contractor safety, environmental & gmp handbook...community also benefits directly from our...

CONTRACTOR SAFETY, ENVIRONMENTAL & GMP

HANDBOOK

STONEWALL PLANT Elkton, VA

Revision No. 0 October 2005

TABLE OF CONTENTS

About This Manual ............................................................................................................. 2

Welcome To Merck’s Stonewall Plant Site ........................................................................ 3

Merck Safety Philosophy.................................................................................................... 4

Quick Reference: General Information and Instructions .................................................... 5

Quick Reference: Contractor Safety Regulations ............................................................... 6

Emergency Telephone Extensions...................................................................................... 7

Plant Security ...................................................................................................................... 8

Evacuation Sector Map....................................................................................................... 9

Evacuation Procedures...................................................................................................... 10

Stonewall Site Building Numbers..................................................................................... 11

Process Safety Management ............................................................................................. 14

General Information and Instructions ............................................................................... 15

Contractor Safety Regulations .......................................................................................... 20

GMP Policy....................................................................................................................... 51

1

ABOUT THIS MANUAL Information required about working at Merck is contained in your company’s contract. Your employer should review this with you. The purpose of this Handbook is to provide information and help familiarize you with site data, regulations and the Contractor Safety Program at Stonewall. Keep this Handbook with you and refer to it, as needed, while you are working at our facility. All provisions of this Handbook supplement all VOSH, OSHA, EPA, DEQ, local, state, federal regulations, and the FDA’s Good Manufacturing Practices. Your designated Merck Project Engineer will review all particulars of your project with you.

2

WELCOME TO MERCK’S STONEWALL PLANT SITE TO: The Employees of All Outside Contractors Welcome to Merck Manufacturing Division’s Stonewall Plant Site. While on our site, you will be working closely with our people and operations; therefore, we would like you to be familiar with our safety procedures and regulations. Merck & Co., Inc. is one of the largest manufacturers of pharmaceuticals in the world. Pharmaceutical production and research facilities must maintain high standards for cleanliness, quality and safety. To help us maintain these standards, Merck has initiated safety programs for our employees. As a contactor on our site, you will be expected to maintain these same standards. The Contractor Safety, Environmental & GMP Handbook has been established to help you comply with Merck security regulations and safety procedures and to explain the rights and responsibilities of contractors operating on our site. Please read this booklet and make sure that you fully understand it. Address any questions you may have to the Merck Project Engineer responsible for your job. Thank you for your cooperation.

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MERCK SAFETY PHILOSOPHY Merck is dedicated to the principle that it will effectively carry out all aspects of its business in a safe manner. We are committed to the safety of our employees, to the surrounding community and to the protection of the environment. Management has the responsibility for conducting the business of our Company in a manner that strives to prevent accidents. All employees are expected to work safely and to contribute to the safety of others. This is a condition of employment for every employee at Merck. Accident prevention contributes to our Company’s well being by avoiding injury or illness to employees, contributing to improved productivity and reducing costs. The community also benefits directly from our accident prevention efforts when potential damage to the environment, or members of the community, is effectively managed. In order for all Merck personnel to understand this Safety Philosophy and to meet its expectations, both general and specific training is required. That training is the responsibility of every level of supervision. Safety training and the prevention of accidents are logical and appropriate parts of how we conduct our business. To say that all accidents can be prevented is a realistic goal, not just a theoretical objective. It is achievable, in part, by eliminating source of danger but where this is not practical. Measures such as personal protective equipment and safety devices should be employed.

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QUICK REFERENCE: GENERAL INFORMATION AND INSTRUCTIONS

After Hour Telephone Numbers ............................................................................................................... 15 Alcoholic Beverages/Drugs ........................................................................................................................ 15 Clothing ....................................................................................................................................................... 15 Conduct ....................................................................................................................................................... 15 Construction Site Review........................................................................................................................... 15 Contractor Personnel on Site..................................................................................................................... 16 Deliveries ..................................................................................................................................................... 15 Dining Facilities .......................................................................................................................................... 16 Drinking Water........................................................................................................................................... 16 Eating........................................................................................................................................................... 19 Equipment Shutdown................................................................................................................................. 15 Fire System.................................................................................................................................................. 15 Grass Area................................................................................................................................................... 16 Large Equipment Deliveries ...................................................................................................................... 15 Material ....................................................................................................................................................... 16 Material Shipping Off-Site ........................................................................................................................ 16 Merck Information ..................................................................................................................................... 16 Merck Procedures ...................................................................................................................................... 16 OSHA & Safety Health Regulations ......................................................................................................... 16 Ozone Depleting Refrigerants ................................................................................................................... 16 Right to Know Requirements .................................................................................................................... 17 Safe Work Permits ..................................................................................................................................... 17 Safety Evaluation........................................................................................................................................ 17 Safety Training/Orientation ...................................................................................................................... 17 Signs............................................................................................................................................................. 18 Site Responsibility ...................................................................................................................................... 18 Smoking....................................................................................................................................................... 18 Temporary Plant Utility Connections....................................................................................................... 18 Temporary Services (Electric, Water, Air, Steam).................................................................................. 15 Toilet and Wash Facilities.......................................................................................................................... 16 Trash............................................................................................................................................................ 19 Trespassing.................................................................................................................................................. 19 Utility Shutdowns ....................................................................................................................................... 15 Weekend Work ........................................................................................................................................... 19 Working Hours ........................................................................................................................................... 19

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QUICK REFERENCE: CONTRACTOR SAFETY REGULATIONS

ARTICLE 01 – Responsibilities ................................................................................................................ 20 ARTICLE 02 – Auditing and Reporting .................................................................................................. 20 ARTICLE 03 – Asbestos ............................................................................................................................ 21 ARTICLE 04 – Barricades (Contractor Supplied).................................................................................. 21 ARTICLE 05 – Burning, Welding, and Hot Work.................................................................................. 22 ARTICLE 06 – Clothing ............................................................................................................................ 23 ARTICLE 07 – Compressed Gas Cylinders (Contractor Supplied) ...................................................... 23 ARTICLE 08 – Concrete and Masonry.................................................................................................... 23 ARTICLE 09 – Confined Space Entry ..................................................................................................... 24 ARTICLE 10 – Cranes (Contractor) ........................................................................................................ 24 ARTICLE 11 – Demolition by Contractor ............................................................................................... 25 ARTICLE 12 – Dust and Fumes ............................................................................................................... 26 ARTICLE 13 – Electrical .......................................................................................................................... 26 ARTICLE 14 – Emergency Numbers ....................................................................................................... 26 ARTICLE 15 – Environmental Policy ...................................................................................................... 27 ARTICLE 16 – Equipment (Contractor’s) .............................................................................................. 37 ARTICLE 17 – Evaluations....................................................................................................................... 38 ARTICLE 18 – Excavations ...................................................................................................................... 38 ARTICLE 19 – Fall Protection.................................................................................................................. 39 ARTICLE 20 – Fire Protection Equipment (Merck’s) ........................................................................... 40 ARTICLE 21 – Flammables and Combustibles....................................................................................... 41 ARTICLE 22 – Hazard Communication.................................................................................................. 41 ARTICLE 23 – Hazardous Waste............................................................................................................. 42 ARTICLE 24 – Heaters (Contractor Portable) ....................................................................................... 42 ARTICLE 25 – Housekeeping by Contractors ........................................................................................ 42 ARTICLE 26 – Incident Reporting By Contractor ................................................................................. 43 ARTICLE 27 – Ladders (Contractor’s) ................................................................................................... 43 ARTICLE 28 – Line Breaking Procedures .............................................................................................. 43 ARTICLE 29 – Liquids (Corrosive Acids and Caustics) ........................................................................ 44 ARTICLE 30 – Lockout and Tagout ........................................................................................................ 44 ARTICLE 31 – Overhead and Underground Utilities ............................................................................ 44 ARTICLE 32 – Personal Protective Equipment ...................................................................................... 45 ARTICLE 33 – Radiation/Radioactive Materials.................................................................................... 45 ARTICLE 34 – Rigging Equipment (Contractor’s) ................................................................................ 46 ARTICLE 35 – Sanitation ......................................................................................................................... 46 ARTICLE 36 – Scaffolds (Contractor’s) .................................................................................................. 46 ARTICLE 37 – Site Orientation for Contractors .................................................................................... 47 ARTICLE 38 – Smoking Policy ................................................................................................................ 47 ARTICLE 39 – Soil Management ............................................................................................................. 47 ARTICLE 40 – Structure Loading ........................................................................................................... 47 ARTICLE 41 – Tar and Melting Pots....................................................................................................... 47 ARTICLE 42 – Vehicle Safety (Contractor’s) ......................................................................................... 48 ARTICLE 43 – Safety Violations (Contractor’s)..................................................................................... 49 ARTICLE 44 – Warning Signs.................................................................................................................. 50 ARTICLE 45 – Roof Access ...................................................................................................................... 50

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EMERGENCY TELEPHONE EXTENSIONS EMERGENCIES: Call x4911 on any site phone and then notify your Merck Project Engineer immediately. FIRES: In case of fire, use a pull box or call the Merck Fire Department, @ x4911 and give details (location, building number). Immediately evacuate the room and wait at the building entrance (outside) to offer input to the Fire Department as to fire location and type. ACCIDENT/INJURY: Merck Health Services and ambulance are available by calling x4911. All injuries, no matter to what extent, must be immediately reported to your Merck Project Engineer. A written report must be prepared during the work period of occurrence. Contractors must include and attach a copy of accident/incident report and follow up investigation reports once completed. RADIATION EMERGENCY: Call x4911. SAFETY: Contact your supervisor or Plant Security on x4234 or x4867 (Guardhouse). SAFETY/SPILL EMERGENCY: x4911 SECURITY: Emergency x4234, x4867 or x4218

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PLANT SECURITY INSPECTION: Security checks will be made on vehicles and tool cases when entering and leaving the site. PLANT ACCESS: With proper authorization, contractors enter and leave the plant site through a gate designated by Merck. SPEED LIMIT: In plant limit is 15 mph. Pedestrians have the right of way. No passing of electrical carts or bicycles. IDENTIFICATION: Contractors/subcontractors must secure an ID pass and wear it in full view at all times. For vehicles entering the site, (pass required) company name/identification must be clearly displayed. The Merck in-plant parking sticker must be installed in view as directed. CAMERA: No cameras or video recorders allowed on site except by special permission and permitting by Plant Security. Passes must be visibly displayed. ON-SITE VEHICLES & PARKING: Inside plant boundaries, a vehicle pass is required which must be approved by Plant Security. Once pass is secured, display openly. Do not block entrance ramps, truck doors, trash docks, fire hydrants or standpipe connections. Do not park over yellow-lined walkways and curbs, or in reserved spaces. Engines must be turned off and keys left in unattended vehicles (exception: diesels which must not be left unattended). Contractor vehicles on site should be kept to a minimum. Any assigned parking spaces to be issued by Merck. Citations will be issued to violators of any of the above violations. TEMPORARY FACILITITES/STORAGE TRAILERS/MOBILE OFFICES: Any temporary office or storage trailers brought on site must be approved by your Merck Project Engineer and the Stonewall Fire Chief. Applications may be obtained from the Plant Security office in Building 2 GSF. PLANT PROTECTION DEPUTY CHIEF: x4911

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EVACUATION SECTOR MAP

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EVACUATION PROCEDURES • In Case of Fire.............................................................................. Dial 4911

(Give location of fire on telephone receiver) • Medical Emergency .....................................................................Dial 4911 • Chemical Spill..............................................................................Dial 4911 • Hazardous Materials ....................................................................Dial 4911 • Police Assistance .........................................................................Dial 4867 or 4234 • Sector Signal – The Powerhouse will activate a series of air horn signals throughout

the site to notify personnel of an emergency occurring in a particular sector. A ten (10) second “alert” signal will sound first followed by the affected sector signal. This sector signal will be repeated three (3) times.

In the event of power failure, manual activation of the Powerhouse signals will occur.

• Plant-wide Evacuation – 10 Second Blast of Plant Horn followed by sector signal 1,

2, or 3 short blasts (repeated 3 times). • Shelter-In-Place – When siren activates, proceed to the nearest shelter-in-place

building designed by YELLOW shelter-in-place sign with BLACK lettering. • Building Evacuation Alarms – Local alarm activated from pull box. • All-Clear Signal – The “All-Clear Signal” of 1-Ten (10) second blast from the Site’s

horns is an indication that an emergency is under control. The All-Clear Signal is sounded on the authorization of the Site’s Incident Commander or designee in charge of the emergency.

• Each contractor must develop, with their Merck Project Engineer an evacuation

plan to include primary and secondary retreat locations. Upon evacuation, each contractor must take a written “roll call” of their employees.

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STONEWALL SITE BUILDING NUMBERS Building Factory Description

1 Powerhouse (original) 1 Powerhouse #4 Boiler 1 Powerhouse #5 & #6 Boilers, T/G

1A Utilities Office 1B Switch Gear 2 General Services

2A Regional Locker Room 3 Guard House (original) 4 Quality Administration 5 Building 5 R.O. Addition 5 Pharmaceutical Manufacturing 5 Building 5 Modernization 5 Building 5 WIP Warehouse

5A Pharmaceutical - SPL 5A Addition 5A Addition 5B Pharmaceutical - VARCO 5C Offices 5C Materials Management - Warehouse 5C Warehouse 5D Warehouse 5D Warehouse Addition 5E Warehouse - Heated Storage 5G Warehouse 11 Utilities - Well #2

11A Utilities - Compressors 12 Utilities - Well #3 13 Safety/Utilities - Well #4 14 Utilities - Wells #5, #6, #7, #8, #9 15 Utilities - Well #10 16 Utilities - Well #11 17 Utilities - Well #12 (across 340)

17A Chlorination Building 21 1/2 Production - Crixivan & Carbidopa

21A 1/2 New - Methanol chiller 21B 1 Production - Carbidopa 21C 2 Production - Crixivan 21E 2 Production Office 21F 2 Production - Crixivan 21G 2 Production - Crixivan 21H 2 Production - Crixivan 21I 2 Production - Crixivan 21J 2 Production - Montelukast 21K 2 Production - Crixivan 24 Health Services

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Building Factory Description 24 Health Services Addition 24 Laboratories, Offices 24 Office and Lab addition 40 Production - Storage 41 1 Production - Organic Synthesis

41SHED Production 41A Utilities Process Cooling - Carbidopa & Crixivan 41B Maintenance Storage 41C Field Shop #1 42C Utilities - Storage 43 1 Production - Isolation/Extraction

43A Safety (Park Rescue Squad Vehicles) 43B 1 Production - Isolation/Extraction 44 Mechanical Stores, Environmental Engineering Offices 44 Mechanical Stores Addition

44A Cold Storage - High Hazard 44B Engineering Office Modular 44D Cold Storage Warehouse 45 Maintenance Shop 45 Maintenance Shop Addition 45 Office renovation

45E Maintenance - Elect. & Inst. Shops 46 #2 Pump House - Fire Suppression 61 Locker Room

61B Utilities - Process cooling 62 Materials Management Warehouse 62 Materials Management Addition

62A Materials Management - Cold Room 62B Materials Management - Cold Room 62C Materials Management - Cold Room 62D Materials Management - Cold Room 62E Maintenance - Site Services 62F Utilities - Glycol/Sugar 63 5 Production - Fermentation 64 Safety

64A Administration - Training 65 Quality Operations Laboratories & Offices 65 Quality Operations Addition 65 Quality Operations Addition 65 Quality Operations Addition 66 Maintenance - PSV Shop

66A Maintenance - Surface Finishers 67 Maintenance Warehouse - Spare Equipment 67 Maintenance Warehouse - Addition 68 Garage 69 Guard House - New

69A Locker Room 80 4 Production - Solvent Recovery

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Building Factory Description 80A Technical Operations Lab 80A Pilot Plant 80B Maintenance - Field Shop 2 80B Maintenance - Field Shop 2 Addition 81 7 Production - Bulk Antibiotic 81 7 Warehouse 81 7 Prep Lab Addition 81 7 DCHA Area 81 7 Production - Bulk Antibiotic

81A/B 7 Production - Bulk Antibiotic 81C 7 Production - Bulk Antibiotic 81D 7 Production - Bulk Antibiotic 81E 7 Offices/Storage 81F 7 IM Milling 81G 7 Production - Bulk Antibiotic - Chiller Bldg. 82 6 Production - Isolation/Extraction 82 Isolation/Extraction now VIP area 82 Antifungal Addition 82 Biotech Lab/Offices 83 5 Production - Fermentation

83A 5 Production - Fermentation 83B 5 Production - Fermentation 83C 5 Production - Fermentation 84 5 Production - Fermentation & Laboratories

84A 5 Production - Fermentation-Radioactive Storage (Demo'd) 84B 5 Production - Ferm. 85 5 Production - Avermectin Loading Station 86 Materials Management Warehouse 87 Materials Management Warehouse - Drum Storage 88 #1 Pump House - Fire Suppression 90 Waste Treatment - Trash Incinerator

90A Waste Treatment 91 Waste Treatment - Sludge Incinerator

91A Waste Treatment - Sludge Drier 92 Waste Treatment - Laboratory 93 Waste Treatment - Odor Control Bldg. 94 Waste Treatment - Belt Filter Presses 95 Drum Wash Building 102 Utilities – Compressed Air, Process cooling 103 Utilities – Compressed Air, Process cooling 108 Old Maintenance Shop 109 Old Press Shop 110 Maintenance - Field Shop 3 110 Maintenance Addition - Field Shop 3 111 Project Engineering Warehouse 800 Waste Treatment - Pumphouse 800 Remote Control Room - Addition 801 Waste Treatment - Compressed Air

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PROCESS SAFETY MANAGEMENT The Stonewall site is regulated by the OSHA Process Safety Management (PSM) Standard (29 CFR 1910.119) due to the quantity and type of hazardous chemicals on site. Both toxic and flammable chemicals regulated under PSM are used in various areas of the site. OSHA mandates that contractors and contract employees must be made aware of the specifics of the standard as it relates to the contract work. Contractor Employer Responsibility Under PSM:

• Ensure contract employees are trained in work practices necessary to perform their job safely.

• Ensure that contract employees are instructed, through documented training, on

the known potential fire, explosion or toxic release hazards related to their job and the process, and in the applicable provisions of the emergency action plan.

• Ensure that each contract employee follow the safety rules of the site.

• Advise the employer of any unique hazards presented by the contract employer’s

work. Contact your Merck Project Engineer or the site Safety Department if you have questions about the Stonewall program and how it relates to contract work.

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GENERAL INFORMATION AND INSTRUCTIONS AFTER HOUR TELEPHONE NUMBERS: Inside the plant, call the Guardhouse @ x4234 or x4867 for Plant Security. After hours dial zero (0) for Security. ALCOHOLIC BEVERAGES/DRUGS: Not allowed on site; users will be immediately removed from the site. Contractor policy must conform with current Merck Drug/Alcohol Site Policy. CONDUCT: Maintain adult professional behavior at all times. Horseplay, fighting or gambling is not permitted. CLOTHING: Must comply with Article 6. CONNECTIONS TO PLANT UTILITITES: TEMPORARY SERVICES (electric, water, air, steam): No connection will be made without approval of your Merck Project Engineer and Plant Utility Supervisor. EQUIPMENT SHUTDOWN: Do not take Merck equipment out of service. Coordinate all shutdowns with your Merck Project Engineer prior to any equipment activity. FIRE SYSTEM: No connections to fire hydrants, hose stations or sprinklers are allowed (for fire use only). Contractors must supply their own fire extinguishers, rated at a minimum of 2A 20BC. UTILITY SHUTDOWNS: Schedule with your Merck Project Engineer (minimum two week lead time) for clearance with Utility Engineer. CONSTRUCTION SITE REVIEW: Contractors shall review with your Merck Project Engineer prior to start of work, the impact on Merck facilities and employees and on contractors’ personnel. CONTRACTOR’S MATERIAL: DELIVERIES: Contractors are responsible for knowing building number and location where materials are to be dropped. Mark shipments with contractor’s name and your Merck Project Engineer’s name and phone number. LARGE EQUIPMENT DELIVERIES: Coordinate with your Merck Project Engineer, prior to shipment for site clearance and crane operating procedures such as lift plans and road closures.

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GENERAL INFORMATION AND INSTRUCTIONS MATERIAL SHIPPING OFF-SITE: Requires External Shipping Order form and Package Pass from your Merck Project Engineer. GRASS AREA: Do not store material and equipment on grass areas. See your Merck Project Engineer for locations. Stack materials neatly and ensure tar pots have spill collectors under them. All lay down areas requires prior approval. MATERIAL: Contractors’ materials and equipment shipped to Stonewall must show contractor’s name, your Merck Project Engineer’s name and building number of destination. CONTRACTOR PERSONNEL ON SITE: Contractors shall maintain a list of all personnel working on the site. The list shall be current and be provided to your Merck Project Engineer so that the Merck Security Access list can be updated to allow their personnel through the gate. Additions and deletions to the list shall be provided to your Merck Project Engineer, in advance, so that delays at the gate are minimized. Contractor personnel not listed on the Merck Security Access System will not be allowed on the site without your Merck Project Engineer’s approval. Lack of advanced notice and prior security list approval can lead to long delays in permitted entrance and the possibility that access will be denied for that day. DINING FACILITIES: Contractors/subcontractors are permitted to use the Merck Cafeteria but are not permitted to use Merck break rooms. DRINKING WATER: Contractors shall provide drinking water. Stonewall water facilities are not to be used unless approved by your Merck Project Engineer. TOILET AND WASH FACILITIES: Contractors shall supply all toilet and wash facilities for their employees. Merck toilets and wash facilities are not to be used by contractors. Do not use Safety Shower/Eyewash for washing or drinking. MERCK INFORMATION: Contractors and all contractors’ personnel must know name and extension number of their assigned Merck Project Engineer and the building number where work is to be done. MERCK PROCEDURES: Contractors shall review, with their Merck Project Engineer prior to start of work, the Merck procedures for fire, spill, or accident reporting, as well as permit requirements, use of Health Services and emergency procedures. Contractors shall be instructed on how to contact their Merck Project Engineer. OSHA & SAFETY HEALTH REGULATIONS: Contractors must also comply with all applicable local, state and federal regulations. OZONE DEPLETING REFRIGERANTS: It is illegal to vent fluorocarbon refrigerants. Contact your Merck Project Engineer, or Site Environmental Engineering at x4818, to ensure that refrigerant is recovered. New refrigerant is non-chlorinated non-

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GENERAL INFORMATION AND INSTRUCTIONS ozone depleting and that written documentation is provided for all refrigerant used or charged into equipment. SAFE WORK PERMITS: Contractors shall obtain the following permits from their Merck Project Engineer or designate:

A. Restricted Roof Access permit – Required Daily B. Burning, Welding, and Hot Work Permits – Required Daily C. Line Breaking Permit – Required Daily D. General Work Permit – Required Daily E. Trenching and Excavation Permits – Required Daily F. Confined Space Entry Permit – Required Daily @ Each Entry G. Asbestos Permit – Required Daily H. Crane Permit – Required Daily

RIGHT TO KNOW REQUIREMENTS: Contractors must maintain, or have available, a complete set of Material Safety Data Sheets associated with the hazardous chemicals brought onto the plant-site. Where a material may have impact on a Merck employee, the contractor must provide the MSDS for this material to the Merck Project Engineer 48 hours prior to using the product (where feasible). Pertinent Merck material Safety Data Sheets will be provided to the contractor when working in hazardous areas. Additional Material Safety Data Sheets will be provided upon request from the contractor. SAFETY EVALUATION: During your work, your Merck Project Engineer will document your safety performance. If unsatisfactory, the removal of your company from the bidder’s list may occur. Individuals violating safety procedures may be removed from the site. SAFETY TRAINING/ORIENTATION: All contractors must complete mandatory contractor safety training/orientation prior to working on the Stonewall Plant site, regardless of the length of their stay. The training is valid for one year. Schedule and coordinate this through your Merck Project Engineer. Once orientation is completed, a dated hard hat sticker or card will be issued to the individual. Safety training/orientation is conducted as follows:

A. Only Merck Safety/Security Personnel are authorized to do Merck Stonewall Plant Contractor Safety Orientations.

B. Merck Safety Orientations will be given Monday through Friday at approximately 7:30 a.m. at the Merck Guardhouse. Site/job specific orientations will continue to be the responsibility of the hiring Construction Manger (CM)/Merck Project Engineer and can be done after the Merck Orientation has been completed. It will be the responsibility of the CM or Merck Project Engineer to notify, in advance, the Merck Guardhouse Safety/Security personnel that new personnel will be arriving and will need orientation. If required, additional orientations will be given on an “as needed” basis. Adequate scheduling and notification is required.

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GENERAL INFORMATION AND INSTRUCTIONS

No “on-the-spot” orientations will be given.

C. Security must be notified, in advance, of a layoff, termination or assignment completion of any individual.

D. In the event of a dismissal, a written memo is required to be sent to the Plant Protection Supervisor the day of the dismissal.

E. A roster of all personnel on site, for each contractor on site, must be sent to Merck Guardhouse Security personnel. It will be the responsibility of each CM/Merck Project Engineer, who has contractor personnel working for them, to provide this information. This will enable Security to check that all personnel are properly badged and appropriate orientations have been received.

F. Every contractor employee shall review the Contractor Safety, Environmental & GMP Handbook and keep the book with them for reference during the job.

G. Drug and Alcohol Program Compliance – Merck requires compliance to a mandatory Drug/Alcohol testing program which applies to all contractors. Specific testing and an approved ID card is required to allow Contractors access to the site. (Reference Merck Drug and Alcohol Policy; re-testing required every 12 months.)

SIGNS: All signs are posted for your safety and plant protection – OBEY THEM!!! Visible “DANGER – Construction Area” signs to be posted by contractors. SITE RESPONSIBILITY: Contractors shall be aware that when working in or near operating departments, the area supervisor and/or manager will also be involved with the project regarding impact on operations. SMOKING: Smoking is PROHIBITED on the Stonewall Plant Site within the confines of the entrance gates. Anyone found smoking will receive permanent expulsion from the plant site. TEMPORARY PLANT UTILITY CONNECTIONS: No connection will be made by Contractors without approved of their Merck Project Engineer and utility supervisor for electricity, water, air, and steam use. TRASH: Do not put trash in Merck dumpsters or other Merck trash receptacles. Contractors will provide their own trash containers, located where directed by their Merck Project Engineer. Merck 55 gallon drums are not to be used as trash receptacles. EATING: Eating is prohibited in factory areas. All food carried inside the plant must be covered. Contractors will eat in designated areas only.

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GENERAL INFORMATION AND INSTRUCTIONS

19

TRESPASSING: Contractors/subcontractors are confined to assigned work areas – no wandering is permissible. WEEKEND WORK: No weekend or holiday work will be permitted unless your Merck Project Engineer approves it. WORKING HOURS: Monday through Friday. Contractors may enter the Guardhouse Gate starting at 6:00 a.m. and must exit the site no later than 6:00 p.m. Exceptions to this require your Merck Project Engineer’s approval and notification to Security.

CONTRACTOR SAFETY REGULATIONS ARTICLE 01 – RESPONSIBILITIES:

A. Contractors have the primary responsibility for on-site safety for all their employees performing work under this agreement.

B. Contractors shall comply with all VOSH/OSHA rules and regulations, state and federal law applicable to the job, as well as all Merck safety requirements.

C. In addition to the VOSH/OSHA, state and federal regulations, each contractor shall use “good judgment" consistent with that contractor's particular trade in cases where there is no precedent case or law.

D. Contractors shall cooperate when an inspection is conducted by Merck or government agencies. Copies of all VOSH/OSHA citation notices shall be submitted to Merck immediately upon contractor's receipt.

E. Contractors are RESPONSIBLE for training personnel and instructing them on all jobs which require specific training and/or competency to meet all applicable VOSH/ OSHA, regulations, state and federal law and Merck requirements.

ARTICLE 02 – AUDITING AND REPORTING:

A. Contractors must appoint a competent safety representative(s) for each job site who will audit the job site on a daily basis, verify compliance of safety standards, and assist other contractor personnel with all safety related matters. On larger projects, a designated competent safety representative will be required.

B. Contractors will conduct weekly safety meetings with their crew members.

C. Contractors will complete, and make available to Merck, minutes from all weekly safety meetings.

D. Contractors will complete, and make available to Merck, a daily job site inspection checklist.

E. Contractors will furnish Merck with a copy of the first report of injury no later than the following day.

F. Contractors must complete and submit to Merck a Prequalification Statement prior to bidding.

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CONTRACTOR SAFETY REGULATIONS

21

G. Contractors must have a written safety and health program which complies with all rules and regulations herein. The safety and health program will include specific details of a Fire Prevention Program, Hazard Communication Program, Confined Space Entry and Fall Protection, or other programs, as needed, based on the contractors’ trade.

H. Contractors must demonstrate an effective controlled substance abuse program.

I. Contractors must implement a safety recognition program for their employees.

J. Contractors will complete, and make available to Merck, documentation of a daily Task Safety Analysis.

ARTICLE 03 – ASBESTOS:

A. Any suspect asbestos should be reported immediately to your Merck Project Engineer and/or Plant Security @ x 4820 or x5583.

B. Asbestos is to be handled only by certified contractors after appropriate governmental agency notifications have been made. This notification must be submitted by Site Environmental Engineering thirty (30) days prior to commencement of asbestos demolition/abatement.

C. Unsafe conditions due to deteriorated asbestos should be reported immediately to your Merck Project Engineer.

ARTICLE 04 – BARRICADES (CONTRACTOR SUPPLIED):

A. Barricades are required around excavations, holes, openings in floor, roof areas, edges of roofs, elevated platforms, around certain types of overhead work and wherever necessary to warn or protect people against falling in, through, or off.

B. Barricades must be suitable for the area of use (i.e., warning type barricade or protective barricade to provide physical protection from falling).

C. Barricades are to be placed around all construction sites.

D. Properly lit barricades must be provided at night.


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ARTICLE 05 – BURNING, WELDING, AND HOT WORK:

A. Contractors will request a Hot Work Permit from their Merck Project Engineer or designated representative. Permit must be followed.

B. Fire extinguisher and/or other fire protection equipment is to be provided by the contractor.

C. A trained fire watch person must be provided by the contractor for each hot work operation.

D. Two fire watches must be provided for overhead work (one above and one below; each with an extinguisher and pressurized water hose to keep floor wet) if the sparks or slag cannot be contained from falling below the overhead work area.

E. Contractors are responsible for assuring that all flammable liquid and flammable gas lines in immediate area have been drained and flushed by plant.

F. Area must be continuously maintained in safe condition during the time work is performed, inclusive of welding screens, blankets and other means to protect others from weld flash, sparks, metal particles, and other dangers.

G. Contractors must inspect the area for a continuous 60 minutes after hot work is completed. Permit must be signed off.

H. When air monitoring is required, the Lower Explosive Limit must be non-detectable prior to any type of burning, welding, or hot work by the contractor. (Air monitoring will be required around or near any areas which may pose a potential fire or explosion threat from flammable or combustible vapors.)

I. If explosive dust is present, contractors must wet down all explosive dust from visible suspension and sweep the debris away from the hot work area.

J. The Merck Representative must be notified to approve the area prior to the start of any burning, welding, or hot work which requires air monitoring and to obtain a Hot Work Permit.

K. No welding or burning is to be done in a closed vessel or tank without notifying a Merck Representative and following proper Confined Space Entry Procedure.

L. Floor slabs and wall penetrations must be checked to ensure no live voltage or other utilities are present. Use instruments of reliable technology to test for voltage. Verify with your Merck Project Engineer before starting.


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ARTICLE 06 – CLOTHING:

A. Hard hats and approved (ANSI Z87) safety glasses with side shields must be worn at all times while on the plant site.

B. Shirts, with sleeves and long pants must be worn at all times on the plant site.

C. Sleeveless shirts and tank tops are not permitted.

D. Avoid loose clothing which may get caught in machinery.

E. Protective steel-toed safety shoes are mandatory.

F. Nylon jackets or other static-generating clothing are not permitted in operating areas due to the potential for static buildup/discharge.

G. All contractor personnel are required to wear gloves while performing their work. Gloves should be visually inspected before wearing for holes, tears and other signs of wear that may reduce the degree of protection originally provided.

ARTICLE 07 – COMPRESSED GAS CYLINDERS (CONTRACTOR SUPPLIED):

A. All cylinders must be secured in an upright position at all times.

B. Oxygen and fuel gas cylinders are to be separated by at least 20 ft. when in storage and placed away from contact which may rupture the tanks.

C. Cylinders must have valve protection caps in place when in storage, or in transportation.

D. Cylinders shall be labeled as to the nature of their contents.

E. Oxygen/Acetylene cylinders in carts will be broken down, capped, and properly stored at end of the shift if they will not be used by next shift.

ARTICLE 08 – CONCRETE AND MASONRY:

A. Contractors must not place loads on any concrete structure until a determination has been made by a contractor employee who is qualified in structural design.

B. Contractors must guard all protruding reinforcing steel to eliminate the hazard of impalement.

C. Contractors must not remove any forms or shoring until a determination has been made by the contractor that the concrete has gained sufficient strength to support


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its weight and superimposed loads.

D. Contractors must establish a limited access zone whenever a masonry wall is being constructed. Masonry walls must be braced to prevent collapse and/or overturning. Barricade tape or temporary fencing must be placed around area of masonry construction to ensure safety of other craft workers and plant employees.

ARTICLE 09 – CONFINED SPACE ENTRY:

A. Contractors are to request and obtain a Confined Space Entry Permit. Permit must be followed.

B. Contractors must abide by the Merck Confined Space Entry Procedure and furnish all appropriate personnel, equipment and support. Contractors must have employees trained in confined space entry.

C. Contractor personnel are to be instructed in the use of air packs through their own training programs. Contractors are to provide the air packs and proof of training.

D. Contractors are required to provide all rescue equipment required for confined space entry. Rescue equipment required for all entries: tripod, full body harness and lifeline or equivalent. Wrist straps may be used in designated areas in replacement of full body harness.

E. Contractors are to provide appropriate number of attendants for the entry. Contractors must also ensure an effective method is in place to contact the Plant First Response Team (i.e. radios, telephones, additional stand by individuals, etc.)

F. Contractors are to provide constant air monitoring throughout entry.

G. Contractors are required to provide a ventilation blower.

H. Visual contact or two-way radio must be available at all times. Radios are to be provided by the contractor.

I. Plant Security (First Response Team) is to be contacted prior to permit issue/entry.

ARTICLE 10 – CRANES (CONTRACTOR):

A. Contractors must inform their Merck Project Engineer one (1) week before a crane is due on site.

B. A Crane Permit must be obtained and completed prior to any lift.


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C. A written lifting plan is required for all equipment and major lifts, and will include all applicable loads, maximum boom extensions, swing radius, calculations and size of crane to be used.

D. Contractors are to coordinate with their Merck Project Engineer to designate a clearing area below for lifts over occupied buildings.

E. A signal person must be provided by the contractor to assist in maintaining proper distances from overhead power lines and to monitor when lifting next to a road or walkway.

F. Safety pins must be installed in outriggers of crane if outriggers have a slot.

G. Contractors shall not lift more than one piece of steel ("Christmas Treeing") when erecting steel.

H. Rated load capacities, recommended operating speeds, special hazard warning, specific hand signal diagram, and special instructions must be visible to the operator while he is at the control station.

I. Cranes are to be operated only by qualified contractor employees.

J. Any crane brought on site will have current inspection certificate.

K. Area inclusive of swing radius is to be barricaded off during operation.

L. Road Closing - Contractors must contact their Merck Project Engineer to notify plant protection of any road closures which would block emergency vehicle access or normal traffic.

ARTICLE 11 – DEMOLITION BY CONTRACTOR:

A. Prior to start, your Merck Project Engineer is to be notified to obtain all shutdown permits and to inspect the area. The shutdown and inspection are to be mutually agreed upon in the project schedule.

B. Trash and debris must never be placed in Merck dumpsters. Contractors must provide their own containers for debris and the containers must be covered at the end of each day.

C. Demolition involving concrete floor slabs, walls, and any area with suspected power utility conduit or wiring must be checked with an instrument of reliable technology to detect the presence of electricity prior to jack hammering, drilling, or saw cutting.


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ARTICLE 12 – DUST AND FUMES:

A. All dust and fumes are to be kept to a minimum and eliminated where possible.

B. Prior to the generation of dust and/or fumes adjacent to occupied areas, contractors must notify their Merck Project Engineer to coordinate any clearances or notifications of the affected areas.

ARTICLE 13 – ELECTRICAL:

A. All temporary power panels shall have covers installed at all times and be acceptable per N.E.C. for area classification.

B. Contractors are to supply ground fault circuit interrupters or provide an assured equipment grounding program for all electrical wiring cords and equipment.

C. Temporary lights shall not be suspended by their extension cords and must be equipped with guards to prevent contact with the bulb.

D. If an approved grounding program is not used, you must provide the following program:

All contractor extension cords must be of the three-wire type. All contractor power tools must be double insulated or grounded properly. Contractors to conduct regular inspections on power tools and cords utilizing color-coded inspection tape for each month as follows:

January and July Red February and August White March and September Blue April and October Green May and November Orange June and December Yellow

*Follow-up inspections required to assure compliance.

ARTICLE 14 – EMERGENCY NUMBERS:

A. Safety/Security x4234, x4867 or x4218 (Merck Guard House) (First contact your supervisor).

B. Chemical Spill/Release x4911

C. Medical x4911


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D. Fire x4911 (Give details on location to Merck Fire Department then call your Merck Project Engineer.)

NOTE: When reporting any emergency, do not hang up the phone until told to do so by Plant Security. ARTICLE 15 – ENVIRONMENTAL POLICY: ENVIRONMENTAL COMPLIANCE: In the context of its operations, Merck is responsible for the protection of and the safety and health of its employees, the community and the environment. Protecting the environment is one of Merck’s highest business priorities. In light of this goal, Merck complies with both the spirit and the letter of all laws and regulations intended to protect the environment. As a contractor at a Merck site, it is your responsibility to protect the environment through your practices and to comply with all site rules. Following is the Stonewall Environmental Procedures for Contractors (Procedure EK 9.3), which can also be found in the Environmental Management System Procedures Manual. 1. PURPOSE

Contractors working at the Stonewall Plant are responsible for conducting their operations with the same high standards for environmental protection as site operations. Contractors are also responsible for complying with all applicable local, State and Federal regulations and Merck policies. This procedure serves to inform contractors of their responsibilities and to serve as a reference for Stonewall Environmental Compliance.

2. SCOPE This policy applies to all contractors working at the Merck & Co., Inc. Stonewall Plant.

3. PROCEDURE

3.1. Spill Reporting All spills of chemicals or hazardous substances must be immediately reported to Plant Protection by dialing x4911. Spills should be stopped, contained and cleaned up immediately with guidance from Plant Protection and/or Environmental Engineering. A spill report should be completed according to Environmental Engineering Procedure EK8.1.1, “Internal Reporting of Chemical Spills and Releases” for every spill; this is the responsibility of the Merck Project Manager/Engineer.


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3.2. Waste Disposal and Recycling

3.2.1. Definitions of Contractor debris/waste and Merck debris/waste: Contractor-generated debris/waste- debris, not previously owned by Merck, remaining from activities of the contractor. For example, this includes excess materials such as off-cuts, damaged or unwanted surplus materials, ready-mix concrete and packaging. All contractor-generated debris/waste is the responsibility of the contractor. Contractors must collect and legally dispose of their waste in accordance with all applicable State and Federal regulations. Merck construction debris/waste- includes all materials previously owned by Merck, which have been removed or demolished during construction. For example, this includes block, brick, soil, asphalt, piping, equipment and metal. The Merck Project Manager/Engineer or a Merck Environmental Engineer from the Environmental Engineering Group will determine the appropriate disposition of this material. Note: Contractors must provide their own dumpsters. Merck dumpsters are not to be used for “contractor-generated debris/waste.” 3.2.2. Rubble Materials

Rubble materials should be segregated, where practical, as follows: A. rubble- brick, block, concrete, asphalt B. clean top soil C. clean fill soil D. clean gravel (gravel that can be re-used) All construction projects should segregate materials as specified above. Rubble (brick, block, concrete, asphalt), soil, gravel and any other “Merck construction debris/waste” must be managed as determined by the Merck Project Manager/Engineer and Environmental Engineering.

3.2.3. Excess concrete

Residual ready-mix concrete, left in the chute of the concrete truck, will be placed at the job site. When set, the concrete shall be removed and disposed of as rubble by the contractor prior to completion of the job. A minimum amount of water should be used for cleaning the chute and should be placed on top and mixed with the excess concrete that has been placed at the job site. Excess ready-mix concrete remaining in the mixing drum will be back-hauled and disposed of by the concrete supplier.


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Under no circumstances may excess concrete be washed to a surface ditch, chemical sewer trench, or any other plant wastewater conveyance system.

3.2.4. Contaminated soil

An extensive investigation has been completed at the plant site to identify areas of soil contamination. These areas are identified as “Areas of Concern” (AOCs). For specific locations see map below depicting AOCs. Contaminated soil may be encountered in AOCs; appropriate measures should be taken prior to starting excavation in these areas. Contaminated soil may also be encountered outside of an AOC. Whenever contaminated soil is encountered the Environmental Engineering Department should be notified and the soil should be segregated and managed as determined by your Merck Project Manager/Engineer and Environmental Engineering.

The Contractor must segregate contaminated soil from clean soil. Grossly contaminated soil can not be used as backfill. The Merck Project Manager/Engineer will ensure that the contaminated soil is handled according to Environmental Engineering Procedure EK 7.2.1, “Soil Management Procedure.” 3.2.5. Merck equipment to be removed or demolished

Disposition of Merck-owned equipment (removed by Contractor from demolition areas) shall be determined by the Merck Project Manager/Engineer. Prior to demolition and removal by the contractor, the equipment will be cleaned-in-place, by Merck, in accordance with the Environmental Engineering Procedure EK 6.4 “Cleaning Manufacturing


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Equipment for Resale. An equipment abandonment form must also be completed by Merck using Environmental Engineering Procedure EK 6.4.1, “Equipment Abandonment Procedure.” Prior to commencing demolition, the contractor must verify with the Merck Project Manager/Engineer that the equipment has been cleaned. After demolition and removal by the contractor, the contractor will deposit the equipment in areas designated by Merck for future use, recycling, or disposal, in accordance with the following: A. Kept as spare equipment for future use, or B. Marked for sale as a surplus asset, or C. Placed in Merck scrap collection area (see 3.2.6.), or D. Special disposal by Merck due to safety or environmental reason.

3.2.6. Scrap Metal for Recycling

All Merck-owned scrap metal must be placed in the plant scrap collection area, located south of the wastewater treatment aeration basins. (Contractors can not take Merck scrap off-site.) Scrap metal shall include, but is not limited to, the following: A. Copper- All copper scrap must be placed in the skip labeled for copper

scrap and copper wire and segregated from other scrap materials. B. PVC coated electrical conduit, which has had the electrical wire and

cable removed. C. Copper wire (insulated and bare). All wire must be placed in the skip

labeled for copper scrap and wire and segregated from other scrap materials.

D. Electric motors (capacitors must be removed). E. Unlined-tanks, equipment and unlined-piping that have undergone

documented clean-outs and have had the insulation removed. Tanks greater than 6’ in diameter should be cut in half. All other tanks must have an opening in both ends, at least 24” in diameter, cut by the Contractor, to allow for inspection.

F. Glass-lined tanks and other glass-lined equipment that have undergone documented clean-outs and have had the insulation removed. Tanks greater than 6’ in diameter should be cut in half. All other tanks must have an opening in both ends, at least 24” in diameter, cut by the Contractor, to allow for inspection.

G. Tanks lined with other materials, including rubber lined tanks, must be evaluated on a case-by-case basis with the scrap dealer. Tanks greater than 6’ in diameter should be cut in half. All other tanks must have an opening in both ends, at least 24” in diameter, cut by the Contractor, to allow for inspection and have had the insulation removed.

H. HVAC and refrigeration equipment that has had the coolants and oils removed. Merck personnel must drain the oil and coolant and place a


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certification sticker on the equipment prior to placement in the scrap metal collection area.

I. HVAC ductwork, that has had the insulation removed. J. Structural steel, hand rails, metal stairs, metal doors (glass must be

removed) and metal windows (glass must be removed). K. Ductile pipe with concrete lining L. Materials painted with lead paint. M. Teflon and Polypropylene lined pipe, that has had the insulation

removed N. Light fixtures that have had the ballast and capacitors removed O. Aerosol cans that have been punctured and drained appropriately.

Materials that are not suitable for scrap include: A. Ballast and capacitors B. Trash (e.g. barricade tape, insulation which has been stripped from

scrap metal, etc.) C. Aerosol cans which have not been punctured and drained. D. Empty paint or tar containers, or other containers that held

construction materials. Proper disposal of these materials is the responsibility of the contractor. These items can not be placed in Merck dumpsters.

If not suitable for scrap, the items listed below should be handled as follows: • After a documented cleaning (see procedure EK 6.4 and EK 6.4.1)

completed by Merck, tanks lined with rubber and other materials should be cut by the Contractor into pieces no larger than 2’ x 3’ and disposed of under the direction of the Merck Project Manager/Engineer and Environmental Engineering.

• Non-metallic ductwork must be disposed of under the direction of Merck Project Manager/Engineer and Environmental Engineering.

Container loading guidelines: • All scrap metal must be placed in the designated roll-off or skip. It is

the responsibility of the contractor to pick-up any scrap which falls on the ground when dumping and place it in the roll-off or skip.

• Wire must be separated and placed in the designated skip for copper scrap and wire at the scrap area.

• In general scrap should be cut down to less than 7’ in length and placed in scrap metal collection skips around the site. The scrap should be cut down to a size that will fit inside of the collection skip and not hang out over the side.

• Large pieces of scrap not to exceed 7’ x 4’ x 40’ in size, can be placed (not dropped) directly into the roll-off from the lower side.

• Scrap must not extend beyond the sides of the scrap roll-off. • Scrap can not be more than 4’ above the top of the roll-off.


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• To prevent loss in transit, light scrap material should not be placed above the top of the roll-off.

3.2.7. Other Materials for Disposal

A. All asbestos materials must be placed directly in the locked asbestos roll-off, which is located east of the Wastewater Treatment Plant aeration basins. Arrangements for placing asbestos in the roll-off should be made with the Merck maintenance personnel responsible for coordinating asbestos abatement activities for the site. No temporary storage of asbestos materials outside of this roll-off is allowed. Merck is responsible for the disposal of all asbestos materials.

B. In the event that piping or equipment, to be removed from a building, is determined by Merck to be hazardous due to contaminants, the contaminated piping and equipment must be segregated from uncontaminated material by the Contractor during removal, as directed by the Merck Project Manager/Engineer. Disposal will be the responsibility of Merck and will be coordinated by the Merck Project Manager/Engineer.

C. In the event that piping or equipment, to be removed from a building, is determined by Merck to be contaminated with radioactive scale due to prolonged use, the contaminated piping and equipment must be segregated from uncontaminated material by the Contractor during removal, as directed by the Merck Project Engineer. Disposal will be the responsibility of Merck and will be coordinated by the Merck Project Engineer.

D. Paint and Empty Paint Containers- Excess paints and solvents that are hazardous waste should be placed in the Paint Collection Drum, located south of building 45B. Contact the M&I supervisor to obtain the key to this locked drum. Disposal of paint containers that have been completely emptied is the responsibility of the contractor. These containers must not be placed in Merck dumpsters.

E. Sandblast grit (i.e., Black Beauty) must be used and managed in a manner that prevents spills to the ground. The presence of sandblast grit on the ground is considered a spill and must be cleaned up appropriately. Unused sandblast grit may be disposed in the contractor dumpster. Disposal of used sandblast grit must be reviewed with Environmental Engineering.

F. Construction documents which contain confidential, proprietary, or sensitive Merck information are considered “Merck construction debris/waste” and must be shredded prior to recycling or disposal.


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These documents may be shredded using an office shredder, or may be placed in collection boxes throughout the site. Construction documents which do not contain confidential, proprietary, or sensitive Merck information are considered “Contractor-generated debris/waste” and disposal is the responsibility of the contractor (see Section 3.2.1.).

3.3 Stormwater Pollution Prevention & Merck Chemical Sewers Nothing may be sewered to the chemical sewer, the sanitary sewer, the cooling water return line, or the surface ditch by a contractor, without permission from the wastewater treatment superintendent. All contractors are responsible for completing work in accordance with the site’s Stormwater Pollution Prevention Plan. A copy of the plan may be obtained from the Environmental Engineering Department. Contractors must also comply with the Virginia Department of Conservation and Recreation Erosion and Sediment Control policies and practices. Questions pertaining to the County Sediment and Erosion Control practices and permits should be addressed to the Site Maintenance Manager. Silt fences, straw bales, or other measures must be taken, when necessary, to prevent solids, construction debris, or construction materials (i.e. black beauty, sand, dirt) from entering the surface ditch system. Excess solids in the surface ditch can lead to a permit violation for the plant. Fuel tanks (stationary and portable), and cans and containers holding hazardous materials must have adequate secondary containment to prevent any spills to the ground, surface ditch or chemical sewer trench. Secondary containment may be a concrete pad or dike or metal or plastic casket or tray or a drip pan. Areas indoors with impermeable flooring may also be considered secondary containment provided inlets to the chemical, sanitary and storm sewers are protected. It is the contractor's responsibility to periodically inspect the secondary containment and to empty any uncontaminated accumulated rainwater, ice, or snow. The presence of any contaminated rainwater, ice or snow or evidence of a spill or leak must be reported immediately. The Environmental Engineering Department will advise the contractor on the proper storage and disposal of the contaminated water. Whenever possible, materials should be stored under cover to prevent contamination of storm water run-off. Machinery should be operated to prevent releases to the environment. All hydraulic equipment should be inspected before use and cutting machines must have catch pans to contain all cutting oil. Should a spill of cutting oil or hydraulic oil occur, it should be reported to Plant Security at x4911 and cleaned up immediately. A spill report should be completed according to Environmental


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Engineering Procedure EK 8.1.1, “Internal Reporting of Chemical Spills and Releases” for every spill; this is the responsibility of the Merck Project Manager/Engineer.

3.4 Storage and Handling of materials brought on-site Use of hazardous materials/chemicals must be reviewed and approved by your Merck Project Engineer, Site Safety Department and Environmental Engineering prior to initiating the project. These materials include but are not limited to, petroleum products stored on-site (i.e. diesel fuel, gasoline, kerosene, lubricants, cutting oils), solvents, paint thinners/reducers, paint removers, coatings/sealing agents, acids, bases, corrosive agents and coolants such as ethylene glycol. Ozone depleting compounds and PCB containing materials are not permitted on the plant site without prior approval from your Merck Project Manager/Engineer and Environmental Engineering. The plant reserves the right to request the contractor to provide alternatives to products that pose a safety or environmental risk. Storage of petroleum products (diesel fuel, gasoline, kerosene, lubricants, cutting oils etc.)- Special Federal and State regulations govern the storage of petroleum products. If a petroleum product is to be stored on-site in a tank with a capacity of 660 gallons or greater, Environmental Engineering must be notified prior to bringing the tank on-site. Tanks, drums, and containers of petroleum products that have a capacity of less than 660 gallons should be labeled with the date that the container was brought on-site and used for petroleum products. If petroleum products will be stored on-site for more than 6 months Environmental Engineering must be notified. Contractors must verify acceptable storage methods (such as secondary containment) and locations with the site Environmental Engineering Department or with the Merck Project Manager/Engineer. All drums, tanks, buckets or other containers must be labeled with their contents. Containers holding chemicals should be routinely inspected by the contractor so leaks can be promptly found, reported, and corrected. Only drums/containers in good condition should be used for material storage. Drums must not be overfilled; 2” of headspace should be left. No drums may be stored upside down. Fiber drums must be protected from the elements. All re-used drums must be triple rinsed, marked as “triple rinsed” and have all other labels removed or spray painted over. The drum must then be labeled indicating the new contents.

3.5 Training All contractors receive a site orientation which includes safety and environmental


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training prior to performing any work on the site. Annual training is required thereafter for all contractors who continue to work on-site or return to work on-site. Plant Protection personnel offer the training every day Monday to Friday. Contractors must be made aware of this procedure during the training. In addition, this procedure is reviewed during the pre-construction meeting defined in Safety Procedure #7.

3.6 Inspections A daily “Job Site Safety and Environmental Inspection Checklist” of the work site is to be completed in accordance with Safety Procedure #7, Attachment IV. This inspection includes essential environmental items and serves as a daily environmental inspection of the job site. “Peer Environmental Inspections” will be completed in conjunction with “Peer Safety Audits.” These inspections will be scheduled and completed by Central Engineering using the attached “Contractor Environmental Inspection” form. Site Engineering will also complete Environmental Inspections on projects they deem appropriate. Copies of the inspections are to be submitted to Environmental Engineering with a summary of deficiencies to be corrected and completion dates for these items. The inspections will be filed by the EE Administrative Assistant and kept for one year after completion of the inspection. Environmental Engineering will verify that follow-up has been completed on any outstanding items. A Quarterly Contractor Environmental Inspection may be completed by Environmental Engineering Department. The Environmental Department will include Central Engineering and Site Engineering personnel as appropriate when conducting this inspection. The inspection will be plant-wide with particular focus on the contractor area north of the plant and other areas set-up by contractors for fabrication and/or storage of materials that are removed from the actual work site (i.e. lay down areas, fabrication shops, etc.). The attached “Contractor Environmental Inspection” form will be completed and action items will be followed-up during the next quarterly inspection.

4. RESPONSIBILITIES

The Environmental Engineering Manager is responsible for ensuring that this procedure is kept current and communicated to plant personnel and contractors. The Environmental Manager is also responsible for ensuring the procedure is followed through regular inspections. These responsibilities may be delegated to other plant personnel as appropriate. Central Engineering and Facilities Engineering Project Managers, Engineers and their Representatives are responsible for conducting environmental inspections, correcting deficiencies identified during inspections and ensuring that their contractors


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have received the training and conduct their operations according to plant procedure and all applicable local, state and federal regulations. These project managers, engineers and their representatives are responsible for reviewing this procedure with the contractors during the pre-construction meeting defined in Safety Procedure #7. Plant Protection Personnel are responsible for providing safety and environmental training to all contractors annually. Information contained in this procedure must be included in the training. Contractors are responsible for complying with the procedure, all other Merck policies and guidance and with all applicable local, State and Federal regulations.

EXCAVATION PROCEDURES: 1. Approval Process:

Any time there will be any sub-surface work performed, the approach for the given task will be discussed and agreed upon with the: A. Merck Project Engineer/Manger B. Merck Plant Coordinating Supervisor C. Environmental Engineering Representative During the Project/Task Approach discussion, if underground and/or above ground utilities are known to exist in the area that is going to be excavated, or if the excavation is within a RCRA AOC, at minimum, the following topics will be discussed: A. Establish horizontal location and routing of pipe(s), utilities, and/or structures.

B. Depth of pipe(s), utilities, and/or structures that are in the area.

C. Materials of construction of utility and use of the utility (i.e., gravity, pressure,

voltage) and type of connections and pipe joints.

D. Utility shut-off locations:

1. Are they accessible? 2. Identify person responsible to shut-off utility if necessary.

E. Definition of limits of excavation (depth and real extent) beyond which permit

modification is required to proceed.

F. Clearly understand sensitivity of pipe, utility, or structure, and plan excavation with appropriate controls, staffing, equipment, supervision, contingencies, and


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standard of care commensurate with the important of the adjacent pipe, utility, or structure.

G. Review and incorporate health and safety plan provisions relative to excavation

activities.

H. Review of known contaminants in the AOC. 2. Permit/Clearance:

A. Permit: Upon agreement with the responsible parties on the project/task approach, an Excavation Permit, Hot Work Permit, and any other permit that is required and necessary must be obtained for the specific task to be performed. The permit must be obtained from your Merck Project Engineer and the approach and specific location of where the project is to be performed will be explained to the Contractor Supervisor.

B. Clearance: In conjunction with the permit, a utilities clearance must be obtained from the Facilities Engineering Department. Clearance must be obtained prior to the time excavation is to commence. The Stonewall Project Liaison will maintain the list of approved excavations. The Facilities Engineering Department will perform the underground utilities clearance and discuss the findings with the Contractor Supervisor. The representative and the Contractor Supervisor will sign the completed utilities clearance form.

ARTICLE 16 – EQUIPMENT (CONTRACTOR’S):

A. Contractor’s equipment brought onto the plant site must be in proper and safe working condition and must be routinely inspected for defects.

B. All mobile equipment such as fork lifts, high reach scissor lifts, cranes, and bucket trucks must have a written inspection checklist filled out daily, prior to operation.

C. Any equipment found to be defective must be removed and repaired before it can be used again.

D. Never lift pipe/steel with a man lift unless lift is supplied with manufacturer’s lifting brackets and material is within lifting capacity.

E. Equipment Modifications Requests (EMR’s) must be submitted to the system owner for any PHP equipment that is to be modified. This must be approved, in


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writing, by the manufacturer and owner prior to any modification.

F. Equipment is not to be used with loads which exceed the recommended rated capacity.

G. Contractors are to use “only” their equipment and not Merck’s.

H. Contractors are to use equipment and tools for their designated purpose.

I. Area around operating equipment such as articulating lifts and cranes are to be roped off to prevent access.

ARTICLE 17 – EVALUATIONS:

A. During the period of the project, routine audits will be performed by the Merck Safety & Industrial Hygiene Department and your Merck Project Engineer.

B. Audit reports, accident records, and contacts will be maintained on file to assist your Merck Project Engineer in reviewing contractor safety performance.

ARTICLE 18 – EXCAVATIONS:

A. Excavation permits are required prior to any excavating.

B. Contractors must notify their Merck Project Engineer, who must submit a Soil Management form to the Stonewall Environmental Engineering Department prior to any excavating. An approved Soil Management Form is required before excavating may begin. All OSHA standards, 29 CFR Parts 1926-650 through 1926.652, will be strictly adhered to.

C. Determine if soil is suspect hazardous prior to excavation. If soil is found to be hazardous, follow Standard 29 CFR 1918.120, also Merck Central Engineering Procedure 8.5 Health & Safety Plan for Hazardous Site.

D. The Project Engineer will be involved in determining overhead and known underground utilities.

E. Contractors’ material for bracing and shoring must be in good condition and of proper dimensions.

F. Excavation to be reviewed each day by a "competent" contractor individual.

G. Contractors must assess soil conditions to determine type of bracing or sloping required for the excavation (i.e., Type A, B, C).


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H. Excavated soil banks are to be retained at least two (2) feet from the edge of the excavation.

I. Instruments of reliable technology must be used prior to excavations to test for the presence of wiring, pipes, and energized electrical cables.

J. Contractors are to provide barricades to protect people from falling into the trench. Lighted barricades must be provided at night.

K. Ladders are to be provided by contractor for access and spaced within twenty-five (25) feet of any worker inside the excavation.

L. Walkways are to be provided over any part of the excavation where employees need to cross. Walkway must have handrails, midrails, and toeboards.

M. Testing of atmosphere must be performed by contractor prior to entry if there is a possibility that hazardous atmospheres exist.

N. Rescue equipment must be provided by contractors prior to being made safe (i.e., full body harness and lifeline, breathing apparatus, basket stretcher) when hazardous atmospheric conditions exist.

ARTICLE 19 – FALL PROTECTION:

A. All work performed six (6) feet or more in elevation or within six (6) feet of an unprotected floor opening, wall opening, or roof edge with a potential six (6) foot fall, requires optimum fall protection (6 feet is calculated from feet to ground level).

B. Approved techniques for providing optimum fall protection include: 1. A properly manufactured/constructed, erected, and secured ladder. When

necessary, tie-offs while on ladders must be completed.

2. A properly manufactured and erected scaffold with complete handrail system (top rail, midrail, toeboards).

3. A properly inspected and operated mobile bucket or scissors lift. When using aerial lifts the elevated workers must work within the confines of the bucket or platform and be tied off to the bucket or platform using a full body harness. Lifts which operate vertically only (i.e. scissors lifts, one person vertical lifts) still require the worker to stay within the confines of the railing, however, tying off to the lift should not be performed unless an engineered approved anchorage point has been provided by the manufacture.


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4. Monthly inspections are required on all fall protection equipment. Once a piece of equipment has been inspected and deemed safe. It is recommended to tag with inspection tape of the following colors:

January and July Red February and August White March and September Blue April and October Green May and November Orange June and December Yellow

5. Guarding all openings along roof edges, building edges, and floor openings

with guard rails, barricades, and/or covers.

6. Other pre-approved methods designed by a registered Professional Engineer (i.e., netting systems, cabling systems)

C. When using the body harness method of fall protection, the contractor employee must, at all times, be tied off by at least one (1) connection between his/her body harness and a secured building structural member or other fall protection device. The tie-off or fall protection device must be of adequate strength to support the fall of that particular worker. Connection points should be designed ahead of time in the design phase of the project work.

D. Employees who are working to provide initial guarding or assembly/disassembly of scaffolds of work platforms and tie-off points may find themselves in potentially unprotected situations for some period of time. Every effort must be made to provide Optimum Fall Protection to these individuals.

E. For unanticipated requirements which occur as the work progresses, the method to be employed for Optimum Fall Protection must be presented in writing, reviewed, and approved by your Merck Project Engineer prior to the commencement of work.

ARTICLE 20 – FIRE PROTECTION EQUIPMENT (MERCK’S):

A. Use of Merck fire protection equipment (including fire hoses and hydrants) is prohibited, except in the case of an emergency.

B. Any accidental damage to Merck fire equipment must be reported to the Guard House immediately at x4234, x4867 or x4218.

C. Merck fire equipment must be accessible at all times. Contractors cannot limit access to such equipment.


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D. Smoke detectors need to be bagged by contractors during any dust-creating work to prevent damage. Contractors must inform their Merck Project Engineer that bagging of detectors is required. Bags must be removed from detectors at the end of each working shift by contractors.

E. Any work on fire systems requires approval by Plant Security and the Merck safety department.

ARTICLE 21 – FLAMMABLES AND COMBUSTIBLES:

A. All contractor-supplied flammable liquids are to be stored in Factory Mutual approved safety cans no larger than five (5) gallons in size.

B. Contractors are required to supply extinguisher, hose, and/or other sufficient fire protection devices for the immediate work area where flammable and combustible material is stored (all extinguishers must be provided by contractors and rated at a minimum of 2A 20BC).

C. For roof work, at least two (2) extinguishers must be provided if flammables are present.

D. No more than twenty-five (25) gallons are to be stored inside buildings without an approved storage cabinet.

E. All outside storage areas must be at least twenty (20) feet from any building.

F. For roof work, no more than a one-day supply of flammables may be placed on the roof during working hours. All flammables should then be removed from the roof, by contractors, at the end of each day.

G. All contractor-supplied flammable and combustible material must be kept away from steam lines, sparks, radiators, heaters, and any other heat source.

ARTICLE 22 – HAZARD COMMUNICATION:

A. Contractors must provide Merck with an MSDS before any hazardous substance is brought onto the plant site.

B. Your Merck Project Engineer will provide an MSDS on any Merck supplied hazardous substance on or near the job site.

C. Separate training must be arranged through your Merck Project Engineer if work will be done near radioactive material.


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D. All liquid containers brought onto the plant site must be properly labeled identifying their contents.

E. The Hazard Communication Checklist must be completed by contractors and their Merck Project Engineer.

F. All spills/releases must be reported to your Merck Project Engineer and Plant Security by calling x4911.

ARTICLE 23 – HAZARDOUS WASTE:

A. Contractors must not remove any hazardous waste. See your Merck Project Engineer for proper procedure.

ARTICLE 24 – HEATERS (CONTRACTOR PORTABLE):

A. All contractor heaters brought onto the site must be Factory Mutual and/or Underwriters Laboratory approved and meet the specific requirements deemed.

B. Contractors must notify their Merck Project Engineer to review and approve all liquid/gas-fueled contractor heaters brought onto the site prior to use. The use of liquid/gas-fueled contractor heaters inside buildings requires the approval of Merck Safety and the Industrial Hygiene Department prior to use.

C. Contractors must request and obtain a Hot Work Permit from their Merck Project Engineer. Permit procedures must be followed.

ARTICLE 25 – HOUSEKEEPING BY CONTRACTORS:

A. All construction materials are to be stored in an orderly manner. If materials are stored adjacent to plant operations, barricade tape must be used around storage area.

B. Keep all exits and access ways unobstructed.

C. Remove all scrap and trash from the job site daily.

D. No contractor debris is to be thrown into the Merck trash bins/dumpsters.

E. Approved metal containers with self-closing covers must be provided for disposal of oily and paint soaked rags.

F. Gang boxes are to be removed immediately from mechanical workspaces upon completion of projects.

G. All threading and cutting machines are to have drip pan containment.


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ARTICLE 26 – INCIDENT REPORTING BY CONTRACTOR:

A. Report all injuries, fires, and spills to your Merck Project Engineer. Include all factual details of any incidents.

B. Contractors are responsible for supplying labor and material required to remedy the incident.

ARTICLE 27 – LADDERS (CONTRACTOR’S):

A. Straight and extension ladders must be tied off or secured to prevent displacement.

B. Metal ladders must not be used for electric welding, or used near any electric lines or services.

C. No ladder is to be painted.

D. No more than one employee is allowed onto a ladder at one time.

E. Ladders are not to be used for skids, braces, workbenches, or any other purpose other than climbing.

F. All straight and extension ladders must be equipped with non-skid safety feet.

G. Ladders must extend no less than thirty-six (36) inches above the landing.

H. Contractors, at no time, are to use Merck ladders or related equipment. ARTICLE 28 – LINE BREAKING PROCEDURES:

A. Contractors must obtain a Line Breaking Permit from their Merck Project Engineer.

B. Permit must be followed any time a line is opened that contains, or has contained, hazardous or pressurized material (i.e., corrosive, biologically active, flammable liquids, various gases, hot materials such as steam).


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ARTICLE 29 – LIQUIDS (CORROSIVE ACIDS AND CAUSTICS):

A. Do not store, handle, apply, or use acids or caustics until a proper procedure has been established. Coordinate this with your Merck Project Engineer.

B. Always wear proper and required P.P.E. (i.e., face shield, gloves, apron) when working with corrosives.

C. Never add water to acid - if dilution is needed add acid to water.

D. A standby person is to be provided by contractors, and emergency water must be immediately available, to any person working with acids and caustics.

E. Do not flush chemicals into drains/sewers without the permission of your Merck Project Engineer.

ARTICLE 30 – LOCKOUT AND TAGOUT:

A. Contractors are to follow Stonewall Lockout/Tagout Procedure and have formal lockout/tagout training. Contractors must affix their lock/tag along with Merck Representative’s lock (contractor employees involved with lockout/tagout must receive formal lockout/tagout training prior to beginning any work relating to such activities).

B. The Merck representative must initiate any lockout and tagout.

C. Lock must be removed at the end of the job with the approval of the originator.

D. Never lock and tag a device unless specifically instructed to do so by your Merck Project Engineer.

E. Never remove another person's tag or lock to operate a switch, valve, or device. ARTICLE 31 – OVERHEAD AND UNDERGROUND UTILITIES:

A. The Merck Project Engineer will identify all overhead and known underground utilities prior to the start of any work.

B. Proper distances must be maintained from all overhead power lines with the use of a signal person.

C. If safe distances near overhead power lines cannot be maintained and an electrical shutdown cannot be performed, then contractors will have to submit a written procedure to their Merck Project Engineer on how they plan to perform the work. This procedure must be reviewed and approved by the Merck Safety and Industrial Hygiene Department.


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ARTICLE 32 – PERSONAL PROTECTIVE EQUIPMENT:

A. All personal protective equipment must be supplied by contractors.

B. Safety glasses (ANSI Z87) with permanently affixed side shields, hard hats and steel-toed safety shoes are required at all times on the job site.

C. Mandatory wearing of the correct goggles or face shield is required when grinding, chipping metal, breaking concrete, pouring corrosive materials, breaking lines that may contain dangerous materials, and in general, whenever the eyes are in danger.

D. Respiratory, hearing, face, skin, eye and hand protection are required for any applicable areas on the job site. Check with your Merck Project Engineer for these specific requirements.

E. Fall protection is required when working on sloping roofs, roof edges, any suspended platform or stage, and generally any elevated work area that has been deemed by your Merck Project Engineer to require fall protection.

F. The only type of body-restraint system allowed to be used will be a full body harness used with a lifeline and lanyard. Safety belts will not be permitted under any circumstances.

ARTICLE 33 – RADIATION/RADIOACTIVE MATERIALS:

A. Be aware of the radiation signs which are posted on the doors of laboratories where radioactive material is used or stored.

B. Refrigerators and equipment in which radioactive material is used or stored are also labeled with the radioactive warning sign. Protective clothing (i.e., disposable gloves, lab coats) should be worn to minimize the potential for skin contamination when working with equipment labeled with the radioactive material warning sign. Plant Security should be contacted if there is a question concerning training or radiological conditions in a laboratory.

C. If contractors remove a radiation source from a piece of equipment or a radiation-producing machine from the site, a copy of the disposal record must be forwarded to Plant Security/Radiation Control Officer must be notified by telephone that the source or machine has been removed.

D. Naturally Occurring Radioactive Material (NORM): Follow site Line Breaking Procedures.


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ARTICLE 34 – RIGGING EQUIPMENT (CONTRACTOR’S):

A. Never rig from a structural member until a determination has been made, by you, that it will support the load being raised.

B. All chain hoists, ropes, hooks, shackles, and beam clamps must be inspected visually before use. Ensure that the capacity is marked on the equipment.

C. Do not leave an unattended and unsecured load hanging on a hoist. ARTICLE 35 – SANITATION:

A. Contractors must provide, in a clean and sanitary condition, all potable water for drinking and washing, adequate toilets, approved containers for disposal of garbage, and any necessary insect control.

B. If hand wash facilities are required, they must be maintained in a clean and sanitary condition.

C. Sewering of waste to the sanitary sewer system - The Merck Project Engineer should be contacted prior to sewering any waste to determine compliance. DO NOT SEWER: any organic solvents or chemical reagents, corrosives, ignitables, reactives, biological materials, radioactive wastes, paints and thinners, grease, mud, sand, non-biological cutting oil, varnishes, metal shavings, mineral oil, gasoline, tar, garbage, petroleum products, glues and adhesives, wood, glass, plastics, rags, waste paper, asphalt residues, or other solid or viscous substances capable of causing obstructions.

ARTICLE 36 – SCAFFOLDS (CONTRACTOR’S):

A. Always use ladders for access - never climb bracing.

B. Handrails, midrails, and toeboards are required.

C. Lock wheels before using.

D. All connections, including casters on rolling scaffolds, shall be pinned.

E. Scaffold is to be secured to the building or structure.

F. Contractors are to determine safe working load of platform.

G. Scaffolds to be erected level on a firm base. No unstable objects (i.e., wooden blocks, concrete blocks) shall be used to support scaffolds or planks. Suspended scaffolds must have adequate anchorage points (full body harness and lifeline must be attached to a separate anchorage point prior to stepping out onto


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any suspended scaffold).

H. Scaffold planks must be laid tight and secured to prevent movement. Planks must overlap between six (6) and twelve (12) inches over the scaffold end supports.

I. Contractors are to appoint a “qualified” individual to perform daily scaffold inspections.

ARTICLE 37 – SITE ORIENTATION FOR CONTRACTORS:

A. Every contractor employee will be required to attend the Merck Safety Orientation prior to entry onto the plant site. Safety orientations must be renewed annually.

B. Every contractor employee shall review the Handbook "Site Information, Regulations and Safety Program for Contractors," and keep the book with them for reference during the job.

C. Drug and Alcohol Program Compliance - Merck requires compliance to a mandatory drug/alcohol testing program which applies to all contractors. Specific testing and an approved ID card is required to allow Contractors access to the site.

ARTICLE 38 – SMOKING POLICY:

A. Smoking is prohibited on the plant site. Violators will be immediately dismissed from the site.

ARTICLE 39 – SOIL MANAGEMENT:

A. The Merck Project Engineer is responsible for completing and obtaining approval of a Soil Management Form, prior to excavating, to determine appropriate soil handling.

ARTICLE 40 – STRUCTURE LOADING:

A. Contractors shall not load structures with weight that will exceed its limits.

B. Contractors must check with their Merck Project Engineer for all load ratings.

C. Contractors must know the capacities of their equipment and weights of load. ARTICLE 41 – TAR AND MELTING POTS:

A. Contractors are to request and obtain a Hot Work Permit from their Merck Project Engineer. Permit must be followed.


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B. Any melting chamber is to be vented.

C. No melting pots are to be used on roof surfaces. All melting pots must be on the ground outside and at least twenty-five (25) feet from any building with containment for spills.

D. Barricades are to be provided when hot liquids are present overhead, on a roof or upper floor.

E. Asphalt saturated roofing mops must be removed from the building prior to completion and safely discarded by contractors.

F. A contractor-supplied fire watch, with an approved fire extinguisher, must stay with the melting pot until it completely cools. A second fire watch, with two approved fire extinguishers, will be needed on the roof if the melted material is transported to roof surfaces.

ARTICLE 42 – VEHICLE SAFETY (CONTRACTOR’S):

A. On-site contractor vehicles must be approved prior to being allowed on site. A vehicle request form must be filled out and submitted to Plant Security for approval.

B. All passengers in motor vehicles must be seated and within the confines of the vehicle.

C. The speed limit inside the plant is 15 mph.

D. All vehicles must be shut off when unoccupied and the keys must be left in them (except diesels, which must not be left unattended).

E. All pedestrians have the right of way on plant site.

F. Parking shall be in specified areas only. Do not block entrance ramps, trash docks, truck doors, park over yellow lined walkways and curbs, and do not park in reserved spaces.

G. No internal combustion vehicle or machinery is to be operated inside buildings unless proper engineering controls have been implemented to minimize carbon monoxide levels.

H. Observe all plant traffic signs.

I. Contractors are responsible for the stability of any material being hauled.


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J. All mobile equipment on site must have an audible backup alarm.

K. Seat belts must be used in all vehicles used to transport personnel, including electric carts.

L. All electric powered vehicles must conform to Merck specifications and requirements (i.e., rear view mirrors).

M. All bicycles used by contractors must receive regular inspections for safe operation and be registered with Plant Security. Bicycles are to be used for transportation only and not hauling of material.

ARTICLE 43 – SAFETY VIOLATIONS (CONTRACTOR’S):

A. The Merck Project Engineer has the right and contractors the responsibility, to observe and stop work until safety violations are corrected.

B. An initial violation will result in a written notification to contractors’ supervisory personnel.

C. Notice of a second violation will be transmitted in writing by the Merck Project Engineer to contractors. Upon receipt of such notice, Contractors must respond in writing within seven (7) days, to owner’s representative advising what corrective action has been taken.

D. A third violation will result in Merck requiring that the contractor’s employee be expelled from the project and the plant site for a minimum of thirty (30) days, with possible permanent expulsion depending on the seriousness of violation.

E. Major violations, and violations that are life or limb threatening, will result in an immediate minimum thirty (30) day dismissal from plant site, with a possible permanent expulsion, depending on the severity of the violation.

F. If a subcontractor employee commits a violation, Contractors shall be required to notify the subcontractor in accordance with the procedures outlined above.

G. The above stepwise procedure can be accelerated and/or expanded to include removal of a contractor’s, or subcontractor’s, entire work force where violation of safety regulations are widespread, the nature of the violation(s) expose other workers and facilities to imminent danger, or the contractor’s supervisors are uncooperative in correcting the violations.

H. The project superintendent/supervisor will be held accountable for the project area safety compliance.


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I. Uncooperative contractors will also be removed from Company bid lists.

J. Contractors shall maintain and document all communications relative to employee violations and shall transmit copies of all such correspondence to owner’s representative.

K. Contractor and subcontractor management, supervisors, and hourly personnel shall be familiar with owner’s Stonewall Safety Procedure No. 7, “Contractor Safety,” and with MERCK’s DRUG/ALCOHOL USE POLICY.

ARTICLE 44 – WARNING SIGNS:

A. Obey all warning signs (i.e., Biohazard, Radioactive)

B. All contractor - installed warning signs, signals, and barricades must be removed when the hazard no longer exists.

ARTICLE 45 – ROOF ACCESS:

A. A Roof Access Permit must be obtained prior to entry on any restricted roof

B. Roofs will be identified by signs which will indicate restriction.

GMP POLICY Merck depends on you to design, develop and construct the facilities and our processes so that we can produce our products. You are working here because of your high quality of work. While you have a tremendous positive impact on our business, there may be times you could have a negative effect on what we do. Whether you are an electrician, pipe fitter, equipment operator, office worker, safety inspector, or an insulator, your activities do affect what we do here. A. Code of Federal Regulations

1. Merck is in the business of manufacturing pharmaceuticals or ethical drugs, and

because of that, is regulated by the FDA, the Food & Drug Administration. These regulations are known as the Good Manufacturing Practice (or GMP) and are law. The GMP regulations are found in Title 21 of the Code of Federal Regulations (CFR). The CFR lists how we must operate in order to manufacture our drugs. There are five key points to these regulations:

a. safety b. identity c. strength d. quality, and e. purity

2. These regulations contain sections that deal specifically with contractors and

construction activities. When Merck engineers design our facilities, they must consider what is stated in the CFR. When project engineers monitor your work, they also must consider what is stated in the CFR. Likewise, when you are operating or working at our facility, you must consider what is stated in the CFR that applies to you.

3. Specifically, 21 CFR 211, Subpart C explains the areas of design, construction, lighting, ventilation, air filtration, air heating and cooling, plumbing, sewage and refuse, washing and toilet facilities, sanitation, and maintenance.

4. In addition to the design and construction of our buildings, the CFR also regulates the types of equipment we use. 21 CFR 211, Subpart D covers equipment design, size and location, equipment construction; equipment cleaning and maintenance.

5. These Subparts are printed on the following pages for your review. Title 21 – Code of Federal Regulations

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GMP POLICY

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B. Subpart C-Buildings and Facilities

1. § 211.42 Design and construction features.

a. Any building or buildings used in the manufacture, processing, packing, or holding of a drug product shall be of suitable size, construction and location to facilitate cleaning, maintenance, and proper operations.

b. Any such building shall have adequate space for the orderly placement of equipment and materials to prevent mix-ups between different components, drug product containers, closures, labeling, in-process materials, or drug products, and to prevent contamination. The flow of components, drug product containers, closures, labeling, in-process materials, and drug products through the building or buildings shall be designed to prevent contamination.

c. Operations shall be performed within specifically defined areas of adequate size. There shall be separate or defined areas for the firm's operations to prevent contamination or mix-ups.

2. § 211.50 Sewage and refuse. a. Sewage, trash, and other refuse in and from the building and immediate

premises shall be disposed of in a safe and sanitary manner.

3. § 211.52 Washing and toilet facilities. a. Adequate washing facilities shall be provided, including hot and cold water,

soap or detergent, air driers or single-service towels, and clean toilet facilities easily accessible to working areas.

4. § 211.56 Sanitation.

a. Any building used in the manufacture, processing, packing, or holding of a

drug product shall be maintained in a clean and sanitary condition, Any such building shall be free of infestation by rodents, birds, insects, and other vermin (other than laboratory animals). Trash and organic waste matter shall be held and disposed of in a timely and sanitary manner.

b. There shall be written procedures assigning responsibility for sanitation and

describing in sufficient detail the cleaning schedules, methods, equipment, and materials to be used in cleaning the buildings and facilities; such written procedures shall be followed.

c. There shall be written procedures for use of suitable rodenticides, insecticides,

fungicides, fumigating agents, and cleaning and sanitizing agents. Such written procedures shall be designed to prevent the contamination of

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equipment, components, drug product containers, closures, packaging, labeling materials, or drug products and shall be followed. Rodenticides, insecticides, and fungicides shall not be used unless registered and used in accordance with the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 135).

d. Sanitation procedures shall apply to work performed by contractors or

temporary employees as well as work performed by full-time employees during the ordinary course of operations.

C. Subpart D-Equipment

1. § 211.63 Equipment design, size, and location.

a. Equipment used in the manufacture, processing, packing, or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance.

2. § 211.65 Equipment construction.

a. Equipment shall be constructed so surfaces that contact components, in-

process materials, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.

b. Any substances required for operation, such as lubricants or coolants, shall not

come into contact with components, drug product containers, closures, in-process materials, or drug products so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.

D. Subpart F – Production and Process Controls

1. § 211.100 Written procedures; deviations.

a. There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall include all requirements in this subpart. These written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control unit.

b. Written production and process control procedures shall be followed in the

execution of the various production and process control functions and shall be documented at the time of performance. Any deviation from the written procedures shall be recorded and justified.

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E. Know Your Work Area

1. There are significant differences as well as similarities between the bulk manufacturing and the finishing areas. However, there are several rules that are common to both. These include:

a. Staying in your work area. Do not enter restricted areas unless you are

authorized and you know the rules for entering that area. b. Following special dress codes for some areas. These will require special

training. c. No smoking or using of tobacco products (including smokeless) on the plant

site. d. No eating in your work area; this includes coffee and chewing gum.

2. Your project engineer will discuss specific issues with you as they apply to your

work area. However, here are some additional key points to keep in mind:

a. Do not change control settings on Programmable Logic Controllers (PLC) or process equipment unless you are authorized.

b. You must report any accidental bumps, damage to drums, pushed buttons, etc. as these actions can affect the quality of our products.

c. Stay away from areas that are corded off and respect these areas. d. Do not go into areas that you are not sure of where they go. e. Observe all signs and if you are not sure what they mean, ask your supervisor

or project engineer. f. “Think Before You Act”

Ask yourself . . . 1. Is the job you are getting ready to perform going to impact the quality of

our products or processes? 2. Will this job task cause contamination by creating dust, or other airborne

particulate? If so, stop and contact a supervisor or project engineer for further evaluation.

IMPORTANT NOTE: If you are working in an area and your work could affect product quality, an employee will walk up to you and ask you to stop your work until the issue can be resolved. You must comply and report to your supervisor. F. Tools

1. You should handle your tools and follow housekeeping practices as follows:

a. You must be accountable for all materials, tools or hardware. Whatever you take into an area must come out of that area.

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b. Do not leave materials laying on drums or equipment as they could contaminate process or the project.

c. Do not lay tools near tank openings. Many vessels are glass-lined. If one of your tools falls into it, this could crack a liner, creating glass particles or allow the product to react with the vessel metal.

d. Keep your work area clean as you work. Use appropriate trash receptacles and when you complete a job be sure to clean the area before you leave. Good housekeeping is important.

G. Plan Your Work Follow all directions and procedures exactly as written or stated. Deviations from your work plan must be documented and reported. Mistakes will happen; be sure to report them to your supervisor immediately.

H. Types of Equipment

There are many types of product containers and pieces of equipment used around the site. Never use any drums, liners, pails, etc. that are part of the process area.

I. Finally . . .

Always be aware that what you do affects your surroundings and could compromise the quality of our products.

EMERGENCY NUMBERS FIRE: x4911 MEDICAL: x4911 SAFETY/SPILL: x4911 SECURITY: x4234, x4867 or x4218

THE PROJECT ENGINEER:

Your interface to Merck

Your Project Engineer’s: Name: ______________________________ Building: ______________________________ Phone: ______________________________ Page No.: ______________________________ Building No. where work is to be done: ______________________________ Zone No.: ______________________________ Primary Retreat: ______________________________ Secondary Retreat: ______________________________

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