Standard Operating Procedure (SOP) for
Name of Procedure using the Boston University “High Hazard Chemical”
Name of Chemical
PROJECT
PRINCIPAL INVESTIGATOR
DEPARTMENT
MAILING ADDRESS
OFFICE/LAB PHONE
Provide office and
lab phone #s
24 HOUR PHONE
PI’s 24 hour contact
number.
AUTHORIZED PERSONNEL
List of all personnel who will handle material or who will have
potential for exposure to the chemical. Include BU ID#.
CHEMICAL IDENTITY, SOURCE, AMOUNT, TRANSPORTATION AND
STORAGE
CHEMICAL NAME AND SYNONYMS
List the chemical name, trade name, commercial product name, and any
synonyms for the compound
CAS #
Provide full Chemical Abstract Service (CAS) code number
NATURE OF THE HAZARD
Fully explain the nature of the physical and/or health hazards, identify
symptoms of overexposure, routes of exposure
Attach MSDS and references
CHEMICAL SOURCE
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Identify the source of the material. If a commercial supplier, provide
stock # or catalogue #
STORAGE LOCATION
Provide the building and room location where the material will be
stored. Indicate how the material is secured, i.e. flammable cabinet,
locked refrigerator, safe, etc.)
.
TRANSPORTATION
Indicate how material is to be transported, i.e., powder in labeled,
sealed, leak proof, double container. Indicate type and amounts
transported
QUANTITY PURCHASED, USED, STORED
Total and average amount purchased and kept on-site. Indicate amounts
in storage and in use
1.0 Purpose and Scope
1.1 The purpose of this SOP is to create specific procedures for safely working with
chemicals deemed highly hazardous in the “High Hazard Chemical” program at
Boston University, and to comply with municipal, state, and federal laws and
regulations, as well as prudent laboratory practices. The chemicals covered under the
policy include chemicals and chemical mixtures having potential to cause a high
health, physical or environmental hazard. This particular SOP applies to all
individuals working with Diphtheria Toxin in a the Lafyatis Laboratory at Boston
University or Boston Medical Center.
2.0 References
2.1 Regulations:
2.1.1 29 CFR 1910 Subpart H Hazardous Materials
2.1.2 29 CFR 1910 Subpart Z Toxic and Hazardous Substances
2.1.3 29 CFR 1910.1450 – OSHA Laboratory Safety Standard
2.1.4 29 CFR 1910.1200 – OSHA Hazard Communication Standard
2.1.5 40 CFR 261 Identification and Listing of Hazardous Waste
2.1.6 Boston Fire Prevention Code
2.1.7 527 CMR MA Board of Fire Prevention Regulations
2.1.8 780 CMR MA State Building Code
2.2 BU Policies:
2.2.1 Boston University Chemical Hygiene Plan
2.2.2 Boston University Guidelines - Transporting Laboratory Materials
Outside of the Laboratory
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2.2.3
2.2.4
2.2.5
Boston University Chemical Inventory Program
Boston University Quarterly Research Safety Inspections Program
Boston University Door Placard Program
2.3 Supplementary Documents
2.3.1 NFPA 45 – National Fire Protection Administration Standard on Fire
Protection for Laboratories Using Chemicals
2.3.2 NFPA Fire Protection Guide for Hazardous Materials
2.3.3 IARC Group 1, 2A and 2B Lists – International Agency for Research on
Cancer lists for known, probable and possible carcinogens
2.3.4 National Toxicology Program list of carcinogens
3.0 Definitions
3.1 High Hazard Chemical: A chemical that has the potential to cause any health,
physical or environmental hazards that require additional safety and/or environmental
practices beyond those of typical laboratory setting, as required by existing
regulations or upon review of the hazards by Environmental Health and Safety EHS),
relevant oversight committees, or other institutional entities.
4.0 Roles & Responsibilities
4.1 Principal Investigator (PI) and Laboratory Safety Coordinator (LSC): Develop,
implement and maintain this specific SOP to safely address high hazard procedures
when using this chemical. Train the laboratory personnel on all applicable
procedures, including this SOP, and ensure that all lab personnel are working in
compliance with this SOP.
4.2 Laboratory Personnel: Review and follow all lab-specific procedures and to always
perform work in the laboratory safely.
4.3 Environmental Health and Safety (EHS): Provide assistance to lab personnel in
developing, implementing and maintaining procedures. Oversee lab safety and
conduct Chemical Hygiene Plan & Laboratory Safety Training.
4.4 Laboratory Safety Coordinator (LSC): Serves as the primary laboratory contact
with EHS for issues related with the SOP.
4.5 Research Occupational Health Program (ROHP): Assists EHS in its review of
High Hazard Chemicals providing medical and technical input.
5.0 Special Requirements
5.1 Laboratory Use:
5.1.1 Administrative and Engineering Controls
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Identify fume hoods, biosafety cabinets and other devices used to limit
exposure. Provide date(s) of certification for each device used
5.1.2 Personal Protective Equipment (PPE)
List all PPE that will be used to control exposure to personnel while
performing the procedure, such as double gloves, respirator, safety
glasses, goggles, gauntlets, lab coats and smocks, etc. Include procedure
for removal of PPE
5.1.3 Chemical Handling and Preparation
This is the most important component of the SOP which requires a
complete and step by step description of how the function should be
performed.
When developing this section consider the possibility of using the
document as a training tool for new employees. Therefore, the details
included should be such that after reading the document the new employee
could obtain a high level of understanding of how the function is
performed.
5.1.4Use Location
Provide building and room location where material is used. Indicate
whether fume hood, biosafety cabinet, etc. is used
5.1.5Wastes Generated
Identify all potentially hazardous wastes generated. Include
contaminated lab ware, PPE, cleaning solutions, etc. here.
5.1.6 Containers and Labels
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Identify signs and labels used to communicate hazard information here.
Follow BU Chemical Hygiene Plan guidelines.
5.1.7 Waste Disposal and Decontamination
Procedures to decontaminate equipment and work surfaces after use, as
well as, PPE disposal.
5.2 Animal Use:
5.2.1 Animal Species to be Dosed
Identify species being dosed
5.2.2 Number of Animals
Identify amount of animals being dosed
5.2.3 Amount of Chemical per Dose/Frequency
Identify Amount of the chemical per dose and the frequency of that dose
5.2.4 Route of Administration
Identify how the animal will be given the dose
5.2.5 Duration of Exposure
Identify how long this exposure will occur
5.2.6 Location of Animal Housing
Identify the location of where the animal will be housed
5.2.7 Animal Housing Requirements
Identify the housing requirements for this animal using the high hazard
chemical
5.2.8 Biological Half-Life
Identify the biological half-life
5.2.9 Routes of Excretion
Please circle: Respiratory, Milk, Urine, Feces, Saliva, Other_________
5.2.10 Toxic Metabolites
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Identify toxic metabolites
5.2.11 Potential Adverse Effects
Identify adverse effects
5.2.12 LASC Potential Exposures
Identify potential exposures
5.2.13 Animal Waste Disposal
Identify how animal waste will be disposed of
5.3 Training
5.3.1 Investigator’s and LASC staff must be trained to the written operating
procedures for chemical handling by the use and disposal prior to
initiation of the project. Training shall include a “dry run” to ensure
familiarity with the procedure. Training shall be provided by the
principal investigator, with assistance from EHS as needed.
5.3.2 Investigator’s staff shall be instructed in animal care procedures, if
animal work is conducted, including the role of LASC personnel in this
project.
5.3.3 All persons working in a laboratory must attend laboratory training for
researchers annually.
5.3.4
Additional Training
List any additional trainings needed to be completed as well as date
completed
5.4 Monitoring Requirements
5.4.1 EHS will identify and implement any appropriate and available
monitoring methods for assessment of occupational exposure to
hazardous chemicals. EHS will assure that controls are in place to
minimize exposures and maintain compliance with any regulatory
requirements specific to the chemical.
5.4.2 Additional Monitoring Requirements
List any additional monitoring requirements as well as date monitored
5.5 Medical Surveillance
5.5.1 ROHP will determine and implement medical surveillance requirements
for researchers and other workers who may be exposed to the hazardous
chemical. The PI will be responsible for insuring that all workers and
researchers comply with the ROHP requirements. Medical surveillance
may take the form of pre-project, periodic, and post-exposure health
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5.5.2
screenings. Medical surveillance may also include the use of biological
indicators from worker or researcher supplied specimens, if appropriate
and methods are available.
Additional Medical Surveillance
List any additional medical surveillance that needs to be done prior to
work, including vaccinations and date received.
5.6 Emergency Response
Identify the emergency response actions that will be taken if a spill
occurs
5.6 Accidental Exposure
Identify the steps that will be taken during an accidental exposure
6.0 Applicable Locations
This applies to all individuals working at Boston University or Boston Medical Center.
7.0 Procedures and Instructions
7.1
If the PI is using or plans to use High Hazard Chemicals, the PI must notify EHS and
develop a SOP for the use of the chemical(s).
7.2
EHS is responsible for reviewing, editing, and circulating the SOP for review to
appropriate parties including Research Occupational Health Program (ROHP),
Laboratory Safety Committee (LSC), Laboratory Animal Science Center (LASC),
Institutional Animal Care and Use Committee (IACUC) and outside experts, as
necessary.
7.3
EHS incorporates any feedback and will circulate the final draft SOP to any necessary
parties for sign-off before approving the SOP.
7.4
EHS approves and the PI implements the SOP.
7.5
The PI must notifying EHS if there are any changes in location, personnel, or
procedures in order to update the SOP.
7.6
EHS periodically audits the SOP to verify that procedures are in place.
7.7
EHS maintains records of the locations where highly hazardous chemicals are used,
including monitoring records from exposure assessments.
TRAINING
1.
Investigator’s staff must be trained to the written operating procedures for chemical handling
by the use and disposal prior to initiation of the project. Training shall include a “dry run” to
ensure familiarity with the procedure.
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INVESTIGATOR'S STATEMENT
The information I have supplied above is a complete and accurate description of all procedures
involving the use of a hazardous chemical/carcinogen in this project. I assure that all personnel under
my direction will be appropriately informed and properly trained prior to working with this agent. I
agree to abide by the safety policies of this institution.
_____________________________
___________________
Signature of Principal Investigator
Date
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