(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:

(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:

(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.