N.Y. Comp. Codes R. & Regs. tit. 6 § 233.4

Current through Register Vol. 46, No. 45, November 2, 2024

Section 233.4 - Testing and monitoring

(a) The owner and/or operator of a pharmaceutical or cosmetic manufacturing process must follow notification requirements, protocol requirements and test procedures of Part 202 of this Title for testing and monitoring of these processes.

(b) The test procedures to determine compliance must be approved by the commissioner and be consistent with Appendix A of part 60 of title 40 of the Code of Federal Regulations (see table 1, section 200.9 of this Title). Depending upon conditions at a test site, one of the following test methods from appendix A of 40 CFR 60 (see table 1, section 200.9 of this Title) must be used to determine volatile organic compound (VOC) concentrations of a gas stream at the inlet and outlet of a control device:

(1) Method 18, Measurement of Gaseous Organic Compound Emissions by Gas Chromatography.

(2) Method 25, Determination of Total Gaseous Organic Emissions as Carbon.

(3) Method 25A, Determination of Total Gaseous Organic Concentration Using a Flame Ionization Analyzer.

(4) Methods not listed above must be approved in advance by the department's representative and the United States Environmental Protection Agency.

(c) Any facility which is not subject to the control requirements of this Part because its annual potential to emit volatile organic compounds are below the applicability levels, must maintain records in a format acceptable to the commissioner's representative that verify the facility's annual potential to emit VOC. Upon request, these records must be submitted to the department.

(d) If an air cleaning device is used, continuous monitors for the following parameters must be installed, periodically calibrated, and operated at all times that the associated process equipment and control equipment are operating:

(1) an exhaust gas temperature of all incinerators;

(2) temperature rise across a catalytic incinerator bed;

(3) breakthrough of volatile organic compounds on a carbon adsorption unit; and

(4) outlet gas temperature of a refrigerated condenser;

(5) temperature of nonrefrigerated condenser coolant supply system; or

(6) any other continuous monitoring or recording device required by the commissioner for the purpose of demonstrating compliance with the control requirements of this Part.

(e) Each monitor must be equipped with a recording device.

(f) Each monitor must be calibrated quarterly.

(g) Each monitor must operate at all times while the associated control equipment is operating.

N.Y. Comp. Codes R. & Regs. Tit. 6 § 233.4