N.Y. Comp. Codes R. & Regs. Tit. 6 § 233.2 - Definitions
(a) For the
purposes of this Part, the general definitions and requirements of Part 200 of
this Title shall apply.
(b) For the
purpose of this Part, the following definitions shall apply:
(1) Annual. Refers to a period of time based
upon a calendar year commencing January 1st and terminating midnight December
31st.
(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) 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) 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) In-process tank. Containers used for
mixing, blending, heating, reacting, holding, crystallizing, evaporating or
cleaning operations in the manufacture of pharmaceuticals.
(6) Lower Orange County metropolitan area.
The area including the towns of Blooming Grove, Chester, Highlands, Monroe,
Tuxedo, Warwick and Woodbury.
(7)
New York City metropolitan area. All of the city of New York, and Nassau,
Suffolk, Westchester and Rockland Counties.
(8) Pharmaceutical manufacturing process. Any
process involving the manufacture of pharmaceutical products and intermediates,
including but not limited to, the following operations:
(i) the manufacture of pharmaceutical
products and intermediates by chemical synthesis;
(ii) the production and separation of
medicinal chemicals including, but not limited to, antibiotics and vitamins
from microorganisms;
(iii) the
manufacture of botanical and biological products by the extraction of organic
chemicals from vegetative materials or animal tissues; or
(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) 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) 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) Reactor. A vat or vessel, which may be
jacketed to permit temperature control, designed to control chemical
reactions.
(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) 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.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.