This document outlines the Hazard Communication Program for Sheffield Pharmaceuticals. It describes the program's responsibilities, document locations, safety data sheet procedures, training requirements, container labeling, and emergency response. The program is designed to ensure employees are informed of chemical hazards and properly protected according to OSHA regulations.

1. CONTROLLED DOCUMENT Printed from MASTERControl on 12/1/2015
Department: EH&S SOP 107-04
Original Issue: 07/07/92 Rev. Date: 3/19/2013
Supersedes: 01/05/06 Effective Date: 01/30/05
Revised by: James Congdon EH&S Coordinator (Electronic Signature on File)
Approved by: Jeff Davis Production Manager (Electronic Signature on File)
Sheffield Pharmaceuticals
Environmental Health and Safety
HAZARD COMMUNICATION
PROGRAM
Environmental Health & Safety
Revised: 3/19/2013

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Department: EH&S SOP 107-04
Original Issue: 07/07/92 Rev. Date: 3/19/2013
Hazard Communication Program
Table of Contents
1. Introduction
2. Scope
3. Responsibilities
4. Document Locations
5. Safety Data Sheet (SDS)
6. Training
7. Container Labeling
8. Non-routine Tasks
9. Outside Contractors
10. Emergencies
Appendix A: Training Program

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Department: EH&S SOP 107-04
Original Issue: 07/07/92 Rev. Date: 3/19/2013
Section 1 Introduction:
Under the Occupational Safety and Health Administration’s Hazard
Communication Standard, 29CFR1910.1200, employers must establish and
maintain a program to evaluate and communicate the hazards of chemicals in
the workplace. This standard requires that employers establish information and
training detailing hazardous properties of chemicals in the workplace, safe
handling procedures, and measures to be taken to protectworkers from these
chemicals. The standard also addresses the labeling of chemical containers and
the management of information sheets. This written Hazard Communication
Program outlines how Sheffield Pharmaceuticals is complying with all of the
elements of the Hazard Communication Standard (HCS).
Section 2. Scope
2.1. Employees Covered
This Program covers workers employed at Sheffield Pharmaceuticals who
may be exposed to hazardous chemicals under normal operating conditions
or reasonably anticipated emergencies. Workers, who encounter hazardous
chemicals only in non-routine, isolated instances, are not covered by this
program.
2.2. Substances Covered
All substances located at Sheffield Pharmaceuticals which posea physical or
health hazard are included, except those specifically exempted by this
program. Exempted substances include hazardous wastes, consumer
products, and articles as defined by OSHA.
Section 3. Responsibilities
3.1. General
Responsibilities for compliancewith this program are as follows:
A. Sheffield Environmental Health and Safety (EHS)
 Developing and periodically updating the written Program

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Department: EH&S SOP 107-04
Original Issue: 07/07/92 Rev. Date: 3/19/2013
 Developing and implementing training programs that comply with
the requirements of the standard and also accommodatethe needs
of individual departments.
 Maintaining the Safety Data Sheet database
B. Individual Departments
 Ensuring that all employees receive Hazard Communication
training prior to working with hazardous chemicals at their work
site
 Ensuring that all applicable containers are labeled appropriately
C. Employees
 Attending required safety training
 Reading chemical labels and Safety Data Sheets when necessary,
and following their instructions and warnings
 Asking for assistance if there are any questions or concerns that
have not been answered by training, container labels, or SDS
3.2. Identificationof Potentially Exposed Employees
The EH&S department will identify potentially exposed personnel based
upon job hazard analysis. This will be aided by input from department
managers and supervisors.
Forthe purposes ofthis program, potentially exposed employees include:
A. Engineering
B. Shipping and Receiving
C. Laboratory Personnel
D. Compounding
E. Filling
Workers who encounter hazardous chemicals in non-routine, isolated
instances only, such as office workers are not covered by this Program.

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Department: EH&S SOP 107-04
Original Issue: 07/07/92 Rev. Date: 3/19/2013
Section 4. DocumentLocations
4.1. Hazard Communication Plan
A hard copyof this plan is available in the EH&S office, and may also be
obtained using Sheffield’s Document Control program MasterControl.
4.2. Safety Data Sheets (SDS)
Safety Data Sheets are stored electronically in a database. This database is
maintained and updated by EH&S.
Section 5. Safety Data Sheets
5.1. General Information
Safety Data Sheets (SDSs) are intended to provide workers and emergency
personnel with procedures for the safe handling of hazardous chemicals.
Training on obtaining information from SDS will be included in affected
departmental training.
5.2. Purchasing and Receiving Procedures
 The Purchasing Department is responsible for assuring that a hard copy
of the SDS is sent to the Shipping and Receiving Department where it is
scanned into an electronic file.
 EH&S adds the SDS to the Database as they are received.
 Effected employees receive training on retrieving SDSs from the
database.
5.3. Accessibility
 SDSs are accessible to employees during their work shift.
 Sheffield Pharmaceuticals will make copies of SDSs available to all
employees and to anyone who may request them.
 SDSs are available to outside contractors uponrequest.

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Department: EH&S SOP 107-04
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5.4. Replacementof Material Safety Data Sheets
All Shipments will include the newest available SDS from the supplier. As
such old and outdated SDSs will be replaced as the new, updated SDSs are
received by Sheffield Pharmaceuticals.
5.5. Creation of a Material Safety Data Sheet
In the event that Sheffield Pharmaceuticals needs to generate its own SDSs
to fulfill compliance or customer obligations, the EH&S department will
oversee the authoring process to ensure they are authored within the
parameters specified in OSHA’s Hazard Communication Standard. After
Completion the SDS will be added to the database for distribution.
Section 6. Training
6.1. Introduction
All potentially exposed employees must be given training in the handling
and safe use of chemicals. Training will be oriented toward the chemical
hazards employees may be exposed to in the normal courseof their work, as
well as those during a foreseeable incident. Appendix A provides an outline
of a typical hazard communication training class. Employees may receive
additional training on Spill Response, Hazardous Chemical Handling,
Flammable Liquid Safety as well as the Lab Safety Plan as necessitated by
their job assignment.
6.2. Training Materials and providers
Training for employees can take many forms. Initial training should be
given by EH&S either in a classroom setting or as a guided online training.
Follow up training can be in the form of online training without guidance
from EH&S. Chemical safety should be a part of all relevant training in
each department.
6.3. Training Circumstances
Exposed employeesmust be trained under the following
circumstances:

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Department: EH&S SOP 107-04
Original Issue: 07/07/92 Rev. Date: 3/19/2013
A. All workers, covered by this standard, who are exposed to hazardous
materials at work, this includes:
 New employees
 Transferred employees
 Whenever new hazards are introduced into the work area
B. Chemical safety training, including the elements required by this
standard, is repeated department-wide on a periodic basis.
6.4. Attendance Records
 For classroomstyle training a record of attendance that includes the
name and department of each employee attending the session will be
taken, and kept on file by Sheffield EH&S. The employee’s
individual training record will be updated by that department’s
manager or training coordinator. Additional an electronic record of
training completed will be kept in OMS.
 Online training records are kept by the online training program.
Additionally the OMS training record for each employee will be
updated as training is completed.
Section 7. Container Labeling
7.1. General Requirements
 All containers of hazardous chemicals must be properly labeled in
accordancewith the requirements of this standard. The label and
information must be in English.
 At a minimum labeling must include:
A. Identity of hazardous chemical.
B. Appropriate hazard warning, including both physical and health
hazards.
C. Name and address of chemical manufacturer, importer, or other
responsible party.
7.2. Inspectionof Incoming Containers
Shipping and receiving personnel are trained to inspect each incoming
container to insure that when it is received; each container is labeled

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Department: EH&S SOP 107-04
Original Issue: 07/07/92 Rev. Date: 3/19/2013
properly. EHS should be notified of any containers that do not conform to
the above requirement so that the appropriate label can be applied
7.3. SecondaryContainers
A secondary container is one that is used to transfer hazardous chemicals
from a primary container for more convenient use.
Secondarycontainers of hazardous materials must be labeled according to
requirements listed in Section 7.1. However, secondarycontainers into
which hazardous chemicals are transferred from labeled containers and
which are intended for only the immediate use of the employee who
performs the transfer are exempt from the labeling requirements. Once the
container is left unattended, it must be properly labeled.
7.4. Placarding
Sheffield may use signs, placards, batch tickets, operating procedures, or
other such written materials in lieu of affixing labels to individual stationary
process containers as long as the alternative method identified the container
to which it is applicable and conveys the required information.
Section 8. Non-Routine Tasks
When an employee is to perform a non-routine task presenting hazards for
which he or she has not already been trained, the employee's supervisor will be
responsible for discussing with the employee the hazards of the task and any
special measures, including personalprotective equipment or environmental
controls, that should be used to protect the employee. EH&S will assist with the
training for non-routine tasks, as necessary.
Section 9. Contractors
It is responsibility of the department manager contracting outside services to
advise the contractorof any chemical hazards that are known to be present in
our facilities and that may be encountered during their work at Sheffield
Pharmaceuticals. EH&S will assist with this as necessary.

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Department: EH&S SOP 107-04
Original Issue: 07/07/92 Rev. Date: 3/19/2013
9.1. Contractors Obligations
Individual contractors are responsible for providing their own employees
with information and training concerning the health hazards, safe handling
procedures, and appropriate protective measures to be used with the
hazardous substances they bring on-site. It is also the responsibility of each
contractorbringing chemicals on site to provide Sheffield with the
appropriate hazard information on these substances. They are required to
inform the manager contracting the services and/or EH&S if they will be
using hazardous chemicals in a manner which could result in a potential
exposure to Sheffield employees working in adjacent areas.
9.2. Contractors Obligations to Sheffield
Contractors that are planning to use hazardous chemicals (sealants, oil
based paints, etc.) within Sheffield must inform the manager contracting the
services and/or EH&S, and specifically identify the materials to be applied
and the safeguards/exposure controls to be used to protect Sheffield
employees working in adjacent areas. Contractors must also remove all
chemical hazardous wastes generated during their operations and all
"residual" waste chemical substances brought on site.
Section 10. Emergencies
In the event of an emergency there are several supporting programs that are
in place to aid in the properhandling of different hazards.
10.1. EmergencyAction Plan
Sheffield’s Emergency Action Plan is gives specific instructions to
employees on how to handle fire, medical, chemical, and other types
of emergencies. The plan indicates who to contact and where to
assemble in the event of an emergency.
10.2. Spill Response
Internal chemical spill are handled following the guidelines given is
Sheffield’s Spill ResponseProcedure. This procedure is designed to
enable employees to categories the type and magnitude of a spill and
respond accordingly.

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Department: EH&S SOP 107-04
Original Issue: 07/07/92 Rev. Date: 3/19/2013
10.3. Environmental Programs
In addition to internal procedures Sheffield also has several
environmental programs designed to control, monitor, or eliminate
pollution. Each one of these programs could be compromised as a
result of a chemical emergency.
 Waste Water Treatment
 Storm Water Plan
 Spill Control and Countermeasure

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Department: EH&S SOP 107-04
Original Issue: 07/07/92 Rev. Date: 3/19/2013
Appendix A: Training Program Outline
1. Hazard Communication Standard
A. Scopeand Application
B. Components
1. Written Plan
2. Labeling
3. Material Safety Data Sheets
4. Training
C. Availability and Accessibility of Information
2. Chemical Hazards
A. Physical and Health Hazards
B. Acute vs. Chronic
C. Routes of Exposure
D. Signs and Symptoms of Overexposure
3. Chemical Incidents
A. Methods to Detect the Presence or Release of Hazardous Chemicals
B. Emergency Equipment and Procedures
C. Spill Cleanup Information
D. Notification Procedures
4. Protective measures
A. Personal protective equipment
B. Ventilation
C. Safety Equipment
5. Chemical Waste
A. Hazardous Waste Disposal
B. Disposal Policies and Procedures
6. Question and Answer Period

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Department: EH&S SOP 107-04
Original Issue: 07/07/92 Rev. Date: 3/19/2013
Revision History
3/19/2013
Complete document re-write and reformatting.