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PFIZER GLOBAL SUPPLY CONTRACTOR EHS MANUAL FOR PUERTO RICO OPERATIONS

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PFIZER GLOBAL SUPPLY

CONTRACTOR EHS MANUAL

FOR PUERTO RICO OPERATIONS

PFIZER GLOBAL SUPPLY, PR OPERATIONS CONTRACTOR EHS MANUAL

Revision 2.0 – May 2012 Page 2 of 58

TOPICS 1 INTRODUCTION .......................................................................................................................................... 5

2 ACRONYMS AND DEFINITIONS .................................................................................................................. 6 2.1 ACRONYMS .......................................................................................................................................................... 6

2.2 DEFINITIONS ........................................................................................................................................................ 6

3 EMERGENCY INFORMATION ..................................................................................................................... 9 3.1 EMERGENCY PHONE NUMBERS FOR PFIZER FACILITIES ....................................................................................... 9

3.2 EMERGENCIES .................................................................................................................................................... 10

3.3 USE OF OCCUPATIONAL HEALTH SERVICES ....................................................................................................... 11

3.3.1 Work-Related Injuries / Illnesses .............................................................................................................. 11

3.4 INTERRUPTIONS TO PFIZER OPERATIONS ........................................................................................................... 12

3.5 REPORTING ACCIDENTS / INCIDENTS / UNSAFE ACTS OR CONDITIONS .............................................................. 12

3.5.1 Verbal Reporting Requirements ................................................................................................................ 12

3.5.2 Written Reporting Requirements ............................................................................................................... 12

4 EMERGENCY ACTION PLAN .................................................................................................................... 12 4.1 GENERAL EVACUATION POLICY ........................................................................................................................ 13

5 CONTACTS ................................................................................................................................................ 13 SITE ENGINEERING SPECIALIST MAINTENANCE (SAFETY / TRAINING PFIZER SPONSOR/SECURITY) ...................... 13

6 BIDDING CONSIDERATIONS .................................................................................................................... 13 6.1 QUALIFICATIONS ............................................................................................................................................... 13

6.1.1 Employee Qualifications ........................................................................................................................... 14

6.2 CONTRACTOR SAFETY OFFICER REQUIREMENTS ............................................................................................... 15

6.3 CONTRACTOR SAFETY MANAGER REQUIREMENTS ............................................................................................ 16

6.4 CONTRACTOR ROLES AND RESPONSIBILITIES .................................................................................................... 16

6.4.1 Contractor Employee Responsibilities ...................................................................................................... 17

6.5 PFIZER SPONSOR ROLES AND RESPONSIBILITIES ................................................................................................ 17

6.6 PFIZER GENERAL SAFETY ORIENTATION ........................................................................................................... 18

6.7 ORIENTATION - LANGUAGE EXCEPTION............................................................................................................. 19

7 POST AWARD SAFETY SUBMITTALS & PRE-MOBILIZATION PLANNING ............................................. 19

8 PRE-TASK PLANNING .............................................................................................................................. 20 8.1 COORDINATION RESPONSIBILITIES .................................................................................................................... 20

8.2 PRE-CONSTRUCTION SAFETY MEETING ............................................................................................................. 20

8.3 JOB SAFETY ANALYSIS (JSA) ............................................................................................................................ 21

8.3.1 JSA Outline................................................................................................................................................ 21

PFIZER GLOBAL SUPPLY, PR OPERATIONS CONTRACTOR EHS MANUAL

Revision 2.0 – May 2012 Page 3 of 58

9 WORK PERMITS ....................................................................................................................................... 22

10 EHS PROGRAM ENFORCEMENT ......................................................................................................... 23 10.1 SAFETY INSPECTIONS ......................................................................................................................................... 23

10.1.1 Pfizer Site Construction Safety and Environmental Inspection Form ....................................................... 23

10.2 MONTHLY SAFETY SUMMARY ........................................................................................................................... 24

11 CHEMICAL SAFETY .............................................................................................................................. 25 11.1 CHEMICALS AT PFIZER ...................................................................................................................................... 25

11.2 HAZARD COMMUNICATION (HAZCOM) & MATERIAL SAFETY DATA SHEETS (RIGHT TO KNOW) .......... 25

11.3 ASBESTOS AND LEAD (PB) IN CONSTRUCTION ................................................................................................... 27

11.4 FLAMMABLE LIQUIDS ........................................................................................................................................ 27

11.5 COMPRESSED GAS CYLINDERS........................................................................................................................ 28

11.6 ENCOUNTERING UNKNOWN OR SUSPECTED HAZARDOUS MATERIALS .............................................................. 29

11.7 ENCOUNTERING UNKNOWN OR / UNEXPECTED CONDITIONS ............................................................................. 29

12 WORK FORCE MANAGEMENT (PARKING, ACCESS, BADGING, WORK RULES) ............................... 29 12.1 USE OF PREMISES ............................................................................................................................................... 29

12.2 BADGES TO ALL CONTRACTORS FOR ID PURPOSES ............................................................................................. 29

12.3 VEHICLES AND EQUIPMENT ACCESS .................................................................................................................. 30

12.4 PARKING ............................................................................................................................................................ 30

12.5 CONTRACTORS WITHIN PFIZER PREMISES........................................................................................................... 31

12.6 CONTRACTORS WORKING ON WEEKENDS ........................................................................................................... 31

12.7 EQUIPMENT IDENTIFICATION ............................................................................................................................. 31

12.8 INSPECTIONS ...................................................................................................................................................... 32

12.9 RESTRICTED ACCESS AREAS .............................................................................................................................. 32

12.10 SMOKING ....................................................................................................................................................... 32

12.11 ALCOHOL / ILLEGAL SUBSTANCES ................................................................................................................. 32

12.12 WEAPONS AND FIREARMS .............................................................................................................................. 33

12.13 CAMERAS, CELL PHONES AND VIDEO RECORDERS ........................................................................................ 33

12.14 BEEPERS, CELL PHONES, OR PERSONAL ELECTRONIC DEVICES ..................................................................... 33

12.15 CONTRACTOR TEMPORARY FACILITIES ......................................................................................................... 33

12.16 PROJECT CONTRACT CLOSURE ...................................................................................................................... 34

12.17 PERSONAL CONDUCT ..................................................................................................................................... 34

13 TRAFFIC CONTROL, BARRICADES AND PEDESTRIAN GUARDING .................................................... 34 13.1 USE OF BARRICADES .......................................................................................................................................... 35

14 PERSONAL PROTECTIVE EQUIPMENT ................................................................................................ 35 14.1 MINIMUM PPE FOR CONSTRUCTION AREAS ........................................................................................................ 35

PFIZER GLOBAL SUPPLY, PR OPERATIONS CONTRACTOR EHS MANUAL

Revision 2.0 – May 2012 Page 4 of 58

15 TOOLS ................................................................................................................................................... 36

16 ELECTRICAL SAFETY ........................................................................................................................... 36

17 EXCAVATION AND TRENCHING ........................................................................................................... 39

18 HOT WORK ........................................................................................................................................... 39

19 STEEL ERECTION ................................................................................................................................. 40

20 FALL PROTECTION .............................................................................................................................. 40 20.1 GENERAL ........................................................................................................................................................... 40

20.2 ROOF WORK ...................................................................................................................................................... 41

20.3 FLOOR OPENINGS ............................................................................................................................................... 41

20.4 CRANES AND MATERIAL HOIST OPERATIONS .................................................................................................... 42

20.5 AERIAL LIFTS ..................................................................................................................................................... 42

20.6 LADDERS ........................................................................................................................................................... 43

20.7 SCAFFOLDS ........................................................................................................................................................ 43

21 HOUSEKEEPING .................................................................................................................................... 44

22 GOOD MANUFACTURING PRACTICES (GMP) .................................................................................... 45

23 ROOF WORK / ROOF ACCESS .............................................................................................................. 46

24 CONFINED SPACE ENTRY .................................................................................................................... 46

25 ENVIRONMENTAL................................................................................................................................. 47 25.1 SOLID WASTE MANAGEMENT - GENERAL GUIDELINES ..................................................................................... 47

25.1.2 Recyclables ................................................................................................................................................ 48

25.2 EROSION AND SEDIMENTATION CONTROL ......................................................................................................... 48

25.3 SPILL PREVENTION ............................................................................................................................................ 50

25.4 EQUIPMENT INSPECTIONS .................................................................................................................................. 50

25.5 ENVIRONMENTAL / HAZARDOUS MATERIAL REMEDIATION .............................................................................. 51

25.6 DE-WATERING ACTIVITIES ................................................................................................................................. 51

25.7 AIR POLLUTION CONTROL ................................................................................................................................. 51

25.8 ENVIRONMENTAL INSPECTIONS ......................................................................................................................... 51

26 VAPOR EMISSIONS AND OCCUPIED SPACES ....................................................................................... 52

27 FUGITIVE EMISSION COMPLIANCE (WHEN APPLICABLE) ................................................................. 52

28 ROOF SEALING ..................................................................................................................................... 52

29 DRAIN LINE/SEWER LINE .................................................................................................................... 52

PFIZER GLOBAL SUPPLY, PR OPERATIONS CONTRACTOR EHS MANUAL

Revision 2.0 – May 2012 Page 5 of 58

1 Introduction

Welcome to Pfizer Global Supply. This Contractor EHS manual has been prepared for Contractors,

their subcontractors, and visitors servicing Pfizer Puerto Rico facilities.

Contractors shall ensure that all employees have reviewed the sections of this document that are

applicable to the work they perform. This document does not relieve the Contractor of their

responsibility to comply with all applicable local, state and federal regulations, laws, ordinances, or

statutes, and Pfizer Global Supply requirements.

Pfizer seeks to engage Contractors who dedicate themselves each day to maintaining an accident-free

work place. SAFETY IS OUR #1 CONCERN. THERE IS NEVER AN ACCEPTABLE REASON FOR COMPROMISING

SAFETY.

Pharmaceutical manufacturing operations are potentially hazardous. Many of these activities involve

the use of known hazardous, flammable, or toxic substances, intermediate drug compounds, and a

broad-range of biological materials, each with its own set of hazards and risks. Contractors must be

aware that numerous hazards exist throughout our Sites, and that the hazards vary widely from lab

bench to lab bench, from floor to floor, and from building to building.

As evidenced by the thousands of Pfizer colleagues safely working at our sites, these hazards can be

effectively managed by following a few standard safety procedures. What is key to remember, is that

whether working at an active production facility, in a laboratory, or even an office, it is every Contractor’s

responsibility to seek out and understand workplace safety precautions, and to take those actions that

will allow them to work safely in their assigned work areas. Each Contractor’s individual responsibility is

to exercise educated, sound judgment and use their own experience and expertise to incorporate EHS

considerations into everything they do.

The goals of this Pfizer Contractor EHS Manual are to:

Assist Contractors in meeting their responsibilities to provide a safe work environment

for their employees, subcontractors, visitors and Pfizer employees at all times;

Provide a safety program to prevent accidents, injuries, and property damage;

Provide general guidance for Pfizer specific issues, and identify additional policies and

resources for reference and support.

Pfizer is committed to achieving full compliance with all federal, state, and local regulations, as

well as Pfizer Corporate Standards. These standards apply to:

All construction and demolition Contractors,

All personnel of Consultant Firms, and

All site support service contractors and subcontractors (including: food service, janitorial,

lab or production support, administrative, security and maintenance).

These Standards are not intended to be inclusive of all local, state, and federal laws and regulations

that Contractors are obligated to comply with.

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2 Acronyms and Definitions 2.1 Acronyms

The following is a list of acronyms frequently used at Pfizer facilities:

ACM Asbestos Containing Material

ANSI American National Standards Institute

BOSG Building and Occupancy Support Group

CM Construction Manager

C&T Communications & Training

CFR Code of Federal Regulations

DOT United States Department of Transportation

EHS Environmental, Health & Safety

EMR Experience Modification Rating

EPA United States Environmental Protection Agency

EQB Environmental Quality Board

FDA United States Food and Drug Administration

FM&E Facilities Maintenance & Engineering

GMP Good Manufacturing Practices

GLP Good Laboratory Practices

HMIS Hazardous Material Information System

JSA Job Safety Analysis

MSDS Material Safety Data Sheet

O&M Operation & Maintenance

OCIP Owner Controlled Insurance Program

OSHA Occupational Safety & Health Administration

PCSM Pfizer Contractor Safety Manager

PGS Pfizer Global Supply

PPE Personal Protective Equipment

PSM Process Safety Management

2.2 Definitions

Construction Industry- all works designated and appropriate identify as construction and

physically separated of the rooms, mechanical areas and others. These works are regulated by

OSHA standard 1926.

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Revision 2.0 – May 2012 Page 7 of 58

Contractor - An outside firm hired by Pfizer Global Supply to provide maintenance, construction,

repair, consultation, validation, calibration or specialty work. Definition also applies to

individuals employed by Contractor firms.

Contract Employee - A person who is employed by someone other than Pfizer, but works at a

Pfizer facility on contracted basis, excluding temporary services directly supervised by Pfizer.

Contractor Fire Watch – An individual assigned by the Contractor for continuous monitoring of

hot work activities. This person shall be adequately trained by the Contractor to use fire

extinguishers and other fire equipment, and shall be familiar with the fire protection systems and

emergency notification procedure of the site. The fire watch will not perform any duties other

than fire watching while hot work is being performed. The fire watch will stay on duty and

inspect work half hour after last hot work operation of the day, specifically for jobs involving open

flames or heat generation.

Contractor Safety Manager - An individual assigned by the Contractor who will act as Safety

Manager. In addition to the qualifications of the a full-time Safety Officer, the Contractor Safety

Manager must be sufficiently educated and trained to provided full scale management of all

components of the CM project safety plan. The Contractor Safety Manager shall have

knowledge of OSHA 1903, 1904, 1910, and 1926 and have completed OSHA 500, 502 and 510

courses. This person shall have a demonstrated working knowledge of the activities to be

executed under the scope of work and pass an interview with the Pfizer EHS Representative.

Contractor Safety Officer - An individual assigned by the Contractor who will act as a full-time

Safety Officer. This person shall meet the requirements as the Contractor Safety

Representative, with the additional requirements of: have completed an authorized OSHA 30

hour General Industry and Construction Safety Training courses (1910 and 1926); have an

OSHA 8 hour Management / Supervisor course; and have demonstrated craft knowledge to

facilitate functional pre-task planning activities.

Contractor Safety Representative – An individual assigned by the Contractor who is

responsible for the Contractor’s safety program and performance. This person has the

responsibility, power, and authority to stop his/her company’s work when and where unsafe

activities or conditions exist. To qualify, as a Contractor Safety Representative the individual

must have completed, at a minimum, an OSHA approved 30 Hour General Construction Safety

Course and General Industry. This person may be a crew leader or superintendent, provided

that they meet the minimum qualifications.

Be able to demonstrate a thorough understanding of general safety, health,

environmental protection, and fire prevention, as well as activity specific issues, related

to all phases of the Contractor’s scope of work;

Have current training, certification and/or licensing where required.

Contractor’s Competent Person - As defined by OSHA, the individual who is capable of

identifying existing and predictable hazards in the surroundings or working conditions which are

unsanitary, hazardous, or dangerous to employees, and who has the authorization to take

prompt corrective measures to eliminate them (see 29 CFR 1926.32). Some standards add

additional specific requirements, which must be met by the competent person.

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Revision 2.0 – May 2012 Page 8 of 58

Contractor’s Qualify Person - means one who, by possession of a recognized degree,

certificate, or professional standing, or who by extensive knowledge, training and experience,

has successfully demonstrated his ability to solve or resolve problems relating to the subject

matter, the work, or the project.

Contractor Safety Orientation – A safety orientation on issues and concerns specific to the site

and area of work given prior to the Contractor starting work in a specific area, given by a hosting

Pfizer Representative.

Critical Lift Permit - A permit must be completed each day prior to starting crane use. A pre-lift

meeting is held at the start of the shift with all personnel involved in the lifting operation.

dBA - Measure of sound, expressed in decibels, on the A scale of a noise dosimeter.

Good Manufacturing Practices (GMP) - Requirement established by the FDA to prevent

product contamination, mix-ups, and errors.

Health and Safety Plan (HASP) - A plan developed by the Contractor when the work is related

to the clean up of hazardous waste, per 29 CFR 1910.120, the Hazardous Waste Operating and

Emergency Response (HazWoper) standard.

High Hazard Work Activities - Work activities that can result in immediate serious injuries or

death.

Hot Work - Any work that presents an ignition source, such as welding, cutting, use of a torch,

grinding, burning or work that involves or creates heat or sparks, use of non-certified electrical

equipment in areas classified as hazardous.

Job Safety Analysis (JSA) – Use method to identify, analyze and document the following:

Step of specific work or task;

Associate existing or potential risks of each step to the health, safety and environment;

Procedures and / or actions to eliminate or minimize the potential / existing risk of each

step.

Lock Out / Tag Out - Lock Out / Tag Out covers the servicing, repair and maintenance of

machines and equipment in which the unexpected energization or start up of the machines or

equipment, or release of stored energy, could harm employees.

This includes, but is not limited to, electrically energized equipment, pressurized piping, chemical

or process piping, hydraulic systems, pneumatic systems, and stored mechanical (potential)

energy. Applies to any system or equipment that presents hazards to employees if a switch is

thrown, valve is opened / closed, or line is broken.

Material Safety Data Sheet (MSDS) - A document provided by the producer or supplier of a

material, conforming to the requirements of 29 CFR 1910.1200 or 29 CFR 1926, that describes

the potential hazards associated with the handling or use of the materials.

Pfizer Sponsor - The Pfizer sponsor is the individual who is responsible for initiating,

coordinating and/or supervising the Contractor’s activities on Pfizer premises. The term Pfizer

PFIZER GLOBAL SUPPLY, PR OPERATIONS CONTRACTOR EHS MANUAL

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sponsor may apply to Pfizer colleagues, or to non-Pfizer Contract Employee hired by Pfizer to

manage contracted services at Pfizer facilities.

Process Safety Management (PSM) – OSHA standard to prevent or minimize the

consequences of catastrophic releases of toxic, reactive, flammable, or explosive chemicals.

Rigging Plan - A written lift plan must be submitted to Pfizer for review prior to any crane

operations on the site describing the details of the load, crane, rigging, location, etc.

Safe Work Plan - A written plan prepared by the Contractor that highlights specific safety

concerns related to the contracted scope of work and how they are to be addressed. The typical

plan summarizes the scope, planned approaches, and relevant safety specifics to assure the

safe completion of the task, operation, or project.

Serious Incident - Any work related incident that result in a fatality or any of the following:

> 24 hour hospital admission

Loss of consciousness and/or concussion

Amputation, broken bone(s) or joint dislocation

Severe burns

Significant loss or impairment of a body function (e.g., sight or hearing)

Explosion or fire resulting in significant property or equipment damage

Electric arc flash or an electric shock from a system greater than 50V

Subcontractor - A Contractor or his/her employee(s), whose contract is subsidiary to a prime

contract between Pfizer and a Contractor.

Unsafe Act - Performance of a task or other activity that is conducted in a manner that may

threaten the health and/or safety of workers.

Vendor - A person or company that provides a product or service to Pfizer; a person from said

company who provides service on a purchased piece of equipment is also considered a vendor.

Workplace - an establishment, job site, or project, at one geographical location containing one

or more work areas.

Work Area - a room or defined space in a workplace where hazardous chemicals are produced

or used, and where employees are present.

3 Emergency Information

3.1 Emergency Phone Numbers for Pfizer Facilities

In the event of an emergency that involves personnel, equipment or facilities, the contractor

should report the emergency by contacting:

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Extension 2000 or calling (787) 858-2323 extension 42000 in Vega Baja Extension 333 or calling (787) 787-846-4300 extension 333 in Barceloneta Extension 53473 (FIRE) or calling (787) 286-4000 extension 53473 in Caguas Extension 4777 or calling (787) 752-7474 extension 4777 in Carolina Extension 7474 or calling (787) 864-4010 extension 7474 in Guayama

3.2 Emergencies

All Contractor personnel must know the location of the nearest phone, fire alarm pull station,

fire extinguisher, emergency eyewash station, emergency shower, and exits from the building.

In the event of an emergency, the Contractors in the Sites must immediately report the

emergency by calling the above extensions and/or activating the nearest visible pull box

station in the area.

Emergency situations may include, but are not limited to:

Accidents and Injuries;

Observed smoke or fire and explosions;

Chemical or hazardous material spills;

Property damage;

Severe weather impacts, and

Security threats

Medical (non occupational event

When reporting an emergency, please provide the following:

Your name, phone number and location;

The location of the incident (building number, floor and room number),

Nature and extent of the incident (injury, accident, spill, smoke/fire, damage, etc.)

The name and amount of the material spilled (if applicable)

The safest route to the spill (if applicable)

Pfizer emergency response personnel will be dispatched immediately. The

Contractors should report to their specific evacuation point area.

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3.3 Use of Occupational Health Services

3.3.1 Work-Related Injuries / Illnesses

Emergencies or injuries are to be reported to the Pfizer sponsor. For other

than minor first aid cases, the injured person should remain at the place of

injury to avoid any hazardous conditions, and await emergency response

personnel.

Employees who are injured or become ill on-site may be seen at Occupational

Health & Wellness Area (OHW) providing their medical condition does not require

immediate transportation to a hospital. Under most circumstances, and by

arrangement with contract and temporary agencies, definitive medical care for

contract and temporary workers are rendered by an outside (non-Pfizer) medical

facility.

When applicable, construction contractors are to provide first aid equipment and

emergency personnel for his employees, as defined in the OSHA Standards. At

least one on-site First Aid/CPR certified person will be provided in each project.

Certifications must be provided to the company upon request.

In the event of an accident during normal working hours, contractor personnel shall

report to their supervisor and go to Pfizer OHW area for evaluation and first aid.

When not in normal working hours (weekend and 3rd shift), contractor personnel

shall report to their supervisor or First Aid certified person. If the accident is serious,

or the injury beyond first aid, they shall immediately notify using the emergency

numbers.

The contractor will also advise the Project Manager of the nature, location, and

severity of the accident. As soon as the injured person(s) has been transported

from the accident site, and any dangerous situation cleared, the contractor shall

rope off (if applicable) the area were the accident occurred.

Arrangements should be made with security personnel for photographs of the

accident site, and for the impounding of any machinery, equipment, or tools,

involved in the accident for use in the investigation.

Equipment involved in the accident will not be allowed to be removed from company

property without approval.

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3.4 Interruptions to Pfizer Operations

Each Contractor is responsible for ensuring that their Pfizer sponsor is fully aware of the scope

and impact of all their work activities, particularly the impact those activities may have on other

Pfizer operations. Issues such as access, egress, storage, temporary shutdowns and or

closures, use of Pfizer property or facilities, etc. must be discussed in a meeting with the Pfizer

sponsor prior to the initiation of any work activity.

3.5 Reporting Accidents / Incidents / Unsafe Acts or Conditions

The following reporting guidelines apply to all accidents, injuries, and unsafe conditions:

3.5.1 Verbal Reporting Requirements

All types of incident / accident (such as fatality, severe or multiple injuries, first aid

injury, property damage, unsafe conditions, environmental releases, etc) must be

reported immediately to the Pfizer sponsor. The notification could be to any Pfizer

colleague or by the use of the emergency notification system.

3.5.2 Written Reporting Requirements

The highest-ranking Contractor representative on-site must complete a Preliminary

Incident Investigation Report or the Contractor’s standard injury reporting form

within the next 24 hours following the incident. A final report must follow as soon as

possible but not later than 10 days of incident, depending on the complexity of the

event.

The incident review may require the participation of the following persons: Project

Manager or Safety Manager, Site Supervisor or Foreman, On-site Safety

Representative (if applicable), injured employee if available (if the injured employee

is unavailable, other employee(s) familiar with the events leading up to accident). If

requested by the PCSM, the Contractor’s vice president, project executive, or

another principal of the company shall also attend.

4 Emergency Action Plan

Pfizer has an Emergency Action Plans (EAP) specific for each Site. Contractors will be required to

comply with the provisions of the site specific EAP.

The Pfizer sponsor shall provide details of the Emergency Action Plan for the assigned work area,

including a review of evacuation routes and assembly.

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Worker orientation relating to the EAP is required upon initial assignment and/or when the EAP changes.

This is accomplished through the contractor safety orientation.

4.1 General Evacuation Policy

When an evacuation alarm has been sounded, all personnel must leave the building

immediately through the nearest exit. Once outside the building everyone goes to their

designated assembly point and wait for further instructions. The access routes should be open

for emergency response personnel. Designated Contractor Safety Representatives shall

account for all project personnel and report to the incident commander.

Reentry to the building or areas are prohibited until emergency response personnel instructs

accordingly or an announcement on the public address system gives the “all-clear” signal, or

by waiving a green flag. In construction areas, the evacuation routes must be clearly identified

in the work zone prior to beginning construction, and be continually maintained until the

permanent evacuation route signage and lighting system is operational.

5 Contacts

Site Engineering Specialist Maintenance (Safety / Training)

Security

Pfizer Sponsor

Site Director/Team Leader Engineering

6 Bidding Considerations Prior to preparing bids for services at Pfizer facilities, Contractors should review this manual and

confirm that their programs meet the requirements of Pfizer’s policies and procedures. The policies,

procedures, and requirements identified in this manual shall be considered contractual obligations.

Non-compliance with this manual will be considered a breach of contract.

6.1 Qualifications

Each Contractor is required to file a Pre-qualification Form with the Pfizer Puerto Rico

Regional Procurement Office prior to being considered for inclusion in the Pfizer

recommended Pre- qualified Bidder List. Contractors must demonstrate a history of safe

operations. Before Contractors are permitted to work on Pfizer property, they must submit

data on their OSHA 300 (A) Form for the last 3 years, and details of any OSHA citations and

abatement activities. Additional supporting information may also be required. They must be

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prepared to provide a copy of their written Safety & Health,HAZCOM and Domestic Violence

programs and discuss their safety program elements. This requirement applies to

subcontractors of all tiers. Contractors, and their subcontractors, may be rejected from

working at Pfizer facilities as a result of their OSHA 300 (A) log history or OSHA Citation

history.

Pfizer solicits pre-qualification updates (including OSHA 300A and insurance verification) on

an annual basis.

6.1.1 Employee Qualifications

The Contractor must provide employee’s training records and certifications, as

required for the specific job or equipment to be conducted. The amount of

certifications will be based following the OSHA Guidelines in accordance to

the job that they will be performing. Proper documentation will be submitted to

the contractor compliance office.

Examples of required documentation may include, but are not limited to:

Competent person for scaffolding training certificate;

Competent person for excavation and trenching training certificate;

Crane certificate

Air compressor certificate

Confined space entrant, attendant, and supervisor training certificate;

Power actuated tools (Hilti guns and similar) training certificate;

Equipment operator licenses (cranes, excavators, etc.);

Lock out / tag out training certificate;

Forklift operator training certificate;

Aerial Lift / Man Lift / Scissor Lift training certificate;

40 Hour Hazardous Waste Operations training certificate;

Annual 8 Hour Hazardous Waste Operations refresher;

Electrical safety training certificate;

Blood-borne Pathogen training certificate;

Fire extinguisher / Fire Watch training certificate;

Annual respirator fit test;

OSHA 1926 in accord with the specific labor

Hazard Communication

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Fall Protection

Hearing Conservation

Only properly trained and documented workers are to be assigned to Pfizer

contracts. Contractor employees must be able to recognize potential hazards

relating to their work activities and their work area and understand the

necessary precautions.

a. Hazardous Waste Operations 29 CFR 1910.120 Applicability

Determination

Due to the nature of the science and manufacturing conducted at Pfizer

facilities, Contractors must evaluate their Hazardous Waste Operations

(HazWoper) training and medical monitoring requirements under 29 CFR

1910.1200 and insure that properly trained and documented workers are

assigned to certain work tasks.

Examples of work areas or assignments where HazWoper requirements

may apply:

Contact with process or waste stream conveyance piping, equipment,

or systems;

Contact with active dust collection or process area / laboratory

ventilation system discharge ducting and filters;

Maintenance and repair activities in active process or laboratory

areas;

Laboratory or process area cleaning, decommissioning, and

demolition;

Hazardous waste management unit operations;

Hazardous waste clean up activities;

Environmental monitoring and remediation.

b. Medical Monitoring for Employees Assigned to Pfizer Facilities

Due to the nature of the science and manufacturing conducted at Pfizer

facilities, Contractors should evaluate medical monitoring requirements for

their employees as required under OSHA 29 CFR 1926.65.

6.2 Contractor Safety Officer Requirements

Typically, a full time safety representative is required for jobs having 10 employees or

more. On projects with less than 10 employees, the supervisor or foremen can perform

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this function, depending on the project’s risks. All the projects shall be discussed with the

contractor compliance representative to determine the risks associated and the way to

prevent incidents related to them. The minimum requirements for the safety

representative and/or foremen are:

5 years experience in Construction Safety, 7 years desired. OSHA 1926 30hrs course for Construction. Safety training and experience

identifying & controlling risks inherent to the work to be executed. GMP concept & Environmental regulations knowledge. Good interpersonal skills and customer oriented. Leadership skills and proactive thinking.

Contractors are responsible for their incident investigations, JSAs, OSHA 300A, training

records, worked hours recording, among others.

Tool box meetings should be provided on weekly basis; daily desirable. Meeting and

attendance must be properly documented.

6.3 Contractor Safety Manager Requirements

For large projects managed under a Construction Management (CM) contract, projects with

manpower loading greater than 40 employees per day, or particularly high-risk projects, Pfizer

will request a full-time Contractor Safety Manager and at least one Safety Officer. In addition

to the qualifications of a full-time Safety Officer, the Contractor Safety Manager must be

sufficiently educated and trained to provide full scale management of all components of the

CM project safety plan.

6.4 Contractor Roles and Responsibilities

At a minimum, all Contractors must:

Comply with the most current version of the OSHA standards;

Plan their work to avoid personal injury, property damage, and disruptions to on-going

Pfizer activities;

Establish, conduct, and document Environmental Health & Safety (EHS) education

programs for their employees that ensure safe work practices;

Provide all necessary procedures, controls and/or equipment to protect safety, property

and the environment;

Immediately report releases, incidents, accidents, and injuries, and as appropriate, take

or participate in corrective actions and investigations;

Use proper waste disposal and emissions controls procedures;

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Develop a Safe Work Plan (SWP) and Job Safety Analysis as appropriate for work

activities;

Continually inspect to ensure that safe work practices are employed;

Implement immediate corrective action for any deficiencies;

Provide written documentation prior to mobilization that all required certifications,

licenses, training, etc. are current for all personal and equipment,

Ensure the proper use, maintenance and repair of all equipment.

Provide all necessary tools and equipment to conduct the job. The use of Pfizer tools,

equipment, and materials is PROHIBITED.

Effectively manage their staff to ensure full compliance with EHS requirements.

6.4.1 Contractor Employee Responsibilities

Every Contractor employee shall:

Use the required PPE, tools and equipment to perform each job;

Review all applicable Pfizer requirements relative to their scope of work

prior to beginning any activity;

Review and understand all project work plans and permits prior to

beginning any activity;

Refrain from beginning any activity until they have a full understanding of

how to complete the task safely and after obtaining applicable work

permits;

Continually observe their co-workers and surroundings and take

immediate action to correct problems, including non-compliance with PPE,

permitting, or policy requirements;

Stop work and notify their supervisor when conditions or activities become

unsafe;

Take full responsibility for their own safety, and the safety of their co-

workers;

Immediately correct any unsafe act or condition;

Immediately notify any incident or emergency situation.

6.5 Pfizer Sponsor Roles and Responsibilities

The Pfizer sponsor shall:

Serve as a primary point of contact for all Contractor related issues.

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Inform the Contractor of any specific potential hazards that may be present in the

Contractor’s work area;

Establish inspection frequency with contractor.

Review Contractor safety performance previous to contract award. The evaluation

should include, but not limited to,

Safety Program to ensure compliance with this guideline.

Review OSHA 300A log for the past three years and current.

Request training evidence for all the employees to be working in the project.

Credentials for the Safety Officer(s) and competent professional(s).

Help the Contractor negotiate the Pfizer organization structure to facilitate timely and

effective coordination of efforts;

Coordinate with EHS to proactively identify and resolve EHS issues in a timely

and efficient manner.

Continually seek out opportunities to improve the overall EHS performance on

their projects, and

Ensure that all required EHS documentation is maintained (training records, permits,

inspections).

Perform periodic inspections of the working area and safety practices depending on

project complexity and level of risks.

Ensure contractors are trained in all necessary GMP procedures required for the job to

be performed, which included but not limited to, gowning/degowning, materials entering

through airlocks, good documentation practices, CRs, etc.

Communicate special events that impacts regular operations beyond project areas,

which includes but not limited to, blocking roads or service areas, crane event, fire

systems disconnections, etc

Ensure contractors comply with medical requirements, when applicable.

6.6 Pfizer General Safety Orientation

To ensure that all Contractor employees are aware of the basic safety requirements within

Pfizer facilities, every employee is required to attend the General Safety Orientation prior to

receiving an identification badge. This regularly scheduled orientation is offered by the Pfizer

sponsor. All Contractor personnel are required to attend a refresher course annually. The

General Safety Orientation provides an overview of rules and expectations involving daily on-

site Contractor activities.

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A badge is issued to each contractor’s employee that takes the General Safety Orientation,

however this is not an authorization to walk through Pfizer facilities without proper escort. The

badge must be visible at all times.

In addition to the General Safety Orientation, a Pfizer sponsor will provide a special site-

specific orientation at each work location prior to the Contractor starting work.

Contractors who plan to attend the Orientation should pre-schedule their attendance

through their Pfizer sponsor, and arrive at the training room with signed and completed

access paperwork provided by the Pfizer sponsor.

6.7 Orientation - Language Exception

A Contractor worker who is unable to communicate in Spanish adequately to complete

the General Safety Orientation can be accommodated provided the employer submits a

written action plan for assuring the safety of the worker while at Pfizer site (this plan is to

be submitted prior to the worker arriving at the site).

In the event the non- Spanish-speaking Contractor worker intends to achieve a valid

Contractor badge, the employer must:

Provide a written plan to Pfizer indicating how safety of the worker and other

requirements of this Manual will be maintained

Provide an interpreter to assist the General Safety Orientation instructor to teach

the individual in his native tongue.

Provide a designated escort to accompany the worker 100% of the time and to

serve as interpreter.

7 Post Award Safety Submittals & Pre-Mobilization Planning The Contractor must submit evidence of their safety program and compliance of training of their

employees to their Pfizer sponsor before work begins. Examples of the types of training topics that may

be requested, but not limited, include:

Confined Space Entry Program -29 CFR 1910.146

Lock Out / Tag Out Program- 29 CFR 1926.417

Respiratory Protection Program-29 CFR 1926.103

Hearing Protection Program-29 CFR 1926.101

Relevant licenses and certifications (i.e. scaffolding, welders, electricians, power tools, etc.)

MSDS log index (and updates)- 29 CFR 1910.1200

Contractors Incident Investigation Reports-

Hazard Communication-29 CFR 1910.1200

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Personal Protective Equipment-CFR 1926.95-105

Scaffolds- 29 CFR 1926.450

Fall Protection- 29 CFR 1926.500

Fire Protection- CFR 1926.24

8 Pre-Task Planning

8.1 Coordination Responsibilities

Due to the nature of construction operations within Pfizer facilities, it is likely that there will be

multiple Contractors on a given project and potentially multiple projects proximate to each

other. This multi vendor, multi project circumstance presents an additional layer of potential

safety hazards. It is the responsibility of each and every Contractor to fully and properly

coordinate their activities with other site Contractors and to consider the activities of others in

protecting the safety of their employees.

To the extent possible, coordination of schedules, work activities, etc. will be done through the

designated Pfizer sponsor; however, communications among and between neighboring

Contractors is prudent.

8.2 Pre-Construction Safety Meeting

Prior to starting work on any given project at Pfizer facilities, the Contractor shall attend a Pre-

Construction Safety Meeting. The primary purpose of this meeting is to have the Contractor

demonstrate and understand project conditions and safety requirements. As such, all

appropriate Contractor personnel (principal, foreman, etc.) shall be in attendance along with

the designated Pfizer sponsor. The contractor compliance representative should attend this

meeting when the Pfizer sponsor considers that is necessary. A job site tour shall be made to

confirm conditions and the Contractor’s awareness of potential safety hazards.

Prior to this meeting, the Contractor shall have submitted their Safety Plan with all required

project submittals (Job Safety Analysis, Permits, Licenses, Trainings, etc). At this meeting a

schedule for regular project safety meetings shall be established. The Contractor’s Project

Manager and designated contractor compliance representative shall meet with their Pfizer

sponsor periodically to review the safety conditions of the job. The Site Safety program will be

observed and followed at all times.

The Site Emergency Evacuation Plan will be discussed and agreed upon. The Contractor and

all of his sub-contractors shall be made aware of the plan to follow in case an emergency

situation.

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8.3 Job Safety Analysis (JSA)

For jobs that represent a high hazard risk to employees and are not covered in any Work

Permit (Section 9), a Job Safety Analysis (JSA) must be submitted and approved prior to

commencing work (Appendix A).

The Contractor is responsible of discussing the approved JSA with his/hers personnel prior to

commencing work. All employees must sign the JSA to acknowledge that it was discussed

and understood.

If the Contractor identifies a risk (during the work execution) that was not considered in the

approved JSA, it is his/hers responsibility to notify the unsafe conditions to the assigned

Sponsor or Compliance Contractor.

The Compliance Contractor will evaluate the new risks and will revise the approved JSA

incorporating the risks identified. The JSA revised, after it is approved, will be discussed once

again with the employees and signed. A copy of the JSA will be maintained in the working

area during the process of the job.

8.3.1 JSA Outline

Job Safety Analysis should address/recognize appropriate issues, such as, but not

limited to:

Barricades

Communication

Confined Space Entry

Crane Rigging Plans

Dust Control

Electrical work

Emergency and Evacuation Plans

Excavations/ Trenches/ Shoring

Fall Protection

Fire Protection

Hazard Analyses

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Hot Work

Housekeeping

Lay down Areas

Lock out/Tag out

PPE (appropriate ANSI standard)

Road Blockages

Special equipment and/or training

Strains/sprains (weight lifting limits)

Extreme Temperature

Weather limitations

Scaffolding and Erection Plan

Secure Temporary Facilities

Steel Erection

Roof Work

Environmental Aspects

Plan should also address any other issues unique to the particular project.

9 Work Permits

Because of the broad range of facilities and operations located across Pfizer sites, several

permits have been developed to meet a broad range of safety requirements.

Certain activities require a task-specific permit. Permit required activities include, but are not limited

to:

Confined Space Entry Permit

Excavation Permit

Lock Out / Tag Out Permit

Hot Work

Process Lines Work Permit

Electrical Work

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10 EHS Program Enforcement

It is the responsibility of each Contractor to comply with the policies and intent of this manual as well

as applicable federal, state, local, and Pfizer requirements. Violations will be brought to the attention

of the personnel involved and the responsible supervisory personnel. Identified violations must be

promptly addressed and corrected. Violations may result in work stoppage at the Contractor’s cost

and will result in progressive enforced action that range from temporary to permanent expulsion of

personnel from the site. If the violations are severe or repetitive, the Contractor may be prohibited

from working for Pfizer in the future. If a Contractor fails to correct a problem, Pfizer reserves the right

to take corrective action and back-charge the cost of any corrective action to the Contractor. Contract

language enables Pfizer to dismiss any individual, crew, or Contractor who fails to comply with the

Pfizer safety, security and environmental rules and regulations.

Contractors may be required to take other corrective actions such as conducting an incident review,

stopping work, holding safety stand down for the entire crew or company, providing increased training

employees, etc. at the discretion of Pfizer.

10.1 EHS Inspections

Contractors are required to conduct and document periodic safety inspections of their

work areas and practices, and those of their subcontractors. Pfizer conducts routine

tours of work areas to evaluate Contractor safety performance, and will request

correction of any observed deficiency. Contractor shall immediately correct hazardous

conditions noted. These observations do not relieve the Contractors of their obligation

to train their workers, provide a safe workplace for them, and insure that they are

working safely.

It is expected that the contractors keep their TIR & LTA rates below the National index

by attending properly the safety inspections in a proactive manner. These safety

inspections were implemented to help the contractor to maintain and improve their

performance

If the contractors safety rate (taken by periodical safety inspections) decrease during

their time working at Pfizer, an action plan to improve their rate shall be developed by

the contractor and approved by the Pfizer Sponsor. Once the action plan is approved,

an immediate implementation is expected. If after the implementation of this plan, the

safety rate does not improve, disciplinary action could be implemented.

10.1.1 Pfizer Site Construction Safety and Environmental Inspection Form

Pfizer’s Site Construction Safety and Environmental Inspection Form

(Appendix D) provide Pfizer Project Engineers or their designees with an

internal means of evaluating project safety and environmental performance

relative to Pfizer safety criteria. Pfizer’s expectation is that all contractors will

continually audit their projects to insure complete compliance with all local,

state, and federal laws and regulations.

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Projects will be evaluated against key environmental, health, and safety

compliance elements and will consider factors, such as:

1. Recognizable EHS risk,

2. Performance consistent with the current Pfizer and OSHA standards.

10.2 Disciplinary Actions

If a critical situation is observed during an inspection or a serious incident occurs in the

project, an interdisciplinary team composed by Pfizer sponsor (team leader), EHS,

Procurement and Contractor Compliance will be appointed to evaluate the situation.

Serious violations could result in disciplinary actions, which may include removal from

the prequalification system and immediate removal from the site. The interdisciplinary

team will evaluate the case, determine corrective actions, agree on responsible person

to execute/communicate the plan, and inform the contractor accordingly.

10.3 Monthly Safety Summary

The Contractor is required to submit to the Pfizer EHS Contractor Safety Coordinator a

monthly safety summary. At a minimum, this report shall include, but will not be limited to:

The total number of hours worked during the reporting period by project

The cumulative number of hours worked on the job (or site) as of the end of the

reporting period;

The total number of near misses that occurred on the job during the reporting period;

The total number of incidents that occurred on the job during the reporting period;

The total number of injuries or illnesses requiring first aid treatment that occurred on the

job during the reporting period;

The total number of injuries or illnesses (recorded on the OSHA 300 log) that occurred

on the job during the reporting period, and

The total number of injuries or illnesses resulting in a lost workday that occurred on the

job during the reporting period.

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11 Chemical Safety

11.1 Chemicals at Pfizer

Pfizer maintains a constantly changing inventory of hundreds of distinct or novel chemical

compounds, ranging in quantities from test tubes to tanker trucks. Managing chemical storage

and handling to prevent cross contamination, human exposure, or adverse interactions is a

monumental task.

When working at Pfizer, all Contractors need to recognize that chemical hazards vary from lab

to lab, floor to floor, and from building to building. Review of signage, placards, warning

devices, and site-specific procedures is an important task for all Contractors.

Because a majority of commonly used commercial construction materials, as well as cleaning

products, are complex chemical mixtures, they present equivalent health and safety risks to

those presented by Pfizer process chemicals.

When dealing with any chemical, it is important to remember that improper handling or

uncontrolled exposure may, but not limited to:

Release noxious odors and harmful or deadly vapors;

Create fire or explosions;

Burn or irritate eyes, skin, or respiratory tract on contact;

Create short-term or immediate (acute) health effects;

Result in long-term (chronic) health problems;

Cause immediate death;

Pfizer sponsors are responsible for notifying Contractors of the potential hazards that may be

encountered given the scope of their work activities that are specific to Pfizer manufacturing,

maintenance, or storage activities. General hazard potential notification shall be provided at

the General Safety Orientation. Site and/or activity specific hazard notification shall be

identified for each Contractor in writing.

11.2 HAZARD COMMUNICATION (HAZCOM) & Material Safety Data Sheets (Right to Know)

Contractors must provide to Pfizer contractor compliance a written inventory and MSDSs of all

chemicals they plan to use (prior to mobilization). Contractors must notify in advance any

change in the chemical inventory and will provide a copy of the new MSDS. All MSDSs

require approval from EHS.

A hard copy of the Contractor's written Hazard Communication Program, chemical inventory,

and MSDS’s shall be available at the job site for review by Pfizer and the Contractor’s

employees. “Available at the job site” shall mean collected in a binder or folder system, clearly

labeled “Hazard Communication – Right to Know” and “Material Safety Data Sheets” and

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placed at the actual work location with the project permits and personnel accountability board

where it may be immediately accessed by project or emergency services personnel. This

provides:

Instant access for info related to a specific chemical,

An instant inventory for emergency responders of the chemicals in a work area,

A physical copy of the MSDS that can be sent with a patient when transported for

emergency medical treatment.

The contractor company shall train all employees as per their written Hazard Communication

Program. All containers shall have legible appropriate labels. The name of the material on the

label, the written inventory, and in the MSDS must be the same.

HAZCOM requirements apply to all chemical based materials, including but not limited to:

Paints

Adhesives (flooring, insulation, piping, metal bonding, etc.)

Sealants

Caulks

Etching compounds (Acidic or Basic)

Cleaning fluids, powders, or pastes

Flammable gases (i.e.: propane)

Non-flammable gases (i.e.: argon)

Flammable liquids

Lubricants

Blasting materials

Solvents

Silica / Silicosis

Any other potentially explosive or hazardous material or any substance considered

flammable, hazardous, extremely hazardous, toxic or deadly by the US EPA, US

DOT, CT DEP or other applicable regulatory body.

Chemicals shall not be stored overnight at the project location or Pfizer facilities without

approval of the Pfizer sponsor. If over-night storage is required, arrangements must be made

through the Pfizer sponsor. Contractors shall store their chemical materials or

hazardous/regulated waste containers in contained locations, approved by Pfizer to prevent

releases to the environment. Containers must be in good condition, clearly labeled, and free

of rust and dents. These containers must comply with all regulatory requirements for adequate

storage.

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The Contractor shall coordinate with the Pfizer sponsor for proper offsite disposal of all

containers and leftover chemical materials brought to Pfizer facilities. Under no

circumstances shall any waste material (paint thinner, paint, acid, cement or cement

washout, lime, oil, gasoline, hazardous materials, etc.) be poured into Pfizer sinks,

drains, soil or released to the environment.

The use of the chemical should also be reflected in the Job Safety Analysis, as any scope of

work involving the use of chemicals cannot be adequately planned without the information

contained in the MSDS (i.e.: acceptable exposure levels, personnel exposure monitoring

requirements, instructions for safe use, required personal protective equipment, etc.).

11.3 Asbestos and Lead (Pb) In Construction

Please contact the Pfizer EHS department regarding site specific Asbestos Programs. The

Pfizer Representative is required to evaluate an area prior to initiating any construction

activities to confirm that the work areas are free of asbestos containing material (ACM), or to

schedule pre-construction abatement activities.

11.4 Flammable Liquids

The following general guidelines apply to the use and storage of flammable liquids at Pfizer

facilities. Adequate hazard analysis must be performed prior to import and storage of

flammable liquids at Pfizer facilities.

Inventory of flammable liquids shall be kept to the absolute minimum possible.

Solvents may only be stored in solvent storage areas or cabinets. Solvents may not

be stored on bench tops or floors. For quantities in excess, special permission must

be secured from the Pfizer contractor compliance.

Solvents must be stored in ventilated cabinets designed for solvent storage. These

cabinets must be equipped with closable metal doors and must not contain any

ignition sources such as electrical outlets, switches, motors, etc. These cabinets

should be reasonably well sealed so that solvent vapors are contained and do not

easily travel to an ignition source.

Solvents must be kept away from traffic areas.

Unnecessary or unused solvents should be disposed of promptly in coordination with

the Pfizer EHS and Utilities representatives.

Every effort should be made to reduce solvent volumes including the use of pint and

liter containers instead of gallons.

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All flammable liquids should be stored in tightly sealed containers.

Safety cans should be used wherever possible for flammable liquids.

Unless properly equipped, ordinary electric refrigerators are not adapted to the storage

of volatile, flammable solvents.

Do not keep small bottles of volatile, flammable liquids in the sunshine or where heat

from a hot plate, burner, or other device may cause the stopper to blow out and release

vapors.

The liquids or their vapors should never be exposed to the atmosphere in the presence

of flame, sparks, or hot surfaces, such as electric heating elements and non-explosion

proof motors in operation.

Sources of ignition some distance away may cause an explosion or fire from vapors

heavier than air that seek the lowest level and may float along the floors for

considerable distances.

Solvents must be transported in solvent carriers to minimize breakage during transport

and to contain spills should they occur.

In the case that spill occurs, the contractor will be responsible for its proper container

as well as its disposal. Any spill needs to be informed to the Pfizer representative.

All containers, drums, and safety cans must be properly grounded and bonded before

the dispensing of the flammable liquid.

All faucets or spouts must be of the self-closing type equipped wi th flame arrestors.

11.5 Compressed Gas Cylinders

The following items represent the minimum requirements for contractors while handling compressed gas cylinders inside the Pfizer premises. The amount of gas cylinders is limited to daily use (otherwise approved by the PM) and must be:

Identified with the Contractor’s name,

Stored and transported upright and in a secure position with proper protective caps.

Handle as an explosive material

Secured with a non-combustible restraint of sufficient strength, such as chains or nylon straps, to prevent overturning of the cylinder. The use of common or electrical wire as a cylinder restraint is prohibited.

Acetylene and oxygen cylinders or other non-compatible materials must be stored

separately (at least 20’ apart) and in well-ventilated areas.

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11.6 Encountering Unknown or Suspected Hazardous Materials

If a Contractor encounters a material which is suspected to contain asbestos, lead paint,

soil contaminates, or any other hazardous chemical or condition, they shall stop work,

leave the area immediately, and report the situation immediately to Pfizer sponsor, who

will follow-up with the appropriate Pfizer personnel. The Contractor shall assume that

any unknown (or unidentified) paint should contain lead and all pipe insulation contains

asbestos material. Only properly licensed and trained Contractors shall disturb,

remediate, or remove materials containing lead or asbestos, or remediate contaminated

soil or residual chemical compounds in coordination with the Pfizer sponsor.

Contractors shall provide proof of proper licensing and training prior to the start of such

work.

11.7 Encountering Unknown or / Unexpected Conditions

If any Contractor encounters an unknown or unexpected condition, material, or circumstance,

work shall be immediately stopped and the Pfizer sponsor shall be immediately notified.

Proper and complete evaluation of the condition, material, or circumstance shall be completed

to Pfizer sponsor satisfaction prior to continuation of the work activity. Documentation of the

condition, the evaluation, and findings shall be produced for the project file.

12 Work Force Management (Parking, Access, Badging, Work Rules)

12.1 Use of Premises

The use of Pfizer site amenities, such as Health Center, Cafeteria and others is limited to

Pfizer colleagues only.

12.2 Badges to all contractors for ID purposes

All Contractors will be identified with an ID Card.

Contractors that require electronic access cards must have a global unique identifier

number in order to assign them an electronic access card. (GIDM)

Pfizer sponsors are responsible to complete the documentation and transactions required

to create the global unique identifier for the contractors.

Electronic access for the contractors is authorized by the sponsor and will comply with

Pfizer requirements.

Contractor compliance group will provide to security an updated list of the contractor

personnel authorized to work in our facilities.

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Security will not provide access to contractors that are not included in the list. Only the

contractor compliance group will authorize the access.

Contractors will document entries and exits in the logbook located at the guard house.

12.3 Vehicles and Equipment Access

Security will inspect contractor’s equipment and vehicles when there are entries or

leaving the plant. Security will verify if there are leaks in the vehicle.

Contractor will fill the property inventory list at the guard house.

Contractor’s vehicles accessing the plant premises must have up to date the Public

Works and Transportation Department stickers.

Contractor’s driver must have a valid license, according to the vehicle be driven.

All vehicles will be parked in the designated areas. Parked vehicles will not obstruct the

access to the pedestrian, entrances, exits or equipment for the emergency response

system.

All vehicles must be in acceptable mechanical conditions (no gasoline, oil or other fluid

leaks) and shall maintain an annual certification by a third party.

12.4 Parking

While driving at Parking Lot and premises:

Follow all transit signs.

The use of seat belts is mandatory for every person riding any motor vehicle.

Always give way to pedestrians.

The handicapped parking is for personnel with Pfizer Medical authorization or official

government documentation.

Park your vehicles in the designated spaces (in reverse) and be sure to occupy only

one parking space.

At the end of the work shift, move your vehicle from the parking lot.

Do not park in the marginal road or any other place out of the designated spaces.

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Mechanical repairs are not permitted in the premises.

Alcohol, drugs, firearms or inappropriate conduct is not permitted in the premises.

Security officers are responsible for verifying that colleagues, temporary personnel,

visitors and contractors are complying with security procedures.

Security officers will issue written warnings to persons and company that does not

comply with the plant established procedures.

12.5 Contractors within Pfizer premises

Contractor’s identification – All contractors must use clothing identifying their company

at all times.

GMP controls – Contractors must maintain clean attire appropriate to enter in areas

where pharmaceutical products are manufactured. Personnel must read and comply

with all signs that advise unsafe areas and/or request special gowning to enter.

Contractor must follow all instructions and shall provide any necessary gowning to

perform the work. All GMP’s controls must be followed as required in the area to be

worked.

Training – Contractor’s sponsors are responsible of identifying and providing the

necessary training to their contracted resources based on the work to be performed.

Security controls - While inside the manufacturing building, contractors must be

escorted all the time by an authorized person. This person can be the Pfizer sponsor or

a supervisor (from the contracted company) with control access authorization. All

contractors must wear all the time the identification card in a visible area.

12.6 Contractors working on weekends

Pfizer will be closed to contractors on weekends and certain holidays unless approved in

advance by the Pfizer sponsor. The sponsor will arrange with Security for non

standard/holiday access by providing the authorization form.

12.7 Equipment Identification

All equipment and materials owned, rented, and/or operated by the Contractor and

subcontractors must be identified with the Contractor’s name, at all time.

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12.8 Inspections

Contractors are to conduct a site inspection with the Pfizer representative before work

begins to address anticipated safety concerns. Contractors shall assure inspections

take place regularly (establish a minimum frequency, if not, inspections may not be as

frequent as required!) to assure compliance with any OSHA standard applicable to their

work. A periodic job site safety inspection is to be conducted and recorded. Contractors

shall take all necessary precautions to keep the work site orderly and protected from

recognized hazards that are likely to cause injury, death, illness, or damage to property

or the environment. All hazards will be addressed before leaving the area (including

breaks or lunch).

All tools and equipment (including vehicles and rigging equipment) shall be in good

condition and inspected daily prior to commence work.

Daily inspections reports shall be kept within the equipment. The daily inspection template

should meet or exceed OSHA requirements and shall include a “Comments” section to specify

all areas that are not applicable. This comment’s section can also be used to specify any

improper working condition or component in the equipment. All documentation shall follow

pharmaceutical industry’s good practices.

12.9 Restricted Access Areas

There are several areas throughout Pfizer facilities that have been designated as restricted

access. These areas have been posted at access points. At no time shall Contractor

employees enter these areas without prior authorization as designated on the restricted

access signs.

12.10 Smoking

Pfizer facilities are non-smoking facilities. Violation of this policy may result in immediate

removal from Pfizer premises.

12.11 Alcohol / Illegal Substances

Individuals (or crews) found in the possession of alcohol and/or illegal substances will be

immediately removed from the site. If alcohol and/or illegal substances are found on-site in a

gang box, connex box, office, or vehicle, and the individual(s) responsible cannot be identified,

the entire crew could be removed from the site. People “under the influence” of alcohol, illegal

substances, or prescription drugs which are incorrectly used shall be removed from the site.

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It is Pfizer's policy that the presence of designated drugs in an employee’s system and/or the

manufacture, sale, distribution, purchase, possession, dispensing and use of such drugs while

engaging in Pfizer business or while on Pfizer premises are strictly prohibited. The drugs so

designated by Pfizer include illegal narcotics, depressants, stimulants and hallucinogens. The

taking of prescription medication in the manner prescribed by a physician is an exception to

this policy provided it does not impair a person’s ability to perform his/her job. Contractor

employees must notify his / her supervisor of this condition.

12.12 Weapons and Firearms

Lethal and non-lethal weapons and firearms of all types, excluding knives used for

construction activities, are prohibited from Pfizer premises at all times.

12.13 Cameras, Cell Phones and Video Recorders

Use of cameras, cell phones and other electronic devices equipped with cameras, video

recorders, tape recorders, and other audio-visual equipment by Contractors without written

authorization from the Pfizer Management is prohibited.

12.14 Beepers, Cell Phones, or Personal Electronic Devices

Electronic devices, such as: Personal Digital Assistants (PDAs – a.k.a. Palm Pilots),

portable CD / DVD/ MP3 players, cameras, cellular phones or similar devices are

prohibited from all production and warehousing areas, where they represent a potential

ignition source due to their non-explosion proof design. Contractors should follow site

guidelines.

12.15 Contractor Temporary Facilities

Pfizer will provide (as space allows) a small area where contractors can locate an office trailer.

The trailer shall always be in optimum conditions and available to be removed from the Pfizer

facilities at any time. This means that trailer’s structure and tires shall always be in working

conditions and with a valid certified inspection. It is a Pfizer’s discretion the duration time that

the trailers can be resident in the premises.

During the duration time, all trailers shall be securely anchored for normal operations and

inclement weather (hurricane season). All hand rails and ladders must comply with OSHA

requirements.

Housekeeping – the contractor is responsible to perform daily cleaning around the

trailer area, which includes but not limited to, disposal of all garbage, construction

debris and mud, among others.

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Welding/working area – a small working shop is allowed to perform minor works. The

area should be adequately equipped for the work to be performed, including but not

limited to, fire extinguishers, fire proof curtains, no flammable or combustible material

around the area, etc. Contractors should follow same rules as the work is performed

inside project area.

Material Storage – Although, it is not recommended, construction materials in the

contractor’s area is allowed. All materials shall be adequately organized and secured.

Pfizer is not responsible for any lost or damage to the contractor’s property.

Security (contractor’s properties) – contractors must maintain all properties (inside and

outside of the trailer) secured. Pfizer is not responsible for any lost or damage to

contractor’s property (including the trailer). The contractor should provide a copy of the

key of the trailer to Security.

Identification – all trailers must be clearly identified in a visible area with: (1) company

name, (2) main contact person, (3) offices phone number and (4) at least two

emergency phone numbers where the owner can be contacted.

12.16 Project Contract Closure

Upon completion of a project, the Contractor shall assure that Safety performance by

Contractors will be communicated to Regional Procurement for consideration as to whether or

not the Contractor should be included on future bid lists. All badges shall be returned to Pfizer

Security.

12.17 Personal Conduct

It is of the utmost importance that, when working on Pfizer premises, all Contractor employees

exercise respect for Pfizer employees, visitors, other contractors, operations, facilities,

equipment and grounds. Harassment / disrespect of any kind, work place violent, hand play or

“horse play” will not be tolerated. Violations of this policy may result in immediate removal

from Pfizer premises.

13 Traffic Control, Barricades and Pedestrian Guarding All signs, signals and barricades shall be visible at all times where a hazard exists, and shall be

obeyed.

When traffic control is required, a written control plan must be given to the Pfizer Security and

Contractor Compliance representative for review and approval.

Contractors performing work in areas accessible by Pfizer employees shall implement controls to

protect pedestrian foot traffic without interruption to Pfizer operations.

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13.1 Use of Barricades

Due to the broad range of activities conducted at Pfizer facilities, on occasion there is a need

to temporarily restrict access to areas of a site. As a general convention, the following

guidelines shall apply at Pfizer sites:

Yellow tapes shall be used to identify areas where temporary operations have altered

the normal configuration or use of the area, or where modified safety procedures may

be in place. Yellow shall signify the need for increased safety awareness, but shall not

prohibit entry to the area.

Red tapes or safety mesh shall be used where imminent hazards exist, or on-going

activities or conditions demand that access to the area be prohibited, or strictly

controlled. Red shall signify that entry to the area is prohibited. Boundaries

delineated by red tape or safety mesh shall not be crossed, except by the party

controlling the space, and only in accordance with the safety procedures applicable to

the area and activities.

Tape shall be used for temporary applications, typically less than a week.

For long term barricading and protection, safety fencing, mesh or chain link fencing

shall be installed. When fencing and railing are installed, it shall be as per

manufacturer’s instructions and sufficiently supported to resist a minimum of 200

pounds of leaning force without yielding. The barricade has to be approved by a

qualified Pfizer person.

14 Personal Protective Equipment If engineering or administrative controls cannot adequately control a potential hazard, Contractors

must insure that its employees are properly trained and are provided with all required personal

protective equipment (PPE) prior to commencing work. The use of personal protective equipment

must comply with all applicable regulations (i.e. respiratory protection, PPE, lead, etc.).

14.1 Minimum PPE for construction areas

The following items are required PPE for all areas:

ANSI approved safety glasses (ANSI Z87.1) with side shields (tinted for exterior use

only);

Hard Hats (ANSI Z89.1-1986);

Safety Foot Wear (ANSI Z41.1-1991)

Long Pants;

Reflective vest when heavy power equipment is operating within the contract limit

line, or when working in high-traffic areas;

Additional PPE Considerations:

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Cut resistant or cut-proof gloves (ANSI certified, specific to task). ANSI Level 4 for high risk of cutting.

Fall retention harness with arresting lanyard as required.

Ear plugs or ear muffs if the work will involve employee exposures to loud noises

(>85 dB)

Respiratory protection (written respiratory protection program and medical

monitoring required). Only NIOSH certified equipment.

For live electrical works on or near:

Fire retardant clothes according with the Hazard Risk Category (HRC), leather

gloves, insulated gloves, Safety shoes (EH) , Face shield according with the HRC,

safety glasses, ear plugs, ninja hood (balaclava) and blankets as required by the

NFPA 70E.

Non-conductive, insulated gloves, boots, and blankets as required by the NEC.

Approved fire resistant clothing as required by NFPA

Fire / heat resistant gloves with gauntlets

UV protective goggles / face shield

Impact resistant face shield

15 Tools The Contractor shall be responsible for the following items:

Maintain power tools in a safe working condition

Designed safety features such as guards and interlocks shall NOT be removed or defeated.

Tools shall be tied off when in use above personnel or other dangerous equipment.

Tools powered by gasoline shall not be used inside occupied buildings unless prior permission given by EH&S

16 Electrical Safety Energized electrical equipment and services represent a significant hazard on every job site.

OSHA's electrical standards address the government's concern that electricity has long been

recognized as a serious workplace hazard, exposing employees to such dangers as electric

shock, electrocution, fires and explosions. OSHA’s regulations related to electrical safety

recognize two key hazard management tactics: elimination of the hazard through shut down

and isolation (Lock Out / Tag Out); or when live circuits must be maintained, protection from

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contact through the use of guarding, insulation, and protective equipment. A special permit is

required for work with live energized equipment and shall be approved by Pfizer Management.

Not only must employee contact with electrical systems be avoided, fires and explosions due to

overheating and arcing of electrical systems must be prevented as well. Pfizer facilities contain

numerous “rated” areas where “explosion proof” or intrinsically safe lights, conduits, motors,

controllers, and switches are used to prevent the ignition of flammable or explosive liquids and

gases. Accidental use of non-rated equipment (such as cell phones, power tools, radios) in

these areas could have catastrophic consequences.

All contractors performing work at or near live energized equipment must follow the OSHA

standard requirements in 29 CFR1910.301-399, 1926.400-449, NFPA 70E and the site’s

Electrical Safety Program.

All contractor employees performing work at or near live energized equipment must be qualified

and received training on electrical safety practices, as contained in the OSHA standard. For live

Electrical Works electrical permit is required according with Pfizer Electrical Safety Program.

The following is a partial list of items to consider when working with or near energized systems:

All permanent and temporary electrical work shall be done in accordance with

National Electric Code, OSHA, our procedures and other applicable standards.

Electrical equipment must meet UL/FM approval for hazardous locations (explosion

proof or intrinsically safe) in all rated pharmaceutical production and warehousing

facilities, and other areas where appropriate.

Contractors shall utilize "ground fault circuit interrupter" (GFCI) protection at the

source when using electrical tools/equipment.

Temporary electrical services installed at job sites shall be equipped with GFCI

protection. GFCI shall also be used when exposed to water.

Electrical equipment inspection is to be done in accordance with the manufacturer’s

specifications, or on a quarterly basis at a minimum.

Frayed or cut electrical cords, or cords with damaged plugs or missing ground

plugs shall be immediately removed from service, rendered unusable, and removed

from the site. Defective tools cannot be stored in tool or gang boxes on site. Pfizer

reserves the right to remove from Site any defective tool or cord immediately.

Welding electrode connections require covers.

Extension cords must be at least 14-gauge heavy-duty three wire cords with a UL

approved three-prong plug, and must be used in conjunction with a ground fault

circuit interruption device located at the power source to protect both the cord and

the tool. Flat extension cords are not allowed on any Pfizer project.

All electrical power tools must be in good condition and equipped with three prong

grounded plug or must be clearly marked as double insulated.

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Temporary area lighting, if required, must be powered by its own circuit and shall

not be used for any other purposes. Temporary lighting fixtures shall be hung from

the insulated grommet attached to the fixtures, and not by the cord or conductors.

Fixtures must be hung with non-conductive material. Fixtures cannot be hung from

fire sprinkler piping, water piping, or ceiling grid.

Welding leads, extension cords, hoses, cables and other such items are to be

suspended a minimum of 7 feet overhead, covered or otherwise protected, to

prevent damage to the cord and the creation of a tripping hazards. Cordless hand

tools are encouraged.

Disconnects (switches) shall be legibly marked to indicate the voltage , circuit and

warnings. Also shall be legibly marked to indicate the purpose, unless located

where the purpose is evident. When multiple disconnects are located on one

panel, each disconnect must be clearly labeled to identify the equipment or circuit it

controls.

Workspace required to access and service electrical systems shall not be used for

storage. The minimum clearance is a minimum of 36” front and 30” wide. No

grounded conductor may be attached to any terminal or lead so as to reverse

polarity. Verify polarity when using double-insulated tools.

Electrical connections shall be installed by qualified personnel and coordinated with

a Pfizer electrician. Certification of the installation by qualified personnel is

required.

.

Electrical tie-ins shall be conducted only on de-energized (locked out and tagged

out) systems. A special permit is required to perform live electrical works.

LOTO and Electrical Safety site procedures shall be followed.

None material can be stored on Electrical rooms.

Remember: isolate it, lock it, tag it, and try it.

Electrically Classified Areas

Pfizer PGS site has areas classified by OSHA as Class I, Class II, Division 1, Division 2,

as well as general purpose areas.

Class I, Division 1 or 2 areas contain flammable materials. Therefore, non electric or

electronic device may be brought in unless it either meets the electrical classification (is

intrinsically safe) or is used with a hot work permit.

Class II, Division I, Division II is an area that contains or exist the possibility of containing

combustible dust. Therefore, non electric or electronic device may be brought in unless it

either meets the electrical classification.

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General purpose is an area that does not contain flammable material or combustibles

dust.

Electrical equipment being installed must meet with area or room electrical classification.

17 Excavation and Trenching Pfizer requires that all excavation work (over 4 feet depth) be conducted under the direction of a

Competent Person for Excavation and Trenching, in accordance with the OSHA standard (1926.650-

652). The Contractor must submit evidence of training for the project’s designated Competent

Person prior to mobilization to the site.

Additional safety considerations for excavation and trenching activities include:

Verify the facility drawings to avoid any potential risk associate with the underground utilities.

The area where earth-moving equipment is working must be barricaded to protect all personnel in

the area.

Excavation equipment must be properly grounded at all times.

If the Contractor encounters any suspect material (i.e. discolored soil, pipe not on Pfizer’s excavation

package drawings), the Contractor shall stop immediately and contact his Pfizer sponsor. If the soil

is contaminated, Pfizer will arrange for its proper removal and disposal.

All personnel working near operating machinery shall where high visibility reflective vests.

Excavations greater than 4 feet deep require a sloping or shoring plan that is designed by a

competent person. Trenches less than 4 feet deep also should be protected when studies show

hazardous ground movement might be expected. For excavation more than 20 feet the design must

be by a professional Engineer License.

18 Hot Work “Hot Work” is a particular safety concern at Pfizer.

A “Hot Work” permit is required for all torch cutting, welding, grinding and spark or heat

generating activities.

During the job a gas detector calibrated must be use to monitor the atmosphere if exist

the possibility of flammable atmosphere.

Sparks must be contained within the immediate work area.

A “fire watch” is required for hot work jobs.

The designated fire watch person shall be adequately trained by the Contractor to use

fire extinguishers or other fire equipment in case of an event.

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Contractor will provide a trained, dedicated fire watches with an ABC extinguisher in good

operating conditions.

No hot work is allowed unless the fire watch is in the immediate work area and within

sight of the hot work.

The fire watch will not perform any duties other than fire watching while hot work is being

performed.

Additional fire watches are also required in other areas that flame or slag may potentially

fall.

Only fire resistant tarps shall be used to catch "slag" and protect equipment against fire.

Contractors shall maintain documentation that fire extinguisher training was completed

for each employee with fire watch responsibility and all employees involved in hot work.

Fire watch will stay at job site for an hour after job is complete to assure that no fire or

other incident is developed aftewards.

19 Steel Erection The Contractor will prepare a steel erection plan per OSHA guidelines (1926.750-761) describing the

Contractor’s work plan and safety measures for review by the Pfizer contractor compliance prior to the

start of work. Fall protection must be discussed prior to any exposure. 100% fall protection and

prevention are required for all operations including connecting, erecting, bolt up, decking installation,

etc. Walking, climbing steel without fall protection is unacceptable. Steel erectors must use man lifts,

Miller system, or other measures to assure 100% fall protection. A safety railing complying with

OSHA of top and mid rail of 1/2-inch wire rope or equal and toe board around the periphery of all

floors and floor opening is required. Maintenance of the perimeter railing system shall be the

responsibility of the steel erector unless otherwise specified in the contract documents. Whenever

practical, the steel erector shall not cut the floor openings. The Contractor who will use the opening

shall only cut floor openings and provide OSHA compliant protection thereafter.

20 Fall Protection

20.1 General

Once a worker leaves the floor, an elevated work situation is created and a proper work

platform must be provided according OSHA standard (1926.500-503). 100% fall protection is

required in areas where the fall hazard is 6 feet or greater from the worker’s foot-level, or

where the individual is working over dangerous equipment. For general industry, according to

OSHA standard (1910.23), fall protection applies where fall hazard is 4 feet or greater. Such

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protection must be either approved guardrails or a combination of safety harness and lanyard.

Anchorage points for tie off shall be able to sustain a minimum load of 5000 lb. per person and

be located at or above the workers shoulder level, at a sufficient height to allow the lanyard to

arrest the fall prior to the employee impacting with the surface or equipment below. Pipes

such as a cable trays and electrical conduit are not to be used for anchors or platforms. Small

diameter pipes, cable trays and electrical conduit are not to be used for anchors or platforms.

Anchor points must be within 6 feet of the worker or else a retractable harness must be used.

Lanyards cannot be strung together. Safety harnesses and lifelines shall be visually inspected

before each use and replaced if found defective or expired.

Examples of elevated work locations requiring fall protection include working on roofs, decks

or platforms within 6 feet of the edge, incomplete scaffolds, working off ladders, ladders or

step ladders adjacent to floor openings where there is fall potential.

20.2 Roof Work

Working on a roof within six feet of the edge requires appropriate fall protection (railings or

safety lines with the proper PPE). The following items represent the minimum requirements

for contractors while working at roof in the Pfizer premises:

Roofing materials shall not be stored within the building. Tar kettles, and similar

melting equipment must be located at least 25 feet, or more away from any building,

structure, or stockpiled combustible material.

Not less than two 15 pound dry chemical fire extinguishers must be provided, and be

readily accessible at each tar kettle location.

Tar kettles, melting equipment, and other fume producing types of equipment are not

to be located in the area of existing fresh air intakes.

The Project Manager prior to placement and start-up must approve the location of

such equipment

If the roof does not have a guardrail or life safety line, the use of safety mesh is

required to limit access of contractors to the edge.

20.3 Floor Openings

Working within six feet of a floor opening (skylight, hole, open hatch, etc.) requires

appropriate fall protection (railings or safety lines with the proper PPE). Floor openings

(holes) shall be protected with a fixed cover, using materials of sufficient strength to support

any imposed load or to equal the design floor loading capacity, or shall be guarded by a

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standard OSHA-compliant fixed railing system with toe boards on all exposed sides except at

entrances to stairways.

When floor openings are protected with covers, the cover shall be clearly marked: “Danger-

Hole – Do Not Remove.” To minimize the exposure time, openings in floors shall not be cut

until the last practical moment, and then only by the Contractor who will utilize or fill this floor

penetration. For example, the concrete for a floor penetration in an elevated slab may be

boxed out, but the decking must be left in place to be cut by the mechanical Contractor who

will utilize the penetration. Precut holes in slabs and metal decking are discouraged. The

Contractor that cuts the floor opening shall be responsible to maintain it, unless “ownership” is

transferred to others in the contract documents.

20.4 Cranes and Material Hoist Operations

The Contractors shall comply with the manufacturer's specifications and limitations applicable

to the operation of any and all cranes and derricks Crane, derrick, and hoist safety hazards are

addressed in specific standards for the general industry, and the construction industry.

Contractors shall provide appropriate barriers around cranes and material hoists to protect

pedestrian and vehicular traffic around the operating area. When cranes are operating and

moving, flag men shall be provided by the contractor and utilized to prevent pedestrian and

vehicular traffic from crossing paths with the crane load.

The cranes must be certified as required and the personnel such as a rigger, operator and

designated signal person must be appropriated trained. A critical lift permit must be completed

each day prior to starting crane use. A pre-lift meeting is held at the start of the shift with all

personnel involved in the lifting operation.

Daily inspections to cranes and all lifting equipment shall be performed and inspection reports

kept with the equipment (refers to Section 12.8 for additional details).

Under no circumstances, slings with any potential loose thread or torn will be allowed on site.

Monthly inspections that document any deficiency will require it decommission.

20.5 Aerial Lifts

Only documented, trained personnel shall be allowed to operate Aerial Lifts according to

OSHA (1926.453-454 and 1910.67). Aerial lifts (scissors lifts and boom lifts) shall only be

used for lifting personnel and their tools and must not be used as material hoists. The

manufacturer’s load limitations and operating requirements must be complied with. Personnel

working in aerial lifts must be tied off to anchorages specifically designed for that purpose

(railings do not meet fall protection anchorage requirements). Lifts that are not equipped with

such anchorages shall not be used. Work shall only be accomplished from the floors of the

baskets and must not involve climbing on basket railings, ladders, or other elevating platforms.

Daily inspections will be performed and inspection reports kept on the equipment.

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20.6 Ladders

The following items represent the minimum requirements for contractors while using ladders in

the Pfizer premises. OSHA standard (1926.1050-1060) also applies.

Ladders are to be visually inspected prior to each use. Ladders found to be

defective are to be removed from the project, and the site.

Only Type I heavy duty or higher ladders shall be used for construction activities.

Ladders must be properly placed on a sound footing.

All ladders shall be used in accordance with manufacturer’s requirements, and only

for the purpose of which they are intended.

Ladders must be secured (tied) at the top point of contact while in use. During the

initial climb to secure the ladder, a second person must be at the base holding the

ladder secure. When a ladder cannot be secured due to the absence of an available

object to tie to, the ladder must be supported by a second person throughout the

course of the work.

Ladders must not be used in the vertical or near vertical position. The base should

be placed ¼ of the ladder’s length out from the vertical plane.

All extension ladders shall extend at least 3 feet above the border where the ladder

rests.

The use of metal or wood ladders is strictly prohibited.

All ladders and their use must comply with OSHA, and company safety standards.

20.7 Scaffolds

All scaffolding, staging, and work platforms must satisfy the applicable OSHA regulations

(1926.450-454) and manufacturer’s erection requirements. The use of site built staging or

scaffolding is not allowed unless prior approval is obtained from the Pfizer representative and

the Contractor Safety Coordinator. The proper use of scaffolding requires that:

Choosing the Right Scaffold for the work.

The scaffold be erected and inspected by a trained, competent person.

The scaffold shall be equipped with an inspection tag with daily notations by the

competent person that the scaffold has been inspected and approved for use.

Footings and anchoring must be sound and rigid and capable of handling the

maximum intended load without settling or being displaced.

Scaffolding must be plumb and level before it can be used.

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All scaffold planking shall be free of imperfections (Class A scaffold lumber), shall

completely cover the entire work area, and comply with all lapping and overhang

requirements as defined by OSHA scaffolding requirements.

Scaffold platforms more than six feet above any working surface must be equipped

with a top rail (42” height), mid rail (21” height), and a toe board (4” high) on all open

sides and ends. If the manufacturer’s requirements are more stringent (i.e. mobile

staging less than 45" wide), they shall superseded these minimum requirements.

Adequate access to work platforms shall be provided. Contractor personnel shall be

forbidden from accessing other platform levels by anything other than manufacturer-

approved stairways or ladders.

Scaffolds must comply with OSHA regulations.

Under no circumstances contractor’s personnel will be allowed to ride on mobile

scaffolds.

Compliant scaffolding will bear a green inspection tag, signed and dated by the

Contractor’s competent person each shift prior to use. If the green or yellow * tag is

not present, or it is not signed and dated, or a red tag is affixed, the elevated work

platform shall be considered unsafe for use. *yellow tag means the scaffold can be

used but some risks are present.

Scaffold erection / dismantling shall be directed by the Contractor’s competent person and in

accordance with the manufacturer’s specifications or the design and specifications of a

licensed professional engineer; specifications shall be available on site.

21 Housekeeping Housekeeping receives major emphasis at Pfizer, since a clean work site provides a solid foundation

for a safe work site. Each Contractor and all his employees are responsible for maintaining high

standards of cleanliness and orderliness; we will not accept anything less.

Housekeeping must be addressed on a continuous basis. Sloppy work practices will not be tolerated.

As a minimum, clean up of each work and lay down area must be done at the end-of-shift to a broom-

clean level. In occupied buildings the work area shall be mopped or swept daily. Hazardous,

flammable, trash, and/or excess waste material is to be removed from the work area daily, in

coordination with Pfizer Representative.

The second aspect of housekeeping is maintaining construction materials in a neat, consolidated, and

organized manner. Unused or excess/scrap materials shall be promptly removed from the site, in

coordination with Pfizer Representative. Contractor will maintain housekeeping conditions in

compliance with OSHA 29 CFR 1910 and 1926 standards.

a. Portable bathrooms - Porto let and washing facilities including hand sanitizers are to be provided

by construction contractors for use by his personnel. Company facilities are not to be used.

Contracted personnel engaged in providing technical support services or administrative support

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may use company sanitary facilities. Secondary containment must be provided for the septic

tanks.

b. Tools and Equipment - Contractors are required to furnish their own tools and equipment. The

tools and equipment should be in good condition. Under no circumstances will they be allowed

to use company tools. The restriction includes lift trucks, hoists, cranes, ladders, etc. The

Sponsor and equipment owner shall authorize any exemption to this rule in writing.

All contractor personnel must be properly trained in the use of these devices, and equipment must be

correctly guarded, and fitted with proper protection.

The metal non-current carrying parts of all electrical appliances must be grounded. Contractors shall

implement either O.S.H.A.’s Ground Fault Interrupt Circuits (G.F.I.C.) or the Assured Equipment

Grounding Conductor Program. Under no circumstances will electrical powered tools be hoisted or

lowered by their electrical cord. All electrical powered tools shall be disconnected while not in use.

22 Good Manufacturing Practices (GMP) Pfizer must assure its product quality and prevent product contamination and therefore have the

following guidelines for Contractors, as a minimum:

The use of appropriate clothing / uniform (with shirts tucked in), free of foreign matter is

required. All contractors need to use a disposable gown over the uniform / cloth when

going to work in the manufacturing areas.

It is mandatory the use of booties over the safety shoes in the manufacturing areas. The

contractors need to change the booties once he/she leave the construction site.

The use of hair nets and beard covers (if applicable) is mandatory to all contractors’

personnel in manufacturing and process areas.

Keep out of areas not assigned to; remember Contractors are authorized entrance only if

signed onto a permit

Eat or drink in manufacturing and process areas is PROHIBITED.

Do not move or use Pfizer containers because this could result in materials being mixed or

incompatible materials being stored together.

Keep your containers, food, beverages, personal items, and equipment out of Pfizer’s

operational work or storage areas.

Do not open or close windows or doors in a Pfizer operational or storage space.

Practice good housekeeping throughout the day. Store debris properly and dispose of daily

in the designated dumpsters.

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The use of jewelry, makeup, contact lenses and false nails are not allowed inside

manufacturing areas and areas where such use represents a potential personal risk, as

determined by the Pfizer EHS Representative.

23 Roof Work / Roof Access Access to roof areas is strictly controlled, as numerous exhaust systems and vents may be

operational throughout such buildings. Roof access must be coordinated through the Pfizer

Representative and area personnel. System shut downs may need to be coordinated to work on, or

near, equipment that may present local hazards (such as chemical or thermal exposure) to workers

due to the composition of the exhaust stream.

The use of flammable torches and flammable cutting equipment are PROHIBITED, in performing cuts

on roof decks and metal siding. They should only be use after a Safe Work Plan (JSA) is completed

with established action plan.

24 Confined Space Entry A confined space, as defined in the OSHA standard, could present special hazards, such as limited

means of egress, potential accumulation of toxic or flammable contaminants, potential for having an

oxygen deficient atmosphere, or presents an entrapment or engulfment hazard. Confined spaces

include, but are not limited to: tanks, process vessels, bins, boilers, tunnels, , excavations as

applicable, ducts, sewers, and pipelines. Open-top spaces with a hazard potential, such as pits,

tubes, vaults and vessels, may also require a confined space permit as determined by the Pfizer

representative. Contractors conducting confined space entry work must have their own written

programs, including training requirements for all personnel involved in confined space entry

operations. Contractors must follow precautions outlined by Pfizer confined space entry procedures,

and be responsible for supplying equipment, tools and trained manpower per the permit. A confined

space permit is required for each work shift.

All confined space entries by contractor’s personnel must be completed in accordance with

OSHA 29 CFR 1910.146 and 1926.21 “Permit Required Confined Spaces”.It is the

contractor’s responsibility that before entering tanks, vessels, or other confined spaces,

safety representative must first inspect spaces.

All confined spaces when possible, should be emptied and thoroughly ventilated. The

contractor and facility safety personnel will test for oxygen content, flammable vapor, and

carbon monoxide.

All confined space entries are to comply with the Confined Space Entry Safety procedure.

The Project Manager will furnish additional instructions related to required safety equipment

for entry. This may involve the use of safety harnesses and lines, lookout assistance outside

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the tank, blanking off lines, use of a respirator, and other items that may be required to

ensure safety entry into a confined space.

The Project Manager is responsible for the coordination of the rescue team availability

during the work in a confined space.

25 Environmental

25.1 Solid Waste Management - General Guidelines

Through daily activity, Contractors generate various types of solid waste. A solid waste is a

solid, liquid, semi-solid or contained gaseous material, which is to be discarded, or has served

its intended purposes. All solid waste generated on a Pfizer work site (construction debris,

boxes, pallets, etc.) must be removed and properly disposed in coordination with Project

owner and EHS Coordinator.

Contractors must supply their own waste collection containers, unless other means of

disposal is agreed upon with the Pfizer representative prior to the start of work.

The receptacle must be in good condition and labeled with the Contractor’s name and

the containers contents.

Waste collection containers must be located under a roofed structure or covered with

a waterproof top at all times.

Any regulated or hazardous waste generated by the Contractor (oil, paint, solvents,

gasoline, etc.) must be promptly removed from the site and properly disposed in

coordination with Pfizer Representative, project owner and EHS Coordinator.

The EHS Representative must approve off-site disposal facilities for construction and

demolition debris. Permits must be required for this operation.

Contractors shall submit to the Pfizer Representative their request for approval of the

disposal site in advance of the work activity.

Each disposal request must indicate the type, estimated volume and nature of the

waste, location of the disposal site, disposal site contact and phone number. Consider recycling alternative before sending any waste to landfill. In the event that Asbestos Containing Materials are found or suspected to exist in an

area to be demolished, contact the Pfizer project representative and EHS representative to discuss the steps to be followed.

Contractor shall not open Pfizer dike valves, fuel tank drainages, nor use such

material (fuel) for its own fuel consumption purposes.

Handling of refrigerant must be in compliance with all federal, state and local

regulations. Any refrigerant work must be coordinated with site refrigerant manager

and/or EHS. Submit evidence of compliance to EHS prior to commencing work.

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Contractor must carry the necessary licenses and related evidence at all times. Class I

refrigerant work is not allowed on-site.Equipment, machinery or vehicles that are

leaking fuel or oil when inspected by a Pfizer Security Technicians at the entrance

gate will not be allowed to enter the premises.

Contractors shall provide documentation to their Pfizer Representative and EHS Coordinator

verifying proper treatment or disposal of non-hazardous waste. This documentation shall be

provided no later than the next proper working day that the non-hazardous waste is

transported for disposal. Pfizer will withhold payment for any invoiced disposal services that

are not fully supported with all required regulatory documentation.

25.1.2 Recyclables

Recyclable solid waste generated at Pfizer will be placed in properly designated

receptacles supplied by Pfizer. Contractors shall dispose as much materials as

possible into Pfizer receptacles. This activity should be performed in coordination with

recycling supervisor and Project Manager.

If the contractor send recycling material outside of Pfizer, it’s necessary to have

the EHS department approval of it. Once its recycled evidence of recycled

materials (pounds) will be submitted to EHS in a monthly basis.

All contractor company with more of 10 employees needs to have a written

Recycling Plan as required by (JCA) Local Law 411 of 2000.

25.2 Erosion and Sedimentation Control

When excavation or demolition activities are conducted at exterior locations at Pfizer facilities,

the Contractor shall be responsible for compliance with all local, state, and federal regulations

related to Erosion and Sedimentation Control. All engineering controls shall comply with the

Puerto Rico Environmental Quality Board Guidelines for Erosion and Sedimentation Control,

as amended, and in accordance with a “CES Plan” Permit and “Permiso General

Consolidado”. Pfizer operates automated storm water quality monitoring systems at some of

its facilities. To insure preservation of the highest surface water quality possible, the following

conditions must be met at all times:

Catch basins drop inlets, open channels, or other storm water control structures

immediately down gradient of the Contractor’s work area must be protected by silt

fences, sediment filters, hay packs, or other equally effective means.

Sedimentation barriers shall be installed down gradient of all disturbed areas, and

shall be maintained until final stabilization is achieved.

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All engineering controls shall be inspected and repaired prior to, and immediately

following, forecasted precipitation events.

Inspections should be conducted as per approve CES plan and a log shall be

maintained at the job site.

A monthly storm water inspection must be completed and submitted to the EHS

Area.

All permanent structures protected during the project shall be inspected and

cleaned of accumulated sediment once final stabilization has been achieved and

temporary engineering controls have been removed.

Active dust control shall be implemented in the work zone. Active dust control may

include use of water trucks, hoses, or other dust control measures approved by

Pfizer EHS.

Use of surfactant-type chemicals for dust control is not allowed at Pfizer.

Accumulated soil and dust shall be damp swept from the areas adjacent to the

construction zones as frequently as necessary to control fugitive dust emissions

from the work zone.

All roadways, walkways, and site work must have provisions for dust control

throughout the project. Roadway dust may require water spray or gravel cover.

Contractors shall spread a thin layer of crushed stone over earth or gravel surfaces

that are left exposed, as directed by Pfizer.

Emissions generated by drilling, hoe ram, jackhammer, grinding or bag dumping

operations require control by vacuum, watering, or other means to prevent the

release of fugitive dust.

Masonry and concrete are to be wet cut, unless other methods to control dust have

been approved.

Cement dust from bag stock should be swept up and properly disposed of not

watered down, due to pH concerns.

No pump discharges, power washing effluents, or similar wastewater may be

discharged into existing floor drains, sinks, storm water management system

structures, or the ground.

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Concrete trucks, mortar mixers or grout pumps may only be washed out at a

designated washout area provided by the Contractor and approved by the Pfizer

representative.

All stockpiles of soil materials shall be surrounded by silt fences and covered with

plastic in case of rain. Plastic covers shall be secured with sufficient numbers of

sand bags to insure that the plastic remains in place throughout all forecast

weather conditions.

All concrete rubble piles must be located out of normal or expect drainage

pathways and surrounded by silt fences and covered with plastic in case of rain.

Run off from concrete rubble storage areas may interfere with Pfizer’s on-site storm

drain pH monitoring system if not properly contained and controlled.

Ensure that all chemicals are properly approved by the EHS Department prior to

delivery to any Pfizer site or commencing any work. Storage and handling of

flammable and combustible liquids shall be in compliance with OSHA requirements.

25.3 Spill Prevention

Contractors who import chemical-based products to Pfizer facilities shall provide a spill control

kit, compatible with the material to be used, and sized to accommodate a failure of the largest

single container they plan to import. Spill kits shall be immediately available in the work areas

where chemicals will be stored or used.

Operators of hydraulically operated equipment shall also maintain a minimum of one spill

control kit sized to accommodate the largest reservoir in their inventory. Plastic liner shall be

used underneath heavy equipment to prevent potential ground and storm water contamination

from leaks.

Equipment, such as pipe cutting, threading, welding machines, etc. shall be located over

absorbing sand box and covered with plastic liner when not in use to prevent runoff

contamination.

25.4 Equipment Inspections

Prior to mobilization to a Pfizer facility, all equipment shall be inspected to confirm that it is in

good operating condition, with all required safety equipment, inspections, and is free of leaks,

drips, or uncontrolled discharges. All internal combustion engines including, emergency

generators, welding machines, compressors, etc., must be approved by EHS and inspected

before entering the facility. Equipment that malfunctions or breaks while at a Pfizer facility shall

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Revision 2.0 – May 2012 Page 51 of 58

be immediately removed from service and repaired. Repairs on-site are not allowed.

Equipments or vehicle with oil leaks or drips are prohibited at Pfizer facility.

Equipment that malfunctions or breaks while at a Pfizer facility shall be immediately removed

from service and repaired.

25.5 Environmental / Hazardous Material Remediation

Contractors shall be solely responsible for all environmental remediation, including all costs,

required to address any release of oil, fuel, or hazardous material as a result of their

operations at any Pfizer facility. In the event of a release, remediation shall be completed to

the full satisfaction of local, state, and federal regulators, and Pfizer EHS. Clean up of

Contractor releases by Pfizer will be charged to the Contractor(s) responsible for the release.

25.6 De-watering Activities

EHS Coordinator approval is needed for de-watering activities (e.g., manholes and trenches).

Contractors shall notify their Pfizer EHS Representative before pumping groundwater or

precipitation from their work area. EHS Coordinator will determine the proper discharge point.

Only clean water, with neutral pH, can be discharged. If necessary, a settling pond for

removal of silt before final discharge must be used.

25.7 Air Pollution Control

Contractors must abide by good management practices to ensure that their daily activities do

not impact the air quality. These shall include, but not be limited to:

No open burning is allowed on Pfizer premises.

Vehicles operated near fresh air intakes shall be equipped with exhaust scrubbers

to minimize impact to interior air quality.

Equipment shall not be allowed to idle for excessive periods of time when not in

use.

Solvent or other noxious emissions shall be evaluated as part of the work planning

process to determine engineering control requirements prior to in field

implementation of the scope of work.

Contractors shall obtain authorization from Pfizer EHS, five days in advance, prior

to introducing internal combustion engines of more than 10 horsepower capacity.

25.8 Environmental Inspections

Contractor work areas may be observed and inspected at any time to ensure

compliance. Pfizer EHS staff or designated representatives will perform inspections.

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Any deficiencies noted during the inspection must be corrected immediately. Repeat or

serious violations could result in disciplinary action and/or expulsion from the site.

26 Vapor Emissions and Occupied Spaces Contractors conducting painting operations or other vapor producing activities (sealing, stripping,

chemical etching, adhesive application, etc.) must obtain prior approval from Pfizer Representative,

taking into account the location of their activities, and the impact to Pfizer employees, other

contractors, and production processes. Vapor emissions from the above-described activities have

the potential to adversely affect indoor air quality, or interfere with active science.

Contractors using vapor emitting products must prepare an air quality control plan that will maintain

indoor air quality below the permissible exposure limits set forth on the manufactures Material Safety

Data Sheet (MSDS). Contractors should be prepared to provide air monitoring equipment,

ventilation equipment, and engineering controls to document and maintain acceptable air quality.

In the event that suitable air quality cannot be achieved, Contractors should be prepared to schedule

activities outside of normal working hours, and protect their employees with an OSHA compliant

respiratory protection program.

Also to be considered is the location of air intakes when operating power equipment outside of

occupied buildings

27 Fugitive Emission Compliance (when applicable) Contractor working with process equipment like tanks, pumps and pipe must be aware to comply

with fugitive emissions program that can include PIPE CONNECTION and identification, ensure that

sampling valve have caps to avoid leak etc. It is contractor responsibility to contact EHS fugitive

emission program specialist to ensure is in compliance with the program.

28 Roof Sealing No contractor can apply sealants that contain any amount of VOC (Volatile Organic Compound),

without an EQB permit. This type of work shall be notified and coordinated with EHS.

29 Drain Line/Sewer line Storm water lines are exclusive for rain water only. Contractor shall take all necessary precautions

to avoid contaminate the storm water line while performing work in process or sewer lines. If it is

necessary, a dye test should be performed.

Also, contractor cannot perform any cleaning work close to storm sewers or sinkholes.

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SUMMARY OF CHANGES

The following are the changes made to the SOP and their reason.

Revision Description of Change

1.0 New

2.0 The following changes were performed on this revision 2.0:

1. Section 2.2: Addition of “Serious Incident” definition.

2. Section 6.2: Addition of minimum requirements for Safety Officer

3. Section 6.5: Provide details of what Safety evaluation should include.

4. Section 6.5: Include three new bullets for Pfizer Sponsors responsibilities.

5. Section 10.1: TIR & LTA rates and contractor’s safety rate.

6. Section 10.2: New section to describe Disciplinary Actions.

7. Section 12.3: Public Works and Transportation Department annual certification for

all vehicles. 8. Section 12.8: Add specifications for equipment’s daily inspection reports.

9. Section 20.1: Specify fall protection requirements for general industry, as per

OSHA 1910.23. 10. Section 20.4: Specify daily inspections requirement for cranes and lifting

equipment.

11. Appendix A: General improvements to JSA form.

12. New Appendix D: Construction Safety & Environmental Checklist

13. New Appendix E: Fall Protection Risk Evaluation Form.

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Revision 2.0 – May 2012 Page 54 of 58

Appendix A:

Job Safety Analysis (JSA) Template

Contractor EHS Manual - Appendix A

Pfizer Global Supply, PR Operations

ANALISIS DE RIESGO DE LA TAREA Información General

Tarea o Proceso:

Pfizer Sponsor: (Nombre )

Área:

Fecha:

Nuevo

Revisión Breve descripción de la tarea:

Compañía y Supervisor a cargo de realizar la tarea:

Equipo de Análisis: Nombre y firma 1. 2. 3. 4.

Revisado por (Firma Pfizer sponsor y/o delegado)

Evaluado por EHS y/o Contractor compliance:

Equipo de Protección Personal (Ver anejo):

Zapatos Seguridad Guantes Indique Cual:______________ Gafas de seguridad Protección Auditiva Casco de Seguridad Escudo Facial

Respirador Purificador Mameluco Delantal Botas de goma Bata de Laboratorio “Goggles”

Vestimenta FR Otro indique: _ ________________ ( Incluir copia de Leyenda del Panel Eléctrico “Breakers” para actualizar)

PASOS BÁSICOS DE LA TAREA EN SECUENCIA POSIBLES RIESGOS ACCIÓN O PROCEDIMIENTO RECOMENDADO PARA

HACER LA TAREA MAS SEGURA Comunicación – Describa todo comunicación a las personas realizando el trabajo, personas adyacentes y / o notificaciones a agencias requeridas por la tarea.

1.

Tarea - Describa detalladamente la tarea en secuencia

1.

Entregar - Describa como dejó el area al finalizar el trabajo

1.

Disposición - Describa como va a disponer de los Materiales sobrantes

Contractor EHS Manual - Appendix A

Documentacion de los colegas que se le ha discutido este JSA

Nombre Firma Fecha

PFIZER GLOBAL SUPPLY, PR OPERATIONS CONTRACTOR EHS MANUAL

Revision 2.0 – May 2012 Page 55 of 58

Appendix B:

Man Hours Reporting Form

Pfizer Global Manufacturing, PR Operations

Contractor EHS Manual - Appendix B

CONTRACTOR’S HEAD COUNT

Project: __________________________________________________

Contractor: __________________________

Pfizer Project Engineer: ____________________________________

Contractor Supervisor / Foreman / Engineer: ____________________________

Week Reported: ________________________

Day Safety Officer

Engineering Supervisor Employees Man Hours Incidents*

NM / FA / R

Monday

Tuesday

Wednesday

Thursday

Friday

Saturday

Sunday

T O T A L M A N H O U R S & I N C I D E N T S

*NM – Near Miss / FA – First Aid / R- Recordable

Note: Please attach incident report with this sheet Signature: ______________/___________ Date: ____________________ (Please Print & Sign)

PFIZER GLOBAL SUPPLY, PR OPERATIONS CONTRACTOR EHS MANUAL

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Appendix C:

Contractor’s Training Assistance Form

Contractor EHS Manual - Appendix C

Pfizer Global Manufacturing, PR Operations

Contractors’ Compliance Program SAFETY AND/OR GMP ORIENTATION FOR CONTRACTORS

Date of Orientation: __________________________ (Fecha de la Orientación) Trainer’s Name: ______________________________________________________________ (Nombre del Orientador) Contractor Company’s Name: __________________________________________________ (Nombre de la Compañía)

ID given / ID entregado: Employee Name / Nombre del Empleado

Print / Letra de Molde Signature / Firma

Last (4) S/S # / Ultimo

(4) Dígitos del SS

License ID # / Numero de Licencia

Access / Acceso

B/R Initials /

B/R Iniciales

Contractor Initials /

Iniciales del Contratista

Date / Fecha

Approved / Entered by: _________________________________________________ Date: _____________________________________

Revised: January 14, 2009

PFIZER GLOBAL SUPPLY, PR OPERATIONS CONTRACTOR EHS MANUAL

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Appendix D:

Construction Safety & Environmental

Checklist Form

Contractor EHS Manual - Appendix D

Page 1 of 5

Construction Site Safety & Environmental Checklist

Pfizer has developed the following Construction Safety & Environmental checklist for use by Pfizer Project Managers and Sponsors as a means of inspecting key safety areas of a capital project. This tool can be used as an informal guide as you walk-down the project to evaluate various aspects of safety. This checklist is a tool, and should not be interpreted as an OSHA compliance auditing system. Pfizer does not provide OSHA compliance monitoring services to contractors and construction managers. Pfizer’s expectation is that all vendors will continually audit their staffs to ensure complete compliance with all local, state and federal laws and regulations. Project Name: Project Manager: Inspector(s): Sign and Date: Sign and Date: Sign and Date: Contractor(s) representative present during inspection: Company: Company: Inspection Date:

Section 1: General Safety/Housekeeping

No. Item Yes No N/A

1. Contractor Safety Manuals on-site and reviewed by all employees.

2. Job Safety Analysis (JSA) available and reviewed by employees.

3. First aid kit, eyewash, and emergency phone numbers listed.

4. Appropriate signage posted in hazardous areas.

5. Adequate lighting available.

6. Handrails, barriers, and warning lines installed properly.

7. Stair risers are of equal height treads uniforms and secure.

8. Work area free of trash and debris.

9. Floor areas free of tripping hazards (electrical cords, materials, scraps, etc.).

10. Traffic control cones, barriers, signs, fences and vests in use.

11. Storage areas and gang boxes are clean and well organized.

12. Containers, chemicals, and gases properly labeled and stored. MSDS on site for all materials.

13. Forms, walls, floors brace as needed. No protruding nails or wires

14. Rebar is bent over or capped. Impalement hazards controlled.

Contractor EHS Manual - Appendix D

Page 2 of 5

Section 2: Permits/Certifications

No. Item Yes No N/A

1. Hot Work Permit in use and visible

2. Excavation Permit in use and visible

3. Lock Out / Tag Out Permit in use and visible

4. Confined Space Entry Permit in use and visible

5. Fall Protection Permit in use and visible

6. Crane Certification on hand

7. Competent Person Evidence of Training on site

Section 3: Environmental Concerns

No. Item Yes No N/A

1. Erosion and sedimentation controls (Track Mats, Silt Fence) in place and maintained.

2. Inspection records maintained.

3. Fuel, oil, and chemical spill kit available and control measures in place.

4. Construction debris segregated for disposal (i.e., concrete, metal, wood).

5. Chemical waste disposal properly controlled by contractor.

Section 4: Personal Protective Equipment

No. Item Yes No N/A

1. Proper PPE in use according to Job Hazard Analysis.

2. Hardhats are worn properly at all times.

3. Approved goggles/safety glasses, and steel-toed shoes are worn at all times.

4. Face shields in use with grinders/chop saws/welding.

5. Dust masks and/or approved respirators in use per JHA.

6. “Hearing Protection Required” signs posted when noise exceeds 85 decibels. Hearing protection in use.

7. Gloves in use for laceration control.

8. Appropriate clothing in use per JHA (Kevlar chain saw chaps, leather gauntlets, welding gloves).

Section 5: Fire Protection and Prevention

No. Item Yes No N/A

1. Welding screens, fire blankets, and designated fire watch in use.

2. Combustible materials and atmospheres identified, protected, and monitored.

Contractor EHS Manual - Appendix D

Page 3 of 5

Section 6: Fall Protection

No. Item Yes No N/A

1. Floor openings, elevator shafts, excavations, and leading edges protected with fixed barriers and / or warning lines.

2. Fall hazards greater than 4 feet identified and protected.

3. 100% Fall Protection systems provided to any employee working above equipment, or more than 4 feel above a work surface.

4. Fall protection systems inspected daily prior to use.

5. Fall protection harness in use while using man lifts.

6. Employees are trained in use of Fall Protection systems.

Section 7: Electrical

No. Item Yes No N/A

1. Temporary light bulbs are covered and hung properly.

2. All cords are in good condition.

3. Ground Fault Circuit Interrupters (GFCI) in use at the power source.

4. Covers are in place on electrical panels. GFCI protected services in use in damp locations.

5. Portable welders properly grounded. Exhaust directed from the work area.

6. Bonding/Grounding cables provided for flammable liquid handling or near flammable atmospheres.

7. Welding leads and extension cords inspected for wear and abrasion.

Section 8: Ladders and Scaffold

No. Item Yes No N/A

1. Scaffold equipment inspected daily by Competent Person, and in good condition.

2. Ladders are free of defects and tied-off as required.

3. Folding ladders only in use open and locked.

4. Ladders extend three feet above the top of the landing.

Section 9: Tools and Equipment

No. Item Yes No N/A

1. Appropriate tools are safely in use.

2. Safety guards and shields operable and in use.

3. Pneumatic tool connections safely wired or secured in place.

4. Hand tools are free of defects and excessive wear.

Contractor EHS Manual - Appendix D

Page 4 of 5

Section 10: Compressed Gas Cylinders

No. Item Yes No N/A

1. Oxygen/acetylene and other gas tanks are secured and stored upright.

2. Cylinder connections are checked for leaks with leak detector.

3. Caps are on tanks when not in use.

Section 11: Excavations

No. Item Yes No N/A

1. Competent Person conducting and documenting inspections.

2. 2-foot clear area at top of trench. Spoils stockpiled to prevent cave-in and erosion.

3. Max. 25 feet to escape ladders. Ladders extent 3-feet above top of trench.

4. Pfizer Utilities (storm, san., elec., gas, steam, water, telecom, fiber-optics, etc.) marked.

5. Trenches are properly sloped or shored as directed by the Competent Person.

Section 12: Hoisting and Rigging

No. Item Yes No N/A

1. Material elevator lifts are properly used.

2. Safety guards are in place.

3. Ropes, pulleys, chains, chokers, shackles, etc. inspected and in good condition.

4. Lifts not overloaded. Load capacity posted.

5. Employees have been trained and are proficient.

6. Daily inspection records maintained.

Section 13: Means of Egress

No. Item Yes No N/A

1. Egress Routes and Emergency Assembly Point signage established and continually maintained.

2. Evacuation air horn in place and functional.

3. Site access by emergency personnel and equipment maintained.

Contractor EHS Manual - Appendix D

Page 5 of 5

Action Plan to Inspection Observations

Section

No. Action Plan Responsible Due Date

Completion Date

PFIZER GLOBAL SUPPLY, PR OPERATIONS CONTRACTOR EHS MANUAL

Revision 2.0 – May 2012 Page 58 of 58

Appendix E:

Fall Protection

Risk Evaluation Form

Forma de trabajos en altura

PFIZER PHARMACEUTICALS LLC

Contractor EHS Manual - Appendix E

1. Información General Fecha Área de trabajo Compañía Persona a Cargo / Núm. Teléfono

(Representante de Pfizer)

Descripción del Trabajo

2. Aplicabilidad de la forma (marque el encasillado para documentar la aplicabilidad del trabajo)

Industria General (29 CFR 1910): Todo trabajo como reparaciones, mantenimientos, limpiezas, etc. de equipos o sistemas, y que no se encuentren debidamente separada e identificada como área de construcción esta forma aplica a trabajos que se realicen a una altura de cuatro (4) pies o mayor.

Industria Construcción (29 CFRR 1926): Todo trabajo que se realicen en áreas debidamente identificadas, físicamente separadas y con acceso exclusivo para contratista y/o proyecto esta forma aplica a trabajos cuya altura es seis pies o mayor.

3. Riesgos asociados al trabajo (marque el encasillado para documentar los riesgos identificados para el trabajo) Si NA Si NA Si NA

Superficies con aberturas laterales Pisos con aberturas Zanjas y/o excavaciones

Techos sin protección Paredes con aberturas No hay lugar de amarre seguro

Rampas, pasillos y plataformas abiertas

Tragaluces con aberturas Otros:___________________________

4. Método utilizado para protección contra caídas (marque el encasillado para documentar el equipo necesario para el trabajo) Si NA Si NA Si NA

Andamio / Plataforma “Scissor Lift” Sistema de posicionamiento

Cubiertas

Sistema de barandas Sistema de arresto personal contra caídas

Línea de advertencia Anclajes apropiados

Arnés con línea retractable Cuerda de seguridad Red de seguridad Jirafa “aerial lift”

Otros:

5. COTEJO DE SEGURIDAD Sí No N/A

1. ¿Se generó, aprobó y discutió un Análisis de Riesgo de la Tarea (JSA) para este trabajo?

2. ¿Se ha verificado que no existe peligro con personal, equipo u operaciones adyacentes? 3. ¿Se han colocado barreras de protección y avisos de precaución en el área de trabajo? 4. ¿Están todos los trabajadores adiestrados y certificados para el trabajo y para la operación de equipo requerido? 5. ¿Se ha identificado el medio de comunicación en caso de una emergencia? Indique cual: ____________________ 6. ¿Están todas las herramientas y/o equipos amarrados? 7. ¿Hay una persona competente a cargo del montaje del andamio? ¿Esta inspeccionado el andamio? 8. ¿Se solicitó la autorización para acceso al techo? Indique nombre: ___________________________ 9. ¿Se ha asignado un vigilante para el trabajo? Indique el nombre: ________________________

6. PERSONAS O REPRESENTANTE DE LA COMPAÑIA QUE REALIZA EL TRABAJO (de necesitar más espacio, utilizar la parte de atrás) Nombre y firma del Personal que Realizará el Trabajo

7. AUTORIZACION

Personalmente he cotejado que se han tomado todas las precauciones requeridas para realizar este trabajo de forma segura.

Personalmente he cotejado que se han tomado todas las precauciones requeridas para realizar este trabajo de forma segura y que he repasado esta información con el personal que estará realizando el trabajo.

_____________________________________ ________________ Nombre y Firma

Representante del área/proyecto o sistema

Fecha

Firma de Contratistas Fecha

8. CONCLUSION DEL TRABAJO

El trabajo ha sido completado y se han restablecido o mantenido todas las condiciones normales de operación. ______________________________

Nombre, Firma y Fecha