VOLUME 47, ISSUE 8

ISSUE DATE: APRIL 20, 2015

RULE ADOPTIONS


ENVIRONMENTAL PROTECTION
ENVIRONMENTAL MANAGEMENT
DIVISION OF ENVIRONMENTAL SAFETY AND HEALTH


47 N.J.R. 782(a)




Adopted New Rule: N.J.A.C. 7:18-2.9A

Adopted Amendments: N.J.A.C. 7:18-1.4 through 1.7, 2.4, 2.5, 2.6, 2.9, 2.10, 2.13, 2.15, 2.20, 4.1, 4.3, 4.5, 5.1, 5.3, 5.4, 5.5, 6.1, 6.4, 7.1, 8, 9.3, 9.4, and 10.4

Regulations Governing the Certification of Laboratories and Environmental Measurements
 
Proposed: November 17, 2014, at 46 N.J.R. 2234(a).
 
Adopted: March 26, 2015, by Bob Martin, Commissioner, Department of Environmental Protection.
 
Filed: March 27, 2015, as R.2015 d.068, with non-substantial changes not requiring additional public notice and comments (see N.J.A.C. 1:30-6.3).
 
Authority: N.J.S.A. 13:1D-9 et seq., 13:1E-1 et seq., 13:1K-6 et seq., 26:2C-1 et seq., 26:2D-70 et seq., 58:10-23.11 et seq., 58:10A-1 et seq., 58:12A-1 et seq., and 58:12A-26 et seq.
 
DEP Docket Number: 08-14-10.
 
Effective Date: April 20, 2015.
 
Expiration Date: October 23, 2020.

This rule adoption can also be viewed or downloaded from the Department's website at www.nj.gov/dep/rules.

N.J.A.C. 7:18, Regulations Governing the Certification of Laboratories and Environmental Measurements, (Laboratory Certification rules) governs the certification of and the procedures used by laboratories that conduct analytical testing in response to many of the Department's regulatory programs. The Department's drinking water, groundwater, wastewater, air, soils, solid waste, hazardous waste, and sludge rules require regulated entities to conduct sampling to ensure compliance with the relevant rules. Laboratories then test the samples and the results of those tests are provided to the Department to demonstrate that the regulated entity is in compliance with the applicable regulatory standards.

In order that the Department is certain that it can rely upon the test results, it requires that tests be conducted only by laboratories that are certified under the Laboratory Certification rules. To obtain and maintain its certification, a laboratory must apply for certification and meet the standards set forth in the Laboratory Certification rules. The Department offers laboratories a choice of certification through the New Jersey Environmental Laboratory Certification Program (NJ-ELCP) pursuant to N.J.A.C. 7:18, or accreditation under the National Environmental Laboratory Accreditation Program (NELAP). The New Jersey accreditation under NELAP is referred to as NJ-NELAP. NJ-ELCP is the New Jersey-specific program, and NJ-NELAP is a national program; both are voluntary. A laboratory is "certified" under NJ-ELCP, and "accredited" under NJ-NELAP. For purposes of this document, in most instances the Department refers to both as "certified."

The adopted amendments substitute the national standards of The NELAC Institute (TNI) for those of the National Environmental Laboratory Accreditation Conference (NELAC). The adopted amendments also address the replacement of the USEPA-conducted performance evaluations with proficiency testing from approved providers, and require laboratories to investigate and take corrective action when a laboratory's analysis of a performance testing sample does not match the results that the sample provider prescribes.

The most substantial amendments pertain to fees. The adopted amendments and new rule restructure the program categories and fees to more accurately reflect the time and effort the Department spends performing the required certification activities, impose a supplemental fee on laboratories that apply for NJ-NELAP certification, and establish a mechanism by which the Department will, through publication in the New Jersey Register of a notice of fee report and administrative changes, adjust the fees.
 
Summary of Public Comments and Agency Responses:

1. Dale Hoover, AXYS Analytical Services Ltd.

2. Joe Jackson, AirNova, Inc.

3. Beverly Preast Carmichael, pCi/Labs, Inc.

4. Wayne Stollings, Triangle Environmental Services, Inc.

The comments received and the Department's responses are summarized below. The number(s) in parentheses after each comment identify the respective commenter(s) listed above.
 
Laboratory Developed and/or Non-Standard Methods

1. COMMENT: If the Department has certified a laboratory to use a particular Alternate Test Procedure (ATP) under the prior rules, will the Department require a reevaluation of that ATP under the adopted rules? (1)

RESPONSE: If a laboratory is certified to use a particular laboratory-developed and/or non-standard method, then the Department will not reevaluate that method under the adopted rules. The requested ATP will fall within one or more of the adopted laboratory-developed and/or non-standard methods categories; the Department will assess the fee for the category or categories.

2. COMMENT: If a laboratory has been certified by an accreditation body other than the Department to use a particular ATP, will the Department require the laboratory to undergo the ATP evaluation for certification from the Department before it will grant NELAP secondary accreditation? What fees will apply? (1)

RESPONSE: By way of background, when a laboratory participates in NELAP it is certified by an accreditation body, such as the Department under NJ-NELAP. The laboratory chooses the accreditation body. The accreditation body that performs the on-site assessment and reviews required documentation for certification is considered the primary accreditation body. The primary accreditation body grants the laboratory primary accreditation. Once a primary accreditation body grants a laboratory NELAP accreditation, the laboratory may then apply to other participating NELAP accreditation bodies for secondary accreditation. This could be necessary, for example, if the laboratory has primary NELAP accreditation from the Florida Department of Health, which is NELAP recognized accreditation body, but requires a New Jersey-specific certification to submit data to the Department. The laboratory may seek secondary accreditation under NJ-NELAP. A NELAP accreditation body that grants accreditation based on another accreditation body's evaluation and approval is considered a secondary accreditation body. Any NELAP accreditation body can be primary or secondary. If the laboratory is providing data to the Department, it must have primary or secondary accreditation under NJ-NELAP, or it must participate in the NJ-ELCP program.

Not all ATPs approved by an accreditation body other than the Department will meet the Department's requirements. Therefore, if the laboratory wants to use the ATP as the basis for data that it will report to the Department, then the Department may need to further evaluate the ATP to ensure consistency with Department program requirements. In that case, the ATP evaluation fee will be assessed. The laboratory-developed and/or non-standard methods category fee(s) will be assessed in all instances.

3. COMMENT: Will the Department continue to offer laboratory-developed methods for the drinking water matrix? If so, under what category and will the process for obtaining an ATP approval at N.J.A.C. 7:18-2.20 apply? (1)

RESPONSE: The Department has established a laboratory-developed and/or non-standard methods category under the drinking water matrix, DW13. All previously approved ATPs will apply, as discussed in the Responses to Comments 1 and 2. Although the ATP is available under the drinking water matrix, only the methods identified in the National Primary Drinking Water Regulations (40 CFR Part 141), and National Primary Drinking Water Regulations Implementation (40 CFR Part 142) may be used for drinking water compliance testing unless approval has been obtained in accordance with 40 CFR 141.27. The Federal rule allows an ATP to be used if the laboratory has the written permission of the state, and the concurrence of the Administrator of the U.S. Environmental Protection Agency (USEPA). If a laboratory requests certification under NJ-ELCP or NJ-NELAP (with the intent to report data to the Department) for an ATP in drinking water, the Department will certify the ATP only if the required approval has been obtained.

If a laboratory is requesting NJ-NELAP primary accreditation from the Department because it wishes to obtain NELAP secondary accreditation from another accreditation body, the Department may grant certification for an ATP for which approval under 40 CFR 141.27 has not been obtained; however, the laboratory cannot use the ATP for drinking water data to be submitted to the Department.
 
NELAP Supplemental Fee

4. COMMENT: The Department states in the proposal Summary that it spends more resources on the 250 NJ-NELAP laboratories than on the 600 NJ-ELCP laboratories (46 N.J.R. at 2238). According to the Department, the number of staff that is needed to administer the NJ-NELAP and the amount of time needed for each of these staff exceed those needed to administer the NJ-ELCP. To account for these differences, the Department is proposing to assess a NELAP Supplemental Fee of $ 3,500 for each laboratory requesting NJ-NELAP accreditation. Based on the information presented in the table in the Economic Impact (46 N.J.R. at 2240), the Department has calculated the supplemental fee incorrectly. The table shows that there are 850 total labs, but only 150 are accredited under NJ-NELAP. If there are 850 laboratories and 250 are accredited under NJ-NELAP, then the supplemental fee per laboratory should be $ 2,100, not $ 3,500. (2)

RESPONSE: The proposal Summary (46 N.J.R. at 2238), which states that there are 250 NJ-NELAP laboratories, is incorrect. The correct number is 150, as set forth in the Economic Impact (46 N.J.R. at 2240), which number was used to calculate the appropriate fee. The proposal Summary (46 N.J.R. at 2238) also incorrectly states that there are 600 NJ-ELCP laboratories. There are 700 NJ-ELCP laboratories. Although the Summary is incorrect, the Department used the correct figures when calculating the supplemental fee.

5. COMMENT: The NELAP supplemental fee will discourage laboratories from participating in NELAP and is punitive to the laboratories who seek to meet the highest accreditation requirements. The Department is assessing the fee to all NELAP laboratories, regardless of whether they possess primary or secondary accreditation with New Jersey. This discourages laboratories that do not conduct New Jersey compliance testing from participating in the NJ-NELAP. (2, 3)

6. COMMENT: Although the State's laboratory certification program was created with a two tier accreditation process, the impact of the supplemental fee for NELAP certification on any laboratory wishing to exercise a secondary accreditation seems to be excessive. The justification given for the surcharge for the NELAP accreditation is the extra reviews it requires. However, in the case of a laboratory seeking secondary accreditation, the extra reviews are not necessary. The primary accreditation entity is supposed to handle all of that responsibility, while the secondary accreditation entity reviews the primary certificate. Nevertheless, the Department does not charge a lower fee for secondary accreditation. The same charge for any level of NELAP accreditation seems to indicate that the NELAP program and associated surcharge are a cash stream, rather than participation in a national accreditation program. (4)

RESPONSE TO COMMENTS 5 AND 6: The Department calculated the NELAP supplemental fee based upon the cost of implementing NJ-NELAP as a whole, rather than on a laboratory by laboratory basis. As it stated in the proposal Summary, New Jersey uses substantially more resources to implement the NELAP program for the 150 participating NELAP laboratories than it does to administer the entire NJ-ELCP program to the 700 participating laboratories.

New Jersey has historically been one of the less expensive sources for accreditation; accordingly, out-of-State laboratories have found NJ-NELAP accreditation to be a particularly cost effective means of obtaining the national accreditation, even if the laboratories do not submit data to the Department. The taxpayers of New Jersey have heretofore subsidized the accreditation of these out-of-State laboratories. The adopted rules are intended to do away with that subsidy.

New Jersey participates in the NELAP program so that it can offer NJ-NELAP certification to laboratories that provide data to the Department and to facilitate greater cooperation among states that participate in NELAP, allowing reciprocity of accreditation between participating accreditation bodies. By offering an alternative to the NJ-ELCP, the Department's Laboratory Certification rules allow a laboratory that provides data to the Department and elsewhere to maintain certification within a single program that is recognized in multiple states. Participation in the NJ-NELAP reduces the certification costs to participating laboratories by reducing the number of individual state program audits the laboratory needs to fund.

A laboratory that requires both New Jersey and national certification can reduce its costs by choosing whether to participate in only the national NELAP program, or to combine NELAP and NJ-ELCP. One option is to obtain primary NELAP accreditation from a accreditation body other than New Jersey, and secondary accreditation under NJ-NELAP. If accreditation under NJ-NELAP is secondary, the laboratory would be subject to the supplemental fee, but would pay the on-site laboratory assessment costs, such as travel costs, only for the team of inspectors from the primary accreditation body. An alternative is to apply for primary accreditation under a NELAP from an accreditation body other than New Jersey, and apply for New Jersey certification under NJ-ELCP. Although the laboratory would save the adopted supplemental fee, it would pay the on-site laboratory assessment costs of both the NELAP accreditation body and the Department. Whether there is a savings to the laboratory would depend on whether the cost of the NJ-ELCP on-site inspection, usually conducted every three or four years, is less than the annual supplemental fee for participation in NJ-NELAP.

A laboratory that provides data only to the Department and obtains the NJ-ELCP certification instead of accreditation under NJ-NELAP would not be subject to the supplemental fee; however, it would still be required to reimburse the Department for the cost of the on-site evaluation. Although there may be some cost savings for the NJ-ELCP laboratory, the laboratory would not have the benefit of national certification and the reciprocal agreements that accreditation under NJ-NELAP provides. Which certification or combination of certifications is appropriate for a particular laboratory is a business decision that the laboratory will make.

7. COMMENT: The Department has based the supplemental fee of $ 3,500 by dividing the cost of the program by the number of NJ-NELAP laboratories. When small laboratories withdraw from the NJ-NELAP program because of the fee, will the Department divide the funding from the NELAP supplemental fee among the few large laboratories that remain in the NJ-NELAP program? Program costs will be reduced. Calculations to fund the administrative costs based solely on the number of laboratories seems flawed. (2)

RESPONSE: The NELAP supplemental fee will not be adjusted if laboratories choose not to participate in NJ-NELAP. As discussed in the proposal Summary, the supplemental fee is based on the number of hours the Department spends to administer the NJ-NELAP program. The cost of the NJ-NELAP program is divided among all NJ-NELAP participants in the form of the supplemental fee. If, as the commenter suggests, some laboratories withdraw from the NJ-NELAP program, program costs will decline. However, as laboratories withdraw, they will not pay the supplemental fee, causing revenues to also decline. The Department anticipates that the surcharge will continue to be necessary to offset the cost of the NJ-NELAP program, even if fewer laboratories participate in the program.
 
Fee Increases Generally

8. COMMENT: The increased fees will have a negative impact on small laboratories. In order to absorb the increased costs associated with these higher fees, laboratories will need to pass the increase onto their customers or reduce laboratory costs by performing only the performance testing that is required under the accreditation program. Performance testing improves laboratory results by providing independent verification of testing methods. If laboratories do not participate in the performance testing, overall laboratory results outside of the NELAP program will suffer. (2)

9. COMMENT: The fee schedule in the existing rules already penalizes smaller laboratories. The proposed fee increases will have a negative impact on laboratories that submit data to states in addition to New Jersey. A laboratory has the choice of absorbing the cost of the increased fees and not passing them to clients, which would have a significant economic impact on the laboratory and its owners and employees, or it could increase its prices to pass the costs to its clients. Only a large laboratory can absorb the increased fees. A laboratory that increases its fees could find itself priced out of some markets, particularly if its competitors are not subject to New Jersey's increased fees. Even if the laboratory increased its prices only for data submitted to New Jersey, the laboratory would incur the cost of developing and tracking a separate billing system. (4)

RESPONSE TO COMMENTS 8 AND 9: The Department acknowledges that the adopted fees will have an impact on laboratories. Fees for the laboratory certification program have remained the same since 1996. Since that time, the Department's costs to implement the laboratory certification program have risen, in part due to inflation and in part due to the increase in the number of certifications offered by the Department. Since 1996, the Department has added certifications for air and emissions, and private well testing, and has added NJ-NELAP accreditation. Accordingly, the Department has required additional resources to implement the laboratory certification program. Because the fees have not changed, the added cost of the program has fallen primarily on New Jersey taxpayers, instead of the participating laboratories. The adopted fees are intended to place the cost of the program back on the participating laboratories.

Laboratories are paid by clients to perform the analyses for which they are certified. How a laboratory chooses to respond to the adopted fees is a business decision that is up to the laboratory. For example, a laboratory may choose, as the commenter suggests, to discontinue performance tests that are not mandatory. Insofar as accreditation under NJ-NELAP and NJ-ELCP are concerned, the laboratory may take whatever measures it deems appropriate, provided that the programs' requirements are met. See also the Responses to Comments 5 and 6, and 12 for a discussion of potential cost savings to laboratories.

10. COMMENT: The increased fees will cause laboratories to abandon the New Jersey market, which will have multiple effects on the State. If there is limited competition, there is less market impact on pricing, which can negatively impact the clients in New Jersey. The concept seems to be that such an impact only falls on the industry being regulated, but that is not the case. The loss of competition becomes a greater concern when there is but a sole source available. At such a point it may become a legal issue, as any regulation requiring sampling would be requiring the use of that single entity. The Federal regulations, which New Jersey enforcement follows, do not have the limiting requirement of accreditation within a certain region. Thus, enforcement could be placed in a position where there were one or fewer options due to accreditation limitations. The costs of any resulting litigation or environmental impacts would be borne by the residents of the State. An option to allow unaccredited laboratories to mitigate this potential would seem to be an alternative, but not a positive one for the accreditation process. (4)

RESPONSE: As discussed above in the Response to Comments 8 and 9, the Department acknowledges that the adopted fees will have an impact on laboratories. Some laboratories may decide to withdraw from the laboratory certification program as a result of the increased fees, which could result in fewer laboratories certified to submit data to the Department. The Department certifies 700 laboratories under the NJ-ELCP program. Even if no laboratories participate in the NJ-NELAP program as a result of the supplemental fee, the Department does not anticipate that the reduction in laboratories certified under NJ-ELCP will be so extensive as to cause the consequences that the commenter suggests.

Under the Safe Drinking Water Act, N.J.S.A. 58:12A-1 et seq., Water Pollution Control Act, N.J.S.A. 58:10A-1 et seq., Radiation Protection Act, N.J.S.A. 26:2D-70 et seq. (for radon and radon progeny), Solid Waste Management Act, N.J.S.A. 13:1E-1 et seq., Industrial Site Recovery Act, N.J.S.A. 13:1K-6 et seq., Spill Compensation and Control Act, 5 N.J.S.A. 8:10-23.11 et seq., Private Well Testing Act, N.J.S.A. 58:12A-26 et seq., and Air Pollution Control Act, N.J.S.A. 26:2C-1 et seq., a laboratory must be certified under the Laboratory Certification rules in order to submit data to the Department. Similarly, the National Primary Drinking Water Regulations (40 CFR Part 141.28) and National Primary Drinking Water Regulations Implementation (40 CFR Part 142.10) require the analysis of drinking water to be conducted by certified laboratories. Accordingly, there is and will continue to be a market for New Jersey-certified laboratories. If laboratories leave the New Jersey market, the remaining laboratories will see an increase in work, and a potential increase in revenue. The increase in revenue could, in turn, lead to laboratories returning to the market. The Department does not believe that the reduction in laboratories will be so severe that it results in only one laboratory remaining to meet the analytical testing needs of the entities submitting results under the Department's various regulatory programs. Accordingly, the Department does not believe it will be necessary for the Department to resort to allowing testing by unaccredited laboratories.

The commenter mentions litigation and environmental impacts, the cost of which would be borne by State residents. Without more information about the litigation and environmental impacts to which the commenter refers, the Department is unable to respond.

11. COMMENT: The Department states that it anticipates the increased fees will have a modest economic impact on the regulated community, and that the higher fees will be assessed on proportionately larger laboratories that will be able to absorb the increase in fees. These statements are general and made without any supporting data. (2)

RESPONSE: The adopted fees reflect the time and effort spent by the Department to certify a laboratory in the various matrices. Fees are lower for the less complex categories within a particular matrix, as those require fewer Department resources. Similarly, the fees are higher for the more complex categories. The Department determined the technical complexity of each individual category based on the time and effort needed to complete the certification activities for that category and matrix, and established the fees accordingly.

Based upon decades of administering the laboratory certification program, the Department has found that smaller laboratories that perform less complex analyses within only a few matrices will incur lower fees than larger full-service laboratories that maintain certification within several matrices. Although both large and small laboratories will need to address their increased costs, large, full-service laboratories that are certified in more matrices and categories are likely more able to absorb the increased costs that the adopted fees represent, since they have a larger client base and conduct more analyses over which they can spread the costs.

12. COMMENT: The proposal discusses the accreditation of on-site brick and mortar laboratories and does not clearly indicate that the rules also apply to mobile laboratories. These laboratories are common for the categories in the air and emissions matrix. The rules will create an incentive for more companies to use mobile analyzers to save costs. (4)

RESPONSE: Both fixed and mobile laboratories are required to be certified in New Jersey if they submit data to the Department. The rules do not distinguish between fixed and mobile laboratories because each must be certified in the categories for which it submits data to the Department. The fee for certification in a particular category applies whether a laboratory is fixed or mobile. A full-service fixed laboratory that is certified in New Jersey and elsewhere, but that submits only air and emissions data to the Department may find it cost effective to obtain the less expensive NJ-ELCP certification for its required Department certification, as discussed in the Response to Comments 5 and 6 above. Similarly, a mobile laboratory that submits air and emissions data only to the Department may also choose certification under NJ-ELCP.

13. COMMENT: The Department's statement that it is "not feasible" to worry about how the rules will affect small businesses is troublesome. Moreover, job retention will be significantly impacted, contrary to the statements in the proposal's Jobs Impact statement. When the housing market and the job market declined in 2007, many small businesses were unable to continue operations. The reduction in the volume of work has already impacted New Jersey with at least one laboratory closing due to fraud allegations and another being charged with illegal dumping of hazardous waste. New Jersey still has one of the highest unemployment rates in the United States. This is not the time to further burden small businesses operating under New Jersey laboratory certification. (3)

RESPONSE: The Department's statement regarding the feasibility of considering the impact of the rules on small businesses was made in the context of the Regulatory Flexibility Analysis (46 N.J.R. at 2243). The New Jersey Regulatory Flexibility Act, N.J.S.A. 52:14B-16 et seq., requires the Department to, in part, indicate how the rule is designed to minimize any adverse economic impact on small businesses (N.J.S.A. 52:14B-19d). The statute directs the Department to use approaches such as differing compliance or reporting requirements or timetables, performance rather than design standards, and an exemption from coverage under the rule to minimize the economic impact on small businesses, to the extent that the approaches are consistent with the objectives of the applicable statutes.

The Department would be unable to maintain the integrity of the laboratory certification program if it provided small businesses with different compliance standards or requirements, or if it exempted small laboratories from the rules. As stated in the Regulatory Flexibility Analysis, "the proposed amendments and new rule relating to fees were designed to minimize adverse economic impacts on all affected laboratories, particularly small businesses, while continuing to meet the need for accurate, precise, and reliable data. It is not feasible for the Department to make further accommodation to small businesses, because to do so would impair the ability of the Department to ensure that all laboratories, including small businesses, are operating in a manner that ensures the accuracy of results" (emphasis added). The Department did consider the economic impact of the fees on small businesses, and provides laboratories with the option of either the State-specific accreditation under the NJ-ELCP, or a national certification under NJ-NELAP, subject to a surcharge. Within each certification program, a laboratory may choose certification in as many or as few matrices or categories as it needs. Except for the surcharge for the national accreditation, the fees are directly related to the categories for which a laboratory seeks certification.

If the Department were to provide separate fee schedules based upon the size of the laboratory, it would still need to cover the cost of operating the laboratory certification program. If fees for smaller laboratories were reduced, fees for larger laboratories would be increased, disproportionally impacting larger laboratories. The adopted fees ensure that the cost of the program is shared by all laboratories, in direct proportion to the services that each laboratory receives.

The commenter provides two examples of the reduction in jobs as a result of the closure of laboratories in New Jersey. The first example is a laboratory that closed as a result of fraud allegations, the second example is a laboratory that was charged with illegal dumping of hazardous waste. Neither example is relevant to whether the adopted rules will impact the creation or retention of jobs in the State.

14. COMMENT: The proposed radiochemistry fees outlined are not consistent with the state of the economy in general, and in New Jersey, specifically. Laboratories charge an average of $ 65.00 for a radiological analysis (gross alpha, 48hr test). In order to be certified to submit the data to the Department, the laboratory must pay a fee of nearly $ 6,000 per year, increased from $ 1,200 under the existing rules. The proposed fee is burdensome and onerous and will severely impact laboratories. Analytical fees will have to increase, or laboratories will have to reduce labor, thus reducing the payroll tax and other revenues to the State. In general, this scenario has the possibility of short cuts in quality and data integrity. (3)

RESPONSE: As discussed above in the Responses to Comments 5 through 9 and 11, the adopted fees are based upon the Department's cost to provide the services to the laboratories. The laboratory certification program's fees have not increased since 1996, resulting in the State's taxpayers subsidizing the participating laboratories through appropriations from the State's general fund to make up the difference between fee revenue and program costs. The Department acknowledges, as stated above in the Responses to Comments 8 and 9, and 10, that the fees will have an impact on laboratories; however, it is appropriate that the laboratories pay the cost of the services that the Department provides to them, which is the basis for the adopted fees. See the proposal's Jobs Impact (46 N.J.R. at 2242) regarding the effect that the Department anticipates the adopted rules will have on job creation and retention.

15. COMMENT: The comparisons between other states' fees are not relevant since the proposed fees are based on the Department's funding needs. (3)

RESPONSE: In the proposal's Economic Impact, the Department provided tables of fees from other states in order to demonstrate that certification fees that New Jersey charged under the prior rules were among the lowest in the country (46 N.J.R. at 2241-2242). The tables also show that the adopted fees are comparable to fees charged by other states with similar laboratory certification programs. As the commenter states, and as is set forth in the within responses to comments, the adopted fees reflect the Department's cost to provide the services to the laboratories. The Department did not base the adopted fees on the fees that other states charge.
 
Summary of Agency-Initiated Changes:

On adoption, the Department is modifying N.J.A.C. 7:18-2.9(f)1iii, which requires a laboratory to reimburse a certification inspector for costs the inspector incurs, including meals. As proposed, the rule states that the Department's certification inspector must present the laboratory with receipts or other evidence of the costs incurred. However, as indicated at N.J.A.C. 7:18-2.9(f)2, the costs to be paid by the laboratory are only those incurred in accordance with State and Federal travel policies. Section X.D.4 of the State of New Jersey Department of the Treasury circular No. 12-14-OMB states that meal expenses that are less than the Federal per diem allowance limits do not require receipts. A copy of the circular is available at www.nj.gov/infobank/circular/circindx.htm. The Department is modifying the rule on adoption to clarify that the certification inspector does not need to present receipts or other evidence of meal costs. Instead, the Federal per diem allowance will apply.

The scope of the radiochemical testing procedures at proposed N.J.A.C. 7:18-6.1(a)3 omits category AE06, Air - Laboratory Developed and/or Non-standard Methods, under the air and emissions matrix. The category is included among the categories for certification at N.J.A.C. 7:18-2.4(h)6, and it is included in the fee table at N.J.A.C. 7:18-2.9(b). It is also referred to in organization of subchapters at Table 2.1 at N.J.A.C. 7:18-2.4(i) as being addressed in Subchapter 6. The Department is modifying N.J.A.C. 7:18-6.1(a)3 on adoption to include category AE06.
 
Federal Standards Statement

Executive Order No. 27 (1994) and N.J.S.A. 52:14B-1 et seq. require that administrative agencies that adopt, readopt, or amend State regulations that exceed any Federal standards or requirements include in the rulemaking document a comparison with Federal law. Although the chapter does incorporate regulations promulgated by the USEPA, the amendments and new rule are not promulgated under the authority of or in order to implement, comply with or participate in any program established under Federal Law, or under a State statute that incorporates or refers to a Federal Law, Federal standards or Federal requirements. The Federal government does not administer a corresponding program, and has no standards or requirements for laboratory certification. Accordingly, the amendments and new rule do not exceed Federal standards or requirements. Accordingly, further analysis is not required.
 
Full text of the adoption follows (additions to proposal indicated in boldface with asterisks *thus*; deletions from the proposal indicated in brackets with asterisks *[thus]*):
 
SUBCHAPTER 1.    GENERAL PROVISIONS
 
7:18-1.4   Certification program requirements
 
(a) A laboratory may request certification in the New Jersey Environmental Laboratory Certification Program (NJ-ELCP) pursuant to N.J.A.C. 7:18 or accreditation in the New Jersey National Environmental Laboratory Accreditation Program (NJ-NELAP) pursuant to the TNI Standards, incorporated herein by reference at N.J.A.C. 7:18-1.5(d).
 
1. A laboratory shall not apply for or maintain simultaneous certification in the NJ-ELCP and NJ-NELAP.
 
2. A laboratory that has obtained NJ-NELAP accreditation pursuant to the TNI Standards shall comply with all sampling, enforcement, and data submittal requirements as established by N.J.A.C. 7:18 pursuant to the statutes specified at N.J.A.C. 7:18-1.1(c).
 
(b)-(e) (No change.)
 
7:18-1.5   Incorporation by reference
 
(a)-(c) (No change.)
 
(d) The TNI Standards (2009), together with amendments and supplements thereto, are incorporated by reference into this chapter. Copies of the TNI Standards are available on the TNI website at www.nelac-institute.org or from TNI at P.O. Box 2439, Weatherford, TX 76086, Telephone: (817) 598-1624.
 
7:18-1.6   Program information; notices; submittals
 
(a) Unless otherwise specified, any questions concerning the requirements of this chapter should be directed to the Department's Office of Quality Assurance at (609) 292-3950. Written inquiries can be directed to the following address:
 
   New Jersey Department of Environmental Protection
   Office of Quality Assurance
   PO Box 420, Mail Code 401-02D
   Trenton, NJ 08625-0420
 
(b) Unless otherwise specified, any submittals of PT sample results, submittals of documents, notices, or other communications required to be made to the Department under this chapter shall be made to the address specified in (a) above. Applications for certification and for renewals and modifications of certifications shall be submitted to the address specified in (a) above.
 
7:18-1.7   Definitions
 
The following words and terms, when used in this chapter, shall have the following meanings. If a definition in this section differs from the corresponding definition in any regulation or other document incorporated by reference under N.J.A.C. 7:18-1.5, the definition in the document incorporated by reference shall control.
 
. . .
 
"Accreditation body" means the agency or department designated at the territory, state, or Federal levels as the recognized authority with responsibility for granting TNI accreditation for a specified field of testing.
 
. . .
 
"Alternate Test Procedure (ATP)" means a procedure that:
 
1. Is a modification of an approved reference method or a procedure that uses the same determinative technique (for example, the physical and/or chemical process used to determine the identity and concentration of an analyte) and measures the same analyte(s) of interest as the approved reference method. The use of a different determinative technique to measure the same analyte(s) of interest as an approved reference method is considered a new method; or
 
2. (No change.)
 
. . .
 
"Authorized proficiency program" or "APP" means the USEPA Radon/Radon Progeny Measurement Proficiency Program, Eastern Environmental Radiation Facility, Montgomery, Alabama 36109, or other program authorized by the Department in writing as being equally stringent. The APP provides the Department with a laboratory's radon/radon progeny results of PT samples. The Department uses the laboratory's results and the expected acceptable limits to partially assess its analytical performance. Pursuant to N.J.A.C. 7:18-2.13, successful analysis of radon/radon progeny PT samples is necessary for obtaining and maintaining radon/radon progeny-in-air certification.
 
. . .
 
"CERCLA (CLP) Program" or "Contract Laboratory Program" means the USEPA contract program for the procurement of analytical data in support of its CERCLA program and the six Categories for which a laboratory may obtain certification from the Department for its CERCLA programs.
 
. . .
 
"Confluent growth" means a bacterial growth that covers the entire filtration area of the filter with no discrete colonies when performing microbiological analysis by the membrane-filter techniques listed in Categories DW01, NPW01, and SCM01. When confluent growth occurs, another sample must be obtained and analyzed using higher dilutions for the membrane-filter technique or using another approved technique.
 
. . .
 
"Field of accreditation" means TNI's approach to accrediting laboratories by matrix, technology, and analyte. Laboratories requesting accreditation for a matrix-technology-analyte combination or for an up-dated/improved method are required to submit only that portion of the accreditation process not previously addressed.
 
. . .
 
"National Environmental Field Activities Program" or "NEFAP" means the overall National Environmental Field Activities Program that is part of the TNI Standards.
 
"National Environmental Laboratory Accreditation Program" or "NELAP" means the overall National Environmental Laboratory Accreditation Program that uses the TNI Standards to grant laboratories national accreditation status.
 
. . .
 
"Proficiency test sample" or "PT sample" means a sample containing a known concentration of one or more specific parameters, used to evaluate the analytical performance of a laboratory.
 
"Proficiency test study" or "PT study" means an organized program in which laboratories participate in the analysis of PT sample aliquots from homogeneous sample batches. The PT samples contain one or more parameters monitored under a regulatory program, for example, the Drinking Water Program. Data from the study are analyzed statistically against a given set of acceptance criteria, to evaluate whether a laboratory's PT data are acceptable or unacceptable.
 
. . .
 
"Reciprocal" means by mutual agreement of two or more states to accept each other's findings regarding the ability of environmental testing laboratories in meeting TNI Standards.
 
"Recognition" means the determination that an accreditation body meets the requirements of the NELAP and is authorized to grant NELAP accreditation to laboratories.
 
. . .
 
"Regulatory sample" means either of the following:
 
1. (No change.)
 
2. A proficiency test (PT) sample.
 
. . .
 
"Stationary source audit sample" or "SSAS" means a blind sample, the composition of which is unknown to the stationary source tester and laboratory, and that is provided to evaluate whether, during a particular test event, the stationary source tester and/or laboratory can produce measurement results within specified acceptance criteria. Audit samples are not analyzed on a regular schedule, but they are analyzed only during the particular event (for example, a compliance test) that is being audited. Audit samples are analyzed, or collected and analyzed, as part of the batch of field test samples using the same personnel, procedures, and materials.
 
. . .
 
"The National Environmental Laboratory Accreditation Conference (NELAC) Institute" or "TNI" means a voluntary organization of state and Federal environmental officials and members purposed primarily to establish mutually acceptable standards for accrediting environmental laboratories and field activity facilities.
 
"TNI recognition" means the determination that an accreditation body meets the requirements of the TNI Standards and is authorized to grant TNI accreditation to laboratories and field activity facilities performing environmental measurements.
 
"TNI Standards" means the plan of procedures developed by TNI for consistently evaluating and documenting the ability of laboratories and field activity facilities performing environmental measurements, to meet nationally defined standards. See N.J.A.C. 7:18-1.5.
 
. . .
 
SUBCHAPTER 2.    PROGRAM PROCEDURES AND REQUIREMENTS
 
7:18-2.4   Categories for certification
 
(a) (No change.)
 
(b) An applicant shall apply for certification to perform sample analysis and to report results for one or more parameters within one or more categories listed in (c) through (h) below.
 
(c) The parameters for which a laboratory may be certified to perform sample analysis in the drinking water matrix are organized within the following categories:
 

 

1.

Category DW01:

Microbiology;

 

 

 

2.

Category DW02:

Parasitology and Molecular Microbiology;

 

 

 

3.

Category DW03:

Inorganic Parameters;

 

 

 

4.

Category DW04:

Analyze-Immediately and Continuous

 

 

Monitoring;

 

 

 

5.

Category DW05:

Asbestos Analysis;

 

 

 

6.

Category DW06:

Metals;

 

 

 

7.

Category DW07:

Metals - ICP, ICP/MS and DCP;

 

 

 

8.

Category DW08:

Organic Parameters - Chromatography;

 

 

 

9.

Category DW09:

Organic Parameters - Chromatography/MS;

 

 

 

10.

Category DW10:

Radiochemistry - Radioactivity and

 

 

Radionuclides;

 

 

 

11.

Category DW11:

Radon in Drinking Water;

 

 

 

12.

Category DW12:

Drinking Water Sample Collection; and

 

 

 

13.

Category DW13:

Drinking Water - Laboratory Developed

 

 

and/or Non-Standard Methods.

 

 

 


 
(d) The parameters for which a laboratory may be certified to perform sample analysis in the non-potable water matrix are organized within the following categories:
 

 

1.

Category NPW01:

Microbiology;

 

 

 

2.

Category NPW02:

Parasitology and Molecular Microbiology;

 

 

 

3.

Category NPW03:

Inorganic Parameters;

 

 

 

4.

Category NPW04:

Analyze-Immediately and Continuous

 

 

Monitoring;

 

 

 

5.

Category NPW05:

Asbestos Analysis;

 

 

 

6.

Category NPW06:

Metals - NPW Preparation Methods;

 

 

 

7.

Category NPW07:

Metals;

 

 

 

8.

Category NPW08:

Metals - ICP, ICP/MS and DCP;

 

 

 

9.

Category NPW09:

Organics - NPW Preparation and Screening;

 

 

 

10.

Category NPW10:

Organic Parameters - Chromatography;

 

 

 

11.

Category NPW11:

Organic Parameters - Chromatography/MS;

 

 

 

12.

Category NPW12:

Toxicity Testing;

 

 

 

13.

Category NPW13:

Radiochemistry - Radioactivity and

 

 

Radionuclides;

 

 

 

14.

Category NPW14:

Radon in Non-Potable Water;

 

 

 

15.

Category NPW15:

Non-Potable Water Sample Collection; and

 

 

 

16.

Category NPW16:

NPW - Laboratory Developed and/or

 

 

Non-Standard Methods.

 

 

 


 
(e) The parameters for which a laboratory may be certified to perform sample analysis in the biological tissue matrix are organized within the following categories:
 

 

1.

Category BT01:

Inorganic Parameters;

 

 

 

2.

Category BT02:

Metals - BT Preparation Methods;

 

 

 

3.

Category BT03:

Metals;

 

 

 

4.

Category BT04:

Metals - ICP, ICP/MS and DCP;

 

 

 

5.

Category BT05:

Organics - BT Preparation Methods;

 

 

 

6.

Category BT06:

Organic Parameters - Chromatography;

 

 

 

7.

Category BT07:

Organic Parameters - Chromatography/MS; and

 

 

 

 

 

 

8.

Category BT08:

BT - Laboratory Developed and/or

 

 

Non-Standard Methods.

 

 

 


 
(f) The parameters for which a laboratory may be certified to perform sample analysis in the solid and chemical materials matrix are organized within the following categories:
 

 

1.

Category SCM01:

Microbiology;

 

 

 

2.

Category SCM02:

Characteristics of Hazardous Waste and

 

 

Physical Analyses;

 

 

 

3.

Category SCM03:

Inorganic Parameters and Preparation;

 

 

 

4.

Category SCM04:

Asbestos Analysis;

 

 

 

5.

Category SCM05:

Metals - SCM Preparation Methods;

 

 

 

6.

Category SCM06:

Metals;

 

 

 

7.

Category SCM07:

Metals - ICP, ICP/MS and DCP;

 

 

 

8.

Category SCM08:

Organics - SCM Preparation and Screening

 

 

Methods;

 

 

 

9.

Category SCM09:

Organic Parameters - Chromatography;

 

 

 

10.

Category SCM10:

Organic Parameters - Chromatography/MS;

 

 

 

11.

Category SCM11:

Polychlorinated Dibenzo-p-dioxins and

 

 

Polychlorinated Dibenzofurans;

 

 

 

12.

Category SCM12:

Radiochemistry - Radioactivity and

 

 

Radionuclides;

 

 

 

13.

Category SCM13:

SCM Sample Collection; and

 

 

 

14.

Category SCM14:

SCM - Laboratory Developed and/or

 

 

Non-Standard Methods.

 

 

 


 
(g) The parameters for which a laboratory may be certified to perform sample analysis and to report results for purposes of determining compliance with the CERCLA(CLP) Program are organized within the following categories:
 

 

1.

Category CLP01:

NPW - Multi-Concentration Inorganics;

 

 

 

2.

Category CLP02:

NPW - Multi-Concentration Organics;

 

 

 

3.

Category CLP03:

NPW - Polychlorinated Dibenzo-p-dioxins and

 

 

Polychlorinated Dibenzofurans;

 

 

 

4.

Category CLP04:

SCM - Multi-Concentration Inorganics;

 

 

 

5.

Category CLP05:

SCM - Multi-Concentration Organics; and

 

 

 

6.

Category CLP06:

SCM - Polychlorinated Dibenzo-p-dioxins and

 

 

Polychlorinated Dibenzofurans.

 

 

 


 
(h) The parameters for which a laboratory may be certified to perform sample analysis in the air and/or emissions matrix are organized within the following categories:
 

 

1.

Category AE01:

Inorganics - Non-Metals Analysis;

 

 

 

2.

Category AE02:

Inorganics - Metals Analysis;

 

 

 

3.

Category AE03:

Asbestos Analysis;

 

 

 

4.

Category AE04:

Organics Analysis;

 

 

 

5.

Category AE05:

Radionuclides Analysis;

 

 

 

6.

Category AE06:

Air - Laboratory Developed and/or

 

 

Non-Standard Methods;

 

 

 

7.

Category AE07:

Air Sample Collection;

 

 

 

8.

Category AE08:

Radon in Air; and

 

 

 

9.

Category AE09:

Radon in Air - Laboratory Developed and/or

 

 

Non-Standard Methods.

 

 

 


 
(i) Table 2.1 illustrates the organization of Subchapters 3 through 9 (N.J.A.C. 7:18-3 through 9).
 
Table 2.1
 
Organization of Subchapters 3 through 9
 

 

Subchapter

Title

Categories

 

 

 

3

General Laboratory

All

 

Facilities &

 

 

Equipment

 

 

 

 

4

Microbiology

DW01-DW02, DW12-DW13, NPW01-NPW02,

 

 

NPW15-NPW16, SCM01, SCM14

 

 

 

5

Chemistry

DW03-DW09, DW12-DW13, NPW03-NPW11,

 

 

NPW15-NPW16, BT01-BT08, SCM02-SCM11,

 

 

SCM13-SCM14, CLP01-CLP06, AE01-AE04,

 

 

AE06-AE07

 

 

 

6

Radiochemistry &

DW10-DW11, DW13, NPW13-NPW14, NPW16,

 

Radon/Radon

SCM12, SCM14, AE05, AE06, AE08-AE09

 

Progeny-in-Air

 

 

 

 

7

Toxicity Testing

NPW12

 

 

 

8

Analyze Immediately

DW04, NPW04

 

and Continuous

 

 

Monitoring

 

 

 

 

9

Sample Requirements

All

 

 

 


 
(j) An out-of-State laboratory, which has received NELAP accreditation from a state that has received NELAP recognition, shall be eligible for reciprocal accreditation to perform environmental sample analyses in accordance with (a) through (i) above, provided:
 
1. The laboratory is NELAP accredited by a state recognized as a NELAP accreditation body for those fields of testing in which the laboratory is requesting accreditation pursuant to this subsection;
 
2.-3. (No change.)
 
(k) (No change.)
 
(l) If, upon review of the documents listed in (j)2 and 3 above, the Department is unable to determine that the out-of-State laboratory has met the requirements of this chapter, then the Department shall contact the NELAP-primary accreditation body and request that it conduct an on-site assessment of the laboratory.
 
7:18-2.5   Procedure for initial application of a laboratory seeking certification
 
(a) A laboratory seeking initial certification for one or more parameters in any category listed in N.J.A.C. 7:18-2.4(c) through (h) shall submit an application to the Department, at the address listed in N.J.A.C. 7:18-1.6(a).
 
(b) The applicant shall complete the application form supplied by the Department, including the following:
 
1.-7. (No change.)
 
8. If the applicant has participated in any Department-authorized proficiency testing study during the 12 months immediately preceding the application, the applicant may submit the results of such proficiency testing for any parameters for which the applicant is seeking certification;
 
9.-12. (No change.)
 
(c)-(d) (No change.)
 
7:18-2.6   Conditions for the granting of certification
 
(a) To be eligible for certification, an applicant shall satisfy all of the requirements listed in (a)1 through 8 below:
 
1.-4. (No change.)
 
5. The applicant satisfies all applicable proficiency testing requirements under N.J.A.C. 7:18-2.13, including, but not limited to, acceptably analyzing any and all PT samples for each parameter within each category for which certification is sought;
 
6. The applicant satisfies the requirements for on-site audits under N.J.A.C. 7:18-2.14, including, but not limited to, the requirement to correct deficiencies identified by the Department in the on-site audit. If the applicant is seeking certification for radiochemistry: radioactivity and radionuclide testing, radon, and radon/radon progeny in air, and the Department is unable to schedule an on-site audit within 90 days after receiving an administratively complete application, the Department may grant temporary approval to a laboratory to analyze radiochemical samples, excluding radon/radon progeny-in-air, until the Department performs the on-site audit. If the Department grants temporary approval, the applicant shall continue to participate in an approved proficiency testing program and acceptably analyze the program's samples;
 
7. The applicant completes its analysis of PT samples and all other requirements for certification within the time specified by the Department; and
 
8. (No change.)
 
(b) (No change.)
 
7:18-2.9   Fees
 
(a) (No change.)
 
(b) The fee schedule is set forth below. To calculate the fee for a given service, add the fee for the administrative activity and the fee for each category affected by the application. For example, if a laboratory seeks an initial certification in category DW01, the fee would be the sum of $ 900.00 (the administrative activity fee) and $ 540.00 (the category fee), for a total of $ 1,440. For NELAP laboratories, the NELAP Supplemental Fee must also be included in the total.
 
Environmental Laboratory Application
 

 

Change-Of-Status And Certification Categories

Fees

 

 

 

I.

Administrative Activities

 

 

 

Initial Application Fee

$ 900.00

 

 

 

Renewal Application Fee

$ 600.00

 

 

 

Request for Modification in Certified, Applied or Interim

$ 400.00

Approval Status

 

 

 

NJ-NELAP Supplemental Fee

$ 3,500

 

 

 

Travel Assessment Fee (per hour, per day, per person)

$ 134.00

 

 

 

Laboratory Developed and/or Non-Standard Methods Application

$ 600.00

and Evaluation Fee

 

 

 

II.

Drinking Water Matrix Categories (DW01-DW13)

 

 

 

DW01

Microbiology

$ 540.00

 

 

 

DW02

Parasitology and Molecular Microbiology

$ 1,675

 

 

 

DW03

Inorganic Parameters

$ 540.00

 

 

 

DW04

Analyze-Immediately and Continuous Monitoring

$ 235.00

 

 

 

DW05

Asbestos Analysis

$ 540.00

 

 

 

DW06

Metals

$ 540.00

 

 

 

DW07

Metals - ICP, ICP/MS and DCP

$ 840.00

 

 

 

DW08

Organic Parameters - Chromatography

$ 840.00

 

 

 

DW09

Organic Parameters - Chromatography/MS

$ 840.00

 

 

 

DW10

Radiochemistry - Radioactivity and Radionuclides

$ 840.00

 

 

 

DW11

Radon in Drinking Water

$ 370.00

 

 

 

DW12

Drinking Water Sample Collection

$ 235.00

 

 

 

DW13

Drinking Water - Laboratory Developed and/or

$ 1,675

 

Non-Standard Methods

 

 

 

 

III.

Non-Potable Water Matrix Categories (NPW01-NPW16)

 

 

NPW01

Microbiology

$ 540.00

 

 

 

NPW02

Parasitology and Molecular Microbiology

$ 1,675

 

 

 

NPW03

Inorganic Parameters

$ 540.00

 

 

 

NPW04

Analyze-Immediately and Continuous Monitoring

$ 235.00

 

 

 

NPW05

Asbestos Analysis

$ 540.00

 

 

 

NPW06

Metals - NPW Preparation Methods

$ 235.00

 

 

 

NPW07

Metals

$ 540.00

 

 

 

NPW08

Metals - ICP, ICP/MS and DCP

$ 840.00

 

 

 

NPW09

Organics - NPW Preparation Methods

$ 235.00

 

 

 

NPW10

Organic Parameters - Chromatography

$ 840.00

 

 

 

NPW11

Organic Parameters - Chromatography/MS

$ 840.00

 

 

 

NPW12

Toxicity Testing

$ 1,675

 

 

 

NPW13

Radiochemistry - Radioactivity and Radionuclides

$ 840.00

 

 

 

NPW14

Radon in Non-Potable Water

$ 370.00

 

 

 

NPW15

Non-Potable Water Sample Collection

$ 235.00

 

 

 

NPW16

NPW - Laboratory Developed and/or Non-Standard

$ 1,675

 

Methods

 

 

 

 

IV.

Contract Laboratory Program Categories (CLP01-CLP06)

 

 

 

CLP01

NPW - Multi-Concentration Inorganics

$ 540.00

 

 

 

CLP02

NPW - Multi-Concentration Organics

$ 840.00

 

 

 

CLP03

NPW - Polychlorinated Dibenzo-p-dioxins and

$ 840.00

 

Polychlorinated Dibenzofurans

 

 

 

 

CLP04

SCM - Multi-Concentration Inorganics

$ 540.00

 

 

 

CLP05

SCM - Multi-Concentration Organics

$ 840.00

 

 

 

CLP06

SCM - Polychlorinated Dibenzo-p-dioxins and

$ 840.00

 

Polychlorinated Dibenzofurans

 

 

 

 

V.

Solid and Chemical Materials Categories (SCM01-SCM14)

 

 

 

SCM01

Microbiology

$ 540.00

 

 

 

SCM02

Characteristics of Hazardous Waste and Physical

$ 235.00

 

Analyses

 

 

 

 

SCM03

Inorganic Parameters and Preparation

$ 540.00

 

 

 

SCM04

Asbestos Analysis

$ 540.00

 

 

 

SCM05

Metals - SCM Preparation Methods

$ 235.00

 

 

 

SCM06

Metals

$ 540.00

 

 

 

SCM07

Metals - ICP, ICP/MS and DCP

$ 840.00

 

 

 

SCM08

Organics - SCM Preparation and Screening Methods

$ 370.00

 

 

 

SCM09

Organic Parameters - Chromatography

$ 840.00

 

 

 

SCM10

Organic Parameters - Chromatography/MS

$ 840.00

 

 

 

SCM11

Polychlorinated Dibenzo-p-dioxins and

$ 840.00

 

Polychlorinated Dibenzofurans

 

 

 

 

SCM12

Radiochemistry - Radioactivity and Radionuclides

$ 840.00

 

 

 

SCM13

SCM Sample Collection

$ 235.00

 

 

 

SCM14

SCM - Laboratory Developed and/or Non-Standard

$ 1,675

 

Methods

 

 

 

 

VI.

Air and Emissions Matrix Categories (AE01-AE09)

 

 

 

AE01

Inorganics - Non-Metals Analysis

$ 370.00

 

 

 

AE02

Inorganics - Metals Analysis

$ 540.00

 

 

 

AE03

Asbestos Analysis

$ 540.00

 

 

 

AE04

Organics Analysis

$ 840.00

 

 

 

AE05

Radionuclides Analysis

$ 840.00

 

 

 

AE06

Air - Laboratory Developed and/or Non-Standard

$ 1,675

 

Methods

 

 

 

 

AE07

Air Sample Collection

$ 370.00

 

 

 

AE08

Radon in Air

$ 370.00

 

 

 

AE09

Radon in Air - Laboratory Developed and/or

$ 1,675

 

Non-Standard Methods

 

 

 

 

VII.

Biological Tissue Matrix Categories (BT01-BT08)

 

 

 

 

 

 

BT01

Inorganic Parameters

$ 540.00

 

 

 

BT02

Metals - BT Preparation Methods

$ 235.00

 

 

 

BT03

Metals

$ 540.00

 

 

 

BT04

Metals - ICP, ICP/MS and DCP

$ 840.00

 

 

 

BT05

Organics - BT Preparation Methods

$ 235.00

 

 

 

BT06

Organic Parameters - Chromatography

$ 840.00

 

 

 

BT07

Organic Parameters - Chromatography/MS

$ 840.00

 

 

 

BT08

BT - Laboratory Developed and/or Non-Standard

$ 1,675

 

Methods

 

 

 

 


 
(c) (No change.)
 
(d) If a laboratory's application for certification is pending as of July 1 in a given year and it has not completed all of the requirements for certification by that date, the laboratory shall pay the Administrative Activities - Renewal Application Fee described in (b) above by July 1, but is not required to pay the fee for the category or categories in which certification is pending. If the laboratory becomes certified in such a category after July 1, it shall pay the fee for the category, pro-rated for the number of months (including any part of a month) remaining until the following July 1. The laboratory shall pay this fee within 30 days after the laboratory becomes certified. For example, if a laboratory applies for certification in Category DW01 on October 1, 2015, but does not become certified in that category until September 15, 2016, it shall pay fees as follows:
 
1. On October 1, 2015, $ 900.00 for the initial application fee and $ 540.00 for the category;
 
2. On July 1, 2016, $ 600.00 for the renewal application fee; and
 
3. Within 30 days after September 15, 2016, $ 450.00 representing the $ 540.00 category fee pro-rated for 10 months.
 
(e) Environmental laboratories applying for or renewing certification for a similar technology in more than one of the following combined categories are eligible for a reduced fee:
 
1. Microbiological parameters, Categories DW01, NPW01, and/or SCM01: $ 1,026;
 
2. Analyze-Immediately and Continuous Monitoring Categories DW04 and NPW04: $ 376.00;
 
3. Metal Categories DW06, NPW07, and/or SCM06: $ 1,026;
 
4. Metals - ICP, ICP/MS, and DCP Categories DW07, NPW08, and/or SCM07: $ 1,596; and
 
5. Radon in Water, Categories DW11 and NPW14: $ 703.00.
 
(f) If the Department conducts an on-site audit of an out-of-State environmental laboratory, the laboratory shall be responsible for payment of the costs incurred by the certification inspector, in accordance with the following:
 
1. The direct cost of overnight accommodations, transportation, meals, miscellaneous expenses, and, if the laboratory is located outside the United States, expenses resulting from foreign currency exchanges, as follows:
 
i. The laboratory shall pay the certification inspector's lodging and transportation expenses directly to the hotel and transportation provider in advance of the on-site audit.
 
ii. If the Department pays the costs identified in (f)1 above, the laboratory shall reimburse the Department within 30 calendar days after the date of the Department's statement to the laboratory, setting forth the costs.
 
iii. If the certification inspector pays the costs identified in (f)1 above, the laboratory shall reimburse the certification inspector directly, within 30 calendar days after the date the certification inspector presents the laboratory with receipts or other evidence of costs incurred. *A receipt or other evidence of costs incurred shall not be required for meals. The laboratory shall reimburse the certification inspector for meals in accordance with the applicable Federal per diem rates.*
 
2. The costs paid by the laboratory under (f)1 above shall be only those incurred by the certification inspector in accordance with State and Federal travel policies, including, but not limited to, motor vehicle mileage reimbursement, and allowances for meals, incidental expenses, and per diem.
 
3. When an overnight stay is necessary in order for the certification inspector to conduct an audit, the Department shall calculate and assess the Travel Assessment Fee in (b) above for the certification inspector's travel time to and from the laboratory, not to exceed seven hours per inspector per travel day. Travel time is measured from the time the inspector leaves his or her home until the time he or she arrives at either the hotel or the laboratory, whichever is first. The Department shall provide the laboratory with a statement specifying the calculated Travel Assessment Fee. Within 30 calendar days after the date of the statement, the laboratory shall remit to the Department the fee specified on the statement. The Travel Assessment Fee shall be in addition to any other fees or expenses payable in accordance with N.J.A.C. 7:18-2.9.
 
(g) If the Department purchases PT samples for a laboratory, the laboratory shall reimburse the Department for the actual cost that the Department incurs to purchase the PT samples. The Department shall provide the laboratory with an invoice specifying the costs incurred. Within 30 calendar days after the date of the invoice, the laboratory shall remit to the Department the amount specified on the invoice.
 
7:18-2.9A   Annual adjustment of fees
 
(a) When, based on budget considerations, the Department determines to adjust the fees established in N.J.A.C. 7:18-2.9, Fees, for the upcoming State fiscal year (which runs from July 1 to June 30), the Department shall:
 
1. Prepare a Fee Adjustment Report, in accordance with (b) below; and
 
2. Publish a notice of administrative change in the New Jersey Register that:
 
i. States that the Fee Adjustment Report is available on the Department's website at www.nj.gov/dep/oqa; and
 
ii. Sets forth the adjusted fees determined as provided at (b) below.
 
(b) In the Fee Adjustment Report, the Department shall:
 
1. Project the total amount of money required to fund the program in the upcoming State fiscal year. This projection shall consider the following:
 
i. The number and type of Department staff required to perform each activity for which fees are charged and the projected total salaries of those staff for the upcoming State fiscal year;
 
ii. The total cost of fringe benefits for those Department staff, calculated as the projected total salaries of those staff multiplied by a percentage set by the New Jersey Department of the Treasury that reflects costs associated with pensions, health benefits, workers' compensation, disability benefits, unused sick leave, and the employer's share of FICA;
 
iii. Indirect costs attributable to those Department staff, calculated as the total salaries and fringe benefits for those staff multiplied by a percentage known as the indirect cost rate. The indirect cost rate is negotiated annually with the U.S. Environmental Protection Agency and is the total of the Department's costs for management and administrative costs applicable to multiple cost objectives (including, but not limited to, indirect management and administrative salary and non-salary costs, applicable fringe benefits, building rent, and the Department's share of the Statewide Cost Allocation Plan) divided by total Department direct salaries plus applicable fringe benefits; and
 
iv. Projected operating costs attributable to those Department staff, including, but not limited to, costs for postage, telephone, travel, supplies, and data system management;
 
2. Project the total amount of revenue expected to be received from fees identified in N.J.A.C. 7:18-2.9 in the upcoming State fiscal year. This projection shall consider the following:
 
i. The amount and type of fees for initial or renewal certifications or modifications of certifications received in the previous State fiscal year. Any trend toward increasing or decreasing certification activities and such trend's impact, if any, on the amount and type of fees anticipated for the upcoming State fiscal year;
 
ii. Other data concerning economic trends reasonably likely to influence the amount and type of fees anticipated for the upcoming State fiscal year; and
 
iii. The fees in effect at the time such projection is made.
 
3. Project the total amount of money to be available from sources other than fees, such as State appropriations or Federal grants, for the upcoming State fiscal year;
 
4. Subtract the amounts in (b)2 and 3 above from the amount in (b)1 above. The remainder is the projected fee revenue shortfall for the upcoming State fiscal year; and
 
5. Divide the projected fee revenue shortfall in (b)4 above by the total amount of revenue expected to be received from fees in (b)2 above to determine the fee adjustment factor. The amounts of the adjusted fees for the upcoming State fiscal year shall be obtained by increasing the existing fees by the fee adjustment factor.
 
(c) When the Department increases fees in accordance with this section, each increased fee shall be rounded to the next whole dollar.
 
7:18-2.10   Environmental laboratory personnel requirements
 
(a) A certified environmental laboratory shall employ qualified personnel who possess the education, training, and experience required under this section. The laboratory shall maintain current employee records that include a resume and college transcript documenting each employee's training, experience, duties, and dates of relevant employment. The laboratory shall include at least the following personnel:
 
1.-2. (No change.)
 
3. A Quality Assurance (QA) Officer. For a laboratory that is certified or seeks to be certified in any of Categories CLP01 through 6, the QA Officer shall meet the applicable requirements of (b)9 below. For any other laboratory, the QA Officer shall meet the applicable requirements of (b) below for a supervisor in any Category, provided, however, that an individual who meets only the requirements for a supervisor in the Categories listed in (b)2 below may serve as the QA Officer only in those Categories; and
 
4. (No change.)
 
(b) No environmental laboratory shall be certified to perform analyses in a Category unless the supervisor and operating personnel (where so indicated) meet the following requirements:
 
1. For microbiological and parasitology and molecular microbiology testing in Categories DW01-DW02, NPW01-NPW02, and SCM01, the supervisor shall meet the requirements of at least one of the qualification levels listed below:
 

 

Qualification

Degree

Microbiology

Years of Experience

Level

 

Credits

Microbiological

 

 

 

Analysis<3>

 

 

 

 

A

>/= BA/BS<1>

4<2>

1

 

 

 

 

 

 

 

 

B

AA<1>

4<2>

3

 

 

 

 

C

None

0<2>

5

 

 

 

 


 
<1> Degree in a chemical, physical, biological, or environmental science from an accredited institution.
 
<2> Courses from an accredited college, or equivalent course from a training institute if supervisor has less than four semester hours credit in bacteriology.
 
<3> Unless the requirements of footnotes 1 and 2 are more stringent, personnel requirements for Parasitology and Molecular Microbiology shall be in accordance with all associated method requirements.
 
2. For Chemical Testing in analyze-immediately and continuous monitoring Categories DW04 and NPW04, and Categories DW03 and NPW03 for turbidity and residue-settleable, the supervisor shall have had at least three months of experience in performing these tests;
 
3. For Chemical Testing in Inorganic Parameters, Characteristics of Hazardous Waste and Physical Analyses, Inorganic Parameters and Preparation, and Inorganics - Non-Metals Analysis Categories: DW03, NPW03, SCM02-03, AE01, and BT01, the supervisor shall meet the requirements of at least one of the qualification levels listed below:
 

 

Qualification

Degree

Years of Chemical Experience Chemical

Level

 

Analysis and/or Training

 

 

 

A

>/= BA/BS<1>

1<2>

 

 

 

B

AA<1>

3<2>

 

 

 

C

None

5<2>

 

 

 


 
<1> Degree in a chemical, physical, biological, or environmental science from an accredited institution.
 
<2> Have at least one year of laboratory experience in the chemical analysis of drinking water, non-potable water, solid and chemical materials, air and/or emissions, or biological tissue samples.
 
4. For Chemical Testing in Metals, Metals-ICP, ICP/MS and DCP, Metals Preparation Categories, Inorganics - Metals Analysis, and Asbestos Analysis Categories: DW05-DW07, NPW05-NPW08, SCM04-SCM07, AE02-AE03, AE07, and BT02-BT04, the supervisor shall meet the requirements of at least one of the qualification levels listed below:
 

 

Qualification

Degree

Years of Chemical Experience Chemical

Level

 

Analysis and/or Training

 

 

 

A

>/= BA/BS<1>

1<2>

 

 

 

B

AA<1>

3<2>

 

 

 

C

None

5<3>

 

 

 


 
<1> Degree in a chemical, physical, biological, or environmental science from an accredited institution.
 
<2> At least one year of laboratory experience in the analysis of drinking water, non-potable water, solid and chemical materials, air and/or emissions, or biological tissue samples; and have six months experience in one or more instrumental techniques for the determination of metals, minerals (asbestos), metal ions, or anions, or have completed a formal training course in the operation of one or more of those instruments.
 
<3> Same as footnote 2 above except that three years of laboratory experience in the analysis of drinking water, non-potable water, solid and chemical materials, air and/or emissions, or biological tissue samples is required.
 
5.-6. (No change.)
 
7. For Chemical Testing in Organic Parameters - Chromatography, Organic Parameters - Chromatography/MS, Organic Sample Preparation Categories, Organics Analysis and Polychlorinated Dibenzo--p-dioxins and Polychlorinated Dibenzofurans Categories: DW08-DW09, NPW09-NPW11, SCM08-SCM11, AE04, and BT05-BT07, the supervisor shall meet the requirements of at least one of the qualification levels listed below:
 

 

Qualification

Degree

Years of Chemical Experience Chemical

Level

 

Analysis and/or Training

 

 

 

A

>/= BA/BS<1>

1<2>

 

 

 

B

AA<1>

3<2>

 

 

 

C

None

5<3>

 

 

 


 
<1> Degree in a chemical, physical, biological, or environmental science from an accredited institution.
 
<2> Have at least one year of laboratory experience in chemical testing of drinking water, non-potable water, solid and chemical materials, air and/or emissions, or biological tissue samples; and have six months experience in the instrumental technique (GC, LC, GC/MS, or LC/MS) being practiced for the analysis of drinking water, non-potable water, solid and chemical materials, air and/or emissions, or biological tissue samples. A formal training course in the instrumental technique for which certification is sought may be substituted for the experience requirements.
 
<3> Same as footnote 2 above except that three years of laboratory experience in chemical testing of non-potable water, solid and chemical materials, air and/or emissions, or biological tissue samples is required.
 
8. (No change.)
 
9. For Chemical Testing in Categories: NPW and SCM-Multi-Concentration Inorganics, NPW and SCM Multi-Concentration Organics, and NPW and SCM-Polychlorinated Dibenzo-p-dioxins and Polychlorinated Dibenzofurans CLP01 - CLP06, the laboratory shall have qualified personnel to perform the analyses under the CLP categories of analysis.
 
10. For Radiochemical Testing in Radiochemistry - Radioactivity and Radionuclides, Radon in Drinking Water, Radon in Non-Potable Water, and Radionuclides Analysis Categories: DW10-DW11, NPW13-NPW14, SCM12, and AE05, the supervisor shall meet the requirements of at least one of the qualification levels listed below:
 

 

Qualification

Degree

Years of Experience Chemical Analysis

Level

 

and/or Training

 

 

 

A

>/= BA/BS<1>

5<2>

 

 

 

B

AA1

7<2>

 

 

 


 
<1> Degree in a chemical, radiochemical, radioisotope technology, biological, physical, or environmental science from an accredited institution.
 
<2> Two years of experience must be in radiochemical analysis.
 
11. For Category AE08, Radon/Radon Progeny-in-Air, the supervisor shall meet the requirements of at least one of the qualification levels listed below:
 

 

Qualification

Degree

Years of Chemical Experience Chemical

Level

 

Analysis and/or Training

 

 

 

A

>/= BA/BS<1>

2<2>

 

 

 

B

AA<1>

4<2>

 

 

 

C

None

6<2>

 

 

 


 
<1> Degree in a chemical, radiochemical, radioisotope technology, biological, physical, or environmental science from an accredited institution.
 
<2> Two years of experience must be in radiochemical analysis.
 
12. For Toxicity Testing in Category NPW12, the supervisor shall meet the requirements of at least one of the qualification levels listed below:
 

 

Qualification

Degree

Credits

Years of Experience

Level

 

 

Toxicity Testing and/or

 

 

 

Training

 

 

 

 

A

>/= BA/BS<1>

6<2>

1<3,4>

 

 

 

 

B

MA<3> or MS<3>

6<2>

__<4>

 

 

 

 

 

 

 

 


 
<1> Degree in a biological or environmental science from an accredited institution.
 
<2> Shall include or be supplemented by six semester credit hours in any of the following subjects: (a) General Zoology; (b) Biological Methods and Experimental Design; (c) Ichthyology.
 
<3> Shall have successfully completed at least six definitive bioassays prior to applying for supervisor. The laboratory shall retain the documentation for these assays, and make it available during an audit by a representative of the Department.
 
<4> Demonstrate competency in the operation of bioassay equipment and techniques during an audit by a representative of the Department.
 
13. For Laboratory Developed and/or Non-Standard Method Categories: DW13, NPW16, SCM14, AE06, AE09 or BT08, the supervisor shall meet the most stringent requirements listed for the category area of interest.
 
14. If the bachelor degree is required and was granted from a regionally accredited United States or Canadian college or university, the requirement is satisfied. If the degree was granted by a foreign college or university, a copy of the evaluation by the World Education Service, Inc., P.O. Box 5087, Bowling Green Station, New York, NY 10274-5087, (212) 966-6311, shall be provided to the Department; and
 
15. (No change in text.)
 
7:18-2.13   Proficiency testing program
 
(a) (No change.)
 
(b) To maintain certification, a certified environmental laboratory shall successfully complete proficiency testing pursuant to (h) through (j) below.
 
1. For all categories other than radiochemical testing, radon in water, and radon/radon progeny-in-air:
 
i. Each certified laboratory shall obtain and analyze PT samples from a Department-approved PT sample provider within the timeframe and in accordance with the schedule that the Department establishes. A Department-approved PT sample provider is one that is accredited by a proficiency test provider accreditor that meets the TNI requirements. The Department will announce at least two pre-determined timeframes a year for the required parameters within a matrix. All laboratories certified for that parameter (including indicator parameters) shall participate in at least one proficiency test study each year per matrix in accordance with the predetermined schedule. If a laboratory fails to successfully complete a proficiency test study, it shall participate in another proficiency test study within the Department's prescribed timeframe;
 
ii.-iii (No change.)
 
2. For radiochemical testing, a laboratory shall acceptably analyze one PT sample obtained from a Department-approved PT sample provider within the prescribed timeframe and schedule designated by the Department per year.
 
3. For radon in water, a laboratory shall acceptably analyze all required PT samples, obtained from a Department-approved PT sample provider within the prescribed timeframe and schedule designated by the Department, not to exceed four samples per year, at such time as radon in water PT samples are available.
 
4. (No change.)
 
(c) Proficiency testing for a specific parameter or group thereof in a particular Category is not required if the Department determines that PT samples are unavailable.
 
(d) Except as provided in (e) through (g) below, the Department-approved PT sample provider shall distribute PT samples or make them available, at times and frequencies that the Department determines are necessary for effective administration of proficiency testing. N.J.A.C. 7:18-2.9(g) provides for the Department to be reimbursed if it purchases PT samples to send to a laboratory for use in the proficiency testing program.
 
(e) A laboratory shall obtain PT samples for the determination of radioactivity and radionuclide parameters in water from a Department-approved PT sample provider within the prescribed timeframe and schedule designated by the OQA.
 
(f) A laboratory shall obtain PT samples for the determination of radon in water from a Department-approved PT sample provider within the prescribed timeframe and schedule designated by the OQA, at such time as radon in water PT samples are available.
 
(g) A laboratory shall obtain PT samples for the determination of radon/radon progeny-in-air from the USEPA's Radon Measurement Program or from a Department-approved PT sample provider.
 
(h) A laboratory participating in the proficiency testing program shall perform the following tasks:
 
1. Receive, examine, and analyze PT samples according to instructions;
 
2. Maintain all records of PT testing results;
 
3. For all Categories, except radiochemical testing, radon in water, and radon/radon progeny-in-air, request that the approved PT sample provider submit results of PT testing to the Department for evaluation in accordance with the Department's instructions;
 
4. For radiochemical testing, radon in water, and radon/radon progeny-in-air Categories, submit results of PT testing in accordance with the directions of the USEPA or the authorized proficiency testing program; and
 
5. For radon/radon progeny-in-air, request that the approved PT sample provider submit evaluated radon measurement proficiency results to the Department.
 
(i) The specific requirements for the proficiency testing program are set forth below in this subsection.
 
1. For a laboratory seeking certification in any Category other than radiochemical testing, radon in water, or radon/radon progeny-in-air:
 
i. A laboratory that has participated in a PT study conducted by a Department-approved PT sample provider for the Drinking Water, Non-Potable Water, Air and Emissions, and/or Solid and Chemical Materials Proficiency Testing Program during the immediate preceding 12 months may submit, for the Department's evaluation, the results for the parameters for which it is applying in the Department's Drinking Water, Non-Potable Water, Air and Emissions, and/or Solid and Chemical Materials Programs. Otherwise, the conditions of (i)1ii below apply; and
 
ii. A laboratory seeking certification in a specific parameter or group thereof under a particular Category shall acceptably analyze a PT sample obtained from a Department-approved PT sample provider. The laboratory shall have two separate opportunities to acceptably analyze PT samples for each parameter. If the laboratory fails in both opportunities to acceptably analyze PT samples for a parameter, the Department shall deny the application for certification. The laboratory may reapply for certification in that parameter.
 
2. For a laboratory seeking certification in radiochemistry, radioactivity and radionuclide testing, or radon/radon progeny-in-air:
 
i. For analysis of radiochemical parameters in water, the laboratory shall have acceptably analyzed a PT study conducted by a Department-approved PT sample provider within the preceding 12 months. If PT samples are unavailable for the required parameters, then results for two cross-check samples that are within the control limits established for each parameter in which certification is sought shall be submitted to the Department for evaluation;
 
ii. For analysis of radon in drinking water and non-potable water samples, the laboratory shall have a Department-approved PT sample provider submit final PT reports indicating that during the applicant's participation in the most recent Radon Intercomparison Study, at least one PT sample or two cross-check samples were within the established control limits within the preceding 12 months; and
 
iii. For analysis of radon/radon progeny-in-air, the laboratory shall have a Department-approved PT sample provider submit final PT reports showing passage of a Department-approved PT study. The PT study administered shall have been performed within the past 12 months and obtained from a Department-approved PT sample provider. The laboratory shall pass a test for each measurement device/technique for which certification is desired, prior to applying for certification.
 
3. For certified environmental laboratories:
 
i. For all Categories, except radiochemical testing, radon in water, and radon/radon progeny-in-air, the Department shall notify the laboratory, in writing by certified mail or other means that provides proof of delivery, of the specific timeframe within which laboratories are required to analyze the PT samples, the due date by which the final PT study results are to be submitted to the Department by the PT sample provider, a list of Department-approved PT sample providers, and the list of parameters required for analysis within the applicable matrix.
 
ii. In connection with a proficiency test announced under (i)3i above, if a laboratory does not meet the deadlines or comply with any requirement set forth in the announcement notice, the laboratory's PT study results shall be considered unacceptable and an additional PT sample shall be analyzed as directed by the Department;
 
iii. For the Radiochemical Categories not included in the Department's pre-determined schedule, the scheduling and requirements for the proficiency test are as established by the Department-approved PT sample provider. For the Radon/Radon Progeny-in-Air Categories, the laboratory shall contact the OQA to obtain a list of exposure facilities approved for the Department's authorized radon/radon progeny-in-air proficiency testing program. The laboratory shall arrange with the exposure facility to schedule an exposure period for the laboratory's test devices;
 
iv.-v. (No change.)
 
vi. The Department may require a laboratory to analyze additional PT samples beyond what is required under (i)3i above, if information available to the Department indicates that the laboratory is failing to acceptably analyze samples;
 
vii. Upon request of any person using or requesting the services of a certified environmental laboratory, the laboratory shall make available all results of the past 12 months' proficiency testing; and
 
viii. Upon a laboratory's receipt of unacceptable results for a PT study, the laboratory shall investigate the cause for the failure and implement any necessary corrective action. This corrective action shall be documented immediately. Documentation shall be maintained and made available to the Department upon request.
 
(j) For all drinking water, non-potable water, air and/or emissions, solid and chemical materials, and radon/radon progeny-in-air parameters tested using Department-approved PT studies, the reported values must fall within the acceptance limits established by the PT sample provider for a given PT sample, except:
 
1. For the radon/radon progeny-in-air measurement proficiency program, the criterion used in evaluating the radon measurement test results requires that the value of the individual relative error (IRE) of radon measurement not exceed 25 percent.
 
7:18-2.15   Cancellation, suspension, or revocation of certification
 
(a) Any certified environmental laboratory may cancel its certification in any Category, or in any parameters within a Category, by notifying the Department in writing. Cancellations during a PT study are subject to N.J.A.C. 7:18-2.13(i)3iv. When totally withdrawing from the environmental laboratory certification program, the environmental laboratory shall enclose its certificate and ACPL with the letter of notification. This cancellation notification shall not entitle the environmental laboratory to any refund of its certification fees.
 
(b) The Department may suspend a certified environmental laboratory's certification for any one or more of the grounds listed below. Grounds for suspension include the following:
 
1. For all Categories, except Radiochemical Testing and Radon/Radon Progeny-in-Air, failure to submit results of PT sample analyses for every required parameter in two consecutive proficiency studies, pursuant to N.J.A.C. 7:18-2.13;
 
2. For the Radiochemical or Radon/Radon Progeny-in-Air Categories, failure to submit results of PT samples in two consecutive PT studies as required under N.J.A.C. 7:18-2.13(h);
 
3. For all Categories, except those in Radiochemical Testing, Radon/Radon Progeny-in-Air, or Categories DW08, DW09, NPW10, NPW11, SCM09, SCM10, SCM11, CLP02, CLP03, CLP05, CLP06, and AE04, failing to acceptably analyze all samples for any one parameter in two consecutive PT studies. This failure is grounds for suspension in the parameter;
 
4. For Categories DW08, DW09, NPW10, NPW11, SCM09, SCM10, SCM11, CLP02, CLP03, CLP05, CLP06, and AE04, failing to acceptably analyze all samples for any one parameter in two consecutive proficiency studies. This failure is grounds for suspension in the method used to analyze the parameter in question;
 
5. For radiochemical parameters, failure to acceptably analyze one PT sample or two cross-check samples per year;
 
6. For determination of radon in water, failure to acceptably analyze all required PT samples, not to exceed four samples per year;
 
7.-9. (No change.)
 
(c)-(f) (No change.)
 
7:18-2.20   Application for alternate test procedure (ATP) approval
 
(a) Modifications to DSAMs or new methods not included in DSAMs, Laboratory Developed, and/or Non-Standard Methods are considered ATPs. A certified environmental laboratory or laboratory holding temporary approval shall not use such a modification or new Laboratory Developed and/or Non-Standard Method unless the Department has approved it as an ATP and added it to the laboratory's Annual Certified Parameter List. Any certified environmental laboratory may apply to the Department for approval of an ATP, in accordance with this section. The Department will not approve a proposed ATP unless it meets the following requirements:
 
1. An ATP proposed as a modification to a DSAM must achieve equal or improved precision, accuracy, and method detection limits or quantitation limits as appropriate when compared to the approved method for the specified parameters;
 
2. If the ATP is proposed as a new method rather than as a modification to a DSAM, the laboratory must demonstrate that the proposed ATP will achieve precision, accuracy, and method detection limits or quantitation limits as appropriate, that are sufficient to meet the data quality requirements of the regulatory program for which the ATP is to be used; and
 
3. For methods that include modifications to the determinative step, preservations, or pretreatment procedures, the laboratory can obtain certification for a laboratory developed and/or non-standard method option on its Annual Certified Parameter List as long as the laboratory and its client agree to the use of the method for other than the reporting of compliance data, or for use as specified in a Quality Assurance Project Plan or other form of contracted analytical services.
 
(b) The Department may approve an ATP for a laboratory method that is driven by client needs for limited use, or for limited use for a facility-specific request.
 
1. (No change.)
 
2. The Department may approve an ATP for limited use by a certified environmental laboratory for a facility-specific request. Facility-specific method requests are methods developed by an environmental laboratory to meet unique analysis requirements of a particular client facility when DSAMs are not applicable. Generally, these methods are DSAMs modified for macro/micro analysis or matrix interferences. The facility-specific ATP can be used only by the certified environmental laboratory that receives the approval, and only for analyses performed for the specified client facility.
 
(c) To apply for an ATP, the certified environmental laboratory shall submit a letter of request to the Department, including:
 
1.-6. (No change.)
 
7. Precision, accuracy, and method detection limits (MDLs) data or quantitation limits as appropriate in a reference matrix for the proposed ATP. MDLs shall be determined as outlined in Appendix B of Section 136 of 40 CFR;
 
8. Precision, accuracy, and MDL data or quantitation limits as appropriate for the parameter(s) of interest spiked into the actual matrices covered by the method;
 
9. Comparability data (precision, accuracy, MDLs, or quantitation limits) for the performance of the proposed ATP versus that of a DSAM if the parameter(s) can be analyzed by the DSAM; and
 
10. (No change.)
 
(d) (No change.)
 
SUBCHAPTER 4.     MICROBIOLOGICAL TESTING
 
7:18-4.1   Scope
 
(a) This subchapter applies to certified environmental laboratories when performing microbiological testing on regulatory samples, and to other laboratories performing microbiological testing on PT samples to become certified. This subchapter applies to microbiological testing for parameters in the following categories:
 
1. Categories DW01 and DW02, Microbiology and Parasitology and Molecular Microbiology;
 
2. Categories NPW01 and NPW02, Microbiology and Parasitology and Molecular Microbiology; and
 
3. Category SCM01, Microbiology.
 
(b)-(c) (No change.)
 
7:18-4.3   Required use of DSAMs
 
(a) In performing microbiological analysis of a regulatory sample (including, without limitation, analysis of a PT sample by a laboratory that is applying to become certified), a laboratory shall use only:
 
1.-2. (No change.)
 
(b) (No change.)
 
7:18-4.5   Requirements for quality assurance/quality control program
 
(a)-(b) (No change.)
 
(c) A laboratory performing microbiological analyses shall conduct the quality control checks specified in the applicable DSAMs, and the following additional checks:
 
1.-4. (No change.)
 
5. Each certified environmental laboratory shall satisfactorily analyze one unknown PT sample per year, when available from a Department-approved PT sample provider, for the parameters within the Categories for which the environmental laboratory has received certification;
 
6.-20. (No change.)
 
SUBCHAPTER 5.    CHEMICAL TESTING
 
7:18-5.1   Scope
 
(a) This subchapter applies to certified environmental laboratories when performing chemical testing on regulatory samples, and to laboratories performing chemical testing on PT samples to become certified. This subchapter applies to chemical testing for parameters in the following categories:
 
1. Air and Emissions:
 
i. Category AE01: Inorganics - Non-Metals Analysis;
 
ii. Category AE02: Inorganics - Metals Analysis;
 
iii. Category AE03: Asbestos Analysis;
 
iv. Category AE04: Organics Analysis;
 
v. Category AE06: Air - Laboratory Developed and/or Non-Standard Method; and
 
vi. Category AE07: Air Sample Collection.
 
2. CERCLA-CLP Program:
 
i. Category CLP01: NPW - Multi-Concentration Inorganics;
 
ii. Category CLP02: NPW - Multi-Concentration Organics;
 
iii. Category CLP03: NPW - Polychlorinated Dibenzo-p-dioxins and Polychlorinated Dibenzofurans;
 
iv. Category CLP04: SCM - Multi-Concentration Inorganics;
 
v. Category CLP05: SCM - Multi-Concentration Organics; and
 
vi. Category CLP06: SCM - Polychlorinated Dibenzo-p-dioxins and Polychlorinated Dibenzofurans.
 
3. Drinking Water Matrix:
 
i. Category DW03: Inorganic Parameters;
 
ii. Category DW05: Asbestos Analysis;
 
iii. Category DW06: Metals;
 
iv. Category DW07: Metals - ICP, ICP/MS and DCP;
 
v. Category DW08: Organic Parameters - Chromatography;
 
vi. Category DW09: Organic Parameters -Chromatography/MS;
 
vii. Category DW12: Drinking Water Sample Collection; and
 
viii. Category DW13: Drinking Water - Laboratory Developed and/or Non-Standard Methods.
 
4. Solid and Chemical Materials Matrix:
 
i. Category SCM02: Characteristics of Hazardous Waste and Physical Analyses;
 
ii. Category SCM03: Inorganic Parameters and Preparation;
 
iii. Category SCM04: Asbestos Analysis;
 
iv. Category SCM05: Metals - SCM Preparation Methods;
 
v. Category SCM06: Metals;
 
vi. Category SCM07: Metals - ICP, ICP/MS and DCP;
 
vii. Category SCM08: Organics - SCM Preparation and Screening Methods;
 
viii. Category SCM09: Organic Parameters - Chromatography;
 
ix. Category SCM10: Organic Parameters - Chromatography/MS;
 
x. Category SCM11: Polychlorinated Dibenzo-p-dioxins and Polychlorinated Dibenzofurans;
 
xi. Category SCM13: SCM Sample Collection; and
 
xii. Category SCM14: SCM - Laboratory Developed and/or Non-Standard Methods.
 
5. Non-Potable Water Matrix:
 
i. Category NPW03: Inorganic Parameters;
 
ii. Category NPW05: Asbestos Analysis;
 
iii. Category NPW06: Metals - NPW Preparation Methods;
 
iv. Category NPW07: Metals;
 
v. Category NPW08: Metals - ICP, ICP/MS and DCP;
 
vi. Category NPW09: Organics - NPW Preparation Methods;
 
vii. Category NPW10: Organic Parameters -Chromatography;
 
viii. Category NPW11: Organic Parameters - Chromatography/MS;
 
ix. Category NPW15: Non-Potable Water Sample Collection; and
 
x. Category NPW16: NPW - Laboratory Developed and/or Non-Standard Methods.
 
6. Biological Tissue Matrix:
 
i. Category BT01: Inorganic Parameters;
 
ii. Category BT02: Metals - BT Preparation Methods;
 
iii. Category BT03: Metals;
 
iv. Category BT04: Metals - ICP, ICP/MS and DCP;
 
v. Category BT05: Organics - BT Preparation Methods;
 
vi. Category BT06: Organic Parameters -Chromatography;
 
vii. Category BT07: Organic Parameters - Chromatography/MS; and
 
viii. Category BT08: BT - Laboratory Developed and/or Non-Standard Methods.
 
(b) (No change.)
 
7:18-5.3   Required use of DSAMs
 
(a) In performing chemical analysis of a regulatory sample (including, without limitation, analysis of a PT sample by a laboratory that is applying to become certified), a laboratory shall use only:
 
1.-2. (No change.)
 
(b)-(c) (No change.)
 
7:18-5.4   Requirements for general environmental laboratory practices
 
(a) A laboratory shall meet the following requirements with respect to laboratory chemicals, reagents, and standards used in chemical testing:
 
1.-7. (No change.)
 
8. The laboratory shall initially standardize prepared titrants. The laboratory shall restandardize such titrants at least quarterly. The laboratory shall restandardize purchased titrants at least quarterly. In standardizing or restandardizing a titrant, the laboratory shall use primary or secondary reagents as specified in the applicable DSAM;
 
9.-10. (No change.)
 
7:18-5.5   Requirements for quality assurance/quality control program
 
(a)-(b) (No change.)
 
(c) A laboratory performing chemical testing shall conduct the quality control checks specified in the applicable DSAMs, and the following additional checks:
 
1.-4. (No change.)
 
5. The laboratory shall prepare calibration curves used in the analysis of metal parameters in Categories DW06, DW07, DW13, NPW07, NPW08, NPW16, SCM06, SCM07, SCM14, AE02, AE06, BT03, BT04, and BT08. When the laboratory uses computer-controlled equipment, the laboratory shall follow the requirements for calibration curves in (c)4 above, except that a minimum of one reagent blank and three standards shall be required, and the laboratory shall follow the manufacturer's instructions for calibrating the instrument and shall verify the calibration curve with two calibration check standards, one at the low end of the concentration range and the other at the high end;
 
6. The laboratory shall analyze blanks at the frequencies required by the applicable DSAM. For methods used in categories AE01, AE02, AE03, AE04, and AE06 that do not address method blank requirements, method blanks shall be performed at a frequency of at least one per batch of 20 environmental samples or less per sample preparation method, or at least once each day of instrument operation, whichever is more frequent. If the method blank result is greater than the detection limit and contributes greater than 10 percent of the total amount of analyte found in the sample, the source of contamination must be investigated and measures taken to eliminate the source of the contamination. If contamination is found, the data shall be qualified in the report;
 
7. For parameters in Categories DW03, DW05-DW07, DW13, NPW03, NPW05, NPW07-NPW08, NPW16, SCM03-SCM04, SCM06-SCM07, SCM14, AE01-AE04, AE06, BT01, BT03-BT04, and BT08, the laboratory shall conduct quality control (QC) check sample analyses to verify the accuracy of the analytical system for the parameter. For each QC check sample analysis, the laboratory shall record the results of the analysis, the date on which the verification analysis was performed, and the method of verification. The laboratory shall have the analyst who performed the analysis sign the record.
 
i.-ii. (No change.)
 
iii. For categories AE01-AE04 and AE06, if a spiking solution is not available, a calibration solution, whose concentration approximates that of the samples, shall be included in each batch and with each lot of media. If a calibration solution must be used for the QC sample, the client will be notified prior to the start of analysis. The concentration of the QC sample shall be relevant to the intended use of the data and either at a regulatory limit or below it.
 
8. In all cases, the laboratory shall conduct matrix spike and matrix spike duplicate sample analyses to verify the accuracy and precision of the DSAM for the applicable parameters in the Categories DW03, DW05-07, DW13, NPW03, NPW05, NPW07-NPW08, NPW16, SCM03-SCM04, SCM06-SCM07, SCM14, AE01-AE04, AE06, BT01, BT03-BT04, and BT08.
 
i.-iii. (No change.)
 
iv. For categories AE01-AE04, and AE06, matrix spikes and matrix spike duplicates are not required for those air samples that are introduced directly into an analytical instrument from SUMMA sampling canisters, sorbent tubes, or polyurethane foam (PUF) traps.
 
9. In all cases, the laboratory shall calculate and document standard deviations for all applicable measurements conducted in Categories DW03, DW05-07, DW13, NPW03, NPW05, NPW07-NPW08, NPW16, SCM03-SCM04, SCM06-SCM07, SCM14, AE01-AE04, AE06, BT01, BT03-BT04, and BT08, in accordance with the following requirements:
 
i. The laboratory shall calculate standard deviations for n-1 degrees of freedom (n samples - 1) for all % R and RPD measurements in (c)7 and 8 above. For this calculation in connection with (c)7 above, the laboratory shall use ongoing data collected from the analysis of 10 QC samples; for this calculation in connection with (c)8 above, the laboratory shall use ongoing data collected from the analysis of 10 matrix, matrix spike pairs. For parameters in Category DW03 and DW05-DW07, the laboratory shall use samples that have been prepared at the MCL. For other parameters, the laboratory shall use samples that have been prepared to approximate the middle of the concentration range normally encountered in the analysis. The laboratory shall record the theoretical or true value. The laboratory shall calculate and plot the mean value, the warning limits (two standard deviations), and the corrective action limits (three standard deviations); and
 
ii. (No change)
 
10.-13. (No change.)
 
SUBCHAPTER 6.    RADIOCHEMICAL TESTING PROCEDURES INCLUDING RADON GAS/RADON PROGENY
 
7:18-6.1   Scope
 
(a) This subchapter applies to certified environmental laboratories when performing radiochemical testing or radon/radon progeny-in-air testing on regulatory samples, and to laboratories performing radiochemical testing or radon/radon progeny-in-air testing on PT samples or two cross check samples to become certified. This subchapter also applies to laboratories performing the 48-Hour Rapid Gross Alpha Test for compliance with the PWTA. This subchapter applies to radiochemical testing and radon/radon progeny-in-air testing for parameters in the following categories:
 
1. Drinking Water Matrix:
 
i. Category DW10, Radiochemistry - Radioactivity & Radionuclides;
 
ii. Category DW11, Radon in Drinking Water; and
 
iii. Category DW13, Drinking Water - Laboratory Developed and/or Non-Standard Methods;
 
2. Non-Potable Matrix:
 
i. Category NPW13, Radiochemistry - Radioactivity & Radionuclides;
 
ii. Category NPW14, Radon in Non-Potable Water; and
 
iii. Category NPW16, NPW- Laboratory Developed and/or Non-Standard Methods;
 
3. Air and Emissions Matrix:
 
i. Category AE05, Radionuclides Analysis;
 
*ii. Category AE06, Air - Laboratory Developed and/or Non-Standard Methods;*
 
*[ii.]* *iii.* Category AE08, Radon in Air; and
 
*[iii.]* *iv.* Category AE09, Radon in Air - Laboratory Developed and/or Non-Standard Methods; and
 
4. Solid and Chemical Materials Matrix:
 
i. Category SCM12, Radiochemistry - Radioactivity and Radionuclides; and
 
ii. Category SCM14 - SCM Laboratory Developed and/or Non-Standard Methods.
 
(b) (No change.)
 
7:18-6.4   Required use of DSAMs
 
(a) In performing radiochemical analysis of a regulatory sample (including, without limitation, analysis of a PT sample by a laboratory that is applying to become certified), a laboratory shall use only:
 
1.-3. (No change.)
 
(b) (No change.)
 
SUBCHAPTER 7.    TOXICITY TESTING
 
7:18-7.1   Scope
 
(a) This subchapter applies to certified environmental laboratories when performing toxicity testing on regulatory samples, and to other laboratories performing toxicity testing on PT samples to become certified.
 
1.-3. (No change.)
 
SUBCHAPTER 8.    ANALYZE-IMMEDIATELY AND CONTINUOUS MONITORING ENVIRONMENTAL MEASUREMENTS
 
7:18-8.1   Scope and general requirements
 
(a) This subchapter applies to certified environmental laboratories when performing analyze-immediately and continuous monitoring environmental measurements on regulatory samples, and to other laboratories performing analyze-immediately and continuous monitoring environmental measurements on PT samples to become certified. This subchapter applies to analyze-immediately environmental measurements of parameters in the following categories (including, but not limited to, chlorine dioxide, dissolved oxygen with probe, pH, ozone, residual chlorine, sulfite, and temperature):
 
1. Drinking Water Matrix - Category DW04, Analyze-Immediately (< 15 min) and Continuous Monitoring; and
 
2. Non-Potable Water Matrix - Category NPW04, Analyze-Immediately (< 15 min) and Continuous Monitoring.
 
(b) In addition to satisfying the applicable requirements of N.J.A.C. 7:18-1 through 3, a laboratory performing analyze-immediately and continuous monitoring environmental measurements within the scope of (a) above shall follow:
 
1.-2. (No change.)
 
(c) A laboratory performing environmental measurements of a sample for analyze-immediately parameters listed in (a)1 or 2 above shall analyze the sample within 15 minutes after collection. The laboratory may perform the analysis in the field, in an on-site mobile laboratory, or in a facility laboratory (such as a laboratory at a wastewater treatment plant).
 
7:18-8.2   Requirements for environmental laboratory equipment, supplies, and materials
 
The supervisor shall have control over the equipment, supplies, and materials used in analyze-immediately and continuous monitoring testing and analysis of regulatory samples. The equipment, supplies, and materials shall be sufficient to perform those tests and analyses, and shall meet the requirements of N.J.A.C. 7:18-3, N.J.A.C. 7:18-5, and the applicable DSAM.
 
7:18-8.3   Required use of techniques specified in DSAMs
 
(a) In performing an analyze-immediately and continuous monitoring analysis of a regulatory sample (including, without limitation, analysis of a PT sample by a laboratory that is applying to become certified), a laboratory shall use only:
 
1.-2. (No change.)
 
(b) (No change.)
 
7:18-8.4   Requirements for quality assurance/quality control program
 
(a)-(b) (No change.)
 
(c) A laboratory performing analyze-immediately and continuous monitoring environmental measurements shall conduct the quality control checks specified in the applicable DSAMs.
 
7:18-8.5   Requirements for records and data reporting
 
(a) The laboratory shall retain records concerning analyze-immediately and continuous monitoring analyses. The records to be retained include raw data records, quality control data records, chain-of-custody forms, laboratory reports, and the information required under (d) below. The laboratory shall retain each record for at least five years after the date of the analysis, provided, however, that the laboratory shall retain records of analyses for 10 years if the person requesting the analyses has informed the laboratory that the analyses were to be performed because of epidemiological or public health concerns.
 
(b)-(f) (No change.)
 
SUBCHAPTER 9.    SAMPLE REQUIREMENTS
 
7:18-9.3   Requirements for inorganic, organic, and radiochemical parameter samples
 
(a) Regulatory samples to be analyzed for one or more inorganic, organic, or radiochemical parameters shall be handled and preserved as follows:
 
1. Drinking water program samples to be analyzed for one or more inorganic or organic parameters shall be handled and preserved in accordance with the applicable requirements of Table 9.1 in N.J.A.C. 7:18-9.4(b);
 
2. Wastewater program samples to be analyzed for one or more chemical parameters shall be handled and preserved in accordance with the applicable requirements in Table 9.2 in N.J.A.C. 7:18-9.4(c);
 
3. Solid/hazardous waste program samples (aqueous non-potable matrices) to be analyzed for one or more chemical parameters shall be handled and preserved in accordance with the applicable requirements in Table 9.2 in N.J.A.C. 7:18-9.4(c);
 
4. Drinking water program samples to be analyzed for one or more radiochemical parameters shall be handled and preserved in accordance with the applicable requirements of Table 9.3 in N.J.A.C. 7:18-9.4(d);
 
5. Wastewater program samples to be analyzed for one or more radiochemical parameters shall be handled and preserved in accordance with the applicable requirements in Table 9.4 in N.J.A.C. 7:18-9.4(e);
 
6. Solid/hazardous waste program samples in the form of soils, liquids, sediments, and sludges shall be handled and preserved in accordance with the applicable requirements in Table 9.5 in N.J.A.C. 7:18-9.4(f);
 
7. (No change.)
 
8. Air program samples to be analyzed for one or more chemical parameters shall be handled and preserved in accordance with the applicable requirements in Table 9.7 in N.J.A.C. 7:18-9.4(h).
 
(b) (No change.)
 
7:18-9.4   Requirements for sample handling and preservation for specific parameters
 
(a)-(b) (No change.)
 
(c) Non-potable water samples and solid/hazardous waste program samples (aqueous non-potable water matrices) shall be handled and preserved in accordance with the requirements of Table 9.2 and the requirements of (c)1 through 3 below. Table 9.2 includes applicable requirements from 40 CFR 136.3 and the USEPA's Test Methods for Evaluating Solid Waste - Physical and Chemical Methods, Third Edition 1986, as updated (referred to below as "SW-846"). If there is any conflict between Table 9.2 and the USEPA rule or publication (including any amendments or supplements) on which any part of Table 9.2 is based, the USEPA rule or publication shall control.
 
1.-3. (No change.)
 
Table 9.2
 
Required Containers, Preservation Techniques, and Holding Times for Non-Potable Water Samples and Solid/Hazardous Waste Program Samples (Aqueous Non-Potable Water Matrices), Except Radiochemical Parameters
 
(No change to the table.)
 
References For Table 9.2 Non-Potable Water Samples and Solid/Hazardous Waste Program Samples (Aqueous Non-Potable Water Matrices)
 
<1-10> (No change.)
 
(d) (No change.)
 
(e) Non-potable water samples that are to be subject to radiochemical measurements shall be handled and preserved in accordance with the requirements of Table 9.4 and the requirements of (e)1 below. Table 9.4 incorporates requirements from 40 CFR 136.3. If there is any conflict between Table 9.4 and 40 CFR 136.3 (including any amendments or supplements), 40 CFR 136.3 shall control.
 
1. (No change.)
 
Table 9.4
 
Required Containers, Preservation Techniques, and Holding Times for Radiochemical Measurements in Non-Potable Water Samples
 
(No change to the table.)
 
(f) Solid/hazardous waste program samples (non-aqueous or solid and chemical materials matrix) shall be handled and preserved in accordance with the requirements of Table 9.5. Table 9.5 incorporates requirements from SW-846. If there is any conflict between Table 9.5 and SW-846 (including any amendments or supplements), SW-846 shall control.
 
Table 9.5
 
Required Containers, Preservation Techniques, and Holding Times for Solid/Hazardous Waste Program Samples (Soils, Liquids, Sediments, and Sludges)
 
(No change to the table.)
 
(g) (No change.)
 
(h) Air and emissions samples shall be handled and preserved in accordance with the requirements of Table 9.7 below. Table 9.7 includes applicable requirements from the methods for the analysis of airborne emissions, listed in 40 CFR 51M, 60A, 61B, and 63A; and The Compendium of Methods for the Determination of Toxic Organic Compounds in Ambient Air (EPA document EPA/625/R-96/010b). If there is any conflict between Table 9.7 and the USEPA rule or publication (including any amendments or supplements), the USEPA rule or publication shall control.
 
Table 9.7
 
Required Container, Preservation Techniques, and Holding Times for Air and Emissions Samples
 
(No change to the table.)
 
SUBCHAPTER 10.     CIVIL ADMINISTRATIVE PENALTIES AND ADMINISTRATIVE ORDERS
 
7:18-10.4   Classes of violations
 
(a) (No change.)
 
(b) "Moderate violation" means any violation of the requirements of this chapter or of any order issued pursuant to this chapter that directly affects the quality of laboratory data. These violations include, but are not limited to, noncompliance with those requirements pertaining to analytical procedures, quality control, data validity and integrity, chain-of-custody, laboratory performance, data reporting and sample collection, recordkeeping, and handling and preservation. A failure to make available or to maintain complete records is equivalent to a violation that directly affects data quality, because the Department is unable to verify facts relevant to data quality without adequate records. Violations of specific provisions of this chapter that are defined as moderate violations include, but are not necessarily limited to:
 
1.-11. (No change.)
 
12. N.J.A.C. 7:18-2.13(b), (c), (d), (e), (f), (g), (h), and (i)3, failure to maintain records of PT samples;
 
13.-17. (No change.)
 
(c) (No change.)