Frequently Asked Questions - Biological Safety
3. Who is affected by the new select agent regulation?
4. Who is exempt from the new select agent regulation?
5. What is an entity or facility?
7. What is transfer and who is a transferor?
8. What is recombinant DNA (rDNA)?
9. What are the NIH Guidelines for research involving recombinant DNA molecules?
10. Which experiments are exempt from the NIH Guidelines?
11. I've submitted an rDNA registration form in the past. When do I need to reapply?
12. Where do I submit my rDNA registration form?
13. Who reviews the rDNA registration forms?
14. Who are the members of the IBC?
15. Who do I contact for more details?
16. Do I need training on federal/university regulations and policies?
17. How many days does it take to review my rDNA registration?
18. How often does the IBC meet?
19. When is my rDNA registration application due for the IBC meetings?
20. How many copies of the rDNA registration forms should I submit?
21. How long is an approved rDNA registration form good for?
22. How will I find out whether my rDNA registration form has received IBC's approval?
23. Can students and postdoctoral researchers submit rDNA registrations?
24. Will I be notified when it is time to renew my rDNA registration form?
25. What are the forms I need to submit?
26. How should I report changes of modifications to my rDNA registration form?
27. Besides the rDNA registration form should I submit anything else?
1) What is the USA PATRIOT Act and how does it relate to the new select agent regulation? Where can I find a copy?
The USA PATRIOT Act is a law signed by
President Bush on October 26, 2001 that places restrictions on persons who
possess select agents and provides criminal penalties for possession of
such agents that cannot be justified for specified peaceful purposes. More
information on the Patriot Act can be found at:
http://www.cdc.gov.od/sap/patriot.htm
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A Select Agent is a microorganism (virus, bacterium, fungus, rickettsia) or toxin listed in Appendix A to Part 72-Select Agents. The term also includes: 1) genetically modified microorganisms or genetic elements from organisms on appendix a. shown to produce or encode for a factor associated with a disease, and 2) genetically modified microorganisms or genetic materials that contain nucleic acid sequence coding for any of the toxins on appendix a or their toxic subunits.
3)
Who is affected by the
new select agent regulation?
Everybody who handles agents
on the list of Select Agents.
Principal investigators (PIs) must register the possession of select
agents with the Biological Safety officer in EHS. Failure to comply could result in criminal penalties.
In addition, the Patriot Act of 2001 prohibits “restricted persons” from
possessing, shipping, transporting or receiving select agents. Also, the
Patriot Act prohibits the possession of a “biological agent, toxin or
delivery” (a list broader than select agents) of a type or quantity that
is not reasonably justified by a prophylactic, protective, bona fide
research, or other peaceful purpose.
4. Who is exempt from the new select agent regulation?
No one who works with, ships, transports or receives anything on the list of Select Agents, is exempt from the provisions of the Patriot Act.
5. What is an entity or facility?
Facility means any individual or government agency, university, corporation, company, partnership, society, association, firm, or other legal entity located at a single geographic site that may transfer or receive through any means a select agent to this part.
Requestor means any person who receives or seeks to receive through any means a select agent subject to this part from any other person.
7. What is transfer and who is a transferor?
Transfer means:
- The conveyance or movement from a point
of origination to a point of destination either:
- from one or territory to another
- or entirely within one contiguous state
or territory.
- from one or territory to another
- Intrafacility transfers within a
registered facility located at a single geographic site are not covered by
the provisions of the CD select agent standard, section 72.6(d), (e) and
(f) provide that:
- the intended use of the agent remains
consistent with that specified in the most current transfer
- for each intrafacility transfer, the facility maintains records that include the name and location of the recipient; the amount of agent transferred, and the date transferred. Such records must be maintained for a period of five (5) years after the date of transfer or for 5 years after the agents are consumed or properly disposed, whichever is longer.
- the intended use of the agent remains
consistent with that specified in the most current transfer
Transferor is any person who transfers or seeks to transfer through any means a select agent to this part to any other person.
8. What is recombinant DNA (rDNA)?
In the context of the NIH guidelines, recombinant DNA (rDNA) molecules are defined as either 1) molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that replicate in a living cell, or 2) molecules that form from the replication of those described in 1.
9. What are the NIH Guidelines for research involving recombinant DNA molecules?
The NIH Guidelines is a document in constant evolution that was first drafted in 1976 by scientists concerned about developing standards for the safe practice of research involving rDNA as well as with organisms containing rDNA. An institution must follow the NIH Guidelines if it is conducting or sponsoring any recombinant DNA research that is funded by NIH.
10. Which experiments are exempt from the NIH Guidelines?
Experiments are typically exempt when they involve rDNA that is:
· Not in organisms and viruses
· Entirely DNA segments from a single non chromosomal or viral DNA source.
· Entirely from a prokaryotic host including its indigenous plasmids or viruses when propagated only in that host or when transferred into another host by well established physiological means.
· Entirely from a eukaryotic host including its chloroplasts, mitochondria, or plasmids when propagated only in that host or a closely related strain of the same species.
· Entirely segments from a different species that exchange DNA by known physiological processes, though one or more may be synthetic equivalent (see Appendix A of the NIH Guidelines)
· Not a significant risk to health or the environments as determined by the NIH Director (see Appendix C of the NIH Guidelines)
Research listed above may not be exempt if it also involves:
· The deliberate transfer of a drug resistance trait to microorganisms not known to acquire the trait naturally if such transfer could compromise the use of the drug to control disease agents in humans, veterinary medicine or agriculture
· Deliberate formation of rDNA containing genes for the biosynthesis of toxin molecules lethal for vertebrates at an LD50 of less than 100 nanograms/kilogram of body weight, or
· The deliberate transfer of rDNA or DNA or RNA derived from rDNA into human research subjects.
11. I've submitted an rDNA registration form in the past. When do I need to reapply?
Institutional Biosafety Committee approval of an rDNA registration is for a maximum of 5 years or to the end of the granting period. You will need to reapply at the end of the funding period or when you make substantial changes to your research using rDNA that were not described in the original proposal.
12. Where do I submit my rDNA registration form?
Send the completed rDNA form to Bev Strakose, 518 Goodell.
13. Who reviews the rDNA registration forms?
Initial screening and review is by the Biological Safety officer (BSO). The BSO
assigns a review status to the registration as b) requires review by the Institutional
Biosafety Committee (IBC) or higher (a
federal agency).
a) no further review needed
The BSO will inform the investigator when the pre-screening/initial review of the rDNA registration is completed and will inform them if the review needs to go to another level.
14. Who are the
members of the IBC?
The IBC currently includes six UMass faculty with a broad spectrum of expertise
on biosafety issues, the Director of Animal Care, the Biological Safety Officer, the
Research Compliance Officer, and two community members.
15. Who do I contact for more details?
For details of general compliance issues contact Hilary Woodcock. E-mail her at hilaryw@ora.umass.edu or call her at (413) 577-0387. For specific questions of biological safety issues contact Maureen O'Leary, Biosafety and Environmental Health Program Head at mcoleary@ehs.umass.edu.
16. Do I need training on federal/university regulations and policies?
The training programs are located at http://ehstrain.admin.umass.edu. Click here and look for the requirements.
17) How many days does it take to review my rDNA registration?
It depends on the level of review needed. It can take any time between 2 days to 1 month. When you submit your registration you can ask for an estimate of how long the review process will take.
18) How often does the IBC meet?
The IBC meets twice a semester. A special meeting may be convened if an rDNA registration needs review by the full committee.
19. When is my
rDNA registration application due for the IBC meetings?
You can submit your rDNA registration at any time since it will be pre-screened,
and usually reviewed, by the Biological Safety Officer (BSO). If the BSO determines it
requires review by the full IBC, a meeting is called as soon as possible (within
2 weeks).
20. How many copies of the rDNA registration forms should I submit?
Only one copy of the registration form is required.
21. How long is an approved rDNA registration form good for?
Approval of an rDNA registration extends to the end of the granting period for a maximum of 5 years. You will need to reapply at the end of the funding period or when you make substantial changes to your research using rDNA that were not described in the original proposal.
22. How will I find out whether my rDNA registration form has received IBC's approval?
You will receive a letter from the compliance office letting you know that your rDNA registration has been reviewed and registered.
23. Can graduate students and postdoctoral researchers submit rDNA registrations?
Graduate students can fill out an rDNA registration but their PI/advisor must sign the form. Postdocs can submit a registration under their own name.
24. Will I be notified when it is time to renew my rDNA registration form?
No. Your rDNA registration is valid for the life of your grant or a maximum of 5 years.. If you make significant changes to your research or wish to continue your project beyond its expiration date you should send a memo to the Biological Safety Officer, EHS, Morrill North stating that you wish to extend your project.
25. What are the forms I need to submit?
You need to submit the rDNA registration form to Bev Strakose, 518 Goodell. You can find this form at http://www.umass.edu/research/comply/rDNAreg.doc
26. How should
I report changes or modifications to my rDNA registration form?
Send a
memo to the Biosafety Officer, EHS, Morrill North stating the changes. She
will let you know if you need to do anything further.
27. Besides the rDNA registration form should I submit anything else?
No. You are not required to submit any other forms other than the rDNA registration form.
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