INSTRUCTIONS FOR THE IBC APPLICATION FORM:

 1. The IBC Application Form  must be completed and submitted to the IBC for review prior to the initiation of all NMSU activities that involve the use of Biohazardous Agents or Recombinant DNA.

Form is to be filled out completely and submitted via campus mail to: IBC, c/o EHS/MSC 3578 or submitted electronically to John Balog <jbalog@nmsu.edu> 

Exceptions are listed below

1. Research applications involving Risk Group (RG) 1 and/or Biosafety Level (BSL) 1 materials that do not involve recombinant DNA do not require review by the IBC.

2. Research using any RG 4 agents or any materials that require BSL 4 containment will not be considered by the IBC for work at any NMSU location or facility (dictated by the lack of qualifying facilities at NMSU).

3. The routine use of most toxins and plant pathogens will not require IBC review and approval. However, the possession, use, or transfer of any toxins or plant pathogens which are listed by the CDC as a Select Agents (severe threat to public health), or are on the USDA-APHIS Agent and Toxin List  (severe threat to animal health/ products or plant health/products), will require IBC review and approval prior to initiation of the project.

2. The form must be completed in its entirety, with all relevant worksheets and intra- and extra- Institutional & Regulatory Approvals attached. See the CHECK LIST for Completion of the IBC Registration Form below. 

3. Approval for biosafety activities is granted for three years after the initial review by the IBC. The Biosafety Officer will conduct annual inspections (Administrative Review) of facilities of approved projects

4. The PI  must submit an Activity Modification Report if and when the project changes significantly in terms of experimental activities, facilities, or for any personnel change, during the approval period.

5. If the PI on a project changes, a new application form must be submitted to the IBC.

6. If any NMSU personnel associated with this activity physically participate in an official capacity at a non-NMSU facility, the IBC approval documentation from the non-NMSU facility must be included with the NMSU-IBC Application/Registration Form.

 CHECK LIST

for the IBC Registration Form

(this form is for PI use and does not need to be submitted to the IBC)

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DEFINITIONS:

Biohazardous Agents

• Any microorganism (including but not limited to bacteria, viruses, fungi, rickettsiae, or protozoa), or infectious substance, or naturally occurring, bioengineered, or synthesized component of any such microorganism or infectious substance that is capable of causing: 1. death, disease or other biological malfunction in a human, an animal, a plant or another living organism; 2. deterioration of food, water, equipment, supplies, or materials of any kind; or 3. a deleterious alteration of the environment.

• Any toxic material or product of plants, animals, microorganisms (including but not limited to bacteria, viruses, fungi, rickettsiae, or protozoa), or infectious substances, or a recombinant or synthesized molecule (whatever the origin and method of production), which includes any poisonous substance or biological product that: 1.  may be engineered as a result of biotechnology; 2.  produced by a living organism; or 3. is an isomer or biological product, homologue, or derivative of such a substance.
    
• Infectious or pathogenic biological agent defined by: 1.  CDC as biosafety level (BSL) 2-4 (BMBL 4th Edition), or 2.  NIH as risk group (RG) 2-4 agent (NIH Guidelines April 2002)  (also see Additional Definitions on page 5 of this Charter document). 
   
• Regulated biological agent or toxin as identified by 1. HHS 42 Code of Federal Regulations (CFR) Part 73   (Select Agents Program); 2. USDA-APHIS lists of Biological Agents and Toxins that pose a severe threat to “animal health or animal products” (9 CFR Part 121); or to “plants health or plant products”  (7 CFR Part 331) (Federal Register 9CFR 121 7CFR 331).  Also see the NACUA Agent and Toxin List as compiled by the National Association of College and University Attorneys (NACUA), as a summary of all of the lists.

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Recombinant DNA 

Nucleic acid molecules constructed outside of living cells by joining natural or synthetic DNA segments to DNA molecules that can be replicated in a living cell.

DNA molecules that result from the replication of those molecules described above.

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Risk Groups

Agents are classified into four Risk Groups (RGs) according to their relative pathogenicity for healthy adult humans by the following criteria:  (1) Risk Group 1 (RG1) agents are not associated with disease in healthy adult humans,  (2) Risk Group 2 (RG2) agents are associated with human disease which is rarely serious and for which preventive or therapeutic interventions are often available,  (3) Risk Group 3 (RG3) agents are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available, (4) Risk Group 4 (RG4) agents are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available. NIH recombinant DNA Guidelines Section II-I-A, and Appendix B.  (NIH Guidelines April 2002)  

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Biosafety Level

A description of the degree of physical containment to be employed for managing infectious materials in the laboratory environment where they are being handled or maintained. The purpose of containment is to reduce or eliminate exposure of laboratory workers, other persons, and the outside environment to potentially hazardous agents. The levels are designated in ascending order, by degree of protection provided to personnel, the environment, and the community.  The essential elements of the four biosafety levels defined by the CDC for activities involving infectious microorganisms and laboratory animals are summarized in Sections III and IV of the Biosafety in Microbiological and Biomedical Laboratories  (BMBL) 4th Edition. (BMBL 4th Edition)

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