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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 233.1 - Applicability and compliance

N.Y. Comp. Codes R. & Regs. tit. 6 § 233.1

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Current through Register Vol. 46, No. 45, November 2, 2024
Section 233.1 - Applicability and compliance
(a) The owner or operator of a pharmaceutical or cosmetic manufacturing process which meets the applicability criteria of this Part must obtain a permit to construct or a certificate to operate prior to commencing construction and/or operation of the process, as required by Part 201 of this Title, which includes the method or methods which will be used to comply with the control requirements of this Part.
(b) The owner or operator of a pharmaceutical or cosmetic manufacturing process at facilities in the New York City metropolitan area must comply with this Part according to the following schedule:
(1) Synthesized pharmaceutical manufacturing processes which were constructed on or before May 10, 1981 at any facility compliance must have demonstrated compliance with this Part by December 1, 1982.
(2) Synthesized pharmaceutical manufacturing processes which were constructed after May 10, 1981 must demonstrate compliance with this Part through the submission of an application for a permit to construct or a certificate to operate containing the method or methods which will be used to comply with the control requirements, prior to commencing construction.
(3) The owner or operator of all other pharmaceutical manufacturing processes not regulated by paragraphs (1) and (2) of this subdivision or cosmetic manufacturing processes, at any facility with annual potential to emit volatile organic compounds from all sources regardless of process type, but excluding combustion installations, that equal or exceed 25 tons must:
(i) submit a compliance plan to the Department of Environmental Conservation by November 15, 1993, which contains a schedule of the steps necessary for the facility to achieve compliance with this Part or reduce the facility's annual potential to emit below the applicability criteria and the dates by which each step will be completed;
(ii) be in compliance with this Part or have permits modified to limit the facility's annual potential to emit below the applicability criteria by June 1, 1995; and
(iii) maintain the VOC control requirements and compliance schedule included in any permit, regulation, rule, administrative order, or any judicial order, until compliance with the provisions of this Part is demonstrated to the satisfaction of the commissioner.
(c) The owner or operator of a pharmaceutical or cosmetic manufacturing process at facilities in the Lower Orange County metropolitan area must comply with this Part according to the following schedule:
(1) Synthesized pharmaceutical manufacturing processes which were constructed on or before May 10, 1981 at any facility for which the annual potential to emit volatile organic compounds from all sources regardless of process type, but excluding combustion installations, equal or exceed 100 tons must have demonstrated compliance with this Part by December 1, 1982.
(2) Synthesized pharmaceutical manufacturing processes which were constructed after May 10, 1981 at any facility for which the annual potential to emit volatile organic compounds from all sources regardless of process type, but excluding combustion installations, equal or exceed 100 tons must demonstrate compliance, through the submission of an application for permit to construct or a certificate to operate containing the method or methods which will be used to comply with the control requirements, prior to commencing construction.
(3) Synthesized pharmaceutical manufacturing processes at any facility for which the annual potential to emit volatile organic compounds from all sources regardless of process type, but excluding combustion installations, equal or exceed 10 tons must:
(i) submit a compliance plan to the Department of Environmental Conservation by November 15, 1993, which contains a schedule of the steps necessary for the facility to achieve compliance with this Part or reduce the facility's annual potential to emit below the applicability criteria and the dates by which each step will be completed;
(ii) be in compliance with this Part or have permits modified to limit the facility's annual potential to emit below the applicability criteria by June 1, 1995; and
(iii) maintain the VOC control requirements and compliance schedule included in any permit, regulation, rule, administrative order, or any judicial order until compliance with the provisions of this Part is demonstrated to the satisfaction of the commissioner.
(4) The owner or operator of all other pharmaceutical manufacturing processes not regulated by paragraphs (1), (2), and (3) of this subdivision or cosmetic manufacturing processes at any facility for which the annual potential to emit volatile organic compounds from all sources regardless of process type, but excluding combustion installations, equal or exceed 25 tons must:
(i) submit a compliance plan to the Department of Environmental Conservation by November 15, 1993, which contains a schedule of the steps necessary for the facility to achieve compliance with this Part or reduce the facility's annual potential to emit below the applicability criteria and the dates by which each step will be completed;
(ii) be in compliance with this Part or have permits modified to limit the facility's annual potential to emit below the applicability criteria by June 1, 1995; and
(iii) maintain the VOC control requirements and compliance schedule included in any permit, regulation, rule, administrative order, or any judicial order until compliance with the provisions of this Part is demonstrated to the satisfaction of the commissioner.
(d) The owner or operator of a pharmaceutical or cosmetic manufacturing process at any facility located outside the New York City metropolitan area and the Lower Orange County metropolitan area must comply with this Part according to the following schedule:
(1) Synthesized pharmaceutical manufacturing processes which were constructed on or before May 10, 1981 at any facility located in the counties of Albany, Cayuga, Columbia, Dutchess, Erie, Genesee, Greene, Livingston, Monroe, Niagara, Onondaga, Orange (excluding the towns of Blooming Grove, Chester, Highlands, Monroe, Tuxedo, Warwick, and Woodbury), Ontario, Orleans, Putnam, Rensselaer, Saratoga (limited to the towns of Clifton Park and Halfmoon, the city of Mechanicville, and the town and village of Waterford), Schenectady, Seneca, Ulster, Wayne, Wyoming or Yates for which the annual potential to emit volatile organic compounds equal or exceed 100 tons must have demonstrated compliance with this Part by December 1, 1982.
(2) Synthesized pharmaceutical manufacturing processes at any facility which was constructed after May 10, 1981 for which the annual potential to emit volatile organic compounds from all sources regardless of process type, but excluding combustion installations, at the facility equal or exceed 100 tons per year must have demonstrated compliance with this Part prior to commencing construction.
(3) Synthesized pharmaceutical manufacturing processes at any facility for which the annual potential to emit volatile organic compounds from all sources regardless of process type, but excluding combustion installations, equal or exceed 10 tons must:
(i) submit a compliance plan to the Department of Environmental Conservation by November 15, 1993, which contains a schedule of the steps necessary for the facility to achieve compliance with this Part or reduce the facility's annual potential to emit below the applicability criteria and the dates by which each step will be completed;
(ii) be in compliance with this Part or have permits modified to limit the facility's annual potential to emit below the applicability criteria by June 1, 1995; and
(iii) maintain the VOC control requirements and compliance schedule included in any permit, regulation, rule, administrative order, or any judicial order until compliance with the provisions of this Part is demonstrated to the satisfaction of the commissioner.
(4) All other pharmaceutical manufacturing processes not regulated by paragraphs (1), (2), and (3) of this subdivision or cosmetic manufacturing processes at any facility for which the annual potential to emit volatile organic compounds from all sources regardless of process type, but excluding combustion installations, equal or exceed 50 tons must:
(i) submit a compliance plan to the Department of Environmental Conservation by November 15, 1993, which contains a schedule of the steps necessary for the facility to achieve compliance with this Part or reduce the facility's annual potential to emit below the applicability criteria and the dates by which each step will be completed;
(ii) be in compliance with this Part or have permits modified to limit the facility's annual potential to emit below the applicability criteria by June 1, 1995; and
(iii) maintain the VOC control requirements and compliance schedule included in any permit, regulation, rule, administrative order, or any judicial order until compliance with the provisions of this Part is demonstrated to the satisfaction of the commissioner.
(e) This Part previously contained a facility-wide emission reduction (bubble) plan involving synthesized pharmaceutical manufacturing processes covered by the provisions of this Part. Any owner or operator of a facility which has operated in accordance with a facility-wide emission reduction plan approved by the commissioner must:
(1) submit a compliance plan to the Department of Environmental Conservation by November 15, 1993, which contains a schedule of the steps necessary for the facility to achieve compliance with this Part or reduce the facility's annual potential to emit below the applicability criteria and the dates by which each step will be completed;
(2) be in compliance with this Part or have permits modified to limit the facility's annual potential to emit below the applicability criteria by June 1, 1995; and
(3) maintain the VOC control requirements and compliance schedule included in any permit, regulation, rule administrative order, or any judicial order until compliance with the provisions of this Part is demonstrated to the satisfaction of the commissioner.
(f) Any process that is subject to the provisions of this Part will remain subject to these provisions even if the emissions of volatile organic compounds from the facility later fall below the applicability criteria.
(g) This Part shall not apply to the following pharmaceutical and cosmetic manufacturing processes and sources:
(1) the manufacture of pharmaceutical or cosmetic products for study rather than eventual sale at facilities which have annual potential to emit volatile organic compounds from all sources, regardless of process type but excluding combustion installations, which are less than 25 tons in the New York City metropolitan area and the Lower Orange County metropolitan area, or which are less than 50 tons outside those areas of the State; and
(2) any reactor, extractor, distillation operation, crystallizer, centrifuge or vacuum dryer which has an emission rate potential for volatile organic compounds equal to or less than 15 pounds per day.
(h) Pharmaceutical and cosmetic manufacturing processes which are not regulated under this Part must comply with all other applicable Parts of this Subchapter.

N.Y. Comp. Codes R. & Regs. Tit. 6 § 233.1