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BioSafety - Practical

The section contains information needed for laboratory work and research here at Stanford University. It is here that you will find information on:

Stanford University Biosafety Manual (2007)

This Biosafety Manual represents the institutional practices and procedures for the safe use and handling of biological materials and recombinant DNA at Stanford University. The Administrative Panel on Biosafety and the Biosafety Manager have prepared this document based on the latest government regulatory requirements, guidelines and current professional standards. To view and download a copy of the Biosafety Manual, click here. If you would like a hard copy, send a request to esegal@stanford.edu.

Biological Agents and Toxins Database

This is the Stanford University database of all biological agents and toxins that are used or stored here; this includes NIH/CDC exempt and non-exempt material and certain toxins. The information collected from the database is solely for use by Stanford personnel. Only Stanford faculty or their designated staff has access to the database. If you would like to only see a list of agents for the database, click here. To enter the database, click here. To register for an account to access the database, click here.

Training

Biosafety training at Stanford University: what you need to learn and how to do it

Biosafety training: all personnel must take this course – Sign up for and complete EHS-1500, Biosafety, through the Stanford Training and Registration System, STARS. STARS can be reached by logging in to Axess at http://axess.stanford.edu and then clicking on the "Training" tab.

Blood Borne Pathogen Training – mandatory for any and all who might come in contact with human and/or primate blood or blood products. Yes, this includes human cells in culture.
For the initial training: Log in to Axess and register for and complete the online course, EHS-1600, Bloodborne Pathogens. For instructions see http://bbp.stanford.edu

Blood Borne Pathogen Exposure Control Plan: a must see/must have site for any and all who have the potential for exposure to blood borne pathogens, including HIV, HBV, and HCV. This information is also available in the Stanford University Biosafety Manual. A copy of your Exposure Control Plan must be kept available in your lab.

Shipping of Biohazardous Goods
Shipping Biological Goods
Shipping with Dry Ice

Current Federal Law requires all persons who ship (this includes the actual packing of the material and filling out of assorted forms) Dangerous Biological Goods, including dry ice, to be trained and certified prior to shipping.

To help determine if what you are shipping falls under Dangerous Biological Goods, click here.

Note: please be aware that DRY ICE is considered a DANGEROUS GOOD and you must ship it according to FAA regulations. Even if there are no additional 'dangerous' items in the shipment, a shipping container with dry ice MUST be labeled and invoiced appropriately by a trained shipper.

The DOT currently mandates that shippers retain a copy of each Dangerous material shipping paper, or an electronic image, for a period of 2 years after the date of shipping. Note that shipping paper means shipping order, bill of lading, manifest or other documents containing required information.

To take the Biological Shipping Training Course, log in to the STARS system via http://axess.stanford.edu (click on the "Training" tab and register for and complete the online training class EHS-2700, DOT: Shipping of Dangerous Biological Goods. ** This training will provide the necessary information for you to become certified for Shipping of Dangerous Goods. You can also access a guide published by the University of New Hampshire (click here) for additional reference date. Upon completion of the training, you must take the written exam (click here for Shipping Exam). Passing the exam will allow you to become certified for two years and/or until regulatory changes occur.

Useful links related to Shipping:

IATA – for Declaration forms

QICSTAT – for useful information

Saf-T-Pak Inc. – information and supplies

FedEx – information and supplies

All-Pak - supplies

CHEMTREC

Stanford University contracts with CHEMTREC to provide 24-hour emergency service for shipping dangerous goods.

The emergency CHEMTREC number to use is 1-800-424-9300. You are to place this on your Shipper's Declaration form.

CHEMTREC registrants are authorized to place the CHEMTREC phone number on their shipping papers, as required by US hazardous materials transportation regulation 49CFR172.604. When using CHEMTREC, please be sure you include "Stanford University" in your sender's address on the box.

We DO NOT recommend that you also put the CHEMTREC number on the product's packaging, particularly if it is not accompanied by another toll-free number to be used for all other product inquiries that are not concerning a product spill, leak fire, exposure or accident.

More information on the CHEMTREC service can be found at http://www.chemtrec.com/Chemtrec/

Export Controls Related to Biologicals and Toxins

Stanford's Export Control Officer (steve.eisner@stanford.edu, 4-7072) must be contacted before any export controlled biological or toxin is shipped abroad so that an export license can be obtained (Note: the export licensing process can take up to two months so plan well in advance). All other exports of biologicals need to be documented with an export Certification signed by the responsible PI. An Export Controls Decision Tree is available to assist PIs with selecting the appropriate Certification. See Stanford University’s export control website for additional details.

Stanford University Hepatitis B Vaccination Declaration

After printing the form, fill it out, sign it, and return it to your supervisor.

Administrative Panel on Biosafety (APB):

What it is: The NIH mandates the establishment of an institutional Biosafety Committee (at Stanford University the APB) for all institutions that receive any support for rDNA research form NIH. Non-compliance may result in termination of NIH funds for all rDNA research at the institution. Additionally, the APB reviews research proposals involving infectious agents, using the CDC/NIH guide 'Biosafety in Microbiological and Biomedical Laboratories', 4th edition. To view APB member roster (2006-2007), click here.

Who needs to apply: to determine if your research needs APB approval, you need to check both the Biosafety levels (if you are working with infectious agents) and the NIH rDNA guidelines. For Biosafety levels, if your organism is classified as BL-1, you do not need approval from the APB. If the level is 2 or 3, you must submit an application. For rDNA, first check the exempt categories. If your experiments do not fall within the exempt class, you must submit and application.

How to submit an application: APB form (the same form used for Biosafety levels and rDNA). The APB meets monthly; to have a protocol reviewed, it must be submitted by the first of the month for that months meeting.

To review a completed sample protocol, click here.

Note for the users of APB form: This form is interactive, and you can save the copy of the form on your drive, fill it out and send it by e-mail as an attachment, print it and send it using regular mail, or FAX it.  You need to have Microsoft Word in order to do that.

- APB renewals and cross-references: To renew a present APB approval or make minor changes, use the Update Form

To cross-reference a new proposal to an already approved proposal, use The Blue Form

- Gene Therapy and Human Subjects: yes, you also need to submit a form to the APB

CDC Select Agents: the Centers for Disease and Prevention (CDC) and the Department of Health and Human Services (HHS) issued "The Antiterorism and Effective Death Penalty Act of 1996", regulation the transfer of select agents. Regulations specify requirements for the packaging, labeling, transport, shipping, and handling for facilities that transfer or receive agents listed in the rule (said agents are capable of causing substantial harm to human health). Select Agents can be viable organisms or specific toxins.
Requirements for Facilities Transferring or Receiving Select Agents
If you only want to check the select agent list:
select agent list.pdf
If you need to dispose of a select agent toxin:
Select Agent Deactivation Chart, Select Agent Recommendations

SU Requirements for Possession of Exempt Quantities of CDC Select Agent Toxins

Laboratory Animal Occupational Health Program (LAOHP): if you will be working with vertebrate animals, unfixed animal tissues or body fluids, or in animal housing areas, this site is for you
http://www.stanford.edu/EHS/research/medsurv/

Personal Protective Equipment (PPE): eye protection, lab coats and gloves – not just fashionable but good for you too

Sharps Injury Log: if an accident involving a sharps occurs with potential exposure to blood borne pathogens, this site will tell you what to do immediately post exposure and what forms you need to fill out.
First you need an SU-17

If a sharps was involved, you will also need a Sharps Injury Log Form

Biosafety Approval Letter Request for fellowships and PI's: if you need an ‘official’ letter for a granting agency, this form will save you a phone call.
This form is interactive, and you can save the copy of the form on your drive, fill it out and send it by e-mail as an attachment. You need to have at least Adobe Acrobat 5.0 in order to do that.

With Acrobat Reader 4.0 you cannot save the changes to the form, but you can still fill it out, print the form with the filled information, FAX it or send using regular mail. Acrobat Reader 5.0 or later takes care of this problem.

Download free Acrobat Reader

Biosafety Cabinets: how to choose which one and how to purchase it

Stanford Univeristy guide to open gas flames in biosafety cabinets.

TSS, Inc. is Stanford University's designated vendor for Biosafety cabinet service. They can be reached at (510) 845-5591.

Autoclaves: how to choose and how to buy

Medical and Biohazardous Waste: Disposal of Medical and Biohazardous waste is regulated by Santa Clara County. To determine the proper waste stream for your materials see the poster labeled Medical and Biohazardous Waste. If this poster is not available in your laboratory, you can print it or call 5-3468 for a hard copy.