environmental impact statement: biovectra phase iv ... · biovectra phase iv expansion –...

Environmental Impact Statement:

BioVectra Phase IV Expansion

Project - Public Version

Report prepared for: BioVectra Inc. 11 Aviation Avenue Charlottetown PE C1E 0A1

Job No. 121810383 - File No. 91937

August 3, 2011

BioVectra Phase IV Expansion – Environmental Impact Statement

August 3, 2011

i

Table of Contents

1.0 INTRODUCTION .................................................................................................................. 1

1.1 OBJECTIVE OF REPORT ................................................................................................... 1

1.2 DESCRIPTION OF PROPONENT AND CONSULTANT ..................................................... 1

1.3 REGULATORY OVERVIEW ................................................................................................ 2

1.4 PERMITS AND APPROVALS .............................................................................................. 2

1.5 PUBLIC CONSULTATION ................................................................................................... 3

2.0 PROJECT DESCRIPTION ................................................................................................... 3

2.1 PROJECT OVERVIEW ........................................................................................................ 3

2.2 PROJECT LOCATION ......................................................................................................... 4

2.3 PROJECT SCHEDULE ........................................................................................................ 4

2.4 CONSTRUCTION ACTIVITIES ............................................................................................ 4

2.4.1 Building Construction ............................................................................................... 5

2.4.2 Tank Farm Construction ........................................................................................... 5

2.4.3 Additional Parking Area ............................................................................................ 5

2.4.4 Emissions and Wastes ............................................................................................. 5

2.5 OPERATION ................................................................................................................... 6

2.5.1 Use of Facility ........................................................................................................... 6

2.5.1.1 Raw Materials ............................................................................................ 6

2.5.1.2 Processing ................................................................................................. 7

2.5.1.3 Distribution ................................................................................................. 7

2.5.2 Emissions and Wastes ............................................................................................. 7

2.5.3 Environmental Management Plan ............................................................................ 8

2.5.4 Decommissioning and Abandonment ....................................................................... 8

3.0 ENVIRONMENTAL SETTING .............................................................................................. 8

4.0 ENVIRONMENTAL EFFECTS ASSESSMENT ................................................................... 9

4.1 PROJECT INTERACTIONS WITH THE ENVIRONMENT ................................................... 9

4.1.1 Project-Environment Interaction Matrix .................................................................... 9

4.1.2 VECs with No Interaction, or No Significant Interaction, with the Project ............... 10

4.1.2.1 VECs with No Interaction with the Project (Ranking of 0)........................ 10

4.1.2.2 VECs with No Significant Interaction with the Project (Ranking of 1) ...... 10

4.2 ACCIDENTS, MALFUNCTIONS, AND UNPLANNED EVENTS ........................................ 11

5.0 CONCLUSION ................................................................................................................. 11


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List of Appendices

APPENDIX A FIGURES AND DRAWINGS

APPENDIX B MASS BALANCE TABLE


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1.0 INTRODUCTION

BioVectra Inc. (BioVectra) has proposed the Phase IV Expansion of their production facility in

Charlottetown, Queens County, Prince Edward Island (PEI) (Figure 1, Appendix A) for the

purpose of partnering with Company X to produce an active pharmaceutical ingredient (API)

derived from an enriched natural produce oil concentrate produced by Company X.

BioVectra manufactures active pharmaceutical ingredients, drug products, pharmaceutical

intermediates, fine chemicals, and enzymes. The company has been in operation for 40 years,

previously under the name of Diagnostic Chemicals Ltd., and currently employs approximately

130 people at two manufacturing locations in Charlottetown, PEI.

1.1 Objective of Report

This document has been prepared by Stantec Consulting Ltd. (Stantec) on behalf of BioVectra

to provide a description of the proposed Phase IV Expansion Project at their production facility

in Charlottetown, PEI, as well as all associated works (collectively referred to as “the Project”).

The objective of this report is to provide Project information to the PEI Department of

Environment, Energy and Forestry to fulfill the requirements of Section 9 of the PEI

Environmental Protection Act (the Act).

1.2 Description of Proponent and Consultant

For the purpose of this Environmental Impact Statement (EIS), BioVectra Inc. is the proponent

and can be contacted via:

Mr. R. Scott Doncaster

Director of Manufacturing

BioVectra Inc.

11 Aviation Avenue

Charlottetown PE C1E 0A1

(tel.) 902-566-6126

(fax) 902-892-0632

[email protected]

mailto:[email protected]


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For the purposes of this EIS, the consultant is Stantec and can be contacted via:

Mr. Dale Conroy, M.Sc.

Stantec Consulting Ltd.

165 Maple Hills Avenue

Charlottetown PE C1C 1N9

(tel.) 902-566-2866

(fax) 902-566-2004

[email protected]

1.3 Regulatory Overview

Section 9 of the PEI Environmental Protection Act (the Act) sets forth the framework for

environmental impact assessments (EIAs) in PEI.

The interpretation of the Act is provided in Section 1 of the Act. Note that the term “undertaking”

is interpreted to include any project which (i) may cause the emission or discharge of any

contaminant into the environment; (ii) have an effect on any unique, rare, or endangered feature

of the environment; (iii) have a significant effect on the environment or necessitate further

development which is likely to have a significant effect on the environment; or (iv) cause public

concern because of its real or perceived effect or potential effect on the environment.

The expansion and operation of a manufacturing facility is considered to be an undertaking.

Section 9(1) of the Act states that “no person shall initiate any undertaking unless that person

first files a written proposal with the Department and obtains from the Minister written approval

to proceed with the proposed undertaking.”

Furthermore, Section 9(2) of the Act states that the Minister, in considering a proposal

submitted pursuant to Section 9(1), may require the Proponent to carry out an EIA and to submit

an EIS; and to notify the public of the proposed undertaking and to provide opportunity for the

public to comment.

Based on the PEI Environmental Protection Act, an EIA is required to be conducted for the

Project, and it is required that an EIS be presented to the Minister for approval of the

undertaking.

1.4 Permits and Approvals

The following departments/agencies have been identified as having a role in issuing permits

and/or approvals for the construction and/or operation of the Project:

mailto:[email protected]


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PEI Department of Environmental, Energy, and Forestry;

City of Charlottetown Water and Sewer Utility;

Charlottetown Airport Authority;

Nav Canada;

PEI Department of Labour; and

Other American and International agencies.

1.5 Public Consultation

It is expected that Level I public consultation, as per the Environmental Impact Assessment

Guidelines (Revised January 2010), will be required for the proposed Project. Level I

consultation involves local newspaper advertisement informing the public of the project

description, contact information for PEIDEEF, and the location(s) that the EIS document is

available for viewing. The duration of advertisement will be determined by the provincial

environmental assessment coordinator.

2.0 PROJECT DESCRIPTION

This section provides a preliminary description of the facilities and construction details that

comprise the Project, based on the design at this time.

It is important to recognize that the project description, equipment, and layout described below

may change slightly with detailed engineering design. The description outlines the most up to

date details of the Project. This section describes the key aspects of the Project, as currently

conceived.

2.1 Project Overview

The proposed expansion has been designed to be a stand alone facility with access via a

pedway to the existing facilities at BioVectra (Drawing 1, Appendix A). The expansion will

consist of approximately 3,350 square metres (m2) of space including a processing facility,

materials storage areas, finished product storage, shipping and receiving, corridors, elevators,

janitorial facilities, stairwells, a meeting room, office space, a quality control laboratory, a

pedway, and women’s and men’s washroom facilities. The building footprint will be

approximately 55 m x 60 m and 12 m in height. There will be one stand alone roof top HVAC

system for the process areas in the new facility. A separate stand alone HVAC system will be

designed for the other non process areas in the new facility. The HVAC systems will be

selected in accordance with the applicable codes and regulatory agencies. The facility will

operate using municipal sewer and water systems and power will be supplied by Maritime

Electric Company, Limited. An upgrade of the main electrical service to the BioVectra facilities

may be required depending on the final detailed design of the expansion.


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The parking area will be located to the south of the new building. The new parking area will

create approximately 30 parking spaces.

The tank farm will be located to the northeast of the new building. The tank farm will store

recovered and virgin polar solvent. The tank farm will meet all applicable provincial fire code

regulations.

2.2 Project Location

The proposed expansion Project will be located at the BioVectra facilities at 11 Aviation Avenue

in Charlottetown, Queens County, PEI. The new building will be located adjacent to the existing

facilities. A minimum buffer zone of 15 metres (m) between the facility and all property

boundaries will be maintained.

2.3 Project Schedule

Construction is expected to begin August 1, 2011 and be completed by October 2012. Key

timelines (subject to change) are outlined below:

building to be weather tight by January 2012; and

commissioning by August 2012.

2.4 Construction Activities

The new building will be designed and constructed as per the requirements of the National

Building Code of Canada (NBC). Upon approval from the regulatory agencies, construction of

the Project will involve the following phases:

building construction;

tank farm construction; and

parking area construction.

During construction work will be conducted between the hours of 7 am and 7 pm; however, work

on the interior of the building may extend beyond 7 pm.

Equipment used during construction may include, but is not limited to, the following: excavators,

trucks, bulldozers, a crane, compaction equipment, asphalt spreaders, and rollers.

A brief description of the Construction activities is provided below.


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2.4.1 Building Construction

The overall area of the new facility will be approximately 3,350 m2. The building will be

constructed of a structural steel frame (potentially galvanized) with metal siding and a torched

on roof. The building will be accessed via the new parking area or the new pedway from the

existing facilities.

Once construction is complete, landscaping of the property will include placing sod or

hydroseeding. The use of grass seed is discouraged as it has the potential to attract birds to

the airport airspace. Landscaping at the site will involve the use of non-invasive plant species.

2.4.2 Tank Farm Construction

Construction of the tank farm will include installation of two 12,500 litre (L) storage tanks and

one 45,000 L tank. Tanks will be double walled and placed on slab. The tanks will be equipped

with leak detection and alarm systems. The overall dimensions of the tank farm will be

approximately 14 m x 11 m. In addition, the tanks will meet the NBC, National Fire Code of

Canada and the PEI Environmental Protection Act – Petroleum Storage Tank Regulations for

the above ground storage of polar solvent (Class IB).

2.4.3 Additional Parking Area

A new parking area will be constructed as part of the expansion project. The parking area will

be approximately 980 m2 and will be able to accommodate approximately 30 vehicles.

Construction material for the parking area will include sandstone, Class A gravel, and asphalt

concrete. All construction materials will be procured by a locally sourced contractor.

2.4.4 Emissions and Wastes

Few emissions and wastes are expected as a result of Construction. Emissions will be limited

to air contaminants and noise from the operation of heavy equipment, and fugitive dust as a

result of excavation activities. The emissions and noise will remain largely confined to the work

site and immediately adjacent areas. As these activities will be conducted between 7 am and 7

pm Monday through Friday, the emissions are not expected to cause a significant nuisance to

nearby residents/businesses.

Construction wastes will be generated during site preparation and construction activities.

Potential sources of nonhazardous or solid wastes generated by Project activities include

packing/crating materials, scrap metals, and domestic wastes. All Project waste will be

disposed of in a provincially approved manner. Waste will be reused or recycled, if possible.

Any trucks hauling waste or debris will be covered. Fugitive dust from the movement of

equipment on unpaved surfaces during construction has the potential to cause adverse


August 3, 2011

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environmental effects to ambient air quality if dust mitigation measures are not used.

Professional judgement and experience of the contractor will be used to identify and address

issues with dust. Water will be applied during periods of heavy activity and/or during dry or

windy periods, to minimize the generation and transport of airborne dust. Waste oil will not be

used for dust control under any circumstances.

Spill kits will be present on-site in case of accidental release of hazardous materials. Waste oils

will be disposed of in accordance with provincial regulations.

2.5 Operation

2.5.1 Use of Facility

The facility will operate 24 hours per day, 7 days per week, as per the current hours of

operation. Operations, maintenance, and laboratory personnel work rotating shifts. The new

building will be used for the manufacturing of the API, a product derived from an enriched

natural product oil concentrate.

Operation of the Project will begin immediately following Construction and will continue for

several decades or longer.

The operation of the building will include heating/cooling of the facility and maintenance

activities. Operation of the tank farm will include storage of both recovered and virgin polar

solvent. During Operation maintenance activities may be performed to upkeep the facility,

including vegetation management, building repairs, and maintenance of the parking area.

2.5.1.1 Raw Materials

Raw materials used in the manufacturing of the API include:

crude natural product oil;

polar solvent (95%);

Amide;

Adsorbent A;

Adsorbent B;

Alkali (50%);

organic acid; and

Antioxidant.


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The manufacturing process will also use water, which will be supplied by the municipal water

source (i.e., City of Charlottetown). The maximum water required for processing is estimated to

be 3.5 million litres per year (L/yr) during full production. Please see Appendix B for mass

balance information regarding the raw materials.

2.5.1.2 Processing

The starting material will go through multiple purification steps resulting in a purified mixture of

the natural production oil. Typical chemical processing unit operations will be employed such as

reaction, filtration and distillation. The final API product will be formulated with antioxidant

before being stored in drums or in stainless steel totes.

2.5.1.3 Distribution

Once manufacturing is complete the finished product will be transported off PEI for final dosage

preparation. The product will be transported by established roadways in refrigerated trucks.

2.5.2 Emissions and Wastes

All solid wastes generated from the BioVectra expansion will be disposed of according to

provincial requirements. Waste items will be recycled or composted where applicable.

The facility will be operating on municipal water and sewage systems.

A scrubber will be installed to ensure exhaust emissions meet provincial regulations. Indoor air

quality at the facility will be maintained through current HVAC code requirement design.

Waste generated during the API manufacturing will include wet amide solids, Adsorbent B,

Adsorbent A, wash water, Alkali and polar solvent. A process for the recovery of wet amide

solids is currently being developed. Until this process is fully developed, the wet amide waste

will be transported off site by truck to a provincially approved disposal facility. If the new

process for the recovery of wet amide solids results in any changes to material use or waste

BioVectra will advise the PEIDEEF. The Adsorbent B/Adsorbent A mixture will also be

transported to a provincially approved disposal site. It is estimated that approximately 40 tons

per year of the Adsorbent B/Adsorbent A mixture will be disposed of. Polar solvent will be

recovered from the manufacturing process and recycled for reuse. Alkali will be neutralized and

disposed of via the domestic sewage system. Domestic sewage from the facility will be treated

at the Charlottetown Waste Treatment Plant. Liquid waste not meeting criteria acceptable to the

Charlottetown Sewer and Water Commission will be trucked off site to Debert, Nova Scotia for

disposal. Based on the aqueous waste volume generated by this process it is expected that an

aqueous treatment system will be added at a later date to decrease the cost of production and


August 3, 2011

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eliminate the requirement to truck the aqueous waste out of province. PEIDEEF will be advised

of this update prior to implementation.

During Operation and Maintenance, a small increase in the emissions of air contaminants and

GHGs may occur locally. The majority of these emissions are expected to be removed by the

scrubber. The overall emissions will be similar to those at the current facility.

2.5.3 Environmental Management Plan

BioVectra operations adhere to their Environmental Management Plan (EMP), which has been

subject to review and approved by PEIDEEF in 2010 (pers. comm. Jay Carr, PEIDEEF).

BioVectra will update the EMP prior to operation of the new process area to account for any

new requirements that are identified.

2.5.4 Decommissioning and Abandonment

The Project is being designed, and will be built and maintained, to be in operation for several

decades or longer. While decommissioning or abandonment of the Project is not currently

envisioned, the Project will at some point be decommissioned at the end of its useful service

life, in accordance with the applicable standards and regulations current at that time.

3.0 ENVIRONMENTAL SETTING

Aviation Avenue is located in the Charlottetown Airport Business Park (Drawing 2,

Appendix A). The business park consists of 43 properties spanning 50.0 hectares (ha). The

lots surrounding the BioVectra facility are currently vacant. Properties within the airport

business park have minimal landscaping, clipped grass, and some trees. Birds and mammals

are discouraged from using the area surrounding the airport as they create potential hazards for

aircrafts.

According to the PEI Land Online mapping application, there is a freshwater marsh

approximately 6.1 ha in size in proximity to the Project. The wetland is approximately 200 m

northeast of the existing BioVectra facility inside the Airport security fencing. The proposed

construction project will be located to the west of the existing facility approximately 350 m from

the existing wetland.

The BioVectra facility is located approximately 400 m east of the nearest residence, which is

located on Brackley Point Road. There is also a cemetery located approximately 500 m to the

west of the facility. Agricultural lands, as well as a small amount of forested lands surround the

airport in the vicinity of BioVectra.


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4.0 ENVIRONMENTAL EFFECTS ASSESSMENT

4.1 Project Interactions with the Environment

To determine the potential for and nature of interactions between the Project and the

environment, the Study Team employs a qualitative rating system. The Study Team rates each

interaction between the Project and each Valued Environmental Component (VEC) based on

the following rating system, with a rating assigned for each interaction based on the professional

judgment and experience of the Study Team, as follows.

0 = No interaction; the environmental effects are not significant and not considered further in

this report.

1 = Interaction occurs; however, based on past experience and professional judgment the

interaction would not result in a significant environmental effect, even without mitigation;

or interaction would not be significant due to application of codified environmental

protection practices that are known to effectively mitigate the predicted environmental

effects. The environmental effects are not significant and not considered further in this

report.

2 = Interaction could result in an environmental effect of concern even with mitigation; the

potential environmental effects are considered further in this report.

Where a potentially significant Project-VEC interaction (i.e., a rating of 2) may occur, further

discussion is provided to evaluate the environmental effect more thoroughly. Where no

interaction or no significant interaction is identified (i.e., a rating of 0 or 1), the rationale of why

no interaction exists, or why a limited interaction can be adequately mitigated without resulting

in significant environmental effects, is provided, but the environmental effects are (by definition)

rated not significant and are not discussed further in this report. Accident, Malfunctions, and

Unplanned Events are addressed in Section 5.3.

The evaluation is tabular for ease in evaluation and communication.

4.1.1 Project-Environment Interaction Matrix

Based on the Project Description, the environmental setting and the methodology described

briefly above, the potential interactions between the Project and the environment are

summarized in Table 4.1.


August 3, 2011

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Table 4.1 Potential Interactions of the Project with the Environment

Project Phase, or Activities/Physical Works Associated with the Project

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Construction 1 0 0 0 0 0 0 0 0 0 0 0

Operation 1 0 0 0 0 0 0 0 0 0 0 0

KEY

0 = No interaction; the environmental effects are not significant and not considered further in this report.

1 = Interaction occurs; however, based on past experience and professional judgment the interaction would not result in a significant environmental effect, even without mitigation; or interaction would not be significant due to application of codified environmental protection practices that are known to effectively mitigate the predicted environmental effects. The environmental effects are not significant and not considered further in this report.

2 = Interaction could result in an environmental effect of concern even with mitigation; the potential environmental effects are considered further in this report.

4.1.2 VECs with No Interaction, or No Significant Interaction, with the Project

4.1.2.1 VECs with No Interaction with the Project (Ranking of 0)

Based on the ratings provided in Table 4.1 above, the Project is not expected to result in any

interaction (i.e., a ranking of 0) with Water Resources, Freshwater Environment, Terrestrial

Environment, Wetland Environment, Marine Environment, Land Use, Heritage Resources,

Current Use of Land and Resources for Traditional Purposes by Aboriginal Persons, Navigation,

Public Health and Safety, and Effects of the Environment on the Project. Due to the nature of

the Project, the environmental setting, and the implementation of the EMP for the operation, the

environmental effects of the Project on these VECs are rated not significant and are not

considered further in this assessment.

4.1.2.2 VECs with No Significant Interaction with the Project (Ranking of 1)

The Project is not expected to result in an interaction that could lead to significant environmental

effects (i.e., a ranking of 1) for the Atmospheric Environment. Emissions during Construction

are expected to be nominal. During Operation the installation of scrubbers is expected to

remove the majority of contaminants in the emissions from the new production facility. Due to

the proposed mitigation and in consideration of the environmental setting (i.e., that the facility is


August 3, 2011

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located adjacent to the Charlottetown Airport), the environmental effects of the Project on the

Atmospheric Environment during Operation are rated not significant and are not considered

further in this assessment.

4.2 Accidents, Malfunctions, and Unplanned Events

BioVectra will incorporate the operations of the Phase IV expansion into their existing

Emergency Response Plan (ERP). The ERP is in place to deal with all potential accidents,

malfunctions, and/or unplanned events affecting the environment as well as employee health

and safety. The ERP conforms to CSA Standard Z731-03 (R2009) Emergency Preparedness

and Response. All workers will be properly trained in practices to prevent workplace accidents

including workplace hazardous materials (WHMIS), first aid, and other training programs.

During construction and operation all work will be conducted in accordance with the Prince

Edward Island Occupational Health and Safety Act. The ERP will be revised and implemented

to coincide with the commissioning of the facility.

5.0 CONCLUSION

Stantec Consulting Ltd. (Stantec) conducted an environmental impact assessment of the

proposed Phase IV expansion (“the Project”), proposed by BioVectra Inc. (BioVectra, “the

Proponent”) in Charlottetown, Queens County, PEI. The Project involves the Construction and

Operation of a production facility to manufacture an active pharmaceutical ingredient derived

from an enriched natural product oil concentrate.

Expansion of the BioVectra facilities will be conducted in accordance with Industry Standard

Best Management Practices for the construction of facilities of this type, as well as local City By-

laws and therefore is expected to be constructed with minimal environmental impact. In

addition, prior to the start up of the operation the existing EMP will be revised to incorporate the

new processing, and therefore is expected to be operated with minimal environmental impact.


August 3, 2011

APPENDIX A

SITE DRAWINGS


August 3, 2011

APPENDIX B

MASS BALANCE TABLE

API batch size 2000 kgAnnual requirement 300000 kg

Material Vac. dry Evap feed BlendMix Filtrate Waste Solid Product Distillate Mix Waste Product Mix Waste Product Mix Acid Wash Mix Waste Non product Product Final

Starting material oil 5120non product oil 2945polar solvent 5478 4070 1409 4070 331 331 331Amide 3072 2302Intermediate oil 2945 2945 2709 2709 2709 59 2650 2650 2650 2478 2317 317 2000 2000water 10240 10476 384 4065 4450 5035 5035Adsorbent A 16 16Adsrobent B 163 163Alkali 384 384organic acid 1220 1220Anti-oxidant 8.80

total mass per step 13670 7014 6656 2945 4070 6122 10476 2709 2888 238 2650 3750 5624 6385 3737 5035 2317 317 2000 2009total ~ volume per step 15216 8162 7053 2945 5218 6122 10476 2709 2888 238 2650 3844 5108 6478 3737 5035 2317 317 2000 2009total volume in USgal 4020 2156 1864 778 1378 1618 2768 716 763 63 700 1015 1349 1712 987 1330 612 84 528 531

EvaporatorAmide Crystallization Solvent Recovery Water Wash Clarification Hydrolysis Water Washes

environmental impact statement: biovectra phase iv ... · biovectra phase iv expansion –...

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