WSR 10-07-163

PROPOSED RULES

DEPARTMENT OF ECOLOGY


[ Order 09-09 -- Filed March 24, 2010, 10:46 a.m. ]

Original Notice.

Preproposal statement of inquiry was filed as WSR 09-19-076.

Title of Rule and Other Identifying Information: Chapter 173-50 WAC, Accreditation of environmental laboratories, the amendments will change the fee structure of ecology's environmental laboratory accreditation program and some business practices to reflect a cut in the program budget. There will also be housekeeping amendments and clarification of the grounds for revoking or suspending accreditation.

Hearing Location(s): Lacey Community Center, 6729 Pacific Avenue, Lacey, on April 27, 2010, at 1:00 p.m.; and at the Moses Lake Fire Department, 701 East Third Avenue, Moses Lake, on April 29, 2010, at 10:00 a.m.

Date of Intended Adoption: August 6, 2010.

Submit Written Comments to: Stewart M. Lombard, P.O. Box 488, Manchester, WA 98353-0488, e-mail stew.lombard@ecy.wa.gov, fax (360) 895-6180, by May 7, 2010.

Assistance for Persons with Disabilities: Contact Joan LeTourneau, (360) 407-6764, by April 20, 2010. Persons with hearing loss, call 711 for Washington relay service. Persons with a speech disability, call 877-833-6341.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: Our current fee structure does not cover the cost of the state environmental laboratory accreditation program. In section 301 of ESHB 1244, the 2009 legislature authorized ecology to increase fees in the 2009-2011 biennium as necessary to meet the actual costs of conducting business. We have eliminated one chemist position and need to raise fees by about forty-five percent to fully fund the remaining program. With the loss of one of our six chemists, we will also need to change some business practices specified in the rule. Specifically, ecology will reduce the frequency of on-site inspections at nondrinking water laboratories, but increase proficiency testing requirements for some of these labs. Without these changes, we cannot cover the cost of the program and will not meet the requirements of the current rule. This proposal will result in an increase in the annual fees we charge environmental laboratories for the accreditation necessary for them to report results to the department of ecology, department of health (DOH), and other entities which require the use of accredited laboratories. The proposal also relaxes the requirement for on-site inspections of nondrinking water laboratories, but increases proficiency testing requirements for some of these labs to help them remain in compliance with the rule.

Reasons Supporting Proposal: 1. Legislative authorization to increase fees to meet the costs of conducting business.

2. Budget reduction in existing program mandates changes to current business practices, including reduced on-site inspection frequencies and increased proficiency testing requirements.

3. Need to clarify rule enforcement provisions and also the grounds for revoking or suspending accreditation.

4. Need to eliminate reciprocity agreements with other states, and also eliminate exemption provisions for certain wastewater discharge laboratories.

5. Housekeeping amendments are needed to bring the rule up-to-date and clarify the definition of some rule language.

Statutory Authority for Adoption: RCW 43.21A.230 allows ecology to accredit environmental laboratories and to assess fees to cover the department's costs. DOH has delegated to ecology in a memorandum of understanding its RCW 43.20.050 authority to certify drinking water laboratories. In section 301 of ESHB 1244, the 2009 legislature gave ecology authority to raise fees for lab accreditation.

Statute Being Implemented: RCW 43.21A.230 allows ecology to accredit environmental laboratories and to assess fees to cover the department's costs. DOH has delegated to ecology in a memorandum of understanding its RCW 43.20.050 authority to certify drinking water laboratories. In Section 301 of ESHB 1244, the 2009 legislature gave ecology authority to raise fees for lab accreditation.

Rule is not necessitated by federal law, federal or state court decision.

Name of Proponent: Washington department of ecology, governmental.

Name of Agency Personnel Responsible for Drafting, Implementation and Enforcement: Stewart M. Lombard, 2350 Colchester Drive, P.O. Box 488, Manchester, WA 98353-0488, (360) 895-6148.

A small business economic impact statement has been prepared under chapter 19.85 RCW.

Small Business Economic Impact Statement

Note: Due to size limitations relating to the filing of documents with the code reviser, the small business economic impact statement (SBEIS) does not contain the appendices that further explain ecology's analysis. Additionally, it does not contain the raw data used in this analysis, or all of ecology's analysis of this data. However, this information is being placed in the rule-making file, and is available upon request.

Executive Summary: Based on research and analysis required by the Regulatory Fairness Act, RCW 19.85.070, ecology has determined that the amendments to chapter 173-50 WAC have a disproportionate impact on small business. Therefore, we must include cost-minimizing features in the rule where it is legal and feasible to do so.

Background:

Use of Accredited Labs: Ecology's Executive Policy 1-22 requires that all environmental data is generated by laboratories capable of providing accurate and legally defensible data, shown by their successful participation in ecology's lab accreditation program. Applicable environmental data include, but are not limited to, results from analysis of water, sediment, sludge, air, soil, plant and animal tissue, and hazardous waste. Applicable analyses include chemical, physical, biological, microbiological, radiological, or other scientific determinations which provide recorded qualitative and/or quantitative results.1

In addition, use of accredited labs is required explicitly by rules pertaining to:

Water supplies.

MTCA (Model Toxics Control Act) hazardous substance analyses.

NPDES (national pollutant discharge elimination system) and other water and stormwater discharge permit programs.

Building codes.

Solid waste landfills.

Solid waste handling standards.

Solid fuel burning devices.

Background of Proposed Rule Amendments: The existing lab accreditation rule (chapter 173-50 WAC) and the included fee structure supporting the environmental lab accreditation program (ELAP) was last updated in 2002. Ecology has been collecting accreditation fees based on that structure since that time, generating revenues that increasingly fail to reflect or cover the costs of administering the lab accreditation program. Over the last three biennia (2004 through 2009), the deficit has grown at an average rate of twenty percent per biennium. The percentage of costs in excess of revenue has grown at an average of 9.5 percentage points each biennium.2

In 2009, as part of fiscal appropriations for the coming biennium, the legislature authorized fee increases to meet costs: The department is authorized to increase the following fees in the 2009-2011 biennium as necessary to meet the actual costs of conducting business and the appropriation levels in this section: Environmental lab accreditation, dam safety and inspection, biosolids permitting, air emissions new source review, and manufacturer registration and renewal.3

Ecology also reduced program costs to meet the appropriation levels set by the legislature's budget. This led to the elimination of one of seven employees in the ELAP program. With one less person to do the work, ecology is not able to audit and accredit as many labs as in the past.

With these lower projected costs, and other proposed amendments to the proficiency testing and auditing sections of the rule, ecology then developed the proposed fee structure.

Existing Lab Accreditation Process4: Under the existing rule, to become accredited, a lab must:

Submit a complete application and pay the appropriate fee.

Submit an acceptable quality assurance manual.

Successfully analyze required proficiency testing samples.

Pass an on-site assessment by ecology or another recognized assessor entity.

To retain accreditation, a participating lab must: Submit results of performance testing sample analyses.

Make required improvements in its quality assurance program.

Report significant changes in facility, equipment, personnel, or quality assurance/control procedures.

Submit a renewal application and pay annual fees.

Submit to required on-site assessments and implement the required recommendations.

Application for Accreditation: Ecology's lab accreditation application process requires labs to provide information on the resources the lab may be use [using] to conduct the tests for which accreditation is requested. This includes: General information about the lab.

Participation in proficiency testing studies.

Discussion of the matrices and testing methods for which a lab is requesting accreditation.

This may also include national environmental laboratory accreditation program (NELAP) accreditation, or accreditation in another state with which ecology has a reciprocity agreement, to support third-party accreditation.

Quality Assurance Manual: The quality assurance (QA) manual identifies policies and procedures designed to achieve reliable results at a lab, and to support external confidence in those results. This includes:

The organizational structure of the lab and the personnel responsible for quality assurance.

A policy with respect to objectives for data quality, including qualitative and quantitative goals, and how they are established.

Policies regarding sampling procedures, as well as the receipt, logging, storage, handling, and acceptance or rejection of samples.

Analytical methods used for testing.

Calibration and quality control (QC) procedures.

Procedures for monitoring performance.

Procedures for data recording, reduction, validation, entry, and reporting.

Timing and responsibility for system assessments and proficiency testing.

Requirements for QA/QC reporting to management, and the frequency of those reports.

Proficiency Testing: Labs that apply for lab accreditation by ecology must submit one set of proficiency testing (PT) results, specific to the parameters for which the lab is seeking accreditation. Ecology has approved a set of providers of PT samples that labs may use for this purpose.5

Labs seeking to continue accreditation must submit two sets of chemistry PT study results each year (semiannually), and one set of microbiology PT study results for drinking water accreditation.

On-Site Assessments: The on-site assessment involves a visit to the lab by ecology's lab accreditation unit. This is not required for some labs with third-party accreditation. Assessors examine documentation and other evidence demonstrating that the lab can produce accurate and defensible data. Assessors verify information provided in the lab's submitted application and quality assurance manual.

The existing lab accreditation rule requires that on-site assessments may be no longer than three years apart, unless a cause for delay is documented. For documented causes, on-site assessments may be four years apart, except for labs accredited to analyze drinking water, and NELAP-accredited labs.6

Existing Lab Accreditation Fees: The existing lab accreditation fee structure is summarized in WAC 173-50-190. It is broken down by both the matrix and test type. Fees owed, per parameter for which a lab applies to be accredited, range between $60 and $345. Similar tests for different matrices carry different fees in some cases - for example, the general chemistry and trace metals tests are $5 more expensive for nonpotable water than for potable. Table 1 outlines the existing fee structure, including maximum fees per accreditation category.


Table 1: Existing Lab Accreditation Fee Schedule (WAC 173-51-190)
Matrix Category Fee/

Parameter

Maximum Fee
Nonpotable Water Chemistry I (General) $65 $1,150
Chemistry II (Trace Minerals) $65 $975
Organics I (GC/HPLC) $115 $975
Organics II (GC/MS) $345 $1,035
Radioactivity $145 $1,380
Microbiology $175 $520
Bioassay/

Toxicity

$230 $1,435
Immunoassay $65 $390
Physical $65 $260
Drinking Water Chemistry I $60 $305
Chemistry II $60 $720
Organics I $155 $615
Organics II $155 $155
Microbiology $155 $460
Solid and Chemical Materials Chemistry I $65 $1,150
Chemistry II $65 $975
Organics I $115 $975
Organics II $345 $1,035
Radioactivity $145 $1,380
Microbiology $175 $520
Immunoassay $65 $390
Physical $65 $260
Air and Emissions Chemistry I $65 $1,150
Chemistry II $65 $97

[$975]

Organics I $115 $975
Organics II $345 $1,035

Regulatory Baseline: The baseline for all analyses of the proposed rule amendments is the regulatory environment in the absence of any changes. Under the current regulatory framework, the process and fees for the accreditation of environmental laboratories would remain as described above. Without the adoption of the proposed rule amendments, the existing process would remain in place. In addition, ELAP would likely suffer cuts and reduced regulatory functionality under a low-revenue scenario.

Changes Under the Proposed Rule Amendments: The proposed amendments to chapter 173-50 WAC make significant changes to elements of the rule concerning fees and timing in the lab accreditation process.7 Ecology's accreditation of environmental labs, and fee increases for accreditation, are authorized by:

RCW 43.21A.230 Certification of environmental laboratories.

Ecology's memorandum of understanding (MOU) with the Washington state department of health.

ESHB 1244, Section 301.

Proposed changes to business practices reflect program reductions in the lab accreditation program, in response to cuts in the state budget.

Specific changes under the proposed amendments include changes to: The general fee structure and maximum fees per category.

Proficiency testing requirements.

Fees for acknowledgement of third-party accreditation.

Organization names and references, updated to reflect current terminology.

Limits on extensions to the time between on-site audits.

Causes of revocation or suspension of accreditation.

Streamlining rule language.

Each of these is described in detail, below.

Changes to the Fee Schedule: The proposed rule amendments change the fee schedule to:

Create uniformity across fees for the same accreditation category.

Streamline the fee structure to facilitate public understanding.

Reflect current costs of funding the lab accreditation program.

This includes reorganization of some accreditation categories into new groups. The proposed fees and maxima are listed in Table 2, below. The proposed rule amendments also include a minimum fee for any accreditation (direct or indirect through third-party accreditation) of $300.


Table 2: Proposed Lab Accreditation Fee Schedule
Category Fee/

Parameter

Fee/

Method

Maximum Fee/

Category

General Chemistry $80 $1,600
Trace Metals $400
Organics I $200
Organics II $500
Microbiology $200
Radiochemistry $250
Bioassay $300 $3,000
Immunoassay $80
Physical $80

Changes to PT: The proposed rule changes the requirement for PT. Ecology proposed this change to create uniformity in PT requirements for microbiology testing. Under the baseline (existing) rule, two PT studies are required annually for chemistry parameters, and one PT study is required annually for microbiology parameters in drinking water. The proposed rule adds one microbiology PT study annually for nondrinking water matrices.

Changes to Third-Party Accreditation Fees: Ecology's proposed rule revises the fees related to accrediting a lab that has other accreditation accepted by ecology. This includes NELAP accreditation, as well as other third party accreditation. Ecology revised these fees to create uniformity across accreditation procedures, and updated them to represent the current costs of the ELAP, including recent cost and employment reductions.

Changes to Third-party Accreditation Fees Include: In-state labs seeking recognition of third-party accreditation no longer pay $345, and instead pay seventy-five percent of the appropriate fee set by the rule for each parameter covered by third-party accreditation.

Out-of-state labs with third-party accreditation no longer pay fees from the baseline (existing) fee schedule, but pay seventy-five percent of fees based on the new fee schedule in the proposed rule.

Drinking water labs no longer pay an additional fee of $115.

Changes to Terminology: Since the last amendments to the lab accreditation rule, the names of some reference materials have changed. For example, EPA has updated its environmental protection agency manual for the certification of laboratories analyzing drinking water from the 4th edition to the 5th edition. These changes make no material change to regulatory requirements for lab accreditation.

Changes to Time between On-Site Audits and Length of Suspension: The proposed rule eliminates the three-year requirement for on-site audits for nondrinking water accredited facilities. This does not mean, however, that no supervision would occur, but rather that paper audits would still be performed under the proposed rule, and on-site investigation would occur as necessary. The proposed rule retains the three-year maximum time between on-site audits at labs accredited for analyzing drinking water.

The proposed rule also eliminates the six-month limit on the length of time a lab's accreditation may be suspended.

Changes to Causes of Revocation or Suspension: The proposed rule adds nonpayment of fees and the failure to maintain third-party accreditation as causes for suspension or revocation of an accreditation. It states that an application for accreditation will not move forward unless the applicant has paid the appropriate fees to ecology.

Streamlining Language: The proposed rule streamlines, reorganizes, and clarifies some language, to facilitate understanding and compliance of the rule. This includes updating and reorganization of definitions, without impact to their meaning in the regulation.

Compliance Costs for Washington Businesses: Ecology calculated, in the cost-benefit analysis (Ecology Publication No. 10-03-025) for the proposed rule amendments, that the proposed rule would result in both quantifiable costs and benefits to Washington businesses. These impacts on Washington businesses are as follows.

The benefits of the proposed amendments over twenty years include: $167 thousand in reduced accreditation fees for some labs.

$1.2 - 4.9 million in reduced on-site audit costs.

Higher assurance of quality results from some labs, stemming from increased frequency of proficiency testing.

Streamlined, clear, and uniform language facilitating compliance and equal treatment of tasks across labs.

Full independent funding of the ELAP through fees, rather than from the state general fund.

The costs of the proposed amendments over twenty years include: $3.5 million in increased accreditation fees for some labs.

$201 thousand in increased proficiency testing costs.

Lower assurance of quality results from some labs, stemming from decreased frequency of on-site inspections.

In this analysis, ecology examined the degree of disproportionality in the increased costs of compliance, across small versus large businesses.

Quantification of Costs and Ratios: Using employment numbers by location where available,8 and otherwise by firm, ecology divided each private entity's compliance costs by the number of employees to calculate cost per employee. New compliance costs resulting from the proposed rule language included net change in accreditation fees, and increased proficiency testing costs.

For the costs of compliance with accreditation fees as set by the proposed rule, as compared to the baseline, the average cost per employee, at the largest ten percent of firms, was $0.89. At small businesses, this average cost was $93 per employee. For the costs of compliance with increased proficiency testing requirements at some labs, the average cost per employee, at the largest ten percent of firms, was $0.24. At small businesses, this average cost was $51 per employee.9

These costs are mitigated by avoided costs associated with reduced on-site audits. Ecology could not confidently assign this benefit to particular businesses due to uncertainty, but expects the avoided costs to correlate with lab size at a declining rate. That is, larger labs would likely have higher costs of compliance with on-site audits, but they would also have economies of scale in those costs. Ecology expects this reduced compliance cost to disproportionately benefit small businesses, on a per-employee basis.

Clearly, the proposed rule has disproportionate cost impact on small businesses, and so ecology must include cost-reducing features in the proposed rule.

Action Taken to Reduce Small Business Impacts: Ecology's capacity to reduce the proposed rule's impact on small businesses was constrained by the scope of the rule making. However, ecology does take actions under the rule that facilitate small business compliance. The lab accreditation unit assists labs participating in ecology's laboratory accreditation program to the extent resources allow. Although they may be conducted in association with on-site assessments, assistance visits are not assessments, and a corrective action report is not required from the lab in response to deficiencies noted during the visit.10 This provides for a lower cost way for labs to ensure their compliance with applicable requirements.

The proposed fee structure charges all labs, regardless of size, fees in proportion to the work ecology must do to grant or maintain their accreditation. This makes the proposed fee more equitable than the existing fee, which subsidizes larger labs with many types of accreditation through additional fees collected from smaller labs with more limited accreditation. If we had retained the existing fee structure and increased fees across-the-board by forty-five percent to recover program costs, this would have had a more disproportionate effect on small business. Also, the proposed fee structure eliminates maximum fees for several categories of testing, and increases the maximum fees in two remaining categories. Both of these changes benefit small business by decreasing subsidization of larger labs.

Small Business Involvement: In the rule development process for the proposed rule amendments, ecology communicated with small businesses, and included input from the small business community in its decision-making process. During November 17-19, 2009, ecology held workshops in Olympia, Everett, and Moses Lake. During these workshops, ecology presented material covering its intent in the rule making, possible options, and the interstate context of the Washington lab accreditation program relative to other states. Ecology collected and responded to comments received during these workshops.

North American Industry Classification System (NAICS) Codes of Impacted Industries: Based on existing environmental labs subject to Ecology accreditation, ecology determined which NAICS codes reflect businesses likely impacted by the proposed rule amendments. The likely impacted NAICS codes are listed in Table 3. This list includes all likely affected private-sector industries.


Table 3: Impacted Industries
1125 2371 3114 3221 3328 4239 4452 5413 5629 7211
1133 2372 3115 3222 3345 4241 4471 5416 6111 7212
1153 2373 3116 3241 3364 4244 4539 5417 6113 8139
2211 2389 3210 3259 3391 4246 4883 5419 6215 8731
2213 3110 3219 3313 4233 4441 5311 5614 6231

Impact on Jobs: By creating additional compliance costs to some businesses, the proposed rule amendments create transfers of money within and across industries. These financial impacts can then filter through the economy (additional or reduced resources to employ individuals, purchase inputs, etc.). Ecology does not believe the compliance costs generated by the proposed rule will result in impacts to lab revenues or competition in the market.

Ecology used the 2002 Washington state office of financial management input-output model to estimate the impacts of financial transfers created by the proposed rule amendments. Table 4 summarizes the distribution of job impacts across industries. The table includes only those industries in which more than 0.1 increase or decrease in jobs occurs per year. Ecology estimated that the proposed rule is likely to generate a small loss of 3.6 jobs in the state economy.11 This job loss comes from the combined impacts of quantifiable fee and proficiency testing costs created by the proposed rule, as well as the reduced compliance costs of on-site inspections.12


Table 4: Significant Annual Job impacts Across the Washington Economy
Industry Change in Jobs*
Retail -0.32414
Legal/Accounting and Bookkeeping/Management Services -0.10611
Architectural, Engineering, and Computing Services -0.20592
Educational Services -1.40417
Ambulatory Health Care Services -0.10186
Nursing and Residential Care Facilities, Social Assistance -0.12333
Arts, Recreation, and Accommodation -0.11665
Food Services and Drinking Places -0.2087
Administrative/Employment Support Services -0.18141
Waste Management/Other, and Agriculture Services -0.18863
TOTAL CHANGES IN JOBS PER YEAR -3.61450

*Industry impacts may not sum to the total due to smaller impacts in industries not listed, and to rounding.


1Paraphrasing taken from ecology's web site http://www.ecy.wa.gov/programs/eap/labs/accred-require.htm, which also lists and links to ecology's requirements for use of accredited labs.

2The deficit grew from $490 thousand in the 2004-2005 biennium, to $588 thousand in 2006-2007, to $704 thousand in 2008-2009. The percentage of costs over revenue grew from forty-seven percent, to fifty-five percent, to sixty-six percent in the respective biennia. Internal analysis. See communication with Stew Lombard and Gary Koshi dated October 20-21, 2009.

3ESHB 1244. Passed by the 61st legislature during the 2009 regular session, section 301(10), http://apps.leg.wa.gov/documents/billdocs/2009-10/Pdf/Bills/House%20passed%20Legislature/1244-S.PL.pdf.

4These procedures are discussed in-depth in ecology's lab accreditation guidance document: Procedural manual for the environmental laboratory accreditation program, November 2002. Ecology publication no. 02-03-055.

5This list is available from the lab accreditation unit at ecology, and is also published in Appendix E of the procedural manual for the environmental laboratory accreditation program, November 2002. Ecology publication no. 02-03-055.

6WAC 173-50-130.

7All proposed changes to rule language, and their significance in this analysis and the associated SBEIS are described fully in Appendix A.

8Washington state department of employment security, www.workforceexplorer.com.

9Note that the reliability and precision of available employment data for impacted businesses is highly variable. Ecology used the best available data in its analyses, stemming from business sources, business databases, and public sources such as the Washington employment security department (see references for more information). For small businesses (especially those not publicly traded), employment data is more likely to be limited to a location, and may underestimate the true number of employees at a given firm. Large businesses are more likely to be publicly traded, exist in business information databases in their entirety, and offer information on employment to shareholders and in reports. This means that the employment data for large businesses is likely a better estimate of actual employment than for small businesses. Ecology chose to use this data because it was the best available, and provides a conservative view of the disproportionality of small versus large-business impacts. It is likely that the cost per employee reported for small businesses is an overestimate. All employment data was reported at the parent-company level to the extent available.

10WAC 173-50-220.

11This annual loss does not indicate that nearly 4 positions would disappear each year, but rather that the equivalent of 3.6 positions would not exist over the full course of the 20 years.

12Ecology could not assign reductions in the cost of on-site audits to specific labs or entities, and so assumed all avoided costs would go to the Testing Laboratories industry (NAICS code 541380). In addition, job losses fall as on-site audits become less frequent. The estimate provided here reflects an average delay of one year in on-site audits.

A copy of the statement may be obtained by contacting Stewart M. Lombard, P.O. Box 488, Manchester, WA 98353-0488, phone (360) 895-6148, fax (360) 895-6180, e-mail stew.lombard@ecy.wa.gov.

A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Stewart M. Lombard, P.O. Box 488, Manchester, WA 98353-0488, phone (360) 895-6148, fax (360) 895-6180, e-mail stew.lombard@ecy.wa.gov.

March 24, 2010

Polly Zehm

Deputy Director

OTS-3057.3


AMENDATORY SECTION(Amending Order 01-12, filed 10/1/02, effective 11/1/02)

WAC 173-50-020   Scope.   (1) The Washington state environmental laboratory accreditation program (WA ELAP) applies to laboratories which conduct tests for or prepare analytical data for submittal to any entity requiring the use of an accredited laboratory. This includes laboratories that analyze drinking water. ((This rule also describes how the department of ecology participates in the National Environmental Laboratory Accreditation Program (NELAP) as an accrediting authority once the department is certified by the National Environmental Laboratory Accreditation Conference (NELAC).))

(2) Accreditation in itself does not authorize use of a specific method for any specific program or project. If such authorization is not granted in documentation governing a program or project within which samples are being analyzed, authorization should be obtained from the laboratory's data user.

(3) Accreditation does not guarantee validity of analytical data submitted by the accredited laboratory but rather assures that the laboratory has demonstrated its capability to reliably generate and report the analytical data (WAC 173-50-040, definition of "accreditation").

[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), 173-50-020, filed 10/1/02, effective 11/1/02; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), 173-50-020, filed 4/20/89 and 3/13/90, effective 4/13/90.]


AMENDATORY SECTION(Amending Order 01-12, filed 10/1/02, effective 11/1/02)

WAC 173-50-030   Objectives.   Objectives of the ((accreditation program)) WA ELAP are to:

Assure accredited laboratories have a demonstrated capability to accurately and defensibly analyze environmental samples;

Assist environmental laboratories in improving their quality assurance/quality control procedures; and

Foster cooperation between the state departments of ecology and health, local agencies, other users of environmental data, and operators of environmental laboratories.

[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), 173-50-030, filed 10/1/02, effective 11/1/02; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), 173-50-030, filed 4/20/89 and 3/13/90, effective 4/13/90.]


AMENDATORY SECTION(Amending Order 01-12, filed 10/1/02, effective 11/1/02)

WAC 173-50-040   Definitions.   Definitions in this section apply throughout this chapter, unless context clearly indicates otherwise.

"Accreditation" - the formal recognition by the department that an environmental laboratory is capable of producing accurate and defensible analytical data. This recognition is signified by issuance of a written certificate accompanied by a scope of accreditation indicating the parameters for which the laboratory is accredited.

The term "accredit" as used in this chapter is intended to have the same meaning as the term "certify" as used in RCW 43.21A.230.

Any laboratory accredited under this chapter shall be deemed to have been certified under RCW 43.21A.230.

The department does not, by accrediting any laboratory pursuant to these rules, vouch for or warrant the accuracy of any particular work done or report issued by that laboratory.

"Accuracy" - the degree to which an analytical result corresponds to the true or accepted value for the sample being tested. Accuracy is affected by bias and precision.

"Analyte" - the constituent or property of a sample measured using an analytical method.

"Analytical data" - the recorded qualitative and/or quantitative results of a chemical, physical, biological, microbiological, radiochemical, or other scientific determination.

"Analytical method" - a written procedure for acquiring analytical data.

"Department" - the state of Washington department of ecology when the term is not followed by another state designation.

"Drinking water certification manual" - the Environmental Protection Agency Manual for the Certification of Laboratories Analyzing Drinking Water, ((4th)) 5th Edition, ((March 1997)) January 2005.

"Ecology accrediting authority" - the supervisor of the lab accreditation unit of the environmental assessment program of the department of ecology.

"Environmental laboratory" or "laboratory" - a facility:

Under the ownership and technical management of a single entity in a single geographical ((locale)) location;

Where scientific ((examinations)) determinations are performed on samples taken from the environment, including drinking water samples; and

Where data is submitted to the department of ecology, department of health, or other entity requiring the use of an accredited laboratory under provisions of a regulation, permit, or contractual agreement.

"Lab accreditation unit" - the lab accreditation unit of the ((environmental assessment program of the)) department of ecology.

(("Mandatory analytical method" - a recognized written procedure for acquiring analytical data which is required by law or a regulatory agency of the federal, state, or local government.))

"Matrix" ((means)) - the ((substance from which a)) material to be analyzed ((is extracted)), including, but not limited to, ground or surface water, wastewater, drinking water, air, solid waste, soil, tissue, nuclear waste, and hazardous waste. For the purposes of establishing a fee structure (WAC 173-50-190(4)), matrices are grouped as follows:

Nonpotable water;

Drinking water;

Solid and chemical materials; and

Air and emissions.

((NELAP accreditations may include other matrices as designated in the NELAC standards.

"NELAC" - the National Environmental Laboratory Accreditation Conference, a voluntary association of state and federal agencies.

"NELAC standards" - the standards for laboratory accreditation published by NELAC, September 5, 2001.

"NELAP" - the National Environmental Laboratory Accreditation Program governed by NELAC.)) "On-site audit" - an on-site inspection and evaluation of laboratory facilities, equipment, records and staff.

"Out-of-state laboratory" - a laboratory that is not located in the state of Washington.

"Parameter" - ((a single determination or sampling procedure, or group of related determinations or sampling procedures using a specific written method)) the combination of one or more analytes determined by a specific analytical method. Examples of parameters include:

The analyte alkalinity by method SM 2320 B;

The analyte zinc by method EPA 200.7;

The set of analytes called volatile organic compounds (VOCs) by method EPA 8260; and

The analyte Total Coli/Ecoli-count by method SM 9222 B/9221 F.

"Procedural manual" - until October 1, 2010, the Department of Ecology Procedural Manual for the Environmental Laboratory Accreditation Program dated November 2002, and beginning October 1, 2010, the Department of Ecology Procedural Manual for the Environmental Laboratory Accreditation Program dated September 2010.

"Proficiency testing (PT)" - evaluation of the results from the analysis of samples, the true values of which are known to the supplier of the samples but unknown to the laboratory conducting the analyses. PT samples are provided by a source external to the environmental laboratory.

(("Quality control" - activities designed to assure analytical data produced by an environmental laboratory meet data quality objectives for accuracy and defensibility. Those activities may include routine application of statistically based procedures to evaluate and control the accuracy of analytical results.))

"Quality assurance (QA)" - activities intended to assure that a quality control program is effective. A QA program is a totally integrated program for assuring reliability of measurement data.

"Quality assurance (QA) manual" - a written record intended to assure the reliability of measurement data. A QA manual documents policies, organization, objectives, and specific QC and QA activities. Volume and scope of QA manuals vary with complexity of the laboratory mission.

(("Recognized analytical method" - a documented analytical procedure developed through collaborative studies by organizations or groups recognized by the users of the laboratory's analytical data.)) "Quality control (QC)" - the routine application of statistically based procedures to evaluate and control the accuracy of analytical results.

"Regulatory program" - a program administered by a federal, state, or other regulatory agency.

(("On-site assessment" - an on-site inspection of laboratory capabilities.

"Primary NELAP accreditation" - granting of NELAP accreditation by the ecology accrediting authority after having determined through direct evaluation that the laboratory is in conformance with the NELAC standards.))

"((Secondary NELAP)) Third-party accreditation" - recognition by the ecology accrediting authority of ((a NELAP)) accreditation ((that was)) granted by another ((NELAP)) accrediting authority.

"WA ELAP" - Washington state environmental laboratory accreditation program.

[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), 173-50-040, filed 10/1/02, effective 11/1/02; 93-20-011 (Order 92-53), 173-50-040, filed 9/22/93, effective 10/23/93; 90-21-090 (Order 90-21), 173-50-040, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), 173-50-040, filed 4/20/89 and 3/13/90, effective 4/13/90.]


AMENDATORY SECTION(Amending Order 01-12, filed 10/1/02, effective 11/1/02)

WAC 173-50-050   Responsibilities of the department.   (1) The department maintains a procedural manual describing specifics of the accreditation process. As a minimum, the procedural manual describes the procedures for:

Submitting an application and fee;

Preparing a quality assurance manual;

Performing proficiency testing;

Conducting on-site ((assessments)) audits;

Accrediting out-of-state laboratories;

((Issuing)) Granting, denying, suspending, and revoking accreditation; and

Notifying laboratories and authorized government officials of accreditation actions.

The department will make the procedural manual available to all interested persons.

(2) Department personnel assigned to assess the capability of drinking water laboratories participating in the ((environmental laboratory accreditation program)) WA ELAP must meet the experience, education, and training requirements established in the ((Environmental Protection Agency)) drinking water certification manual.

(((3) When granting NELAP accreditations, the ecology accrediting authority is responsible for those actions designated in applicable chapters of the NELAC standards. If a NELAC standard is more stringent than the corresponding standard in this chapter, the NELAC standard applies for laboratories seeking NELAP accreditation.))

[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), 173-50-050, filed 10/1/02, effective 11/1/02; 93-20-011 (Order 92-53), 173-50-050, filed 9/22/93, effective 10/23/93; 90-21-090 (Order 90-21), 173-50-050, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), 173-50-050, filed 4/20/89 and 3/13/90, effective 4/13/90.]


AMENDATORY SECTION(Amending Order 01-12, filed 10/1/02, effective 11/1/02)

WAC 173-50-060   Responsibilities of environmental laboratories.   When applying for initial accreditation (see WAC 173-50-130 for maintaining an existing accreditation), managers of environmental laboratories must:

Submit an application (WAC 173-50-063) and required fees (WAC 173-50-190) to the department fiscal officer;

Submit a copy of the laboratory's quality assurance manual (WAC 173-50-067);

Submit an initial set of acceptable PT ((sample analysis)) results (WAC 173-50-070); and

Undergo an on-site ((assessment)) audit (WAC 173-50-080).

[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), 173-50-060, filed 10/1/02, effective 11/1/02; 90-21-090 (Order 90-21), 173-50-060, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), 173-50-060, filed 4/20/89 and 3/13/90, effective 4/13/90.]


AMENDATORY SECTION(Amending Order 01-12, filed 10/1/02, effective 11/1/02)

WAC 173-50-063   Application.   (1) Through the application, laboratory managers:

Request accreditation for specific parameters;

Calculate fees due to the department; and

Provide evidence that sufficient personnel and equipment are available to successfully perform analytical methods as specified in the application.

(2) Through review of the application submitted by the applicant laboratory, the lab accreditation unit determines if:

Requested parameters are eligible for accreditation;

The fee calculated by the applicant laboratory is correct; and

Personnel and equipment are adequate to support successful performance of requested parameters.

(3) Following the review, the lab accreditation unit advises the applicant laboratory of any required changes.

[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), 173-50-063, filed 10/1/02, effective 11/1/02.]


AMENDATORY SECTION(Amending Order 01-12, filed 10/1/02, effective 11/1/02)

WAC 173-50-067   Quality assurance manual.   (1) The lab accreditation unit reviews and approves the laboratory's QA manual prior to the initial on-site ((assessment)) audit. The QA manual submitted concurrently with the application must be in detail and scope commensurate with the size and mission of the laboratory. Guidelines for contents of the QA manual are in the procedural manual.

(2) The QA manual must address QA and QC requirements of applicable regulatory programs. For drinking water laboratories, such requirements are found in the drinking water certification manual.

(((3) For laboratories applying for primary NELAP accreditation, QA requirements, including the conduct of specific QC tests, are those designated in the NELAC standards. If a NELAC standard is more stringent than the corresponding standard in this chapter, the NELAC standard applies for laboratories seeking NELAP accreditation.))

[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), 173-50-067, filed 10/1/02, effective 11/1/02.]


AMENDATORY SECTION(Amending Order 01-12, filed 10/1/02, effective 11/1/02)

WAC 173-50-070   ((Performance audit.)) Proficiency testing (PT).   (1) The lab accreditation unit advises applying laboratories of specific requirements for participation in proficiency ((tests. Such tests are completed)) testing (PT) studies for applicable parameters ((no more frequently than twice annually. Current)). Proficiency tests conducted under the provisions of other recognized programs may be used to satisfy ((the accreditation program proficiency testing)) these requirements. The lab accreditation unit determines the sufficiency of such ((audits)) proficiency tests.

(2) ((Drinking water)) Accredited laboratories must analyze a minimum of one PT sample per applicable microbiology parameter per year and two PT samples for applicable chemistry parameters per year.

(3) The lab accreditation unit may require the laboratory to submit raw data along with the report of analysis of PT samples.

(4) The lab accreditation unit may waive proficiency tests for certain parameters if PT samples are not readily available or for other valid reasons.

(5) Applying laboratories are responsible for obtaining PT samples from vendors ((certified by the National Institute of Standards and Technology (NIST) or otherwise)) approved by the lab accreditation unit. No fee shall be charged to the department for the purchase or analysis of PT samples.

(((6) For laboratories applying for NELAP accreditation, proficiency testing requirements are those designated in the NELAC standards. If the NELAC standard is more stringent than the corresponding standard in this chapter, the NELAC standard applies for laboratories seeking NELAP accreditation.))

[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), 173-50-070, filed 10/1/02, effective 11/1/02; 93-20-011 (Order 92-53), 173-50-070, filed 9/22/93, effective 10/23/93; 90-21-090 (Order 90-21), 173-50-070, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), 173-50-070, filed 4/20/89 and 3/13/90, effective 4/13/90.]


AMENDATORY SECTION(Amending Order 01-12, filed 10/1/02, effective 11/1/02)

WAC 173-50-080   On-site ((assessment)) audit.   The laboratory must undergo ((a system)) an on-site audit by the department to assess critical elements and areas of recommended practices. The laboratory must assist/accommodate department of ecology personnel during on-site ((assessments)) audits as required.

(1) Critical elements for accreditation. Elements of an environmental laboratory's operations which are critical to the consistent generation of accurate and defensible data are critical elements for accreditation. Critical elements are subject ((of)) to intense scrutiny throughout the accreditation process. The ecology accrediting authority may deny, revoke, or suspend accreditation for deficiencies in critical elements. Functional areas including critical elements are:

(a) Analytical methods. The on-site ((assessment)) audit seeks to determine if documentation of ((mandatory or recognized)) analytical methods:

Are present at the laboratory;

Readily available to analysts; and

Being implemented. If the laboratory is using a locally-developed method, the on-site ((assessment)) audit may include an evaluation of the adequacy of that method.

(b) Equipment and supplies. The on-site ((assessment)) audit seeks to determine if sufficient equipment and supplies as required by analytical methods are:

Available;

Being adequately maintained; and

In a condition to allow successful performance of applicable analytical procedures.

To gain and maintain accreditation, laboratories must demonstrate that equipment and supply requirements of applicable regulatory programs are being met.

(c) QA and QC records. The on-site ((assessment)) audit includes a review of QA and QC records for programs/projects within which the laboratory is generating analytical data for submission to the data user.

(d) Sample management. The on-site ((assessment)) audit includes a review of applicable procedures for receipt, preservation, transportation, and storage of samples. The laboratory is responsible only for those elements of sample management over which it has direct control. To gain and maintain accreditation, laboratories must demonstrate that sample management requirements of applicable regulatory programs are being met.

(e) Data management. The on-site ((assessment)) audit includes a review of activities necessary to assure accurate management of laboratory data including:

Raw data;

Calculations; and

Transcription, computer data entry, reports of analytical results.

To gain and maintain accreditation, laboratories must demonstrate that data management requirements of applicable regulatory programs are being met.

(2) Recommended practices. Recommended practices are those elements of laboratory operations which might affect efficiency, safety, and other administrative functions, but do not normally affect quality of analytical data. Normally these practices would not be the basis for denial or revocation of accreditation status. Functional areas within which recommended practices may be noted are:

(a) Personnel. The department seeks to determine if managerial, supervisory, and technical personnel have adequate training and experience to allow satisfactory completion of analytical procedures and compilation of reliable, accurate data. Minimum recommended education and experience criteria for laboratory personnel are specified in the ((program)) procedural manual.

(b) Facilities. The department seeks to determine if laboratory facilities allow efficient generation of reliable, accurate data in a safe environment.

(c) Safety. The department may refer serious safety deficiencies to appropriate state or federal agencies.

(3) ((NELAC requirements. For laboratories applying for NELAP accreditation, on-site assessment requirements are those designated in the NELAC standards. If the NELAC standard is more stringent than the corresponding standard in this chapter, the NELAC standard applies.

(4))) Drinking water laboratory requirements. For laboratories applying for accreditation of drinking water parameters, on-site ((assessment)) audit requirements are those designated in the drinking water certification manual. If such a standard is more stringent than the corresponding standard in this chapter, the drinking water certification manual applies.

[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), 173-50-080, filed 10/1/02, effective 11/1/02; 93-20-011 (Order 92-53), 173-50-080, filed 9/22/93, effective 10/23/93; 90-21-090 (Order 90-21), 173-50-080, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), 173-50-080, filed 4/20/89 and 3/13/90, effective 4/13/90.]


AMENDATORY SECTION(Amending Order 01-12, filed 10/1/02, effective 11/1/02)

WAC 173-50-090   Evaluation and issuance of certificate.   (1) After preliminary requirements (WAC 173-50-060 through 173-50-080) have been met, the lab accreditation unit submits a report to the affected laboratory concerning the results of the overall accreditation process. The report may:

List((s)) findings;

((Assesses)) Assess the importance of each finding; and

Make((s)) recommendations concerning actions necessary to assure resolution of problems.

(2) After completing the accreditation review, the ecology accrediting authority decides whether accreditation should be granted.

(a) If accreditation is warranted, the department issues a certificate and accompanying scope of accreditation. The certificate remains the property of the department and must be surrendered to the department upon revocation or voluntary termination of accreditation status.

(b) If accreditation is not warranted, the department issues a report specifying areas of deficiency and steps necessary to upgrade the laboratory to accredited status. In such cases, the laboratory must provide documentation that the specified deficiencies have been corrected. Based on such documentation the ecology accrediting authority decides whether to grant or deny accreditation.

[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), 173-50-090, filed 10/1/02, effective 11/1/02; 93-20-011 (Order 92-53), 173-50-090, filed 9/22/93, effective 10/23/93; 90-21-090 (Order 90-21), 173-50-090, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), 173-50-090, filed 4/20/89 and 3/13/90, effective 4/13/90.]


AMENDATORY SECTION(Amending Order 01-12, filed 10/1/02, effective 11/1/02)

WAC 173-50-100   Interim accreditation.   (((1))) If ((for valid reasons resulting from a deficiency in)) the department ((and not)) is unable to complete the accreditation process through no fault of the laboratory, the ecology accrediting authority may grant interim accreditation ((may be granted)). To be considered for interim accreditation, the laboratory must:

Submit an application and applicable fees;

Successfully complete applicable proficiency tests; and

Submit a QA manual that meets the requirements of WAC 173-050-067.

The lab accreditation unit may also require the laboratory to submit an analytical data package as evidence of analytical capability.

(((2) For NELAP accreditation, the only valid reason for granting interim accreditation is the delay of an on-site assessment for reasons beyond the control of the laboratory.))

[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), 173-50-100, filed 10/1/02, effective 11/1/02; 93-20-011 (Order 92-53), 173-50-100, filed 9/22/93, effective 10/23/93; 90-21-090 (Order 90-21), 173-50-100, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), 173-50-100, filed 4/20/89 and 3/13/90, effective 4/13/90.]


AMENDATORY SECTION(Amending Order 01-12, filed 10/1/02, effective 11/1/02)

WAC 173-50-110   Provisional accreditation.   (1) The ecology accrediting authority may grant provisional accreditation to laboratories which can consistently produce valid analytical data but have deficiencies requiring corrective action. When the laboratory has corrected such deficiencies, it must provide evidence of correction to the lab accreditation unit, or request a follow-up on-site ((assessment)) audit, as appropriate. If the lab accreditation unit determines the deficiencies have been corrected, the ecology accrediting authority awards full accreditation as in WAC 173-50-090.

(2) The ecology accrediting authority may renew a provisional accreditation for a subsequent accreditation period if laboratory management has demonstrated that all reasonable measures to correct deficiencies have been exhausted.

(3) For drinking water laboratories, specific conditions warranting provisional accreditation and specific actions required of the laboratory when provisional accreditation is granted are found in the drinking water certification manual.

(((4) Provisional accreditation does not apply to NELAP accreditations.))

[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), 173-50-110, filed 10/1/02, effective 11/1/02; 90-21-090 (Order 90-21), 173-50-110, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), 173-50-110, filed 4/20/89 and 3/13/90, effective 4/13/90.]


AMENDATORY SECTION(Amending Order 01-12, filed 10/1/02, effective 11/1/02)

WAC 173-50-120   Accreditation categories.   (1) Environmental laboratories are accredited within one or more of the matrix groups defined in WAC 173-50-040. ((Additionally)) Within each matrix group, accreditation is granted within the following broad categories:

General chemistry ((I (General)));

((Chemistry II ())Trace metals(()));

Organics I (((Gas Chromatography (GC) and High Pressure Liquid Chromatography (HPLC) Methods)));

Organics II (((Gas Chromatography/Mass Spectrometry (GC/MS) Methods))) (Category II methods use mass spectrometer detectors);

(( Radioactivity;))

Microbiology;

Radiochemistry;

Bioassay((/Toxicity));

Immunoassay; and

Physical.

Within these categories, laboratories are specifically accredited for well-defined parameters, such as, but not limited to, those suggested in the procedural manual, using specific((, recognized)) analytical methods or sampling techniques chosen by the applying laboratory.

(2) The scope of accreditation accompanying the accreditation certificate indicates the parameters for which the laboratory is accredited, and any applicable qualifications, such as interim or provisional accreditation.

(3) ((For laboratories granted NELAP accreditation,)) The scope of accreditation also indicates the matrix groups within which each parameter applies. Those matrix groups may include, but are not limited to:

Nonpotable water;

Drinking water;

Solid and chemical materials;

(( Biological tissue;)) and

Air and emissions.

((For laboratories granted NELAP accreditation, the scope of accreditation may also indicate the technology, such as gas chromatography/electron capture detection (GC/ECD) or inductively coupled plasma/mass spectrometry (ICP/MS), associated with each parameter.))

[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), 173-50-120, filed 10/1/02, effective 11/1/02; 93-20-011 (Order 92-53), 173-50-120, filed 9/22/93, effective 10/23/93; 90-21-090 (Order 90-21), 173-50-120, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), 173-50-120, filed 4/20/89 and 3/13/90, effective 4/13/90.]


AMENDATORY SECTION(Amending Order 01-12, filed 10/1/02, effective 11/1/02)

WAC 173-50-130   Requirements for maintaining accreditation status.   (1) Accreditation is granted for a one-year period and expires one year after the effective date of accreditation. ((Except for NELAP accreditation which is limited to one year, exceptions to the one year accreditation may be made for documented cause. In such cases, accreditation may be granted for a period up to two years.))

(2) Renewal requires the laboratory to submit:

An application and appropriate fees;

An update of the laboratory's ((quality assurance)) QA manual if applicable; ((and))

Evidence of accreditation by a third party when appropriate; and

Successful completion of proficiency testing requirements.

(3) For laboratories accredited for drinking water parameters, on-site ((assessments)) audits are required at periods not to exceed three years from the previous on-site ((assessment)) audit. ((For documented cause, on-site assessments may be extended up to four years from the previous assessment, except for laboratories accredited to analyze drinking water and NELAP accredited laboratories.))

(4) For laboratories not accredited for drinking water parameters, the schedule of on-site audits will be determined by the ecology accrediting authority.

[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), 173-50-130, filed 10/1/02, effective 11/1/02; 93-20-011 (Order 92-53), 173-50-130, filed 9/22/93, effective 10/23/93; 90-21-090 (Order 90-21), 173-50-130, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), 173-50-130, filed 4/20/89 and 3/13/90, effective 4/13/90.]


AMENDATORY SECTION(Amending Order 01-12, filed 10/1/02, effective 11/1/02)

WAC 173-50-140   Denying accreditation.   (1) The ecology accrediting authority may deny accreditation if the applicant laboratory:

Fails to comply with standards for critical elements of the on-site ((assessment)) audit;

Misrepresents itself to the department;

Fails to disclose pertinent information in the application;

Falsifies reports of analysis including ((PT)) proficiency testing results;

Engages in unethical or fraudulent practices concerning generation of analytical data;

Is deficient in its ability to provide accurate and defensible analytical data; or

Fails to render applicable fees.

(2) A laboratory may be denied accreditation for a specific parameter for unsatisfactory ((analysis of that parameter in)) proficiency ((tests)) testing results.

(3) Laboratories denied accreditation may appeal under the provisions of WAC 173-50-200. If an appeal does not result in action favorable to the laboratory, and following correction of deficiencies, laboratories denied accreditation may reapply for accreditation to include payment of appropriate fees as determined in WAC 173-50-190.

(((4) Reasons for denial of NELAP accreditation are as specified in the NELAC standards.))

[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), 173-50-140, filed 10/1/02, effective 11/1/02; 90-21-090 (Order 90-21), 173-50-140, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), 173-50-140, filed 4/20/89 and 3/13/90, effective 4/13/90.]


AMENDATORY SECTION(Amending Order 01-12, filed 10/1/02, effective 11/1/02)

WAC 173-50-150   Revoking or suspending accreditation.   (1) Revocation of accreditation is the withdrawal of a previously granted accreditation. Revocation may involve the entire laboratory or one or more individual parameters.

(2) Suspension of accreditation is for a specified period ((not to exceed six months)) during which the affected laboratory corrects deficiencies that led to the suspension. Suspension may involve the entire laboratory, or one or more individual parameters.

(((2))) (3) The ecology accrediting authority may suspend or revoke accreditation if the accredited laboratory:

Fails to comply with standards for critical elements of an on-site ((assessment)) audit;

Violates a state rule relative to the analytical procedures for which it is accredited;

Misrepresents itself to the department;

Falsifies reports of analysis including ((PT)) proficiency testing results;

Engages in unethical or fraudulent practices concerning generation of analytical data;

Is deficient in its ability to provide accurate and defensible analytical data; ((or))

Refuses to permit entry for enforcement purposes (WAC 173-50-210);

Fails to render applicable fees; or

Fails to maintain third-party accreditation.

(((3))) (4) A laboratory having had its accreditation suspended or revoked may appeal under the provisions of WAC 173-50-200. If an appeal does not result in action favorable to the laboratory, and following correction of deficiencies, a laboratory having had its accreditation revoked may reapply for accreditation to include payment of appropriate fees as determined in WAC 173-50-190.

(((4) Reasons for revocation or suspension of NELAP accreditation are as specified in the NELAC standards.))

[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), 173-50-150, filed 10/1/02, effective 11/1/02; 90-21-090 (Order 90-21), 173-50-150, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), 173-50-150, filed 4/20/89 and 3/13/90, effective 4/13/90.]


AMENDATORY SECTION(Amending Order 01-12, filed 10/1/02, effective 11/1/02)

WAC 173-50-170   Third-party accreditation.   (1) The department may recognize accreditation (or certification, registration, licensure, approval) of a laboratory by a third party when the accreditation process is determined to be equivalent to that described in this chapter.

(2) Laboratories applying for recognition of a third party's accreditation submit:

An application and associated fee (WAC 173-50-190(7));

A copy of the third party's certificate;

A copy of the third party's scope of accreditation;

A copy of the third party's most recent on-site ((assessment)) audit report;

A copy of the laboratory's corrective action report relative to the on-site ((assessment)) audit, if applicable; and

A complete set of the most recent ((PT)) proficiency test results for the applicable parameters.

(3) In consideration of a request to recognize a third party's accreditation as the basis for accreditation by the ecology accrediting authority, the lab accreditation unit reviews the application and supporting documentation to assure compliance with minimum accreditation requirements as stated in this chapter. If the review is favorable, a certificate and scope of accreditation are granted as in WAC 173-50-090.

(4) Laboratories granted third-party accreditation must notify the laboratory accreditation unit immediately of changes in the status of their third-party accreditation.

(5) Washington laboratories accredited or applying for accreditation in recognition of a third party's accreditation must notify the lab accreditation unit of on-site ((assessments)) audits scheduled by the third party and allow a department observer to attend such on-site ((assessments)) audits.

(((5) Primary NELAP accreditation cannot be granted in recognition of the accreditation by a third party.))

[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), 173-50-170, filed 10/1/02, effective 11/1/02; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), 173-50-170, filed 4/20/89 and 3/13/90, effective 4/13/90.]


AMENDATORY SECTION(Amending Order 01-12, filed 10/1/02, effective 11/1/02)

WAC 173-50-190   Fee structure.   (1) Fees in this chapter are in U.S. dollars and are established to cover costs of administering the ((accreditation program)) WA ELAP. Fees shall be assessed for each parameter or method within each matrix, except as noted in subsection (3) of this section. The fee per parameter or method for each category, and the maximum fee per category ((for each matrix)) where applicable, are identified in Table 1.

(2) Examples of parameters or methods for each category are published in the procedural manual. Accreditation may be requested for parameters in addition to those listed in the procedural manual.

(3) When a fee is assessed ((only once)) for a ((given)) specific drinking water parameter ((even though that specific)) or method, the laboratory may be accredited for the same parameter ((may be accredited under more than one matrix)) or method in nonpotable water without paying an additional fee.

TABLE 1 - FEE SCHEDULE

((MATRIX CATEGORY FEE/

PARAMETER

MAX FEE PER CATEGORY
Nonpotable Water Chemistry I $65 $1150
(General)
Chemistry II $65 $975
(Trace Metals)
Organics I $115 $975
(GC/HPLC)
Organics II $345 $1035
(GC/MS)
Radioactivity $145 $1380
Microbiology $175 $520
Bioassay/Toxicity $230 $1435
Immunoassay $65 $390
Physical $65 $260
Drinking Water Chemistry I $60 $305
(General)
Chemistry II $60 $720
Organics I $155 $615
(GC/HPLC)
Organics II $155 $155
(GC/MS)
Microbiology $155 $460
Solid and

Chemical

Materials

Chemistry I $65 $1150
(General)
Chemistry II $65 $975
(Trace Metals)
Organics I $115 $975
(GC/HPLC)
Organics II $345 $1035
(GC/MS)
Radioactivity $145 $1380
Microbiology $175 $520
Immunoassay $65 $390
Physical $65 $260
Air and Emissions Chemistry I $65 $1150
(General)
Chemistry II $65 $975
(Trace Metals)
Organics I $115 $975
(GC/HPLC)
Organics II $345 $1035))
(GC/MS)
CATEGORY FEE PER PARAMETER FEE PER METHOD MAX FEE PER CATEGORY
General Chemistry $80 -- $1,600
Trace Metals -- $400 --
Organics I -- $200 --
Organics II -- $500 --
Microbiology $200 -- --
Radiochemistry $250 -- --
Bioassay $300 -- $3,000
Immunoassay $80 -- --
Physical $80 -- --

(4) The minimum fee for accreditation, either direct or through recognition of a third-party accreditation, is three hundred dollars.

(5) In addition to paying the fee indicated in Table 1, out-of-state laboratories must pay for the actual cost of travel associated with on-site ((assessments)) audits. The department invoices the laboratory for such costs after completion of the on-site ((assessment)) audit.

(((5))) (6) The laboratory must pay applicable fees before:

Its quality assurance manual is reviewed by the department;

The on-site ((assessment)) audit is conducted if applicable; and

Interim, provisional, or full accreditation is granted.

(((6))) (7) The fee for recognition of a third party accreditation (WAC 173-50-170)((, other than NELAP accreditation (WAC 173-50-190(9)), is three hundred forty-five dollars.

(7) The fee for recognition of a laboratory under a reciprocity agreement (WAC 173-50-160) is three hundred forty-five dollars, or as specified in the reciprocity agreement, but not less than three hundred forty-five dollars.

(8) The fee for recognition of accreditation by a NELAP accrediting authority for laboratories in Washington is three hundred forty-five dollars. For out-of-state laboratories, the fee for recognition of accreditation by a NELAP accrediting authority is the fee indicated in Table 1.

(9) For drinking water laboratories, the base fee to defray the extra cost incurred by the department because of the need to coordinate directly with two regulatory agencies is one hundred fifteen dollars.

(10))) is three-fourths (75%) of the fee indicated in Table 1.

(8) If a laboratory withdraws from the accreditation process after the application has been processed, but before accreditation is granted, the fee is ((nonrefundable)) refundable, less an amount up to ((an amount of two)) three hundred ((thirty)) dollars as reimbursement for costs of processing the application. If a laboratory withdraws from the accreditation process after the on-site ((assessment)) audit has been completed, the department may retain the entire fee including reimbursement of travel costs if applicable.

(((11))) (9) Dollar amounts listed in Table 1 and subsections (((6))) (4), (7), and (8)((, (9), and (10))) of this section may be adjusted every year based on inflation as indicated by the Implicit Price Deflator for State and Local Government Services as published by the economic and revenue forecast council. Dollar amounts listed in Table 1 and subsections (((6))) (4), (7), and (8)((, (9), and (10))) of this section may be decreased at any time the department determines they are higher than needed to meet accreditation program requirements. The department notifies affected parties of any fee adjustment at least thirty days prior to the effective date of the adjusted fee.

[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), 173-50-190, filed 10/1/02, effective 11/1/02; 93-20-011 (Order 92-53), 173-50-190, filed 9/22/93, effective 10/23/93; 90-21-090 (Order 90-21), 173-50-190, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), 173-50-190, filed 4/20/89 and 3/13/90, effective 4/13/90.]


AMENDATORY SECTION(Amending Order 01-12, filed 10/1/02, effective 11/1/02)

WAC 173-50-210   Enforcement.   (1) For the purpose of conducting on-site ((assessments or otherwise enforcing)) audits or inspections to ensure compliance with this chapter, the department may, during regular business hours, enter ((any)) business premises in which analytical data pertaining to accreditation under the provisions of this chapter are generated or stored.

(2) Refusal to permit entry for such purposes ((shall)) may result in denial((,)) or revocation((, or suspension)) of accreditation ((or registration status)).

[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), 173-50-210, filed 10/1/02, effective 11/1/02; 90-21-090 (Order 90-21), 173-50-210, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), 173-50-210, filed 4/20/89 and 3/13/90, effective 4/13/90.]


AMENDATORY SECTION(Amending Order 01-12, filed 10/1/02, effective 11/1/02)

WAC 173-50-220   Assistance to laboratories.   Laboratories scheduled to undergo an on-site ((assessment)) audit may request a training session be conducted by department staff in conjunction with that ((assessment)) audit. Accredited laboratories may also request on-site assistance at times other than the on-site ((assessment)) audit. Whether requested as part of the on-site ((assessment)) audit or otherwise, the department will provide such assistance to the extent allowed by staff resources available at the time.

[Statutory Authority: RCW 43.21A.230. 02-20-090 (Order 01-12), 173-50-220, filed 10/1/02, effective 11/1/02; 90-21-090 (Order 90-21), 173-50-220, filed 10/19/90, effective 11/19/90.]


REPEALER

     The following sections of the Washington Administrative Code are repealed:
WAC 173-50-160 Reciprocity.
WAC 173-50-180 Exemptions.

Washington State Code Reviser's Office