APPENDIX IRegulated Medical Wastes Defined
Medical wastes covered under New York State and federal regulations:
WASTE CLASS DESCRIPTION
I) Cultures and stocks Cultures and stocks of infectious agents and associated biologicals, including:
cultures from medical and pathological laboratories; cultures and stocks of infec-
tious agents from research and industrial laboratories; wastes from the produc-
tion of biologicals; discarded live and attenuated vaccines; and culture dishes and
devices used to transfer, inoculate and mix cultures.
2) Pathological wastes Human pathological wastes, including tissues, organs, body parts and body
fluids that are removed during surgery or autopsy, or other medical procedures
and specimens of body fluids and their containers.
3) Human blood and • liquid waste human blood;
blood products • products of human blood;
• items saturated and/or dripping with human blood, or
• items that were saturated and/or dripping with human blood that are now
caked with dried human blood, including serum, plasma and other blood
components, and their containers, which were used or intended for use in
either patient care, testing and laboratory analysis or the development of
pharmaceuticals. Intravenous bags are also included in this category.
4) Sharps Sharps that have been used in animal or human patient care or treatment or in
medical, research or industrial laboratories, including hypodermic needles, syr-
inges (with or without the attached needle), Pasteur pipettes, scalpel blades,
blood vials, needles with attached tubing and culture dishes (regardless of
presence of infectious agents). Also included are other types of broken or un-
broken glassware that were in contact with infectious agents, such as used slides
and cover slips.
5) Animal waste Contaminated animal carcasses, body parts and bedding of animals that were
known to have been exposed to infectious agents during research (including
research in veterinary hospitals), production of biologicals, or testing of
6) Contact wastes Wastes from surgery or autopsy that were in contact with infectious agents, in-
cluding soiled dressings, sponges, drapes, lavage tubes, drainage sets, underpads
and surgical gloves.
7) Laboratory wastes Laboratory wastes from medical, pathological, pharmaceutical or other research,
commercial, or industrial laboratories that were in contact with infectious agents,
including slides and cover slips, disposable gloves, laboratory coats and aprons.
8) Dialysis wastes Dialysis wastes that were in contact with the blood of patients undergoing
hemodialysis or renal dialysis, including contaminated disposable equipment and
supplies such as tubing, filters, disposable sheets, towels, gloves, aprons and
9) Isolation wastes Biological waste and discarded materials contaminated with blood, excretion, ex-
udates or secretions from humans who are isolated to protect others from cer-
tain highly communicable diseases, or isolated animals known to be infected with
highly communicable diseases.
10) Unused sharps The following unused, discarded sharps: hypodermic needles, suture needles, syr-
inges, and scalpel blades.
SUNY College of Environmental Science and Forestry
RECOMBINANT DNA RESEARCH REGISTRATION
IBC Reg. # _____________
Biosafety Level ___________
Do Not Write in this Box (IBC Only)
If your research involves any of the following, you are exempt from submitting this IBC form and from NIH Guidelines pertaining to recombinant DNA.
(1) Recombinant DNA in Tissue Culture
Recombinant DNA molecules containing less than one-half of any eukaryotic viral genome.
(2) Escherichia coli K-12 Host-Vector Systems
Experiments which use Escherichia coli K-12 host vector systems, with the exception of those experiments listed in Appendix C-11-A, are exempt from the NIH Guidelines provided that: (i) the Escherichia coli host does not contain conjugation proficient plasmids or generalized transducing phages; or (ii) lambda or lambdoid or Ff bacteriophages or non-conjugative plasmids (see Appendix C-VII-B, Footnotes and References of Appendix C), shall be used as vectors. However, experiments involving the insertion into E. coli K-12 of DNA from prokaryotes that exchange genetic information (see Appendix C-VII-C, Footnotes and References of Appendix C) with E. coli may be performed with any E. coli K-12 vector (e.g., conjugative plasmid). When a non-conjugative vector is used, the E. coli K-12 host may contain conjugation-proficient plasmids either autonomous or integrated, or generalized transducing phages. For these exempt laboratory experiments, Biosafety Level (BL) 1 physical containment conditions are recommended. For large-scale fermentation experiments, the appropriate physical containment conditions need be no greater than those for the host organism unmodified by recombinant DNA techniques; the Institutional Biosafety Committee can specify higher containment if deemed necessary.
(3) Saccharomyces Host-Vector Systems
Experiments involving Saccharomyces cerevisiae and Saccharomyces uvarum host-vector systems, with the exception of experiments listed in Appendix C-III-A, are exempt from the NIH Guidelines. For these exempt experiments, BL 1 physical containment is recommended. For large-scale fermentation experiments, the appropriate physical containment conditions need be no greater than those for the host organism unmodified by recombinant DNA techniques; the Institutional Biosafety Committee can specify higher containment if deemed necessary.
(4) Bacillus subtilis or Bacillus licheniformis Host-Vector Systems
Any asporogenic Bacillus subtillis or asporogenic Bacillus licheniformis strain that does not revert to a spore-former with a frequency greater than 10-7 may be used for cloning DNA with the exception of those experiments listed in Appendix C-IV-A, Exceptions. For these exempt laboratory experiments, BL-1 physical containment conditions are recommended. For large-scale fermentation experiments, the appropriate physical containment conditions need be no greater than those for the host organism unmodified by recombinant DNA techniques; the Institutional Biosafety Committee can specify higher containment if it deems necessary.
(5) Extrachromosomal Elements of Gram Positive Organisms
Recombinant DNA molecules derived entirely from extrachromosomal elements of the organisms belonging to the following bacterial genera: Bacillus, Clostridium, Lactobacillus, Listeria, Pediococcus, Staphylococcus, and Streptococcus, with species names provided in NIH Guidelines (April 2002).
( ) New Research (Date of Initiation): ___________________
( ) Ongoing Research Revision
1. Principal Investigator _________________________
2. Department/Faculty _________________________
3. Office Number/Building _________________________
4. Phone Numbers _________________________
5. Lab Location _________________________
6. Project Title _________________________
7. Granting Agency (if applicable) ________________________
8. Provide a Project Summary (1 page maximum)
9. Sources of DNAs _________________________
10. If a eukaryotic virus, is it more than 2/3 of the viral genome?
11. Will this research include genetic modification of any human or exotic animal or plant pathogen? If yes, describe the risk group level (NIH Guidelines, Appendix B) and the genetic modifications to the pathogenic agent and the containment level to be used.
12. Specify the nature (e.g., genomic, cDNA, synthetic, coding or non-coding sequence(s) of the inserted DNA
13. Host(s) and vectors to be used _________________________
14. Will the experiments involve transgenic, whole animals, whole plants, or greater than 10L of cell culture? If so, explain
15. Will a foreign gene be expressed in the host?
If yes, specify the protein(s), materials, toxins, antigens, etc. (include incidental genes of vector
16. Physical containment level to be used (Biosafety Levels, BL1, BL2, BL3 or BL4; refer to Federal Guidelines)
17. Do you plan to release recombinants (cells or DNAs or whole organisms) into the environment? _________
If so, additional notification or approval is required from the federal government (USDA/EPA/NIH).
18. What disposal methods will be used? __________________________
19. Names of personnel participating in the recombinant DNA work: ____________________________________________
20. Attach the abstract of your proposal as an appendix to this form.
NAME ROOM/BUILDING PHONE
21. I accept full responsibility for the safe conduct of the recombinant DNA work described
above. I will inform all personnel of the hazards associated with the work and the
level of containment required to perform this research safely. I will make them aware
of the Federal Guidelines associated with the Biosafety Level that is being required to
perform the work.
Principal Investigator: ___________________________________________ ______________________
RETURN TO: James P. Nakas (IBC Chairperson)
201 Illick Hall
Environmental and Forest Biology
SUNY College of Environmental Science and Forestry
1 Forestry Drive
Syracuse, NY 13210
Phone: (315) 470-6769
IBC Chair: ___________________________________________________ _______________________
Assessment of the Levels of Physical and Biological Containment
Containment of recombinant DNA molecules generated by the utilization of these procedures and hosts is described in section III-A-1-b of the NIH Guidelines for research involving recombinant DNA (Revised January 29, 1980). Experiments will be conducted under BL2 + HVI conditions.
BL2 physical containment requires the following laboratory procedures (Section II-B-2):
- Laboratory doors shall be kept closed while experiments are in progress.
- Work surfaces shall be decontaminated daily, and immediately following spills of organisms containing recombinant DNA molecules.
- All laboratory wastes shall be steam sterilized (autoclaved) before disposal. Other contaminated materials such as glassware, animal cages, laboratory equipment, and radioactive wastes shall be decontaminated by a means demonstrated to be effective before washing, reuse, or disposal.
- Mechanical pipetting devices shall be used; pipetting by mouth is prohibited.
- Eating, drinking, smoking, and storage of food are not permitted in the laboratory area in which recombinant DNA materials are handled.
- Persons shall wash their hands after handling organisms containing recombinant DNA molecules and when they leave the laboratory.
- Care shall be exercised to minimize the creation of aerosols. For example, manipulations such as inserting a hot inoculating loop or needle into a culture, flaming an inoculation loop or needle so that it splatters, and forceful ejection of fluids from pipettes or syringes shall be avoided.
- Contaminated materials that are to be steam sterilized (autoclaved) or decontaminated at a site away from the laboratory shall be placed in a durable leak-proof container, which is closed before removal from the laboratory.
- Only persons who have been advised of the nature of the research being conducted shall enter the laboratory.
- The universal biohazard sign shall be posted on all laboratory access doors when experiments requiring P2 containment are in progress. Freezers and refrigerators or other units used to store organisms containing recombinant DNA molecules shall also be posted with the universal biohazard sign.
- An insect and rodent control program shall be instituted.
- The use of laboratory gowns, coats, or uniforms is required. Laboratory clothing shall not be worn to the lunchroom or outside of the building in which the laboratory is located.
- Animals not related to the experiment shall not be permitted in the laboratory.
- Use of the hypodermic needle and syringe shall be avoided when alternative methods are available.
- The laboratory shall be kept neat and clean.
- Experiments of lesser biohazard potential can be carried out concurrently in carefully demarcated areas of the same laboratory.