laboratory will have an easier mechanism to document each analyst's demonstration of capability. The laboratory will be able to use a form that fits their procedures and will not need to keep the documentation with the analyst's personnel file. Minimal cost saving for each working analyst. 2) The previously required glassware cleaning procedure will be eliminated for chemistry testing. Quality control steps will be used to monitor for contamination. The laboratory will use any procedure to clean glassware that will produce clean glassware free of contamination. 3) Expiration dates for reagents are not required unless provided by the manufacturer. Laboratories may eliminate one procedure (for setting expiration dates) and may use reagents until they reach the set expiration date or the quality of the reagent decreases. 4) Proficiency testing challenges may now be reported to the laboratory's limit of quantitation instead of to a set reporting level. Laboratories will now be able to treat the proficiency testing sample as they would any sample they receive and not perform special calibration and quality checks to be able to report to a lower level than they routinely do.

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

As part of ongoing review of administrative rules in the Department to reduce unnecessary negative business impacts, this rule change adopts a current standard that provides more flexibility to regulated business. Positive fiscal impact on business.

David Patton, PhD, Executive Director

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

Health
Disease Control and Prevention, Laboratory Improvement
CANNON HEALTH BLDG
288 N 1460 W
SALT LAKE CITY, UT 84116-3231

Direct questions regarding this rule to:

• David Mendenhall at the above address, by phone at 801-965-2530, by FAX at 801-965-2544, 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:

10/03/2011

This rule may become effective on:

10/10/2011

Authorized by:

David Patton, Executive Director

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[Chapter 4, "Accreditation Process", of the National Environmental Laboratory Accreditation Conference Standards approved 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 2010[2008], 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[Chapter 2, "Proficiency Testing", of the National Environmental Laboratory Accreditation Conference Standards approved July 2003], 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[Chapter 5, Quality Systems, of the National Environmental Laboratory Accreditation Conference Standards approved June 2003], 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: [March 15, 2010]2011

Notice of Continuation: February 26, 2007

Authorizing, and Implemented or Interpreted Law: 26-1-30(2)(m)