Section 53.3 - General requirements for an equivalent method determination(a)Manual methods. A manual Federal equivalent method (FEM) must have been shown in accordance with this part to satisfy the applicable requirements specified in this subpart A and subpart C of this part. In addition, a PM sampler associated with a manual method for PM10, PM2.5, or PM10-2.5 must have been shown in accordance with this part to satisfy the following additional requirements, as applicable: (1)PM10. A PM10 sampler associated with a manual method for PM10 must satisfy the requirements of subpart D of this part.(2)PM2.5Class I. A PM2.5 Class I FEM sampler must also satisfy all requirements of subpart E of this part, which shall include appropriate demonstration that each and every deviation or modification from the FRM sampler specifications does not significantly alter the performance of the sampler.(3)PM2.5Class II.(i) A PM2.5 Class II FEM sampler must also satisfy the applicable requirements of subparts E and F of this part or the alternative requirements in paragraph (a)(3)(ii) of this section.(ii) In lieu of the applicable requirements specified for Class II PM2.5 methods in subparts C and F of this part, a Class II PM2.5 FEM sampler may alternatively meet the applicable requirements in paragraphs (b)(3)(i) through (iii) of this section and the testing, performance, and comparability requirements specified for Class III equivalent methods for PM2.5 in subpart C of this part.(4)PM10-2.5Class I. A PM10-2.5 Class I FEM sampler must also satisfy the applicable requirements of subpart E of this part (there are no additional requirements specifically for Class I PM10-2.5 methods in subpart C of this part).(5)PM10-2.5Class II.(i) A PM10-2.5 Class II FEM sampler must also satisfy the applicable requirements of subpart C of this part and also the applicable requirements and provisions of paragraphs (b)(3)(i) through (iii) of this section, or the alternative requirements in paragraph (a)(5)(ii) of this section.(ii) In lieu of the applicable requirements specified for Class II PM10-2.5 methods in subpart C of this part and in paragraph (b)(3)(iii) of this section, a Class II PM10-2.5 FEM sampler may alternatively meet the applicable requirements in paragraphs (b)(3)(i) and (ii) of this section and the testing, performance, and comparability requirements specified for Class III FEMs for PM10-2.5 in subpart C of this part.(6)ISO 9001. All designated FEMs for PM2.5 or PM10-2.5 must be manufactured in an ISO 9001-registered facility, as defined in § 53.1 and as set forth in § 53.51 .(b)Automated methods. All types of automated FEMs must have been shown in accordance with this part to satisfy the applicable requirements specified in this subpart A and subpart C of this part. In addition, an automated FEM must have been shown in accordance with this part to satisfy the following additional requirements, as applicable: (1) An automated FEM for pollutants other than PM must be shown in accordance with this part to satisfy the applicable requirements specified in subpart B of this part.(2) An automated FEM for PM10 must be shown in accordance with this part to satisfy the applicable requirements of subpart D of this part.(3) A Class III automated FEM for PM2.5 or PM10-2.5 must be shown in accordance with this part to satisfy the requirements in paragraphs (b)(3)(i) through (iii) of this section, as applicable. (i) All pertinent requirements of 40 CFR part 50, appendix L, including sampling height, range of operational conditions, ambient temperature and pressure sensors, outdoor enclosure, electrical power supply, control devices and operator interfaces, data output port, operation/instruction manual, data output and reporting requirements, and any other requirements that would be reasonably applicable to the method, unless adequate (as determined by the Administrator) rationale can be provided to support the contention that a particular requirement does not or should not be applicable to the particular candidate method.(ii) All pertinent tests and requirements of subpart E of this part, such as instrument manufacturing quality control; final assembly and inspection; manufacturer's audit checklists; leak checks; flow rate accuracy, measurement accuracy, and flow rate cut-off; operation following power interruptions; effect of variations in power line voltage, ambient temperature and ambient pressure; and aerosol transport; unless adequate (as determined by the Administrator) rationale can be provided to support the contention that a particular test or requirement does not or should not be applicable to the particular candidate method.(iii) Candidate methods shall be tested for and meet any performance requirements, such as inlet aspiration, particle size separation or selection characteristics, change in particle separation or selection characteristics due to loading or other operational conditions, or effects of surface exposure and particle volatility, determined by the Administrator to be necessary based on the nature, design, and specifics of the candidate method and the extent to which it deviates from the design and performance characteristics of the reference method. These performance requirements and the specific test(s) for them will be determined by Administrator for each specific candidate method or type of candidate method and may be similar to or based on corresponding tests and requirements set forth in subpart F of this part or may be special requirements and tests tailored by the Administrator to the specific nature, design, and operational characteristics of the candidate method. For example, a candidate method with an inlet design deviating substantially from the design of the reference method inlet would likely be subject to an inlet aspiration test similar to that set forth in § 53.63 . Similarly, a candidate method having an inertial fractionation system substantially different from that of the reference method would likely be subject to a static fractionation test and a loading test similar to those set forth in §§ 53.64 and 53.65 , respectively. A candidate method with more extensive or profound deviations from the design and function of the reference method may be subject to other tests, full wind-tunnel tests similar to those described in § 53.62 , or to special tests adapted or developed individually to accommodate the specific type of measurement or operation of the candidate method.(4) All designated FEM for PM2.5 or PM10-2.5 must be manufactured in an ISO 9001-registered facility, as defined in § 53.1 and as set forth in § 53.51 . 71 FR 61271 , Oct. 17, 2006