Current through Register Vol. 56, No. 6, March 18, 2024
(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. The Department may approve an ATP for limited use by a certified environmental laboratory if the ATP is developed by the environmental laboratory to improve the analysis of a specific parameter. If the Department approves the ATP for limited use, it can be used only by the certified environmental laboratory that receives the approval.
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. The name and address of the certified environmental laboratory seeking the ATP approval;
2. The name of the Department program that requires the parameter analysis;
3. Applicable permit numbers or site identification numbers;
4. The name of each parameter and method for which approval of the ATP is being requested;
5. Justification for using the ATP instead of those methods included in DSAMs;
6. A detailed description (standard operating procedure) of the proposed ATP, including any references to published studies of the applicability of the ATP to the effluents, source water, waste or matrices in question;
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. The ATP application fee required under 7:18-2.9.
(d) The Department shall evaluate applications for ATP approvals in accordance with (a) above. The certified environmental laboratory shall remit the ATP approval fee required under 7:18-2.9 after the Department has accepted the ATP for evaluation. The fee is applicable whether or not the ATP is approved.
