(a) Each owner or operator of a source subject to the provisions of this subpart shall comply with these requirements on and after the compliance date specified in §63.360(g). The standards of this section are summarized in Table 1 of this section.

Table 1 of Section 63.362—Standards for Ethylene Oxide Commercial Sterilizers and Fumigators

Open Table
Existing and new sources Source type Sterilization chamber vent Aeration room vent Chamber exhaust vent
Source size <907 kg (<1 ton) No control required; minimal recordkeeping requirements apply (see §63.367(c)).
    ≥907 kg and <9,070 kg (≥1 ton and <10 tons) 99% emission reduction (see §63.362(c)) No control No control.
    ≥9,070 kg (≥10 tons) 99% emission reduction (see §63.362(c)) 1 ppm maximum outlet concentration or 99% emission reduction (see §63.362(d)) No control.

(b) Applicability of emission limits. The emission limitations of paragraphs (c), (d), and (e) of this section apply during sterilization operation. The emission limitations do not apply during periods of malfunction.

(c) Sterilization chamber vent at sources using 1 ton. Each owner or operator of a sterilization source using 1 ton shall reduce ethylene oxide emissions to the atmosphere by at least 99 percent from each sterilization chamber vent.

(d) Aeration room vent at sources using 10 tons. Each owner or operator of a sterilization source using 10 tons shall reduce ethylene oxide emissions to the atmosphere from each aeration room vent to a maximum concentration of 1 ppmv or by at least 99 percent, whichever is less stringent, from each aeration room vent.

(e) [Reserved]

[59 FR 62589, Dec. 6, 1994, as amended at 66 FR 55583, Nov. 2, 2001]


Tried the LawStack mobile app?

Join thousands and try LawStack mobile for FREE today.

  • Carry the law offline, wherever you go.
  • Download CFR, USC, rules, and state law to your mobile device.