§ 63.11499 — What Are The Standards And Compliance Requirements For Heat Exchange Systems?

(a) Except as specified in paragraph (d) of this section, if the cooling water flow rate in your heat exchange system is equal to or greater than 8,000 gal/min and is not meeting one or more of the conditions in § 63.104(a)(1) through (4), then you must comply with one of the requirements specified in table 8 to this subpart.

(b) For equipment that meets Current Good Manufacturing Practice (CGMP) requirements of 21 CFR part 211, you may use the physical integrity of the reactor as the surrogate indicator of heat exchanger system leaks when complying with Item 1.a in Table 8 to this subpart.

(c) Any reference to SSM provisions in other subparts that are referenced in paragraphs (a) and (b) of this section or Table 8 to this subpart do not apply.

(d) If you are required to comply with the requirements in § 63.104(f) through (j) and (l) as specified in item 1.c of table 8 to this subpart (for heat exchange systems with a cooling water flow rate greater than or equal to 8,000 gal/min), then you must also comply with the requirements in paragraphs (d)(1) through (6) of this section.

(1) Replace each occurrence of “For each source as defined in § 63.101,” with “For each affected source as described in § 63.11494(d),”.

(2) Replace each reference to § 63.100(k)(10) with § 63.11494(i).

(3) Replace each occurrence of “semi-annual periodic report required by § 63.152(c)”, “semi-annual periodic report”, or “periodic report” with “semiannual compliance report”.

(4) The phrase “Except as specified in paragraph (g)(6) of this section,” in § 63.104(g)(4) does not apply.

(5) Section 63.104(g)(6) and (h)(6) do not apply.

(6) Beginning no later than the compliance dates specified in § 63.11494(i), you must not inject water into or dispose of water in the heat exchange system if the water is considered wastewater as defined in § 63.11502.