(b) For the purpose of this Part, the following definitions shall apply:

1. (1) Annual. Refers to a period of time based upon a calendar year commencing January 1st and terminating midnight December 31st.
2. (2) Condenser. A device which cools a gas stream to a temperature at which all or some of the vaporized volatile organic compounds in the gas stream will condense and will be removed.
3. (3) Cosmetic manufacturing process. Any process producing or blending chemicals for use in cosmetic products and/or manufacturing cosmetic products by chemical processes. Cosmetic products include, but are not limited to, colognes, perfumes, and nail polish.
4. (4) Control system. Any control devices, including, but not limited to condensers, which are designed and operated to reduce the quantity of contamiants, including but not limited to volatile organic compounds emitted to the atmosphere.
5. (5) In-process tank. Containers used for mixing, blending, heating, reacting, holding, crystallizing, evaporating or cleaning operations in the manufacture of pharmaceuticals.
6. (6) Lower Orange County metropolitan area. The area including the towns of Blooming Grove, Chester, Highlands, Monroe, Tuxedo, Warwick and Woodbury.
7. (7) New York City metropolitan area. All of the city of New York, and Nassau, Suffolk, Westchester and Rockland Counties.

8. (8) Pharmaceutical manufacturing process. Any process involving the manufacture of pharmaceutical products and intermediates, including but not limited to, the following operations:

   1. (i) the manufacture of pharmaceutical products and intermediates by chemical synthesis;
   2. (ii) the production and separation of medicinal chemicals including, but not limited to, antibiotics and vitamins from microorganisms;
   3. (iii) the manufacture of botanical and biological products by the extraction of organic chemicals from vegetative materials or animal tissues; or
   4. (iv) the formulation of pharmaceuticals into various dosage forms including, but not limited to, tablets, capsules, injectable solutions or ointments, that are to be taken by the patient immediately and in accurate amounts.
9. (9) Potential to emit. The maximum capacity of an air contamination source to emit any air contaminant under its physical and operational design. Any physical or operational limitation on the capacity of the facility or air contamination source to emit any air contaminant, including air pollution control equipment and/or restriction on the hours of operation, or on the type or amount of material combusted, stored, or processed shall be treated as part of the design only if the limitation is contained in enforceable permit conditions. Fugitive emissions, to the extent that they are quantifiable, are included in determining the potential to emit.
10. (10) Production equipment exhaust system. A device for collecting and directing volatile organic compound fugitive emissions from reactor openings, centrifuge openings, and other vessel openings out of the work area for the purpose of protecting workers from exposure and/or to reduce vapor concentrations below the lower explosive limit.
11. (11) Reactor. A vat or vessel, which may be jacketed to permit temperature control, designed to control chemical reactions.
12. (12) Separation operation. A process that separates a mixture of compounds, including liquids and/or solids into two or more components. Specific mechanisms include extraction, centrifugation, filtration and crystallization.
13. (13) Synthesized pharmaceutical manufacturing process. Any process involving the manufacture of pharmaceutical products and intermediates by chemical synthesis. The production and recovery of materials produced via fermentation, extraction of organic chemicals from vegetative materials or animal tissues, and formulation and packaging of the product are not considered to be synthesized pharmaceutical manufacturing processes.