CFR 2025 Title 40 - Vol 6 - Sec 53.9 - Conditions of designation

Sep 4, 2026

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Environmental Protection Agency requirements for designating a candidate method as a FRM or FEM under 40 CFR Part 53.9 are specified, including notice procedures, maintenance of current designation lists, and conditions tied to applicant compliance. The designation depends on providing required manuals, preventing unreasonable hazards during normal or malfunctioning use, maintaining performance within specified limits for at least one year, and applying prominent, permanently affixed EPA labels with method identification numbers. Additional obligations cover range labeling, purchaser recordkeeping and notifications, handling modifications without selling as reference or equivalent methods, and sustaining ISO 9001 manufacturing facility status.

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§ 53.9 Conditions of designation

Conditions for FRM or FEM designation

Appeal and cancellation context

Environmental Protection Agency § 53.9 FRM or FEM (as applicable) until the designation is published in the FEDERAL REGISTER. (b) Upon designation, a notice indicating that the method has been designated as a FRM or FEM shall be sent to the applicant. (c) The Administrator will maintain a current list of methods designated as FRM or FEM in accordance with this part and will send a copy of the list to any person or group upon request. A copy of the list will be available via the Internet and may be available from other sources. [71 FR 61276, Oct. 17, 2006, as amended at 75 FR 35597, June 22, 2010; 89 FR 16382, Mar. 6, 2024] § 53.9 Conditions of designation. Designation of a candidate method asa FRM or FEM shall be conditioned to the applicant’s compliance with the following requirements. Failure to comply with any of the requirements shall constitute a ground for cancellation of the designation in accordance with § 53 .11. (a) Any method offered for sale as a FRM or FEM shall be accompanied by a copy of the manual referred to in § 53 .4(b)(3) when delivered to any ultimate purchaser, and an electronic copy of the manual suitable for incorporating into user-specific standard operating procedure documents shall be readily available to any users. (b) Any method offered for sale as a FRM or FEM shall generate no unreasonable hazard to operators or to the environment during normal use or when malfunctioning. (c) Any analyzer, PM 10 sampler, PM 2.5 sampler, or PM 10–2.5 sampler offered for sale as part of an FRM or FEM shall function within the limits of the performance specifications referred to in § 53 .20(a), § 53 .30(a), § 53 .35, § 53 .50, or § 53 .60, as applicable, for at least 1 year after delivery and acceptance when maintained and operated in accordance with the manual referred to in § 53 .4(b)(3) . (d) Any analyzer, PM 10 sampler, PM 2.5 sampler, or PM 10–2.5 sampler offered for sale as a FRM or FEM shall bear a prominent, permanently affixed label or sticker indicating that the analyzer or sampler has been designated by EPA as a FRM or FEM (as applicable) in accordance with this part and displaying any designated method identification number that may be assigned by EPA. (e) If an analyzer is offered for sale asa FRM or FEM and has one or more selectable ranges, the label or sticker required by paragraph (d) of this sectionshall be placed in close proximity to the range selector and shall indicate clearly which range or ranges have been designated as parts of the FRM or FEM. (f) An applicant who offers analyzers, PM 10 samplers, PM 2.5 samplers, or PM 10–2.5 samplers for sale as FRM or FEMs shall maintain an accurate and current list of the names and mailing addresses of all ultimate purchasers of such analyzers or samplers. For a period of 7 years after publication of the FRM or FEM designation applicable to such an analyzer or sampler, the applicant shall notify all ultimate purchasers of the analyzer or sampler within 30 days if the designation has been canceled in accordance with § 53 .11 or § 53 .16 or if adjustment of the analyzer or sampler is necessary under § 53 .11(b) . (g) If an applicant modifies an analyzer, PM 10 sampler, PM 2.5 sampler, or PM 10–2.5 sampler that has been designated as a FRM or FEM, the applicant shall not sell the modified analyzer or sampler as a reference or equivalent method nor attach a label or sticker to the modified analyzer or sampler under paragraph (d) or (e) of this section until the applicant has received notice under § 53 .14(c) that the existing designation or a new designation will apply to the modified analyzer or sampler or has applied for and received notice under § 53 .8(b) of a new FRM or FEM determination for the modified analyzer or sampler. (h) An applicant who has offered PM 2.5 or PM 10–2.5 samplers or analyzers for sale as part of a FRM or FEM may continue to do so only so long as the facility in which the samplers or analyzers are manu

FAQs

What happens after a method is designated as FRM or FEM under § 53.9?

After designation, EPA sends a notice to the applicant indicating the method has been designated as a FRM or FEM. EPA also maintains a current list of designated methods and provides copies upon request, including via the Internet.

What requirements must an applicant meet for a candidate method to be designated as a FRM or FEM?

Designation is conditioned on applicant compliance with requirements in § 53.9, including providing the required manual to purchasers, ensuring normal-use and malfunctioning-use safety, meeting performance specifications for at least one year, and applying prominent EPA labels showing the designated method identification number.

How does § 53.9 treat modified analyzers or samplers after they have been designated?

An applicant must not sell a modified analyzer or sampler as a reference or equivalent method and must not attach the required designation label until EPA provides notice that the existing or new designation applies, or until a new FRM/FEM determination is applied for and received.

Sep 4, 2026

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