No. 31910 (Amendment): R444-14. Rule for the Certification of Environmental Laboratories

DAR File No.: 31910
Filed: 08/28/2008, 05:22
Received by: NL

RULE ANALYSIS

Purpose of the rule or reason for the change:

This amendment will incorporate the current methods described in the Code of Federal Regulations (CFR) and update the references to the national accreditation program to its current name.

Summary of the rule or change:

This amendment incorporates the latest version of the CFR for the each of the three federal programs associated with this rule. These sections outline which methods may be approved for use by a certified laboratory. The national accreditation program has merged with an existing standards development organization and changed its name. This amendment will change those name references as needed.

State statutory or constitutional authorization for this rule:

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

This rule or change incorporates by reference the following material:

40 CFR 136, 141, 142, 261 (July 1992 - 2008)

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 CFRs consist of adding new methods that are accepted by the regulating programs. The change allows the laboratories to pick newer technologies if desired. Changing methods will carry with it a cost to validate the new method and may or may not reduce the cost of testing using a newer technology.

small businesses and persons other than businesses:

Changes to the incorporated CFRs consist of adding new methods that are accepted by the regulating programs. The change allows the laboratories to pick newer technologies if desired. Changing methods will carry with it a cost to validate the new method and may or may not reduce the cost of testing using a newer technology.

Compliance costs for affected persons:

This amendment provides additional method choices to laboratories and adds no additional compliance cost. Using newer methods/technologies may potentially lower the long term cost of testing.

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. This rule incorporates the latest version of the CFRs with some new methods available for use. 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:

Health
Epidemiology and Laboratory Services, 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 801-584-8470, by FAX at 801-584-8501, or by Internet E-mail at [e-mail]

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:

10/15/2008

This rule may become effective on:

10/22/2008

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.

R444-14-2. 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.

 

R444-14-4. 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 2008[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.

 

R444-14-7. Recognition of TNI[NELAP] Accreditation.

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

 

KEY: laboratories

Date of Enactment or Last Substantive Amendment: [July 1, 2005]2008

Notice of Continuation: February 26, 2007

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