Statutes, codes, and regulations
New York Codes, Rules and Regulations
Title 6 - DEPARTMENT OF ENVIRONMENTAL CONSERVATIONChapter III - AIR RESOURCESSubchapter A - PREVENTION AND CONTROL OF AIR CONTAMINATION AND AIR POLLUTION
Part 233 - PHARMACEUTICAL AND COSMETIC MANUFACTURING PROCESSES
Section 233.3 - Control requirements

N.Y. Comp. Codes R. & Regs. tit. 6 § 233.3

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Current through Register Vol. 46, No. 45, November 2, 2024
Section 233.3 - Control requirements
(a)Process equipment requirements.

The owner or operator of a pharmaceutical or cosmetic manufacturing process subject to this Part must control the volatile organic compound emissions from reactors, extractors, distillation operations, crystallizers, centrifuges, and vacuum dryers which have an emission rate potential of more than 15 pounds per day as follows:

(1) When surface condensers are used, the condenser outlet gas temperature must not exceed the allowable temperature limit described for each associated vapor pressure in the Table 1.

Table 1

VOC vapor pressure at 20° C (psi)Allowable condenser outlet gas temperature (° C)
> 5.8 - 25
> 2.9 - 15
> 1.50
> 1.010
> 0.525

(2) If the operation of a condenser at the exit temperature specified above results in freezing and consequent plugging of the condenser, the allowable exit temperature may be raised to a maximum of 2°C above the freezing point of the volatile organic compound.
(3) In cases where the condenser outlet gas temperature is not readily measurable due to negligible gas flow rate, the temperature of the condenser coolant may be used in lieu of condenser outlet gas temperature as long as the temperature of the condenser coolant does not exceed the allowable condenser outlet gas temperature shown in Table 1.
(b)Air dryer and production equipment exhaust system requirements.

Except as provided under subdivision (a) of this section, the owner or operator of a pharmaceutical or cosmetic manufacturing process subject to this Part must not operate, cause, allow or permit the operation of any air dryer or production exhaust system which conducts fugitive volatile organic compounds from a work area unless the emissions to the outdoor atmosphere are controlled as follows:

(1) for air dryers and production equipment exhaust systems with an emission rate potential of volatile organic compounds of 330 pounds per day or more, 90 percent control is required;
(2) for air dryers and production equipment exhaust systems with an emission rate potential of volatile organic compounds of less than 330 pounds per day, an emission reduction to 33 pounds per day is required.
(c)VOC transfer requirements.

For the transfer of volatile organic compounds with vapor pressures greater than 4.1 psi at 20°C from trucks or railcars to storage tanks with capacities greater than 2,000 gallons, other than tanks with floating roofs, vapor recovery or equivalent controls, a vapor balance system or equivalent control that provides at least 90.0 percent control of the volatile organic compound emissions is required.

(d)Storage tank requirements.

For all storage tanks that store volatile organic compounds with vapor pressures greater than 1.5 psi at 20°C, pressure/vacuum conservation vents set at 0.03 psi must be installed, unless more effective control equipment is used.

(e)Centrifuge and filter requirements.

All centrifuges containing volatile organic compounds, rotary vacuum filters processing volatile organic compounds and any other filters having an exposes liquid surface where the liquid contains volatile organic compounds and exerts a total vapor pressure of 0.5 psi or more at 20°C must be enclosed unless production, sampling, maintenance, or inspection procedures require operator access.

(f)In-process tank requirements.

For in-process tanks containing a volatile organic compound, covers must be installed on openings to these tanks. Tank openings must remain covered unless production, sampling, maintenance, or inspection procedures require operator access.

(g)Leak requirements.

All leaks from which a liquid containing volatile organic compounds can be observed running or dripping must be repaired the first time the equipment is off-line for a period of time long enough to complete the repair, but not later than 15 days after the leak is discovered. If the leaking component cannot be repaired until the process is shut down, and a shut down cannot be done within the 15 days after the leak is detected, the leaking component must then be repaired before the process is restarted.

(h)
(1) The commissioner may allow processes subject to this Part to operate with a lesser degree of control than what is required per subdivisions (a)-(g) of this section provided that a process specific reasonably available control technology (RACT) demonstration has been made to the satisfaction of the commissioner. Process specific RACT demonstrations must be submitted with the application for a permit to construct, a certificate to operate, or renewal of a certificate to operate for an existing source under the provisions of Part 201 of this Title. Such process specific RACT demonstrations must be submitted to the United States Environmental Protection Agency as a revision to the State Implementation Plan and must address the technical and economic feasibility of:
(i) utilizing demonstrated and proven emission control technologies which would achieve the degree of control required in subdivision (a)-(g) of this section;
(ii) utilizing demonstrated and proven emission control technologies which would not achieve the degree of control required in subdivision (a)-(g) of this section;
(iii) utilizing demonstrated and proven production modification methods which would result in real, documented, and enforceable reductions in the volatile organic compound emissions from the process.
(2) Facilities with processes subject to this Part with an annual potential to emit less than five tons of volatile organic compounds will only be required to comply with subparagraphs (1)(i) and (1)(iii) of this subdivision in order to demonstrate that a lesser degree of control is RACT for these processes.
(3) The commissioner may allow sources which use natural gas fired afterburners as control devices for processes subject to this Part, to shut down these natural gas fired afterburners from November 1st through March 31st for the purposes of natural gas conservation, provided that the commissioner has determined that this action will not jeopardize air quality. Such evidence must be submitted with the application for a permit to construct, a certificate, or renewal of a certificate to operate for an existing source under the provisions of Part 201 of this Title.

N.Y. Comp. Codes R. & Regs. Tit. 6 § 233.3