(1) The owner or operator of a source subject to emissions standards in § 63.362 shall comply with the monitoring requirements in § 63.8 of subpart A of this part, according to the applicability in Table 1 of § 63.360, and in this section.
(2) Each owner or operator of an ethylene oxide sterilization facility subject to these emissions standards shall monitor the parameters specified in this section. All monitoring equipment shall be installed such that representative measurements of emissions or process parameters from the source are obtained. For monitoring equipment purchased from a vendor, verification of the operational status of the monitoring equipment shall include completion of the manufacturer's written specifications or recommendations for installation, operation, and calibration of the system.
(b) For sterilization facilities complying with § 63.363(b) or (d) through the use of an acid-water scrubber, the owner or operator shall either:
(1) Sample the scrubber liquor and analyze and record once per week the ethylene glycol concentration of the scrubber liquor using the test methods and procedures in § 63.365(e)(1). Monitoring is required during a week only if the scrubber unit has been operated; or
(2) Measure and record once per week the level of the scrubber liquor in the recirculation tank. The owner or operator shall install, maintain, and use a liquid level indicator to measure the scrubber liquor tank level (i.e., a marker on the tank wall, a dipstick, a magnetic indicator, etc.). Monitoring is required during a week only if the scrubber unit has been operated.
(c) For sterilization facilities complying with § 63.363(b) or (c) through the use of catalytic oxidation or thermal oxidation, the owner or operator shall either comply with § 63.364(e) or continuously monitor and record the oxidation temperature at the outlet to the catalyst bed or at the exhaust point from the thermal combustion chamber using the temperature monitor described in paragraph (c)(4) of this section. Monitoring is required only when the oxidation unit is operated. From 15-minute or shorter period temperature values, a data acquisition system for the temperature monitor shall compute and record a daily average oxidation temperature. Strip chart data shall be converted to record a daily average oxidation temperature each day any instantaneous temperature recording falls below the minimum temperature.
(4) The owner or operator shall install, calibrate, operate, and maintain a temperature monitor accurate to within ±5.6 °C (±10 °F) to measure the oxidation temperature. The owner or operator shall verify the accuracy of the temperature monitor twice each calendar year with a reference temperature monitor (traceable to National Institute of Standards and Technology (NIST) standards or an independent temperature measurement device dedicated for this purpose). During accuracy checking, the probe of the reference device shall be at the same location as that of the temperature monitor being tested. As an alternative, the accuracy temperature monitor may be verified in a calibrated oven (traceable to NIST standards).
(d) For sterilization facilities complying with § 63.363(b) or (c) through the use of a control device other than acid-water scrubbers or catalytic or thermal oxidizers, the owner or operator shall monitor the parameters as approved by the Administrator using the methods and procedures in § 63.365(g).
(e) Measure and record once per hour the ethylene oxide concentration at the outlet to the atmosphere after any control device according to the procedures specified in § 63.365(c)(1). The owner or operator shall compute and record a 24-hour average daily. The owner or operator will install, calibrate, operate, and maintain a monitor consistent with the requirements of performance specification (PS) 8 or 9 in 40 CFR part 60, appendix B, to measure ethylene oxide. The daily calibration requirements of section 7.2 of PS 9 or section 2.3 of PS 8 are required only on days when ethylene oxide emissions are vented to the control device.
[59 FR 62589, Dec. 6, 1994, as amended at 66 FR 55584, Nov. 2, 2001]
Title 40 published on 2014-07-01
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