EH&S Corporate
Standard

Environmental
Sustainability
EHS03-S03-02

Environmental Sustainability
Corporate Standard

Prepared by:
Leslie Burns

Date

EHS Manager, Whitby Regional Operations
Corporate Sustainability Subject Matter Expert (SME)

Prepared by:Charlotte Poullet

Date

EHS Manager, Puerto Rico Operations
Corporate Sustainability Subject Matter Expert (SME)

Prepared by:
Teresa Canton Turnbow

Date

Sr. EHS Specialist, Cincinnati Regional Operations
Corporate Sustainability Subject Matter Expert (SME)

Environmental Sustainability

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2|PageApproval by:
Marvin Faber

Date

VP, Global EH&S

Approval by:
Ray Guidotti

Date

SVP Global Engineering and Capacity Planning

Approval by:Peter McCullough

Date

Chief Procurement Officer

Approval by:
Harry Gill

Date

SVP Quality and Continuous Improvement

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PurposePatheon has made a Commitment to demonstrate Leadership in Environmental
Sustainability by minimizing our impact on the environment through the conservation ofnatural resources and by conducting our business in an environmentally responsible
manner. This document describes the key elements that must be incorporated into an
environmental sustainability program to establish priority, execution and alignment withthis commitment.

2.0

Scope
This document applies to all Patheon facilities.

3.0

Responsibilities
3.1

Executive Leadership Team
Demonstrate leadership and advocate priority for all of Patheon to align withEnvironmental Sustainability Vision, Mission and Goals.

3.2

Site Leadership
Provide sufficient resources and support implementation of the standard andprogram elements described below. Ensure participation in site environmental
sustainability program by all employees.

3.3

Corporate EH&&S
Provide sufficient resources, support and advocacy at the Executive Committee,
Corporate and Site levels to execute a successful environmental sustainability
program.

3.4

Sustainability Subject Matter Experts (SME)
Support Corporate EH&S
EH S by demonstrating a leadership position in their area ofexpertise to advance Patheon’s Environmental Sustainability Commitment.
Develop thehe global standard for Environmental Sustainability. Provide guidanceand support to Global Executive Team, Corporate, and each site regarding
design, implementation, or optimization of the environmental sustainability
program.

3.5

Site EH&S
Establish new or review existing environmental sustainability programs
program andensure consistency
consisten with the global standard. Assure appropriate training is
conducted for all employees.

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Supervisors
Ensure employees under their supervision are aware and receive training on
environmental sustainability program requirements and procedures. Set
expectation for all employees’ participation.

3.7

Employees
Work in compliance with sustainability program requirements and procedures.

4.0

Key Elements
4.1

Risk Management
4.1.1

Environmenta Sustainability Risk Assessment
Environmental
When quoting, reviewing, or developing a new or modified product,
process facility or equipment the environmental sustainability impact
process,should be assessed. Conduct a risk assessment to determine
environmental sustainability impact using the Risk Assessment Tool from
Corporate Standard EHS04-S09
EHS04
(Risk
Risk Management)
Management and Corporate
Standard EHS04-S02
EHS04 S02 (EH&S Assessment for New Projects). Controls
should be implemented based on the Risk Management Hierarchy:






Elimination/Substitution
Engineering Controls
Awareness Means
Procedural and Administrative Controls
Personal Protective Equipment

Update the risk assessment as available information or assumptions (e.g.
sold quantities) change.
4.1.2

Site Programs
rograms
All programs shall meet
meet local regulatory requirements at a minimum andas required in Corporate Standard EHS03
EHS03-S02
S02 (Environmental
Protection). Sites shall review existing programs and put actions in place
Protection).
to meet the requirements of all elements of this standard. Where
programs
grams are not yet in place, programs shall be initiated as per therequired elements of this standard.

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Monitoring and Measurement
Sites shall put appropriate metrics in place for each element of thisstandard to demonstrate compliance and improvements
improvemto theenvironmental sustainability.

4.2

Communication
4.2.1

Training
Employees who will be responsible for the implementation of any of thetechnical elements of the site environmental sustainability program shallbe trained appropriately to carry out their functions in a safe and efficientmanner, and according to applicable legislation and site/corporate
policies, procedures, and standards.
standards

4.2.2

Employee Awareness
All Employees shall be made aware of the current environmental
sustainability programs in place at the site, ideally during on-boarding.
onAs
new programs are initiatedinitiated or current programs revised, all employees
shall be made aware of the changes that impact their job functions inorder to maintain compliance to the program and to improve the overall
environmental sustainability of the site.

4.3

Compliance
4.3.1

Documents & Records
Documents and records are to be maintained for each of the elements ofthis standard according to local legislative requirements. Sites shallmaintain adequate records and documentation to demonstrate the level ofcompliance to this standard, and to monitor continuous improvement
initiatives.

4.3.2

Auditing
As per the Auditing Program ((see Corporate Standard EHS04-S07:
Auditing Program
Program)) periodic audits must be conducted in order toevaluate compliance with site-specificsite specific procedures, corporate standards
standards,
and regulatory requirements.

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5.1

Administrative Requirements
5.1.1

Programs
Documented programs outlining the required practices to support eachof the elements of this standard shall be in place.

5.1.2

Corporate ReportingAs requested from Corporate EH&S, sites shall provide environmental
sustainability metrics to comply with requested reporting, webpage
posting or for client / public disclosure.

5.2

Program Requirements:
5.2.1

General:Patheon business processes and manufacturing practices should bedesigned to ensure the best possible use of all resources In order tominimize the amount of waste generated. Detailed review of processes
and maintenance of equipment will ensure maximum efficiency.
efficiency The
following are general components that should be present: Consumption of every resource at Patheon facilities must be wellmanaged.
 Build awareness concerning consumption at work and at home.
 Motivate employees to take steps to reduce their consumption
consumpti(rewards / recognition).
 Seek out best practices and technology related to natural resource
conservation.
 Periodic analysis of resource consumption to maintain focus onconservation.
 Report to management on consumption and results of efforts toconserve achieved.

5.2.2

Safety of Chemicals
Where possible, reduce risks by replacing highly hazardous chemical
substances with less dangerous substances. Consider all types ofhazards (e.g. reactivity, toxicity, mobility, persistence, potential forenvironmental damage, public acceptance, etc.) and the reliability of theenvironmental
assessment when comparing the substitute chemicals with the initialsolution.

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storage, handling and disposal of all chemicals, with special emphasis on
dangerous goods. Support / comply with national and international risk
reduction programs for substances which constitute a threat. Patheonspecific programs for replacing such substances will be set up on a casecase
by-casecase basis.
Regularly
egularly search for possible synthesis and process improvements andevaluate new technologies. Consider the full life
life-cycle
cycle of these materials(including production, transport, use and disposal). Specifically control
specially regulated materials:



5.2.2

Narcotarcotics
ics and drugs that have the potential of illegal use,
Environmentally hazardous substances.
Recycle materials where reasonably possible.

Air Emissions Control
Take the necessary measures according to the following priority list: Avoid emitting pollutants to the atmosphere Reduce quantities of pollutants.
 Control the remaining pollutant emissions in order to meet all
regulatory and corporate standards.
 Maintain a continuous improvement program for production processes(process development).
 Control unavoid
unavoidable
able pollutants at the source whenever possible.
 Where applicable pre-treat
pre treat the waste streams to avoid impairment of
the functioning of end
end-of-pipe
pipe equipment and processes.
 Monitor emissions and the corresponding data in accordance withregulatregulatory
and corporate standards.
Ensure integrity of installations, thus avoiding contamination. Protect the
air from undue contamination, in particular from toxic substances, volatileorganic
rganic carbon (VOC) compounds, ozone-depleting
depleting compounds,
greenhouse gases (in particularparticular halogenated hydrocarbons - CFC, HCFC,
PFC,HFC), carbon dioxide (CO2), nitrogen oxides (NOx), sulfur dioxide(SO2), dust and particulate matter.
Limit physical effects on air (e.g. heat input or extraction, clouding, noise,light, disturbance of wildlife).
wild
Ensure early detection of leaks. Develop and implement systems andprocesses to handle situations when leaks occur.
Where necessary, treat waste air in an exhaust air treatment system.
Ensure air emission control in case of malfunctioning or outag
outage of such
systems. Ensure immediate detection of such situations.

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Land/Soil/Waste Management:
Maintain adequate systems, installations and procedures to avoid
accidental or insidious contamination of the soil. Avoid landfillingwherever possible.
Initiate
tiate a process that generates waste only after determining an
acceptable method of re-using,re using, recycling or disposing of the waste. Treat
waste and residual materials using the following prioritization
methodology (from most preferred to least preferred):







Reduce the amount of waste generated by a process
Reuse the waste generated in another process or consider sellingthese materials as raw materials or for energy recovery.
Recycle the waste, as far as technically, ecologically (in terms ofenergy expenditure
expenditure and generation of further waste) and economicallyfeasible.
Incinerate with energy recovery
Incinerate without energy recovery
Landfill

Collect and identify all waste and residual materials. Separate thematerials to assist in their further use or in optimizing waste disposal.
Avoid mixing of waste. Safely store and transport wastes according totheir hazards
Document type, quality and quantity of all wastes and residual materials
and the pathway of their disposal. Ensure safekeeping of thisdocumentation for an unlimited period. Ensure compliance with all local
documentation
regulatory and Patheon provisions regarding such documentation.
Re-useuse or recycle wastes and residual material whenever possible andsensible. Consider selling these materials as raw materials or for energy
recovery. If not re-used
re used or recycled internally, ensure that you select an
outside partner who operates on an acceptable
cceptable EH&S level
level. Verify thisby audit.
Ensure proper transport of the waste materials, in full compliance withlocal regulations.
regulations
Do not landfill pharmaceutical and chemical wastes or any hazardous
materials.
5.2.4

Water / Effluent:Protect water bodies and groundwater from contamination from persistentand poorly degradable chemicals, halogenated compounds (in particularsolvents), heavy metals, insoluble contaminants, unacceptable nonnon
deactivated biological materials, particularly if they are geneticallygenetical
modified active pharmaceutical ingredients and process intermediates.
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cooling, influence on the circulation). Where necessary wastewater mustbe treated in a suitable wastewater treatment plant (own plant or common
plant with other companies or the public).
Ensure protection of water bodies and groundwater in the event ofmalfunctioning or outage of the wastewater treatment plant. Ensure
detection is provided for these situations.
situations. Ensure integrity of plants andinstallations (and in particular wastewater systems) and thus avoid
infiltration of contaminants into the soil. Ensure early detection of non
nonintegrity.
Avoid excessive exploitation of water resources. Reduce water
consumption.
mption. Consider possibilities to capture, re-use
re use and recycle usedwater. Optimize the quantity of water used in all types of processes. Usetechnologies and equipment designed to consume less water.
5.2.5

Energy Management:
Energy Management programs must align with Patheon Energy
Management Engineering Standard (ENG-SE6-EM1)
EM1)
Manageanage energy production, distribution and consumption (energy
management system) to minimize environmental impact.
impact Measure andmonitor all energy flows
flo using metered technology and systematicallylook for energy conservation opportunities.
Reduce emissions from energy production, distribution and consumption
by conceptual and engineering measures. Where possible, use low
sulfur fuels with favorable carbon dioxide coefficients. Optimize
combustion technology (e.g. to reduce NOx emissions). Encourage or theuse of co-generation
co generation and energy recovery technologies whereappropriate.
Optimally design new buildings, machines and processes to minimize
energyergy consumption and to use sustainable types and sources of energy.
Optimize existing buildings, machines and processes regarding energy
consumption.
Evaluate potential and feasibility (e.g. reasonable cost) of alternative
energies while maintaining uni
uninterrupted
nterrupted energy supply wherever this isof importance for the operation.

5.2.6

Buildings/Installations/Infrastructure:

Design buildings and installations using environmentally safe
technologies (containment vs. relief, passive vs. active, etc.) as part of theUser Requirement Specification. Perform risk analyses at multiple points
in the design and planning process and implement the identified
measures. Use appropriate materials, including recycled material where
possible. Carefully select the energy sourc
sources
es and use best available
energy technology where feasible.
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Minimize land use and soil sealing through appropriate master planning of
the Site and building design. Consider seepage of uncontaminatedwater. Build the necessary safety equipment (alarms, automaticashutdown, release installation).
Construct buildings and installations in a way that they can be operated
and maintained in a safe manner, and not by primarily relying on worker
behavior. Provide clear and comprehensive standard operatingprocedures
dures and instruction manuals prior to use of new/modified facility or
equipment.
Maintain and buildings and installations using a Preventive
reventive Maintenance
Program.
rogram. Provide the necessary heating, cooling and ventilation andoptimizing for environmental protection.
protection. Reduce heating, cooling andventilation to what is really necessary and use best available HVAC
technology with special emphasis on heat recovery where feasible.

Fire safety and life safety should be inherent in the design. Build thenecessary fire protection installations and escape routes. Install thenecessary monitoring and communication systems. Organize appropriate
emergency response.
5.2.7

Suppliers, Service providers, Outsourcing partners, Contractors:
When selecting suppliers, service
service providers, outsourcing partners orcontractors, consider their EH
EH&S
S performance and sustainability practices
in addition to their quality, financial, technical or capacity capabilities.
The depth of the evaluations and the decision criteria depend on thenature of the proposed level of business with these partners:
 Inherent EH&S
EH S risks and problems in the supplies or services
delivered Specificity for our type of business vs. general types of supplies orservices, volume of the contract, exclusivity vs. commodity.
 Regularly evaluate existing suppliers, service providers, outsourcing
partners and contractors regarding their EHS performance throughquestionnaires, and where necessary by means of audits.
Urge existing suppliers, vendors and contractors who do not meet our
minimum environmental sustainability requirements to implement the
CAPA’s and to improve their performance and standards. Ensure a
process is in place for contract termination and exit strategy
st(e.g. findingand qualifying an alternate supplier) as necessary for unresponsivenessor non-compliancecompliance with requirements. Contracts should containcorresponding environmental sustainability requirement complianceprovisions (ie. EH&S agreement).
agreement

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5.2.8Logistics / Transportation:
Ensure safe and secure storage of environmentally hazardous materials
with the necessary safety measures according to the inherent hazards
associated with the materials. Separate nonnon-compatible
compatible materials.
Construct warehouses
warehouse for appropriate heating and cooling for materials
stored.. Ship materials in containers of good integrity asa per regulatory
specification to minimize EHS and material impact in the event of anincident.
Optimize transport of all materials, especially those
those classified as
dangerous goods, for safety and ecology and consider selecting the mostecological transport means and routes. Avoid unnecessary transport andensure full compliance with transport regulations.
Verify that only contract transport and wa
warehousing
rehousing service providers witha regulatory compliant EH
EH&S level are utilized.

-END –

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Patheon4815 Emperor Blvd, Suite 300
Durham NC 27703-8470 USA
P: +1 919 226 3200
F: +1 919 474 2269
www.patheon.com
PatheonKingfisher Drive
Covingham, Swindon
Wiltshire SN3 5BZ UK
P: +44 1793 524411
F: +44 1793 487053
www.patheon.com
Patheon
7F Wakamatsu Building, 3-3-6
Nihonbashi Hon-cho, Chuo-ku,
Tokyo 103-0023
Japan
P: +81 3 6202 7666
F: +81 3 6202 7676
www.patheon.jp

Environmental Sustainability

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866.PATHEON · www.patheon.com · doingbusiness@patheon.com