40 CFR 136.4 - Application for and approval of alternate test procedures for nationwide use.
(a) A written application for review of an alternate test procedure (alternate method) for nationwide use may be made by letter via email or by hard copy in triplicate to the National Alternate Test Procedure (ATP) Program Coordinator (National Coordinator), Office of Science and Technology (4303T), Office of Water, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460. Any application for an alternate test procedure (ATP) under this paragraph (a) shall:
(1) Provide the name and address of the responsible person or firm making the application.
(2) Identify the pollutant(s) or parameter(s) for which nationwide approval of an alternate test procedure is being requested.
(3) Provide a detailed description of the proposed alternate test procedure, together with references to published or other studies confirming the general applicability of the alternate test procedure for the analysis of the pollutant(s) or parameter(s) in wastewater discharges from representative and specified industrial or other categories.
(4) Provide comparability data for the performance of the proposed alternative test procedure compared to the performance of the reference method.
(b) The National Coordinator may request additional information and analyses from the applicant in order to determine whether the alternate test procedure satisfies the applicable requirements of this part.
(c) Approval for nationwide use. (1) After a review of the application and any additional analyses requested from the applicant, the National Coordinator will notify the applicant, in writing, of acceptance or rejection of the alternate test procedure for nationwide use in CWA programs. If the application is not approved, the National Coordinator will specify what additional information might lead to a reconsideration of the application, and notify the Regional Alternate Test Procedure Coordinators of such rejection. Based on the National Coordinator's rejection of a proposed alternate test procedure and an assessment of any approvals for limited uses for the unapproved method, the Regional ATP Coordinator or permitting authority may decide to withdraw approval of the method for limited use in the Region.
(2) Where the National Coordinator approved an applicant's request for nationwide use of an alternate test procedure, the National Coordinator will notify the applicant that the National Coordinator will recommend rulemaking to approve the alternate test procedure. The National Coordinator will notify the Regional ATP Coordinator or permitting authorities that they may consider approval of this alternate test procedure for limited use in their Regions based on the information and data provided in the applicant's application. The Regional ATP Coordinator or permitting authority will grant approval on a case-by-case basis prior to use of the alternate test procedure for compliance analyses until the alternate test procedure is approved by publication in a final rule in the Federal Register.
(3) EPA will propose to amend 40 CFR part 136 to include the alternate test procedure in § 136.3. EPA shall make available for review all the factual bases for its proposal, including any performance data submitted by the applicant and any available EPA analysis of those data.
(4) Following public comment, EPA shall publish in the Federal Register a final decision on whether to amend 40 CFR part 136 to include the alternate test procedure as an approved analytical method.
(5) Whenever the National Coordinator has approved an applicant's request for nationwide use of an alternate test procedure, any person may request an approval of the method for limited use under § 136.5 from the EPA Region.