CONTENT COPY OF ORIGINAL Ministry of Ministère de Environment and l’Environnement et de l'Énergie
Apotex Inc. 150 Signet DriveNorth York, OntarioM9L 1N9
You have applied in accordance with Section 9 of the Environmental Protection Act for approval of:
- three (3) manifolded Antibiotics Laboratory fume hoods, designated 3701-AH-03-FH-01 through -03 inclusive, exhaustedby two (2) exhaust fans operating in parallel, discharging into the atmosphere through a single stack, with stack parametersas outlined in the attached Schedule "A";
- three (3) manifolded Cephalosporin Laboratory fume hoods, designated 3701-AH-04-FH-01 through -03 inclusive,exhausted by two (2) exhaust fans operating in parallel, and one (1) emergency fan discharging into the atmospherethrough a single stack, with stack parameters as outlined in the attached Schedule "A";
- one (1) Antibiotics Laboratory Perchloric acid fume hood, designated 3701-AH-03-FH-04, exhausted by one (1) exhaustfan discharging into the atmosphere through a stack, with stack parameters as outlined in the attached Schedule "A";
- one (1) Cephalosporin Laboratory perchloric acid fume hood, designated 3701-AH-04-FH-04, exhausted by one (1)exhaust fan discharging into the atmosphere through a stack, with stack parameters as outlined in the attached Schedule"A";
- one (1) standby diesel generator set, having a rating of 60 kilowatts, to provide power during emergency situations,exhausting to the atmosphere at a maximum volumetric flow rate of 0.26 actual cubic metres per second at an approximatetemperature of 523 degrees Celsius, through a stack having an exit diameter of 0.10 metre, extending 2.3 metres aboveroof and 7.1 metres above grade; and
- four (4) natural gas fired roof top units, two (2) natural gas fired boilers and two (2) natural gas fired water heaters witha total maximum heat input of 5,255,000 kilojoules per hour; each exhausting into the atmosphere through individual stacksor vents, with stack parameters as outlined in the attached Schedule "B".
all in accordance with the application for a Certificate of Approval (Air) dated December 7, 2001 signed by J. B. Boughsand all supporting information including the letters dated January 30, May 8 and 29 and September 12, 2002, prepared andsubmitted by Michael Storoniak, P.Eng., of SNC-LAVALIN Pharma, on behalf of Apotex Inc. SCHEDULE “A” - FUME HOODS This Schedule “A” forms part of the Certificate of Approval (Air) CONTENT COPY OF ORIGINAL Source Identifier Description Stack Gas Flow Stack Diameter Stack Height Stack Height Rate (cubic metres (meters) above roof above grade per second) (meters) (meters) SCHEDULE “B” - NATURAL GAS FIRED COMBUSTION EQUIPMENT This Schedule “B” forms part of the Certificate of Approval (Air) Source Identifier Equipment Description Maximum Heat S tack Height S tack Input (kilojoules Diameter above roof per hour) (meters) (metres) above grade (metres) SCHEDULE “B” - NATURAL GAS FIRED COMBUSTION EQUIPMENT - continued Source Identifier Equipment Description Maximum Heat S tack Height S tack Input (kilojoules Diameter above roof per hour) (meters) (metres) above grade (metres) For the purpose of this Certificate of Approval and the terms and conditions specified below, the following definitionsapply:
(i) "Act" means the Environmental Protection Act;
(ii) "Certificate" means this Certificate of Approval (Air) issued in accordance with Section 9 of the Act;
(iii) "Company" means Apotex Inc., Weston Road Site;
(iv) "Director" means any Ministry employee appointed by the Minister pursuant to Section 9 of the Act;
CONTENT COPY OF ORIGINAL
(v) "Equipment" means the exhaust system including the eight (8) fume hoods and associated fans, described in theCompany's application, this Certificate and in the supporting documentation referred to herein, to the extent approved bythis Certificate;
(vi) "Manual" means a document or a set of documents that provide written instructions to staff of the Company; and
(vii) "Ministry" means the Ontario Ministry of the Environment. You are hereby notified that this approval is issued to you subject to the terms and conditions outlined below:OPERATION AND MAINTENANCE
1. The Company shall ensure that the Equipment is properly operated and maintained at all times. The Company shall:
(1) Prepare not later than three (3) months after the date of this Certificate and update, as necessary, a Manualoutlining the operating procedures and a maintenance program for the Equipment, including:
(a) routine operating and maintenance procedures in accordance with good engineering practicesand as recommended by the Equipment suppliers;
(c) procedures for any record keeping activities relating to operation and maintenance of theEquipment; and
(d) all appropriate measures to minimize emissions from all potential sources, including spill clean-up procedures;
(2) Implement the recommendations of the operating Manual; and
(3) Retain, for a minimum of two (2) years from the date of their creation, all records on maintenance, repairand inspection of the Equipment, including records of any spills, complete with the date, name and amount ofsubstance spilled and action taken to clean-up the spill, and make these records available for review by staff ofthe Ministry upon request. The reasons for the imposition of these terms and conditions are as follows:
1. Condition No. 1 is included to emphasize that the Equipment must be maintained and operated according to a procedurethat will result in compliance with the Act, the regulations and this Certificate.
In addition, the Company is required to keep records and to provide information to staff of the Ministry so thatcompliance with the Act, the regulations and this Certificate can be verified. CONTENT COPY OF ORIGINAL In accordance with Section 139 of the Environmental Protection Act, R.S.O. 1990, Chapter E-19, as amended, you may bywritten Notice served upon me, the Environmental Review Tribunal and in accordance with Section 47 of theEnvironmental Bill of Rights, S.O. 1993, Chapter 28, the Environmental Commissioner, within 15 days after receipt ofthis Notice, require a hearing by the Tribunal. The Environmental Commissioner will place notice of your appeal on theEnvironmental Registry. Section 142 of the Environmental Protection Act, provides that the Notice requiring the hearingshall state:
1. The portions of the approval or each term or condition in the approval in respect of which the hearing is required, and;2. The grounds on which you intend to rely at the hearing in relation to each portion appealed.
3. The name of the appellant;4. The address of the appellant;5. The Certificate of Approval number;6. The date of the Certificate of Approval;7. The name of the Director;8. The municipality within which the works are located;
And the Notice should be signed and dated by the appellant.
Section 9, Environmental Protection Act* Further information on the Environmental Review Tribunal’s requirements for an appeal can be obtained directly from the Tribunal at: Tel: (416) 314-4600, Fax: (416) 314-4506 or www.ert.gov.on.ca This instrument is subject to Section 38 of the Environmental Bill of Rights, that allows residents of Ontario to seek leaveto appeal the decision on this instrument. Residents of Ontario may seek leave to appeal within 15 days from the date thisdecision is placed on the Environmental Registry. By accessing the Environmental Registry at www.ene.gov.on.ca, you candetermine when the leave to appeal period ends.The above noted works are approved under Section 9 of the Environmental Protection Act.
DATED AT TORONTO this 26th day of September, 2002
Neil Parrish, P.Eng. DirectorSection 9, Environmental Protection Act
JS/c: District Manager, MOEE Toronto District OfficeMichael A. Storoniak, P.Eng., SNC-Lavalin Pharma Inc.
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