[Code of Federal Regulations]
[Title 40, Volume 5]
[Revised as of July 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR53.9]

[Page 12-13]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 53--AMBIENT AIR MONITORING REFERENCE AND EQUIVALENT METHODS--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 53.9   Conditions of designation.

    Designation of a candidate method as a reference method or 
equivalent method 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 Sec. 53.11.

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    (a) Any method offered for sale as a reference or equivalent method 
shall be accompanied by a copy of the manual referred to in 
Sec. 53.4(b)(3) when delivered to any ultimate purchaser.
    (b) Any method offered for sale as a reference or equivalent method 
shall generate no unreasonable hazard to operators or to the environment 
during normal use or when malfunctioning.
    (c) Any analyzer, PM10 sampler, or PM2.5 
sampler offered for sale as part of a reference or equivalent method 
shall function within the limits of the performance specifications 
referred to in Sec. 53.20(a), Sec. 53.30(a), Sec. 53.50, or Sec. 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 
Sec. 53.4(b)(3).
    (d) Any analyzer, PM10 sampler, or PM2.5 
sampler offered for sale as a reference or equivalent method shall bear 
a prominent, permanently affixed label or sticker indicating that the 
analyzer or sampler has been designated by EPA as a reference method or 
as an equivalent method (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 as a reference or equivalent 
method and has one or more selectable ranges, the label or sticker 
required by paragraph (d) of this section shall be placed in close 
proximity to the range selector and shall indicate clearly which range 
or ranges have been designated as parts of the reference or equivalent 
method.
    (f) An applicant who offers analyzers, PM10 samplers, or 
PM2.5 samplers for sale as reference or equivalent methods 
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 reference or equivalent 
method designation applicable to such an analyzer or sampler, the 
applicant shall notify all ultimate purchasers of the analyzer or 
PM2.5 or PM10 sampler within 30 days if the 
designation has been canceled in accordance with Sec. 53.11 or 
Sec. 53.16 or if adjustment of the analyzer or sampler is necessary 
under Sec. 53.11(b).
    (g) If an applicant modifies an analyzer, PM10 sampler, 
or PM2.5 sampler that has been designated as a reference or 
equivalent method, 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 
Sec. 53.14(c) that the existing designation or a new designation will 
apply to the modified analyzer, PM10 sampler, or 
PM2.5 sampler or has applied for and received notice under 
Sec. 53.8(b) of a new reference or equivalent method determination for 
the modified analyzer or sampler.
    (h) An applicant who has offered PM2.5 samplers or 
analyzers for sale as part of a reference or equivalent method may 
continue to do so only so long as the facility in which the samplers or 
analyzers are manufactured continues to be an ISO 9001-registered 
facility, as set forth in subpart E of this part. In the event that the 
ISO 9001 registration for the facility is withdrawn, suspended, or 
otherwise becomes inapplicable, either permanently or for some specified 
time interval, such that the facility is no longer an ISO 9001-
registered facility, the applicant shall notify EPA within 30 days of 
the date the facility becomes other than an ISO 9001-registered 
facility, and upon such notification, EPA shall issue a preliminary 
finding and notification of possible cancellation of the reference or 
equivalent method designation under Sec. 53.11.
    (i) An applicant who has offered PM2.5 samplers or 
analyzers for sale as part of a reference or equivalent method may 
continue to do so only so long as updates of the Product Manufacturing 
Checklist set forth in subpart E of this part are submitted annually. In 
the event that an annual Checklist update is not received by EPA within 
12 months of the date of the last such submitted Checklist or Checklist 
update, EPA shall notify the applicant within 30 days that the Checklist 
update has not been received and shall, within 30 days from the issuance 
of such notification, issue a preliminary finding and notification of 
possible cancellation of the reference or equivalent method designation 
under Sec. 53.11.

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