§ 52.2454 Prevention of significant deterioration of air quality for Merck & Co., Inc.'s Stonewall Plant in Elkton, VA.
(a) Applicability. (1) This section applies only to the pharmaceutical manufacturing facility, commonly referred to as the Stonewall Plant, located at Route 340 South, in Elkton, Virginia (“site”).
(2) This section sets forth the prevention of significant deterioration of air quality preconstruction review requirements for the following pollutants only: carbon monoxide, nitrogen oxides, ozone (using volatile organic compounds as surrogate), particulate matter with an aerodynamic diameter less than 10 microns (PM10), and sulfur dioxide. This section applies in lieu of § 52.21 for the pollutants identified in this paragraph as well as particulate matter, but not for particulate matter with an aerodynamic diameter less than or equal to a nominal 2.5 microns (PM2.5) regulated as PM2.5; however, the preconstruction review requirements of § 52.21, or other preconstruction review requirements that the Administrator approves as part of the plan, shall remain in effect for any pollutant which is not specifically identified in this paragraph and is subject to regulation under the Act.
(b) Definitions. For the purposes of this section:
12-month rolling total for an individual pollutant or the total criteria pollutants, as specified in paragraph (d) of this section, is calculated on a monthly basis as the sum of all actual emissions of the respective pollutant(s) from the previous 12 months.
Act means the Clean Air Act, as amended, 42 U.S.C. 7401, et seq.
Completion of the powerhouse conversion means the date upon which the new boilers, installed pursuant to paragraph (g) of this section, are operational. This determination shall be made by the site based on the boiler manufacturer's installation, startup and shakedown specifications.
Permitting authority means either of the following:
(1) The Administrator, in the case of an EPA-implemented program; or
(2) The State air pollution control agency, or other agency delegated by the Administrator, pursuant to paragraph (o) of this section, to carry out this permit program.
Process unit means:
(1) Manufacturing equipment assembled to produce a single intermediate or final product; and
(2) Any combustion device.
Responsible official means:
(1) The president, secretary, treasurer, or vice-president of the business entity in charge of a principal business function, or any other person who performs similar policy or decision-making functions for the business entity; or
(2) A duly authorized representative of such business entity if the representative is responsible for the overall operation of one or more manufacturing, production, or operating facilities applying for or subject to a permit and either:
(i) The facilities employ more than 250 persons or have gross annual sales or expenditures exceeding $25 million (in second quarter 1980 dollars); or
(ii) The authority to sign documents has been assigned or delegated to such representative in accordance with procedures of the business entity.
Site means the contiguous property at Route 340 South, Elkton, Virginia, under common control by Merck & Co., Inc., and its successors in ownership, known as the Stonewall site.
(c) Authority to issue permit. The permitting authority may issue to the site a permit which complies with the requirements of paragraphs (d) through (n) of this section. The Administrator may delegate, in whole or in part, pursuant to paragraph (o) of this section, the authority to administer the requirements of this section to a State air pollution control agency, or other agency authorized by the Administrator.
(d) Site-wide emissions caps. The permit shall establish site-wide emissions caps as provided in this paragraph.
(1) Initial site-wide emissions caps. The initial site-wide emissions caps shall be based on the site's actual emissions during a time period, within five years of the date of permit issuance, which represents normal site operation. The permitting authority may allow the use of a different time period upon a determination that it is more representative of normal source operation. Actual site-wide emissions shall be calculated using the actual operating hours, production rates, and types of materials processed, stored, or combusted during the selected time period.