Original Notice.

     Preproposal statement of inquiry was filed as WSR 01-24-099.

     Title of Rule: Chapter 173-50 WAC, Accreditation of environmental laboratories.

     Purpose: This amendment will allow ecology to grant accreditation for tests on matrices other than water, for physical tests, and for drinking water tests, and to grant accreditation as a national environmental laboratory accreditation program (NELAP) accrediting authority. Also, the revision will allow collection of sufficient fees to make the accreditation program self supporting.

     Other Identifying Information: All resources for implementation of the laboratory accreditation program come from the general fund and are partially offset by collection of fees. The offset currently covers direct costs, which are approximately two-thirds of total costs. This rule revision will allow fee collections to balance program expenditures.

     Statutory Authority for Adoption: RCW 43.21A.230.

     Statute Being Implemented: Chapter 43.21A RCW allows but does not require this rule.

     Summary: Chapter 173-50 WAC establishes the procedures to be taken by environmental laboratories to become accredited and thus meet state requirements for use of accredited labs. Department of Health has an essentially identical program for accreditation of labs that submit drinking water data. The amended chapter 173-50 WAC will combine these two programs. The amended WAC will also allow ecology to accredit for tests of soil, tissue, air, and other nonwater matrix samples. It will also allow but not require ecology to become a national environmental laboratory accreditation program accrediting authority.

     Reasons Supporting Proposal: Combining the lab accreditation programs will be a significant advantage to labs participating in both ecology's and health's programs. Accreditation for matrices in addition to water will assure labs have a demonstrated capability to provide reliable data for such samples. Designating ecology as a NELAP accrediting authority will allow Washington labs to gain NELAP accreditation without incurring the additional (travel) cost of having another state provide that service. A revised fee schedule will afford ecology full compensation for the cost of administering the accreditation program.

     Name of Agency Personnel Responsible for Drafting, Implementation and Enforcement: Perry Brake, Supervisor, Ecology Lab Accreditation Unit, 2350 Colchester Drive, P.O. Box 488, Manchester, WA 98353-0488, (360) 895-6149.

     Name of Proponent: Department of Ecology, governmental.

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

     Explanation of Rule, its Purpose, and Anticipated Effects: Chapter 173-50 WAC needs to be expanded to include granting accreditation for tests on matrices other than water, for physical tests and for drinking water tests. The WAC currently allows granting such accreditations, but does not allow collecting fees for these services. Furthermore, there is a need for the department to become an accrediting authority within the national environmental laboratory accreditation program (NELAP). All resources for implementation of the laboratory accreditation program come from the general fund and are partially offset by collection of fees. The offset currently covers direct costs, which are approximately two-thirds of total costs. The primary objective of this rule revision is to allow fee collections to balance program expenditures.

     Proposal Changes the Following Existing Rules: This revision of chapter 173-50 WAC will negate the need for chapter 246-390 WAC, Department of Health's drinking water certification rules.

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

     Scope of SBEIS: As intended by the cited acts, this impact statement deals with laboratories operated within the private sector of the economy. Some laboratories affected by the rule are also operated by government entities (cities, counties, water and sewer districts, publicly-owned utilities, state, and federal agencies). The impact of fee changes proposed by this rule amendment is not examined in this SBEIS other than to state here that for the smaller of those government entities, the proposed fee increase is insignificant, amounting to an increase of 2.5% for most, and for some, a small decrease. Section I addresses proposed increases which will have a continuing impact because those fees are paid each year. Section II addresses associated (indirect) costs which may be incurred by some entities in preparing for accreditation of their laboratories for new analytical procedures not previously accredited. Generally, these costs will impose a noncontinuing (one-time) impact. Finally, Section III summarizes actions that have been taken or are proposed to mitigate the impact of accreditation fees on those small businesses for which the fee increase is found to be significant.

     Summary of Proposed Rule Amendments: The environmental laboratory accreditation program implementing chapter 173-50 WAC needs to be expanded to include granting accreditation:

•     For tests on matrices other than water;

•     For physical tests;

•     To labs that analyze drinking water and report resulting data to Department of Health; and

•     As a national environmental laboratory accreditation program (NELAP) accrediting authority.

     The current version of chapter 173-50 WAC would allow granting these new accreditations, but without amendment, it would not allow the department to collect fees for these services. All resources for implementation of the laboratory accreditation program come from the general fund, and are offset by collection of fees. The primary objective of this rule revision is to allow fee collections to balance program expenditures as program staff is increased to allow providing the new services to accredited labs. There will be no new industries entering the accreditation program because of the proposed rule revision. Furthermore, the proposed rule revisions alone will not cause any new business within any given industry to enter the accreditation program.

     Summary of Economic Impact: Fees imposed by the environmental laboratory accreditation program as amended are expected to have a significant impact on only one industry, commercial (for profit) testing labs, encompassing only a few businesses in the state. While the fees do tend to place a proportionally higher burden on smaller businesses within a given industry, the burden is not so substantial that it will reduce competition, reduce employment, reduce new employment opportunities, reduce innovation, or threaten the existence of any small businesses.

     Accreditation has been shown to be an economic benefit to most commercial testing laboratories (i.e., laboratories that analyze environmental samples as a business)¹. Furthermore, some testing labs, especially those that analyze drinking water AND other environmental samples, will benefit from a reduction in fees because of the enhanced efficiency of the combined program.

     Associated (i.e., nonfee) costs are not readily quantifiable and not justifiably attributable to the laboratory accreditation program. Associated costs are realized by activities whose laboratories are not meeting scientific standards inherent in doing accurate analyses (standards imposed by others, such as EPA, and not the accreditation program).

     The other type of laboratory is operated by businesses which are required to report environmental data in compliance with a permit issued by the Department of Ecology. Some of these businesses hire commercial laboratories to perform all or some of their required analyses, while others conduct the analyses in their own laboratories. Presently, seventy businesses, all permitted wastewater dischargers operating their own laboratories, participate in the laboratory accreditation program. Wastewater dischargers not operating their own laboratories may be affected by the proposed fee increases because the commercial laboratories to which they send their samples for analysis may pass on to their clients their increased costs of being accredited.

     A basic assumption of this analysis is that all affected businesses will pay a fee which in most cases will increase as a result of rule amendment. The fee will be direct if they operate their own laboratory, or indirect if the commercial laboratories they contract increase their charges for analyses. From the standpoint of economic impact on businesses that use accredited laboratory services, this assumption presents a worst case situation. A best case situation would involve no indirect fee increases because the supporting lab chose not to pass on the fee increase because of concern over losing clientele. Furthermore, essentially all labs serve more than one business. Thus, a lab with, for example, four customers, even if it passed through all of its fee increase, would only pass along 1/4 of the increase to each customer (on average). The actual impact will probably be closer to the best case situation than to the situation presented in this statement.

     When chapter 173-50 WAC was promulgated, the following were used as the basis for determining economic impact. The 1982 Census of Manufacturers; Washington, the 1982 Census of Service Industries: Miscellaneous Subjects, and the 1982 Census of Wholesale Trade: Washington (all U.S. Department of Commerce, Bureau of the Census, 1985) were used to estimate average sales to payroll ratios. The 1987 Employment and Payrolls in Washington State by County and Industry (Washington State Department of Employment Security, 1988) was used to determine average number of employees and total 1987 wages paid per industry. The average wages paid within a business and the sales to payroll ratio were used to estimate the average sales. From these, estimates were made of the fee imposed by this rule as a percentage of sales (one of the methods of estimating economic impact allowed by RCW 19.85.040). For this SBEIS, comparable documents were used by the department to compile a list of industries showing "minor and negligible" thresholds for most Washington industries based on 1990 data.

     Although the references cited above are not current, they are considered sufficient to support the conclusion that the laboratory accreditation program, including proposed fee increases, does not have an unwarranted economic impact on any industry or business in Washington. Table 1 below shows the anticipated impact on Washington industries. The "Fee Now" and "Projected Fee" columns in Table 1 reflect the current (2002) situation. Note that the determination of "significance" is based on the fee increase and not the absolute fee. Note also that for only one industry, testing labs at the bottom of the list, is the fee increase significant.

     Determining Program Cost: The accreditation process involves:

•     Submittal by each laboratory of a comprehensive application;

•     Submittal of a quality assurance (QA) manual;

•     Submittal of performance evaluation sample analysis results; and

•     Successful completion of and an on-site audit.

     The cost of reviewing the application, the laboratory's accreditation manual, and the results of the performance evaluation sample analysis are considered in determining the cost of administering the accreditation program to the department. The primary factor in determining cost to the department, however, is the system audit, or on-site inspection, which must be conducted at each laboratory prior to accreditation and every three years thereafter. Generally, the effort required of the department in conducting the system audit is directly proportional to the scope of the laboratory's analytical operations. The accreditation fee to defray program costs is therefore directly determined by the number and complexity of analytical parameters for which the laboratory seeks accreditation. Within the commercial testing laboratory industry (NAICS 8734)², small laboratories will analyze fewer parameters and consequently be charged proportionately smaller fees, and smaller fee increases as a result of the proposed rule revision.

     Larger, multi-discipline laboratories are charged higher fees commensurate with the increased effort required in the accreditation process. For other businesses, the fee is also proportional to the scope (and size) of the laboratory, but not necessarily to the size of the business. Large businesses discharging few potentially harmful materials into the environment may be required to analyze only a few parameters and would therefore have a small laboratory and pay a small fee. However, within each industry, there is generally a direct correlation between business size and the fee imposed by this rule.

     Potentially, each business discharging wastewater in accordance with permits issued pursuant to chapters 173-220, 173-216, and 173-226 WAC (NPDES, state, and general wastewater discharge permit regulations, respectively) could be affected by the fee increases projected in the revision of chapter 173-50 WAC. While there are hundreds of such businesses, this SBEIS shows that proposed fee increases will not have a significant impact on any of these small businesses.

Table 1 - Projected Economic Impact on Small Businesses

NAICS	INDUSTRY	No. of Small Bus.	AVG $K SALES	% PROFIT	% M&N	THRESHOLD $	FEE NOW $	PROJ'D FEE $	INCREASE	INCREASE SIGNIFICANT?	NOTE
21222	Gold/Silver Mining	6	6491	1	0.001	64.91	124	127	3	NO	1
21232	Sand/Gravel Mining	18	439	1	0.001	4.39	124	127	3	NO	1
311612	Meat Processing	39	14871	4.08	0.0041	607.3	417	429	12	NO
31151	Dairy Products	12	25393	2.2	0.0022	558.66	355	365	10	NO
31142	Fruit & Veg Canning	76	5390	2.6	0.0026	140.15	62	64	2	NO
31212	Breweries	12	13326	3.96	0.004	527.94	62	64	2	NO
311711	Seafood Canning	35	3294	3.77	0.0038	124.22	62	64	2	NO
321113	Sawmills	7	8179	2.52	0.0025	226.46	124	127	3	NO
321212	Plywood Plants	11	6102	1.6	0.0016	97.83	62	64	2	NO
321219	Recons. Wood Prod	2	6231	1.4	0.0014	369.05	62	64	2	NO
322110	Pulp Mills	4	30040	6.29	0.0063	1889.06	372	382	10	NO
32212	Paper Mills	8	8037	4.9	0.0049	393.85	372	382	10	NO
325120	Indust Gas Mfg	2	4716	4.79	0.0048	225.7	62	64	2	NO
324110	Petroleum Refineries	5	14271	3.5	0.0035	499.5	372	382	10	NO
327320	Concrete/Cement	9	4361	1.93	0.0019	84.29	124	127	3	NO
331312	Aluminum Producers	3	15697	3	0.003	470.93	372	382	10	NO
33281	Metal Coaters	3	3578	2.8	0.0028	100.19	186	191	5	NO
332813	Electroplating	5	2543	2.1	0.0021	53.41	186	191	5	NO
33441	Electronics	8	9256	3.8	0.0038	351.57	124	127	3	NO
33621	Motor Vehicle Mfg	2	2008	5	0.004	80.44	62	64	2	NO
336413	Aircraft Parts Mfg	9	10112	7.03	0.007	710.67	496	510	14	NO
33661	Ship/Boat Building	4	4496	1.6	0.0016	71.95	62	64	2	NO
488490	Road Transport Spt	3	869	1	0.001	8.69	62	64	2	NO	1
221111	Hydroelectric	29	33059	1	0.001	330.59	372	382	10	NO
22132	Sanitary Services	12	22159	7.8	0.0079	1728.47	310	319	9	NO
325110	Petrochemical Mfg	21	52818	2.66	0.0027	1403.10	256	263	7	NO
42271	Petroleum Wholesale	21	143321	1.08	0.0011	1547.12	496	509	13	NO
53112	Nonresidential Building Lessors	6	1681	1.3	0.0019	21.86	248	255	7	NO
72121	RV Parks & Campgrounds	11	1753	3.9	0.0039	68.37	248	255	7	NO
541380	Testing Labs	49	3732	6.06	0.0061	226.10	2240	3360	1120	YES

Note: (1) Percent profits arbitrarily set at 1% (no specific data available)

     The impact on affected industries in the state is discussed in the remainder of this section and summarized in Table 1 above. Although not shown in Table 1, another important aspect of this fee program is that in no case is the fee significant for a small business while being negligible for large businesses within the same industry (which could be very unfavorable to the small business). For commercial testing labs, the proposed fee increase is significant for the few large businesses in the industry. Furthermore, for some of the small testing labs, there may be a fee decrease.

     Within most affected industries (e.g., pulp and paper), essentially all businesses in the industry are impacted by these rules because all are wastewater discharge permit holders. Many permitted dischargers (probably the majority of state-permitted dischargers, for example) are not affected by chapter 173-50 WAC because their permits do not require reporting of accreditable analytical data (e.g., some report only temperature and/or flow, neither of which require accreditation). The majority of industries in the state as defined in chapter 19.85 RCW will not be affected directly or indirectly by the accreditation program. A detailed discussion is provided only for the Commercial Testing Laboratories industry, the sole industry affected.

     Impacts on industries in the state having small businesses likely to be affected by the accreditation program are summarized in Table 1, which shows the following:

•     The number of units (small businesses) in that industry involved in lab accreditation;

•     The average annual sales (in thousands of dollars) for the small units;

•     The percent profit realized in 1990 by each industry (unless otherwise indicated by notes in which case a 1% profit was assigned, representing a worst case since profit margins for all other affected industries were greater than 1%);

•     The percent limit below which a fee increase would be minor and negligible (% M&N) for the industry, set as 0.1% of the percent profit;

•     The "%M&N" threshold in dollars (i.e., average sales times %M&N);

•     Average fee now (before rule amendment);

•     Average projected fee (following proposed 2002 rule amendments);

•     The projected fee increase for the average business; and

•     Whether the projected fee is significant (yes) or negligible (no).

     Impacts on Commercial Testing Laboratories (NAICS 541380): Not all laboratories in NAICS 541380 are affected by the accreditation program. There are several which test materials other than those of interest to the Department of Ecology (or, in the case of drinking water labs, to the Department of Health), such as construction materials, food, and other products. However, many test environmental materials (e.g., water, hazardous waste) and submit data to the department. Others test drinking water and report data to the Department of Health. Criticality of accuracy of the these analyses dictates accreditation for those parameters; complexity of most analyses dictates an involved and therefore costly accreditation process. It is unlikely any actions other than those mentioned in Section III can be undertaken to significantly mitigate the economic impact on commercial testing labs.

     Accreditation fees are directly proportional to the number and complexity of analytical parameters for which a laboratory is accredited. Consequently, the magnitude of the fee for any given business is directly related to the size of the laboratory. Small laboratories with limited capabilities generally analyze few parameters and are therefore charged a relatively small fee. Large, multi-functional laboratories are charged larger fees. The minimum possible fee for a given laboratory will be $64, although no such uni-functional laboratory has been identified. A more probable minimum fee is $237 which would be the fee for a laboratory conducting limited microbiology tests (e.g., fecal coliforms only). At least one such laboratory exists in the state. The maximum possible fee following proposed rule amendments will be approximately $10,000. Here again, it is unlikely such an omni-functional laboratory exists, although some come close. The most probable maximum fee is approximately $7,000, and that would not be for a lab defined as a small business in chapter 19.85 RCW.

     The fee projected for an average small commercial testing laboratory is $3,360, which is well above the M&N threshold of $226 for the industry, making the fee significant. While the fee is also significant for large businesses in this industry, the smaller the lab, the more significant the fee. This inequity in favor of the large laboratories is not easily avoided because part of the fee is based on ecology's need to evaluate administrative functions such as sample and data management that are not related to size of the lab or its annual sales. Fees for both large and small laboratories are in accordance with the effort required of ecology in the accreditation process. These fees cannot be reduced for either small or large labs if the program is expected to be self supporting. On the other hand, the bulk of the fee INCREASES proposed in this rule revision are primarily based on accreditation for tests that are done only by the larger testing labs. Thus the majority of additional fees to be imposed by ecology will be on the larger businesses in this mostly small-business industry. Nevertheless, the average fee increase of $1,120 is significant causing the department to seek mitigation wherever possible. Mitigation of the impact of the fee increase is addressed in Section III.

     The current fee structure has not been a problem with commercial testing labs since program inception in 1989, and given the economic value of the accreditation itself, the fee is not considered by the majority of participating labs to be excessive. For a commercial laboratory, the ability to produce quality data is its main marketable commodity, which means that evidence attesting to that quality (i.e., an accreditation), has great value. Furthermore, most of the laboratories, and particularly the smaller ones, benefit in terms of increased efficiency as a result of going through the accreditation process. Increased efficiency should lead to increased productivity which will help offset increased costs of accreditation. Experience gained in implementing the accreditation program to date has shown this to be the case for most laboratories and the trend is expected to continue. Furthermore, there are currently fifty-four Washington labs that are paying fees to both the health and ecology lab accreditation programs. Consolidation of the accreditation function under ecology will actually reduce the cost of doing business for those labs. For some labs, there will actually be a fee decrease.

     Impact of Fees on Profits: Laboratory accreditation fees are not taxes on profits but rather a cost of doing business which may be incorporated into the price of a laboratory's (or its parent organization's) output. Because the fees are generally such a small percentage of sales, large businesses and most small businesses will probably not find it necessary to raise prices because of current or projected accreditation fees. The exception might be very small commercial laboratories (i.e., those with only one or two employees), of which there are very few in the state.

     For most commercial laboratories, the cost of accreditation fees can be passed on to customers in the form of increased prices for analytical services. Since all laboratories in the state performing environmental analyses will be affected by the fee increases, in a manner designed to be as equitable as possible, the economic impact will affect most laboratories. As previously mentioned, the exception could be the very small lab that performs a specialized type of analysis. Because the fee for such a lab could be a significant percentage of sales, the lab might be forced to increase prices to recover the costs of fee increases. Larger, multidiscipline laboratories performing the same type of analysis would not be required to increase prices for the same test to the same extent as the smaller, unidiscipline lab. This may appear to give the larger lab an unfair advantage. The advantage is possibly already enjoyed because the larger lab, with more capital, is more likely to be operating efficiently and charging less than the small lab. However, it is important to note that the bulk of the fee INCREASE will be borne by larger labs because it is they that will enjoy the benefit of accreditation for matrices in addition to water and the other new services offered as a result of this rule revision.

     A significant portion of the analytical work performed by commercial testing laboratories involved in this fee program is contract work for ecology. The department has published a policy statement and promulgated rules which require use of accredited laboratories. Other state and private entities, including out-of-state entities, require (or at least prefer) use of ecology-accredited laboratories to do their environmental analyses. These requirements should result in increased sales for accredited laboratories. Because neither neighboring state has an environmental lab accreditation program (Oregon is developing one), Washington commercial testing laboratories are perhaps better able to compete against neighboring state laboratories for environmental analyses. Also, it is known that in some cases, Washington testing labs have not been able to successfully bid on projects from out-of-state entities which require labs to be accredited for soil, tissue, and other matrices for which ecology accreditation has not heretofore been granted. For all these reasons, accreditation is an economic benefit for the accredited commercial lab. The benefit should exceed any adverse impact of increased charges for analysis to recover fees. Realizing this, many laboratories opt to initially absorb accreditation costs within their profit margin, anticipating that the profit margin will eventually increase as a result of accreditation.

     Section I Summary: Fees imposed by the environmental laboratory accreditation program have a significant effect on only a few industries representing only a few businesses in the state. The only industry for with [which] the projected fee increase will be significant is the commercial testing lab industry. The projected fee increases for such labs do not place a proportionally higher burden on smaller business within a given industry, and in fact, just the opposite is true. But even for the larger labs which will be carrying most of the burden of fee increases, that burden is not so significant that it will reduce competition, reduce employment, reduce new employment opportunities, reduce innovation, or threaten the existence of any businesses in this industry. Accreditation, and an expanded scope of existing accreditations, is expected to be an economic benefit to most commercial testing laboratories. Consolidation of the drinking water and environmental lab functions will reduce fees for some of the fifty-four labs that are currently paying fees to both programs.

     Increases in associated costs (indirect costs other than fees) for laboratories currently practicing what would normally be considered acceptable laboratory procedures will be minimal. These costs will consist primarily of costs associated with time lost in undergoing the on-site audit which will be more extensive for labs requesting the new services (drinking water or NELAP accreditation, or accreditation for matrices other than water). Well-prepared laboratories would already be analyzing performance evaluation samples, would have a formal quality assurance (QA) program as documented in a QA manual, would need no new equipment or additional personnel or training, would be performing QA tests such as duplicate and spiked samples, and would be keeping adequate QA records.

     Other laboratories will lack some or all of these elements of good laboratory practices, necessitating expenditures to bring the laboratory up to acceptable standards for the newly offered accreditation parameters. The extent of the expenditures will vary depending upon the requirements. The associated costs cannot be readily quantified or even estimated without knowing the status of an individual laboratory. The most common deficiency is likely to be lack of a sufficient QA program as documented in a QA manual. To minimize expense to deficient laboratories, assistance is available from ecology in preparation of such manuals.

     Section II Summary: Associated costs are not readily quantifiable and not justifiably attributable to the laboratory accreditation program. Associated costs will be incurred by entities whose laboratories are not currently meeting acceptable standards.

     To mitigate the impact of indirect costs on laboratories participating in the accreditation program, several actions have already been taken by ecology. For example, a model quality assurance manual was written and has been made available gratis to any lab entering the program. Likewise, an MS Excel program which automates the process of monitoring results of quality control tests in the lab was written by ecology and made available to laboratories free of charge. These and other forms of assistance from the laboratory accreditation unit of Department of Ecology will be used to mitigate the impact of indirect costs on labs seeking accreditation for the new services.

     There is one new fee proposed in this rule revision that has not yet been addressed in this SBEIS because it is not imposed on Washington businesses. The revised chapter 173-50 WAC will establish a fee to be collected from out-of-state laboratories to recognize their national environmental laboratory accreditation program (NELAP) accreditation granted by other states. The fee for this service will be from several hundred to a few thousand dollars annually. This will significantly mitigate the magnitude of fee increases imposed on Washington labs.

     During the rule amendment process, other mitigating actions will be sought and aggressively pursued.

¹ For more detail, see the discussion below of the impact on environmental testing laboratories.

² In the late 1990s, the North American Industry Classification System (NAICS) replaced the Standard Industrial Classification system (SIC) for categorizing economic activities.

     A copy of the statement may be obtained by writing to Perry Blake, Washington Department of Ecology, P.O. Box 488, Manchester, WA 98353-0488, pbra461@ecy.wa.gov, phone (360) 895-6149, fax (360) 895-6180.

     RCW 34.05.328 does not apply to this rule adoption. The current rule amendment is not subject to the requirements of RCW 34.05.328 for significant legislative rules because the current rule amendment adopts existing Washington state requirements for lab accreditation without material change. The responsibility for drinking water lab accreditation is being transferred from the Department of Health to the Department of Ecology, and the Department of Ecology is further implementing accreditation for matrices that already require accreditation in Washington state.

     Hearing Location: Eastern Washington University, Conference Room, 705 West 1st Avenue, Spokane, WA, on July 2, 2001 [2002], at 10:00 a.m.; and at the Headquarters, Department of Ecology Auditorium, 300 Desmond Drive, Lacey, WA, on July 3, 2001 [2002], at 10:00 a.m.

     Assistance for Persons with Disabilities: Contact Perry Brake by June 24, 2002, (360) 895-4169, TDD (360) 407-6006, or (360) 407-7006 (voice).

     Submit Written Comments to: Perry Brake, Ecology Lab Accreditation Unit, P.O. Box 488, Manchester, WA 98353-0488, fax (360) 895-6180, e-mail pbra461@ecy.wa.gov, by August 6, 2001.

     Date of Intended Adoption: October 1, 2002.

May 21, 2002

Linda Hoffman

Deputy Director

OTS-5693.1

AMENDATORY SECTION(Amending Order 89-1 and 89-1A, filed 4/20/89 and 3/13/90, effective 4/13/90)

WAC 173-50-010   Purpose.   Department of ecology, department of health, and other data users require persons and organizations submitting analytical data under the purview of their programs to use environmental laboratories which are accredited. The purpose of this chapter is to establish a state program for accreditation of environmental laboratories which conduct tests ((for or prepare data for submittal)) and submit data to the department of ecology, the department of health, and other data users. The accreditation program ((implemented under this chapter)) is designed to satisfy the intent of RCW 43.21A.230.

[Statutory Authority: RCW 43.21A.230. 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-010, filed 4/20/89 and 3/13/90, effective 4/13/90.]

     (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. 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.]

     • 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. 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.]

     (((1))) "Accreditation" ((means)) - the formal recognition by the department that an environmental laboratory is capable of producing accurate and defensible analytical data((,)). This recognition is signified by ((the)) issuance of a written certificate accompanied by a scope of accreditation indicating ((those)) the parameters ((and methods)) for which the laboratory ((has been)) 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 ((certifying or)) accrediting any laboratory pursuant to ((this chapter)) these rules, vouch for or warrant the accuracy of any particular work done or report issued by ((the)) that laboratory.

     (((2))) "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.

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

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

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

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

     "Environmental laboratory" ((means any)) - a facility:

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

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

     • Where data ((from which)) is submitted to the department of ecology, department of health, or other data user under ((the)) provisions of a ((department)) regulation, permit, or contractual agreement.

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

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

     (((6))) "Matrix" means the substance from which a material to be analyzed is extracted, such as 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.

     (((7))) "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.

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

     "Parameter" ((means)) - a single determination or sampling procedure, or group of related determinations or sampling procedures using a specific written method ((chosen by an applying laboratory)).

     (((8) "Performance audit" means)) "Proficiency testing (PT)" - evaluation of the results ((of analyses of unknown)) from the analysis of PT samples ((whose)). The true values of PT samples are unknown to the laboratory conducting the analyses ((and which)). PT samples are provided by a source external to the environmental laboratory. ((Such samples may be referred to as performance evaluation samples.

     (9))) "Quality control" ((means those)) - 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.

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

     (((11))) "Quality assurance manual" ((means)) - a written record ((of the)) intended to assure the reliability of measurement data. A QA manual documents policies, organization, objectives, and specific ((quality control)) QC and ((quality assurance)) QA activities ((established for use in an environmental laboratory to assure accuracy of analytical results)). Volume and scope of ((quality assurance)) QA manuals vary with complexity of the laboratory mission.

     (((12))) "Recognized analytical method" ((means)) - a documented analytical procedure ((for analysis of an environmental sample which was)) developed through collaborative studies by organizations or groups recognized by the ((department)) users of the laboratory's analytical data.

     (((13) "System audit" means an on-site inspection of laboratory capabilities by an agency external to the laboratory.

     (14) "Registration" means participation of a laboratory in a program to prepare the laboratory for accreditation, signified by issuance of a written certificate accompanied by a scope of registration indicating those parameters for which the laboratory has achieved registration status.

     (15) "Registered" means the status of continued participation in the preparatory program. Only laboratories owned and operated by municipalities, industries, and other activities which are dischargers as defined in chapter 173-220 or 173-216 WAC shall be eligible for participation in the preparatory program. Such laboratories are also eligible for accreditation. The department does not, by registering any laboratory pursuant to these rules, vouch for or warrant the accuracy of any particular work done or report issued by the laboratory.

Note:

Above referenced chapters are available through the Department of Ecology, P.O. Box 47600, Olympia, WA 98504-7600.))

     "Regulatory program" - a program administered by a federal, state, or other regulatory agency. Examples include, but are not limited to, the following federal Environmental Protection Agency programs:

     • The Clean Water Act (CWA);

     • The Safe Drinking Water Act (SDWA);

     • The Resource Conservation and Recovery Act (RCRA);

     • The Comprehensive Environmental Response Compensation and Liability Act (CERCLA);

     • The Toxic Substances Control Act (TSCA);

     • The Clean Air Act (CAA); and

     • The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

     "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 NELAP standards.

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

[Statutory Authority: RCW 43.21A.230. 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.]

     (4) Managers of environmental laboratories desiring accreditation or registration shall submit an application along with appropriate fees to the department fiscal officer, submit results of performance evaluations, a quality assurance manual and other required documentation to the quality assurance section, and assist/accommodate department personnel during system audits as required.)) (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;

     • Accrediting out-of-state laboratories;

     • Issuing, 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 must meet the experience, education, and training requirements established in the Environmental Protection Agency Manual for the Certification of Laboratories Analyzing Drinking Water.

     (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. 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.]

     (3) Eligible laboratories shall achieve registration status by submitting a completed application, paying required fees, and submitting a quality assurance manual to the quality assurance section.)) 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 (WAC 173-50-080).

[Statutory Authority: RCW 43.21A.230. 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.]

     • Request accreditation for specific parameters;

     • Calculate fees due 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.

[]

     (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.

[]

     (((2) Submission of raw data along with the report of analysis of the performance evaluation sample may be required at the discretion of the quality assurance section.

     (3) Performance audits for certain accreditation parameters may be waived at the discretion of the quality assurance section if performance evaluation samples are not available or for other valid reasons.

     (4) Accredited laboratories and laboratories seeking accreditation which fail to accurately analyze a performance evaluation sample may be allowed a second performance audit. If necessitated by a second failure, a third performance audit may be allowed (as an exception to subsection (1) of this section) only after the laboratory has investigated cause for failure in the preceding audits and completed corrective actions.

     (5) Registered laboratories shall submit results of performance evaluation sample analyses to the quality assurance section. Registration status shall not be denied or revoked solely for failure to accurately analyze performance evaluation samples. Registered laboratories shall investigate causes for errors in performance evaluation sample analysis results which have been identified as unacceptable or otherwise in error. The results of this investigation shall be reported to the quality assurance section within forty-five days of receipt of the performance evaluation report. The report to the quality assurance section shall identify probable causes for error and corrective actions taken to preclude recurrence.

     (6) Applying laboratories shall be responsible for obtaining performance evaluation samples. No fee shall be charged to the department for analysis of performance evaluation samples.)) (2) Drinking water 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. 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.]

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

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

     • Are present at the laboratory((,));

     • Readily available to analysts((,)); and

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

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

     • Available((,));

     • Being adequately maintained((,)); and ((are))

     • 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) Quality assurance. The laboratory quality assurance manual shall be reviewed for adequacy prior to the system audit. The system audit shall include a review of quality assurance plans and quality assurance/quality control records for programs/projects within which the laboratory is generating analytical data for submission to the department.)) (c) QA and QC records. The on-site assessment 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 ((system audit shall)) on-site assessment includes a review of applicable procedures for receipt, preservation, transportation, and storage of samples. The laboratory ((shall be held)) 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 ((system audit shall include a review of applicable procedures for checking documentation of)) on-site assessment includes a review of activities necessary to assure accurate management of laboratory data including:

     • Raw data((,));

     • Calculations((,));

     • Transcription ((and)), computer data entry, reports of analytical results((, and other activities necessary to assure accurate management of laboratory data)).

     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((, shall be brought to the attention of laboratory management under the heading of "recommended practices" and individually, shall)). 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 ((system audit shall)) department seeks to determine if managerial, supervisory, and ((analytical)) 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 ((shall be)) are specified in the program procedural manual.

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

     (((c) Safety. When the system audit notes laboratory safety problems, those judged serious shall be referred to appropriate state or federal agencies.

     (3) Registered laboratories shall be advised in a written system audit report prepared by the department of deficiencies in meeting critical element and recommended practice standards. The laboratory must respond in writing to the department within forty-five days of receipt of the system audit report concerning corrective actions taken as a result of the system audit report.)) (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 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. 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.]

     (2) Registration. Registered laboratories shall be issued a certificate and accompanying scope of registration. The certificate shall remain the property of the department of ecology and shall be surrendered to the department upon revocation of the registration status.)) (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:

     • Lists findings;

     • Assesses the importance of each finding; and

     • Makes 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 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. 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.]

     (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. 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.]

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

[Statutory Authority: RCW 43.21A.230. 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.]

     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. 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.]

     (2) Registration shall be granted for a one-year period and shall expire one year after the effective date of registration. Renewal shall require submission of an application and appropriate fees, an update of the laboratory's quality assurance manual, and completion of a new performance audit. System audits shall be required for renewal of registration at periods not to exceed three years from the previous system audit.)) (2) Renewal requires the laboratory to submit:

     • An application and appropriate fees;

     • An update of the laboratory's quality assurance manual if applicable; and

     • Successful completion of proficiency testing requirements.

     On-site assessments are required at periods not to exceed three years from the previous on-site assessment. 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.

[Statutory Authority: RCW 43.21A.230. 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.]

     (2) A laboratory may be denied registration status only for failure to render appropriate fees, for failing to disclose pertinent information in the application, or for misrepresenting its capabilities.)) (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;

     • Misrepresents itself to the department;

     • Fails to disclose pertinent information in the application;

     • Falsifies reports of analysis including PT 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.

     (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. 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.]

     (2) Registration status may be revoked for failure to submit a renewal application, failure to pay appropriate fees, failure to submit required performance evaluation sample analysis results, failure to report on corrective actions taken if performance evaluation results are unacceptable or otherwise in error, failure to submit to a system audit, failure to report on corrective actions taken on deficiencies identified in a system audit, repeated failure to correct the deficiencies identified in the performance or system audits, or for misrepresenting the capabilities of the registered laboratory.)) (1) Revocation of accreditation is the withdrawal of a previously granted accreditation. Revocation may involve the entire laboratory or one or more individual parameters. 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) 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;

     • 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 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 for enforcement purposes (WAC 173-50-210).

     (3) 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. 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.]

     (4) In granting secondary NELAP accreditation, the ecology accrediting authority must recognize the accreditation of other NELAP accrediting authorities.

[Statutory Authority: RCW 43.21A.230. 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-160, filed 4/20/89 and 3/13/90, effective 4/13/90.]

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

[Statutory Authority: RCW 43.21A.230. 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.]

     (2) Exemption ((shall be)) is granted only for those analytical parameters included in the federal Environmental Protection Agency Quality Assurance Program. The exemption status shall be reviewed annually based upon submittal by the laboratory of a new application and updated evidence of continued participation in a sufficient quality assurance program.

Note:

The federal Environmental Protection Agency does not presently administer a complete quality assurance program for wastewater dischargers in the state of Washington, such as would provide an exemption under subsection (1) of this section. Thus, this exemption is not presently available. The Environmental Protection Agency considers annual analysis of performance evaluation samples to constitute only one element of participation in a quality assurance program. The complete Environmental Protection Agency Quality Assurance Program is described in their Order 5360.1, "Policy and Program Requirements to Implement the Mandatory Quality Assurance Program," which is the basis for exemption requirements stated in subsection (1) of this section.

[Statutory Authority: RCW 43.21A.230. 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-180, filed 4/20/89 and 3/13/90, effective 4/13/90.]

TABLE 1 - FEE SCHEDULE

     (2) Out-of-state laboratories shall coordinate directly with the quality assurance section to determine the anticipated cost of completing the accreditation process. Reimbursement of the cost of travel and per diem shall be added to the normal fee indicated in WAC 173-50-190(1).

     (3) On-site inspections shall not be conducted nor shall interim or provisional or other accreditations be granted until appropriate fees have been received by the department.

     (4) The fee to defray costs to the department recognition of third-party accreditation (WAC 173-50-170) shall be three hundred dollars. The fee for recognition of a laboratory under a reciprocity agreement (WAC 173-50-160) shall be three hundred dollars, or as specified in the reciprocity agreement, but not less than three hundred dollars.

     (5) Apart from the fee process, applicant laboratories shall be required to acquire and analyze performance evaluation (PE) samples for parameters specified by the quality assurance section. The source of PE samples, if other than the federal Environmental Protection Agency, shall be approved by the quality assurance section. To the extent feasible as determined by the quality assurance section, performance evaluation samples already being analyzed by the applicant laboratories, shall be used to fulfill performance audit requirements of this chapter.

     (6) In addition to fees as determined by the number of parameters and methods in WAC 173-50-190(1), laboratories seeking registration status are required to pay an annual fee of six hundred dollars.

     (7) If a laboratory withdraws from the accreditation process after the application has been processed, but before accreditation or registration is granted, the fee will be nonrefundable up to an amount of two hundred dollars as reimbursement for costs of processing the application.

     (8) Dollar amounts listed in subsections (1), (4), (6), and (7) of this section may be adjusted every two years 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 subsections (1), (4), (6), and (7) of this section may be decreased at any time the department determines they are higher than needed to meet program requirements. The department shall notify affected parties of any fee adjustment at least thirty days prior to making any fee adjustment.)) (1) Fees in this chapter are in U.S. dollars and are established to cover costs of administering the accreditation program. The fee per parameter and maximum fee per category for each matrix are identified in Table 1.

     (2) Examples of parameters 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) A fee is assessed only once for a given parameter even though that specific parameter may be accredited under more than one matrix.

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		$65			$390
	(General)
	Chemistry II		$65			$760
	Organics I		$175			$690
	(GC/HPLC)
	Organics II		$175			$175
	(GC/MS)
	Microbiology		$175			$520
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)

     (4) In addition to paying the fee indicated in WAC 173-50-190(4), out-of-state laboratories must pay for the actual cost of travel associated with on-site assessments. The department invoices the laboratory for such costs after completion of the on-site assessment.

     (5) The laboratory must pay applicable fees before:

     • Its quality assurance manual is reviewed by the department;

     • The on-site assessment is conducted if applicable; and

     • Interim, provisional, or full accreditation is granted.

     (6) 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 WAC 173-50-190(4).

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

     (11) Dollar amounts listed in subsections (6), (7), (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 subsections (6), (7), (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. 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.]

[Statutory Authority: RCW 43.21A.230. 93-20-011 (Order 92-53), § 173-50-200, filed 9/22/93, effective 10/23/93; 90-21-090 (Order 90-21), § 173-50-200, filed 10/19/90, effective 11/19/90; 89-10-001 and 90-07-017 (Order 89-1 and 89-1A), § 173-50-200, filed 4/20/89 and 3/13/90, effective 4/13/90.]

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

[Statutory Authority: RCW 43.21A.230. 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.]

[Statutory Authority: RCW 43.21A.230. 90-21-090 (Order 90-21), § 173-50-220, filed 10/19/90, effective 11/19/90.]

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